In this chapter, the following terms have the meanings indicated. Terms Defined. “Advanced practice nurse” means a: Certified nurse practitioner; Certified nurse midwife; or Certified registered nurse anesthetist. “Board” means the Maryland State Board of Nursing. “Certified nurse midwife (CNM)” means a registered nurse who is: Certified by the Board to practice nurse midwifery under COMAR 10.27.05; Certified by the American College of Nurse-Midwives; or Certified by the American Midwifery Certification Board. “Certified nurse practitioner” means: A registered nurse who, by reason of certification under COMAR 10.27.07, may practice in Maryland as a nurse practitioner under the terms of that chapter; or If out-of-State, a registered nurse who qualifies as a nurse practitioner in the state in which services are provided. “Certified registered nurse anesthetist (CRNA)” means a registered nurse who is certified to practice nurse anesthesia by the Board under COMAR 10.27.06. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits. “Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02. “Program” means the Maryland Medical Assistance Program. “Provider” means an advanced practice nurse who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. The provider shall: Meet all license requirements as set forth in COMAR 10.09.36.02; and Be licensed and hold all certifications as required by the Board. If practicing out-of-State, the provider shall meet the regulatory requirements of the state in which the services are provided. To participate in the Program, a provider shall: Meet all conditions for participation as set forth in COMAR 10.09.36.03; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. Subject to §B of this regulation, the Program covers medically necessary services rendered to participants as follows: For nurse practitioners: Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.07; or If out-of-State, nurse practitioner services authorized in the state in which the services are provided; For nurse midwives: Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.05; or If out-of-State, nurse midwife services authorized in the state in which the services are provided; For certified registered nurse anesthetists: Medically necessary services within the provider’s scope of practice and in collaboration with an authorized provider as described in COMAR 10.27.06; or If out-of-State, certified registered nurse anesthetist services authorized in the state in which the services are provided; Laboratory services when the advanced practice nurse is not required to register their office as a medical laboratory pursuant to Health-General Article, Title 17, Subtitle 2, Annotated Code of Maryland; and Drugs and supplies within the advanced practice nurse’s scope of practice. The services in §A of this regulation shall be: Medically necessary; and Described in the participant’s medical record in sufficient detail to support the invoice submitted for those services. Under this chapter, the Program does not cover the following: Services not medically necessary; Services prohibited by the Maryland Nurse Practice Act or by the Board; Advanced practice nursing services included as part of the cost of: An inpatient facility; A hospital outpatient department; or A freestanding clinic; Visits by or to the provider solely for the purpose of the following: Prescription, drug, or food supplement pick-up; Recording of an electrocardiogram; Ascertaining the patient’s weight; Interpretation of laboratory tests or panels; or Prescribing or administering medication; Drugs and supplies which are acquired by the provider at no cost; Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take oral medications are documented in the patient's medical record; Services paid under the free-standing dialysis program as described in COMAR 10.09.22; Immunizations required for travel outside the continental United States; Prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control; Acupuncture; Hypnosis; Travel expenses; Investigational or experimental drugs and procedures; Services denied by Medicare as not medically justified; Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service; Laboratory or X-ray services performed by another facility, which shall be billed to the Program directly by the facility; and For certified nurse midwives, a separate visit charge on date of delivery. The provider shall submit the request for payment in the format designated by the Department. The Department reserves the right to return to the provider, before payment, all requests for payment not properly completed. The provider shall charge the Program the provider's: Customary charge to the general public for similar services; and Acquisition cost for injectable drugs or dispensed medical supplies. The provider shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by the Program; or The Program rates as described in COMAR 10.09.02.07. If a service is free to individuals not covered by the Program: The provider: May charge the Program; and Shall be reimbursed in accordance with §D of this regulation; and The provider's reimbursement is not limited to the provider's customary charge. Payments on Medicare claims are authorized, if: Services are covered by the Program; The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make supplemental payments on Medicare claims subject to the following provisions: Deductible insurance shall be paid in full; and Coinsurance shall be paid at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Program rate. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; or Professional services rendered by mail. The Program may not make direct payment to participants. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The Program shall reimburse for all medical laboratory services according to the fees established under COMAR 10.09.09. An advanced practice nurse who is employed by or under contract to any physician, clinic, or hospital may not bill for any service for which reimbursement is sought by the physician, clinic, or hospital. The Program may not reimburse nurse midwives for prenatal or postpartum care once the patient has been referred to a physician for completion of prenatal or postpartum care. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Note: For the current Medical Assistance Eligibility regulations, see COMAR 10.09.24 and 10.09.25. Effective date: May 1, 1975 (2:7 Md. R. 525) Amended effective January 7, 1976 (3:1 Md. R. 41) and March 17, 1976 (3:6 Md. R. 358); amended as an emergency provision effective November 23, 1976 (3:26 Md. R. 1535) Chapter revised effective April 27, 1977 (4:9 Md. R. 714) Regulation .01CCC adopted effective November 23, 1977 (4:24 Md. R. 1805) Regulation .02A amended as an emergency provision effective July 1, 1977 (4:13 Md. R. 1026); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545) Regulation .02A amended effective April 4, 1980 (7:7 Md. R. 707) Regulation .02B amended effective November 23, 1977 (4:24 Md. R. 1805) Regulations .04B, C and .05B amended effective October 3, 1980 (7:20 Md. R. 1878) Regulation .05C amended as an emergency provision effective July 1, 1977 (4:12 Md. R. 945); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545); amended as an emergency provision effective November 10, 1977 (4:25 Md. R. 1910); adopted permanently effective March 10, 1978 (5:5 Md. R. 325) Regulation .05C repealed effective October 3, 1980 (7:20 Md. R. 1878) Regulation .06B amended as an emergency provision effective January 1, 1978 (5:1 Md. R. 14); adopted permanently effective May 5, 1978 (5:9 Md. R. 683) Regulation .06B amended effective July 1, 1978 (5:13 Md. R. 1051) Regulation .06B amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1202); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) Regulation .06B amended effective July 1, 1980 (7:13 Md. R. 1278) Regulation .06B amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1346); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) Regulation .08A amended effective December 26, 1980 (7:26 Md. R. 2422) Regulations .09 and .10B amended as an emergency provision effective August 15, 1977 (4:16 Md. R. 1205); adopted permanently effective November 23, 1977 (4:24 Md. R. 1805) Regulations .10B and .11B amended effective December 28, 1979 (6:26 Md. R. 2073) Regulation .10D repealed effective August 8, 1980 (7:16 Md. R. 1594) Regulation .10D adopted as an emergency provision effective November 1, 1982 (8:21 Md. R. 1703); adopted permanently effective March 1, 1982 (9:4 Md. R. 331) Regulation .11D amended as an emergency provision effective July 1, 1977 (4:12 Md. R. 945); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545); amended as an emergency provision effective August 15, 1977 (4:16 Md. R. 1205); adopted permanently effective November 23, 1977 (4:24 Md. R. 1805); amended effective December 1, 1978 (5:24 Md. R. 1797); amended effective December 28, 1979 (6:26 Md. R. 2073) Regulation .12A amended as an emergency provision effective January 1, 1983 (10:3 Md. R. 207); emergency status extended at 10:8 Md. R. 720; emergency status expired April 30, 1983 Regulation .16C amended effective October 3, 1980 (7:20 Md. R. 1878) Regulation .17 adopted effective February 14, 1983 (10:3 Md. R. 209) Regulation .18A amended effective January 31, 1983 (10:2 Md. R. 109) Regulation .18B adopted as an emergency provision effective July 26, 1982 (9:17 Md. R. 1696); emergency status extended at 9:23 Md. R. 2254; adopted permanently effective November 30, 1982 (9:23 Md. R. 2259) Chapter repealed effective May 1, 1983 (10:6 Md. R. 558) Effective date: May 14, 1990 (17:9 Md. R. 1090) Regulation .01 amended effective May 31, 1999 (26:11 Md. R. 854) Regulation .02C amended effective May 31, 1999 (26:11 Md. R. 854) Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .05G, Q amended effective May 31, 1999 (26:11 Md. R. 854) Regulation .06 amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .06 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .06C,D,G amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .06E amended effective May 31, 1999 (26:11 Md. R. 854) Regulation .06F amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .06K adopted effective May 31, 1999 (26:11 Md. R. 854) Regulations .01—.10 under Nurse Practitioner Services repealed and new Regulations .01—.08 under Advanced Practice Nurse Services adopted effective August 28, 2017 (44:17 Md. R. 834) Regulation .03 amended effective August 21, 2023 (50:16 Md. R. 725) Regulation .06H, I amended effective August 21, 2023 (50:16 Md. R. 725) The following terms have the meanings indicated. Terms Defined. “Attending physician” means a physician, other than a house officer, resident, intern, or emergency room physician, directly responsible for the patient's care. “Board” means the Board of Physician quality Assurance. “Consultant-specialist” means a licensed physician who meets one of the following criteria: Has been declared board certified by a member board of the American Board of Medical Specialties and currently retains that status; Can demonstrate satisfactory completion of a residency program accredited by the Liaison Committee for Graduate Medical Education, or the appropriate Residency Review Committee of the American Medical Association; Has been declared board certified by a specialty board approved by the Advisory Board of Osteopathic Specialists and the Board of Trustees of the American Osteopathic Association; Has been declared board eligible by a specialty board approved by the Advisory Board of Osteopathic Specialists; Can demonstrate, if a residency program was completed in a foreign country, that qualifications and training are acceptable for admission into the examination system of the appropriate American Specialty Board. “Consultation” means written opinion or advice rendered by a consultant-specialist whose opinion or advice is requested by the patient's attending physician for the further evaluation or management of the patient by the attending physician. If the consultant-specialist assumes responsibility for the continuing care of the patient, a subsequent service rendered by the consultant-specialist is not a consultation. The consultation shall be provided in the specialty in which the consultant-specialist is registered with the Program. “Cosmetic surgery” means surgery which can be expected to improve a patient's physical appearance, but does not restore or materially improve a body function. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Direct supervision” means that a physician-employer is physically present in the same area of a facility as a nonphysician providing the service or services. A physician may supervise only two nonphysician practitioners at any given time. “Free-standing clinics” means those clinics not associated with a hospital which are under the direction of a physician or dentist. “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Medicare-Certified Facility” means one which is certified for Medicare by the regional office of the Health Care Financing Administration to furnish dialysis services directly to chronic kidney disease patients. “Mental health services” means those services described in COMAR 10.09.70.10C rendered to treat an individual for a diagnosis set forth in COMAR 10.09.70.10A. “Multispecialty setting” means that type of medical practice which exists in a teaching hospital or in a group practice which is composed of physicians with different specialties. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Patient” means a recipient awaiting or undergoing health care or treatment. “Physician” means an individual legally licensed to practice medicine by the Board or in the state in which the physician's practice is located. “Preauthorization” means an approval required from the Department or its designee before services can be rendered. “Preoperative day” means an inpatient day in a general hospital before surgery for a patient admitted for a surgical procedure, or a day before surgery for a patient admitted for a nonsurgical service as an inpatient in a general hospital once the need for surgery has been established and the patient's condition is satisfactory for surgery. “Prescriber” means a physician, dentist, podiatrist, or other professional authorized to prescribe legend drugs and authorized by the Department to participate in the Program. “Prescription” means a written order for medication, or medical supplies or equipment, signed by the prescriber. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual, association, partnership, or incorporated or unincorporated group of physicians duly licensed or certified to provide services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. “Referral” means a transfer of the patient from one physician to another for diagnosis and treatment of the condition for which the referral was made. The physician to whom the referral is made, whether a generalist or specialist, will be considered as the primary care physician and not as a consultant. “United States” means the 50 states, the District of Columbia, and the U.S. territories. “Utilization control agent (UCA)” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to professional standards. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided. The provider shall ensure that all X-ray or other radiological equipment is inspected and meets the standards established by COMAR 10.14.02 or other applicable standards established by the state in which the service is provided. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. General requirements for participation in the Program are that a provider shall: Meet all the conditions for participation as set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. Specific requirements for participation in the Program as a physicians’ services provider require that the provider: Shall submit documentation of consultant-specialist status if applying for that status; May not place a restriction on a participant’s right to select providers of his or her choice; May not knowingly employ or contract with a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance participants unless prior written approval has been received from the Department; Shall agree to personally sign all requests for laboratory or other diagnostic services, or to require that copies of personally signed order sheets be supplied to participating providers of these services; Shall agree, when requesting laboratory or other diagnostic services, to supply his or her individual practitioner identification (rendering) number to those participating providers; Shall agree to identify by the individual physician practitioner's identification number each physician assistant who is authorized by the physician to request laboratory services; and Shall comply with the requirements for the delivery of mental health services in accordance with COMAR 10.09.59 and 10.67.08. The Program covers the following medically necessary services rendered to participants: Physicians’ services rendered in the physician’s office, the participant’s home, a hospital, a skilled or intermediate care nursing facility, a freestanding clinic, or elsewhere when these services are: Performed by the physician or one of the following: Another licensed physician either in the physician's employ or one who renders services through a reciprocal agreement as a substitute physician, A certified registered physician's assistant, licensed registered nurse, certified psychologist, or a certified social worker, provided that the individual performing the service is in the physician's employ and is under the physician's direct supervision and performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of physicians' services, A certified nurse midwife who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.05; and A certified nurse practitioner who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.07. Clearly related to the participant’s individual medical needs as diagnostic, curative, palliative, or rehabilitative services; Adequately described in the participant’s medical record; Consultations; Diagnostic procedures to include: Procedures related to the patient's medical needs; Laboratory services performed by a physician or personnel under the physician's direct supervision, when the physician is not required to register his office as a medical laboratory pursuant to Health-General Article, Title 17, Subtitle 2, Annotated Code of Maryland; Drugs dispensed by the physician within the limitations of COMAR 10.09.03; Injectable drugs administered by the provider within the limitations of COMAR 10.09.03; Medical equipment and supplies dispensed by the physician within the limitations of COMAR 10.09.12; Abortions performed in accordance with the Health-General Article, Title 20, Subtitles 1 and 2, Annotated Code of Maryland; Sterilizations when performed according to criteria contained in 42 Code of Federal Regulations §§441.250—441.258 and when the appropriate forms, as established by guideline, are properly completed and attached to the claim; Vaccine administrations when the vaccines: Meet the following conditions for coverage under the Vaccines for Children Program: Covered under the Vaccines for Children program; Administered to participants eligible for the Vaccines for Children program; and Administered by providers eligible to be reimbursed for vaccine administration under the Vaccines for Children program; or Are supplied to providers by the federal government at no charge, including but not limited to the administration of COVID-19 vaccinations. Services which are not covered are: Physician services not medically justified; Nonemergency dialysis services related to chronic kidney disorders unless they are provided in a Medicare-certified facility; Physician inpatient hospital services rendered during any period that is in excess of the length of stay authorized by the Utilization control agent (UCA); Physician services denied by Medicare as not medically necessary; Services which are investigational or experimental; Autopsies; Physician services included as part of the cost of an inpatient facility, hospital outpatient department, or free-standing clinics; Payment to physicians for specimen collections, except by venipuncture, and capillary or arterial puncture; Injectable medications, and visits solely for the administration of injectable medications, unless medical necessity and the patient’s inability to take appropriate oral medications are documented in the patient’s medical records; Vaccine administration unless covered under Regulation .04 of this chapter; Visits solely to accomplish one or more of the following: Prescription, drug or food supplement pick-up, collection of specimens for laboratory procedures, Recording of an electrocardiogram, Ascertaining the patient's weight; Interpretation of laboratory tests or panels; Medical Assistance prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control; Drugs and supplies dispensed by the physician which are acquired by the physician at no cost; Disposable medical supplies; Services prohibited by the Board of Physician Quality Assurance; Services which are provided outside the United States; Services which do not involve direct patient contact; Sterilization reversal procedures; Prescriptions for drugs written on prescription pads that do not prevent copying, modification, or counterfeiting; Physician-administered drugs from manufacturers that do not participate in the Federal Drug Rebate Program; and Any covered service that requires a preauthorization, including physician-administered drugs and injectable medications, that is rendered without an approved preauthorization from the Program. Preoperative evaluations for anesthesia are included in the fee for administration of anesthesia and the provider may not bill them as consultations. Referrals from one physician to another for treatment of specific patient problems may not be billed as consultations. The operating surgeon may not bill for the administration of anesthesia or for an assistant surgeon who is not in the operating surgeon's employ. Payment for consultations provided in a multispecialty setting is limited by criteria established by the Department. The Department will not pay a provider for those laboratory or x-ray services performed by another facility. The Department will pay directly the facility performing those services. The Program does not cover services rendered to an inpatient before one preoperative inpatient day, unless preauthorized by the Program. The provider may not bill the Program for services rendered under the supervising physician's provider number by an employed nonphysician extender, such as: A physical therapist; An occupational therapist; A speech language pathologist; An audiologist; or A nutritionist. Services not rendered in-person shall comply with the telehealth requirements established in COMAR 10.09.49 and any other subregulatory guidance issued by the Department. The following procedures or services require preauthorization: Cosmetic surgery; Contact lens evaluation and fitting; Lipectomy and panniculectomy; Transplantations of vital organs; Services rendered to an inpatient before one preoperative day; Surgical procedures for the treatment of obesity; Surgical procedures for the purpose of gender reassignment; and Elective services from a noncontiguous state. Services which have been determined by Medicare to be ineffective, unsafe, or without proven clinical value are generally presumed to be not medically necessary, but will be preauthorized if the provider can satisfactorily document medical necessity in a particular case. These services are found in the Medicare Carriers Manual, Part 3, Claims Process, Chapter II, Coverage Issues Appendix. Physicians dispensing or prescribing eyeglasses shall comply with the requirements of COMAR 10.09.14. The Department will preauthorize services when the provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. Non-Medicare claims require preauthorization according to §§A—D of this regulation. Physicians rendering mental health services shall comply with the preauthorization requirements of COMAR 10.09.70.07. The provider shall submit the request for payment on the form designated by the Department. The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department. Except as provided in §F of this regulation, the Provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §D of this regulation; and The provider's reimbursement is not limited to the provider's customary charge. The Maryland Medical Assistance Program's procedures for payment are contained in the following documents, the provisions of which are incorporated by reference: The Professional Services Provider Manual and Fee Schedule (Effective January 2024); and The Medical Laboratories Fee Schedule pursuant to COMAR 10.09.09.07D. Except as provided in §F of this regulation, the Department will pay for covered services at the lesser of: Physician's customary charge or acquisition cost unless the service is free to individuals not covered by Medicaid; or The Department's fees in accordance with §D of this regulation. The Program shall reimburse providers up to the acquisition cost for diagnostic and therapeutic radiopharmaceuticals, contraceptive products and devices, and injectable medications when the provider submits documentation indicating that the acquisition cost of the product, device, or drug is greater than the reimbursement allowed in §E of this regulation. The Program reserves the right to negotiate and establish a different fee for a physician or a group of physicians under contract to a hospital to provide services when a portion of the cost of the contract is paid as the hospital's cost, provided this fee does not exceed limitations set forth in §E of this regulation. Supplemental payments on Medicare claims are made subject to the following provisions: Deductible insurance will be paid in full; Beginning with August 1, 2010 dates of service, and subject to the limitations of the State budget, coinsurance, shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare are payable according to §E of this regulation. Payments on Medicare claims are authorized if the: Provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; Services are covered by the Program; Initial billing is made directly to Medicare according to Medicare guidelines. The provider may not bill the Department or the participant for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; or Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. The Program will make no direct payment to participants. The Program will reimburse the provider for dispensed drugs at rates established in COMAR 10.09.03. The provider shall bill the Program in accordance with COMAR 10.09.03 using the Pharmacy Invoice. The Program will reimburse the provider for dispensed medical supplies at actual cost or at rates established by COMAR 10.09.12, whichever is less. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Providers shall bill the Program in the following manner: A physician whose laboratory is not required to be registered pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under these regulations; A physician whose laboratory is registered as a medical laboratory pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under COMAR 10.09.09. Reimbursement. The Program shall reimburse providers for all laboratory and other diagnostic services performed by a physician, or by authorized personnel under that physician's supervision, for that physician's patients. Reimbursement shall be according to all applicable provisions of COMAR 10.10.06 and fees established according to §D of this regulation. Maximum reimbursement may not exceed the Medicare laboratory fee established by the Maryland Medicare carrier recognized by the Program. The Program shall reimburse providers for mental health services performed by a physician according to the fees established under COMAR 10.21.25 and the requirements of this chapter. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. If the Department determines that a provider, physician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a physician from participation in Medicare, the Department will take similar action. The Department may consult with the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The Department will give the findings and recommendations of this group consideration. The Department will give the provider reasonable notice of its intention to impose sanctions. In the written notice the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants, before rendering additional services, that the provider no longer honors Medical Assistance cards. If the Department determines that a provider participating in the Program as a case manager has violated any provision of the agreement executed under the terms of Regulation .03B of this chapter, the Program may suspend or disqualify the provider from participating as a case manager without otherwise restricting the provider’s participation as a physician. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: July 1, 1967 Amended effective September 1, 1967; October 1, 1967; January 1, 1969; July 1, 1969; December 1, 1969; July 1, 1970; July 1, 1971; January 1, 1976 (2:29 Md. R. 1739) Regulation .22 adopted effective October 13, 1976 (3:21 Md. R. 1206); recodified as Regulation .11 on December 8, 1976 (3:25 Md. R. 1467) Existing regulations repealed and new Regulations .01—.10 adopted effective December 8, 1976 (3:25 Md. R. 1467) Regulation .02C amended effective December 15, 1978 (5:25 Md. R. 1854) Regulation .04D amended effective December 15, 1978 (5:25 Md. R. 1854) Regulation .04K, L adopted effective January 13, 1978 (5:1 Md. R. 18) Regulation .04K amended effective July 1, 1978 (5:12 Md. R. 967) Regulation .04L repealed effective July 1, 1978 (5:12 Md. R. 967) Regulation .05F adopted effective December 15, 1978 (5:25 Md. R. 1854) Regulation .07 amended effective December 15, 1978 (5:25 Md. R. 1854) Regulation .07G amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) Regulation .07I amended effective April 6, 1979 (6:7 Md. R. 676); repealed effective July 1, 1979 (6:13 Md. R. 1126) Regulation .07N amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .11 repealed effective June 29, 1979 (6:13 Md. R. 1126) Regulations .01—.08 amended effective July 1, 1979 (6:13 Md. R. 1126) Regulation .01 amended effective December 12, 1988 (15:25 Md. R. 2902) Regulation .01A-1, A-2, A-3, N-2 adopted effective October 1, 1985 (12:19 Md. R. 1848) Regulation .01B amended effective October 15, 1990 (17:20 Md. R. 2426); December 29, 1997 (24:26 Md. R. 1757); March 6, 2000 (27:4 Md. R. 453) Regulation .01B amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443) Regulation .01B amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) Regulations .01B, .03B, .06, and .07Q amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1286) (Emergency provisions are temporary and not printed in COMAR) Regulation .01B amended effective July 10, 2023 (50:13 Md. R. 512) Regulation .01J-1 adopted effective August 12, 1985 (12:16 Md. R. 1606) Regulation .01N-1 adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721) Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03 amended effective July 10, 2023 (50:13 Md. R. 512) Regulation .03A amended effective October 1, 1985 (12:19 Md. R. 1848) Regulation .03B adopted effective December 29, 1997 (24:26 Md. R. 1757) Regulation .03B amended effective March 6, 2000 (27:4 Md. R. 453); August 28, 2017 (44:17 Md. R. 834) Regulation .03G amended effective October 1, 1985 (12:19 Md. R. 1848); December 12, 1988 (15:25 Md. R. 2902) Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03I—K amended effective December 12, 1988 (15:25 Md. R. 2902) Regulation .03J adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .03K adopted effective October 1, 1985 (12:19 Md. R. 1848) Regulation .03 amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) Regulation .03O adopted effective October 15, 1990 (17:20 Md. R. 2426) Regulation .04 amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183) Regulation .04 amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221) Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453) Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); July 10, 2023 (50:13 Md. R. 512) Regulation .04A amended effective August 17, 1981 (8:16 Md. R. 1365); December 12, 1988 (15:25 Md. R. 2902) Regulation .04A amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) Regulation .04A amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443) Regulation .04A amended effective February 3, 2014 (41:2 Md. R. 91); August 28, 2017 (44:17 Md. R. 834) Regulation .04C amended effective December 12, 1988 (15:25 Md. R. 2902) Regulation .04G amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1202); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) (adopted as Regulation .04K; recodified as Regulation .04G at 6:13 Md. R. 1126) Regulation .04G amended as an emergency provision effective July 28, 1980 (7:16 Md. R. 1588); adopted permanently effective November 28, 1980 (7:24 Md. R. 2257) Regulation .04G amended effective December 12, 1988 (15:25 Md. R. 2902) Regulation .04J adopted effective October 1, 1985 (12:19 Md. R. 1848) Regulation .05A amended effective August 12, 1985 (12:16 Md. R. 1606); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2902); December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); February 5, 2001 (28:2 Md. R. 99) Regulation .05A amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) Regulation .05A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) Regulation .05A amended effective June 23, 2014 (41:12 Md. R. 667); December 10, 2015 (42:24 Md. R. 1505); July 10, 2023 (50:13 Md. R. 512); June 24, 2024 (51:12 Md. R. 618) Regulation .05D amended effective December 12, 1988 (15:25 Md. R. 2902) Regulations .05G and .06A adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721) Regulation .05H adopted effective October 15, 1990 (17:20 Md. R. 2426) Regulation .05H repealed effective March 6, 2000 (27:4 Md. R. 453) Regulation .05H adopted as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); adopted permanently effective September 11, 2006 (33:18 Md. R. 1505) Regulation .05I adopted effective July 10, 2023 (50:13 Md. R. 512) Regulation .06A amended effective June 20, 1983 (10:12 Md. R. 1072); February 9, 1987 (14:3 Md. R. 273); December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757) Regulation .06A amended effective October 10, 2016 (43:20 Md. R. 1109) Regulation .06A, D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) Regulation .06E adopted effective April 4, 1980 (7:7 Md. R. 708) Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834) Regulation .06F adopted effective December 29, 1997 (24:26 Md. R. 1757) Regulation .07 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .07 amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) Regulation .07 amended effective March 6, 2000 (27:4 Md. R. 453) Regulation .07 amended as an emergency provision effective December 18, 2003 (31:2 Md. R. 81); amended permanently effective April 26, 2004 (31:8 Md. R. 646) Regulation .07 amended effective June 14, 2021 (48:12 Md. R. 470); July 10, 2023 (50:13 Md. R. 512) Regulation .07C amended effective December 16, 1996 (23:25 Md. R. 1785) Regulation .07C, E, I amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); amended permanently effective November 1, 1982 (9:21 Md. R. 2106) Regulation .07D amended effective December 6, 1982 (9:24 Md. R. 2390); May 1, 1983 (10:8 Md. R. 725); November 21, 1983 (10:23 Md. R. 2063) Regulation .07D amended as an emergency provision effective January 27, 1984 (11:4 Md. R. 312); emergency status expired May 26, 1984 Regulation .07D amended effective May 27, 1984 (11:10 Md. R. 863) Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811) Regulation .07D amended effective March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542) Regulation .07D amended as an emergency provision effective March 1, 1986 (13:6 Md. R. 668); emergency status expired June 30, 1986 Regulation .07D amended effective June 2, 1986 (13:11 Md. R. 1273); Regulation .07D amended as an emergency provision effective July 1, 1986 (13:12 Md. R. 1371); amended permanently effective December 1, 1986 (13:18 Md. R. 2020) Regulation .07D amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); amended permanently effective October 6, 1986 (13:20 Md. R. 2210) Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987 Regulation .07D amended effective December 1, 1986 (13:22 Md. R. 2398) Regulation .07D repealed and new Regulation .07D adopted effective February 9, 1987 (14:3 Md. R. 273); amended effective October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903); January 1, 1989 (15:26 Md. R. 2983); July 1, 1989 (16:12 Md. R. 1335) Regulation .07D amended as an emergency provision effective September 8, 1989 (16:20 Md. R. 2178); adopted permanently effective January 1, 1990 (16:25 Md. R. 2710) Regulation .07D amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) Regulation .07D amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .07D amended effective December 9, 1991 (18:24 Md. R. 2643) Regulation .07D amended as an emergency provision effective October 26, 1993 (20:23 Md. R. 1799); emergency status extended at 20:24 Md. R. 1863 and 21:11 Md. R. 949; emergency status expired July 4, 1994 Regulation .07D amended effective July 4, 1994 (21:13 Md. R. 1156) Regulation .07D amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183); emergency status expired April 30, 1995 Regulation .07D amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221) Regulation .07D amended effective December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757) Regulation .07D amended effective February 5, 2001 (28:2 Md. R. 99) Regulation .07D amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443) Regulation .07D amended as an emergency provision effective July 1, 2005 (32:17 Md. R. 1437); amended permanently effective October 24, 2005 (32:21 Md. R. 1707) Regulation .07D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) Regulation .07D amended as an emergency provision effective July 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 27, 2007 (34:17 Md. R. 1507) Regulation .07D amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) Regulation .07D amended effective November 16, 2009 (36:23 Md. R. 1817); November 14, 2011 (38:23 Md. R. 1421); October 28, 2013 (40:21 Md. R. 1775); December 22, 2014 (41:25 Md. R. 1478); February 27, 2017 (44:4 Md. R. 252); August 28, 2017 (44:17 Md. R. 834); August 27, 2018 (45:17 Md. R. 803); December 31, 2018 (45:26 Md. R. 1241); October 7, 2019 (46:20 Md. R. 844); June 24, 2024 (51:12 Md. R. 618); June 9, 2025 (52:11 Md. R. 532) Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625) Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .07J, M, N amended effective December 12, 1988 (15:25 Md. R. 2902) Regulation .07O amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07O amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07Q amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) Regulation .07Q amended effective December 29, 1997 (24:26 Md. R. 1757) Regulation .07R adopted effective October 1, 1985 (12:19 Md. R. 1848) Regulation .07S adopted effective December 16, 1996 (23:25 Md. R. 1785) Regulation .08 amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .08A amended effective December 12, 1988 (15:25 Md. R. 2902); July 10, 2023 (50:13 Md. R. 512) Regulation .09A, B amended effective March 1, 1982 (9:4 Md. R. 331) Regulation .09E amended effective December 12, 1988 (15:25 Md. R. 2902): July 10, 2023 (50:13 Md. R. 512) Regulation .09F adopted effective October 1, 1985 (12:19 Md. R. 1848) Regulation .09F amended effective July 10, 2023 (50:13 Md. R. 512) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Regulation .11 amended effective July 10, 2023 (50:13 Md. R. 512) In this chapter, the following terms have the meanings indicated. Terms Defined. "340B price" means the price at which drugs are purchased as authorized under Section 340B of the Public Health Service Act. “Actual acquisition cost (AAC)” means the amount paid by a provider for a drug or product less all discounts, rebates, refunds, chargebacks, incentives, and price reductions. “Allowable cost” means the maximum amount which the Program will reimburse for the drug or product portion of the prescription. “Approved unit dose system” means a drug distribution system approved by the Department that is used to prepare and distribute an individual, properly labeled dose of medication for a patient in a nursing facility. “Brand name drug” means: A single source drug; An innovator multiple source drug; or A drug submitted for payment as brand medically necessary. “Compounded prescription for intravenous therapy” means a prescription that: Combines two or more ingredients; Is prepared by using aseptic technique under a laminar flow clean bench; and Is administered to a patient intravenously. “Controlled substance” means a drug as defined under 21 U.S.C. §802. “Convenience package” means a smaller or specially packaged quantity of a product prepared for the convenience of a patient or provider as opposed to the regular packaging. “Copayment” means the amount a participant is liable to pay for prescriptions, when applicable, which is deducted from provider reimbursement. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX, Social Security Act, 42 U.S.C. §1396 et seq. “Diluent component” means a liquid used for reconstitution or dilution of an active ingredient in compounded prescription intravenous therapy. “Direct price” means, for drugs identified by the Program, the price charged by a pharmaceutical manufacturer to a dispensing pharmacy for a product supplied to the pharmacy without intermediate distribution charges, less any rebates, discounts, refunds, chargebacks, incentives, and price reductions. “Drugs” means legend drugs (those requiring a prescription under federal or State law) or over-the-counter (OTC) drugs (those not requiring a prescription under federal or State law). “Early and periodic screening, diagnosis, and treatment (EPSDT)” means a program of preventive health care services for Medical Assistance individuals younger than 21 years old. “EPSDT-related service” means diagnosis and treatment necessary to correct or manage health problems detected by a screening performed by a certified EPSDT provider. EPSDT-related services are rendered by a certified EPSDT provider or an appropriate Medical Assistance provider. “Family planning services” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health. “Federally qualified health center (FQHC)” means an entity as defined by Health-General Article, §24-1301, Annotated Code of Maryland, and §1905(l)(2)(B) of the Social Security Act. “Federal supply schedule (FSS)” means the drug pricing program under the collection of multiple award contracts used by federal agencies, U.S. territories, Indian tribes, and other specified entities to purchase supplies and services from outside vendors. “Federal upper limit (FUL)” means the upper limit of payment for multiple source drugs for which a specific maximum allowable cost has been established by the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services pursuant to 42 CFR §447.514. “Freestanding clinics” means those clinics, not associated with a hospital, which are under the direction of physicians as further defined in COMAR 10.09.08.01. “Generic drug” means a drug that is: Available to pharmacy providers from at least one manufacturer; Rated as therapeutically equivalent by the U.S. Food and Drug Administration; and Not a brand name drug. “Innovator multiple source drug” means a multiple source drug that was originally marketed under an original new drug application approved by the U.S. Food and Drug Administration. “Institutional pharmacy” means a pharmacy owned and operated by a hospital, nursing facility, or clinic. “Invoice” means: A form issued or approved by the Department for use by providers in submitting bills for payment; or A bill issued by a manufacturer or wholesaler to a provider which indicates proof of purchase and the: Actual acquisition cost paid by the provider; or The direct price charged to the provider by the manufacturer. “Maintenance medication” means medication in chronic therapeutic categories corresponding to the following American Hospital Formulary Service (AHFS) classification numbers: Cardiac drugs (24:04); Antilipemic agents (24:06); Hypotensive agents (24:08); Vasodilating agents (24:12); Sclerosing agents (24:16); Alpha-adrenergic blocking agents (24:20); Beta-adrenergic blocking agents (24:24); Calcium-channel blocking agents (24:28); Renin-angiotensin-aldosterone system inhibitors (24:32); Hydantoins (28:12:12); Oxazolidinediones (28:12:16); Succinimides (28:12:20); Anticonvulsants, miscellaneous (28:12:92); Replacement solutions (40:12) (potassium supplements only); Diuretics (40:28); Lipotropic agents (56:24); Contraceptives (68:12); Estrogens and antiestrogens (68:16); Antidiabetic agents (68:20); Antihypoglycemic agents (68:22); Parathyroid (68:24); Progestins (68:32); Thyroid and antithyroid agents (68:36); Vitamins (88:00); Sodium fluoride (92:00); and Iron preparations, oral (20.04.04) (oral products in which ferrous sulfate is the only active ingredient and chewable tablets of any ferrous salt if combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation). “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “National average drug acquisition cost (NADAC)” means the average price paid by retail community pharmacies to acquire a prescription or over-the-counter covered out-patient drug as calculated by the Centers for Medicare and Medicaid Services. “Nominal price” means a price that is less than 10 percent of the average manufacturer price (AMP) in the same quarter for which AMP is computed. “Nursing facility” means an institution as further defined in COMAR 10.09.10.01B(30), and classified as a long-term care facility. “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. “Pharmacist” means an individual licensed in good standing to practice pharmacy in the state where the service is provided. “Pharmacy” means an establishment or institution licensed in good standing that is required to obtain a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland, or a similar entity legally authorized to dispense legend drugs to the public in the state in which the establishment or institution is located. “Pharmacy and Therapeutics Committee” means a committee established by the Department to develop recommendations for pharmacy practices including but not limited to development of a preferred drug list according to Regulation .12 of this chapter. “Preauthorization” means an approval required from the Department or its designee before a drug is dispensed. “Preferred drug list” means a list of recommended drugs developed by the Department that is based on the recommendations of the Pharmacy and Therapeutics Committee. “Prescriber” means a physician, dentist, podiatrist, or other professional licensed in good standing to prescribe legend drugs in the state in which the service is provided. “Prescription” means an order by a prescriber, or a prescriber’s order transferred from one pharmacist to another, for Program covered pharmacy services in accordance with applicable federal and State laws conveyed in one of the following forms: An original order signed by the prescriber and written on tamper-resistant paper which shall contain industry-recognized features designed to prevent: Unauthorized copying of a prescription form; Erasure or modification of information written on the prescription by the prescriber; and Use of counterfeit prescription forms; A fax of an original order signed by the prescriber sent directly from the prescriber to the pharmacy provider; An electronic order; or An oral order from the prescriber to the pharmacist if the: Pharmacist promptly writes or prints out and files the prescription; Prescription is not for a Schedule II controlled dangerous substance; and Prescription is not for certain drugs that have been determined by the Secretary to present an emerging threat in the State because of increasing abuse and diversion. “Professional dispensing fee” means the professional fee as defined in 42 CFR §447.502. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual, association, partnership, or incorporated or unincorporated group of individuals duly licensed or certified to provide services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by issuance of an individual account number. “Single source drug” means a covered drug which is produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application. “State actual acquisition cost (SAAC)” means, for those drugs or products identified by the Program, the Program’s or its designee’s calculation of AAC, based on a survey of providers’ actual prices paid to acquire drugs or products marketed or sold by specific manufacturers, when NADAC is unavailable. “State Formulary” means drug products listed in the United States Food and Drug Administration's Current List of Approved Drug Products with Therapeutic Equivalence Evaluations unless disqualified by the Department in conformity with Health Occupations Article, §12-504, Annotated Code of Maryland. “State-only participants” means those participants in the Program administered and financed by the State who do not meet the technical requirements of Title XIX of the Social Security Act and for whom the State does not claim federal financial participation. “Usual source of supply” means a wholesaler, distributor, or manufacturer from whom pharmacy providers within the State most frequently obtain their pharmaceuticals. “Wholesale acquisition cost (WAC)” means the price pharmaceutical manufacturers and distributors charge to wholesale distributors who provide retail and institutional pharmacies with products used to fill prescriptions. A pharmacy may not qualify as a provider without first having obtained a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery and to dispense drugs in the state in which the service is provided. To participate in the Program, the provider shall: Meet the licensure requirements in Regulation .02 of this chapter; Apply for participation in the Program using the application form designated by the Department; Be approved for participation by the Department; Accept, as payment in full, the amounts paid by the Program plus any copayment required by Regulation .05C(5) of this chapter; Maintain adequate records and prescriptions for a minimum of 6 years, and make them available for inspection, upon request, to the Department or its designee; Ensure that all prescriptions contain sufficient information to justify the invoice charges; Provide services without regard to race, creed, color, age, sex, national origin, marital status, physical or mental handicap; Agree that the provider may not employ knowingly a person who has been disqualified from the Program to compound or dispense Medical Assistance prescriptions, unless prior written approval has been received from the Department; Verify the participant’s eligibility before dispensing covered drugs; Place no restriction on the participant’s right to select providers of the participant’s choice; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant; Maintain a record of the individual who picks up a prescription that includes: The prescription number; The name of the individual picking up the prescription; The signature of the individual picking up the prescription; and The date the prescription was picked up; Reverse invoice charges for any prescription not picked up by the participant or their designee within 14 days; Maintain a record of a participant or designee’s written authorization for automatic refill, if automatic refills are provided; Agree that the provider may not deny services to any participant because of the individual’s inability to pay the copayment; Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant; On the Department’s request, provide within 15 days all invoices, as defined in Regulation .01B(24)(b) of this chapter, to assess the AAC; and Participate in the cost of dispensing survey and, on the Department’s request and within the Department’s timeline, provide to the Department all documentation that the Department or its designee determines is necessary. The Department shall cover: Legend drugs except certain drugs for which federal financial participation is prohibited pursuant to 42 CFR §441.25; Schedule V cough preparations; Contraceptives; Hypodermic needles and syringes; Supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home; Enteric coated aspirin when prescribed for: The treatment of arthritic conditions as certified on the prescription in the prescriber's own handwriting or by the dispenser after consultation with the prescriber; and At least 250 tablets of 325 milligrams each, whether for initial prescriptions or refills. Nonlegend ferrous sulfate oral preparations in the following strengths, dosage forms, and quantities only: Drops (125 milligrams per milliliter) in units of 50 milliliter dropper bottles; Elixir (220 milligrams per 5 milliliters) in quantities of at least 473 milliliters; Syrup (90 milligrams per 5 milliliters) in quantities of at least 473 milliliters; and Tablets (300 milligrams to 325 milligrams) in quantities of at least 100 tablets; Nonlegend chewable tablets of any ferrous salt if: The tables are combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals; The participant is under 12 years old; and The quantity dispensed is at least 60 tablets and not more than a 100-day supply; Nonlegend ergocalciferol liquid (8,000 international units per milliliter); and Any nonlegend drug determined by the Program to be cost effective. Prescription Requirement. Except as provided in §B(2) of this regulation, a prescription is required for all items to be covered under this regulation even if the item is not a legend drug or otherwise does not require a prescription under federal or State pharmacy law. A prescription is not required for various forms of latex condoms or other drugs or products identified by the Program, each within the limits established by the Program. The Department may cover legend drugs not otherwise covered by §A of this regulation when: The drugs are identified as necessary to address a drug shortage as identified by the United States Food and Drug Administration; and The Department determines the coverage of the drugs medically necessary. Except as specifically identified as being covered under Regulation .04 of this chapter, the following are not covered: Nonlegend drugs; Medical supplies and durable equipment; Any original prescription for a controlled substance dispensed more than 30 days after the date it was ordered; Drugs supplied to hospital inpatients; Drugs and supplies dispensed by the provider with an actual acquisition cost of $0; Experimental or investigational drugs; Except where authorized by the Department to be covered under this Regulation, injectables dispensed by a provider for administration by the prescriber; Food supplements or infant formulas, including supplemental vitamin and mineral products when administered orally; Sugar or salt substitutes; Cosmetics, medicine chest supplies, and sundries including all soaps, all body powders, all body oils or body lotions, cotton balls, adhesive strip bandages, cotton-tipped applicators, suntan products, deodorants, dentifrices, tissues, convenience packages of covered items, hot water bottles, ice caps, heating pads, soft cervical collars; Alcoholic beverages; Ostomy supplies; Those services authorized for payment to a prescriber, hospital, nursing facility, hospital outpatient department, or freestanding clinic; Oral drugs or injections for central nervous system stimulants, anorexigenics, and any other agents when used for weight control; Drug products for which federal financial participation is prohibited pursuant to 42 CFR §441.25; Ovulation stimulants unless used to treat an iatrogenic infertility; Effective January 1, 2006, any Part D drug for individuals who are eligible for Medicare Part D benefits; Drugs or products used for hair growth or other cosmetic purposes; Any drug or supply that is covered and reimbursed by the Department under any other chapter of this subtitle; and Any drug or product the Department determines is not medically necessary. Prescriptions requiring preauthorization according to Regulation .06 of this chapter are not covered unless the required preauthorization has been obtained from the Department or its designee. Limitations on Covered Services. The allowable cost of ingredients dispensed pursuant to a prescription may not exceed an upper limit as established in Regulation .07, of this chapter. Refills. The prescriber shall authorize refills only on the original prescription if the prescriber determines a refill is necessary and appropriate. The Program may authorize no more than 11 refills, not to exceed other applicable federal and State limitations. The pharmacy may not automatically refill a prescription unless authorized in writing by the recipient or their designee. Days Supply. The total amount dispensed under one prescription order, including refills, is limited to a 360 days supply, not to exceed other applicable federal and State limitations. Unless otherwise specified, prescriptions shall be limited to a 34 day supply at one time. Unless otherwise specified, maintenance medication shall be limited to: A 34-day supply for the initial prescription; and Up to a 100-day supply at one time for all subsequent prescriptions. Prescriptions shall be dispensed at the lower of the quantity prescribed or the maximum days supply allowed at one time unless: The Program authorizes a reduction of the quantity; or The prescription is the final refill for the balance remaining on the total prescription order. Providers may partially fill a prescription for Schedule II controlled dangerous substances, but the remaining portion of the prescription may not be later filled. Oral sodium fluoride products used in the prevention of dental caries are limited to an original prescription of up to a 120-day supply with up to two refills, not to exceed a total of a 360-day supply. Prescriptions for drugs packaged by the manufacturer as an unbreakable unit may be dispensed in increments of appropriate package size. Whether for an initial or subsequent prescription, contraceptive prescriptions may be dispensed in up to a 12 months supply at one time. Generic Drugs. Except as limited by §C(4)(b) and (c) of this regulation, when a drug product is prescribed by its nonproprietary or generic name, a provider shall substitute as follows: A drug product in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, therapeutically equivalent to the drug as prescribed; or A drug product with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, bioequivalent to the drug as prescribed as rated by the U.S. Food and Drug Administration. A provider may not substitute a generic drug for a brand name drug under §C(4)(a) of this regulation if: The prescriber specifically directs otherwise; and The prescriber requests and received approval from the Program. The Department shall only authorize a provider to substitute a drug product under this regulation when there will be a savings in or no increase in cost to the Department. Copayment for Services Rendered on or after July 1, 2005. There will be no pharmacy copayment for prescriptions for the following: Individuals younger than 21 years old; Pregnant women; Institutionalized individuals who are inpatients in long-term care facilities or other institutions requiring spending all but a minimal amount of income for medical costs; Family planning drugs and devices; and Individuals who are American Indians or Alaskan Natives. The copayments for prescriptions not excluded from a copayment under §C(5)(a) of this regulation are: $3 for prescriptions for brand name drugs not on the preferred drug list; $1 for prescriptions for generic drugs and brand name drugs on the preferred drug list; and $1 for prescriptions for antiretroviral drugs in American Hospital Formulary Service therapeutic class 8:18:08. Reimbursement may not be made: For nonlegend enteric coated aspirin tablets in strengths other than 300 to 325 milligrams; For any other nonlegend aspirin products such as sustained release capsules, buffered tablets, compressed tablets, liquid preparations or combination products in which aspirin is only one of the active ingredients; For nonlegend ferrous sulfate products in strengths or dosage forms not listed in Regulation .04A(8) of this chapter; For nonlegend iron products combined with other active ingredients, except for chewable tablets as described in Regulation .04A(9) of this chapter; or At a reimbursement level which exceeds the maximum allowable cost established by the Program. Condoms dispensed by pharmacy providers are subject to the following limitations: The recipient shall present a Medical Assistance card with a current eligibility period; Only 12 condoms may be dispensed to an individual at one time; The provider may dispense condoms only to the individual named on the Medical Assistance card; Natural membrane condoms are not covered; and Both the recipient receiving the condoms and the provider shall sign the dispensing documentation. A compounded prescription for intravenous therapy is subject to the following limitations: The Program may not cover a compounded prescription for intravenous therapy if a premixed, therapeutically equivalent commercial intravenous therapy is available from a commercial source; The Program may not cover the diluent component of a compounded prescription for intravenous therapy; and All claims submitted require new prescription numbers. Prescriptions dispensed to participants residing in nursing facilities are subject to the following limitations: Claims shall be identified as nursing facilities prescriptions by coding mechanisms determined by the Program; Credits for unused unit dose medication and any other medication which may legally be returned to pharmacy stock: Shall be made within 60 days of Program payment; May not take into account any professional fee paid by the Program; and Shall adjust for leave of absence prescriptions; and Multiple prescriptions dispensed to a recipient residing in a nursing facility for the same drug product or compounded prescription shall receive only one professional fee per calendar month except for: Leave of absence prescriptions; Prescriptions for intravenous therapy; and Prescriptions for Schedule II-V controlled substances. Tamper Resistant Prescriptions. Prescriptions written on or after April 1, 2008, that do not contain at least one of the tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered. Prescriptions written on or after October 1, 2008, that do not contain all three tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered. No covered drug or supply identified under Regulation .04 of this chapter shall be reimbursed under Regulation .07 of this chapter if: Federal financial participation from the Centers for Medicare & Medicaid Services is not available for the drug or supply; or Prior authorization for the drug or supply is required under Regulation .06 of this chapter but was not obtained. A drug is not covered for State-only participants if: The manufacturer has not provided the same rebate to the State for State-only participants’ purchases of drugs as is required under Section 1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)); The Program has provided notice to the manufacturer of the manufacturer's failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and The manufacturer has failed to demonstrate to the Secretary that the drug’s availability is essential to State-Only participants. A manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation or under 42 U.S.C. §1396r-8(c) more than 3 years after the date the rebate was paid. The provider shall obtain preauthorization from the Department or its designee for any prescription for: Antibiotic liquids requiring reconstitution for amounts exceeding a 14-day supply; Nonmaintenance drugs for more than a 34 day supply; A usual and customary charge exceeding $2,500; Female hormones for biologic males when used for treating sexual aggression; Vitamin and mineral products when given by nasogastric, jejunostomy, or gastrostomy tube in the home; Drugs rejected by the point-of-sale system because of edits established by the Program to ensure appropriate utilization of medication before the prescription is dispensed, if the Department does not allow provider level overrides; Where a prescriber has filed an official report of an adverse event or product problem with the Program or the United States Food and Drug Administration regarding a generic drug, the brand name drug used as an alternative to that generic drug; Drugs identified by the Program that are subject to fraud or abuse; or Drugs not on the preferred drug list developed under Regulation .12 of this chapter except for: Antiretrovirals; or Any other drugs or classes of drugs as determined by the Department. Off-Label Uses of Drugs. The Department may require preauthorization for an off-label use of a drug. Except as provided in §B(3) of this regulation, the Department or its designee may not grant preauthorization for an off-label use of the drug if: The off-label use is inconsistent with generally accepted standards of care; The drug is prescribed for a non-medically accepted indication; The drug is prescribed in a manner not approved by the U.S. Food and Drug Administration; or The off-label use is not documented in and supported by the latest edition of: The American Hospital Formulary Service Drug Information (AHFS-DI); The Thompson Micromedex Drugdex; or The United States Pharmacopeia. The Department or its designee may grant preauthorization for the off-label use of mental health drugs for individuals 18 years old and younger within the limits established by the Program. Preauthorization is not required for: Prescriptions for oral contraceptive drug products; Drugs dispensed in unit dose form to patients in a nursing facility by a provider using an approved unit dose system. Preauthorization Process. The provider or the prescriber, if appropriate, ordering a drug subject to preauthorization, shall: Contact the Department or its designee through an established 24-hour hot-line to request preauthorization; and Provide required information and documentation. The Department or its designee shall respond to a request for preauthorization by telephone or facsimile request within 24 hours of receipt of a request for preauthorization. A 72-hour supply of the prescribed drug shall be allowed: In an emergency as determined by the prescriber; In an emergency as determined by the pharmacist, if possible in consultation with the prescriber; or If the Department does not provide a response to a preauthorization request within 24 hours. A preauthorization granted by the Department or its designee under this Regulation may not be used by any person as indicating that the individual for whom the prescription was ordered is eligible for Program benefits on the day the prescription is filled or that the Department will guarantee reimbursement for the prescription. All Program restrictions and requirements on eligibility, covered services, and limitations on reimbursement remain in effect. A 30-day emergency supply of atypical antipsychotic drugs not on the preferred drug list shall be: Immediately authorized by the Department or its designee in an emergency as determined by the: Prescriber; or Pharmacist, if unable to contact the prescriber; and Limited to a one-time 30-day period. Reconsideration of Adverse Decisions. The Department or its designee shall respond within 48 hours of receiving all necessary documentation of a written request from a participant or provider for reconsideration of an adverse decision on a preauthorization request. The Department or its designee shall ensure that all adverse decisions of reconsiderations are reviewed and issued by a physician. Appeals of adverse decisions of reconsideration requests shall be filed in accordance with Regulation .10 of this chapter. The Department or its designee may: Require preauthorization for more than ten prescriptions including refills per 30-day period per noninstitutionalized participant; and May exclude certain drugs such as antibiotics from the limit as appropriate. The provider shall produce records to verify any charge to the Program upon request. The provider shall bill all appropriate insurance carriers before requesting payment from the Department. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The provider shall submit a request for payment on a form designated by the Department. The Department may return to the provider all invoices not properly completed. The pharmacy provider shall charge the Program the provider’s usual and customary charge to the general public for similar prescriptions. The physician or osteopath shall charge the Program his actual acquisition cost for the drugs dispensed. Determination of Allowable Cost. For covered legend drugs and nonlegend drugs, allowable cost shall be: The NADAC; or When the NADAC is unavailable, the lowest of the: WAC plus 0 percent; FUL; and SAAC. For covered legend brand name drugs for which the prescriber files an official report of an adverse event or product problem regarding a generic drug with the Program or the United States Food and Drug Administration, or when the Department requires the brand name drugs to be dispensed, the allowable cost shall be: The NADAC of the branded product; or When the NADAC of the branded product is unavailable, the lower of the: WAC plus 0 percent; or SAAC. For condoms dispensed by pharmacy providers, the allowable cost shall be as described in §H(1) of this regulation. For covered over-the-counter products, and covered medical supplies, the allowable cost shall be as described in §H(1) of this regulation. For covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail, the allowable cost shall be: The NADAC; or When the NADAC is unavailable, the lowest of the: WAC plus 0 percent; FUL; or SAAC. Except when purchased at the 340B price by a provider, the allowable cost for covered clotting factors shall be the lower of the: WAC plus 0 percent; or AAC plus 8 percent. For 340B covered entities or FQHCs that fill Program participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act, the allowable cost shall be the provider’s AAC. For facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS, the allowable cost shall be the provider’s AAC. For facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, the allowable cost shall be the provider’s AAC. Payment for Covered Services to a Pharmacy. Payment for covered legend and nonlegend drugs, over-the-counter products, and covered medical supplies is the lower of: The provider's charge according to §F of this regulation, less any applicable co-payment according to Regulation .05C(5) of this chapter; or The amount that is: The allowable cost of the item in §H(1) of this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for covered legend brand name drugs as indicated in §H(2) of this regulation shall be the lower of: The provider’s charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or The total of: The allowable cost of the item in §H(2) of this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for condoms will be the lower of the: The provider's charge according to §F of this regulation; or Allowable cost according to §H(3) of this regulation. Copayment is not required for condom orders. Payment for covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail shall be the lower of the: Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or The total of: The allowable cost of the item in §H(5) of this regulation; Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for clotting factor shall be lower of the: Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or Amount that is: The allowable cost of the item in §H(6) of this regulation; Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for providers that fill Medicaid participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act shall be the total of: The allowable cost of the item in §H(7) of this regulation; Plus the applicable professional dispensing fee indicated in §I(12) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS shall be the total of: The allowable cost of item in §H(8) this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. Payment for facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, shall be the total of: The allowable cost of item in §H(9) this regulation; Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and Less any applicable copayment according to Regulation .05C(5) of this chapter. The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for participants residing in nursing facilities shall be $11.67. The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for individuals other than residents in nursing facilities shall be $10.67. The professional dispensing fee for covered services rendered on or after April 1, 2017 to a pharmacy for medication purchased at the prices authorized under Section 340B of the Public Health Services Act shall be $12.12. The Department may pay a pharmacy using an approved unit dose system on the basis of a monthly dispensing fee per nursing home resident. The value of the fee may not be higher than the pharmacy’s usual and customary charge to non-Medicaid patients for similar services. Payment for Covered Services to a Physician or Osteopath. Except as provided in §J(2) of this regulation, the Program shall reimburse a physician or osteopath for covered drugs dispensed at the lower of: The physician's or osteopath's actual acquisition cost, less any applicable copayment according to Regulation .05C(5) of this chapter; or The allowable cost of the item in §H of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter. The Program shall reimburse a physician or osteopath for covered drugs dispensed to Medicaid participants on the same basis as reimbursement to a registered pharmacist if: The physician or osteopath dispenses the covered drugs on a regular basis in the physician's or osteopath’s office; The physician's or osteopath’s office is not located within a 10-mile radius of a Medicaid participating pharmacy; and The Program, after consultation with the Board of Pharmacy, has verified that the physician or osteopath is dispensing drugs in accordance with accepted pharmacy standards. In order to determine whether the current professional dispensing fee is appropriate, the Department will periodically conduct surveys to determine the actual costs involved in filling a prescription in the State. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or third-party source, whichever is less. The provider shall reimburse the Department for any overpayment. If the Department determines that a provider, pharmacist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. The Department may consult with the State Pharmaceutical Association, the State Board of Pharmacy, and the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The findings and recommendations of these groups will be given consideration. The Department will give the provider reasonable notice of its intentions to impose sanctions. In the written notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. Any provider voluntarily withdrawing from the Program or removed or suspended from the Program according to this section shall notify recipients that he no longer honors Medical Assistance cards before rendering additional services. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. The Department may establish a Pharmacy and Therapeutics Committee (Committee). The Committee shall consist of the following 12 members: Five members of the Committee shall be Maryland licensed pharmacists residing in the State, including a pharmacist with expertise with mental health drugs; Five members of the Committee shall be Maryland licensed physicians residing in the State, including a psychiatrist; and Two members of the Committee shall be consumer representatives residing in the State. Consideration for membership on the Committee shall be given to appointing physicians and pharmacists participating in the Program or with experience in developing or practicing under a preferred drug list. The Committee members shall: Be appointed by the Secretary; Have 3 year terms; Be allowed to serve more than one term; and Elect a chairman and vice chairman. The Committee shall: Meet at least twice a year; To the extent feasible, review all drug classes included on the list at least once every 12 months; Develop recommendations for a preferred drug list for the Program by considering the: Clinical efficacy of the drug; Cost effectiveness of the drug, including any supplemental rebates from manufacturers; and Needs of Program recipients, such as the ease of drug therapy administration, rate of compliance with drug therapy instructions, and frequency of prior authorization; Recommend: The addition or deletion of existing drugs as necessary; Preauthorization criteria; and Conditions or illnesses to be exempted from prior authorization based on clinical data; and Consider medically accepted off-label use of U.S. Food and Drug Administration (FDA) approved drugs. The Department shall: Inform the Committee of any decisions regarding the preferred drug list; Annually publish the preferred drug list; Maintain an updated preferred drug list that is available electronically; Ensure, based upon timely notice from the manufacturer, that any new products are reviewed at the next regularly scheduled meeting of the committee; Provide an expedited review process for newly approved drugs designated as priority by the FDA; and Provide manufacturers and the public an opportunity to submit written material to the committee. The preferred drug list developed by the Department based on the recommendations of the Pharmacy and Therapeutics Committee: May not include certain therapeutic classes including antiretroviral medications used to treat the AIDS virus, which are exempt from preauthorization as indicated in Regulation .06A(12) of this chapter; Shall, for therapeutic classes other than those described in §G(1) of this regulation, include at least one drug approved by the FDA for use in the specific therapeutic class, in every therapeutic class for which the FDA has approved three or fewer drugs for use; and Shall, in every therapeutic class other than those described in §G(1) of this regulation, offer a choice of at least two pharmaceutical or biological entities without an administrative preference for each therapeutic class in which there are four or more pharmaceutical or biological entities approved by the FDA. The Department may negotiate and collect supplemental rebates from manufacturers. Health-General Article, §§2-104(b), 15-103, 15-103.1, 15-105, 15-118, and 15-148, Annotated Code of Maryland Effective date: February 16, 1966 Amended effective March 15, 1967; July 1, 1967; December 1, 1969; July 1, 1971; January 22, 1975 (2:2 Md. R. 86); March 18, 1975 (2:9 Md. R. 659); July 1, 1975 (2:15 Md. R. 1066); January 1, 1976 (2:29 Md. R. 1739) Existing regulations repealed and new regulations adopted effective September 1, 1976 (3:18 Md. R. 981) Regulation .01 amended effective June 1, 1985 (12:10 Md. R. 961); April 30, 1988 (15:8 Md. R. 1009); March 14, 1989 (16:4 Md. R. 497) Regulations .01, .02, .04, .05A, .06, .07H, and .09A—C amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1203); expired November 10, 1979 Regulations .01, .03, .05 and .07 amended as an emergency provision effective November 15, 1988 (15:23 Md. R. 2654); emergency status expired March 13, 1989 Regulations .01, .05C, .07H, H-1 amended as an emergency provision effective October 1, 1982 (10:1 Md. R. 19); adopted permanently effective January 30, 1983 (10:1 Md. R. 29) Regulations .01 and .07 amended as an emergency provision effective December 31, 1987 (15:2 Md. R. 117) (Emergency provisions are temporary and not printed in COMAR) Regulations .01—.05 and .07 amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1113); amended permanently effective October 23, 1995 (22:21 Md. R. 1615) Regulations .01, .05, and .07 amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1081); amended permanently effective December 30, 1996 (23:26 Md. R. 1860) Regulations .01B, .05C, and .07C, H—J amended as an emergency provision effective April 1, 1991 (18:8 Md. R. 861); amended permanently effective July 8, 1991 (18:13 Md. R. 1482) Regulation .01B amended effective July 1, 1992 (19:11 Md. R. 1015) Regulations .01B, .05C, and .07I amended as an emergency provision effective July 9, 1998 (25:16 Md. R. 1261); amended permanently effective October 19, 1998 (25:21 Md. R. 1574) Regulation .01B amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .01B amended effective March 3, 2003 (30:4 Md. R. 316) Regulation .01B amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired effective January 1, 2004 Regulation .01B amended effective February 16, 2004 (31:3 Md. R. 207); November 23, 2006 (33:23 Md. R. 1794); April 21, 2008 (35:8 Md. R. 805); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896); December 31, 2018 (45:26 Md. R. 1242) Regulations .01C, N, S; .07F, H; and .09A—C amended effective November 11, 1979 (6:22 Md. R. 1779) Regulation .01E-1—E-3 adopted effective December 26, 1980 (7:26 Md. R. 2422) Regulation .01H-1 amended effective May 5, 1986 (13:9 Md. R. 1029) Regulation .01P amended effective February 8, 1980 (7:3 Md. R. 263) Regulations .02B; .04F (recodified from §H); .05B; .07F-1, H-1 (recodified from §§G and J, respectively) adopted effective November 11, 1979 (6:22 Md. R. 1779) Regulation .03 amended effective March 14, 1989 (16:4 Md. R. 497); November 28, 2011 (38:24 Md., R. 1502); March 31, 2014 (41:6 Md. R. 378); September 25, 2017 (44:19 Md. R. 896) Regulation .03K adopted effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03L adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .04 amended effective May 1, 1979 (6:7 Md. R. 576); February 8, 1980 (7:3 Md. R. 263); July 11, 1988 (15:14 Md. R. 1654); November 28, 2011 (38:24 Md., R. 1502); June 14, 2021 (48:12 Md. R. 470) Regulation .04A amended effective October 17, 1980 (7:21 Md. R. 1994); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637); July 1, 1992 (19:12 Md. R. 1134) Regulation .04A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707) Regulation .04A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822) Regulation .04A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .04A amended effective March 3, 2003 (30:4 Md. R. 316); February 16, 2004 (31:3 Md. R. 207); September 25, 2017 (44:19 Md. R. 896) Regulation .04C adopted effective March 31, 2025 (52:6 Md. R. 267) Regulation .04E amended effective October 29, 1984 (11:21 Md. R. 1811) Regulation .04G adopted effective March 9, 1987 (14:5 Md. R. 579) Regulation .05 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .05 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) Regulation .05A amended effective May 1, 1979 (6:7 Md. R. 576); November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); October 17, 1980 (7:21 Md. R. 1994); October 29, 1984 (11:21 Md. R. 1811); March 9, 1987 (14:5 Md. R. 579); July 11, 1988 (15:14 Md. R. 1654); July 1, 1992 (19:12 Md. R. 1134) Regulations .05A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707) Regulation .05A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822) Regulation .05A amended effective February 16, 2004 (31:3 Md. R. 207); March 13, 2006 (33:5 Md. R. 520); June 14, 2021 (48:12 Md. R. 470); March 31, 2025 (52:6 Md. R. 267) Regulation .05A, C amended effective October 22, 2018 (45:21 Md. R. 973) Regulation .05B amended effective July 1, 1992 (19:12 Md. R. 1134) Regulation .05C amended effective December 26, 1980 (7:26 Md. R. 2422); March 9, 1987 (14:5 Md. R. 579); September 7, 1987 (14:18 Md. R. 1966); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:24 Md. R. 2769); March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637) Regulation .05C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861) Regulation .05C amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707) Regulation .05C amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); amended permanently effective November 10, 2003 (30:22 Md. R. 1579) Regulation .05C amended effective September 27, 2004 (31:19 Md. R. 1432); August 1, 2005 (32:15 Md. R. 1320); December 6, 2007 (34:24 Md. R. 2157); March 31, 2014 (41:6 Md. R. 378) Regulation .05D and E adopted as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769) Regulation .05F and G adopted effective April 21, 2008 (35:8 Md. R. 805) Regulation .05-1 adopted as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); adopted permanently effective December 1, 1992 (19:23 Md. R. 2040) Regulation .05-1 amended effective November 28, 2011 (38:24 Md., R. 1502) Regulation .05-1A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .05-1A amended effective March 3, 2003 (30:4 Md. R. 316); September 25, 2017 (44:19 Md. R. 896) Regulation .06 amended effective November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); November 8, 1981 (8:21 Md. R. 1707); August 30, 1982 (9:17 Md. R. 1708); December 19, 1983 (10:25 Md. R. 2268); October 29, 1984 (11:21 Md. R. 1811); September 7, 1987 (14:18 Md. R. 1966); December 12, 1988 (15:24 Md. R. 2769) Regulation .06 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .06 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) Regulation .06A amended effective July 1, 1992 (19:12 Md. R. 1134); October 10, 2016 (43:20 Md. R. 1109); June 14, 2021 (48:12 Md. R. 470) Regulation .06A, C amended effective December 6, 2007 (34:24 Md. R. 2157) Regulation .07 amended effective March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) Regulation .07C amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07C amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861) Regulation .07G amended effective June 1, 1985 (12:10 Md. R. 961); May 5, 1986 (13:9 Md. R. 1029); May 4, 1987 (14:9 Md. R. 1080); October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009); July 11, 1988 (15:14 Md. R. 1654) Regulation .07G amended as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769) Regulation .07H amended as an emergency provision effective July 1, 1977 (4:14 Md. R. 1080); emergency status extended at 4:23 Md. R. 1728; adopted permanently effective November 4, 1977 (4:23 Md. R. 1734) Regulation .07H amended effective July 1, 1978 (5:12 Md. R. 967); May 1, 1979 (6:7 Md. R. 576); July 1, 1980 (7:13 Md. R. 1278); March 9, 1987 (14:5 Md. R. 579); July 1, 1987 (14:13 Md. R. 1473); July 11, 1988 (15:14 Md. R. 1654) Regulation .07H amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1204); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) Regulation .07H amended as an emergency provision effective July 1, 1982 (9:11 Md. R. 1122); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) Regulation .07H amended as an emergency provision effective July 1, 1984 (11:14 Md. R. 1246); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811) Regulation .07H-1 amended effective March 9, 1987 (14:5 Md. R. 579) Regulation .07H, I amended effective September 27, 2004 (31:19 Md. R. 1432) Regulation .07I amended effective March 19, 1990 (17:5 Md. R. 637) Regulation .07I amended as an emergency provision effective July 30, 1991 (18:17 Md. R. 1911); amended permanently effective October 15, 1991 (18:19 Md. R 2099) Regulation .07I amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707) Regulation .07I amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) Regulation .07I amended effective March 3, 2003 (30:4 Md. R. 316); June 14, 2021 (48:12 Md. R. 470) Regulation .07J adopted as an emergency provision effective July 1, 1980 (7:13 Md. R. 1266); adopted permanently effective October 17, 1980 (7:21 Md. R. 1995) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Regulation .12 adopted effective March 3, 2003 (30:4 Md. R. 316) Regulation .12 amended as an emergency provision effective September 18, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .12E amended effective November 23, 2006 (33:23 Md. R. 1794) Regulation .12G amended effective December 6, 2007 (34:24 Md. R. 2157) Table I adopted effective June 1, 1985 (12:10 Md. R. 961) Table I repealed and new Table I adopted effective May 5, 1986 (13:9 Md. R. 1029); amended effective October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009) In this chapter, the following terms have the meanings indicated. Terms Defined. “Activities of daily living” means functions normally associated with mobility, eating, elimination, body hygiene and dressing. “Attending” means the role of an individual who establishes the plan of treatment and certifies the necessity for home health services for a participant following a hospitalization. “Case coordinator” means a licensed health professional designated by a home health agency to coordinate the care of a participant. “Certified nurse midwife (CNM)” means an individual who meets licensure requirements and conditions for participation as a certified nurse midwife set forth in COMAR 10.09.01. “Certified nurse practitioner” means an individual who meets the licensing requirements and conditions for participation as a nurse practitioner set forth in COMAR 10.09.01. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. 1396 et seq. “Electronic Visit Verification (EVV)” has the meaning stated in COMAR 10.09.36.03-2. “Face-to-face” means contact with a participant that occurs in person or via audio-visual telehealth in accordance with COMAR 10.09.49. “Health team” means the physician or nonphysician practitioner and the home health agency personnel who render services listed in Regulation .04B of this chapter to a participant. “Home” means the place of residence occupied by the participant, including a domiciliary level facility, but other than a hospital, nursing facility, or other medical institution. “Home health agency” means a public or private agency or organization, or part of an agency or organization, that meets the requirements for participation in Medicare. “Home health aide” means a person who meets the requirements of COMAR 10.07.10, and has received instruction from, and renders services under the supervision of, a registered nurse. “In person” means contact with a participant that occurs in the physical presence of the participant and the provider. “Intermittent” means services which are furnished on a medically predictable recurring basis. “Licensed nurse” means a person who is licensed as a registered nurse or as a licensed practical nurse in the jurisdiction in which the service is provided. “Medicaid average rate” means the average projected per diem rate established for the Department's fiscal year as specified in COMAR 10.09.10.07B(2) multiplied by 30. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medical supplies” means items which are generally recognized under accepted standards of medical practice as serving a therapeutic or diagnostic purpose and are medically necessary to enable home health agency personnel to carry out effectively the care the physician has ordered for the treatment or diagnosis of the patient's illness or injury, and which are accounted for in billing records. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. 1395 et seq. “Newborn early discharge assessment” means a visit to the newborn infant and postpartum mother to observe and assess the health status of both the newborn and the mother. “Nonphysician practitioner” means an individual who: Is licensed as a certified nurse practitioner, clinical nurse specialist, a certified nurse-midwife, or a physician assistant in the jurisdiction in which the service is provided; and Works in collaboration with or under the supervision of the ordering practitioner. “Occupational therapist” means a person who is licensed or registered as an occupational therapist in the jurisdiction in which the service is provided. “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. “Part-time” means services, usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of an illness or injury. “Physical therapist” means a person who is licensed or registered as a physical therapist in the jurisdiction in which the service is provided. “Physician” means an individual who meets the licensure requirements and conditions for participation set forth in COMAR 10.09.02. “Physician assistant” means an individual who meets license requirements and conditions for participation set forth in COMAR 10.09.55. “Program” means the Maryland Medical Assistance Program. “Progress note” means a dated, written notation by a member of the health team which summarizes facts about the care given and the patient's response during a given period of time, specifically addresses the established goals of treatment, is consistent with the patient plan of care, is written immediately following each visit, and is part of the provider's permanent record for the participant. “Provider” means a person or an organization who meets the requirements of Regulations .03 and .04 of this chapter and who, through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. “Speech-language pathologist” means a person who is licensed as a speech-language pathologist in the jurisdiction in which the service is provided. “Supervision” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic evaluation of the act of accomplishing the function or activity. “Support system” means a family member, friend, neighbor, or any person who renders services, which would otherwise be covered under Regulation .04 of this chapter, to the participant. “Telehealth” has the meaning stated in COMAR 10.09.49.02. “Visit” means the time spent rendering a covered service to a participant at home by an individual employed by a home health agency. “Witness” means a person who on behalf of the participant is able to personally verify at the time of service that the participant received home health care. A home health agency shall be licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland, or shall be part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland, or shall be legally authorized to provide home health services in the jurisdiction in which the service is provided. To be a provider, a home health agency shall be a participating home health agency under Medicare. To participate in the Program, the home health agency shall: Apply for participation in the Program using the form designated by the Department; Be approved for participation by the Department; Have in effect a provider agreement with the Department; Accept payment by the Department as payment in full for covered services rendered and make no additional charge to any person for covered services; Provide verification to the Department, in the manner prescribed by the Department, of all changes in the provider's charges within 10 days of the occurrence of the changes; Maintain all patient care, medical supply, timesheets, official agency recipient or witness signature records, and billing records for a minimum of 6 years after completion of an audit by the Department and make them available, upon request, to the appropriate State and federal personnel or their designees during office hours; Secure from the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner a written plan of treatment which relates the items and services to the participant's medical condition; Maintain a participant's plan of care based on the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment for the participant; Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap; Verify the participant's eligibility; Place no restriction on a participant's right to select his choice of providers under this subtitle; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant; Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant; Provide services in person unless expressly authorized by the Department to render services via telehealth; and If not rendering services in person, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. Plan of Treatment. The plan of treatment under §B(8) shall include: Prognosis; Diagnoses; Treatment goals; Frequency of visits for each type of service ordered; Duration of treatment of each type of service ordered; Rehabilitation potential; Functional limitations; Permitted and prohibited activities; Diet; Medications; Treatments; Mental status; Medical supplies; Durable medical equipment; Safety measures to protect against injury; and Other appropriate items. The plan of treatment shall be reviewed, updated, and signed at least every 60 days by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner, in consultation with the registered nurse or the case coordinator. The physician, physician assistant, certified nurse midwife, or certified nurse practitioner shall: Sign and date the initial plan of treatment; and Document that the physician or nonphysician practitioner, who is not employed by the home health agency, has had a face-to-face encounter with the participant no more than 90 days before the home health start of care date or within 30 days of the start of the home health care, including the date of the encounter. For participants admitted immediately to home health upon discharge from a hospital or post-acute setting, the attending acute or post-acute physician shall document the clinical findings of the face-to-face encounter. The plan of treatment shall be part of the provider's permanent record for the participant. Plan of Care. For each type of service ordered, the plan of care under §C(9) shall, at a minimum, include: Goals of treatment; Actions or procedures needed to meet the goals; Dates the goals are expected to be achieved; Problems encountered, if any; Revision of goals and actions or procedures, whenever necessary; and Appropriate discharge activities. The plan of care shall be reviewed, dated, and signed at least every 60 days by the registered nurse or the case coordinator upon consultation with the appropriate health team. The plan of care is a part of the provider's permanent record for the participant. The Program covers the services listed in §§B and C of this regulation when the services are: Provided upon the written order of a physician, physician assistant, certified nurse midwife, or certified nurse practitioner; Furnished under the current plan of treatment; Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service; Consistent with the current diagnosis and treatment of the participant's condition; In accordance with accepted standards of medical practice; Required by the medical condition rather than the convenience or preference of the participant; Considered under accepted standards of medical practice to be a specific and effective treatment for the participant's condition; Required on a part-time, intermittent basis; Rendered in the participant's home, or other setting when normal life activities take the participant outside the home, by an approved provider; Received by the participant as documented by the participant's signature or the signature of the participant's witness on the home health agency's official forms; and Adequately described in the signed and dated progress notes. The Program covers the following services: Skilled nursing services provided by a licensed nurse when the complexity of the services, or the condition of a participant, requires the judgment, knowledge, and skills of a licensed nurse; Home health aide services provided by a home health aide, that include: Assistance with activities of daily living as defined in Regulation .01B of this chapter when performed in addition to other home health services; Other health care services properly delegated by the registered nurse pursuant to the Maryland Nurse Practice Act as set forth in Health Occupations Article, Title 8, Annotated Code of Maryland, that may include, but are not limited to: Noninvasive parts of ostomy or catheter care; Nonsterile dressing changes; Procedures; Exercises; Reporting of the participant's condition and needs; and Completion of appropriate records; Physical therapy services, provided by a physical therapist: When the condition of a participant requires the judgment, knowledge, and skills of a licensed or registered physical therapist; When the services are directly related to the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment, which specifies: Body part or parts to be treated; Type of modalities or treatments to be rendered; Expected results of physical therapy treatments; Frequency and duration of treatment; When the services are of a diagnostic, rehabilitative, or therapeutic nature and: Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in physical functioning in a reasonable and generally predictable period of time; or Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state; Occupational therapy services, provided by an occupational therapist: When the condition of the participant requires the judgment, knowledge, and skills of a licensed occupational therapist; When the services are provided with the expectation that there will be a significant practical improvement in a participant's level of physical functioning within a reasonable period of time; and When the services fall within one or more of the following categories: Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests; Selection and teaching of task-oriented therapeutic activities designed to restore physical function; Teaching of compensatory techniques to improve the level of independence in the activities of daily living; Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance; Improvement of mobility skills; and Speech-language pathology services performed by a licensed speech-language pathologist when the: Services are of a diagnostic, rehabilitative, or therapeutic nature and: Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in a reasonable and generally predictable period of time; or Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state; and The condition of a recipient requires the judgment, knowledge, and skills of a speech-language pathologist. The Program covers a provider's newborn early discharge assessment visit to a participant when the assessment: Is 4 hours or less; Is ordered by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner; Is delivered to a participant and a participant's mother who have been discharged within 48 hours after delivery; Occurs within 36 hours after discharge; Includes: An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant; An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse physical symptoms of the mother; Collection of a blood specimen for newborn screening as described in COMAR 10.52.12; An evaluation of risk factors that identify biological factors for the infant, maternal health behaviors, psychosocial environmental problems, or any other concerns or problems perceived by the nurse that are identified on a form specified by the Department; and Referrals for any continuing health care services, including skilled nursing services under COMAR 10.09.53 or home health services under this chapter; and Is conducted by a registered nurse. A provider may deliver services in §B of this regulation via telehealth if: The Department expressly authorizes the provider to render services via telehealth; and The patient's plan of care specifies that the service may be delivered via telehealth. The Program does not cover the following: Nonskilled services rendered by licensed nurses, physical therapists, occupational therapists and speech pathologists; Services and medical supplies that are not medically necessary and appropriate; Durable medical equipment except as covered under COMAR 10.09.12; Services primarily for the purpose of housekeeping, including but not limited to: Cleaning of floor and furniture; Laundry; and Shopping; Home health aide services unless biweekly supervisory visits by a registered nurse in the participant’s home are made, every second visit of which shall include observations of the delivery of services by the aide to the participant; Home health aide services rendered to participants with chronic conditions when those participants require only assistance with activities of daily living as defined in Regulation .01B of this chapter unless preauthorized as specified in Regulation .06 of this chapter; Meals; More than one visit per type of service per day, unless preauthorized as specified in Regulation .06 of this chapter; Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which payments by the Program to the provider exceed the Medicaid average nursing facility rate unless preauthorized as specified in Regulation .06 of this chapter; Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day unless preauthorized as specified in Regulation .06 of this chapter; Services for investigational and experimental purposes; Services specified in Regulation .04 of this chapter to persons eligible for Medicare coverage of those services; A service not documented as received by the participant as indicated by the participant’s signature or the signature of a witness on the home health agency's official form; Supervisory visits by a registered nurse to monitor services of a home health aide; Initial assessments by a therapist or a registered nurse; Services provided for the convenience or preference of the participant or primary caregiver rather than as required by the participant’s medical condition; Services specified in Regulation .04 of this chapter which duplicate or supplant services performed by the participant and those services rendered by the participant’s family; Services which are covered by other insurance or entitlement programs; Newborn early discharge services provided more than one time to a participant; A newborn early discharge visit provided on the same day as another skilled nursing visit billed under this chapter; and Home health services ordered by an: Individual who is not enrolled as a provider in the Program with an active status on the date of service; and Entity, facility, or another provider that is not an individual. Preauthorization is required for: More than one visit per type of service per day; Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which the provider anticipates payments from the program in excess of the Medicaid average nursing facility rate; Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day; and Any instances in which home health aide services without skilled nursing services are provided. Preauthorization may be: Issued by telephone when the provider submits to the Department or its designee adequate documentation demonstrating that the service or services are medically necessary. Denied when the Department, after taking into consideration the particular circumstances of the participant, determines the payments to the provider for any service or combination of services rendered during any 30-day period would exceed the cost to the program of any alternative services which could be used for the same purpose. The provider shall submit his request for payment on the form designated by the Department. To receive payment for services under Regulation .04 of this chapter, a provider and its workers shall use the Electronic Visit Verification method and data management system approved by the Department to document time and submit claims in accordance with COMAR 10.09.36.03-2. The provider shall submit requests for payment for supplies on the same invoice which requests payment for the visit during which the supplies were used. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. Payment Rates. The provider shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate in accordance with the Department's fee schedule. For out-of-State providers, rates shall be paid at the lower of the following: The home state's Medicaid rate for the same service rendered by the same provider if the provider participates in its home state Medicaid Program; or The rate paid for the same service rendered by a provider in the nearest Maryland county. The Department shall pay home health providers for medical and other supplies which are used during a covered home health visit as part of the treatment ordered by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner at a rate that is the lesser of the: Provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or Medicaid rate for the supply or pharmaceutical under COMAR 10.09.12 and 10.09.03. Subject to the limitations of the State budget, the fee schedule rates shall be adjusted annually by the same factor used by the Centers for Medicare and Medicaid Services in updating Medicare's prospective payment system rates. The annual fee schedule rate adjustment shall be limited to a maximum of 5 percent and be effective the date on which Medicare's rate changes are implemented. The fee schedule effective January 1, 2025 is as follows: Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The Department shall reimburse for supervision of home health aide services by a registered nurse as part of the home health aide reimbursement. Payment to a provider of newborn early discharge services may not exceed the rate for one skilled nursing visit. The Department shall reimburse for preauthorized home health services upon verification that a face-to-face encounter with the participant was performed as described under Regulation .03C of this chapter. The home health provider shall identify the individual who ordered the home health services by recording the individual practitioner's National Provider Identifier (NPI) number on the claim. Recovery and reimbursement regulations are set forth in COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36. Appeal procedures are set forth in COMAR 10.09.36. State regulations are interpreted as set forth in COMAR 10.09.36. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: July 1, 1985 (12:11 Md. R. 1048) Regulations .01B and .05L amended, and .05M adopted as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .01B amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .03C amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .04B amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656) Regulation .05F, I amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .05F, J amended effective April 4, 1988 (15:7 Md. R. 849) Regulation .06A amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656) Regulation .07E amended effective April 4, 1988 (15:7 Md. R. 849) Regulation .07F amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07F amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08B amended effective November 12, 1990 (17:22 Md. R. 2656) Regulation .10A amended effective May 12, 1986 (13:9 Md. R. 1029) Chapter revised as an emergency provision effective October 1, 2000 (28:1 Md. R. 21); emergency status extended at 28:7 Md. R. 687 and 28:22 Md. R. 1931 (see 28:24 Md. R. 2125); emergency status expired October 28, 2001 Chapter revised effective October 29, 2001 (28:21 Md. R. 1856) Chapter revised effective March 12, 2007 (34:5 Md. R. 560) Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787); September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004) Regulation .02 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03B amended effective June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004) Regulation .03C amended effective September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470) Regulation .04 amended effective June 14, 2021 (48:12 Md. R. 470) Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .04B amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .04C repealed effective September 26, 2016 (43:19 Md. R. 1072) Regulation .04D amended effective March 10, 2008 (35:5 Md. R. 641) Regulation .04D adopted effective November 27, 2023 (50:23 Md. R. 1004) Regulation .05 amended effective December 27, 2010 (37:26 Md. R. 1787); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470) Regulation .05W amended effective March 10, 2008 (35:5 Md. R. 641) Regulation .06 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .06B amended effective June 14, 2021 (48:12 Md. R. 470) Regulation .07 amended effective December 27, 2010 (37:26 Md. R. 1787); November 27, 2023 (50:23 Md. R. 1004) Regulation .07D amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D, H amended effective June 14, 2021 (48:12 Md. R. 470) Regulation .07E amended effective June 14, 2010 (37:12 Md. R. 800); May 11, 2026 (53:9 Md. R. 412) Regulation .07H adopted effective September 30, 2013 (40:19 Md. R. 1544) Regulation .07I adopted effective January 1, 2018 (44:26 Md. R. 1214) In this chapter, the following terms have the meanings indicated. Terms Defined. “Adverse action” means any action taken by the DASO to deny, reduce, terminate, delay, or suspend a covered service. “Aftercare” means the period of follow-up care after initial services are rendered, during which any additional related services rendered by the same provider are included in the payment for the original services. “Ambulatory surgical center (ASC)” means any Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. “Appeal” means the process: To resolve a participant's dispute with any adverse action taken by the DASO to deny, reduce, terminate, delay, or suspend a covered service; and Governed by: COMAR 10.01.04; and Any and all applicable court orders. “Benefits” means a schedule of dental services to be administered by the DBA to Medical Assistance participants pursuant to this chapter. “Brick and mortar dental office” means the fixed and permanent location where the mobile dental unit: Is linked through either ownership or a legally binding contract; and Transmits participant records. “Claim” means an itemized statement requesting payment for services rendered by health care providers, such as dentists, billed: Electronically; Through a web-based portal; or Manually on the American Dental Association (ADA) claim form. “Consultation” means written opinion or advice rendered by a dentist, upon request by the patient's attending physician or dentist, for the further evaluation or management of the patient by the attending physician or dentist. If the consultant dentist assumes responsibility for the continuing care of the patient, a subsequent service rendered by the consultant is not a consultation. “Dental Administrative Services Organization (DASO)” means an entity with which the Department contracts to administer dental benefits by performing some or all of the following functions: General administration; Regulatory compliance; Network administration; Member services; Claims administration; Data reporting and analysis; Medical management; or Quality monitoring. “Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq., or the Department's designee. “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means comprehensive and preventive health care pursuant to 42 U.S.C. §1396d(e) as amended by OBRA 1989. “Emergency services” means services necessary for the treatment of any condition requiring immediate attention for the relief of pain, hemorrhage, acute infection, or traumatic injury to the teeth, supporting structures (that is, periodontal membranes, gums, and alveolar bone), the jaws, and tissues of the oral cavity. “EPSDT certified provider” means a physician, physician assistant, or nurse practitioner certified by the Department to provide EPSDT services. “Free-standing clinic” means a health care facility approved for participation in the Maryland Medical Assistance Program that is not licensed as a hospital or as part of a hospital or nursing home and that is not administratively part of a health maintenance organization or physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of the clinic administrator (as defined in 42 CFR §405.1801) or a health officer and which is organized and operated to provide clinic services. “General supervision” has the meaning stated in COMAR 10.44.21 and 10.44.27. “Hospital” has the meaning stated in Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland. “Maryland Healthy Smiles Dental Program” means the Maryland Medicaid dental program. “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means that a service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice, dental practice, or both; The most cost effective service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medicare” means the insurance program administered by the Federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 et seq. “Mobile dental unit” means any self-contained facility in which dentistry will be provided and which may be moved, towed, or transported from one location to another to provide clinically necessary and appropriate dental care in the unit. “Mobile dental practice” means any practice which provides the necessary and clinically appropriate dental equipment to be delivered to a community based location where dental services will be provided on site. “Network provider” means a health care entity or health care professional that has executed a provider agreement with Maryland Medicaid. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Preauthorization” means an approval required from the Department or its designee before the provision of dental or oral health care services. “Primary dental office” means the fixed and permanent location where the mobile dental unit: Is linked through either ownership or a legally binding contract; and Transmits participant records. “Program” means the Maryland Medical Assistance Program. “Provider” means: An individual dentist, duly licensed to provide services for participants, or an association, partnership, or an incorporated or unincorporated group of dentists so licensed, that, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number; or An approved dental school whose students are permitted under Health Occupations Article, §4-301(b)(1), Annotated Code of Maryland, to treat dental patients and which, through appropriate agreement with the Department, has been identified as a Program provider by issuance of an individual account number. “Referral” means a transfer of the patient from a physician or dentist to a dentist for diagnosis and treatment of the condition for which the referral was made. The dentist to whom the referral is made will no longer be considered the consultant. “REM” means the fee-for-service managed care program for individuals who have certain rare and expensive health care conditions set forth in COMAR 10.09.69. “Self-ligating braces” means braces which utilize a permanently installed, moveable component to secure the archwire without the use of ligatures. “Traditional comprehensive orthodontic treatment” means a coordinated diagnosis and treatment to improve craniofacial dysfunction or dentofacial deformity which may utilize fixed and removable orthodontic appliances and focus on specific objectives at various stages of dentofacial development. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. A dentist shall be licensed and legally authorized to practice dentistry in the state in which service is provided. All dentists and dental hygienists working for a mobile dental unit or mobile dental practice shall be currently licensed and registered with the Maryland Board of Dental Examiners. The driver of the mobile dental unit: Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; May not have violations related to the operation of a motor vehicle in the last 3 years; and May not have any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years. An EPSDT certified provider shall be: A doctor of medicine licensed and legally authorized to practice in the state in which the service is provided; A nurse practitioner who is licensed and certified to practice in the state in which services are provided; A physician assistant who is licensed to practice in the state in which services are provided; or A local health department, or a federally qualified health center, which has on its staff, and under whose supervision EPSDT services are delivered: A doctor of medicine licensed in the state in which the service is provided; A nurse practitioner licensed and certified in the state in which services are provided; or A physician assistant licensed in the state in which services are provided. The provider shall ensure that all X-ray or other radiological equipment is inspected and meets the standards established in COMAR 26.12.01 or other applicable standards established by the state in which the service is provided. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services rendered, and: If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. General requirements for participation in the Program are that a provider shall: Comply with requirements set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. To participate in the Program as a dental provider, a provider shall meet the licensure requirements established in Regulation .02 of this chapter. To participate in the Program as an EPSDT certified provider of fluoride varnish services, the provider shall: Have MDH Certification for the Application of Fluoride Varnish; and Meet the following requirements: Be board-certified in one of the following: Pediatrics; Family practice; or Internal medicine; Be a licensed physician, physician assistant, or licensed and certified nurse practitioner, delivering primary health care to children and adolescents; or Be a local health department or a federally qualified health center. The provider shall: Complete the Dental Provider Application; and Submit verification of the National Provider Identifier (NPI) Number. Mobile Dental Unit and Mobile Dental Practice. The mobile dental unit shall provide or arrange for comprehensive dental services with a participating Maryland Healthy Smiles Dental Program provider. The mobile dental unit and mobile dental practice shall be linked through either ownership or a legally binding contract to a brick and mortar dental office that has a permanent and fixed location. The brick and mortar dental office shall participate in the Maryland Healthy Smiles Dental Program. The mobile dental unit and mobile dental practice shall have and utilize the electronic technology that enables the same day exchange of patient records with: The brick and mortar dental office; and If requested, the dental office of the parent or legal guardian's choice. The mobile dental unit and mobile dental practice service area shall be limited to 30 miles in a rural setting and 10 miles in an urban setting from the brick and mortar dental office that the mobile dental unit and mobile dental practice is either owned by or with which the dental office holds a legally binding contract. A mobile dental unit and mobile dental practice shall: Maintain dental records for the patient; Observe all patient rights; Obtain written, informed consent from a parent or legal guardian, which shall: Be renewed each school year before treating a minor; and Allow the parent or legal guardian to request that the dental records be sent to a provider of their choice; Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating: Equipment; Flammability; Construction; Infection control; Sanitation procedures; and Zoning; Comply with the statutes and regulations of the Maryland Department of the Environment for all dental radiographic and imaging equipment; Obtain, keep current, and make readily available all applicable county and city licenses or permits necessary to operate the mobile dental unit or mobile dental practice which would include the active dentist, hygienist and dental assistant licenses and the dental radiographic and imaging equipment permits; Provide an update to the Department regarding any mobile dental unit or mobile dental practice provider changes within 72 hours; Provide access to a ramp or a lift if services are provided to disabled individuals; Have ready access to a properly functioning sterilization system; Have ready access to an adequate supply of potable water, including hot water; Have immediate access to toilet facilities; Have an appropriately covered noncorrosive metal container for refuse and waste materials; Have carbon monoxide and smoke detection devices or systems installed and in proper working condition; Have a chair designed and purposed exclusively for the provision of dental services; Have a dental treatment light; Have a radiograph unit with appropriate processing equipment; Have an evacuation unit suitable for dental surgical use; Have written procedures for medical emergencies; Have appropriate equipment to treat medical emergencies; Have appropriate and sufficient dental instruments and infection control supplies; and Have any other equipment or system that is necessary to provide the services being rendered by the mobile dental unit or mobile dental practice. Dental hygienists or dental assistants may not solely operate a mobile dental unit or mobile dental practice. The owner or owners of a mobile dental unit or mobile dental practice shall submit a business plan to the dental administrative service organization for the mobile unit or mobile dental practice that includes: The mission of the mobile dental unit and mobile dental practice; Verification of ownership of the mobile dental unit and mobile dental practice; A list of the clinical practitioners that will render services in the mobile dental unit or mobile dental practice; and The targeted population. The Program covers medically necessary dental services for participants younger than 21 years old and eligible former foster care participants younger than 26 years old, including but not limited to the following: Emergency, preventive, diagnostic, and treatment services; Semiannual cleaning, fluoride treatment and examination; Pit and fissure sealants for the occlusal surfaces of posterior permanent teeth that are without decay; Orthodontic care for conditions which: Have adjusted case scores of at least 15 points on the Handicapping Labio-Lingual Deviations Index (HLD) Table No. 4; and Cause dysfunction due to a handicapping malocclusion that is supported by comprehensive pretreatment orthodontic records, which include at a minimum: Cephalometric head film with analysis; Panoramic or full series periapical radiographs; Extra-oral and intra-oral photographs; Clinical summary with diagnosis; HLD score sheets from attending orthodontist; and Treatment plan; Consultations for participants who meet the requirements of §A(1), (2), (3), or (4) of this regulation; Drugs dispensed or injectable drugs administered by the dentist within the limitations of COMAR 10.09.03; Oral Health assessment by an EPSDT certified provider, and if determined medically necessary, the application of fluoride varnish for children 9 months old through 5 years old; General anesthesia during dental procedures, when it is medically necessary; and Fluoride varnish. The Program covers the following medically necessary dental services for participants 21 years old or older: Periodic, limited, and comprehensive oral examinations; X-rays, including: First and each additional intraoral periapical film; Single, two, three, or four film bitewings, which are limited to: Two per patient per year for REM participants 21 years old or older; or One per patient per year for pregnant participants 21 years old or older; and One panoramic radiographic image every 36 months; Prophylaxis for adults, which is limited to: One per patient per 3 months for REM participants 21 years old or older; or Two per patient per 12 months for adults ages 21 and over; Topical application of fluoride, which is limited to: One application per patient per 6 months for REM participants 21 years old or older; or One application per patient per year for pregnant and postpartum participants 21 years old or older; Amalgam restorations for permanent teeth for one, two, three, four, or more surfaces, which are limited to one identical restoration per tooth per 24 months; Resin restorations for anterior permanent teeth for one, two, three, four, or more surfaces or involving incisal angle, which are limited to one identical restoration per tooth per 24 months; Other restorative services including: Recementing of crowns, which is limited to two times for the same crown; Prefabricated stainless steel crown for permanent teeth; Fillings — sedative, interim or temporary filling; and Pin retention — per tooth, in addition to restoration; Pulp capping, direct and indirect, excluding final restoration; Gingovectomy or gingivoplasty — per quadrant, which is limited to two quadrants per year per patient; Periodontal scaling and root planning — per quadrant; Full mouth debridement, which is limited to one per patient per 2 years, and may not be completed on the same day as prophylaxis; Periodontal maintenance — following active periodontal therapy, which is limited to two per patient per year; Adjustment of complete maxillary and mandibular denture; Adjustment of partial maxillary and mandibular denture; Recementing of bridge, which is limited to two times for the same bridge; Extractions of: Coronal remnants for deciduous teeth; and Erupted tooth or exposed root; Biopsy of oral tissue, hard or soft; Alveoplasty, in conjunction or not in conjunction with extractions — per quadrant; Incision and drainage of abscess intraoral; and Palliative emergency treatment of dental pain that is not associated with recently rendered service. The Program shall reimburse for covered services in §§A and B of this regulation if: The services are rendered in: The dentist's office; The participant's home by an approved mobile dental unit; A general acute hospital; A skilled or intermediate care nursing facility; A free-standing clinic; An EPSDT certified provider's office; An approved mobile dental unit or mobile dental practice; A Medicare-certified ambulatory surgical center; or Via telehealth in compliance with COMAR 10.09.49. The services are provided by the dentist or one of the following: Another licensed dentist enrolled with Medicaid in the dentist’s employ; A dental hygienist or dental assistant, provided that the individual rendering the service is: In the dentist's employ or in the employ of a public health program; Under general supervision of a licensed dentist; and Within the scope of the individual’s training or certification for the purpose of assisting in the provision of dental services; or An EPSDT certified provider for the purpose of applying fluoride varnish; The services are clearly related to the participant's individual dental care needs as ameliorative, diagnostic, curative, palliative, preventive, or rehabilitative services; and The services are adequately described on the participant's dental care record in accordance with record-keeping practices detailed in COMAR 10.44.30. The Program places the following limitations upon covered services: Reimbursement for a complete radiographic survey or full series of X-rays of the mouth may not be made more frequently than once every 3 years to the same provider, or in the case of a group practice, to any partner or associate of that practice, unless medically necessary or specifically required or requested by the Program. For any traumatic injury case, a provider may be reimbursed for a maximum of four panoramic or other extra-oral radiographs. When services are rendered by members of a group practice or association, reimbursement to the group practice or association shall also be limited to a maximum of four panoramic or other extra-oral radiographs. Endodontic therapies and pulpectomies may not be covered when: Root resorption has started and exfoliation is imminent; Gross periapical or periodontal pathosis is demonstrated on the radiograph; or The general oral condition does not justify endodontic therapy. Reimbursement for crowns will be limited to permanent resin fused to metal crowns, permanent porcelain fused to metal crowns, permanent nonprecious metal (full cast), provisional resin crowns, prefabricated zirconia crowns, and stainless steel crowns. Composite restorations will be covered for all teeth when necessary for the particular conditions of the patient. Replacement dentures for participants who meet the requirements of Regulation .04A(3) of this chapter will be covered only when: Dentures have been lost, broken, or stolen after 1 year of placement; or Adjustment, repair, relining, or rebasing of the patient's present denture does not make it serviceable. Rebasing is included in the 6 months of aftercare following denture placement, and may not be provided more frequently than once every 2 years after that. Reimbursement for endodontic therapy includes all diagnostic tests, preoperative and postoperative radiographs, preoperative and postoperative treatments, pulpotomies and pulpectomies. Reimbursement for a sinus closure will only be made when this service is rendered as a separate procedure and not in conjunction with the removal of a tooth. Separate reimbursement will not be made for cavity liners and office visits, as these procedures are considered to be components of the necessary treatment. These services may not be billed to the participant. The provider may bill for emergency treatment or for the actual dental procedures rendered during an emergency visit, but not for both. Gold restorations, gold crowns, and gold replacement appliances are not covered services. The Program's fee for a complete series of intra-oral radiographs including bitewings, represents the maximum payable for any combination of periapical X-rays and bitewings. Assistant surgeons' services are covered only: As specified in Regulation .07M of this chapter; If the procedures were rendered in a hospital or a Medicare-certified ambulatory surgery center; and If the assistant surgeon is a dentist. The Program does not cover: Fixed bridge work; Cosmetic procedures; Inpatient hospital dental or oral health care services rendered during an admission; Services which are investigational or experimental; Local anesthesia as a separate charge; Duplication of dentures; Drugs and supplies dispensed by the dentist which are acquired by the dentist at no cost; Referrals; Diagnostic models as a separate charge; Office visits as a separate service; Immediate dentures; Consultant payments when a member of the house staff of a hospital either requests or provides the consultations or, in the case of a group practice, to any partner or associate of that practice who either requests or provides the consultation; Aftercare services as a separate charge to a provider or, in the case of a group practice, to any partner or associate of that practice; Services when reimbursement is included under another segment of the Program; Unilateral partial dentures replacing fewer than three teeth, excluding third molars; Implants; More than one, per participant per lifetime, of the following services: Traditional comprehensive orthodontic treatment; or Self-ligating braces; and Services rendered without the required preauthorization. Preauthorization is issued when: Program procedures are met; Program limitations are met; The provider submits to the Department, adequate documentation demonstrating that the service to be preauthorized is medically necessary; and The participant is eligible for the service. Preauthorization is required for the following: Resin fused to metal crown; Porcelain fused to metal crown; Nonprecious metal crown (full cast); Apicoectomies and periradicular services; Certain periodontal services; Complete upper/lower denture; Partial upper/lower denture (including clasps and teeth); Any elective clinical or surgical procedure not listed on the current dental fee schedule; Surgery normally considered cosmetic but qualified by traumatic or pathological causation; Laboratory rebasing of dentures; Addition of teeth or clasps to an existing, functional complete or partial denture; General restorative treatment to be rendered in a hospital; Special periodontal appliances; Apexification and recalcification procedures; Hemisection, including any root removal, including endodontic therapy; Overdenture complete; Overdenture partial; Condylectomy; Meniscectomy; Arthrotomy; and All orthodontic procedures. At a minimum, the documentation required when requesting preauthorization for the following services is: A complete radiographic survey of the mouth for: Complete or partial dentures; or Except in the case of special needs children, where sedation would be required for a complete radiograph of the mouth, special periodontal appliances and periodontal therapies; Individual periapical radiographs for: Except in the case of special needs children, where sedation would be required for an individual periapical radiograph or bitewing, endodontic therapy (periapicals and bitewings shall be submitted when the request is for posterior teeth); Apicoectomy; Except in the case of special needs children, where sedation would be required for an individual periapical radiograph, periradicular and apexification or recalcification services; and Full coverage permanent crown restorations (excludes stainless steel and provisional resin crowns); and Full mouth radiographs and a periodontal chart, identifying the depths and locations of the pockets, when periodontal services are requested. Except as described in §F of this regulation, preauthorization is valid for dental services when the services are approved and completed within 6 months after the date of the receipt of the preauthorization number from the Program. Preauthorization normally required by the Program is waived when the services are covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A—D of this regulation. Preauthorization for Orthodontic Treatment. Preauthorization is required for traditional comprehensive orthodontic treatment and for self-ligating braces for the correction of medically necessary conditions, which cause dysfunction due to a handicapping malocclusion. At a minimum the following comprehensive pretreatment documentation shall be submitted: Cephalometric head film with analysis; Panoramic or full series of periapical radiographs; 68 diagnostic quality extra-oral and intra-oral photographs; Clinical summary with diagnosis; HLD score sheets from attending orthodontist; and Treatment plan. Preauthorization for periodic orthodontic treatment is valid for: 24 months for traditional comprehensive orthodontic treatment; or 12 months for self-ligating braces. To obtain compensation from the Department for covered services, the provider shall submit a request for payment on the form designated by the Department with the following data or attachments: If applicable, the preauthorization number shall be inserted in the designated appropriate field on the invoice claim form; If applicable, pathology reports shall be attached to the claim form; and If applicable, comprehensive narratives shall be attached to the claim form for those services that are “By Report”. The Department reserves the right to return to the provider, before payment, all invoices not properly signed or completed. All prosthetic appliances shall be inserted in the mouth and adjusted before the Program is billed, except when the patient has expired, cannot be located, or refuses to return for completion of treatment. In these cases, the Department will reimburse the provider 80 percent of the maximum State fee for the procedure code for the laboratory bill only. The provider shall charge the Program the provider's customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §E of this regulation; and The current Maryland Medicaid Dental Services Fee Schedule and Procedure Codes CDT is incorporated by reference, effective January 1, 2024. The provider shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate in accordance with the Department's fee schedule. The provider may not bill the Department or the participant for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail or telephone; or Providing a copy of a participant's medical record when requested by another licensed provider on the participant's behalf. Reimbursement for Traditional Comprehensive Orthodontic Treatment. The Program shall reimburse for orthodontic treatment for a maximum of 24 periodic visits at an established rate, provided the treatment meets the standards established in COMAR 10.09.05.06F. Orthodontic treatment is a once in a lifetime benefit. Reimbursement for Self-Ligating Braces. The Program shall reimburse for: A pre-orthodontic visit; Comprehensive orthodontia; and A maximum of 12 periodic treatment visits at an established rate, provided the treatment meets the standards established in COMAR 10.09.05.06F. When a claim is submitted to the Program for the banding of self-ligating braces, the following documentation shall be submitted with the claim: A photograph of the recipient's oral cavity to confirm the placement of self-ligating braces; and A statement signed by the parent or guardian of the child receiving treatment, acknowledging that: Orthodontic services are a once in a lifetime benefit; and The participant will not be able to pursue additional orthodontic services from the Medicaid Program at a later date. The Department may not make direct payment to nurses, dental assistants, anesthetists, or dental hygienists. The Department may not make direct payment to the participant. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Those dental clinics licensed as part of a hospital in Maryland may charge and be reimbursed according to rates approved by the Health Services Cost Review Commission (HSCRC) pursuant to COMAR 10.37.03. Payment for assistant surgeons' services is a maximum of 20 percent of the listed fee paid to the primary surgeon or the fee as determined by the Program for the treatment rendered. The minimum allowance is $25 or the dentist's charge, whichever is lower. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the participant for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. If the Department determines that a provider, dentist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Department; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. The Department shall give to the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. Any provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify participants that the provider no longer honors Medical Assistance cards before rendering additional services. Providers may exercise appeal rights pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. The provider may appeal a decision to the Office of Administrative Hearings as specified in COMAR 10.09.36.09. Except when the language of a specific regulation indicates an attempt by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: January 1, 1976 (2:29 Md. R. 1740) Regulations .01—.10 amended effective October 13, 1976 (3:21 Md. R. 1206) Regulations .01I, .04A, .05, and .06B amended as an emergency provision effective February 1, 1982 (9:2 Md. R. 110); emergency status extended at 9:11 Md. R. 1122 and 9:17 Md. R. 1697 (Emergency provisions are temporary and are not printed in COMAR) Regulation .06C adopted effective April 4, 1980 (7:7 Md. R. 708) Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) Regulation .07F amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended to June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) Regulation .07L amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Chapter revised effective January 1, 1983 (9:25 Md. R. 2480) Regulations .01, .04, and .05 amended as an emergency provision effective December 2, 1992 (19:26 Md. R. 2282); amended permanently effective June 1, 1993 (20:10 Md. R. 851) Regulation .01B amended effective October 1, 1985 (12:19 Md. R. 1848); August 27, 2007 (34:17 Md. R. 1507); May 19, 2008 (35:10 Md. R. 972) Regulation .01B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787); March 30, 2015 (42:6 Md. R. 511); March 14, 2016 (43:5 Md. R. 385); August 14, 2017 (44:16 Md. R. 808); May 20, 2019 (46:10 Md. R. 485); November 15, 2021 (48:23 Md. R. 979); July 10, 2023 (50:13 Md. R. 512); October 13, 2025 (52:20 Md. R. 1001) Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .02 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .02 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02C amended effective October 13, 2025 (52:20 Md. R. 1001) Regulation .02D amended effective May 19, 2008 (35:10 Md. R. 972) Regulation .02E amended effective May 20, 2019 (46:10 Md. R. 485) Regulation .02F amended effective August 14, 2017 (44:16 Md. R. 808) Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 485); July 10, 2023 (50:13 Md. R. 512) Regulation .03B amended effective May 19, 2008 (35:10 Md. R. 972) Regulation .03E amended effective November 15, 2021 (48:23 Md. R. 979); October 13, 2025 (52:20 Md. R. 1001) Regulation .03F adopted effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03F amended effective March 14, 2016 (43:5 Md. R. 385); August 14, 2017 (44:16 Md. R. 808) Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .04 amended effective May 19, 2008 (35:10 Md. R. 972) Regulation .04 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .04 amended effective August 14, 2017 (44:16 Md. R. 808); May 20, 2019 (46:10 Md. R. 485); November 15, 2021 (48:23 Md. R. 979); July 10, 2023 (50:13 Md. R. 512) Regulations .04A, .05A, and .07E amended, and .07N adopted as an emergency provision effective February 1, 1989 (16:3 Md. R. 336); adopted permanently effective June 1, 1989 (16:10 Md. R. 1108) Regulation .04B amended effective October 13, 2025 (52:20 Md. R. 1001) Regulation .04C amended effective December 27, 2010 (37:26 Md. R. 1787); March 30, 2015 (42:6 Md. R. 511) Regulation .05 amended effective October 1, 1985(12:19 Md. R. 1848); May 19, 2008 (35:10 Md. R. 972) Regulation .05 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .05 amended effective May 20, 2019 (46:10 Md. R. 485); October 13, 2025 (52:20 Md. R. 1001) Regulation .05A amended effective August 14, 2017 (44:16 Md. R. 808) Regulation .05B amended effective November 15, 2021 (48:23 Md. R. 979) Regulation .05C repealed effective July 10, 2023 (50:13 Md. R. 512) Regulation .06 amended effective May 19, 2008 (35:10 Md. R. 972) Regulation .06 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .06 amended effective November 15, 2021 (48:23 Md. R. 979) Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .06B amended effective October 1, 1985 (12:19 Md. R. 1848); December 24, 1990 (17:25 Md. R. 2907); July 10, 2023 (50:13 Md. R. 512) Regulation .06D amended effective August 14, 2017 (44:16 Md. R. 808) Regulation .06F amended effective December 27, 2010 (37:26 Md. R. 1787); March 14, 2016 (43:5 Md. R. 385) Regulation .07 amended effective October 1, 1985 (12:19 Md. R. 1848) Regulation .07 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .07 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1381); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) Regulation .07 amended effective May 19, 2008 (35:10 Md. R. 972) Regulation .07 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .07 amended effective December 27, 2010 (37:26 Md. R. 1787); May 20, 2019 (46:10 Md. R. 485); July 10, 2023 (50:13 Md. R. 512) Regulation .07D, F, G amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07E amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811) Regulation .07E amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .07E amended effective April 20, 1998 (25:8 Md. R. 596) Regulation .07E amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); amended permanently effective October 30, 2000 (27:21 Md. R. 1976) Regulation .07E amended as an emergency provision effective October 1, 2001 (28:23 Md. R. 2052); adopted permanently effective January 21, 2002 (29:1 Md. R. 23) Regulation .07E amended as an emergency provision effective March 25, 2004 (31:8 Md. R. 643); amended permanently effective June 21, 2004 (31:12 Md. R. 911) Regulation .07E amended effective August 15, 2005 (32:16 Md. R. 1392); August 27, 2007 (34:17 Md. R. 1508); March 30, 2015 (42:6 Md. R. 511); October 13, 2025 (52:20 Md. R. 1001) Regulation .07E, G amended effective August 27, 2018 (45:17 Md. R. 803) Regulation .07E, I amended effective November 15, 2021 (48:23 Md. R. 979) Regulation .07E, I, K amended effective August 14, 2017 (44:16 Md. R. 808) Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07L amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .08 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1381); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029); August 14, 2017 (44:16 Md. R. 808) Regulation .09 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .09D amended effective August 14, 2017 (44:16 Md. R. 808) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .10 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) Regulation .10 amended effective October 13, 2025 (52:20 Md. R. 1001) Regulation .11 amended effective August 14, 2017 (44:16 Md. R. 808) This chapter governs residential substance use disorder services for adults, effective July 1, 2017. In this chapter, the following terms have the meanings indicated. Terms Defined. “Accrediting body” means an entity approved by the Secretary or the Secretary’s designee, under Health-General Article, §19-2302, Annotated Code of Maryland. “Administrative day” means a day of services rendered to a participant who no longer requires the level of care the provider is licensed to deliver, but still requires the level of care in an ASAM Level 3.3, 3.5, or 3.7 setting. “Administrative service organization (ASO)” means the entity under contract with the Department to provide administrative services to operate the Maryland Public Behavioral Health System. “American Society of Addiction Medicine (ASAM) criteria” means an instrument designed to indicate placement guidelines for admission, continued stay, and discharge of individuals with a substance use disorder. “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services. “Available” means a staff member is on-site, available by phone, or on call. “Behavioral Health Administration” means the administration within the Department that establishes regulatory requirements that behavioral health providers are to maintain in order to become certified or licensed by the Department. “Certified counselor” means a provider approved by the Board of Professional Counselors and Therapists under COMAR 10.58. “Coordinating aftercare services” means being responsible for assisting participants with resources, appointments, and discharge plans. “Crisis intervention” means the methods used to offer short term immediate help to individuals who have experienced an event that produces mental, physical, emotional, and behavioral distress. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Discharge plan” means a written description of specific goals and objectives to assist the participant upon leaving treatment. “Documentation” means the written medical record. “Evidence-based practice” means a practice approved by the Behavioral Health Administration that applies to certain clinical or rehabilitative interventions provided by public mental health service providers. “Facility director” means an individual on staff who is responsible for overseeing the daily operation of the residential treatment facility. “Individualized treatment plan” means a written plan that: Addresses the individual’s biopsychosocial needs through goals and objectives; and Is updated as needed according to the treatment modality. “License” means the approval issued by the Secretary or designee that permits a behavioral health provider to operate in Maryland. “Licensed mental health clinician” means a staff member who is eligible to provide mental health services as outlined in COMAR 10.09.59.04A. “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Participant” census means a record of participants actively in the care of the provider. “Program” means the Maryland Medical Assistance Program. “Progress” note means an objective documentation of the participants progress in relation to specific treatment goals and objectives. “Provider” means a residential treatment facility that provides professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting. “Substance use disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances. “Substance use disorder services” means the services for which a participants diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter. To participate in the Program, a provider shall: Meet the license requirements stated in COMAR 10.09.36.02 and, after April 1, 2018, COMAR 10.63.01.05; Be accredited by a Maryland-approved accrediting body; and Be licensed by the Behavioral Health Administration (BHA) for each level of care. General requirements for participation in the Program are that a provider shall: Comply with requirements set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. To participate in the Program as a residential substance use disorder provider, the provider shall: Be in compliance with COMAR 10.63.03 as applicable to each ASAM level of care; Be in compliance with all ASAM requirements for each applicable level of care; Demonstrate competence in the ability to deliver a minimum of three evidence-based practice services; Complete all required documentation associated with the application process; Maintain verification of licenses and credentials, including background checks, of all professionals employed by or under contract with the provider in their respective personnel files; Maintain staffing within each ASAM level of care as described in §§C—G of this regulation; Increase staffing within each ASAM level of care at a ratio to correspond with the participant census to meet required ASAM level of service delivery for each patient; Maintain adequate documentation of each clinical contact with a participant as part of the medical record, which includes, at a minimum: An individualized treatment plan; The date of all clinical encounters with start and end times and a description of services provided; Documentation of all clinical services received by the participant; Progress notes updated on each day services are provided; An individualized discharge plan; and An official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate degree or title on all clinical progress notes; Maintain adequate documentation indicating that the participant continues to meet the medical necessity criteria for the applicable ASAM level of care; Make the documentation required under this subtitle, or necessary to substantiate compliance with this subtitle, available as requested to carry out required activities, to the: Department; ASO; Core Service Agency; Local addictions authority; Local behavioral health authority; Office of Inspector General of the Department; and Office of the Attorney General Medicaid Fraud Control Unit; and Comply with all federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164.04 Participant Eligibility and Referral. A residential, low-intensity level 3.1 provider shall: Provide therapeutic services for a minimum of 5 hours per week; Coordinate aftercare services through: Peer support; or A licensed provider; At a minimum, maintain the following staff: A part-time program director on-site 20 hours per week; A clinical director serving the program 20 hours per week who: May also be the program director; Is responsible for the supervision of the program’s clinical services, counselors, peer support staff, and coordination of all care provided by outside programs; and Is identified under COMAR 10.09.59.04 as an individual practitioner provider or certified and approved by the Board of Professional Counselors and Therapists as a supervisor; A licensed or certified counselor on-site 40 hours per week; Peer support staff; and At least one staff member on duty between 11 p.m. and 7 a.m. who is: Certified in cardiopulmonary resuscitation; Certified in Narcan administration; and Trained in crisis intervention. A residential, medium intensity level 3.3 provider shall: Have sufficient physician, physician assistant, or nurse practitioner services to: Provide initial diagnostic work-up; Provide identification of medical and surgical problems for referral; and Handle medical emergencies when necessary; Provide therapeutic activities from 20 to 35 hours per week; Coordinate aftercare services through: Peer support; or Licensed provider; Have at least one staff member: Certified in cardiopulmonary resuscitation; Trained in crisis intervention; and On duty between 11 p.m. and 7 a.m.; Have a part-time facility director on-site 20 hours per week; and At a minimum, maintain the following staff: A physician, nurse practitioner, or physician assistant on-site 4 hours per week and 1 hour on call; A psychiatrist or psychiatric nurse practitioner available 3 hours per week; A registered nurse or licensed practical nurse on-site 40 hours per week; and An on-site multi-disciplinary team consisting of: A clinical supervisor; A licensed mental health clinician; A certified counselor under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and Peer support staff. A residential, high intensity level 3.5 provider shall: Have sufficient physician, physician assistant, or nurse practitioner services to: Provide initial diagnostic work-up; Provide identification of medical and surgical problems for referral; and Handle medical emergencies when necessary; Provide a minimum of 36 hours of therapeutic activities per week; Coordinate aftercare services through: Peer support; or A licensed provider; Have at least one staff member: Certified in cardiopulmonary resuscitation; Trained in crisis intervention; and On duty between 11 p.m. and 7 a.m.; Have a part-time facility director on-site 20 hours per week; and At a minimum, have the following staff: A physician, nurse practitioner, or physician assistant on-site 1 hour per week; A psychiatrist or psychiatric nurse practitioner available 1 hour per week; An on-site multi-disciplinary team consisting of: A clinical supervisor; A licensed mental health clinician; Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and Peer support staff. A residential, intensive level 3.7 provider shall: Have sufficient physician, physician assistant, or nurse practitioner services to: Provide initial diagnostic work-up; Provide identification of medical and surgical problems for referral; and Handle medical emergencies when necessary; Provide a minimum of 36 hours of therapeutic activities per week; Coordinate aftercare services through: Peer support; or Licensed provider; Have at least two staff members: Certified in cardiopulmonary resuscitation; Trained in crisis management; and On duty between 11 p.m. and 7 a.m.; Have a part-time facility director on-site 20 hours per week; and At a minimum, have on staff a: Physician, nurse practitioner, or physician assistant on-site 5 hours per week and 2 hours on call; Psychiatrist or psychiatric nurse practitioner available 10 hours per week; Nurse on-site 168 hours per week, with a minimum of 56 hours provided by a registered nurse; On-site multi-disciplinary team consisting of: A clinical supervisor; A licensed mental health clinician; Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and Peer support staff. A withdrawal management service level 3.7-WM provider shall: Have a part-time facility director on-site 20 hours per week; Coordinate aftercare services through: Peer support; or Licensed provider; and At a minimum, have on staff: A physician, nurse practitioner, or physician assistant on-site 20 hours per week and 4 hours on call; A psychiatrist or psychiatric nurse practitioner available 8 hours per week; A registered nurse on-site 56 hours per week; A licensed practical nurse on-site 112 hours per week; and An on-site multi-disciplinary team consisting of: A clinical supervisor; A licensed mental health clinician; Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and Peer support staff. A participant is eligible for substance use disorder services under this chapter if the participant: Is enrolled in the Program and is not enrolled in Medicare on the day a service is rendered; Meets the Department’s medical necessity criteria based on the ASAM placement criteria for each level of care; and Is 18 years old or older and is not receiving care from a provider under COMAR 10.09.23.04. A residential, low intensity level 3.1 provider shall provide: Therapeutic substance use disorder services for a minimum of 5 hours per week; and Services in a structured environment in combination with low-intensity treatment and ancillary services to support and promote recovery. A residential-medium intensity level 3.3 provider shall: Provide clinically managed substance use disorder treatment 20 to 35 hours per week based on a comprehensive assessment; and Provide services in a structured environment in combination with medium-intensity treatment and ancillary services to support and promote recovery. A residential, high intensity level 3.5 provider shall: Provide clinically managed substance use disorder treatment at least 36 hours per week based on a comprehensive assessment; and Provide services in a highly structured environment, in combination with medium-intensity to high-intensity treatment and ancillary services to support and promote recovery. A residential-intensive level 3.7 provider shall: Provide medically monitored, intensive substance use disorder treatment at least 36 hours per week based on a comprehensive assessment; and Offer a planned regimen of 24-hour professionally directed evaluation, care, and treatment in an inpatient setting. A withdrawal management service level 3.7 provider shall offer 24-hour medically supervised evaluation and withdrawal management. The Program shall cover services under this chapter rendered via telehealth in accordance with COMAR 10.09.49 when: Provided by licensed or certified staff; The originating site at which the participant receives the service is the adult residential substance use disorder service site; and Total services rendered via telehealth comprise no more than 50 percent of all clinical services. The Program does not cover the following in a residential substance use disorder treatment facility for adults: Services not medically necessary; ASAM Level 2 services by any provider; Except for services rendered to individuals in a residential, low-intensity program, ASAM Level 1 services by any provider; Services not specified in Regulation .06 of this chapter; Services beyond the provider’s scope of practice; Investigational and experimental drugs and procedures; Services rendered but not appropriately documented; and Services not preauthorized as required in Regulation .08 of this chapter. Additional services rendered via telehealth when telehealth services comprise more than 50 percent of a participant's weekly clinical services. The provider shall obtain authorization from the ASO to provide residential substance use disorder services outlined in Regulation .06 of this chapter. The ASO agent shall authorize services that are: Medically necessary for the applicable level of service as outlined by ASAM criteria for admission; and Of a type, frequency, and duration that are consistent with expected results and cost-effectiveness. No payment shall be rendered for services that have not been authorized by the Department or its designee. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. For dates of service from July 1, 2023 through December 31, 2023, rates for the services outlined in this chapter shall be as follows: For ASAM Level 3.1, the provider shall receive $104.62 per diem; For ASAM Level 3.3, the provider shall receive $233.14 per diem; For ASAM Level 3.5, the provider shall receive $233.14 per diem; For ASAM Level 3.7, the provider shall receive $358.93 per diem; and For ASAM Level 3.7-WM, the provider shall receive $436.38 per diem. For dates of service from January 1, 2024 through June 30, 2024, rates for the services outlined in this chapter shall be as follows: For ASAM Level 3.1, the provider shall receive $112.99 per diem; For ASAM Level 3.3, the provider shall receive $251.79 per diem; For ASAM Level 3.5, the provider shall receive $251.79 per diem; For ASAM Level 3.7, the provider shall receive $387.64 per diem; and For ASAM Level 3.7-WM, the provider shall receive $471.40 per diem. For dates of service beginning July 1, 2024, rates for the services outlined in this chapter shall be as follows: For ASAM Level 3.1, the provider shall receive $116.38 per diem; For ASAM Level 3.3, the provider shall receive $259.34 per diem; For ASAM Level 3.5, the provider shall receive $259.34 per diem; For ASAM Level 3.7, the provider shall receive $399.27 per diem; and For ASAM Level 3.7-WM, the provider shall receive $485.54 per diem. Administrative Days. The Department shall pay at the daily rate based on the patient’s ASAM level of care when: The participant’s required level of care has changed, and the following conditions are met: The provider has implemented a predischarge planning program and initiated placement activities for the participant at the earliest appropriate time; The provider has actively pursued placement of the participant at the required level of care in an appropriate facility during the entire period of administrative days; The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §E(1)(a)—(b) of this regulation for the entire period of the administrative stay claimed for reimbursement; and The participant is transferred promptly to the first available appropriate facility licensed and certified for the required level of care; and The participant is at an inappropriate level of care but cannot be moved, and the following conditions are met: The attending physician has declared that, because of physical or emotional problems, the participant is unable to be moved; and The reason the participant cannot be moved is adequately documented by the attending physician in the participant’s record. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09. Health-General Article, §§2-104(b), 7.5-204(c), 7.5-205(d), 15-105(b), and 15-141.2, Annotated Code of Maryland Effective date: September 11, 2017 (44:18 Md. R. 865) Regulation .02B amended effective April 4, 2022 (49:7 Md. R. 465); October 16, 2023 (50:20 Md. R. 886) Regulation .03C amended effective April 4, 2022 (49:7 Md. R. 465) Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .04A amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .06F adopted effective October 16, 2023 (50:20 Md. R. 886) Regulation .07 amended effective December 30, 2019 (46:26 Md. R. 1164); October 16, 2023 (50:20 Md. R. 886) Regulation .09 amended effective October 16, 2023 (50:20 Md. R. 886); September 16, 2024 (51:18 Md. R. 808) Regulation .09C amended effective December 31, 2018 (45:26 Md. R. 1242); December 30, 2019 (46:26 Md. R. 1164); April 4, 2022 (49:7 Md. R. 465) Regulation .09D—E amended effective April 4, 2022 (49:7 Md. R. 465); November 24, 2025 (52:23 Md. R. 1138) The following terms have the meanings indicated. Terms Defined. “Adult Day Care Assessment and Planning System (ADCAPS)” means a system that is comprised of a comprehensive assessment completed by a registered nurse, which is designed to evaluate the participant’s strengths and needs, and to facilitate the development of a problem list, service plan, and plan of care. “Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with the waiver, this chapter, and COMAR 10.09.30, assesses waiver applicants and participants. “Advance directive” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland. “Community Settings Questionnaire” means the participant survey, completed annually or when a participant changes medical day care centers or sites, that is part of the State’s strategy to validate provider compliance with federal requirements on home and community based settings. “Daily attendance record” means a daily attendance account of the physical presence of each medical day care participant that: Is designed by the provider; Is signed and dated by the staff designated to take attendance or by the medical day care director; and Includes the name, medical assistance number, date of service, and arrival and departure times, of each participant, including documentation of time of temporary absences. “Department” means the Maryland Department of Health. “Home and community based services waiver” means a program implemented by the Department and approved by the Secretary of Health and Human Services, which authorizes the waiver of certain specified federal statutory requirements limiting coverage for home and community based services under the Maryland Medical Assistance Program. “Licensed practical nurse” means an individual licensed to practice licensed practical nursing under Health Occupations Article, Title 8, Annotated Code of Maryland. “Licensed social worker” means an individual who is licensed to practice social work under Health Occupations Article, Title 19, Annotated Code of Maryland. “Maintenance services” means the periodic monitoring of medically stable patients and the services provided in order to maintain their health care status. “Medical Assistance Program” means the Program administered by Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients. “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults, who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living. “Medical day care center” means a facility operated for the purpose of providing medical day care services in an ambulatory care setting to medically handicapped adults who do not require 24-hour inpatient care, but, due to their degree of impairment, are not capable of full-time independent living. “Medical director” means an individual who is: Licensed to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland; and Employed by the medical day care center either as a staff member or by a contractual agreement. “Medically handicapped adult” has the meaning stated in Health-General Article, §14-301(c), Annotated Code of Maryland. “Medically necessary” means that a service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Multidisciplinary team” means the group consisting of members of the medical day care center’s professional staff, the participant, the participant’s authorized representative, health care professionals, and waiver case managers, as appropriate, that establishes and updates the participant’s service plan and plan of care. “Occupational therapist” means an individual who practices occupational therapy under Health Occupations Article, Title 10, Annotated Code of Maryland. “Occupational therapy” means medically prescribed treatment concerned with improving or restoring functions which have been impaired by illness or injury or, when function has been permanently lost or reduced by illness or injury, concerned with improving the individual's ability to perform those tasks for independent functioning. “Participant” means an individual: Who is a medically handicapped adult as defined under §B(14) of this regulation and who is certified by the Department or its designee as requiring nursing facility services, as defined under COMAR 10.09.10, but whose condition does not require institutional care if medical day care services or other services that provide alternatives to institutional care are available; Who is enrolled in a home and community based services waiver that includes medical day care as a waiver service; and Whose disabilities and needs cannot be satisfactorily and totally met in an episodic ambulatory care setting but require participation at least 1 day a week in a day-long rehabilitative or maintenance ambulatory care program which provides a mix of medical and social services and is authorized in the participant’s home and community based services waiver service plan. “Personal care services” means assistance with activities of daily living. “Physical therapist” means an individual licensed to practice physical therapy under Health Occupations Article, Title 13, Annotated Code of Maryland. “Physical therapy” means treatment of disease and injury through use of: Therapeutic exercise and modalities of heat, cold, water, light, electricity, massage and radiant energy (other than roentgen rays, radium or use of electricity for cauterization in surgery); or Administration and interpretation of tests and measurements of neuromuscular and musculoskeletal functions; or Both §B(22)(a) and (b) of this regulation. “Plan of care” means a written plan established by the multidisciplinary team in accordance with COMAR 10.12.04.22, based upon a medical order and an assessment of the participant’s health status and special care requirements. “Preventive services” means those services designed to prevent the occurrence and/or progression of disease at an early stage before complications and serious disabilities develop. “Primary care provider” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant. “Program” means the Maryland Medical Assistance Program. “Provider” means a facility licensed under COMAR 10.12.04 furnishing medical day care services through an appropriate agreement with the Department and identified as a provider by the issuance of an individual account number. “Provider agreement” means a contract between the Department of Health and the provider of medical day care, specifying the services to be performed, methods of operation, financial and legal requirements which shall be in force before Program participation in medical day care. “Recipient” means a person who is certified for, and is receiving, Medical Assistance benefits. “Referral” means to direct a participant, family member, or caretaker to the appropriate community agency or health care provider, or to contact the agency or provider on the participant's behalf, to facilitate access to needed services. “Registered nurse” means an individual licensed to practice as a registered nurse under Health Occupations Article, Title 8, Annotated Code of Maryland. “Secretary” means the Secretary of Health. “Service Plan” means an approved document which specifies the type, amount, frequency, and duration of all waiver and other Medicaid services required to safely support the waiver participant in the community. “Significant change in condition” means a change in the participant’s physical, mental, or psychological status as identified by the comprehensive assessment performed by a registered nurse. “Specially equipped vehicles” means those vehicles used to transport participants with severe physical disabilities that limit mobility. “Supervision” means initial direction or periodic monitoring of the actual activity. The provider shall be licensed under COMAR 10.12.04. Requirements for providing medical day care services are that the providers shall: Meet the licensure requirements as provided in Regulation .02 of this chapter; Meet the requirements of COMAR 10.09.36; Be open to participants at least 6 hours a day, 5 days a week, and post hours of operation; Verify the licenses and credentials for all professionals employed by or contracting with the medical day care center; Provide or arrange for the provision of any covered service, as specified in Regulation .05 of this chapter, or any other service which is required by a plan of care; Demonstrate to the satisfaction of the Program that a need exists for medical day care in the service area and that the provider has the necessary expertise to deliver the service; Have policies and procedures as required under COMAR 10.12.04; Maintain medical records for each participant which shall include, as a minimum, the following: An application for admission; The medical day care center's plan of care as required under §M(3)—(4) of this regulation; The current home and community based services waiver service plan or the approved medical day care preauthorization form for the participant; Medical orders for all services rendered which may include, but is not limited to, the: Type and duration of service; Frequency of service; and Dosage and frequency of medications when prescribed; The medical history, chronic illnesses, principal and significant diagnoses, prognoses, prescribed medications, special diets, allergies, and assessments of the recipient's physical and mental status specifying the general types of activities the recipient can and cannot do; The documentation of daily nursing observations for the first 5 days of attendance, and monthly after the first 5 days of attendance; and The initial social history, ADCAPS assessment, and, when needed, social service and activity progress notes; Have an emergency plan for each participant which includes, as a minimum, an easily located file on each participant, listing: The name and telephone number of the participant’s primary care provider; The advance directive in accordance with Health-General Article, §5-602, if requested or made by the participant; All allergies identified by the participant or the participant’s primary care provider; The treatments or medications for a participant's conditions; and The name and telephone number of a family member, caregiver, or friend to be notified in case of emergency; Provide training for medical day care staff in emergency procedures, including cardiopulmonary resuscitation and first aid; Have accurate daily attendance records that are easily retrievable and available for review by the Program; Have accurate daily transportation records that are easily retrievable and available for review by the Program, and shall include, as a minimum, each participant's transportation plan; Establish a multidisciplinary team who shall: Assess the participant to determine the appropriateness of the medical day care center's care, interventions, and activities; Determine the medical, psychosocial, and functional status of each participant by: Establishing the ADCAPS evaluations on the date of admission; and Completing the assessment with an initial plan of care within 30 days, after which the ADCAPS evaluations shall be conducted every 4 months; Develop an individual plan of care in conjunction with the service plan; Review and update with the participant or participant’s representative, the individual plan of care semi-annually, or more frequently when a significant change in condition is identified or reported; and Obtain the signature of the participant or the participant’s representative to document their approval of the individual plan of care semi-annually, or more frequently when a significant change in condition is identified or reported. Have a quality assurance program which includes, as a minimum, health care audits and utilization reviews that: Consist of a review of medical records on all participants that evaluate the appropriateness of admissions, the efficiency, adequacy, and coordination of provided services, and the length of stay and discharge practices, as needed; Include the following elements: Development of outcome criteria for presenting problems common to the medical day care center's participants; Description of actual outcomes as abstracted from the medical day care center's medical records for all the participants served over a specific time period for each presenting problem for which outcome criteria have been developed; Evaluation of actual outcomes compared with the outcome criteria to identify problem areas or reasons for suboptimal care; Documented submission of recommended corrective action to the program director; and Reassessment of the appropriateness of the recommended corrective action as revealed by the outcomes of the next audit; and Is signed and dated by the program director or designee; and Have a signed and dated corrective action plan transferring the participant to the appropriate service, if it is determined that the medical day care center's program is not appropriate for an individual participant. The medical day care center shall have adequate staffing capability to monitor the participants at all times. The composition of the staff depends in part on the needs of the participants and on the number of participants the medical day care center serves. At a minimum, the medical day care center shall meet the requirements of COMAR 10.12.04.14. The medical day care center shall also have: A full-time or part-time licensed social worker, who has at least 1 year of experience providing services to adults in a health care setting; and A full-time, part-time, or contractual medical director who: Has 1 year of experience in the care of impaired adults; and May function as the primary care provider for those participants who do not have a primary care provider, consult with staff regarding a participant’s condition and medical needs, and assist with the development of the medical day care center’s health care policies. The medical day care center is required under COMAR 10.12.04 to have a director who has a bachelor's degree or is a registered nurse. When the director is not a registered nurse, the center shall designate a health director who is a registered nurse. The health director shall: Establish, develop, and amend the center's health care policies and procedures; Supervise health care services; Manage the delivery of all required health care services to ensure that needed services are provided in a timely manner by appropriate personnel consistent with each individual's plan of care; and Consult with other health care providers to coordinate care, services, and referrals. The Program reimburses for a day of care which includes the following services: Health care services supervised by the director, medical director, or health director, which emphasize primary prevention, early diagnosis and treatment, rehabilitation and continuity of care, including the following: Participation in the development of the individual participant's plan of care; Participation in the determination of the participant's medical, psychosocial, and functional status; Consultation with the participant’s primary care provider; and Consultation with staff regarding a participant's condition and health care needs; Nursing services performed by a registered nurse or by a licensed practical nurse under the supervision of a registered nurse which include: The evaluation of the needs of the participants for nursing care; The supervision of any nursing staff; Preventive and maintenance services; Observation and monitoring of participant's condition; Rehabilitative services; The teaching and training activities in appropriate self-care techniques; The supervision of medication normally self-administered; The provision of health education; Discharge planning; and Nursing services that may be delegated to other staff in accordance with the Maryland Nurse Practice Act, Health Occupations Article, Title 8, Annotated Code of Maryland; Physical therapy services, performed by or under supervision of a licensed physical therapist, which meet the following conditions: Are of a diagnostic, rehabilitative, therapeutic, or maintenance nature, and are provided with the expectation based on the assessment made by the primary care provider, that a participant will improve significantly in a reasonable and generally predictable period of time, or are necessary for the establishment of a safe and effective maintenance program required in connection with a specific disease state; Are directly related to the primary care provider’s written plan of care which specifies: Part or parts to be treated; Type of modalities or treatments to be rendered; Expected results of physical therapy treatments; Frequency and duration of treatment; The complexity and sophistication of the services, or the condition of a participant, requires the judgment, knowledge, and skills of a licensed physical therapist; and The services are considered within accepted standards of medical practice to be a specified and effective treatment for a participant's condition; Occupational therapy services, performed by an occupational therapist, that meet the following conditions: The treatment requires the special skills of an occupational therapist; The services are directly related to the primary care provider’s written plan of care which specifies the treatment to be rendered, the frequency and duration of treatment, and the expected results of treatment; The treatment is provided with the expectation that there will be a significant practical improvement in a participant's level of functioning within a reasonable period of time; and The services fall within one or more of the following categories: Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests; Selection and teaching of task-oriented therapeutic activities designed to restore physical function; Teaching of compensatory techniques to improve the level of independence in the activities of daily living; Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance according to COMAR 10.09.12; and Improvement of mobility skills; Personal care services which include assistance with activities of daily living such as: Bathing; Eating; Toileting; Dressing; and Ambulation; Nutrition services which include the following: Meals and snacks as specified under COMAR 10.12.04.20; Therapeutic diets as specified under COMAR 10.12.04.20; and Dietary counseling and education; Social work services performed by a licensed, certified social worker or licensed social work associate which include: Screening and interviewing or assisting designated staff with screening and interviewing all referrals to determine the general appropriateness of the prospective participant for the full assessment process and medical day care participation; Ongoing services to include: Identifying the emotional and social needs of participants during the rendering of medical day care services; Maintaining linkages with community support resources for the participant including relatives, friends, and other care providers; Counseling to improve the participant's response to the plan of care, chronic condition, and prospects for recovery or stabilization, but does not include diagnosing or treating mental disorders; Counseling a participant and a participant's family in the availability and utilization of public and private community agency services, referral to, and coordination of these services; Assisting participants in obtaining those health care services which are not available through the medical day care center (such as vision care, podiatry, medical equipment, etc.); Counseling participants individually to assist with acclimation to the medical day care center's services and to promote active involvement in their plan of care; Coordinating and implementing group and family counseling in conjunction with plan of care goals; Writing notes in the participant’s records that reflect the social work activities performed; Participating in the multidisciplinary team meetings; and Assisting participants with completing the Community Settings Questionnaire; and Discharge planning and referral services including: Written procedures for discharge, referral, and follow-up; A discharge summary with post discharge goals; Recommendations for continuing care; and Referral to appropriate community service agencies and health care providers to facilitate the participant's return to more independent living; Activity programs in accordance with COMAR 10.12.04.15C; and Transportation services that: Are in accordance with COMAR 10.12.04.27; Are provided or arranged for a participant by the medical day care staff; Maximize the following types of transportation services in an effort to achieve the least costly, yet appropriate means of transportation for a participant: Walking, for a person who lives within walking distance of the medical day care center and who is sufficiently mobile; Family-supplied transportation provided by friends, neighbors, or volunteers; and Public transportation services; Are procured by the provider after options described in §A(10)(b) of this regulation have been exhausted; Are the responsibility of the provider to: Arrange contractual agreements with transportation providers to meet the transportation needs of the participants; and Group participants, where possible, in the same taxi, van or specially equipped vehicles, to minimize the cost of transportation; Are provided in accordance with records that clearly indicate both a primary transportation plan and a back-up plan; Are documented, indicating the type of transportation used by each participant; Are scheduled to ensure that a participant's one-way transit time does not exceed 1 hour as specified under COMAR 10.12.04.27; and Are included in the day of care for: Trips and outings which are part of the activities program; and A participant's medical appointment escorted by center staff. The Department shall reimburse for a day of care when this care is: Authorized in the participant's waiver service plan; Medically necessary; Adequately described in progress notes in the participant's medical record, signed and dated by the individual providing care; Provided to a participant certified annually by the Department as requiring nursing facility care as specified under COMAR 10.09.10; and Provided to participants certified present at the medical day care center a minimum of 4 hours a day by an adequately maintained and documented participant register. Medical day care services are not covered for: Individuals who do not meet the definition of “participant” in Regulation .01B of this chapter; and Individuals younger than 16 years old. Covered services do not include: Days of service in excess of the frequency specified in the participant’s home and community based services waiver service plan; Services which are not part of those services listed in Regulation .05 of this chapter; Services for a number of participants that exceeds the provider’s licensed capacity on a given day; More than one day of care, per participant, per day; and A day of care provided on the same day that the following services are provided and billed to the Department: Day habilitation services under COMAR 10.09.26; Supported employment services under COMAR 10.09.26; Programs of All-Inclusive Care for the Elderly under COMAR 10.09.44; Senior center plus services under COMAR 10.09.54; Adult day care reimbursed under the State of Maryland's human service contracts; or On-site psychiatric rehabilitation services under COMAR 10.09.59. The provider is entitled to reimbursement from the Program when: The participant is enrolled in a home and community based services waiver; and The service is specified in the participant’s home and community based services waiver service plan. Requests for Payment. All requests for payment of services rendered shall be submitted in accordance with COMAR 10.09.36. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Payment to a provider shall be limited to the number of days each participant attends the medical day care center, as authorized by a participant’s home and community based services waiver service plan. Payment shall be made only to a qualified medical day care provider. Payment may not be made to a participant, or to individual nurses, physicians, social workers, activity coordinators, or aides for services rendered in connection with the provision of medical day care. Per Diem Rate. Payment to a medical day care services provider shall be as follows: For dates of service from January 1, 2021 through October 31, 2021, $88.95 per diem; For dates of service from November 1, 2021 through June 30, 2022, $93.58 per diem; For dates of service [on or after] from July 1, 2022 through December 31, 2023, $104.81 per diem; For dates of service from January 1, 2024 through June 30, 2024, $113.19 per diem; and For dates of service on or after July 1, 2024, $116.59 per diem. Subject to the limitations of the State budget, the per diem rate shall increase on July 1 of each year by 4 percent. Payment to a provider of medical day care services may not exceed the lesser of the: Per diem rate established under §D of this regulation; or Provider's customary charge to the general public for services covered by the Program, unless the service is free to individuals not covered by Medicaid. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §D of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. Recovery and reimbursement shall be in accordance with COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions shall be in accordance with COMAR 10.09.36. Appeal procedures shall be in accordance with COMAR 10.09.36. State regulations shall be interpreted in accordance with COMAR 10.09.36. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-111, Annotated Code of Maryland Effective date: January 1, 1980 (6:26 Md. R. 2073) Regulations .03B, C and .07D amended effective March 10, 1986 (13:5 Md. R. 543) Regulation .03D adopted effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03E adopted and .07A amended effective January 30, 1984 (11:2 Md. R. 113) Regulation .07A amended effective June 3, 1985 (12:11 Md. R. 1049) Regulation .07F amended as an emergency provision effective July 1, 1983 (10:12 Md. R. 1070); adopted permanently effective September 12, 1983 (10:18 Md. R. 1608) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Chapter revised effective May 1, 1989 (16:8 Md. R. 909) Regulations .01B and 07A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulations .03J and K and .09 amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); adopted permanently effective November 1, 1990 (17:21 Md. R. 2529) Regulation .09A amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .09A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .09D amended effective July 4, 1994 (21:13 Md. R. 1157); November 24, 2003 (30:23 Md. R. 1651) Regulation .09-1 adopted as an emergency provision effective February 1, 2002 (29:4 Md. R. 412); emergency status expired June 30, 2002 Chapter revised effective January 14, 2008 (35:1 Md. R. 17) Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) Regulation .01B amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485) Regulation .03 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) Regulation .03H, I amended effective May 20, 2019 (46:10 Md. R. 485) Regulation .03H, M amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .03M amended effective April 4, 2011 (38:7 Md. R. 431); May 18, 2020 (47:10 Md. R. 516) Regulation .04A amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .04A, B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) Regulation .04B amended effective February 22, 2010 (37:4 Md. R. 340); April 4, 2011 (38:7 Md. R. 431); May 20, 2019 (46:10 Md. R. 485) Regulation .05 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) Regulation .05A amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485); May 18, 2020 (47:10 Md. R. 516) Regulation .06 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) Regulation .06B amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485) Regulation .07 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) Regulation .07 amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .08 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) Regulation .08 amended effective October 10, 2016 (43:20 Md. R. 1110) Regulation .08B amended effective February 15, 2016 (43:3 Md. R. 272) Regulation .08D amended effective April 6, 2009 (36:7 Md. R. 523); February 22, 2010 (37:4 Md. R. 340); October 31, 2011 (38:22 Md. R. 1345); May 20, 2019 (46:10 Md. R. 486); May 18, 2020 (47:10 Md. R. 516)​; November 14, 2022 (49:23 Md. R. 995); October 16, 2023 (50:20 Md. R. 886); November 24, 2025 (Md. R. 52:23 1138) Regulation .08-1 adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired August 22, 2008 Regulation .09 amended effective April 4, 2011 (38:7 Md. R. 431) In this chapter, the following terms have the meanings indicated. Terms Defined. “All-inclusive cost-per-visit rate” means the rate that is established for Federally Qualified Health Centers (FQHCs) which includes all services that are rendered to a participant on a given date of service. “Clinic services” means preventive, diagnostic, therapeutic, rehabilitative or palliative items or services furnished by or under the direction of a licensed physician or dentist either in a freestanding clinic, or outside the clinic if the: Participant does not reside in a permanent dwelling or have a fixed home or mailing address; and Service is provided by clinic personnel. “Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession. “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Direct supervision” means that a physician is: Physically present in the same area of a facility as a nonphysician providing the services required in the physician's plan of care unless standing orders and protocols are provided for physician extenders such as nurse practitioners, nurse midwives, and physician assistants; and Readily available for consultation. “Early and periodic screening, diagnosis and treatment (EPSDT)” means the provision of preventive health care, including medical and dental services under 42 CFR §441.50 et seq. (1981), and COMAR 10.09.23 for assessing growth and development and for detecting and treating health problems in Medical Assistance enrollees younger than 21 years old. “Extraordinary one-time circumstance” means a highly unusual event beyond the control of a federally qualified health center (FQHC), such as an earthquake or flood, which results in an increase in the FQHC's operating costs. Freestanding Clinic. “Freestanding clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. “Freestanding clinic” does not include a clinic or clinic site located in a participant’s home. Home. “Home” means the house, apartment, trailer, licensed health care facility, or other dwelling in which a participant resides. “Home” does not include dedicated commercial space in a high-rise apartment building. “Hospital” means an institution which: Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and Is licensed under COMAR 10.07.01 or is licensed by the state in which the service is provided. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Mental health services” means those services described in COMAR 10.67.08.02 that are rendered to treat an individual for a diagnosis as set forth in COMAR 10.67.08.02M and N. “Out-stationed eligibility worker” means an employee of a federally qualified health center who is responsible for the receipt and initial processing of applications for Medical Assistance for pregnant women, and children born after September 30, 1983, who are younger than 19 years old in accordance with 42 CFR 435.904. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Patient care policies” means written policies and protocols, describing patient care practices and procedures: Established for the clinic's operation by a group of professional personnel, including one or more physicians affiliated with the freestanding clinic; and Approved by the signature of the clinic's medical director. “Plan of care” means a written plan for the evaluation, treatment, and follow-up of each patient, maintained in the individual's medical record and containing, at a minimum, the following information where applicable: Patient identification data, dates of service, and medical history; Chief complaint, physical findings, and presumptive diagnosis; Plan of treatment; Results of all laboratory tests and diagnostic radiology procedures ordered and performed; Referral to consultant specialist and consultants report; Medications administered and prescribed, with notations indicating quantity, strength, dosage, and refill instructions; and Final diagnoses, other therapy ordered, and follow-up plan. “Preauthorization” means the approval required from the Department or its designee before services can be rendered. “Primary care services” means those medical care services which address a patient's general health needs, including the coordination of the individual's health care with the responsibility for the: Prevention of disease; Promotion and maintenance of health; Treatment of illness; and When appropriate, referral to other specialists for more intensive care. “Program” means the Maryland Medical Assistance Program. “Provider” means a freestanding clinic which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. “Qualified provider” means an individual that meets the definition of a qualified provider under Health-General Article, §§20-103(a) and 20-207, Annotated Code of Maryland. “Rural health clinic” means a facility that meets the definition of a rural health clinic as contained in 42 CFR §491.2(f). “Scope of services change” means a permanent and substantial change in the services or practices of a FQHC that results from one or more of the following: The addition or deletion of a Medicaid-covered FQHC service as described in §1905(a)(2)(B) and (C) of the federal Social Security Act; The addition, elimination, expansion, or reduction of a Health Resources and Service Administration (HRSA) approved FQHC practice location; or A change in costs for out-stationed eligibility worker services. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. A physician or osteopath providing services in a freestanding clinic shall be licensed and legally authorized to practice medicine in the state in which the service is provided. The provider shall ensure that all X-ray and other radiological equipment: Is maintained and inspected in compliance with the requirements of the Maryland Radiation Act, Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland; and Meets the standards established by COMAR 26.12.01—26.12.03, or other applicable standards established by the state in which the service is provided. The provider shall ensure that a Clinical Laboratory Improvement Amendment (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of: Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and COMAR 10.10.06; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. When applicable, abortion clinics shall be licensed in accordance with COMAR 10.12.01. General requirements for participation in the Program are that a provider shall: Meet all the conditions for participation as set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. Specific requirements for participation in the Program as a freestanding clinic provider require that the provider: Meet the applicable standards and requirements of Regulation .04 of this chapter; Verify the licenses and credentials of all professionals employed by or under contract with the freestanding clinic to provide services; Have clearly defined, written, patient care policies; Maintain adequate documentation of each contact with each participant as part of the plan of care, which, at a minimum, shall include: Date of service; Participant’s chief medical complaint or reason for visit; A brief description of the physical findings and the service provided, including procedures and progress notes; and A legible signature and printed or typed name of professional providing care, with the appropriate title; Have written, effective procedures for infection control under COMAR 10.06.01 Communicable Diseases; Maintain adequate administrative and medical records which are defined as having documentation sufficient in quantity, scope, and detail to confirm that the freestanding clinic services are provided in accordance with this chapter; Be approved by the Medicaid program in the state in which the service is provided; and Provide for in-house program evaluation and clinical record review which assess use of services for appropriateness in meeting client's needs. In the absence of specifically applicable regulations, a freestanding clinic shall: Comply with §A of this regulation; Comply with specific conditions, which may be included in the written agreement; and Accept reimbursement according to COMAR 10.09.02 Physicians’ Services. Abortion clinics shall provide services in accordance with Health-General Article, §20-209, Annotated Code of Maryland. The Program covers the services listed in §§B—E of this regulation according to the conditions and requirements indicated. Medically Necessary Services. The program covers medically necessary services as described in §§C, D, and E of this regulation and in Regulation .05 of this chapter, rendered to participants by a freestanding clinic, when these services are performed by a physician or by: A registered nurse, a psychologist, or a social worker, provided that the individual performs the service within the scope of the individual’s license or certification for the purpose of assisting in the provision of physicians’ services; A nurse midwife, a nurse practitioner, a licensed practical nurse, or a registered physician’s assistant, provided that the individual performs the services within the scope of the individual's license or certification; or An addictions counselor who meets the requirements in accordance with COMAR 10.58.07. Family Planning Clinic Services. To participate in the Program as a family planning clinic, a provider shall meet the requirements of Regulation .03 of this chapter and §§B and C(2) of this regulation and shall: Participate in the Title X: National Family Planning Program; or Provide documented evidence of adherence to and compliance with standards established for family planning by the State of Maryland, Planned Parenthood, or the American College of Obstetricians and Gynecologists. Covered services include: Complete initial and annual physical examination including auscultation of heart and lungs for all patients; Pelvic examination, including bimanual and speculum, and Pap smears on all females annually, unless clinical indication for more frequent examination exists; Laboratory tests including, but not limited to: Hemoglobin or hematocrit, or both, for all patients; Urinalysis for albumin sugar for all patients; Sexually transmitted disease (STD) testing for all patients; Pregnancy testing if indicated by physical examination or history, or both; Rubella titer of all females without documentation of prior rubella immunization which may be done by documented referral to a known provider of this service; Contraceptive methods and devices approved by the Federal Drug Administration, their insertion, filling, or removal, and education on proper use; Rectal examination, if indicated; Basic education regarding human sexuality and reproduction, for all patients; Advice and counseling regarding all family planning methods, including natural family planning measures and sterilization procedures, the availability and effectiveness of methods, procedures involved in each method and untoward effects and potential complications of each method when performed according to §B of this regulation; Sperm count and analysis done on premises or by appropriate documented referral; Sterilizations, including vasectomy, when coded as family planning and when the appropriate forms, as established by Program guidelines, are properly completed and attached to the claim; Post-vasectomy follow-up; and Referral mechanism and documented referral for all patients demonstrating illness, disease, or pregnancy. Abortion Clinic Care. To participate in the Program as an abortion clinic, the provider shall meet the requirements of Regulations .02 and .03 of this chapter and §B of this regulation and shall: Meet all applicable state and local requirements for licensure and certification in the state or jurisdiction in which the clinic is located; and Ensure abortions are performed by a qualified provider and in compliance with all applicable Program regulations. Covered services shall include: An abortion procedure for pregnancies which shall include a pelvic examination, and preoperative and postoperative care; Laboratory tests to include pregnancy test, urinalysis for sugar and albumin, hemoglobin or hematocrit, or both, and Rh factor typing; Pap smear; Anesthesia or sedatives or analgesics or any combination of these drugs; Referral to family planning clinic for follow-up family planning; Gross and microscopic tissue examination if there is any doubt in the proper identification of the extracted product of conception concerning composition or completeness; and Obstetrical pelvic ultrasound. Rural Health Clinic Services. To participate as a rural health center, the provider shall: Meet the requirements of Regulations .03 and .05A of this chapter; and Be federally certified in accordance with 42 CFR Part 491, Subpart A. Covered services include rural health clinic services as defined in 42 CFR §440.20. The provider shall follow the general rural health center rules and regulations in accordance with 42 CFR §405.2400—42 CFR §405.2417. To participate as a federally qualified health center, the provider shall meet the requirements of Regulations .03 and .04B of this chapter and shall: Meet the conditions for coverage in accordance with 42 CFR §491, Subpart A; Be enrolled in the EPSDT/Healthy Kids Program as provided in COMAR 10.09.23 and provide EPSDT/Healthy Kids services to participants who are eligible to receive them; Supply the Department with financial and other information as requested; Meet one of the following conditions: Meet all of the requirements for receiving a grant under §329, 330, or 340 of the Public Health Service Act, 42 U.S.C. §254(c), as determined by the Secretary of the United States Department of Health, and in accordance with 42 CFR §405.2401; Receive a waiver from the Secretary of the United States Department of Health and Human Services of one or more of the requirements for receiving a grant pursuant to §329, 330, or 340 of the Public Health Service Act; or Be an outpatient health program or facility operated by a tribe or tribal organization under the Indian Self-Determination Act or by an Urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act; Comply with the requirements contained in COMAR 10.09.59 if delivering mental health services and COMAR 10.09.80 when providing substance use disorder services; and Comply with the requirements contained in COMAR 10.09.05, if rendering dental services. Covered services are the same as those authorized to be provided by rural health clinics as described in 42 CFR §440.20(b), rural health clinic services, and 42 CFR §440.20(c), other ambulatory services furnished by a rural health clinic. In the event that the provider elects to institute a scope of services change, the provider shall: Notify the Department of its intent to institute the scope of services change: Not later than 30 days before it begins to deliver services under the scope of services change; or Within 30 days after the adoption of this section; and Provide the Department with any information the Department needs to: Assure continuity of care for enrollees; Arrange for the processing and payment of claims; or Otherwise administer services to Medical Assistance participants under the provider's scope of services change. Rate Revisions for FQHCs Due to Scope of Services Change or Extraordinary One-Time Circumstance. If an FQHC implements a change in the FQHCs scope of services or if the FQHC experiences an extraordinary one-time circumstance, the FQHC or the Department may request a revision of the FQHC's prospective rate of reimbursement. The FQHC shall provide the Department with written notification no later than 30 days after the implementation of the scope of services change or the occurrence of the one-time circumstance. After receiving notification from an FQHC that the FQHC plans to institute a scope of services change, the Department shall notify the FQHC within 30 days if the Department wishes to request a revision to an FQHC's rate. An FQHC or the Department may not request more than one rate revision per FQHC per calendar year under this regulation. When an FQHC or the Department requests a rate revision based on §D(1) of this regulation, the FQHC shall submit to the Department or its designee a cost report and supporting documentation. The cost report and supporting documentation required under §D(5) of this regulation shall: Be submitted within 90 days after the end of the first 1-year period immediately following the implementation of the scope of service change or the occurrence of the extraordinary one-time circumstance; Reflect the change in costs relating to the rate revision request for the center's operations for the first 1-year period immediately following the implementation of the scope of service change or the occurrence of the extraordinary one-time circumstance; Conform with the standards described in §C of this regulation and instructions issued by the Department or its designee; Contain an explanation of the scope of services change or extraordinary one-time circumstance and schedules to support the calculation of the change in the cost-per-visit rate; and Be subject to verification and adjustment by the Department or its designee. Rate revisions granted under this section shall be effective the date the change of scope was approved by the Health Resources and Services Administration (HRSA) or the occurrence of the extraordinary one-time circumstance. The revised rate granted under this section shall be the rate referenced in §A(3) of this regulation. Rates of reimbursement established according to this regulation shall be for: Payment of covered services rendered to participants; and Determining supplemental payments under COMAR 10.09.65.21A. The Program does not cover the following: Services not specified in Regulation .04 of this chapter; Services not medically necessary; Investigational and experimental drugs and procedures; Procedures solely for cosmetic purposes; Services denied by Medicare as not medically justified; Freestanding clinic services for inpatient participants in State-operated facilities serving individuals with intellectual disabilities; Freestanding clinic services provided to hospital inpatients; Freestanding clinic visits when patients are referred to hospital outpatient departments or emergency rooms for services ordinarily provided in freestanding clinics covered by this chapter; Freestanding clinic visits solely for the purpose of one or more of the following: Prescription drugs or collection of laboratory specimens, unless otherwise allowed; Certification or recertification of food supplements; Performing laboratory tests required only for certification or recertification of food supplement programs; Nutritional assessments in the absence of diagnosis of nutritional disorders, unless EPSDT or primary health services are provided at the same time; Ascertaining the patient's weight; Interpretation of laboratory tests or panels; and Measurement of blood pressure; Office visits solely for the administration of injectable medications, unless medical necessity and the patient’s inability to take appropriate oral medications are documented in the medical record; More than one visit per day to the same freestanding clinic, unless the additional visit is adequately documented as: An emergency situation; or A visit to a different specialty; Central nervous system stimulants and anorectic agents when used for weight control; Immunizations required solely for travel outside the continental United States; Vision care services excluded under COMAR 10.09.14 or COMAR 10.09.23; Separate billing for services which are specifically included as part of another service; Separate reimbursement to a practitioner for services provided in a freestanding clinic in addition to the freestanding clinic reimbursement; Payment for more than one visit to complete an EPSDT screening service; Visits solely for group or individual health education; Freestanding clinic visits in addition to an EKG procedure when the EKG procedure is the only purpose for the visit; and Services for which preauthorization is required under Regulation .09 of this chapter but has not been obtained. Reimbursement for Family Planning Clinics. The Department shall pay the family planning clinic the lesser of the provider’s customary charge or the provider’s acquisition cost, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with COMAR 10.09.02.07D; and The provider’s reimbursement is not limited to the provider’s customary charge. Reimbursement for Abortion Clinics. For dates of service on or after April 1, 2015, the Department shall pay the abortion clinic the lesser of the provider’s customary charge, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with COMAR 10.09.02.07D; and The provider’s reimbursement is not limited to the provider’s customary charge. Reimbursement for Rural Health Clinics. The Department shall reimburse rural health clinics in accordance with 42 CFR §447.371. The Department shall pay all other freestanding clinics at the lesser of the provider’s customary charge, or the provider’s acquisition cost, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with COMAR 10.09.02.07D; and The provider’s reimbursement is not limited to the provider’s customary charge. Federally qualified health centers shall be reimbursed for covered services once the provider is in compliance with all federal and State requirements. The only well-child visits that are eligible for Program reimbursement are those that are billed as EPSDT screens. Payment of Allowable Costs. Federally qualified health centers shall be paid 100 percent of the FQHC’s allowable costs, subject to the limitations contained in §§D—G of this regulation, that are related to the provision of covered services. Allowable costs will be determined in accordance with Medicare principles of cost reimbursement as contained in 42 CFR 413.5, unless otherwise specified in this chapter. Providers' allowable costs are subject to audit and verification by the Department or its designee. Costs not adequately documented, return on equity, bad debts incurred by private pay, Medicare patients, or third-party payers, and bad debts resulting from denied costs of the Program are not allowable in establishing reimbursement rates. Services covered under §1915(g) of Title XIX of the Social Security Act, which are called targeted case management services, and the costs associated with these services, are excluded when establishing reimbursement rates. All-Inclusive Cost-per-Visit Rate. Reimbursement to providers of federally qualified health center services shall be on a per-visit basis. The Department or its designee shall establish an all-inclusive interim and an all-inclusive final cost-per-visit rate for each provider. Each provider shall have a rate established for primary care services. A rate for dental care services shall be established if the service is offered. The all-inclusive cost-per-visit rate for primary care visits covers the allowable costs associated with covered primary care, mental health, and substance abuse services. FQHCs may not charge the program, other than an all-inclusive cost-per-visit rate, for any ambulatory service. The all-inclusive cost-per-visit rate for dental care visits covers only those services that are reimbursed by the Program under COMAR 10.09.05. Other dental services are not reimbursable. Providers' costs, except for those of OB/GYN physicians, for staff who provide radiology services, for off-site visits, and for out-stationed eligibility workers, are divided into the following four cost centers: General service cost center is composed of those costs associated with the depreciation of the facility's building or buildings and equipment, the operation of the plant, the administration and management of the facility, medical records, and those administrative costs associated with pharmacy and EPSDT services which are not reimbursed under a different payment methodology; Primary care services costs are composed of those costs, including supplies, associated with health care staff, including laboratory technicians, who provide direct care to patients; Dental services costs are the costs of supplies and health care staff associated with the provision of dental services to patients; and Non-reimbursable costs are those costs that are not reimbursable under this payment methodology. The interim and final cost-per-visit rates for each service shall be determined by dividing the provider's allowable costs for each service by the total number of visits to the provider for each service. Calculation of the Interim All-Inclusive Cost-per-Visit Rate. An interim all-inclusive cost-per-visit rate shall be established for the first 2 years of operation. Providers shall be divided into those located in urban areas and those located in rural areas. Baltimore City and the Maryland counties of Allegany, Anne Arundel, Baltimore, Carroll, Cecil, Charles, Harford, Howard, Montgomery, Prince George's, St. Mary’s and Wicomico are urban areas. All other Maryland counties are rural areas. Providers located out-of-State shall be placed in the same reimbursement class as that of the nearest Maryland county. An interim all-inclusive cost-per-visit rate shall be established for primary care and for dental care services, if applicable, for each provider, by averaging the current FQHC all-inclusive cost-per-visit rate amounts for each area, urban or rural. Calculation of the Final All-Inclusive Cost-per-Visit Rate. Following the close of the provider's 2nd fiscal year, the Department or its designee shall determine the final all-inclusive cost-per-visit rate for primary care services and, if offered, for dental care services, for those fiscal years based on the costs stated in the cost report for the 2 fiscal years and subject to the limitations in these regulations. The provider shall submit to the Department or the Department's designee, on the form prescribed, direct and indirect costs and statistical data applicable to patient care. The provider's cost report shall be reviewed in accordance with the standards referenced in §C(1) of this regulation to determine the allowable costs and the number of visits for that cost reporting period. In calculating the final all-inclusive cost-per-visit rates, the limitation on general service cost center costs described in §D(5)(a) of this regulation shall apply. Once the all-inclusive cost-per-visit rate has been determined for each fiscal year, each provider is eligible for additional primary care reimbursement for services rendered by OB/GYN physicians, staff who provide radiology services, off-site visits, and out-stationed eligibility workers. Costs for these additional services are limited to salaries and fringe benefits, including any malpractice insurance, that are paid by the provider. The additional primary care reimbursement shall be calculated by taking the sum of the provider's expenditures for OB/GYN physicians, for staff who provide radiology services, out-stationed eligibility workers, and off-site visits. This sum is divided by the total number of primary care visits. The resulting rate shall be added to the all-inclusive cost-per-visit rate. The final all-inclusive cost-per-visit rate shall be determined by averaging the all-inclusive cost-per-visit rates for the 2 fiscal years and by adding, if applicable, the additional rate for OB/GYN, staff who provide radiology services, or off-site visits. This final all-inclusive cost-per-visit rate shall be implemented retroactively to the start date of the FQHC’s operation. The final all-inclusive rate shall be increased by the Medicare Economic Index (MEI) each calendar year. The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. The provider shall keep all records available for a period of 6 years subject to inspection or audit by the Department or the Department's designee at any reasonable time during normal business hours. Cost Reporting. A provider shall submit to the Department or the Department's designee a cost report, and other financial and statistical information requested, within 3 months after the close of the provider's 2nd fiscal year, unless the Department grants the provider an extension or the provider discontinues participation as a federally qualified health center. The following apply: The Program may grant a provider an extension if the provider makes a written request setting forth the specific reasons for the request and the Department determines that the request is reasonable; or If a provider discontinues participation as a federally qualified health center, it shall submit its cost report and other financial and statistical data to the Department within 45 days after the effective date of termination. Cost reports are considered to have been received by the Department or the Department's designee when the submitted reports are completed according to the instructions issued by the Department, or the Department's designee. If a provider's cost report has not been received within 3 months after the close of the provider's 2nd fiscal year or within the deadline set by the Department after an extension has been granted, the Department shall reduce the provider's current interim all-inclusive cost-per-visit rate by 20 percent for visits paid during the calendar month in which the report is due and any subsequent calendar month until the report has been submitted. This amount shall be eligible for repayment to the provider upon final cost settlement for the fiscal year or fiscal years from which the payments were withheld. When a provider's cost report is received by the last day of the 6th month after the end of the provider's 2nd fiscal year and the Department or the Department's designee determines that the final all-inclusive cost-per-visit rate is different than the interim all-inclusive cost-per-visit rate, the increase or decrease is applicable to all reimbursable visits retroactively. The Department or its designee shall notify each provider of the results of the verification of the provider's cost report. The provider may appeal the final cost settlement by following the procedures described in COMAR 10.09.36.09. Calculation and Reimbursement of Number of Visits for FQHC Services Rendered to MCO Enrollees. The FQHC shall transmit all of the encounter data to the appropriate MCO. The MCO shall reimburse the FQHC their established all-inclusive cost-per-visit rate for all eligible visits. The FQHC shall have the responsibility of reconciling the number of eligible visits with the MCOs. Each MCO shall transmit all of its FQHC encounter visits to the Department. For an FQHC, the calculation of the number of MCO enrollee visits is as follows: For each 6-month period thereafter, the number of eligible visits received for each period shall be totaled by the Department 12 months after the end of the period; The number of visits reported in §H(5)(a) of this regulation shall constitute the number of visits on which final payments shall be made to each MCO as reported by each FQHC for that 6-month period; The MCO shall receive an interim supplemental payment once every 3 months (quarterly); The interim supplemental payment shall be modified by a final reconciliation of the number of eligible visits applicable to a previous 6-month period received by the Department within 1 year from the end of the 6-month period; and The final payment made to each MCO according to this regulation is not subject to cost settlement. The following procedures or services require preauthorization: Vision care according to COMAR 10.09.14.06 and COMAR 10.09.23; Mental health services which shall comply with the requirements of COMAR 10.09.59; Substance use disorder services which shall comply with the requirements of COMAR 10.09.80; and Dental services which shall comply with the requirements of COMAR 10.09.05. The Department or its’ designee shall preauthorize services when the provider submits adequate documentation demonstrating that the service to be preauthorized is medically necessary. Preauthorization is valid only for services rendered or initiated within 60 days of the date preauthorization was issued. The patient shall be an eligible participant at the time the service is rendered. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment shall be made for services needing preauthorization from the Program only if authorization for those services has been obtained before the services were rendered. The provider shall submit a completed request for payment in the format designated by the Department with any required documentation. The Program reserves the right to return to the provider, before payment, all invoices not properly completed with a diagnosis, procedure code, and description of the services provided. The provider shall bill the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with COMAR 10.09.02.07D; and The provider’s reimbursement is not limited to the provider’s customary charge. The Department shall authorize payment on Medicare cross-over claims only if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that the services are medically necessary; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: A deductible shall be paid in full; Coinsurance shall be paid at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but considered medically necessary by the Program, shall be paid according to the limitations of this chapter. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; Home visits unless specifically authorized by federal law or regulation; More than one visit to complete an EPSDT screen; and Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. The Program may not make direct payment to participants. The Program may not make a separate direct payment to any person employed by or under contract to any freestanding clinic for services provided in a freestanding clinic. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09. State regulations shall be interpreted in conformity with COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: September 14, 1981 (8:18 Md. R. 1479) Regulations .03A and .04A amended effective November 23, 1981 (8:23 Md. R. 1856) Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113) Regulation .07D, F amended as an emergency provision effective July 1, 1985 (12:14 Md. R. 1426) Regulation .07D—H amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1348); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) Regulation .07G amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1171); adopted permanently effective October 29, 1984 (11:21 Md. R. 1812) Regulation .07N amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Regulations .01—.11 repealed effective October 1, 1985 (12:19 Md. R. 1849) Regulations .01—.11 adopted effective October 1, 1985 (12:19 Md. R. 1849) Regulation .01 amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .03A amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .03B amended effective May 28, 1990 (17:10 Md. R. 1219) Regulation .04 amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .04A amended effective May 28, 1990 (17:10 Md. R. 1219) Regulation .04B amended as an emergency provision effective July 1, 1986 (13:13 Md. R. 1473); adopted permanently effective December 1, 1986 (13:19 Md. R. 2120) Regulation .04E amended as an emergency provision effective November 1, 1985 (12:23 Md. R. 2214); adopted permanently effective May 6, 1986 (13:3 Md. R. 271) Regulation .04E amended as an emergency provision effective September 2, 1986 (13:22 Md. R. 2394); emergency status extended to April 5, 1987 (14:4 Md. R. 412) Regulation .04E amended effective April 6, 1987 (14:7 Md. R. 830); July 1, 1987 (14:13 Md. R. 1473) Regulation .04F amended effective January 1, 1989 (15:26 Md. R. 2983) Regulation .04G amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .04G amended effective May 28, 1990 (17:10 Md. R. 1219) Regulation .05 amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .05E amended effective June 26, 2000 (27:12 Md. R. 1139) Regulation .07F amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .07I amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Chapter revised as an emergency provision effective February 1, 1991 (18:7 Md. R. 765); emergency status extended at 18:14 Md. R. 1604 (July 12, 1991); revised permanently effective July 8, 1991 (18:13 Md. R. 1482) Regulation .01B amended effective January 20, 1992 (19:1 Md. R. 32); November 20, 1995 (22:23 Md. R. 1801); August 4, 2003 (30:15 Md. R. 991) Regulations .01B, .04, .05A, and .08A amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1148); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) Regulations .01 and .05C amended as an emergency provision effective December 23, 1995 (23:2 Md. R. 93); adopted permanently effective April 8, 1996 (23:7 Md. R. 552) Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .04 amended effective August 1, 1994 (21:15 Md. R. 1305) Regulation .04B amended effective February 17, 2003 (30:3 Md. R. 179); March 5, 2012 (39:4 Md. R. 336) Regulation .04D amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .04E amended as an emergency provision effective April 1, 1992 (19:7 Md. R. 741); amended permanently effective July 1, 1992 (19:12 Md. R. 1135) Regulation .04E amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1468); amended permanently effective December 1, 1992 (19:23 Md. R. 2041) Regulation .04E amended effective December 19, 1994 (21:25 Md. R. 2105) Regulation .05 amended effective November 20, 1995 (22:23 Md. R. 1801); August 4, 2003 (30:15 Md. R. 991) Regulation .05C amended as an emergency provision effective October 15, 1992 (19:22 Md. R. 1979); amended permanently effective February 1, 1992 (20:2 Md. R. 112) Regulation .05E adopted effective June 26, 2000 (27:12 Md. R. 1139) Regulation .05-1 adopted effective August 4, 2003 (30:15 Md. R. 991) Regulation .05-1B, C amended effective August 15, 2005 (32:16 Md. R. 1392) Regulation .06 amended effective May 23, 1994 (21:10 Md. R. 844) Regulation .07I amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) (Recodified to Regulation .09I) Regulation .09E amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .11C adopted effective January 24, 2011 (38:2 Md. R. 84) Regulation .12 amended effective January 24, 2011 (38:2 Md. R. 84) Chapter revised effective March 5, 2012 (39:4 Md. R. 337) Regulation .04B amended effective March 5, 2012 (39:4 Md. R. 336) Regulation .06G amended effective October 14, 2013 (40:20 Md. R. 1652) Regulations .01—.13 repealed and new Regulations .01—.14 adopted effective April 1, 2015 (42:6 Md. R. 512) Regulation .01B amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .02E amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .03 amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404) Regulation .04D amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .05A amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .05D amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .06 amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .07A, B, D amended effective July 4, 2016 (43:13 Md. R. 712); February 27, 2017 (44:4 Md. R. 252) Regulation .09C amended effective October 16, 2023 (50:20 Md. R. 886) Regulation .10C amended effective February 27, 2017 (44:4 Md. R. 252) Regulation .10C, F amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .10F amended effective October 24, 2016 (43:21 Md. R. 1166); October 16, 2023 (50:20 Md. R. 886) Regulation .10G amended effective October 16, 2023 (50:20 Md. R. 886) In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.36.01 are applicable to this chapter. Terms Defined. “Authorized practitioner” means a physician, osteopath, dentist, podiatrist, nurse midwife, nurse anesthetist, nurse practitioner, or physician assistant employed by a physician or clinic. Freestanding Clinic. “Freestanding clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. “Freestanding clinic” does not include a clinic or clinic site located in a participant’s home. “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and which is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. “Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease. “Order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Preauthorization” means the approval required from the Department or its designee before services can be rendered. “Reference laboratory” means a medical laboratory, which is enrolled with the Program as either a provider or a renderer, to which a medical laboratory provider refers specimens from Medical Assistance participants for analysis. “Referring laboratory” means a medical laboratory provider that refers specimens from Medical Assistance participants for analysis. “Special handling” means a circumstance in which specimen collection and pickup are accomplished as independent procedures to be responsive to the medical needs of the participant or to preserve viability or condition of the specimen. “Standing order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services to be supplied over a specific time period, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. Medical laboratories are required to ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed. Medical laboratories located in Maryland shall be in compliance with COMAR 10.10.01. Out-of-State Laboratories. Laboratories with representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed, and that requirements of applicable sections of COMAR 10.10.01 are met. Laboratories without representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03, except that a signature on the services order specified in COMAR 10.09.36.03A(19) is not required. Specific requirements for participation in the Program as a medical laboratory include all of the following: Be in compliance with all applicable license, certification, environmental, legal, and professional requirements to perform the clinical laboratory services offered; Maintain records adequate to substantiate the ordering, performance, and reporting of clinical laboratory services performed or referred; Agree to seek reimbursement from the Program only for services set forth in Regulation .04 of this chapter when provided to eligible participants; Agree to refrain from billing participants for noncovered services set forth in Regulation .05 of this chapter; and Agree to abide by all provisions set forth in Regulation .07 of this chapter when seeking reimbursement from the Program. The Program covers the following services: Medically necessary laboratory services, when the services are: Rendered to participants in a physician's office, hospital, freestanding clinic, or medical laboratory; Provided according to the laws and regulations of the state and locality in which they are rendered; Rendered pursuant to a properly completed order or standing order; Adequately documented in the provider’s files; Clinical and diagnostic services for which certification by the Centers for Medicare and Medicaid Services (CMS) under CLIA exists, if required; and Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service; Transportation of specimens by medical laboratories when special handling is required by medical necessity when documentation is supplied to the provider by the authorized ordering practitioner; and Collection of specimens by venipuncture, capillary puncture, or arterial puncture. The following are not covered: Services for which the medical laboratory provider cannot supply a properly completed order or standing order identifying the individual practitioner who ordered the laboratory services; Services not adequately documented in the participant’s medical records; Services denied by Medicare as not medically necessary; Clinical laboratory services, for which certification by HCFA under CLIA is required, when these services are performed by laboratories that are not certified to perform those services; Procedures that the provider knows or should know are investigational or experimental in nature; Services included by the Program as part of the charge made by an inpatient facility, hospital outpatient department, freestanding clinic, or other Program-recognized entity; Medical laboratory services related to autopsies; Medical laboratory services for which there was insufficient quantity of specimen, improper specimen handling, or other circumstances that would render the results unreliable; and Laboratory services ordered by an: Individual who is not enrolled as a provider in the Program with an active status on the date of service; and Entity, facility, or another provider that is not an individual. Preauthorization is required for any service identified as needing preauthorization in the current laboratory fee schedule, in accordance with Regulation .07D of this chapter. The provider shall submit the request for preauthorization according to the procedures established by, and in the form designated by, the Department. Preauthorization is issued when: Program procedures are met; and The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. Preauthorization is valid for services rendered or initiated within 90 days of the date issued. Preauthorization for Services Billed to Medicare. If Medicare covers and approves a service for which preauthorization by the Program is normally required, the Program shall waive preauthorization requirements for that service. If Medicare rejects the entire claim or any part of a claim for a service that normally requires preauthorization, and the claim is referred to the Program for payment, the Program shall pay only for the Medicare-rejected covered services if authorization for those services was obtained prior to the date of service. General policies for payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. Medical laboratory providers shall identify the individual who ordered the laboratory services by recording the individual practitioners National Provider Identifier (NPI) number on the claim. Unless the service is free to individuals not covered by Medicaid, the provider shall charge the Program the lesser of: The providers customary charge to the general public; or The providers customary charge to other third-party payers. Providers are reimbursed according to the 2022 Medical Laboratory Fee Schedule (Effective March 2022). All the provisions of this document are incorporated by reference. The Department will pay for covered services the amount that is the lower of the following: Provider's charge according to §C of this regulation; or Departments maximum rates according to §D of this regulation. Payments on Medicare claims are authorized if: The provider accepts Medicare assignments; Initial billing is made directly to Medicare according to Medicare guidelines; and Medicare has determined that services were medically justified. Supplemental payment on Medicare claims is made subject to the following provisions: Deductible insurance will be paid in full; Beginning with August 1, 2010 dates of service, coinsurance shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but covered by the Program, will be paid according to §E of this regulation. The provider may not bill the Department for: Completion of forms and reports; Broken or missed appointments; or Services listed in Regulation .05 of this chapter. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. When seeking reimbursement for medical laboratory services which are subjected to panel billing regulations or are part of a panel, the medical laboratory provider shall bill the Department the panel rate or the sum of the charges of the individual tests, whichever is less. A referring laboratory provider may bill the Program for laboratory services performed by a reference laboratory when the: Reference laboratory is: Enrolled with the Program as either a medical laboratory provider or a renderer; and CLIA certified for the procedures performed; Procedures which were referred, and the identity of the reference laboratory, are identified on the invoice; and Referring laboratory charges not more than the amount it actually paid the reference laboratory. Standing orders shall: Conform to the specifications for orders found in Regulations .01 and .04 of this chapter; Include: A date which shall become the starting date of the order unless another starting date is specified on the order; and Specific instructions outlining the schedule of services to be provided pursuant to the order; and Be effective for a maximum of 90 days or, for dialysis patients, be effective for a maximum of 1 year. All indices, calculated values, or other results that are not directly determined, are considered part of the parent procedures and are not separately billable to either the Program or the participant. Only those panels or profiles that have a composition specified by CPT or the Program are reimbursable as panels or profiles by the Program. Reimbursement for these recognized panels or profiles is not authorized unless each and every component of the panel or profile is performed. Two or more of the following chemistry tests shall be reimbursed at a rate that is the lesser of the provider's lowest charge to the general public or third-party payers, or the Program's maximum reimbursement for these chemistry tests when performed as panels: Albumin, serum; Bilirubin, direct; Bilirubin, total; Calcium, total; Carbon dioxide (bicarbonate); Chloride, blood; Cholesterol, serum, total; Creatine kinase (CK), (CPK), total; Creatinine, blood; Glucose, quantitative; Glutamyltransferase, gamma (GGT); Lactate dehydrogenase (LD), (LDH); Phosphatase, alkaline; Phosphorus, inorganic; Potassium, serum; Protein, total, except refractometry; Protein, total, refractometric; Sodium, serum; Transferase, aspartate amino (AST) (SGOT); Transferase, alanine amino (ALT) (SGPT); Triglycerides; Urea nitrogen, quantitative (BUN); and Uric acid, blood. All of the tests listed in §O of this regulation that are ordered on or performed on the same specimen shall be billed as if performed simultaneously. General policies for recovery and reimbursement that are applicable to all providers are set forth in COMAR 10.09.36.07. General policies governing cause for suspension or removal and imposing sanctions that are applicable to all providers are set forth in COMAR 10.09.36.08. General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: August 31, 1977 (4:18 Md. R. 1398) Regulation .01 amended effective August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159) Regulation .02 amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .03A repealed effective September 21, 1979 (6:19 Md. R. 1518) Regulation .03E amended effective December 15, 1978 (5:25 Md. R. 1854); August 22, 1988 (15:17 Md. R. 2049) Regulation .03E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03J adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .04A amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159) Regulation .04A amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .04C adopted effective July 11, 1988 (15:14 Md. R. 1654) Regulation .05 amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159) Regulation .05A and D amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .05B repealed effective August 12, 1985 (12:16 Md. R. 1606) Regulation .07 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .07B amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .07D amended effective December 15, 1978 (5:25 Md. R. 1854); February 15, 1982 (9:3 Md. R. 221) Regulation .07E amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) Regulation .07E amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1812) Regulation .07E amended effective December 6, 1982 (9:24 Md. R. 2390); November 21, 1983 (10:23 Md. R. 2063); May 27, 1984 (11:10 Md. R. 863); March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542); June 2, 1986 (13:11 Md. R. 1273); December 1, 1986 (13:22 Md. R. 2398) Regulation .07E amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); adopted permanently effective October 6, 1986 (13:20 Md. R. 2210) Regulation .07E amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987 Regulation .07E repealed and new Regulation .07E adopted effective February 9, 1987 (14:3 Md. R. 273); amended October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903) Regulation .07E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625) Regulation .07H amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended at 6:12 Md. R. 1045; adopted permanently effective June 1, 1979 (6:11 Md. R. 979) Regulation .07K amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07K amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .07L adopted effective December 15, 1978 (5:25 Md. R. 1854) Regulation .07M adopted effective February 6, 1989 (16:2 Md. R. 159) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, D amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Chapter revised as an emergency provision effective July 21, 1995 (22:16 Md. R. 1218); adopted permanently effective November 20, 1995 (22:23 Md. R. 1801) Regulation .01B amended effective September 18, 2000 (27:18 Md. R. 1665); April 29, 2002 (29:8 Md. R. 700); July 24, 2023 (50:14 Md. R. 593) Regulation .03A amended effective April 29, 2002 (29:8 Md. R. 700); July 16, 2018 (45:14 Md. R. 696) Regulation .03B amended effective July 24, 2023 (50:14 Md. R. 593) Regulation .04 amended effective September 18, 2000 (27:18 Md. R. 1665) Regulation .04A amended effective April 29, 2002 (29:8 Md. R. 700); January 1, 2018 (44:26 Md. R. 1214); July 24, 2023 (50:14 Md. R. 593) Regulation .05 amended effective September 18, 2000 (27:18 Md. R. 1665); October 10, 2016 (43:20 Md. R. 1109); January 1, 2018 (44:26 Md. R. 1214) Regulation .05A amended effective April 29, 2002 (29:8 Md. R. 700) Regulation .05B amended effective July 24, 2023 (50:14 Md. R. 593) Regulation .06 adopted effective July 24, 2023 (50:14 Md. R. 593) Regulation .07B amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .07B, D amended effective April 29, 2002 (29:8 Md. R. 700) Regulation .07C, D amended effective September 18, 2000 (27:18 Md. R. 1665) Regulation .07C, H amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D amended effective December 12, 2011 (38:25 Md. R. 1581); February 27, 2017 (44:4 Md. R. 252) Regulation .07D, E amended effective June 14, 2021 (48:12 Md. R. 472) Regulation .07D, M amended effective July 24, 2023 (50:14 Md. R. 593) Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .07L-P adopted effective September 18, 2000 (27:18 Md. R. 1665) Regulation .07L amended effective July 31, 2017 (44:15 Md. R. 759) In this chapter, the following terms have the meanings indicated. Terms Defined. “Accrual basis” means recording revenue in the period when earned, regardless of when collected, and recording expenses in the period when incurred, regardless of when paid. “Administrative day” means a day of care rendered to a recipient who no longer requires the level of care being provided. “Allowable cost” means costs that are includable in the per diem rate and that represent the provider's actual cost as verified by the Department or the Department's designee. “Appropriate facility” means a facility located within a 25-mile radius of the location of the facility currently rendering care to the recipient or a more distant facility if acceptable to the recipient, which facility is licensed and certified to render the recipient's required level of care. “Bad debts” means amounts considered to be uncollectible from accounts and notes receivable that were created or acquired in providing services. “Accounts receivable” and “notes receivable” are designations for claims arising from rendering services which, when made or entered, were considered collectible in money in the relatively near future. “Case mix index (CMI)” means a numeric score that identifies the average relative nursing resource needs for the residents classified under the Resource Utilization Group (RUG) based on the assessed nursing needs of the resident, whose values are set forth as CMI Set F01, located at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIMDS30TechnicalInformation.html. “Centers for Medicare and Medicaid Services (CMS)” means the federal agency that is located in the U.S. Department of Health and Human Services that administers the Medicare and Medicaid programs. “Change of ownership” means: One of the following occurs: The merger of the provider into the acquiring entity and the acquiring entity's tax identification number remains; The assignment, transfer, disposition, lease, or sale of all or substantially all of a provider’s assets to another entity; The consolidation of two or more providers, resulting in the creation of a new entity; or The merger of the provider into another entity, or the consolidation of two or more entities, resulting in the creation of a new entity; A provider’s Medical Assistance participating provider number dissolves or will no longer be utilized for purposes of billing the Program for covered services; and A new Medical Assistance participating provider number or tax identification number is used instead. “Cost center” means one of the groups into which similar categories of costs are assigned for reimbursement rate determination: Administrative and Routine, Other Patient Care, Nursing Service, and Capital. “Cost report period case mix index” means the simple average of the day weighted facility case mix indices for residents of all payer sources from the final quarterly resident rosters for a nursing facility, carried to four decimal places, for the quarterly resident roster periods that most closely match a cost reporting period. “Credit balance” means: A third party payment, which is in addition to the Medicaid payment; The Medicaid payment in excess of the amount due the provider; or A duplicate payment. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Facility” means a facility licensed under COMAR 10.07.02 and certified as meeting the requirements of Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., for participation as a nursing facility. “Facility average Medicaid case mix index” means the day-weighted average case mix index for all identified Medicaid days from each nursing facility's final resident roster for each resident roster quarter calculated as the sum of the number of days each assessment associated with a Medicaid payer source is active times the assessment CMI divided by the sum of all Medicaid payer source days. “Final report” means the third party liability audit report issued to a provider stating the total amount due to the Department as a result of the completed audit. “Fiscal year” means a 12-month reporting period covering the same period as the facility's tax return, unless waived by the Department according to standards found in Medicare Provider Reimbursement Manual, HCFA Publication 15-1. “Indemnity bond” means a bond posted by the provider to ensure that the provider is able to fulfill any financial obligations to the Department upon sale of the facility. “Interim Working Capital Fund” means funding made available to providers on a temporary basis that shall be repaid to the Department. “Market basket index” means inflation indices from the latest Skilled Nursing Home without Capital Market Basket Index, published 2 months before the period in which rates are being calculated and which is available from CMS at www.cms.gov, or a comparable index available from, and used by, CMS, if this index ceases to be published by Global Insight, Inc. or its successor. “Maryland Health Care Commission” means the agency established by Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. “Medicaid” means Medical Assistance provided under the State Plan approved under Title XIX of the Social Security Act. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medicare upper payment limit” means that aggregate payments to nursing facilities may not exceed the limits established for such payment in 42 CFR §447.272. “Minimum Data Set (MDS)” means the MDS required by 42 CFR §483.20 and set forth in the Resident Assessment Instrument published by CMS, and available at www.cms.gov, incorporated herein by reference, as amended and supplemented, a core set of screening, clinical, and functional status elements, including common definitions and coding categories that forms the foundation of the assessment required for all residents in Medicare-certified or Medicaid-certified nursing facilities. “New facility” means: A facility that has not been a provider during the previous 12-month period or, for rates effective January 1, 2015 and after, does not have a cost report in the price database as set forth in Regulation .09B(1) of this chapter; and A facility not defined as a replacement facility. “Noncompliant” means: A provider fails to submit to the Department the required quarterly report of credit balances; A provider fails to submit a quarterly report which provides sufficient data relating to the credit balances it maintained during that quarter; or A random audit by the Department reveals errors or omissions in a provider's credit balance report. Nursing Facility (NF). “Nursing facility” means an institution which is primarily engaged in providing to residents: Skilled nursing care and related services for residents who require medical or nursing care; Rehabilitation services for the rehabilitation of injured, disabled, or sick persons; or On a regular basis, health-related care and services to individuals who, because of their mental or physical condition, require care and services (above the level of room and board) which can be made available to them only through institutional facilities. “Nursing facility” means an institution which is licensed by the Department under COMAR 10.07.02. “Nursing facility” does not include an institution which is primarily for the care and treatment of mental diseases, an intellectually disability or a developmental disability. “Nursing facility services” means services provided to individuals who do not require hospital care, but who, because of their mental or physical condition, require skilled nursing care and related services, rehabilitation services, or, on a regular basis, health-related care and services (above the level of room and board) which can be made available to them only through institutional facilities. “Owner” means a party or entity having any ownership interest in the facility. “Patient day” means care of one patient for 1 day of service. The day of admission is counted as 1 day of care, but the day of discharge is not counted. If a patient is discharged on his day of admission, 1 patient day will be counted. “Payroll-Based Journal” means a system for facilities to submit staffing information to meet the requirements of §6106 of the Affordable Care Act (ACA) that requires facilities to electronically submit direct care staffing information (including agency and contract staff) based on payroll and other auditable data. “Personal needs fund” means that portion of the recipient's resource retained by the recipient for his personal use. “Predischarge plan” means: A written document describing who has operational responsibility for discharge planning; The manner in and methods by which that person will function; The time period in which each recipient's need for discharge planning will be determined; The maximum time period after which a reevaluation of each recipient's discharge plan will be made; The local resources available to the provider, the individual, and the attending physician to assist in developing and implementing individual discharge plans; and Provisions for periodic review and reevaluation of the provider's discharge planning program. “Program” means the Medical Assistance Program. “Prospective rate” means a facility-specific quarterly per diem rate based on the RUG classification system, and calculated as the sum of: Administrative and Routine rate as calculated in accordance with Regulation .09 of this chapter; Other Patient Care Rate as calculated in accordance with Regulation .10 of this chapter; Capital Rate as calculated in accordance with Regulation .11 of this chapter; and Nursing Rate as calculated in accordance with Regulation .12 of this chapter. “Provider” means a facility which has in effect a provider agreement with the Department. “Provider agreement” means the contract between the Department and the provider covering the obligations of the parties under the Medical Assistance Program. “Purchaser” means an entity that participates in a change of ownership with a provider by: Having a provider merge into the entity; Accepting the assignment, transfer, disposition, or sale of all or substantially all of a provider’s assets; or Being a new entity that results from the consolidation of the provider with a third party. “Quality measure” means a specific performance criterion, as described in Regulation .15 of this chapter, used to assess a facility’s performance level. “Random sample” means the selection for audit by the Department of representative share of the providers complying with the requirement of submitting a quarterly report of credit balances to the Department. “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Recreational services” means those organized activities provided for the enjoyment of the patients that are designed to promote their physical, social, and mental well-being. “Reimbursement class” means the group of providers for which a separate per diem rate will be prepared in the Administrative and Routine, Other Patient Care, and Nursing Service cost centers based on geographic region as set forth in Regulation .30 of this chapter. “Relative of the owner” means the owner's husband, wife, natural parent, natural child, sibling, adopted child, adoptive parent, stepparent, stepchild, stepbrother, stepsister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent, or grandchild. “Replacement facility” means: A newly constructed nursing facility that replaces an existing licensed and certified facility; or A facility that was closed for significant renovation that reopens and is approved by the Department as a replacement facility. “Resident roster” means a list of all residents in a nursing facility for a calendar quarter based on MDS assessments and tracking forms, accurately and successfully transmitted by the nursing facility into the CMS-approved submission system, used for the calculated day-weighted case mix indices for Medicaid, Medicare, and other payment sources. “Resource” means that portion of a recipient's income available toward the cost of medical and remedial care as determined by the Department or its designee. “Resource Utilization Group (RUG)” means the version IV (RUG-IV), 48-Group classification system, that has been developed by CMS for grouping nursing facility residents according to the residents’ functional status and anticipated uses of services and resources as identified from data supplied by the MDS. “Secretary” means the Secretary of Health. “Special focus facility” means a facility identified by the Centers for Medicare and Medicaid Services as having: More problems than other nursing homes; More serious problems than other nursing homes; and A pattern of serious problems that has persisted over a long period of time. “Specialized rehabilitative therapy services” means those services furnished by a provider as an integral part of a patient's care plan ordered by a physician and provided in conjunction with continuous nursing care for the purpose of the restoration of normal form and function after injury or illness. The services shall be performed by a licensed physical therapist, licensed physical therapy assistant, or registered occupational therapist. “Standby letter of credit” means a written instrument prepared by a provider's bank authorizing the Department to draw on the bank, upon sale of the facility. “Statewide average case mix index” means the simple average of all of the cost report period case mix indices for the rate year. “Statewide average Medicaid case mix index” means the Medicaid day weighted average of all nursing facilities’ case mix indices for the Medicaid days identified on the final resident rosters for each resident roster quarter. “Substandard quality of care” means a finding of substandard care in accordance with 42 CFR §488.301. “Third party” means any individual entity or program that is or may be liable to pay all or part of the medical cost of any medical assistance furnished to a recipient under the Medical Assistance Program, including private health insurance, employment related health insurance, medical support from absent parents, automobile insurance, court judgments or settlements from a liability insurer, state workers' compensation, first party probate-estate recoveries, or any federal programs. “Third party liability audit” means a financial review of Medical Assistance payments to a provider to ascertain the legal liability of third parties to pay for care and services available under the Medical Assistance Program. “Third party liability review” means a financial review of the credit balances of a nursing facility to ascertain the legal liability of third parties to pay for care and services available under the Medical Assistance Program. “Uniform cost report” means the cost report format which each facility is required to use in the submission of its fiscal year cost and utilization data, including supplemental schedules and other balance sheet and administrative data. In order to participate in the Program, a provider shall be licensed by the Department, pursuant to Health-General Article, §19-301 et seq., Annotated Code of Maryland, and COMAR 10.07.02, and shall obtain other licenses, as may be required by applicable State and local laws. To participate in the Program, the provider shall: Be certified by the Department at its total licensed nursing facility bed capacity as meeting the requirements of Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., for participation as a nursing facility; Be in compliance with preadmission screening and resident review requirements as described by 42 CFR Part 483, Subpart C (1996); Be in compliance with the requirements of COMAR 10.09.36; Be approved for participation by the Department; Have a provider agreement in effect; Employ an organized medical staff or a medical director who is a licensed physician; Provide, according to the needs of the recipient, those services listed in Regulation .04 of this chapter; Accept payment by the Department as payment in full for covered services rendered and make no additional charge to any person for covered services except as provided for in Regulation .28 of this chapter; Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee; Provide services without regard to race, color, age, sex, national origin, marital status, physical or mental handicap; Verify the recipient's eligibility; Place no restriction on a recipient's right to select providers of his choice; Have in effect a predischarge plan; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized in accordance with Regulation .06 of this chapter, the provider may not seek payment for that service from the recipient; Perform utilization control functions for all recipients designated eligible for nursing facility services as described by 42 CFR §§346.370, 456.360, 456.371, 456.380, and 456.381 (1996), and as required by the Utilization Control Plan for Selected Institutional Services Reimbursed by the Maryland Medical Assistance Program; Notify the Department or its designee of patient activity or circumstance that affects placement, eligibility, or reimbursement on such form and at such time as specified by the Department; Before discharging any Medical Assistance recipient certified as requiring nursing facility services, place in the recipient's permanent medical record the following information on a consent form designated by the Department, a copy of which shall be submitted to the Department and to the Office on Aging: A certification that the recipient or guardian has: Been informed of the recipient's right to remain in the discharging facility and have the cost of care paid by the Medical Assistance Program; Been informed that the Medical Assistance Program will not pay for room and board in a setting outside of a nursing facility and that the Program may pay for the cost of medical services received outside of a nursing facility subject to medical and financial eligibility determinations and covered services limitations; Been informed of the recipient's right as a patient, as stated in the Health-General Article, §19-345, Annotated Code of Maryland; Been informed of the services provided by and the location of the alternative placement; Voluntarily given informed consent to the transfer; If the recipient or guardian is unable or unwilling to sign the consent form, submit to the Department a written explanation of the reason written consent was not obtained, a copy of which shall be placed in the recipient's medical record; Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient; Include in all contracts with a cost or value over a 12-month period of $10,000 or more, with any subcontractor, a clause allowing the Department or its agent access to the subcontractor's books, documents, and records which are necessary to verify the nature and extent of costs of the services furnished under the contract in accordance with the principles established under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., and contained in the Medicare Provider Reimbursement Manual, HCFA Publication 15-1; Meet the requirements in the Certificate of Need application approved by the Maryland Health Resources Planning Commission; Notify the Medical Assistance Program, in writing, of the contemplated sale of the facility or a controlling interest not less than 30 days before the date of the change of ownership; Assure that an individual who is eligible for Medical Assistance at the time of application for admission to a nursing home, or would become eligible within 6 months following admission, has a long-term care assessment made available before admission, at no charge to the individual, pursuant to COMAR 10.09.30. The evaluation is advisory only and may not restrict the right of an individual to select nursing home services; and Not less than 30 days before the date of any change of ownership, except when the Program agrees to a shorter period, provide the Department the notification and indemnity bond, letter of credit, or certificate of assurance required by Regulation .25D(1)—(3) of this chapter. The Program covers routine care and the following supplies, equipment, and services when appropriate to meet the needs of the recipient: Those described in the Maryland Department of Health regulations entitled “Requirements for Long Term Care Facilities”, 42 CFR Part 483, Subpart B (1996), subject to limitations in Regulation .05 of this chapter. Over-the-counter drugs. Bed reservations for recipients who are on a leave of absence to visit with friends or relatives or to participate in State-approved therapeutic or rehabilitative programs for a maximum of 18 days in any calendar year and without any limitation on the number of days per visit. Repealed. Administrative days approved by the Department or its designee according to the conditions set forth in Regulation .26D of this chapter. Specialized rehabilitative therapy services which meet the conditions listed below: Physical Therapy. Physical therapy services for Medical Assistance Program purposes are those services furnished to a recipient which meet all of the following conditions: The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified physical therapist; The services are of such a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, or skills of a qualified physical therapist; The services are performed by or under the supervision of a qualified physical therapist; The services are provided with the expectation, based on the assessment made by the physician of the recipient's restorative potential after any needed consultation with the qualified physical therapist, that the recipient will improve significantly in a reasonable, and generally predictable, period of time; The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and The services are reasonable and necessary to the treatment of the recipient's condition. Occupational Therapy. Occupational therapy services for Medical Assistance Program purposes are those which meet the following conditions: The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified occupational therapist; The services are on a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, and skills of a qualified occupational therapist; The services are performed by a qualified occupational therapist; The services are for the purposes of improving or restoring functions which have been impaired by illness or injury or, if function has been permanently lost or reduced by illness or injury, to improve the individual's ability to perform those tasks required for independent functioning; The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and The services are reasonable and necessary to the treatment of the recipient's condition. Speech Therapy. Speech therapy services for Medical Assistance Program purposes are those services furnished to a recipient which meet all of the following conditions: The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified speech and language pathologist; The services are of such a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, and skills of a qualified speech and language pathologist; The services are performed by or under the supervision of a qualified speech and language pathologist; The services are provided with the expectation, based on the assessment made by the physician of the recipient's restorative potential after any needed consultation with the qualified speech and language pathologist, that the recipient will improve significantly in a reasonable, and generally predictable, period of time; The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and The services are reasonable and necessary to the treatment of the recipient's condition. Supplies and equipment necessary to meet the needs of the recipient, including but not limited to: ABD pads. Adhesive strip bandages. Adhesive tape (regular and non-allergenic). Airways — oral and nasal. Alcohol and alcohol sponges. Ambu bags. Antiseptics and cleansing agents (over-the-counter). Applicators. Bandages. Beds, high-low, adjustable. Bed pans and urinals. Bed rails. Bibs. Body lotions (over-the-counter). Canes. Catheters (including Foley or other indwelling). Catheter trays. Chest or body restraints. Clean catch kits. Clinical medicine glasses — disposable or otherwise. Cotton and cotton balls. Covered water pitchers. Crutches. Dentifrices and denture adhesives. Denture cups. Deodorant (personal and room). Diagnostic aids (Clinitest, Acetest, Hematest, Testape, etc.). Dietary supplements (including tube feeding). Disposable diapers or incontinency care pads. Disposable wash cloths. Douche apparatus. Drainage bags and catheter tubing. Emesis basins. Enema apparatus. Enemas and douches (including prepared). Eye pads. First aid supplies. Gauzes. Hot water bottles and covers. Hydraulic lifts. Ice bags. Infusionarm boards. Intermittent positive pressure breathing machines (I.P.P.B.). Intravenous poles, portable. Irrigation trays. Levine tubes (plastic or regular). Lubricants and oils. Mouth washes. Nasal atomizers. Needles (cardiac, clysis or intravenous, permanent or disposable). Oxygen for occasional and emergency use. Continuous oxygen is covered under the provisions of COMAR 10.09.18 Oxygen and Related Respiratory Equipment Services. Oxygen masks, cannulas, catheters, and related equipment, including portable equipment for use with occasional or emergency oxygen. Equipment used for continuous use oxygen is covered under the provision of COMAR 10.09.18 Oxygen and Related Respiratory Equipment Services. Paper tissues. Personal toilet items (toothbrush, soap, shampoo, razor, shaving cream, sanitary pads). Petroleum jelly. Powder, medicated or non-medicated—over-the-counter. Pumps, aspiration and suction. Rectal tubes. Rubber or plastic gloves and finger cots. Rubber or plastic pants. Rubber or plastic sheeting. Rubber or sponge rings. Sand bags. Scales, including chair scales. Sheepskin, natural or synthetic. Slings. Special mattresses for decubiti care. Sphygmomanometers. Stethoscopes. Stryker and Foster frames. Suction machines, gastric and tracheal. Suction tubing. Surgical dressings, including sterile sponges. Suture removal kits. Suture trays. Syringes, plastic, glass, or bulb. Tape removers. Thermometers, oral, rectal, universal, bath. Tongue depressors. Tracheostomy equipment and supplies. Traction equipment. Trapeze and bed frame equipment. Trays, cut-down. Tubing. Walkers and walkerettes. Wheel chairs. Administration of enemas. Administration of oxygen. Back rubs. Decubiti care and over-the-counter medication. Colostomy, ileostomy, and nephrostomy care. Hand feeding or self-help eating devices. Incontinency care. Personal laundry. Personal toilet (routine shaving, hair washing and arranging, routine toenail clipping, adequate bathing). Private room for isolation purposes. Special diets, including diabetic. Tray service. Tube feeding. Portable X-ray services. Respirator management in licensed comprehensive care beds which have been determined by the Department to meet the standards for respiratory care units under COMAR 10.07.02. Intravenous therapy and venipuncture. Noninvasive traction apparatus services (cervical, Buck's extension, pelvic). Emergency resuscitation procedures, including coronary pulmonary procedures. Restorative nursing care. Physician-ordered physical restraints and protective devices. Negative pressure wound therapy. The following are not covered: Services by an out-of-State nursing facility unless the Department and the nursing facility execute a provider agreement; Audiology services; Services reimbursed under Title XVIII of the Social Security Act; and Services for which payment is made directly to a provider other than the nursing facility. The Department of Human Services shall certify the recipient for financial eligibility, and the Department or its designee shall certify the recipient as requiring nursing facility services, except as provided in Regulation .26D of this chapter. The Department or its designee will certify as requiring nursing facility services only those financially eligible recipients requiring nursing facility services as defined in Regulation .01B of this chapter. A provider shall be paid the prospective rate for nursing facility services as defined in Regulation .01B of this chapter plus the Nursing Facility Quality Assessment add-on identified in Regulation .11E of this chapter. When necessary, each facility’s per diem rate shall be reduced by the same percentage to maintain compliance with the Medicare upper payment limit requirement. Power wheelchairs and bariatric beds are not included in the prospective rate, but may be preauthorized for payment in accordance with COMAR 10.09.12. Support Surfaces. Support surfaces are not included in the prospective rate. A provider shall be paid a per diem rate for providing appropriate specialized support surfaces to patients with pressure ulcers or in recovery from myocutaneous flap or graft surgery for a pressure ulcer. A Class A support surface is a mattress replacement which has been approved as a Group 2 Pressure Reducing Support Surface by the Medical Policy of the Medicare Durable Medical Equipment Regional Carrier. A Class A support surface shall be reimbursed per day at the Medicare Durable Medical Equipment Regional Carrier Maryland monthly fee cap, in effect at the beginning of the State fiscal year, for HCPCS Code E0277 multiplied by 12 and then divided by the number of days in the State fiscal year. A Class B support surface is an air fluidized bed which has been approved as a Group 3 Pressure Reducing Support Surface by the Medical Policy of the Medicare Durable Medical Equipment Regional Carrier. A Class B support surface shall be reimbursed per day at the Medicare Durable Medical Equipment Regional Carrier Maryland monthly fee cap, in effect at the beginning of the State fiscal year, for HCPCS Code E0194 multiplied by 12 and then divided by the number of days in the State fiscal year. Negative pressure wound therapy is not included in the prospective rate, but is reimbursed in accordance with rates established under COMAR 10.09.12. Reimbursement shall include the cost of pumps, dressings, and containers associated with this procedure. Nursing facilities that are owned and operated by the State are not paid in accordance with the provisions of §A of this regulation, but are reimbursed reasonable costs based upon Medicare principles of reasonable costs as described at 42 CFR Part 413. Aggregate payments for these facilities may not exceed Medicare upper payment limits as specified at 42 CFR §447.272. If the Medicare upper payment limit is above aggregate costs for this ownership class, the State may elect to make supplemental payments to increase payments up to the Medicare upper payment limit. Final facility rates for the period July 1, 2024 through June 30, 2025 shall be each nursing facility’s quarterly rate, exclusive of the amount identified in Regulation .13A(2) of this chapter, increased by the budget adjustment factor of 2.703 percent, plus the Nursing Facility Quality Assessment add-on identified in Regulation .11E of this chapter and the ventilator care add-on amount identified in Regulation .13A(2) of this chapter when applicable. A provider may request an allotment from the Interim Working Capital Fund if the facility for which an allotment is requested has not had any of the following deficiencies cited in any survey conducted by the Office of Health Care Quality during the calendar year preceding the calculation of the allotment, using the scope and severity matrix found in the Centers for Medicare and Medicaid Services State Operations Manual for Survey and Certification, Part 7, §7400E: Two or more “G” level deficiencies; or One or more “H” or higher level deficiencies. A provider operating a facility with any of the deficiencies described in §A of this regulation may be eligible for an allotment if the facility has undergone an arm's length change of ownership, as determined by the Department, since the latest survey that resulted in the deficiencies. The Department may deny an allotment from the Interim Working Capital Fund if the Department, based on sufficient information, concludes that the requesting provider is not able to repay the allotment on a timely basis. The maximum allotment for any provider shall be 0.015 times the total Medicaid payments to that provider in the prior State fiscal year. Recalculation. In March of each year, the Department shall recalculate the maximum allotment based on Medicaid payments for the prior State fiscal year. If the recalculated maximum allotment is: Less than the amount the provider carried over from the prior year, the provider shall repay the difference to the Department within 30 days of the date the Department provides notice that a repayment is due; or Greater than the amount carried over from the prior year, the provider may request the difference from the Department. Revocation. The Department may revoke the allotment based on: Quality of care violations; Changes in business practice that are detrimental to Medicaid recipients; Impending bankruptcy; or Other good cause shown. If the Department revokes the allotment, the provider shall repay the total allotment to the Department within 15 days of the notice of revocation. In order to obtain an allotment, the provider shall agree that it holds the allotment in constructive trust for the State subject to recoupment or immediate payment on demand by the State. The Interim Working Capital Fund expires on May 1, 2025. Providers shall repay all outstanding funds to the Department by May 1, 2025. The Department may grant repayment extensions, not longer than 60 days, under extraordinary circumstances. The Administrative and Routine cost center includes: Administrative expenses; Medical records expenses; Training expenses; Dietary; Laundry; Housekeeping; Operation and maintenance; and Capitalized organization and start-up costs. The Department shall initially establish cost center prices for the rate period January 1, 2015 through June 30, 2015, and thereafter rebase the cost center prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or, if a significant change in provider behavior or costs has resulted in payment that is inequitable, across providers. The Department shall rebase based on the following steps: The price database shall be established using the most recent desk reviewed Nursing Home Uniform Cost Report for each current provider, or the immediately prior owner of that nursing facility, that is available 2 months before the period for which prices are being established or rebased; If no desk reviewed cost report is available, that provider shall be excluded from the price database; The total cost center expenses for each cost report in the price database shall be adjusted from the midpoint of each cost reporting period to the midpoint of the rate year for which the price is being established based on the following steps: A monthly market basket index shall be calculated based on the following calculations: The index factor for each cost reporting period shall be calculated by dividing the index associated with the midpoint of the rate year by the index associated with the midpoint of the cost reporting period; and The indexed costs shall be calculated as total cost center expenses times the index factor; Each cost report's indexed Administrative and Routine costs shall be divided by the greater of total resident days or days at full occupancy times an occupancy standard calculated as the Statewide average occupancy, not including providers with occupancy waivers, plus 1.5 percent to arrive at the Administrative and Routine cost per diem; and For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of Administrative and Routine cost per diems identified in §B(4) of this regulation to calculate the Administrative and Routine Medicaid day weighted median as follows: Array the Administrative and Routine cost per diems for each geographic region from low to high; For each Administrative and Routine cost per diem, identify the Medicaid days from the nursing facilities’ cost reports; Calculate a cumulative Medicaid day total; and Identify the median Administrative and Routine cost per diem as the Administrative and Routine per diem associated with the cumulative Medicaid days that first equals or exceeds half the number of total Medicaid days for the geographic region. The final price for Administrative and Routine costs for each reimbursement class shall be calculated as the geographic regional Medicaid day weighted median multiplied by 1.025. For years between periods when the prices are rebased, the final cost center price shall be adjusted by the change in the indexes as calculated in §B(3) of this regulation that correspond to midpoint of the prior rate year to the midpoint of the new rate year. The final Administrative and Routine rate for each nursing facility is the Administrative and Routine price for its reimbursement class. The reimbursement classes for the Administrative and Routine cost center are specified under Regulation .30A of this chapter. Kosher Kitchen Add-on. Nursing facilities that maintain kosher kitchens and have Administrative and Routine costs in excess of the Administrative and Routine price in their reimbursement class that are attributable to dietary expense shall receive an add-on to its final price in an amount up to 15 percent of the median per diem cost for dietary expense in its reimbursement class. For years between periods when the kosher kitchen add-ons are rebased, the kosher kitchen add-on shall be calculated as the prior year kosher kitchen add-on multiplied by the rate year monthly index divided by the prior year monthly index as identified in §B(3)(a) of this regulation. The Other Patient Care cost center includes: Medical director administrative expenses; Pharmacy; Recreational activities; Patient care consultant services; Food cost (unprepared); Social services; and Religious services. The Department shall initially establish Other Patient Care prices for the rate period January 1, 2015, through June 30, 2015, and thereafter rebase the Other Patient Care prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. The Department shall rebase based on the following steps: The indexed costs shall be calculated as set forth in Regulation .09B(1)—(3) of this chapter; Each cost report's indexed Other Patient Care costs shall be divided by the actual days of nursing facility services to arrive at the Other Patient Care cost per diem; For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of Other Patient Care cost per diems identified in §B(2) of this regulation to calculate the Other Patient Care Medicaid day weighted median using the method established in Regulation .09B(5) of this chapter; The final price for Other Patient Care costs for each reimbursement class is calculated as the geographic regional Medicaid day weighted median multiplied by 1.07; and For years between periods when the prices are rebased, the final price for Other Patient Care costs shall be calculated as set forth in Regulation .09D of this chapter. The final Other Patient Care rate for each nursing facility is the Other Patient Care price for its reimbursement class. The reimbursement classes for the Other Patient Care cost center are specified under Regulation .30B of this chapter. Kosher Kitchen Add-on. Nursing facilities that maintain kosher kitchens and have Other Patient Care costs in excess of the Other Patient Care price in its reimbursement class that are attributable to food costs shall receive an add-on to its final price an amount up to 15 percent of the median per diem cost for food costs in its reimbursement class. For years between periods when the kosher kitchen add-ons are rebased, the kosher kitchen add-on shall be calculated as the prior year kosher kitchen add-on multiplied by the rate year monthly index divided by the prior year monthly index as identified in Regulation .09B(3)(a) of this chapter. The Capital cost center includes: Real estate taxes; and Fair rental value. Final Capital Cost. The determination of a provider's allowable final Capital per diem rate for the cost items under §A of this regulation is calculated as follows: Appraise each facility at least every 4 years; 2 months before the period for which final Capital rates are being calculated, determine the most recent appraisal for each facility; Determine the cost report for each facility that covers the date of valuation of the appraisal identified in §B(1)(b) of this regulation, or, if a cost report covering the date of valuation has not been filed by the facility, determine the closest match to the date of valuation available 2 months before the period for which final Capital rates are being calculated; Multiply the ending licensed nursing facility beds from the cost report in §B(1)(c) of this regulation, adjusted for accuracy using information available 2 months before setting the rate in this regulation, by the land per bed amount from the appraisal to calculate a total land amount; Sum the total land amount, building, and equipment; Divide the total appraisal amount by the number of ending licensed nursing facility beds, under §B(1)(d) of this regulation, to determine an appraised value per bed; Apply a maximum appraised value per bed of $120,000; Multiply the final appraised value per bed times the number of ending licensed nursing facility beds, under §B(1)(d) of this regulation, to determine the facility’s gross value; For facilities in Baltimore City, multiply the facility’s gross value by 10 percent to determine the facility’s annual fair rental value; For facilities in all jurisdictions except Baltimore City, multiply the facility’s gross value by 8 percent to determine the facility’s annual fair rental value; Divide the facility’s annual fair rental value by the greater of actual resident days, or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter, to establish a fair rental value per diem rate; Divide real estate taxes obtained from the most recent desk reviewed cost report available 2 months before the start of the rate year by the greater of actual resident days, or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter, to establish a real estate tax per diem rate; and Sum the fair rental value and the real estate tax per diem rates. The appraisal may not include any value associated with a Certificate of Need for nursing home beds. The final Capital rate for nursing facilities that have a change in the number of licensed beds or have replacement beds placed into operation during a State fiscal year shall not be recalculated as a result of that change until such time as an appraisal incorporating the changes is selected according to §B(1)(b) of this regulation and used in the facility’s rate calculation. The provider may protest the appraisal by submitting written notification to the Department within 90 days of receipt of the appraisal. If the protest cannot be resolved administratively, the provider may appeal under Regulation .34 of this chapter. Nursing facilities that are required to pay an assessment in accordance with COMAR 10.01.20.02 shall receive a Quality Assessment add-on calculated as follows: Sum the assessed days reported on the Nursing Facility Quality Assessment Payment Reporting Forms for the quarters covering the calendar year preceding the rate year; Multiply the assessed days by the assessment rate established for the rate quarters; and Divide the total assessed amount by the sum of the total patient days reported on the quarterly Nursing Facility Quality Assessment Payment Reporting Forms. The Nursing Service cost center includes all nursing expenses related to the direct provision of patient care. The Department shall initially establish Nursing Service prices for the rate period January 1, 2015, through June 30, 2015, and thereafter rebase the Nursing Service prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. The Department shall rebase based on the following steps: The indexed costs shall be calculated as set forth in Regulation .09B(1)—(3) of this chapter; Each cost report's indexed Nursing Service costs shall be divided by the actual days of nursing care to arrive at the indexed Nursing Service cost per diem; The indexed Nursing Service cost per diem shall be normalized to the Statewide average case mix index by multiplying the indexed Nursing Service cost per diem by the facility’s normalization ratio calculated as the Statewide average case mix index divided by the cost report period case mix index rounded to four decimals which creates the Normalized Nursing Cost per diem; For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of cost per diems identified in §B(3) of this regulation to calculate the Medicaid day weighted median using the method established in Regulation .09B(5) of this chapter; The final price for Nursing Service costs for each reimbursement class is calculated as the geographic regional Medicaid day weighted median Nursing Service cost multiplied by 1.0825; and For years between periods when the prices are rebased, the final price for Nursing Service costs shall be adjusted as set forth in Regulation .09D of this chapter. The final Nursing Service rate for each nursing facility for each quarter is calculated as follows: Determine the Nursing Service price for the facility’s geographic region; Calculate an initial nursing facility rate by multiplying the price by the facility average Medicaid case mix index divided by the Statewide average case mix index; Calculate a Medicaid adjusted Nursing Service cost per diem by multiplying the per diem identified under §B(2) or C(5) of this regulation by the Medicaid case mix adjustment ratio calculated as the facility average Medicaid case mix index divided by the cost report period case mix index rounded to four decimals; Calculate the final Nursing Service rate as the initial nursing facility rate reduced by any positive difference between 95 percent of the initial nursing facility rate and the Medicaid adjusted Nursing Service cost per diem; and For years between periods when the prices are rebased, the indexed Nursing Service cost per diem identified under §B(2) of this regulation shall be adjusted as set forth in Regulation .09D of this chapter. The reimbursement classes for the Nursing Service cost center are specified under Regulation .30C of this chapter. Resident Rosters. A nursing facility shall electronically transmit MDS assessment information in a complete, accurate, and timely manner. The Department shall provide a preliminary resident roster to a nursing facility based on the facility’s transmitted MDS assessment information for a calendar quarter on the fifth day of the second month following the end of the calendar quarter, provided that the nursing facility has transmitted the MDS assessment information by the 15th day following the end of the calendar quarter. The distribution of the preliminary resident roster shall serve as notice of the MDS assessments transmitted and provide an opportunity for the nursing facility to correct and transmit any missing MDS record. The Department shall provide a final resident roster to a nursing facility based on the facility’s transmitted MDS assessment information for a calendar quarter, provided that the nursing facility has transmitted the MDS assessment information by the 25th day of the second calendar month following the end of the calendar quarter. The Department may not consider MDS assessment information for the purpose of reimbursement rate calculations for a calendar quarter that is not submitted by the 25th day of the second calendar month following the end of the calendar quarter, except as provided in §E(6) of this regulation. The Department may only grant an exception to compliance with the electronic MDS assessment transmission due dates if the delay has been caused by fire, flood, act of God, or other good cause. The Department or its designated contractor shall distribute preliminary and final resident rosters according to the following schedule: Case Mix Index Calculation. The Department shall use the resource utilization group to adjust Nursing Service costs and to determine each nursing facility’s Nursing Service rate component. The Department shall adjust a nursing facility's case mix reimbursement rates quarterly based on the change in case mix of each facility according to the following schedule: The facility average Medicaid case mix index obtained from January 1 through March 31 shall be used to adjust rates effective July 1 through September 30 of the same calendar year; The facility average Medicaid case mix index obtained from April 1 through June 30 shall be used to adjust rates effective October 1 through December 31 of the same calendar year; The facility average Medicaid case mix index obtained from July 1 through September 30 shall be used to adjust rates effective January 1 through March 31 of the following calendar year; and The facility average Medicaid case mix index obtained from October 1 through December 31 shall be used to adjust rates effective April 1 through June 30 of the following calendar year. If the Department or its contractor determines that a nursing facility has delinquent MDS resident assessments, for purposes of determining both facility CMI averages, the assessments shall be assigned the case mix index associated with the RUG group “BC1” or its successor. A delinquent MDS shall be assigned a CMI value equal to the lowest CMI in the RUG classification system, or its successor. For each resident roster quarter, the Department shall calculate a Statewide average case mix index and a Statewide average Medicaid case mix index from all final resident rosters. A Medicaid case mix index equalizer shall be used to prevent any aggregate increase or decrease in expected State fiscal year Medicaid program expenditures for the rate quarters beginning every October, January and April, as follows: The Statewide average Medicaid case mix index for the July rate quarter shall be divided by the Statewide average Medicaid case mix index for the rate quarter identified in §F(2) of this regulation to determine the Medicaid case mix index equalizer for the quarter; Each facility average Medicaid case mix index for use in the rate quarter for each nursing facility shall be multiplied by the Medicaid case mix index equalizer to result in a facility Medicaid equalized case mix index; and The facility Medicaid equalized case mix index shall be used in place of the facility Medicaid case mix index in the calculation of the initial and final Nursing Service rate in §C of this regulation for every October, January, and April rate quarter. To determine cost report period case mix index for cost reporting periods starting before the midpoint of a calendar quarter, the associated quarterly resident roster period CMIs are used. If a cost report end date is before the midpoint of a calendar quarter, the associated quarterly resident roster period CMIs are not used. Assignment of Different Geographic Region. The Department may approve a provider's request to be included in a different Nursing Service cost center geographic region of this chapter upon review of sufficient documentation. Documentation shall show that the assigned geographic region is not appropriate for the provider and that economic conditions have placed the provider directly in competition with facilities in a geographic region other than the one to which the provider has been assigned by the Department. Payment of higher wages, or higher total expenditures, is not in itself sufficient to demonstrate that the provider is subject to economic conditions different from other providers in its reimbursement class. All approved waivers for geographic regions shall be effective for the following State fiscal year for the purpose of establishing the final Nursing Service rate in §C of this regulation, Nursing Service prices established in §B of this regulation shall be based on all facilities in a geographic region that do not have an approved waiver to be included in a different geographic region plus facilities with an approved waiver to receive prices in that geographic region. Nursing facilities with licensed nursing facility beds, which have been determined by the Department to meet the standards for ventilator care under COMAR 10.07.02, shall be reimbursed as follows: Services for residents receiving ventilator care shall be reimbursed as follows: The Nursing Service rate identified in Regulation .12 of this chapter shall be calculated with a facility average Medicaid case mix index that includes only residents receiving ventilator care; and An amount of $285 shall be added to the total prospective rate; The facility average Medicaid case mix index for rates under §A of this regulation are not subject to the Medicaid case mix index equalizer adjustment in Regulation .12F(6) of this chapter; Nursing facilities adding ventilator care services for the first time, which have been determined by the Department to meet the standards for ventilator care under COMAR 10.07.02, shall be reimbursed as described in §A of this regulation, except that the facility average Medicaid case mix index is assumed to be that of RUG classification ES3 (or its future equivalent); The facility should request this rate from the Department at least 60 days before the opening of the ventilator unit; For years between periods when the Nursing Services prices are rebased, the final price for Ventilator costs shall be adjusted as set forth in Regulation .09D of this chapter; and For residents not receiving ventilator care, the Initial Facility Nursing Service rate identified in Regulation .12 of this chapter shall be calculated with a facility average Medicaid case mix index that excludes residents receiving ventilator care. In order to be eligible to receive funds through the pay-for-performance program under the provisions of Regulations .15—.19 of this chapter: The provider shall be subject to quality assessment under COMAR 10.01.20; and During the 1 year period ending March 31 of the prior State fiscal year, the provider may not have been: Identified by the federal Centers for Medicare and Medicaid Services as a special focus facility; Denied payment for new admissions by the Department; or Identified by the Department as delivering substandard quality of care. Providers shall receive a composite score based on the following: Staffing levels, as described in §B of this regulation, shall comprise 20 percent of each facility’s score; Staffing stability, as described in §C of this regulation, shall comprise 15 percent of each facility’s score; Maryland Health Care Commission Nursing Facility Family Survey, as described in §D of this regulation, shall comprise 30 percent of each facility’s score; Minimum Data Set Clinical Quality Indicators, as described in §E of this regulation, shall comprise 30 percent of each facility’s score; and Staff immunization survey, as described in §F of this regulation, shall comprise 5 percent of each facility’s score. Staffing Levels. Staffing and hours of work shall be determined using the Payroll-Based Journal data for the 9-month period ending March 31 of each fiscal year. A facility’s average staffing level shall be determined from its most recent data reported in accordance with §B(1) of this regulation. Total staff hours shall be divided by average daily census during the period specified in §B(1) of this regulation to establish the facility’s average daily staffing. A facility’s average acuity shall be determined based on the facilities Minimum Data Set Resource Utilization Groups (RUG) during the 6-month period ending December 31 of the most recent State fiscal year. To establish expected staffing hours, each RUG group will be multiplied by the corresponding hours under Regulation .31B of this chapter and divided by the total days of care during the same period. The result from §B(3) of this regulation shall be multiplied by 1.26555 to establish the facility’s staffing goal. The facility’s staffing level from §B(2) of this regulation shall be divided by the facility’s staffing goal from §B(4) of this regulation to determine a score based on its percentage of the goal. A facility staffing exceeding its goal shall be scored at 100 percent. Providers shall receive 0—20 points based upon the scoring methodology described under Regulation .16 of this chapter. Staff Stability. On or before May 31 of the fiscal year, nursing facilities, excluding continuing care retirement communities and facilities with fewer than 45 beds, shall report data on individual nursing staff members’ length of employment using a format and procedures designated by the Department. This data shall include all nursing staff employed by the facility during the pay period that includes March 31 of the fiscal year. Providers that fail to comply with §C(1) of this regulation shall receive 0 points. Staff stability is based upon dates of employment for nursing staff reported in accordance with §C(1) of this regulation. Staff stability shall be determined by the percentage of staff employed by the facility for 2 years or longer at the time of the report. Providers shall receive 0—15 points based upon the scoring methodology described under Regulation .16 of this chapter. Family Satisfaction. Family satisfaction shall be determined based on results from the facility’s most recent Nursing Facility Family Survey administered by the Maryland Health Care Commission. Providers shall receive 0—30 points based upon the scoring methodology described under Regulation .16 of this chapter, as follows: 0—6 points shall be based upon questions regarding general satisfaction; and 0—24 points shall be based on several categories of questions regarding specific aspects of care and environment in the nursing facility. Minimum Data Set Clinical Quality Indicators. Providers shall receive scores for the 3-month period ending December 31 of the most recent prior State fiscal year based on the following quality indicators for long-stay residents from the Minimum Data Set published by the federal Centers for Medicare and Medicaid Services: Percent of High-Risk Residents Who Have Pressure Sores; Percent of Residents with a Fall Resulting in Major Injury; Percent of Residents Who Have/Had a Catheter Inserted and Left in Their Bladder; Percent of Residents with a Urinary Tract Infection; Percent of Long-Stay Residents Given Influenza Vaccination During the Flu Season; and Percent of Long-Stay Residents Who Were Assessed and Given Pneumococcal Vaccination. Providers shall receive 0—5 points for each quality indicator based on the scoring methodology described under Regulation .16 of this chapter. Staff Immunizations. Providers shall receive a score based on the percentage of nursing facility staff, which includes all staff classifications, that have been vaccinated against seasonal influenza. Providers shall receive 0, 2, or 5 points for this quality measure. Facilities shall submit data to the Department regarding all individuals employed or contracted by the facility during the period September through April 15. Benchmark. The benchmark for staff vaccinations is 90 percent. Nursing facilities that achieve the benchmark for at least 90 percent but less than 95 percent for seasonal flu shall receive 2 points. Nursing facilities that meet or exceed the benchmark of 95 percent for seasonal flu shall receive 5 points. Facilities with less than 90 percent may not receive points for this quality measure. Facilities that are eligible for pay-for-performance under Regulation .14 of this chapter shall receive a score for each quality measure described in Regulation .15 of this chapter. For the quality measures described in Regulation .15B—E of this chapter, a facility is ranked and awarded points as follows: The highest ranked facility receives 100 percent of the points available; The median score, weighted by total days of care, receives 50 percent of the points available; Zero points would be received by any facility whose raw score is below the median by an amount equal to or greater than the difference between the highest score and the median score; and All other facilities will receive points proportionate to where the score falls within the range between the highest and zero. Points for each quality measure are summed. In order to be eligible for improvement payment, a facility: Shall meet the eligibility criteria specified in Regulation .14 of this chapter; Shall be eligible and receive a composite score during the current fiscal year and the prior fiscal year; and May not be receiving a payment based upon its score as described in Regulation .19C of this chapter. Facilities shall be ranked according to the greatest point increase compared with the prior fiscal year. The Department shall report scores for pay-for-performance quality measures in Regulation .15 of this chapter, on or about July 1 of each year, based on data compiled during the prior fiscal year. A facility shall have 30 days from the date of the report to review and comment on performance data. If the Department determines that there are any errors in transcription of the data provided to the Department, or calculation of scores, ranks, or payment amounts, all facilities shall be rescored and revised scores shall be distributed. A final 30-day review period shall be allowed if the rescoring results in significant modifications. Beginning State fiscal year 2021, and each year thereafter, 1 percent of the budget allocation for nursing facility services shall be distributed based on pay-for-performance scores. Eighty-five percent of the amount identified in §A of this regulation shall be distributed to the highest scoring facilities, representing 40 percent of the eligible days of care, in accordance with the methodology described in Regulation .16 of this chapter. Funds shall be distributed among the facilities identified in §B of this regulation, based on the facility’s relative score, such that the highest-scoring facility shall receive twice the amount per day as the lowest-scoring facility receiving payment. Fifteen percent of the amount identified in §A of this regulation shall be distributed to the facilities that qualify for payment for improvement in accordance with Regulation .17 of this chapter. Funds shall be distributed among the facilities included in §D of this regulation, based on a facility’s relative point increase from the prior fiscal year, such that the facility with the greatest point increase shall receive twice the amount per day as the facility with the smallest point increase. A facility shall receive a lump-sum payment based on the per diem amount determined in accordance with §C or E of this regulation, multiplied by the facility’s Medicaid days of care in the facility’s most recent cost report, not to exceed 1 year. Out-of-State nursing facilities that are not special rehabilitation nursing facilities and do not meet the exception to cost reporting requirements set forth in Regulation .21M of this chapter shall be reimbursed at a rate that is the lesser of: The average Statewide quarterly rate identified by Regulation .07 of this chapter for in-State nursing facilities minus the quality assessment; and The out-of-State facility’s Medicaid per diem rate provided by the state in which the facility is located, or, if the state provides the facility with more than one Medicaid per diem rate, the facility’s lowest per diem rate. Out-of-State nursing facilities that are not special rehabilitation nursing facilities and do meet the exception to cost reporting requirements set forth in Regulation .21M of this chapter shall be reimbursed the average Statewide quarterly rate identified by Regulation .07 of this chapter for in-State nursing facilities minus the quality assessment. Out-of-State special rehabilitation nursing facilities shall be reimbursed by the Program when the following conditions are met: The facility is accredited by the Commission on Accreditation of Rehabilitation Facilities; The facility is licensed and certified as a nursing facility; and Services for which reimbursement is requested have been preauthorized by the Program. The rate for each resident in an out-of-State special rehabilitation nursing facility shall be negotiated to: Be less than the cost of available institutional alternatives; and Not exceed the home state's Medicaid rate for the same service by the same provider if the provider participates in its home state Medicaid program. The provider shall include, for purposes of cost finding, direct and indirect costs applicable to recipient care. The provider shall specifically identify, in the cost report, costs associated with related organizations. The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. This system of accounts will provide as a minimum: Maintenance of a chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements; Proper reference to supporting invoice, voucher, or other form of original evidence; Maintenance of an appropriate time reporting system for all personnel and proper payroll authorizations and vouchers; Provision for payment by check (when financial transactions involve numerous small expenditures, an imprest petty cash fund may be established, provided adequate supporting vouchers are maintained); Maintenance of records on all assets capitalized and depreciation on the assets; Maintenance of appropriate records of patient days by level of care; Maintenance of records on an accrual basis; Maintenance of a daily midnight bed census by recipient name in a form prescribed by the Department (use of the prescribed form may be waived by the Department or its designee where a provider demonstrates the ability to maintain a superior system of census information); and Maintenance of other records as required by the Department. The provider shall keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours. Upon request by the Department or its designee, documentation of costs shall be made available by the provider during the course of verification. The provider shall have 30 days from the date of the request to provide documentation for undocumented costs. Costs for which documentation is not provided within the 30 days shall be deemed not allowable. The Department may grant, in writing, an extension of time upon written demonstration by the provider of good cause. Records shall be retained for 6 years after the month the cost report to which the materials apply is filed with the Department or its designee. Financial and Statistical Data Required. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. If reports are not received within 3 months and an extension has not been granted, the Department shall reduce the per diem rate by 3 percent for services provided during the calendar month after the month in which the report is due and any subsequent calendar month through the month during which the report has been submitted. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. A 1-month extension will be granted upon written request in advance by the provider. The Department may not grant an extension longer than 1 month unless the delay in filing the report has been caused by fire, flood, or act of God, and an extension is not allowed past March 31 after the calendar year during which the provider's fiscal year ended unless the report cannot be submitted by that date due to fire, flood, or act of God. When a report is not submitted by the last day of the sixth month after the end of the provider's fiscal year, the Department shall impose one or more sanctions as provided for in Regulation .33 of this chapter. For purposes of §§E and F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The Department, at its option, may request an additional cost report from a provider when a: Change in the location of a provider's operation occurs; or Significant change occurs that would affect the appraised value of a facility, such as an increase in the number of beds by more than 10 percent. If the Department exercises its option under the provisions of §I of this regulation, the period covered by the two reports in the specific provider’s fiscal year shall be divided as follows: Beginning of fiscal year to date of change; and Date of change through the end of the fiscal year. Except as indicated in §L of this regulation, administrative and routine, other patient care, and capital costs incurred by the provider exclusively for providing ventilator care are not allowed in these cost centers, but are allowable nursing service costs. For any provider who provides ventilator care on 50 percent or more of its Maryland Medical Assistance days of care, all costs incurred by the provider exclusively for providing ventilator care are not allowable costs. A provider which renders a minimal number of Maryland Medical Assistance days of care may not be subject to cost reporting or field verification requirements for a specified fiscal period when the following criteria are met: The provider bills the Maryland Medical Assistance Program for less than 1,000 Maryland Medical Assistance days of care during the provider's fiscal period; and The provider gives notice to the Program within 3 months after the end of the provider's fiscal period of the intent to not file a cost report for that period. The notice required in §M(2) of this regulation shall include: An assurance that the provider billed the Medical Assistance Program for less than 1,000 days of care in the fiscal period; and A statement that the provider agrees to accept as final reimbursement the average rate paid to all other nursing facilities in the facility’s geographic region identified in Regulation .30A of this chapter, minus the quality assessment add-on for facilities that are exempt from Nursing Facility Quality Assessment identified in COMAR 10.01.20. A provider that does not incur costs for over-the-counter drugs on behalf of its private pay residents may adjust its report in order to ensure final reimbursement that more accurately reflects its costs for Medicaid days of care. The provider shall divide its costs by Medicaid and other government-paid days, multiply the quotient by its private pay days of care, and report the product as an adjustment to its over-the-counter drug costs. Out-of-State facilities are not subject to cost reporting requirements Desk Reviews. The Department or its designee may conduct a desk review of the costs before establishing the Administrative and Routine and Other Patient Care prices and Nursing Service rates. The Department or its designee shall notify each provider participating in the Program if any adjustments resulted from the desk review. Desk review adjustments shall be used in the computation of any future rate for the facility or the facility’s future owner that is based on the reported or desk reviewed costs, until the rate is rebased. Field Verifications. The Department or its designee may conduct a field verification of the reported or desk reviewed costs affecting reimbursement rates. The Department or its designee shall notify each provider participating in the Program of the results of the field verification. Field audit adjustments shall be used in the computation of any future rate for the facility or the facility’s future owner that is based on the reported or desk reviewed costs, until the rate is rebased. Field audit adjustments shall be used in the recomputation of any past rate for the facility or the facility’s past owner that is based on the reported or desk reviewed costs. If the recomputation of rates results in a rate that differs more than 2 percent from the initial rate computation excluding the quality assessment, the Department shall initiate an adjustment for the impacted service dates within 60 days after the notification described in §B(2) of this regulation. Field audit adjustments shall only affect the facility’s rates and do not affect prices or rates for other facilities within the geographic region. Out-of-State facilities are not subject to field verification requirements. Quarterly Reports of Credit Balances. A provider shall report the credit balances of the nursing facility to the Department on a quarterly basis. Third Party Liability Review. The Department shall conduct a third party liability review of the reports of the credit balances provider under §A of this regulation. Third Party Liability Audit of Random Sample. The Department or its designee may conduct a third party liability audit of a random sample of the reports of credit balances reviewed under §B of this regulation. Third Party Liability Audit of Noncompliant Nursing Facility. Subject to §D(2) of this regulation, the Department or its designee may conduct a third party liability audit of a nursing facility that is found to be noncompliant under §B of this regulation. In conducting the third party liability audit, the Department or its designee may only review the financial information of the nursing facility for the 2-year period immediately before the first day of the audit period in which the nursing facility was found to be noncompliant. Appeal Rights of Nursing Facility. A provider may appeal the results of a final report of a third party liability audit by filing written notice with the Department within 30 days after the provider receives the final report from the Department. An individual at the Department who did not participate in the final report shall: Review the appeal and contact a provider representative, if clarification is necessary; and Issue a report that either revises or concurs with the final report of the third party audit. A provider may appeal the results of the report issued by the Department under §E(2) of this regulation by filing written notice with the Nursing Home Appeal Board within 30 days of receipt of the report. If the provider does not appeal the results of the third party liability audit by filing written notice with the Department: The amount due as set out in the final report shall be paid to the Department within 60 days of the receipt by the provider of the results of the third party liability audit; or On or after the 61st day, after receipt by the provider of the results of the third party liability audit, the Department may withhold the amount as set out in the final report from future payments due the provider by the Department unless an agreed on payment plan has been entered into by the Department and the provider. If the provider appeals the results of a final report of a third party liability audit as authorized under §E(1) of this regulation, interest shall be charged on the amount appealed and shall continue until date of payment. The interest rate shall be based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. After a decision adverse to the provider by the Nursing Home Appeal Board and written notice to the provider of that decision by the Department: The amount determined to be due to the Department as a result of the third party liability audit shall be paid to the Department with accrued interest due; or On or after the 61st day, the Department may withhold the amount due pursuant to the decision of the Nursing Home Appeal Board from future payments due the provider by the Department unless an agreed on payment plan has been entered into by the Department and the provider. MDS Validation. In order to validate that the Nursing Service rate is supported by medical record documentation, accurately coded and submitted, the Department shall conduct periodic MDS validation reviews, which shall: Compare the MDS assessment coding with the corresponding medical record documentation to determine unsupported MDS assessments; Determine the completeness, timeliness, and accuracy of resident MDS assessments identified on the resident roster; and Determine the completeness and accuracy of the resident payment source listed on the resident roster. Findings from the MDS validation may be used to adjust a nursing facility’s per diem payment rate to reflect the validated case mix index used in the rate setting process. Ventilator Care Validation. In order to validate that days paid for residents that meet the requirements for ventilator care are supported by medical record documentation of the need for ventilator care services, the Department shall conduct a periodic ventilator care validation. Findings from the ventilator care validation shall be used to recoup payments for days not supported by medical record documentation. The Department shall establish rates for new nursing facilities, replacement facilities, and nursing facilities with a change of ownership as outlined in §§B—D of this regulation. New Nursing Facilities. Until such time as an appraisal for the new facility is available as set forth in Regulation .11B(1)(b) of this chapter, the fair rental value per diem rate shall be based on the lower of the facility’s construction costs plus the assessed land value divided by the number of licensed beds, or the maximum appraised value per bed in Regulation .11B(1)(g) of this chapter. A new nursing facility shall be assigned the Statewide average Medicaid CMI until assessment data submitted by the nursing facility is used in a quarterly rate determination. The nursing facility shall be assigned to the appropriate geographic region, as specified under Regulation .30 of this chapter, for purposes of assigning the Nursing Service rate, the Other Patient Care price, and the Administrative and Routine price. The geographic region price for Nursing Service costs shall be multiplied by the new nursing facility’s Medicaid CMI until there is a nursing facility cost report used in the rebasing process. The fair rental value per diem rate shall use days as the greater of total estimated resident days or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter and the maximum bed value identified in Regulation .11B(1)(g) of this chapter. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the fair rental value per diem rate shall be calculated using estimated resident days. At the completion of the waiver period, either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. Upon providing the real estate bills to the State which incorporate the new construction at least 15 days before the start of operations or at least 15 days before the beginning of any calendar quarter, the real estate tax per diem rate shall be calculated in accordance with Regulation .11B(1)(l) of this chapter. This amount shall be used for the period from the time of submission until the next facility cost report is filed. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the real estate tax per diem rate shall be calculated using estimated resident days. At the completion of the waiver period, either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. For the first 2 State fiscal rate setting years, or portions thereof, new nursing facilities that are required to pay an assessment in accordance with COMAR 10.01.20.02 shall receive a Quality Assessment add-on calculated as follows: Estimate the assessed days to be reported on the Nursing Facility Quality Assessment Payment Reporting Forms for the quarters covering the upcoming State fiscal rate setting year or portion thereof; Multiply the estimated assessed days by the assessment rate anticipated for the rate quarters; and Divide the total estimated assessed amount by the sum of the total estimated patient days. At the completion of either of these first two rate setting periods, either the State or the facility may initiate a settlement payment should the estimates vary from the actual by more than 10 percent. Replacement Facilities. Until such time as an appraisal for the replacement facility is available as set forth in Regulation .11B(1)(b) of this chapter, the fair rental value per diem rate shall be based on the lower of the facility’s construction costs plus the assessed land value divided by the number of licensed beds, or the maximum appraised value per bed in Regulation .11B(1)(g) of this chapter. The fair rental value per diem rate shall use days as the greater of total estimated resident days or days at full occupancy times an occupancy standard calculated as the Statewide average under Regulation .09B(4) of this chapter. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter the fair rental value per diem rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. Upon providing the real estate bills to the State, which incorporate the new construction, at least 15 days before the start of operations or at least 15 days before the beginning of any calendar quarter, the real estate tax per diem rate shall be calculated in accordance with Regulation .11B(1)(l) of this chapter. This amount shall be used for the period from the time of submission until the next facility cost report is filed. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the real estate tax per diem rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. The replacement facility fair rental value rate shall be effective beginning on the date the replacement facility meets the requirements in Regulations .02 and .03 of this chapter. Except for the fair rental value portion of the Capital rate, the replacement facility shall be paid exactly as the original facility. The replacement facility rates shall be based on the original facility’s average Medicaid case mix index and cost report costs. Change of Ownership. Except when the Program agrees to a shorter notification period, when there is an anticipated change of ownership of a provider, not less than 30 days before the date of the change of ownership: The provider shall: Notify the Program of the anticipated change of ownership; and If the provider has not filed for bankruptcy, post an indemnity bond or a standby letter of credit, or provide assurance satisfactory to the Program that the purchaser shall assume and be responsible for all financial obligations of the existing provider; and The purchaser shall: Notify the Program of the intent to engage in a change of ownership and the desire to enroll in the Program; Submit a provider application and execute a provider agreement with the Department; and If the provider has filed for bankruptcy, post an indemnity bond or a standby letter of credit, or provide some assurance satisfactory to the Program that the purchaser shall assume and be responsible for all financial obligations of the existing provider. Indemnity Bond or Standby Letter of Credit. The indemnity bond or standby letter of credit required by §D(1)(a)(ii) or (b)(iii) of this regulation shall be in the amount of: 10 percent of the Program billings for each unsettled fiscal period prior to January 1, 2015 outstanding; All unpaid amounts due and owing the Program for each settled fiscal period before January 1, 2015; 5 percent of the Program billings for the most recent annual fiscal period; and All debt owed by the provider to the Interim Working Capital Fund under Regulation .08 of this chapter. The indemnity bond or standby letter of credit obligation under §D(2)(a) of this regulation shall remain in effect until all financial liabilities are resolved. If a court of competent jurisdiction discharges the debt of a bankrupt provider, the Program shall release to the purchaser the difference between the indemnity bond or standby letter of credit required under §D(1)(b)(iii) of this regulation and the amount of the financial obligation discharged by the court. The purchaser shall submit a provider application and execute a provider agreement with the Department before being assigned a prospective rate. The new owner shall assume the old owner’s facility average Medicaid case mix index and cost reports. The new owner shall be paid at the same rates as the old nursing facility provider except for the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter in which the Capital rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. Recreational Services. The allowable costs of recreational services of a facility shall be based on an hourly or salary rate, not on a fee-for-service basis. Over-the-Counter Drugs. The cost of over-the-counter drugs is not to exceed the average wholesale price plus 50 percent, or the usual selling price, whichever is lower. Leave of Absence. The Department shall pay the sum of the rates identified in Regulations .09—.11 of this chapter, less patient resources for the cost of reserving beds for recipients for therapeutic home visits or participation in State-approved therapeutic or rehabilitative programs, subject to the following conditions: The recipient's plan of care provides for the absence; The leave of absence does not exceed 18 days during any calendar year; The recipient's attending physician shall complete the physician's authorization form not more than 30 days before the recipient's anticipated leave of absence; and The facility submits the physician's authorization form to the Department with the facility's invoice, which covers the month in which the leave of absence occurred. Administrative Days. The Department shall pay the sum of the rates identified in Regulations .09—.11 of this chapter, and 50 percent of the rate identified in Regulation .12 of this chapter, less patient resources for administrative days, documented on forms designated by the Department, which satisfy the following conditions: The recipient’s required level of care has changed, and the following conditions are met: The Department or its designee has determined that the recipient’s level of care is provided by an Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID); The provider has implemented a predischarge planning program and initiated placement activities for the recipient at the earliest appropriate time; The provider has actively pursued placement of the recipient at the required level of care in an appropriate facility during the entire period of administrative days; The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §D(1)(a)—(c) of this regulation for the entire period of the administrative stay claimed for reimbursement; and The recipient is transferred promptly to the first available appropriate facility licensed and certified for the required level of care; When institutional care is no longer appropriate, and the following conditions are met: The Department or its designee has determined that the recipient no longer requires the level of care, which is provided by a nursing facility or Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID); The provider has implemented a predischarge planning program and initiated placement activities for the recipient at the earliest appropriate time; The provider has actively pursued placement of the recipient at the required level of care at home or in an appropriate setting during the entire period of administrative days; The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §D(2)(a)—(c) of this regulation for the entire period of the administrative stay claimed for reimbursement; and The recipient is transferred promptly after appropriate placement has been found; and When the recipient is at an inappropriate level of care but cannot be moved, and the following conditions are met: The attending physician has declared that, because of physical or emotional problems, the recipient is unable to be moved; The reason the recipient cannot be moved is adequately documented by the attending physician in the recipient's record; and Reevaluation by the attending physician of the recipient's inability to be moved and appropriate documentation of it in the recipient's record have been made at least every 60 days. Bed Occupancy. The Statewide average occupancy, defined in Regulation .09B(4) of this chapter, shall be calculated after the exclusion of all providers which operated under a waiver of the occupancy standard during any part of the cost report period. A waiver of the occupancy standards defined in Regulation .09B(4) of this chapter may be made by the Department under the following conditions: During a period not to exceed the first 12 months of operation for a newly constructed facility or for a newly constructed portion of an existing facility; During periods throughout which the occupancy standard could not be attained due to labor strike, fire, flood, or act of God, when this event is reported to the State licensing authority within 10 days of the event and request for waiver is submitted to the Program within 30 days of the event; For a period not to exceed 12 months when a voluntary reduction in licensed nursing facility bed capacity has been granted by the Department and the provider has received prior approval from the Program to reduce available beds while renovations are being completed; For a period not to exceed 12 months after a new provider acquires an existing facility which has been operated by the previous provider below the occupancy standard due to a ban on admissions, and when prior approval for the waiver has been granted by the Program; For a period not to exceed 12 months after a new provider acquires an existing facility which was in bankruptcy and operated below the occupancy standard at the time of purchase; or For a period not to exceed 12 months after a new provider has acquired or leased a building that was not licensed as a nursing facility immediately before the provider's acquisition or lease. When a waiver is granted under the provisions of §F(3) of this regulation, the occupancy standards shall be applied to the reduced licensed capacity. A waiver of the occupancy standards defined in Regulation .09B(4) of this chapter may not be allowed due to a ban on admissions or under any circumstances other than those described in §F of this regulation. Rates that are determined in accordance with the provisions of §F of this regulation are effective only for the period during which the waiver of the occupancy standard is in effect. The following costs are not allowable in establishing prospective rates: Costs not adequately documented; Costs for chaplaincy training and other religious training programs; Bad debts incurred by private pay or Medicare patients or third-party payers and bad debts resulting from denied costs of the Program; Recipient resources certified as available for medical and remedial care by the Department of Human Services which are uncollected; Advertising expenses, except those necessary for personnel recruitment; Stockholder costs incurred primarily for the benefit of stockholders or other investors, including the costs of stockholders' annual reports and newsletters, annual meetings, mailing of proxies, stock transfer agent fees, stock exchange registration fees, stockbroker and investment analysis, stock issuance costs, and accounting and legal fees for consolidating statements for Securities and Exchange Commission purposes; Any contributions, whether charitable or not, to any individual or organization; Public relations expenses; Costs of maintaining a recipient in a private room which exceeds costs of a semiprivate room; Cost of depreciable assets and minor equipment useful for a lifetime of at least 2 years, with a historical cost of at least $500 or an aggregate historical cost of at least $500 if they are purchased in a quantity of like or similar items; Civil money penalties, fines, and all costs associated with sanctions, including receivership, initiated by the Department or any other local, State, or federal government agency; Interest paid by a provider under Regulation .23E(5) of this chapter; Administrator compensation for any owner, or relative of the owner, in excess of the limits established based on the results of the 2001 nonowner administrator compensation survey, trended forward based on the percentage of the annual increase or decrease in the All Items category of the Consumer Price Index for All Urban Consumers (CPI-U), as follows: For facilities with 1—74 beds, the median compensation from that group; For facilities with 75—199 beds, the median compensation from that group; and For facilities with 200 or more beds, the median compensation from all facilities with 200 or more beds; Compensation for any administrator, who is not an owner, or relative of the owner, in excess of the limits established based on the results of the 2001 nonowner administrator compensation survey, trended forward based on the percentage of the annual increase or decrease in the All Items category of the Consumer Price Index for All Urban Consumers (CPI-U), as follows: For facilities with 1—74 beds, the 75th percentile compensation from that group plus 15 percent; For facilities with 75—199 beds, the 75th percentile compensation from that group plus 15 percent; For facilities with 200—299 beds, the 75th percentile compensation from all facilities with 200 or more beds plus 15 percent; and For facilities with 300 or more beds, 15 percent more than the limit established in §N(3) of this regulation for the facilities with 200—299 beds; Assistant administrator compensation for any owner, or relative of the owner, in excess of 80 percent of the maximum administrator compensation for the facility established in accordance with §M of this regulation; Compensation for any assistant administrator, who is not an owner, or relative of the owner, in excess of 80 percent of the maximum administrator compensation for the facility established in accordance with §N of this regulation; Central office employee compensation for any owner or relative of the owner in excess of the amount established in accordance with §M of this regulation, for the bed size category determined as the sum of beds if multiple facilities, plus 10 percent; Compensation for any central office employee, who is not an owner, or relative of the owner, in excess of the amount established in accordance with §N of this regulation, for the bed size category determined as the sum of beds if multiple facilities, plus 10 percent; Costs incurred in any effort to acquire a Certificate of Need or an exemption from a Certificate of Need for nursing home beds; Costs incurred for specialized support surfaces used for pressure ulcer care; Legal, accounting, and other professional expenses related to an appeal challenging a payment determination pursuant to Regulations .23E and .34 of this chapter unless a final adjudication is issued sustaining the nursing facility's appeal; A percentage of the legal, accounting, and other professional expenses related to an appeal as described in §U of this regulation, based upon the proportion of additional reimbursement denied to the total additional reimbursement sought on appeal, if a facility prevails on some but not all issues raised in the appeal or action; Any charges assessed by the Department for recovery of overpayments; and Direct service costs for physical, occupational, and speech therapy. The Department of Human Services will determine the application of a recipient's resource to the cost of medical or remedial care pursuant to COMAR 10.09.24. The provider shall collect a recipient's resource available for medical or remedial care, as certified by the Department of Human Services. The total of a recipient's available resource for medical or remedial care and the Department's payment may not exceed the provider's per diem rate. The provider shall show sums collected from a recipient's available resource as patient revenue. If a provider administers a recipient's personal needs fund, it shall administer the fund according to guidelines established by the Department. Upon request during normal business hours, a provider shall make available for verification by the Department or its designee the records of all transactions involving recipient's personal needs funds. A provider may not use a recipient's personal needs fund for care or services which are either allowable as part of the per diem cost or otherwise covered by the Medical Assistance Program. Upon request during normal business hours, 7 days a week, for a minimum of 3 hours each day, a provider shall allow a recipient to withdraw or otherwise use his personal needs fund. A provider may not use a recipient's personal needs fund for care or services not requested or not provided. A recipient's personal needs fund may not be used to retire a pre-existing debt. The reimbursement classes for the Administrative and Routine cost center are as follows: Facilities in the Baltimore metropolitan region consisting of the following counties: Anne Arundel; Baltimore; Carroll; Harford; and Howard; Facilities in Baltimore City; Facilities in the Washington region consisting of the following counties: Charles; Montgomery; and Prince George's; Facilities in the nonmetropolitan region consisting of the following counties: Allegany; Calvert; Caroline; Cecil; Dorchester; Frederick; Garrett; Kent; Queen Anne's; St. Mary's; Somerset; Talbot; Washington; Wicomico; and Worcester. The reimbursement classes for the Other Patient Care cost center are based on the county groupings as specified in §A of this regulation. For services provided prior to July 1, 2019, the reimbursement classes for the Nursing Service cost center are as follows: Facilities in the Baltimore region consisting of Baltimore City and Baltimore County; Facilities in the Central Maryland region consisting of the following counties: Anne Arundel; Carroll; and Howard; Facilities in the Washington region consisting of the following counties: Charles; Frederick; Montgomery; and Prince George's; Facilities in the nonmetropolitan region consisting of the following counties: Calvert; Caroline; Cecil; Dorchester; Harford; Kent; Queen Anne's; St. Mary's; Somerset; Talbot; Wicomico; and Worcester; Facilities in the Western Maryland region consisting of the following counties: Allegany; Garrett; and Washington. Effective July 1, 2020, the reimbursement classes for the Nursing Service cost center are as follows: Facilities in the Baltimore Metro region consisting of Baltimore City and the following counties: Anne Arundel; Baltimore; Carroll; Cecil; Harford; and Howard; Facilities in the Washington Metro region consisting of the following counties: Calvert; Charles; Frederick; Montgomery; Prince George’s; and St. Mary’s; Facilities in the Eastern region consisting of the following counties: Caroline; Dorchester; Kent; Queen Anne’s; Somerset; Talbot; Wicomico; and Worcester; and Facilities in the Western region consisting of the following counties: Allegany; Garrett; and Washington. During the period July 1, 2019 through June 30, 2020, reimbursement for the Nursing Service cost center shall be the sum of 50 percent of the amount calculated in accordance with the reimbursement classes under §C of this regulation and 50 percent of the amount calculated in accordance with the reimbursement classes under §D of this regulation. Personnel Types and Category Groupings. Minimum Data Set Resource Utilization Groups Hourly Weights. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the recipient for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. If the recipient is eligible for benefits from another payment source and elects to forfeit those benefits, the Program may reduce payment by the value of the benefits forfeited. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed; Denial of payment for new Medicaid admissions. Federal Remedies. If the Department determines that a provider is not in substantial compliance with federal requirements for participation in the Program, the Department may impose any of the remedies available under 42 CFR Part 488, Subpart F—Enforcement of Compliance for Long-Term Care Facilities with Deficiencies. The Department shall use the criteria set forth in 42 CFR Part 488, Subpart F, as the basis for imposing these remedies. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. The Department will give reasonable written notice to the nursing facility, to recipients, recipient's next of kin, and others who may be affected, of its intention to impose sanctions. The written notice will state the effective date and specific reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. Except as provided for in §B of this regulation, providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Nursing Home Appeal Board. Appeals regarding rate calculations or cost report adjustments which cannot be resolved administratively go to the Nursing Home Appeal Board. The Appeal Board shall be composed of the following members: A representative of the nursing home industry who is: Knowledgeable in Medicare and Medicaid reimbursement principles; and Appointed by the Secretary; An individual who: Is employed by the State; Knowledgeable in Medicare and Medicaid reimbursement principles; Did not directly participate in the field verification or desk review; and Is appointed by the Secretary; and A third member selected by the first two members of the Board. When the Board is reviewing an appeal from a provider in which a Board member is employed or in which he has a financial or personal interest, the Secretary shall designate an alternate for that member. If the provider elects to appeal to the Appeal Board and the Appeal Board finds in favor of the provider, the Department shall initiate a claims adjustment settlement for the impacted service dates within 60 days after the notification of the findings. The Department or any provider aggrieved by a reimbursement decision of the Appeal Board may not appeal to the Board of Review but may take a direct judicial appeal. The appeal shall be made as provided for judicial review of final decisions in the Administrative Procedure Act, §10-222, State Government Article, Annotated Code of Maryland. An appeal shall be filed in accordance with COMAR 10.01.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, 15-105, 19-14B-01, and 19-310.1, Annotated Code of Maryland Effective date: July 9, 1975 (2:15 Md. R. 1070) Regulation .03E amended effective January 30, 1976 (3:4 Md. R. 216) Regulation .03H amended effective December 31, 1975 (3:4 Md. R. 216) Regulation .03Q adopted as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); adopted permanently effective October 21, 1977 (4:22 Md. R. 1671) Regulation .03X amended effective September 29, 1976 (3:20 Md. R. 1143) Regulation .05 amended effective August 17, 1977 (4:17 Md. R. 1298) Regulation .06 amended as an emergency provision effective April 1, 1977 (4:8 Md. R. 631); emergency status extended at 4:17 Md. R. 1291) Regulation .06 amended effective August 17, 1977 (4:17 Md. R. 1298) Regulation .06B amended effective January 30, 1976 (3:4 Md. R. 216) Regulation .06C adopted as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); adopted permanently effective October 21, 1977 (4:22 Md. R. 1671) Regulation .07 amended effective August 17, 1977 (4:17 Md. R. 1298) Regulation .09 amended effective August 17, 1977 (4:17 Md. R. 1298) Regulation .09A amended effective September 29, 1976 (3:20 Md. R. 1143) Regulation .09B amended as an emergency provision effective April 1, 1977 (4:8 Md. R. 631); emergency status extended at 4:17 Md. R. 1291 Regulation .09B, D amended effective January 30, 1976 (3:4 Md. R. 216) Regulation .09A amended as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); amended permanently effective October 21, 1977 (4:22 Md. R. 1671) Regulation .09A amended as an emergency provision effective June 13, 1978 (5:13 Md. R. 1039) Regulations .03 and .09 amended as an emergency provision effective January 1, 1978 (5:1 Md. R. 15) Regulations .03, .06, .08, and .09 amended as an emergency provision effective March 15, 1978 (5:9 Md. R. 681) Chapter revised effective July 1, 1978 (5:13 Md. R. 1051) Regulations .01U, HH, II, LL; .02; .03; .04G; .07; .09; .11E amended effective December 14, 1979 (6:25 Md. R. 1980) Regulation .01M-1 and M-2 adopted effective July 1, 1980 (7:13 Md. R. 1278) Regulations .01O, .03D, and .11E amended effective January 1, 1980 (6:26 Md. R. 2074) Regulations .01JJ, KK; .07-1; .08A-1 adopted effective December 14, 1979 (6:25 Md. R. 1980) Regulation .01P repealed effective January 1, 1980 (6:26 Md. R. 2074) Regulation .05A repealed effective December 14, 1979 (6:25 Md. R. 1980) Regulation .07B amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1132); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07-2 adopted effective July 1, 1980 (7:13 Md. R. 1278) Regulation .08E amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .11 amended effective December 20, 1982 (9:25 Md. R. 2482) Regulation .16A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .18 adopted effective October 25, 1982 (9:21 Md. R. 2106) Chapter revised effective January 1, 1983 (9:25 Md. R. 2480) Regulation .01B amended effective June 6, 1983 (10:11 Md. R. 975); August 10, 1987 (14:16 Md. R. 1773) Regulation .01B amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1627); adopted permanently effective December 1, 1986 (13:21 Md. R. 2320) Regulation .03 amended as an emergency provision effective February 18, 1983 (10:6 Md. R. 536) Regulation .03P amended, Q adopted effective June 6, 1983 (10:11 Md. R. 975) Regulation .03R adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .03S adopted effective July 28, 1986 (13:15 Md. R. 1734) Regulation .03T and U adopted effective August 10, 1987 (14:16 Md. R. 1773) Regulation .04G amended effective October 29, 1984 (11:21 Md. R. 1812) Regulation .05 amended effective June 1, 1988 (15:11 Md. R. 1331) Regulation .07B amended and .07H adopted as an emergency provision effective June 27, 1983 (10:14 Md. R. 1257); adopted permanently effective October 24, 1983 (10:21 Md. R. 1901) Regulation .07B amended effective June 6, 1983 (10:11 Md. R. 975); August 10, 1987 (14:16 Md. R. 1773) Regulation .07B and E amended effective July 1, 1984 (11:12 Md. R. 1063) Regulation .07B, C, F, G amended and .07C-1 adopted as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); adopted permanently effective December 1, 1986 (13:22 Md. R. 2398) Regulation .07C amended effective October 29, 1984 (11:21 Md. R. 1812) Regulation .07D amended effective July 18, 1983 (10:14 Md. R. 1262); July 1, 1987 (14:13 Md. R. 1473); June 1, 1988 (15:11 Md. R. 1331); July 1, 1988 (15:13 Md. R. 1553) Regulation .07D amended as an emergency provision effective January 26, 1988 (15:4 Md. R. 469); adopted permanently effective May 15, 1988 (15:8 Md. R. 1009) Regulation .07E amended effective January 27, 1986 (13:2 Md. R. 137); July 1, 1988 (15:13 Md. R. 1533); September 5, 1988 (15:18 Md. R. 2147) Regulation .07E amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1627); adopted permanently effective December 1, 1986 (13:21 Md. R. 2320) Regulation .07G amended effective December 29, 1986 (13:26 Md. R. 2807) Regulation .07H repealed effective August 10, 1987 (14:16 Md. R. 1773) Regulation .08 amended as an emergency provision effective July 1, 1985 (12:14 Md. R. 1427); emergency status expired November 4, 1985 Regulation .08 amended effective November 4, 1985 (12:22 Md. R. 2103) Regulation .09A amended effective September 5, 1988 (15:18 Md. R. 2147) Regulation .10E amended effective August 10, 1987 (14:16 Md. R. 1773) Regulation .10I amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .12D repealed effective August 10, 1987 (14:16 Md. R. 1773) Regulation .13E amended as an emergency provision effective January 1, 1983 (10:1 Md. R. 21); adopted permanently effective May 1, 1983 (10:7 Md. R. 634) Regulation .13F amended as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); adopted permanently effective December 1, 1986 (13:22 Md. R. 2398) Regulation .14K adopted as an emergency provision effective June 27, 1983 (10:14 Md. R. 1257); adopted permanently effective October 24, 1983 (10:21 Md. R. 1901) Regulation .14K repealed effective August 10, 1987 (14:16 Md. R. 1773) Regulation .17A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .19 amended effective June 6, 1983 (10:11 Md. R. 974) Chapter revised effective November 27, 1989 (16:23 Md. R. 2505) Regulations .01, .07—.12, .16, and .25 amended as an emergency provision effective January 14, 1992 (19:3 Md. R. 299); emergency status expired June 30, 1992 Regulations .01, .07—.13, .16, .17, .23, and .25 amended as an emergency provision effective July 1, 1992 (19:14 Md. R. 1272); amended permanently effective November 1, 1992 (19:21 Md. R. 1891) Regulations .01, .04, .08—.11, .16, .17, .20, .21, and .23 amended as an emergency provision effective July 1, 2005 (32:19 Md. R. 1584); emergency status expired August 31, 2005 Regulation .01B amended effective March 19, 1990 (17:5 Md. R. 638); December 29, 1997 (24:26 Md. R. 1758) Regulation .01B amended as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); amended permanently effective August 16, 2004 (31:16 Md. R. 1255) Regulation .01B amended effective May 9, 2005 (32:9 Md. R. 848); December 9, 2005 (32:24 Md. R. 1904) Regulation .01B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527) Regulation .01B amended effective January 24, 2011 (38:2 Md. R. 84); October 3, 2011 (38:20 Md. R. 1202); October 14, 2013 (40:20 Md. R. 1652) Regulation .02 amended effective December 29, 1997 (24:26 Md. R. 1758) Regulation .03 amended effective March 19, 1990 (17:5 Md. R. 638); December 29, 1997 (24:26 Md. R. 1758) Regulation .03V amended effective October 3, 2011 (38:20 Md. R. 1202) Regulation .03W adopted effective October 3, 2011 (38:20 Md. R. 1202) Regulations .04, .10L, .11F, O, and .25B amended as an emergency provision effective July 3, 1990 (17:16 Md. R. 1986); amended permanently effective November 1, 1990 (17:21 Md. R. 2529) Regulations .04, .05, .07—.11, .13, .16, and .25 amended and new Regulation .09-1 adopted as an emergency provision effective October 1, 1999 (26:23 Md. R. 1775); adopted permanently effective January 9, 2000 (26:27 Md. R. 2015) Regulation .04 amended effective August 15, 1994 (21:16 Md. R. 1383); December 29, 1997 (24:26 Md. R. 1758) Regulation .04D repealed effective March 18, 2013 (40:5 Md. R. 411) Regulation .04E amended effective December 9, 2005 (32:24 Md. R. 1904); March 18, 2013 (40:5 Md. R. 411) Regulation .04BB adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .04BB adopted effective September 22, 2008 (35:19 Md. R. 1716) Regulation .05 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .05 amended effective February 16, 2004 (31:3 Md. R. 207) Regulation .05G amended effective December 29, 1997 (24:26 Md. R. 1758) Regulation .06 amended effective December 29, 1997 (24:26 Md. R. 1758); July 8, 2002 (29:13 Md. R. 990) Regulations .07—.11 amended as an emergency provision effective December 1, 2001 (29:1 Md. R. 17) Regulations .07—.11-1 and .26 amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1114); emergency status expired November 1, 1995; amended permanently effective November 6, 1995 (22:22 Md. R. 1658) Regulation .07 amended effective July 8, 2002 (29:13 Md. R. 990) Regulation .07 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .07 amended effective February 16, 2004 (31:3 Md. R. 207) Regulation .07 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527) Regulation .07 amended effective November 28, 2011 (38:24 Md. R. 1502); March 18, 2013 (40:5 Md. R. 411); December 12, 2013 (40:24 Md. R. 2016); December 11, 2014 (41:24 Md. R. 1427) Regulation .07A amended effective June 25, 1990 (17:12 Md. R. 1494) Regulation .07A-2 adopted effective February 12, 2007 (34:3 Md. R. 297) Regulation .07A-2 amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 Regulation .07A-2, C amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .07A-2, C amended effective September 22, 2008 (35:19 Md. R. 1716) Regulation .07A-3 adopted effective September 22, 2008 (35:19 Md. R. 1716) Regulation .07A-3 amended effective April 6, 2009 (36:7 Md. R. 523) Regulation .07A-4 adopted effective April 6, 2009 (36:7 Md. R. 523) Regulation .07B amended effective February 12, 2007 (34:3 Md. R. 297) Regulation .07C amended effective March 19, 1990 (17:5 Md. R. 638) Regulation .07C-1 amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .07C-2 and C-3 adopted effective April 5, 2010 (37:7 Md. R. 570) Regulation .07C-4 adopted effective December 27, 2010 (37:26 Md. R. 1787) Regulation .07-1 adopted as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); adopted permanently effective August 16, 2004 (31:16 Md. R. 1255) Regulation .07-1F, I amended effective April 10, 2006 (33:7 Md. R. 668); August 27, 2007 (34:17 Md. R. 1508); September 22, 2008 (35:19 Md. R. 1716) Regulation .07-1I amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527) Regulation .07-1I amended effective January 24, 2011 (38:2 Md. R. 84); October 3, 2011 (38:20 Md. R. 1202); February 18, 2013 (40:3 Md. R. 218); February 3, 2014 (41:2 Md. R. 91); December 11, 2014 (41:24 Md. R. 1427) Regulations .08—.11-1, .17, .20, and .21 amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1081); amended permanently effective November 4, 1996 (23:22 Md. R. 1496) Regulations .08—.11 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1149) (Emergency provisions are temporary and not printed in COMAR) Regulations .08—.11 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1181); amended permanently effective October 19, 1998 (25:21 Md. R. 1574) Regulations .08—.11, .13, and .16 amended as an emergency provision effective July 1, 1999 (26:16 Md. R. 1237 and 26:18 Md. R. 1369); emergency status expired September 30, 1999 Regulation .08 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .08 amended effective February 16, 2004 (31:3 Md. R. 207); September 22, 2008 (35:19 Md. R. 1716); March 18, 2013 (40:5 Md. R. 411) Regulation .08B amended effective July 1, 1993 (20:12 Md. R. 996); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904) Regulation .08B, E amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 Regulation .08B, E amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .08B, E amended effective April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502); December 12, 2013 (40:24 Md. R. 2016) Regulation .08B, E, H amended effective September 22, 2008 (35:19 Md. R. 1716) Regulation .08E amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904) Regulations .08E, .09E, and .10L amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 95); emergency status extended at 21:9 Md. R. 744; emergency status expired June 5, 1994 Regulations .08E, .09E, and .10L amended as an emergency provision effective July 1, 1994 (21:16 Md. R. 1379); emergency status expired November 7, 1994 Regulation .08H adopted effective September 11, 2006 (33:18 Md. R. 1505) Regulation .08H repealed as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 Regulation .08H repealed as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .09B amended effective July 1, 1993 (20:12 Md. R. 996); October 20, 1997 (24:21 Md. R. 1449) Regulation .09E amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449) Regulation .09E amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .09E amended effective February 16, 2004 (31:3 Md. R. 207); December 9, 2005 (32:24 Md. R. 1904) Regulation .09E amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 Regulation .09E amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .09E amended effective April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502) Regulation .09E, F amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .09E, H amended effective September 22, 2008 35:19 Md. R. 1716) Regulation .09H adopted effective September 11, 2006 (33:18 Md. R. 1505) Regulation .09H repealed as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286 Regulation .09H repealed as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .10 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .10 amended effective February 16, 2004 (31:3 Md. R. 207) Regulation .10C amended effective September 20, 2010 (37:19 Md. R. 1283) Regulation .10G amended effective December 9, 2005 (32:24 Md. R. 1904) Regulation .10G amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 Regulation .10G amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .10G amended effective September 22, 2008 35:19 Md. R. 1716); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502); March 18, 2013 (40:5 Md. R. 411); December 12, 2013 (40:24 Md. R. 2016) Regulation .10I amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) Regulation .10L amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449) Regulation .10N adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .10N adopted effective September 22, 2008 35:19 Md. R. 1716) Regulation .11 amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) Regulation .11 amended effective July 8, 2002 (29:13 Md. R. 990) Regulation .11 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003; March 18, 2013 (40:5 Md. R. 411) Regulation .11 amended effective February 16, 2004 (31:3 Md. R. 207) Regulation .11C amended effective July 1, 1993 (20:12 Md. R. 996) Regulation .11C amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 95); emergency status extended at 21:9 Md. R. 744 and 21:16 Md. R. 1379; emergency status expired August 14, 1994 Regulation .11C amended effective August 15, 1994 (21:16 Md. R. 1383); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904) Regulation .11C amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 Regulation .11C amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .11C amended effective September 22, 2008 35:19 Md. R. 1716); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); December 12, 2013 (40:24 Md. R. 2016) Regulation .11G amended effective August 15, 1994 (21:16 Md. R. 1383); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904); April 5, 2010 (37:7 Md. R. 570); December 12, 2013 (40:24 Md. R. 2016) Regulation .11U adopted effective August 15, 1994 (21:16 Md. R. 1383) Regulation .11U adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892; emergency status expired September 3, 2008 Regulation .11U adopted effective September 22, 2008 35:19 Md. R. 1716) Regulation .11-1 adopted as an emergency provision effective January 6, 1994 (21:2 Md. R. 96); adopted permanently effective May 1, 1994 (21:7 Md. R. 530) Regulation .11-1 repealed as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .11-1 repealed effective February 16, 2004 (31:3 Md. R. 207) Regulations .11-1—.11-6 adopted effective January 24, 2011 (38:2 Md. R. 84) Regulation .11-1A amended effective November 28, 2011 (38:24 Md. R. 1502) Regulation .11-2E amended effective November 28, 2011 (38:24 Md. R. 1502) Regulation .12A amended effective February 12, 2007 (34:3 Md. R. 297) Regulation .13 amended effective March 19, 1990 (17:5 Md. R. 638) Regulation .13E amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) Regulation .13I amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .13I amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .13L adopted effective August 15, 1994 (21:16 Md. R. 1383) Regulation .13P adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .13P adopted effective September 22, 2008 35:19 Md. R. 1716) Regulation .14 amended effective June 6, 1994 (21:11 Md. R. 951) Regulation .14C-1 adopted as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); adopted permanently effective October 1, 2001 (28:19 Md. R. 1684) Regulation .14G amended effective March 19, 1990 (17:5 Md. R. 638) Regulation .15 amended effective March 19, 1990 (17:5 Md. R. 638); October 3, 2011 (38:20 Md. R. 1202) Regulation .15A amended effective March 17, 2003 (30:5 Md. R. 366) Regulation .15B amended as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); amended permanently effective August 16, 2004 (31:16 Md. R. 1255) Regulation .16 amended effective February 19, 1990 (17:3 Md. R. 297); December 29, 1997 (24:26 Md. R. 1758); July 8, 2002 (29:13 Md. R. 990); March 18, 2013 (40:5 Md. R. 411) Regulation .16D amended effective April 5, 2010 (37:7 Md. R. 570) Regulations .16E and G, and .17J amended and .17K adopted as an emergency provision effective April 4, 1991 (18:9 Md. R. 1004); adopted permanently effective July 22, 1991 (18:14 Md. R. 1609) Regulations .16E and G amended and .30 adopted as an emergency provision effective January 1, 1991 (18:2 Md. R. 146); emergency status expired April 8, 1991 (18:9 Md. R. 1005) Regulation .16E amended effective September 27, 2004 (31:19 Md. R. 1432); October 14, 2013 (40:20 Md. R. 1652) Regulation .16F amended effective March 17, 2003 (30:5 Md. R. 366) Regulation .16F amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .16F amended effective February 16, 2004 (31:3 Md. R. 207); December 9, 2005 (32:24 Md. R. 1904); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502) Regulation .16G amended effective June 3, 1996 (23:11 Md. R. 810) Regulation .17 amended effective July 8, 2002 (29:13 Md. R. 990); May 9, 2005 (32:9 Md. R. 848); December 9, 2005 (32:24 Md. R. 1904); March 18, 2013 (40:5 Md. R. 411); December 11, 2014 (41:24 Md. R. 1427) Regulation .17K amended and L—O adopted effective June 6, 1994 (21:11 Md. R. 951) Regulation .18A amended effective March 18, 2013 (40:5 Md. R. 411) Regulations .20—.23 amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 96); adopted permanently effective May 1, 1994 (21:7 Md. R. 531) Regulation .20 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1181); amended permanently effective October 19, 1998 (25:21 Md. R. 1574) Regulation .20 amended effective December 9, 2005 (32:24 Md. R. 1904) Regulation .21 amended effective December 9, 2005 (32:24 Md. R. 1904) Regulation .22 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 Regulation .22 amended effective September 22, 2008 35:19 Md. R. 1716) Regulation .23 amended effective December 9, 2005 (32:24 Md. R. 1904) Regulation .24A, B amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .24A, B amended effective February 16, 2004 (31:3 Md. R. 207); March 18, 2013 (40:5 Md. R. 411) Regulation .25B amended effective August 15, 1994 (21:16 Md. R. 1383); February 16, 2004 (31:3 Md. R. 207); February 12, 2007 (34:3 Md. R. 297); March 18, 2013 (40:5 Md. R. 411) Regulation .25C amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 Regulation .27A amended effective June 6, 1994 (21:11 Md. R. 951) Regulation .27A-1 adopted as an emergency provision effective October 16, 1995 (22:22 Md. R. 1654); adopted permanently effective January 15, 1996 (23:1 Md. R. 25) Regulation .27C amended effective December 29, 1997 (24:26 Md. R. 1758) Regulation .28 amended effective January 24, 2011 (38:2 Md. R. 84) Regulation .30 adopted effective May 9, 2005 (32:9 Md. R. 848) Chapter revised effective April 13, 2015 (42:7 Md. R. 567) Regulation .07-1I amended effective December 19, 2016 (43:25 Md. R. 1384); January 1, 2018 (44:26 Md. R. 1214) Regulation .07-2 amended effective February 29, 2016 (43:4 Md. R. 331) Regulation .07-2L, M adopted effective December 19, 2016 (43:25 Md. R. 1384) Regulation .07-2N adopted effective January 1, 2018 (44:26 Md. R. 1214) Regulation .10-1B amended effective February 29, 2016 (43:4 Md. R. 331); December 19, 2016 (43:25 Md. R. 1384) Regulation .11-2B amended effective December 19, 2016 (43:25 Md. R. 1384) Regulation .11-7C amended effective December 19, 2016 (43:25 Md. R. 1384) Regulation .11-8C amended effective December 19, 2016 (43:25 Md. R. 1384) Regulation .12-1A, B amended effective February 29, 2016 (43:4 Md. R. 331) Regulation .13O amended effective February 29, 2016 (43:4 Md. R. 331) Regulation .15-1 amended effective February 29, 2016 (43:4 Md. R. 331) Regulation .15-1D amended effective December 19, 2016 (43:25 Md. R. 1384) Regulation .16-1G amended effective February 29, 2016 (43:4 Md. R. 331) Regulation .16-1I adopted effective February 29, 2016 (43:4 Md. R. 331) Regulation .25C adopted effective December 19, 2016 (43:25 Md. R. 1384) Regulation .28B amended effective February 29, 2016 (43:4 Md. R. 331) Chapter revised effective July 2, 2018 (45:13 Md. R. 664) Regulation .01B amended effective June 14, 2021 (48:12 Md. R. 472) Regulation .07 amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .07G amended effective May 20, 2019 (46:10 Md. R. 486); December 30, 2019 (46:26 Md. R. 1164); November 14, 2022 (49:23 Md. R. 995); September 16, 2024 (51:18 Md. R. 808), March 31, 2025 (52:6 Md. R. 267) Regulation .07H, I adopted effective November 14, 2022 (49:23 Md. R. 995) Regulation .08H amended effective May 20, 2019 (46:10 Md. R. 486); December 30, 2019 (46:26 Md. R. 1164); June 14, 2021 (48:12 Md. R. 472); November 14, 2022 (49:23 Md. R. 995); August 7, 2023 (50:15 Md. R. 681); September 16, 2024 (51:18 Md. R. 808); March 31, 2025 (52:6 Md. R. 267) Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .13A amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .15 amended effective June 14, 2021 (48:12 Md. R. 472) Regulation .19 amended effective June 14, 2021 (48:12 Md. R. 472 Regulation .19A amended effective November 14, 2022 (49:23 Md. R. 995) Regulation .21P adopted effective November 14, 2022 (49:23 Md. R. 995) Regulation .22B amended effective November 14, 2022 (49:23 Md. R. 995) Regulation .30 amended effective December 30, 2019 (46:26 Md. R. 1164) This chapter governs the determination of eligibility for the Maryland Children's Health Program with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014. Eligibility for the Maryland Children's Health Program may be established for children younger than 19 years old whose family income is equal to or less than 200 percent of the federal poverty level. In this chapter, the following terms have the meanings indicated. Terms Defined. “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). Applicant. “Applicant” means an individual whose written application for the Maryland Children's Health Program has been submitted to the local health department or the local department of social services but has not received final action. “Applicant” includes an individual whose application is submitted through a representative. “Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an Insurance Affordability Program to the Department or its designee. “Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. “Authorized Representative” has the meaning stated in COMAR 10.01.04.12. “Child” means an individual younger than 21 years old. “Child recipient” means a child younger than 19 years old who is certified as eligible for the Program. “Children’s Health Insurance Program” means the program for uninsured targeted low-income children established under Title XXI of the Social Security Act. “Department” means the Maryland Department of Health. “Designee” means any entity designated to act on behalf of the Department such as: Baltimore City or a county social services department under the supervision of the Department of Human Services; Baltimore City Health Department and its subgrantees, or a county health department; and The Maryland Health Benefit Exchange. “Determination” means a decision regarding an applicant's eligibility for the Maryland Children's Health Program. “Eligibility worker” means an employee of the local health department, or the local department of social services, responsible for determining the eligibility of applicants and recipients. Emergency Medical Condition. “Emergency medical condition” means a condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the patient's health in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part. “Emergency medical condition” includes labor and delivery. “Emergency medical condition” does not include services related to an organ transplant procedure. “Family members” means those individuals living with the applicant whose income is counted, or would be counted if there were any, as household income under Regulation .07B of this chapter. “Federal poverty level” means the nonfarm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981. “Inpatient services” means services received by a recipient while in a medical institution, birthing center, or clinic for which Medical Assistance is provided. “Institution for mental diseases” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed under COMAR 10.07.04. “Insurance Affordability Program” means a program that is one of the following: The Maryland State Medicaid program; The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; An optional state basic health program established under §1331 of the Affordable Care Act; A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; or A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act. “Living together” means sharing a common household. “Local health department (LHD)” means the Baltimore City Health Department and its subgrantees, or a county health department. “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. “MAGI Exempt Coverage Group” means coverage groups such as Aged, Blind, Disabled; Categorically Needy; and Medically Needy as defined under COMAR 10.09.24.02, whose eligibility is not determined by MAGI. “Maryland Children's Health Program (Program)” means the program established in Health-General Article, §15-301 et seq., Annotated Code of Maryland, to provide comprehensive medical care and other health care services to certain children. “Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program. “Maryland Medicaid Managed Care Program” means the Health Choice Program authorized by: Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland; and A waiver issued by the federal government under §1115 of the Social Security Act. “Medical Assistance (Medicaid)” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible individuals. “Period under consideration” means the specific months which are assessed in order to determine eligibility. Public Institution. “Public institution” includes an: Institution that is the responsibility of a government unit or over which a government unit exercises administrative control; or An establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. “Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves not more than 16 residents. “Qualified alien” means an individual who: Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA); Has been granted asylum in the United States as a refugee under §208 of the INA; Has been admitted into the United States as a refugee under §207 of the INA; Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year; Has had deportation withheld under §243(h) of the INA; Has been granted conditional entry into the United States under §203(a)(7) of the INA which was in effect before April 1, 1980; Is a documented or undocumented immigrant who has been battered or subjected to extreme cruelty by the individual's U.S. citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the alien, if: The spouse or parent consented to, or acquiesced in, the battery or cruelty; The immigrant has filed a Violence Against Women Act (VAWA) immigration case or a family-based visa petition with Immigration and Naturalization Service (INS); and In the opinion of the agency providing benefits, there is a substantial connection between the battery or cruelty and the need for the benefits to be provided; Is a victim of a severe form of trafficking who has been subjected to: Sex trafficking if the act is induced by force, fraud, or coercion, or the individual induced to perform the act is younger than 18 years old; or Involuntary servitude; Is a member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or Is an American Indian born in Canada to whom §289 of the INA applies. “Recipient” means an individual who is certified as eligible for the Maryland Children's Health Program. “Redetermination” means a determination regarding the continuing eligibility of a recipient. “Spouse” means an individual who has been determined to be the husband or wife of another person under State law and for the purpose of determining eligibility for Social Security benefits. “Title XIX” means the title of the Social Security Act, 42 U.S.C. §1396 et seq., which governs establishment of a medical assistance program for low income individuals. “Title XXI” means the title of the Social Security Act through which funding is provided, in part, for the Maryland Children's Health Program. Eligibility may be established for the Maryland Children's Health Program for children younger than 19 years old whose household income is equal to or less than 200 percent of the federal poverty level. The Department or its designee shall determine eligibility for children. The Department or its designee shall give oral, written, or electronic information about the Maryland Children’s Health Program such as: Requirements for eligibility; Available services; An individual's rights and responsibilities; Information in plain English, supported by translation services; and Information accessible to disabled individuals requesting an application. An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply. The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means, and in a manner accessible to disabled individuals requesting an application. A resident temporarily absent from the State but intending to return may apply for health coverage from an Insurance Affordability Program by telephone, mail, in-person, internet, and other available electronic means to the Department or its designee in any jurisdiction. The individual shall: Demonstrate continued residency in the State; and Meet all nonfinancial and financial requirements in order to be determined eligible. Application Filing and Signature Requirements. An individual who wishes to apply for health coverage under an Insurance Affordability Program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice. For the purpose of establishing eligibility of a child applicant who is neither pregnant nor postpartum, a parent or stepparent living with the child shall complete and sign the written, telephonic, or electronic application. If the child does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application. The date of application shall be the date on which a written, telephonic, or electronic, signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee. An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §I of this regulation. Period Under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established under §G of this regulation. For a child, the period under consideration is the 12-month period beginning with the month of application. Processing Applications — Time Limitations. When a written, telephonic or electronic application is filed, a decision shall be made promptly but not later than: 10 days from the date of application when filed at the local health department; or 30 days from the date of application when filed at the Department or its designee, but not the local health department. The time standards specified in §J(1) of this regulation cover the period from the date of application to the date the Department or its designee sends a written or electronic notice of its decision to the applicant. The Department or its designee shall inform the applicant by written or electronic notice of the missing information needed to determine eligibility, and the applicable time limit of 10 or 30 days. When an applicant fails to complete the application or to provide the required information needed to determine eligibility within the 10 or 30 day limit provided under §J(1)of this regulation, the applicant shall be determined ineligible. If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, a new period under consideration shall be established based on the date the new application is filed. Required Information. All information needed to determine eligibility for the Maryland Children's Health Program shall be reported. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. Social Security Number. As a condition of eligibility, an applicant shall furnish to the Department or its designee a Social Security number for the applicant. If the applicant cannot furnish a Social Security number, the applicant shall apply for a number. Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant complies with this subsection. Eligibility may not be established until the applicant: Furnishes a Social Security number; or Requests the assignment of the number through the Social Security Administration. Failure to provide the required Social Security number shall result in ineligibility for the applicant. If an applicant lacks the resources to meet the requirements of this regulation, the Department or its designee services shall assist the applicant in obtaining the necessary documents, and any costs incurred shall be paid for out of administrative funds. If the application indicates that a Social Security number was issued previously, the Department or its designee shall request validation of the number by the Social Security Administration. Individuals described under COMAR 10.09.24.05D(4)(b) who are applying for limited benefits to treat an emergency medical condition are not subject to the requirements in §A(1)—(4) of this regulation. Third-Party Liability. A recipient shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for the recipient's medical expenses. A recipient shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. In accident situations, a recipient shall notify the Department or its designee of the: Time, date, and location of the accident; Name and address of the attorney; Names and addresses of all parties and witnesses to the accident; and Police report number if an investigation is made. The Department or its designee shall: Maintain a written or electronic record including documentation of any required elements of eligibility; and Restrict disclosure of information concerning a recipient to purposes directly connected with the administration of the Medical Assistance Program, including: Establishing eligibility; Determining the extent of coverage under Medical Assistance; Providing services for recipients; and Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Medical Assistance Program. An applicant or recipient shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic or electronic application. Citizenship. In order to be eligible for full benefits under the Maryland Children's Health Program, an individual shall meet the federal requirements for Medical Assistance eligibility as a citizen or qualified alien, as specified at COMAR 10.09.24.05. Residency. In order to be eligible for benefits under this chapter, an individual shall be a resident of Maryland, in accordance with the requirements at COMAR 10.09.24.05-3. Age. In order to be eligible for benefits under this chapter, a child shall be younger than 19 years old. Inmate of a Public Institution. In order to receive benefits under this chapter, an individual may not be an inmate of a public institution, as specified at COMAR 10.09.24.05-5B. Institution for Mental Diseases. In order to be eligible for benefits under this chapter, an individual between 21 and 64 years old or a child applying under Title XXI of the Social Security Act may not be a patient in an institution for mental diseases, unless such individuals are eligible in accordance with COMAR 10.09.24.05-5C. No Private Health Insurance. In order to be eligible for benefits under Title XXI of the Social Security Act, an individual whose income is equal to 133 percent but less than 200 percent of the Federal Poverty Level, may not be covered by an employer-sponsored health benefit plan. An alien who fails to meet the requirements under §A of this regulation, but meets all other nonfinancial and financial factors of eligibility under this chapter, may be determined eligible for coverage under COMAR 10.09.24.05-2. Documentation of Citizenship and Identity. An applicant may not be determined eligible for Maryland Children’s Health Program until the requirements of this regulation are met. An applicant or recipient shall be required as a condition of eligibility to provide documentary evidence of identity as well as citizenship or nationality, to the Department's satisfaction, based on federal requirements, if the individual is: Declared to be a citizen or national of the United States; and Being determined for: Initial eligibility based on an application filed on or after September 1, 2006; or Continuing eligibility based on a redetermination with an end date on or after September 30, 2006. An applicant may be determined eligible for Maryland Children’s Health Program for a period of 90 days to provide requested documents. When an applicant fails to provide documentation of citizenship within the 90 day period, the applicant shall be determined ineligible. If an applicant or recipient fails to meet the requirements of §H of this regulation within the time standards specified in Regulation .04J(1) of this chapter, and the time standards are not extended, the Department shall: Deny eligibility for an applicant; or Terminate eligibility for a recipient, in accordance with the requirements for timely notice in COMAR 10.01.04. The requirements at §H of this regulation shall be met for all Medical Assistance coverage groups except for: Supplemental Security Income beneficiaries; Newborns who are deemed eligible, for a period of 1 year, for Medical Assistance based on the mother's Medical Assistance eligibility for the newborn's date of birth; Newborns deemed eligible who are born to an otherwise eligible non-qualified alien woman meeting the requirements of under COMAR 10.09.24.05-2 who has filed an application and has been determined eligible for Medical Assistance for the newborn's date of birth; Individuals who are entitled to Medicare benefits or enrolled in any part of Medicare; Individuals receiving SSDI disability insurance benefits under §223 of the Social Security Act, or monthly benefits under §202 of the Social Security Act, based on the individual's disability; Children who are receiving foster care or adoption assistance under Title IV-B or Title IV-E of the Social Security Act; and Other categories of individuals who are considered by the federal government to have previously presented satisfactory documentary evidence of identity as well as citizenship or nationality. Continuing eligibility for a recipient may not be approved at redetermination until the requirements of §H of this regulation are met. If there is documentation in an applicant's or recipient's written or electronic record or a federal or state's database that demonstrates that the individual meets the requirements of §H of this regulation, the individual shall be considered to meet the requirements of §H of this regulation, unless the: Department has cause to question the documentation previously accepted; or Federal government requires additional documentation. The applicant shall report the income of any family member, except for the income of a member that does not file a federal tax return and is not claimed as a federal tax dependent. Determining Countable Household Income. In determining an applicant's financial eligibility for the Maryland Children's Health Program, the applicant's current household income is considered. For the child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the child applicant and the following family members when living with the child applicant: The child applicant's parents; and At the option of the child applicant's parents, any of the child applicant's siblings. For the married child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the married child applicant and the married child applicant's spouse. When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application. Treatment of Income. Countable gross income for the Maryland Children’s Health Program shall be the household income calculated according to MAGI. MAGI income limits shall be: Converted from traditional income limits to account for elimination of income disregards. Increased by 5 percentage points of the federal poverty level for the following circumstances: When an individual’s income exceeds the Medicaid income standard; and The income standard is the highest income standard under which the individual can be determined eligible. Household Composition. For purposes of determining the income standard applicable to an applicant or recipient, the following rules apply. An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made. For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: Spouse; and Natural, adopted or step children. In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals: Natural, adopted, or step parents; and Natural, adopted, or step siblings. In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made. No resources or assets test may be applied to an applicant or recipient who is subject to a MAGI-based income test. An applicant is financially eligible for the Maryland Children's Health Program if, for the period under consideration, the applicant's countable household income as determined under Regulation .07 of this chapter does not exceed 200 percent of the federal poverty level for a family size equal to the size of the family for child applicants younger than 19 years old. For a newborn, certification begins on the day the child is born to an eligible woman and ends on the last day of the month of the child's 1st birthday. For an eligible child, certification begins on the first day of the month of application, or up to 3 months before the month of application, if medical expenses were incurred during the earlier months, and continues until the day the child is determined ineligible. A child who, on the day the child becomes 19 years old, is receiving acute inpatient services under this chapter and who, but for attaining that age, would remain eligible for Medical Assistance benefits, shall continue to receive benefits until the end of the stay for which acute inpatient services are furnished. Individuals may be certified for a period of continuous eligibility as described in COMAR 10.09.24.12. A child certified for the Program is entitled to all health benefits through the Maryland Medicaid Managed Care Program. In the case of an alien who is eligible for benefits under COMAR 10.09.24.05D(4)(b), covered services are limited to those that are necessary for the treatment of an emergency medical condition, as defined under Regulation .02B of this chapter. Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following: For eligible individuals: The basis and effective date for eligibility; Instructions for reporting changes that may affect the recipients eligibility; and The right to request a hearing; For ineligible individuals: A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; Information regarding application for MAGI Exempt coverage groups; and The right to request a hearing. Recipient Responsibility. After an individual has been determined to be eligible for MCHP and is enrolled in MCHP: The Department shall periodically redetermine the recipient's eligibility for MCHP as specified under §D; and The recipient or the recipient's representative shall, within 10 days of the occurrence, notify the Department if there is a change in the recipient's, the recipient's parent's, or the recipient's guardian's: Income; Employment; Address; or Health insurance coverage status. A recipient or the recipient's representative shall limit use of the Medical Assistance card to the individual whose name appears on the card. When written or electronic notice of cancellation is received, a recipient shall discontinue use of the Medical Assistance card on the first day of ineligibility and return the card to the Department. Failure to comply with the provisions of §B(1)—(3) of this regulation may result in: The termination of assistance; or Referral to the Department for fraud investigation, or for criminal or civil prosecution. A recipient shall cooperate with the Department’s quality control and audit review process, including verification of all information pertinent to the determination of eligibility. If the recipient refuses to cooperate, the recipient's coverage shall be terminated subject to the regulation governing timely and adequate notice under COMAR 10.01.04. Unscheduled Redetermination. The Department or its designee shall: Promptly make an unscheduled redetermination of a child recipient's eligibility when changes in circumstances or relevant facts are: Reported by someone on the recipient's behalf, or Brought to the attention of the Department or its designee from other responsible sources; Notify the recipient that redetermination is required to establish continuing eligibility; and Notify the recipient of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. Eligibility Decisions. Recipients who are determined: Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or Ineligible because of a change in circumstances or failure to establish eligibility following a change in circumstance shall be sent notice in accordance with §A(2) of this regulation. A recipient whose eligibility has been canceled may reapply at any time after the cancellation of eligibility and a new period under consideration shall be established. Scheduled Redetermination. Except for children eligible as newborns of eligible women, the Department or its designee shall make a scheduled redetermination of a child recipient's eligibility at least every 12 months. The requirements relating to hearings under COMAR 10.01.04 apply to this chapter. The requirements relating to fraud and abuse under COMAR 10.09.24.14 apply to this chapter. The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, with the exception of COMAR 10.09.24.15A(1) and (2), apply to this chapter. State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation. Health-General Article, §§2-104(b), 15-101(f), 15-103, 15-105, and 15-301 et seq., Annotated Code of Maryland, Ch. 202, Acts of 2003 Effective date: Regulations .01—.17 adopted as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); adopted permanently effective November 30, 1998 (25:24 Md. R. 1773) Regulations .02—.07 and .09—.13 amended as an emergency provision effective July 1, 2001 (28:14 Md. R. 1319); amended permanently October 29, 2001 (28:21 Md. R. 1856) Regulation .01B amended effective November 10, 2003 (30:22 Md. R. 1580) Regulations .01B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) Regulation .02B amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .03B amended effective November 10, 2003 (30:22 Md. R. 1580) Regulations .03B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) Regulation .04I amended effective June 21, 2004 (31:12 Md. R. 911) Regulation .06 amended effective October 8, 2007 (34:20 Md. R. 1737) Regulation .06A amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .06C amended effective June 21, 2004 (31:12 Md. R. 911) Regulation .06I amended effective April 19, 2010 (37:8 Md. R. 614) Regulation .07C amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .08A, B amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .09A amended effective June 21, 2004 (31:12 Md. R. 911); April 19, 2010 (37:8 Md. R. 615) Regulation .10A amended effective November 10, 2003 (30:22 Md. R. 1580) Regulations .10A amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) Chapter revised effective January 6, 2014 (40:26 Md. R. 2162) Regulation .11D adopted effective April 13, 2026 (53:7 Md. R. 328) In this chapter, the following terms have the meanings indicated. Terms Defined. “Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific supply or piece of equipment, excluding token charges for charity patients and substandard charges for welfare and other low income patients. “Customized equipment” means durable medical equipment which is uniquely constructed or substantially modified by the provider from the standard product: For a specific recipient according to the description and orders of a physician; and In such a way that the equipment can only be used by the specific recipient. “Department” means Maryland Department of Health as defined in COMAR 10.09.36.01. “Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medically necessary purpose and, with the exception of disposable gloves and incontinence supplies, have no practical use in the absence of illness, injury, disability, or health condition. “Durable medical equipment” means equipment which satisfies all of the following requirements: It can withstand repeated use; It is used to serve a medically necessary purpose; and It has no practical use in the absence of illness, injury, disability, or health condition. “Home” means that place of residence occupied by the recipient, including an assisted living facility, but other than a hospital, nursing facility, or other medical institution. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. “Incontinence” means the inability to refrain from yielding to the urge to urinate or defecate for persons previously having bowel or bladder control or individuals who are lacking bowel or bladder control due to congenital anomalies or postnatal insult. “Invoice” means a form designated by the Department for use by providers in submitting bills for payment. “Maximum allowable reimbursement” means the payment limitation established by the Department. “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medicare” means Medicare as defined in COMAR 10.09.36.01. “Nursing facility” means a facility licensed as a comprehensive care or extended care facility pursuant to COMAR 10.07.02. “Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body. “Physical therapy program” means an established program that outlines the prescribed equipment and treatment, along with frequency, duration, and goals or expected outcome of the recipient. “Prepayment authorization” means the approval required from the Department or its designee before services can be reimbursed. “Prescriber” means a physician, dentist, podiatrist, physician’s assistant, clinical nurse specialist, or nurse practitioner licensed in the state in which the prescriber's practice is maintained who has examined the recipient. “Prescriber order” means a document on the prescriber's letterhead or prescription form which details the: Patient name and Medical Assistance number; Item needed including the accessories, adaptions, modifications, and attachments considered medically necessary and medically appropriate by the prescriber; Estimated quantity of the item; Length of time of need; Date of face-to-face encounter and how the health status of the recipient at the time of the face-to-face encounter is related to the items prescribed; and Prescriber’s signature. “Prescription” means a written order for medical supplies or equipment, signed by the prescriber. “Program” means program as defined in COMAR 10.09.36.01. “Prosthetic device” means: An artificial device to replace, in whole or in part, a leg, arm, or eye; or An artificial breast, including surgical brassiere. “Provider” means provider as defined in COMAR 10.09.36.01. “Recipient” means recipient as defined in COMAR 10.09.36.01. Wholesale cost. “Wholesale cost” means the price paid by the provider to the manufacturer or any other supplier for disposable medical supplies or durable medical equipment after consideration of both primary discounts and secondary volume and prompt payment discounts applicable at the time the manufacturer's invoice is paid. “Wholesale cost” includes, but is not limited to: Shipping; Handling; and Insurance costs. “Wholesale cost” does not include associated costs such as: Evaluation; Assembly by the provider; Fitting and adjustment; and Delivery to the recipient. Providers of services shall meet the licensing requirements as set forth in COMAR 10.09.36.02. To participate in the Program, the provider: Effective January 1, 2018, shall be in an approved status with Medicare; Effective April 1, 2012 through December 31, 2017, shall, unless exempt from Medicare accreditation requirements: Be accredited by a Medicare-approved accreditation organization; Provide documentation of: Accreditation; or Having submitted an application for accreditation; and Be accredited or terminated from the Program; Shall meet the conditions for participation as set forth in COMAR 10.09.36.03; Shall be prepared to furnish necessary service and repairs to equipment dispensed by the provider; Shall certify residential service agency status as set forth in COMAR 10.07.05 by submitting either a: Copy of the license; or Form supplied by the Department which documents exempt status; May not charge the recipient any fee or deposit; Shall collect and report as a collection any and all possible rebates or other third-party reimbursement; Shall mark durable medical equipment with an identification tag as specified and provided by the Program, noting the tag number on all appropriate delivery tickets; and Shall participate in the Program's recycling efforts as set forth in Regulation .07O of this chapter. The following medically necessary items are covered when ordered by an individual who is enrolled as a provider in the Program on the date of service: Disposable medical supplies; Durable medical equipment; Repairs to purchased durable medical equipment; All disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients; Orthotic devices; Repair of orthotic devices; Replacement of orthotic devices; Prosthetic devices which include: Artificial eyes; Breast prostheses, including surgical brassiere; Upper and lower extremity, full and partial, to include stump cover or harnesses where necessary; and Custom-designed, fabricated, fitted, or modified devices to treat partial or total limb loss for purposes of restoring physiological function; Repair of prosthetic devices; Replacement of prosthetic devices; Individually form-fitted support stockings, leg or arm, including all fitting, dispensing, and follow-up care, for recipients for whom these supports are medically necessary, not to exceed two at one time, three times in a 12-month period for recipients 21 years old or older; Evaluation for equipment that was subsequently provided through the Department's recycling program as described in Regulation .07O of this chapter; Speech generating, augmentative, and alternative communication devices for recipients enrolled under fee-for-service or a Managed Care Organization; and Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home. The items in §A of this regulation are covered when medically necessary for use in the recipient's: Home; School; or Place of employment. The items in §A(8)—(10) of this regulation are covered once annually when medically necessary for the purpose of performing physical activities including running, biking, swimming, strength training and other activities to maximize overall health. Repairs under §A(3) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions for equipment that was purchased for the recipient while the recipient lived in the community. Items in §A(8)—(10) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions. Replacements under §A(10) are covered: Once annually for devices less than 3 years old if the replacement is for the following reasons: A change in the physiological condition of the patient; Unless necessitated by misuse, because of an irreparable change in the condition of the prosthetic device or the component of the prosthetic device; or Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device; and For devices more than 3 years old subject to §§B and C of this regulation. Documentation Required. Items in §A of this regulation are covered only when adequate documentation is obtained by the provider and kept on file as part of the permanent business records of the provider. This documentation includes, but is not limited to the: Signed and dated prescriber order including documentation that a face-to-face encounter occurred within 6 months before ordering services; Recertifications of continuous medical need; Delivery ticket signed by the recipient or the recipient's representative where the identification of the person signing and the exact nature of the items delivered is clearly evident on the delivery ticket; Make, model, and serial number of the item, as applicable; and Cost of the item to the provider for individually considered items reimbursed under a cost-plus methodology. For purchased equipment, the delivery ticket shall note the identification tag number and also include a statement which notifies the recipient that the equipment has been purchased by the State of Maryland and remains the property of the Department of Health. Documentation shall be retained for 6 years and be made available upon request by the Department. The Department may arrange for the provision of any covered service listed in §A of this regulation under an exclusive contract with a vendor or vendors that has been awarded in accordance with State regulations and policies governing contracts and procurements. The Program does not cover: Incontinency pants and disposable underpads unless the following conditions are met: The incontinence supplies are medically necessary for medical conditions associated with prolonged urinary or bowel incontinence; For pull-on underwear type garments, the recipient is capable of independently putting on and removing the garment; and Disposable incontinence supplies meet, at a minimum, the following absorbent capacity standards: For children's diapers and underwear, not less than 800cc; For youth diapers and underwear, not less than 1,000cc; For small adult diapers and underwear, not less than 1,200cc; For medium adult diapers and underwear, not less than 1,750cc; For large, extra large, and bariatric adult diapers and underwear, not less than 2,000cc; and For disposable underpads, not less than 1,000 cc; Osteogenesis stimulators unless the following criteria are met: The use is for noninvasive therapy; The bone fracture is at least 6 months old, except when used for pseudarthrosis; and The space gap of the fracture measures 1/2 centimeter or less, except when used for pseudarthrosis; Osteogenesis stimulators beyond the first 6 weeks of use unless evaluations at the 6-week and 3-month intervals after initial date of service verify recipient use of at least 50 percent of the time prescribed, on a form designated by the Program; The following durable medical equipment: Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, emesis basins, posture support chairs, over-the-bed tables; Self-help devices including, but not limited to, grab bars, shower stools, and commode seats; Abdominal supports; Bed boards; Enema bags; Environmental controls; Exercise equipment and devices, unless home use of such equipment is a necessary component of an active physical therapy program; Geriatric chairs; Heating pads or lamps; Hot water bottles; Hydrocollators; Ice bags; Knee cages; Nasal atomizers; Restraints; Sitz baths; Soft collars; Whirlpools; Whirlpool bath equipment; Disposable medical supplies and durable medical equipment provided in a facility or by a group when reimbursement is covered by another segment of the Program; Items which are investigational or experimental in nature; Nutritional supplements supplied by a DMS/DME provider under this chapter if the provider is also a licensed pharmacy and has a Medicaid Pharmacy provider number; Food supplements or infant formulas, including enteral nutritional products and supplemental vitamin and mineral products, when administered orally; Purchase of used equipment, except as approved by the Department as per Regulation .07L of this chapter; Equipment if the recipient owns or otherwise has access to useable equipment that serves the same purpose as the requested equipment; Replacement of equipment or a device while the item is still under warranty or before having met the Department’s life expectancy schedule unless prepayment authorization has been obtained. Replacement of a prosthetic device or component if necessary due to misuse. Rental of any equipment not in good working condition for the entire length of rental; Rental of equipment for any period longer than 90 days without renewed documentation of continued medical need from the prescriber for each 90-day period; Modifications to motor vehicles; Disposable medical supplies and durable medical equipment ordered by an individual who is not enrolled as a provider in the Program on the date of service; and Disposable medical supplies and durable medical equipment ordered by an entity, facility, or other provider that is not an individual. Prepayment authorization is required for: Disposable medical supplies with a charge exceeding $500, except as specified in §B(1) and (4) of this regulation and durable medical equipment on the approved list of items as individual consideration (I/C); All incontinency pants for recipients 3 through 15 years old in excess of 240 in any 30-day period, and disposable underpads for recipients 3 through 15 years old in excess of 135 in any 30-day period; All incontinency pants for recipients 16 years old or older in excess of 180 in any 30-day period, and disposable underpads for recipients 16 years old or older in excess of 100 in any 30-day period; All disposable incontinency pants and all disposable underpads for recipients younger than 3 years old; Disposable medical supplies and durable medical equipment not on the approved list of items; Any rental of durable medical equipment after 3 months of rental; All repairs to purchased durable medical equipment exceeding $500; Durable medical equipment with a purchase price of $1,000 or more except as specified in §B(1) and (4) of this regulation; Prosthetics and orthotics with a charge exceeding $1,000 except as specified in §B(1) and (4) of this regulation; and Medical equipment, supplies not listed on the approved list of items. Prepayment authorization is not required for: Any disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients; Prosthetic devices under $1,000; Orthotic equipment under $1,000; and Enteral and parenteral supplies not exceeding one unit per day. For the rental of durable medical equipment, the following prepayment authorization requirements apply: For durable medical equipment below $1,000: Months 1 through 3, the rental does not require a prepayment authorization; Months 4 through 10, the rental does require a prepayment authorization; and Month 10 is the final rental month, after which the item is considered purchased. For durable medical equipment above $1,000, and items requiring individual consideration: Months 1 through 10, the rental does require prepayment authorization; and Month 10 is the final rental month, after which the item is considered purchased. The prescriber shall submit requests for prepayment authorization, when required, using the format and procedures designated by the Department. Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile shall be followed by a request for prepayment authorization, which shall be submitted immediately to the Department. Providers shall call the Program before making a request via facsimile. Except as provided in §H of this regulation, providers shall submit prepayment authorization requests to the Program not later than 30 days following the first date of service. Prepayment authorization is issued when: Program procedures are met; The prescriber submits to the Department adequate documentation demonstrating that the service to be authorized is medically necessary; and A request for supplies or equipment on the list of approved items, or on the list but without a specified maximum Program price, is accompanied by the manufacturer's suggested retail price or an invoice or other documentation of the wholesale cost, whichever is applicable under Regulation .07 of this chapter. Prepayment authorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—G of this regulation. The Department is not responsible for any reimbursement to a provider for any service provided which requires prepayment authorization unless the authorization has been granted by the Program. Payment procedures shall be as set forth in COMAR 10.09.36.04. The provider’s billed charges to the Program may not exceed the provider’s customary charge. If the item is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with the provisions of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. The provider shall give the Program the full advantage of any and all manufacturer's warranty offered on the item. Effective July 1, 2022, the Department shall pay providers 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare rate established January 1 of each year for prosthetic devices. For prosthetic devices for which Medicare has not established a rate, the Department shall pay providers the manufacturer’s suggested retail price of the item, less 26.5 percent. The payment shall include all fitting, dispensing, and follow-up care. Charges for osteogenesis stimulators shall include all follow-up care, batteries, repairs, and replacement parts within the limitations of Regulation .05E and F, at the following times: Initial date of service; After 6-week evaluation; After 3-month evaluation. With the exception of items free to individuals not covered by Medicaid, the Department shall reimburse providers for the purchase of covered services at the lesser of the provider’s customary charge or: For the purchase of items for which Medicare has established a rate: Disposable medical supplies and durable medical equipment other than enteral nutritional products and enteral and parenteral therapy supplies at 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate established January 1 of each year; Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(1) of this regulation; Enteral and parenteral therapy supplies as established in §F-1(2) of this regulation; and For medical equipment for which Medicare has established a rental rate, the purchase price shall be 10 times the lowest rural, non-rural, or competitive bidding area (CBA) Medicare monthly rental rate. For the purchase of items for which Medicare has not established a rate: Disposable medical supplies not otherwise specified in this section are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or the provider’s wholesale cost plus 37.2 percent; Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(3) of this regulation; Enteral and parenteral therapy supplies as established in §F-1(4) of this regulation; Incontinence supplies at the provider's wholesale cost plus 25 percent; Customized equipment at the provider's choice of the manufacturer's suggested retail price minus 30 percent or provider's wholesale cost plus 40 percent; and Durable medical equipment, not otherwise specified in this section, are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or provider’s wholesale cost plus 27.4 percent. Enteral Nutritional Product and Enteral and Parenteral Supply Reimbursement Rates Effective February 1, 2021. Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit: Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit: Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit: Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit: The Department shall reimburse providers for the monthly rental of covered services as follows: For items for which Medicare has established a purchase rate, 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate divided over 10 months; For items for which Medicare has not established a purchase rate, items will be rented at the provider’s choice of: The manufacturer’s suggested retail price minus 41.2 percent, divided over 10 months; or The provider’s wholesale cost plus 27.4 percent, divided over 10 months; and After 10 months of monthly rental, the item will be considered purchased. The Department reserves the right to prorate the monthly rental amount for daily rentals. The Department shall pay for repairs to purchased durable medical equipment according to the following: The provider's choice of wholesale cost plus 37.2 percent or the manufacturer's suggested retail price minus 31.4 percent to the provider for all materials; Labor costs shall be billed in quarter hour increments using the appropriate procedure code and shall be reimbursed the lesser of: The supplier’s customary charge unless the service is free to individual not covered by Medicaid; or The reimbursement rate specified in the Medicaid Durable Medical Equipment Program's approved list of items. The determination to purchase or rent medical equipment shall be based on the prescriber's best faith estimate of length of time the equipment will be needed by the recipient. When the equipment is ordered for: 10 or more months, the provider shall charge the Program for a purchase, unless: The items cannot be purchased, in which case the items shall continue to be rented for the duration of their need at the amount determined on the fee schedule or elsewhere in this chapter; or There is justification to request a rental rather than a purchase of the item, and a request for prepayment authorization is submitted to and approved by the Program before the submission of the invoice for the item; and Less than 10 months, the provider shall charge the Program for rental of the item for the duration of the medical necessity except that: If the equipment is still medically necessary after 10 months of rental and the equipment is purchasable, the tenth rental payment is the final rental payment, and the equipment is considered purchased by the Program; or If there is justification to request a purchase rather than a rental of the item, a request for prepayment authorization shall be submitted to the Program and approved by the Program before the submission of the invoice. Medical equipment that is determined by the Department to require frequent and substantial servicing in order to avoid risk to the recipient's health shall be reimbursed at the rental rate in accordance with §G of this regulation until either the equipment is no longer medically necessary or the recipient is no longer eligible for Medical Assistance fee-for-service benefits. Every 90 days during the rental term the provider shall obtain recertification from the prescriber and keep in the provider's records a recertification of continuous medical need that the equipment is still medically necessary. The Department shall review purchase prices and rental charges for items for which Medicare has not established a rate at least every 3 years. If services are provided under a contract pursuant to Regulation .04F of this chapter, the Department shall reimburse the contracted vendor or vendors at rates and under conditions in accordance with the contract or contracts. Once an item has been purchased in full, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered by the Department or its designee. The Department may arrange for the provision of recycled equipment under an exclusive contract with a vendor or vendors that have been awarded in accordance with State regulations and policies governing contracts and procurement. The Department also may determine the geographical scope and the types of equipment, or both, to be included under the contract. The vendor or vendors shall be reimbursed at a rate and under terms established in the contract. For equipment that is not covered under a contract awarded under §O of this regulation, the provider that originally furnished the equipment to the recipient shall recover the equipment after it is no longer required by the recipient. After recovery of the equipment, the provider shall determine the viability of recycling the item and, upon its reissue, bill the Program 75 percent of the Program's original payment. To the extent that the Department chooses to use an exclusive contract to provide recycled equipment under §O of this regulation, the Department shall reimburse providers for evaluation of a recipient for equipment that is subsequently provided through the Department's recycling program at 11.5 percent of the reimbursement rate established under §§AH of this regulation. The Department will authorize payment on Medicare claims if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; The services are covered by the Program; Initial billing is made directly to Medicare according to Medicare guidelines. Supplemental payments on Medicare claims are made subject to the following provisions: Deductible insurance will be paid in full; Coinsurance will be paid in full; Services not covered by Medicare, but by the Program, will be paid in accordance with the limitations of §I of this regulation. The provider may not bill the Department for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail or telephone; or Fitting, dispensing, or follow-up care except as set forth in §D of this regulation. The methodology in §§F and G of this regulation shall be used to establish a list of approved items with the corresponding procedure code, maximum allowable reimbursement amount, useful life expectancy, and maximum number allowed. This list shall be made available to the providers for ease of administration of the Program. When the approved list of items contains a price for a procedure code, the Department shall reimburse providers the lesser of the price listed in the approved list or the provider’s customary charge unless the service is free to individuals not covered by Medicaid. The provider shall ensure that the equipment is in good working condition both throughout the rental of the equipment and at the end of the rental term. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Durable medical equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing medical equipment and supplies. Refills. For durable medical equipment or disposable supplies, or both that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order. The provider shall maintain documentation of contact and confirmation of any changes and modifications of the order for audit purposes. The provider shall contact the recipient or designee regarding refills no earlier than 7 business days before the anticipated delivery date or anticipated shipping date. For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product. The disposable medical supplies or durable medical equipment provider shall identify the individual who ordered the disposable medical supplies and durable medical equipment by recording the individual practitioners National Provider Identifier (NPI) number on the claim. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeal procedures shall be as set forth in COMAR 10.09.36.09. State Regulations shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland Effective date: January 1, 1976 (2:29 Md. R. 1740) Regulation .04A amended effective February 8, 1980 (7:3 Md. R. 264) Regulation .05 amended effective February 8, 1980 (7:3 Md. R. 264) and April 4, 1980 (7:7 Md. R. 708) Chapter revised effective June 26, 1981 (8:13 Md. R. 1139) Regulation .01B amended effective July 11, 1988 (15:13 Md. R. 1553) Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572); May 29, 1989 (16:10 Md. R. 1108) Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .04A amended effective July 1, 1987 (14:13 Md. R. 1473); May 29, 1989 (16:10 Md. R. 1108) Regulation .04B amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); May 29, 1989 (16:10 Md. R. 1108) Regulation .04E amended effective July 2, 1984 (11:13 Md. R. 1176); August 12, 1985 (12:16 Md. R. 1606) Regulation .04F G adopted effective June 2, 1986 (13:11 Md. R. 1273) Regulation .04H adopted effective March 23, 1987 (14:6 Md. R. 715) Regulation .05 amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655); May 29, 1989 (16:10 Md. R. 1108) Regulation .05A-3 and A-4 adopted, B amended effective July 1, 1987 (14:13 Md. R. 1473) Regulation .05B and D amended effective June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715) Regulation .06 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273); Regulation .06A amended effective March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); May 30, 1988 (15:11 Md. R. 1331); July 11, 1988 (15:13 Md. R. 1553) Regulation .06D amended effective May 30, 1988 (15:11 Md. R. 1331) Regulation .06D-1 amended effective August 12, 1985 (12:16 Md. R. 1606) Regulation .07 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273); May 29, 1989 (16:10 Md. R. 1108) Regulation .07 amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2392); amended permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .07B-1 adopted effective August 12, 1985 (12:16 Md. R. 1606) Regulation .07C-1 repealed effective August 12, 1985 (12:16 Md. R. 1606) Regulation .07C-1 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715) Regulation .07C-2 adopted effective July 1, 1987 (14:13 Md. R. 1473) Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) Regulation .07D amended effective October 1, 1983 (10:19 Md. R. 1691); June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); July 1, 1988 (15:13 Md. R. 1554); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655) Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129) Regulation .07D, F-1 adopted effective August 12, 1985 (12:16 Md. R. 1606) Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625); June 2, 1986 (13:11 Md. R. 1273) Regulation .07F-2 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715) Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07Q amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)) Regulation .07Q amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2105) Chapter revised effective March 16, 1992 (19:5 Md. R. 577) Chapter revised effective November 16, 1998 (25:23 Md. R. 1696) Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 30, 2012 (39:8 Md. R. 533); June 9, 2025 (52:11 Md. R. 532) Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568); January 1, 2018 (44:26 Md. R. 1214) Regulation .03G amended effective September 11, 2006 (33:18 Md. R. 1505) Regulation .04 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); June 9, 2025 (52:11 Md. R. 532) Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470); June 9, 2025 (52:11 Md. R. 532) Regulation .04E amended effective April 30, 2012 (39:8 Md. R. 533) Regulation .05 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); January 1, 2018 (44:26 Md. R. 1214) Regulation .05A amended effective February 9, 2009 (36:3 Md. R. 208) Regulation .05D amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .05K amended effective June 9, 2025 (52:11 Md. R. 532) Regulation .05L adopted effective June 9, 2025 (52:11 Md. R. 532) Regulation05M-Q amended effective June 9, 2025 (52:11 Md. R. 532) Regulation .06 amended effective January 7, 2002 (28:26 Md. R. 2272); August 1, 2005 (32:15 Md. R. 1320); October 16, 2023 (50:20 Md. R. 887) Regulation .06A amended effective February 9, 2009 (36:3 Md. R. 208) Regulation .06A,B amended effective June 9, 2025 (52:11 Md. R. 532) Regulation .06D amended effective June 9, 2025 (52:11 Md. R. 532) Regulation .06E amended effective September 29, 2003 (30:19 Md. R. 1331); June 9, 2025 (52:11 Md. R. 532) Regulation .07 amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 19, 2010 (37:8 Md. R. 615); April 30, 2012 (39:8 Md. R. 534); July 4, 2016 (43:13 Md. R. 712); October 16, 2023 (50:20 Md. R. 887) Regulation .07D amended effective February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470) Regulation .07F amended effective February 9, 2009 (36:3 Md. R. 208); February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470) Regulation .07F-1 adopted effective June 14, 2021 (48:12 Md. R. 470) Regulation .07Z adopted effective January 1, 2018 (44:26 Md. R. 1214) In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” has the meaning stated in COMAR 10.09.36. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36. “Medical Care Programs” has the meaning stated in COMAR 10.09.36. “Medicare” has the meaning stated in COMAR 10.09.36. “Program” has the meaning stated in COMAR 10.09.36. “Provider” has the meaning stated in COMAR 10.09.36. “Recipient” has the meaning stated in COMAR 10.09.36. Providers shall meet all licensing requirements as set forth in COMAR 10.09.36. To participate in the Program, the provider shall: Comply with the conditions for participation as set forth in COMAR 10.09.36; Be approved as a provider of ambulance services by Medicare. The program covers copayment and deductible payments for Medicare-approved services to Maryland Medical Assistance recipients. The Program does not cover any payment for service other than coinsurance and deductible as approved by Medicare. Payment procedures for this chapter are set forth in COMAR 10.09.36. The Department will authorize payment on Medicare ambulance claims if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; The services are covered by the Program; Initial billing is made directly to Medicare according to Medicare guidelines; Medicare has determined that services were medically justified. The Department will make supplemental payment on Medicare ambulance claims, subject to the following conditions: Deductible insurance will be paid in full; Coinsurance will be paid in full. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Recovery and reimbursement for this chapter are set forth in COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions for this chapter are set forth in COMAR 10.09.36. Appeal procedures for this chapter are set forth in COMAR 10.09.36. The interpretive regulation for this chapter is set forth in COMAR 10.09.36. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: January 1, 1976 (2:29 Md. R. 1740) Chapter revised September 23, 1977 (4:20 Md. R. 1545) Regulation .01 amended effective January 23, 1989 (16:1 Md. R. 70) Regulation .01B and .05I amended, and .05J adopted as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .01C-1 adopted and D amended effective July 1, 1986 (13:13 Md. R. 1492) Regulation .03B amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113); January 23, 1989 (16:1 Md. R. 70) Regulation .04A amended effective July 1, 1986 (13:13 Md. R. 1492) Regulation .05 amended effective July 1, 1986 (13:13 Md. R. 1492) Regulation .06A amended effective July 1, 1986 (13:13 Md. R. 1492) Regulation .06E adopted effective April 4, 1980 (7:7 Md. R. 708) Regulation .07 amended effective January 23, 1989 (16:1 Md. R. 70) Regulation .07A-1 adopted, E and G amended effective July 1, 1986 (13:13 Md. R. 1492) Regulation .07A-1 amended effective February 22, 1988 (15:4 Md. R. 473) Regulation .07D amended effective July 1, 1978 (5:12 Md. R. 968); January 1, 1980 (6:26 Md. R. 2075); July 1, 1980 (7:13 Md. R. 1279) Regulation .07D amended as an emergency provision effective July 1, 1982 (9:11 Md. R. 1123); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) Regulation .07E amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625) Regulation .07H amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) Regulation .07J amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07J amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Chapter revised effective September 16, 1991 (18:18 Md. R. 2005) Regulation .01B amended effective July 18, 1994 (21:14 Md. R. 1229) Regulation .03 amended effective July 18, 1994 (21:14 Md. R. 1229) Regulation .04 repealed and new Regulation .04 adopted effective July 18, 1994 (21:14 Md. R. 1229) Regulation .05 amended effective July 18, 1994 (21:14 Md. R. 1229) Regulation .06 repealed effective July 18, 1994 (21:14 Md. R. 1229) Regulation .07 amended effective July 18, 1994 (21:14 Md. R. 1229) In this chapter, the following terms have the meanings indicated. Terms Defined. “Acquisition cost” means actual cost of a product to a provider. “Board” means the State Board of Examiners in Optometry. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Diagnostically certified optometrist” means a licensed optometrist who is certified by the Board to administer topical ocular diagnostic pharmaceutical agents to the extent permitted under Health Occupations Article, §11-404, Annotated Code of Maryland. “EPSDT partial screen” means less than the complete package of various screening procedures required by the State Periodicity Schedule that an EPSDT participant receives at a given age. “EPSDT screen” means EPSDT screen as defined in COMAR 10.09.23.01. “Invoice” means a form designated by the Department for use by providers in submitting bills for payment. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Ophthalmologist” means a physician skilled in diseases of the eye. “Ophthalmic lenses or optical aids” means a lens, contact lens, prism, or vision aid which has a therapeutic effect on a patient, or which will contribute to the visual welfare of a patient. “Optician” means an individual, partnership, or company which meets applicable licensing requirements as a qualified grinder or dispenser of ophthalmic lenses or optical aids, and which is capable of translating, filling, and adapting ophthalmic prescriptions, products, and accessories. “Optometric clinic or center” means a facility, which provides services for patients under the supervision of a licensed optometrist. Optometric Examination. “Optometric examination” means a series of tests and measurements used to determine the extent of visual impairment, or the correction required to improve visual acuity, performed by a licensed optometrist. “Optometric examination” includes as a minimum: Reviewing a patient's history, past prescriptions, and specifications when available; Visual analysis; Ophthalmoscopy of internal eye; Tonometry without anesthetic when indicated or for a patient 40 years old or older; Muscle balance examination; Gross visual field testing when indicated; Writing of lens formula and other prescription data when needed, as well as specific instructions for future care; Other tests when indicated by §B(12)(b)(i)—(vii) of this regulation; and Subsequent progress evaluations when indicated. “Optometrist” means an individual who is licensed by the Board to practice optometry or by the state in which the service is rendered. “Orthoptic treatment” means the use of instruments to measure and enhance the binocular coordination of the eyes (a category of “visual training”). Practice Optometry. “Practice optometry” means, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland, to use any means known in the science of optics or eye care, except surgery, to: Detect, diagnose, and treat any optical or diseased condition in the human eye; Prescribe eyeglasses or lenses to correct any optical or visual condition in the human eye; Give advice or direction on the fitness or adaptation of eyeglasses or lenses to an individual for the correction or relief of a condition for which eyeglasses or lenses are worn; and Use, or permit the use of an instrument, test card, test type, test eyeglasses, test lenses, or other device to aid in choosing eyeglasses or lenses for an individual to wear. “Practice optometry” includes, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland: The administration of topical ocular diagnostic pharmaceutical agents; The administration and prescription of therapeutic pharmaceutical agents; and The removal of superficial foreign bodies from the cornea and conjunctiva. “Preauthorization” means an approval required from the Department or its designee before providing services. “Prescriber” means a physician or optometrist licensed to prescribe optical aids, and authorized by the Department to participate in the Program. “Prescription” means a written order for treatment or optical aids, or both, signed by the prescriber. “Program” means the Maryland Medical Assistance Program. “Progress evaluation” means a follow-up visit, when indicated, to determine the effectiveness of an eye examination, prescription, or series of orthoptic treatments. “Provider” means a physician (when dispensing ophthalmic lenses or visual aids), optometrist, optometric clinic or center, or optician, recognized by the Department to participate in the Program. “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Routine adjustment” means an adjustment made to an optical aid other than an adjustment required because of damage. “Screening” means tests or measurements, other than an eye examination, performed to discover the possibility of difficulty in vision. “Therapeutically certified optometrist” means a licensed optometrist who is certified by the Board to administer or prescribe therapeutic pharmaceutical agents or remove superficial foreign bodies from a human eye, adnexa, or lacrimal system to the extent permitted under Health Occupations Article, §11-404.2, Annotated Code of Maryland. “Visual training” means use of instruments or other means to measure and enhance the binocular coordination of the eyes and visual perceptual functions. An optometrist shall be licensed to practice optometry in the state in which service is provided. An optician shall meet the legal requirements of the state in which the service is provided. An ophthalmologist shall be licensed to practice medicine in the state in which the service is provided. To participate in the Program, the provider shall: Apply for participation in the Program using the application form designated by the Department; Be approved for participation by the Department; Verify the recipient's eligibility; Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee; Provide service without regard to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap; Not knowingly employ an optometrist, optician, or physician to provide services to Medical Assistance patients after that optometrist, optician, or physician has been disqualified from the Program, unless prior approval has been received from the Department. Accept payment by the Department as payment in full for services rendered and make no additional charge to any person or covered services; Use first quality materials that meet the criteria established by the Department; Place no restriction on a recipient's right to select providers of the recipient's choice; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the recipient; Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient. The program covers the following vision care services: A maximum of one optometric examination every 2 years for recipients 21 years old or older and a maximum of one every year for recipients younger than 21 years old, to determine the extent of visual impairment or the correction required to improve visual acuity, unless the time limitations are waived by the Department, based on medical necessity; Subject to §B, of this regulation, a maximum of one pair of eyeglasses every year, unless the time limitations are waived by the Department, based on medical necessity; Examination and eyeglasses for a recipient with a medical condition, other than normal physiological change necessitating a change in eyeglasses (before the normal time limits specified in §§A and B of this regulation have been met) when a preauthorization has been procured; Visually necessary optometric care rendered by an optometrist when these services are: Provided by the optometrist or a licensed employee; Related to the patient's health needs as diagnostic, preventive, curative, palliative, or rehabilitative services; and Adequately described in the patient's record; and Optician services when the services are: Provided by the optician, optometrist, or ophthalmologist, or by an employee under the optician's, optometrist's, or ophthalmologist's supervision and control; Adequately described in the patient's record; Ordered or prescribed by an ophthalmologist or optometrist. Eyeglasses. The eyeglasses under §A(2) of this regulation shall have first quality, impact resistant lenses, except in cases where prescription requirements cannot be met with impact resistant lenses. Frames shall be made of fire-resistant, first-quality material. In order to be entitled to receive eyeglasses under §A(2) of this regulation, a recipient shall meet at least one of the following conditions: The recipient requires a diopter change of at least 0.50; The recipient requires a diopter correction of less than 0.50 and this has been preauthorized according to Regulation .06, of this chapter, based on medical necessity; The recipient's present eyeglasses have been damaged to the extent that they affect visual performance and cannot be repaired to effective performance standards, or are no longer usable due to a change in head size or anatomy; or The recipient's present eyeglasses have been lost or stolen. The following are not covered: Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients 21 years old and older; Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients which were not ordered as a result of a full or partial EPSDT screen; Repairs, except when repairs to eyeglasses are more cost-effective than replacing with new eyeglasses; Combination or metal frames except when required for proper fit; Cost of travel by the provider; A general screening of a Medical Assistance population; Visual training sessions which do not include orthoptic treatment; Routine adjustment. An optometrist certified by the Board as qualified to administer diagnostic pharmaceutical agents may use the following agents in strengths not greater than the strengths indicated: Agents directly or indirectly affecting the pupil of the eye, including the mydriatics and cycloplegics listed below: Phenylephrine hydrochloride (2.5 percent); Hydroxyamphetamine hydrobromide (1 percent); Cyclopentolate hydrochloride (0.5—2 percent); Tropicamide (0.5 and 1 percent); Cyclopentolate hydrochloride (0.2 percent) with Phenylephrine hydrochloride (1 percent); Dapiprazole hydrochloride (0.5 percent); and Hydroxyamphetamine hydrobromide (1 percent) and Tropicamide (0.25 percent); and Agents directly or indirectly affecting the sensitivity of the cornea including the: Topical anesthetics listed below: Proparacaine hydrochloride (0.5 percent); and Tetracaine hydrochloride (0.5 percent); and Diagnostic topical anesthetic and dye combinations listed below: Benoxinate hydrochloride (0.4 percent) — Fluorescein sodium (0.25 percent); and Proparacaine hydrochloride (0.5 percent) — Fluorescein sodium (0.25 percent). An optometrist certified by the Board as qualified to administer and prescribe topical therapeutic pharmaceutical agents is limited to: Ocular antihistamines, decongestants, and combinations of them, excluding steroids; Ocular antiallergy pharmaceutical agents; Ocular antibiotics and combinations of ocular antibiotics, excluding specially formulated or fortified antibiotics; Anti-inflammatory agents, excluding steroids; Ocular lubricants and artificial tears; Tropicamide; Homatropine; Nonprescription drugs that are commercially available; and Primary open-angle glaucoma medications, in accordance with a written treatment plan developed jointly between the optometrist and an ophthalmologist. The following services require written preauthorization: Optometric examinations to determine the extent of visual impairment or the correction required to improve visual acuity before expiration of the normal time limitations; Replacement of eyeglasses due to medical necessity or because the eyeglasses were lost, stolen, or damaged before expiration of the normal time limitations; Contact lenses; Subnormal vision aid examination and fitting; Orthoptic treatment sessions; Plastic lenses costing more than equivalent glass lenses unless there are six or more diopters of spherical correction or three or more diopters of astigmatic correction; Absorptive lenses, except cataract; Ophthalmic lenses or optical aids when the diopter correction is less than: -0.50 D. sphere for myopia in the weakest meridian; +0.75 D. sphere for hyperopia in the weakest meridian; +0.75 additional for presbyopia; ±0.75 D. cylinder for astigmatism; A change in axis of 5° for cylinders of 1.00 diopter or more; A total of 4 prism diopters lateral or a total of 1 prism diopters vertical. Preauthorization is issued when: Program procedures are met; Program limitations are met; The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. Preauthorization is valid only for services rendered or initiated within 60 days of the date issued. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A — C of this regulation. Form for Request for Payment. The provider shall submit a request for payment on the form designated by the Department. The request for payment shall document the following, when applicable: Preauthorization; Prescriptions; Need for combination or metal frame; Laboratory invoices. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. The provider shall charge the Program the provider’s customary charge to the general public for similar professional services. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §F of this regulation;and The provider’s reimbursement is not limited to the provider’s customary charge. The provider shall charge acquisition cost for eyeglass frames, eyeglass lenses, contact lenses, and other optical aids. Vision care services are reimbursed according to COMAR 10.09.23.01-1. The Department will pay professional fees for covered services at the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The Department's fee schedule. The Department will pay for materials at acquisition costs not to exceed the maximums established by the Department. Payments on Medicare claims are authorized if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; Services are covered by the Program; Initial billing is made directly to Medicare according to Medicare guidelines. Supplemental payment on Medicare claims is made subject to the limitations of the State budget and the following provisions: Deductible insurance will be paid in full; Beginning with August 1, 2010 dates of service, coinsurance shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but covered by the Program, according to §E, of this regulation. The provider may not bill the Department for: Services rendered by mail or telephone; Completion of forms and reports; Broken or missed appointments; or Providing a copy of a recipient's patient record when requested by another licensed provider on behalf of the recipient. The Department's payment for lenses, frames, case, fitting, and dispensing covers any routine follow-up and adjustments for 60 days, and no additional fees will be paid. The Department will make no direct payment to the recipient. Payment for contact lenses is made as follows: For the prescription, fitting, training, and adaptation of contact lenses which includes the: Specification of optical and physical characteristics; Fitting of lenses to the wearer; Training of the wearer; Incidental revision of the lenses during training; and Adaptation of the lenses to the wearer; For the supply of contact lenses; and For the follow-up of successfully fitted extended wear lenses. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. A provider shall reimburse the Department for any overpayment. If the Department determines that a provider, ophthalmologist, optometrist, optician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: January 1, 1976 (2:29 Md. R. 1740) Chapter revised September 14, 1977 (4:19 Md. R. 1469) Regulations .01, .04, and .05 amended as an emergency provision effective January 1, 1993 (20:2 Md. R. 108); amended permanently effective July 1, 1993 (20:12 Md. R. 996) Regulation .01 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .01A amended effective March 12, 1984 (11:5 Md. R. 463) Regulation .01B amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .01J amended effective January 1, 1983 (9:25 Md. R. 2483) Regulation .03D, I—K amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .03F amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .03J amended effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .04 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .04A and B amended effective January 1, 1983 (9:25 Md. R. 2483) Regulation .04B amended effective August 27, 2007 (34:17 Md. R. 1508) Regulation .05 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .05A amended effective August 27, 2007 (34:17 Md. R. 1508) Regulation .05B amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .06 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .06A amended effective April 17, 1981 (8:8 Md. R. 721) Regulation .06B amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .06D adopted effective April 4, 1980 (7:7 Md. R. 708) Regulation .07 amended effective November 29, 1999 (26:24 Md. R. 1858); October 10, 2005 (32:20 Md. R. 1655); July 4, 2016 (43:13 Md. R. 712) Regulation .07C amended effective April 17, 1981 (8:8 Md. R. 721) Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .07D amended effective August 10, 1987 (14:16 Md. R. 1774); January 2, 1995 (21:26 Md. R. 2186) Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625); March 24, 2008 (35:6 Md. R. 698); January 12, 2009 (36:1 Md. R. 21); February 27, 2017 (44:4 Md. R. 253) Regulation .07H amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) Regulation .07I amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .07M amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07M amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07M amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07M amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) In this chapter, the following terms have the meanings indicated. Terms Defined. “Ambulatory surgical center” means any distinct, Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. “Board” means the State Board of Podiatric Medical Examiners. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. 1396 et seq. “Emergency services” means treatment for traumatic injury or infection other than athlete's foot or chronic mycotic infection of the nail bed. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the service is provided. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Medicare” means the insurance program administered by the Federal Government under Title XVIII of the Social Security Act, 42 U.S.C. 1395 et seq. “Nursing facility” means a skilled nursing facility certified for participation pursuant to Title XVIII or Title XIX of the Social Security Act, or an intermediate care facility certified for participation pursuant to Title XIX of the Social Security Act, which has entered into a provider agreement with the Department. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Personal hygiene care” means routine hygienic care in the absence of pathology. “Podiatrist” means a Doctor of Podiatry (D.P.M.) who is licensed to practice podiatry by the Board or by the state in which the service is rendered. Practice Podiatry. “Practice podiatry” means to diagnose or surgically, medically, or mechanically treat any ailment of the: Human foot or ankle; Anatomical structures that attach to the human foot; or Soft tissue below the midcalf. “Practice podiatry” does not include: Surgical treatment of acute ankle fracture; or Administration of an anesthetic, other than a local anesthetic. “Preauthorization” means an approval required from the Department or its designee before rendering services. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual, association, partnership, or an incorporated or unincorporated group of podiatrists, duly licensed to provide services for participants, and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. “Routine care” means the cutting or removing of corns and calluses, and the trimming, cutting, clipping, or debriding of toenails. “Utilization control agent” means the organization responsible for reviewing the use of medical services to determine medical necessity and lengths of stay according to professional standards. The Provider shall meet all license requirements as set forth in COMAR 10.09.36.02. In order to participate in the Program a podiatrist shall be licensed to practice podiatry in the state in which service is provided. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. General requirements for participation in the Program are that a provider shall: Comply with requirements set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. Specific requirements for participation in the Program as a podiatry services provider require that the provider: Ensure that all X-ray or other radiological equipment is inspected and meets the standards established by COMAR 10.14.03, or other applicable standards established by the state in which the service is provided; Not knowingly employ another podiatrist to provide services to Medical Assistance patients after that podiatrist has been disqualified from the Program, unless prior approval has been received from the Department. The Program covers the following medically necessary services: Podiatric services rendered in the podiatrist's office, the participant's home, a hospital, a nursing facility, a free standing clinic, or elsewhere when these services are: Performed by the podiatrist or another licensed podiatrist in the podiatrist’s employ; Performed on the: Human foot or ankle; Anatomical structures that attach to the human foot; or Soft tissue below the midcalf; Clearly related to the participant’s individual medical needs as diagnostic, curative, palliative, or rehabilitative services; and Adequately described on the participant’s medical record. Routine podiatric care rendered in an office, home, nursing home, or licensed assisted living facility for participants who have a metabolic, neurologic, or vascular disease affecting the lower extremities, including but not limited to: Arteriosclerosis obliterans (A.S.O., arteriosclerosis of the extremities, occlusive peripheral arteriosclerosis); Buerger’s disease (thromboangiitis obliterans); Peripheral neuropathies involving the feet, associated with: Traumatic injury; Leprosy or neurosyphilis; or Hereditary disorders, such as hereditary sensory radicular neuropathy, angiokeratoma corporis diffusum (Fabry’s) and amyloid neuropathy; and The following conditions, if the patient is under the active care of a doctor of medicine or osteopathy who documents the condition: Diabetes mellitus; Chronic thrombophlebitis; Peripheral neuropathies involving the feet, associated with: Malnutrition and vitamin deficiency such as malnutrition (general and pellagra), alcoholism, malabsorption (celiac disease and tropical sprue), and pernicious anemia; Carcinoma; Diabetes mellitus; Drugs and toxins; Multiple sclerosis; or Uremia (chronic renal disease). Drugs dispensed by the podiatrist in an emergency or drugs which cannot be self-administered within the limitations of COMAR 10.09.03; Injectable drugs administered by the podiatrist within the limitations of COMAR 10.09.03; Medical equipment and supplies prescribed by the podiatrist within the limitations of COMAR 10.09.12; and Emergency services and related follow-up care. The Program does not cover the following under this chapter: Services which are not medically necessary; Investigational or experimental drugs or procedures; Services prohibited by the Maryland Podiatry Act or the State Board of Podiatric Medical Examiners; Services denied by Medicare as not medically justified; Drugs and supplies which are acquired by the podiatrist at no cost; Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take oral medications are documented in the patient's medical record; More than one visit per day unless adequately documented in the patient's medical record as an emergency; Visits by or to the podiatrist solely for the purpose of the following: Prescription or drug pick-up; Collection of specimens for laboratory procedures, except by venipuncture, capillary or arterial puncture; and Interpretation of laboratory tests or panels; Physical therapy; Orthotics and inlays of any type and related services; Disposable medical supplies; Administration of anesthesia as a separate charge; Personal hygiene care; Routine care, except visits for participants who are diabetic or who have a vascular disease affecting the lower extremities; Non-surgical hospital visits; Laboratory or X-ray services not performed by the provider or under the direct supervision of the provider; and Podiatric inpatient hospital services rendered during an admission denied by the utilization control agent or during a period that is in excess of the length of stay authorized by the utilization control agent. Routine podiatric care is limited to one visit every 60 days for participants who have diabetes or peripheral vascular diseases that affect the lower extremities when rendered in the podiatrist's office, the participant’s home, or a nursing facility. A licensed podiatrist shall perform in a licensed hospital or ambulatory surgical center, subject to the provisions of Health-General Article, §19-351, Annotated Code of Maryland, all surgical procedures of the ankle below the level of the dermis, arthrodeses of two or more tarsal bones, and complete tarsal osteotomies. A licensed podiatrist who performs these procedures in an ambulatory surgical center shall: Have current privileges at a licensed hospital for the same procedures; and Meet the requirements of the ambulatory surgical center. Preauthorization is required for any procedure not included in the current fee schedule. Preauthorization is issued when: Program procedures are met; The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. Preauthorization is valid only for services rendered or initiated within 90 days of the date issued. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire claim or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A—C of this regulation. The provider shall submit his request for payment on the form designated by the Department including all required documentation. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed. The provider shall bill the provider's customary fees, but may not bill a fee in excess of that charged the general public for similar services, except for injectable drugs and dispensed medical supplies, in which case the provider shall charge the Program the provider's acquisition cost. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §D of this regulation; and The provider's reimbursement is not limited to the provider's customary charge. The Program shall pay for medically necessary covered services at the lower of the provider's amount billed to the Program or the maximum reimbursement rates set forth in COMAR 10.09.02.07D. Payments on Medicare claims are authorized if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; Services are covered by the Program; Initial billing is made directly to Medicare according to Medicare guidelines. Supplemental payment on Medicare claims are made subject to the limitations of the State budget and the following provisions: Deductible insurance will be paid in full; Beginning with August 1, 2010 dates of service, coinsurance shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but by the Program, according to §E above. The provider may not bill the Department or the participant for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; Laboratory or X-ray services not performed by the provider or under the direct supervision of the provider; or Photocopying of medical records when requested by another licensed provider on behalf of the participant. The Program will make no direct payment to participants. The Program shall reimburse providers for all laboratory services according to the fees established under COMAR 10.09.09.07 and for all radiological services under COMAR 10.09.02.07. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the participant for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. A provider shall reimburse the Department for any overpayment. If the Department determines that a provider, podiatrist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. The Department may consult with the Peer Review Committee of the Maryland Podiatry Association. The Department will give consideration to the findings and recommendations of this group. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants that he or she no longer accepts Medical Assistance before rendering additional services. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: January 1, 1976 (2:29 Md. R. 1741) Chapter revised September 14, 1977 (4:19 Md. R. 1470) Regulation .01 amended effective June 14, 1999 (26:12 Md. R. 925) Regulation .01B amended effective January 2, 2006 (32:26 Md. R. 1997); August 27, 2007 (34:17 Md. R. 1507); July 16, 2018 (45:14 Md. R. 696) Regulation .01P adopted effective February 15, 1982 (9:3 Md. R. 221) Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03A amended effective August 21, 2023 (50:16 Md. R. 725) Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .04 amended effective July 16, 2018 (45:14 Md. R. 696) Regulation .05A amended effective February 15, 1982 (9:3 Md. R. 221) Regulation .05A, B amended effective July 16, 2018 (45:14 Md. R. 696) Regulation .05C amended effective January 2, 2006 (32:26 Md. R. 1997) Regulation .06A amended effective April 20, 1979 (6:8 Md. R. 656); September 19, 1980 (7:19 Md. R. 1806); June 14, 1999 (26:12 Md. R. 925) Regulation .06B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .06C amended effective July 16, 2018 (45:14 Md. R. 696) Regulation .06D adopted effective April 4, 1980 (7:7 Md. R. 708) Regulation .07 amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07C amended effective September 19, 1980 (7:19 Md. R. 1806) Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) Regulation .07D amended effective March 11, 1985 (12:5 Md. R. 482) Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .07D amended effective February 24, 1997 (24:4 Md. R. 291); June 14, 1999 (26:12 Md. R. 925); June 24, 2002 (29:12 Md. R. 927); August 27, 2007 (34:17 Md. R. 1507); February 27, 2017 (44:4 Md. R. 252) Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625) Regulation .07G amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended at 6:12 Md. R. 1045; adopted permanently effective June 1, 1979 (6:11 Md. R. 979) Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430); July 16, 2018 (45:14 Md. R. 696); August 21, 2023 (50:16 Md. R. 725) Regulation .07H amended effective June 14, 1999 (26:12 Md. R. 925); January 2, 2006 (32:26 Md. R. 1997); July 16, 2018 (45:14 Md. R. 696) Regulation .07J amended effective June 14, 1999 (26:12 Md. R. 925) Regulation .07K amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07K amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1984) Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029); July 16, 2018 (45:14 Md. R. 696) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .09E amended effective July 16, 2018 (45:14 Md. R. 696) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Regulation .11 amended effective July 16, 2018 (45:14 Md. R. 696) In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrative Services Organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System. “Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department. “Core Service Agency” means the local mental health authority responsible for planning, managing, and monitoring public mental health services at the local level. “Crisis” means the experience of stress, emotional or behavioral symptoms, difficulties with substance use, or a traumatic event that compromises an individual’s ability to function within their current family and living situation, school, workplace, or community, as defined by the individual experiencing the crisis. “Crisis intervention” means the ability to perform or provide crisis assessment, crisis de-escalation, psychoeducation, brief behavioral support, and referral and linkage to appropriate services and supports. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. “Licensed mental health professional” means a: Psychiatrist; Licensed psychologist; Psychiatric nurse practitioner (CRNP-PMH); Clinical nurse specialist in psychiatric and mental health nursing (APRN-PMH); Licensed certified social worker-clinical (LCSW-C); Licensed clinical alcohol and drug counselor (LCADC); Licensed clinical marriage and family therapist (LCMFT); Licensed clinical professional art therapist (LCPAT); Licensed clinical professional counselor (LCPC); or Properly supervised: Licensed master social worker (LMSW); Licensed graduate alcohol and drug counselor (LGADC); Licensed graduate marriage and family therapist (LGMFT); Licensed graduate professional art therapist (LGPAT); Licensed graduate professional counselor (LGPC); Licensed certified social worker (LCSW); or Psychology associate. “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Program” has the meaning stated in COMAR 10.09.36.01. “Provider” means an organization or an individual practitioner furnishing the services covered under this chapter which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number. To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02, 10.63.01.05, and 10.63.02.03. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. To participate in the Program, a provider of behavioral health crisis services shall: Meet the conditions for licensure and practice as set forth in COMAR 10.63.01, 10.63.02, and 10.63.06; Have clearly defined and written patient care policies; Maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, meets the following requirements: Includes the date of service with service start and end times; Includes the participant’s primary behavioral health complaint or reason for the visit; Includes a brief description of the service provided, including progress notes; Includes an official e-Signature, or a legible signature, along with the printed or typed name, and appropriate title of each individual providing services, including each separate member of the mobile crisis team; Is made available to the Department or its designee as requested; and Complies with all federal statutes and regulations, including but not limited to the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Part 2 and 45 CFR Parts 160 and 164.04. To participate in the Program, a mobile crisis team provider shall: Comply with COMAR 10.63.03.20; Be available to provide services outlined in Regulation .05 of this chapter 24 hours a day, 7 days a week; Provide a timely response with a two-person team as described in COMAR 10.63.03.20; Comply with staffing and supervision requirements as described in COMAR 10.63.03.20F; and Ensure all crisis team staff members receive training as required and approved by the Department. To participate in the Program, a behavioral health crisis stabilization center provider shall: Comply with COMAR 10.63.03.21; Be open and accessible to walk-ins 24 hours a day, 7 days a week; Comply with the staffing requirements described in COMAR 10.63.03.21E; Maintain the ability to initiate withdrawal management capabilities for all substances as well as initiate medication assisted treatment for opioid use disorder; and Equally accept individuals presenting due to an emergency petition and individuals presenting voluntarily. A participant is eligible for mobile crisis team services and behavioral health crisis stabilization center services if they are experiencing a crisis as defined in Regulation .01 of this chapter. A participant is eligible for behavioral health crisis services if the service is appropriate to the specific provider type listed in Regulation .05 of this chapter. The Department shall reimburse for the services in §§B—C of this regulation when these services have been documented, pursuant to the requirements in this chapter, as necessary. Mobile crisis team services shall: Comply with COMAR 10.63.03.20; Consist of an in-person response by at minimum a two-person team; Include an initial assessment by a licensed mental health professional, which may be rendered via telehealth only when the licensed mental health professional functions as a third team member; Involve the following interventions and objectives: Crisis intervention and stabilization of the individual’s behavioral health crisis; Safety planning; and Referrals to community supports, including behavioral health providers, health providers, or social and other services; and Include mobile crisis follow-up outreach by means of telephone, telehealth, or in-person contact with the individual served, family members, caregivers, or referred providers. Behavioral health crisis stabilization center services shall: Comply with COMAR 10.63.03.21; Consist of an initial nursing assessment and physical exam by a registered nurse in collaboration with a physician or psychiatric nurse practitioner; Include an initial evaluation by an approved physician or psychiatric nurse practitioner in accordance with COMAR 10.63.03.21F; Include a crisis assessment completed by a licensed mental health professional; and Involve the following interventions and objectives: Crisis intervention and stabilization of the individual’s behavioral health crisis; Safety planning; Pharmacological interventions, including the ability to initiate withdrawal management capabilities for all substances, and initiate medications for medication assisted treatment for opioid use disorder; and Referrals to community-based services or to higher levels of care as clinically indicated. The Program does not cover the following: Services not delivered in compliance with Regulation .05 of this chapter; Services not medically necessary; Investigational or experimental drugs and procedures; Services solely for the purpose of: Prescribing medication; Administering medication; Drug or supply pick-up; Collecting laboratory specimens; Interpreting laboratory tests or panels; or Administering injections; Separate reimbursement to an employee of a program for services that have been provided by and reimbursed directly to a program; Services provided to or for the primary benefit of individuals other than the participant; Mobile crisis team services rendered by telehealth with the exception of those specified as permissible via telehealth in Regulation .05 of this chapter; Behavioral health crisis stabilization center services rendered by telehealth with the exception of those specified in COMAR 10.63.03.21; Services provided to participants in a hospital inpatient setting; and Services rendered but not appropriately documented. Providers may not be reimbursed by the Program for: Behavioral health crisis stabilization center services exceeding 23 hours 59 minutes; Presumptive and definitive drug testing when billed by a behavioral health crisis stabilization center; or Transportation costs. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. For dates of service June 1, 2024 through June 30, 2024, rates for the services outlined in this chapter shall be as follows: For services delivered through a mobile crisis team: Mobile crisis team services — $111.80 per 15-minute unit increment; and Mobile crisis follow-up outreach — $111.80 per 15-minute unit increment. For services delivered through a behavioral health crisis stabilization center: Behavioral health crisis stabilization services — $721.21 per diem; and Office-based evaluation and management services, according to COMAR 10.09.02.07D. For dates of service beginning July 1, 2024, rates for the services outlined in this chapter shall be as follows: For services delivered through a mobile crisis team: Mobile crisis team services — $115.15 per 15-minute unit increment; and Mobile crisis follow-up outreach — $115.15 per 15-minute unit increment. For services delivered through a behavioral health crisis stabilization center: Behavioral Health Crisis Stabilization Center — $742.85 per diem; and Office-based evaluation and management services, according to COMAR 10.09.02.07D. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Appeal procedures for providers are as set forth in COMAR 10.09.36.09. Appeal procedures for applicants and participants are as set forth in COMAR 10.01.04. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: May 27, 2024 (51:10 Md. R. 525) Regulation .07C amended effective July 7, 2025 (52:13 Md. R. 655) Regulation .07D adopted effective July 7, 2025 (52:13 Md. R. 655) In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Direct supervision” means that a licensed physical therapist is personally present and immediately available within the same treatment area as the physical therapy assistant to give aid, direction, and instruction when physical therapy procedures or activities are performed. “Initial evaluation” means the determination of the participant's condition by taking a case history and the administration of appropriate tests on the first visit. Treatment provided at this visit is considered to be part of the initial evaluation. “Medical Assistance Program” means the program of comprehensive medical and other health related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, family, or provider. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395—1395ccc. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Patient” means a person awaiting or undergoing health care or treatment. “Physical therapist” means an individual licensed by the Maryland Board of Physical Therapy Examiners or similarly licensed or certified by the appropriate licensing body in the state or jurisdiction in which the service is provided and within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland, or within the scope established by the jurisdiction of the provided service. “Physical therapist assistant” means an individual licensed as a physical therapy assistant, working under the direct supervision of a licensed physical therapist, and performing limited physical therapy procedures that are assigned by a licensed physical therapist within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland, or who is otherwise similarly licensed or certified by the appropriate licensing body in the state or jurisdiction where the service is provided and performing therapy procedures within the scope established by the state or jurisdiction of license or certification. “Physical therapy aide” means a nonlicensed person in the employ of a physical therapist. “Physician” means an individual licensed to practice medicine by the state in which the physician's practice is located. “Plan of care” means the plan of treatment aimed at achieving the anticipated functional goals. “Prescriber” means a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist licensed to prescribe physical therapy. “Program” means the Medical Assistance Program. “Progress” means the measurable improvement as related to goals. “Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or similarly licensed or certified to provide health care services for participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. “Treatment order” means a written prescription for physical therapy signed by a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist. To provide services as a physical therapist under this chapter, a physical therapist shall be licensed by the State Board of Physical Therapy Examiners of Maryland to practice physical therapy, as defined in Health Occupations Article, Title 13, Annotated Code of Maryland, or by the appropriate licensing body in the jurisdiction where the physical therapy services are performed. To provide services as a physical therapist assistant under this chapter, a physical therapist assistant shall be licensed by the State Board of Physical Therapy Examiners of Maryland to practice as a physical therapist assistant as defined: In Health Occupations Article, Title 13, Annotated Code of Maryland; or By the appropriate licensing body in the jurisdiction where the physical therapy assistant services are performed. To participate in the Program, the provider shall: Comply with all requirements established in COMAR 10.09.36; If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department; and Maintain the office and medical equipment so that they are free of hazards to the health and safety of participants. The Physical Therapy Program covers medically necessary physical therapy services ordered in writing by a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist when the services are: Provided by a licensed physical therapist or by a licensed physical therapist assistant under a licensed physical therapist's direct supervision; Provided in the provider’s office, the patient’s home, a domiciliary level facility, or via telehealth in accordance with COMAR 10.09.49 or other subregulatory guidance issued by the Department; Diagnostic, rehabilitative, or therapeutic, and directly related to the written treatment order; Of sufficient complexity and sophistication, or the condition of the patient is such, that the services of a physical therapist are required; Rendered pursuant to a written treatment order which: Is signed and dated by the prescriber; Specifies the following: Part or parts to be treated; and Expected results of physical therapy treatments; Is kept on file by the therapist as a part of the patient's permanent record, subject to review by the Department or its designee; and Is not altered by the therapist unless: Medically indicated; Signed by the therapist; Necessary changes are made; The prescriber is notified of the change; and The change is noted in the patient's record; and Recorded in the patient's permanent record which includes: The treatment order of the prescriber; The initial evaluation by the therapist and significant past history; All pertinent diagnoses and prognoses; Contraindications, if any; and Progress notes documented in accordance with the requirements listed in COMAR 10.38.03.02-1A(2), C, and D. The Physical Therapy Program covers an initial evaluation, on a one-time-only basis, per condition, when the requirements of §A, of this regulation, are met. If the prescribing order exceeds 30 days, the therapist shall request a new order from the prescriber for continued therapy. The Program does not cover the following: Services provided in a facility or by a group where reimbursement for physical therapy is covered by another segment of the Program; Services performed by physical therapist assistants when not under the direct supervision of a physical therapist; Services performed by physical therapy aides; or Experimental treatment. A physical therapist may only supervise two physical therapy assistants at a time. The provider shall submit the request for payment of services rendered according to procedures established by the Department and in the format designated by the Department. The provider shall certify on the invoice that the treatment order is on file and was in effect at the time that services were rendered. The provider shall specify on the invoice the type of treatment provided. A provider shall bill the Program the provider’s customary charge. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with the rate provisions of §E of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. The services covered in this chapter are reimbursed according to COMAR 10.09.23.01-1. The Department will pay for covered services, the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The Department's fee schedule. Supplemental payment on Medicare claims for patients is made subject to the limitations of the State budget and the following provisions: Deductible insurance will be paid in full; Beginning with August 1, 2010 dates of service, coinsurance shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but covered by the Program, according to §F, in this regulation. Payments on Medicare claims are authorized if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; Services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The provider may not bill the Department for: Services rendered by mail or telephone; Completion of forms and reports; or Broken or missed appointments. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The Department may return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department. Recovery and reimbursement for this chapter are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions for this chapter are as set forth in COMAR 10.09.36.08. The Department may consult with a peer review committee approved by a local chapter of the American Physical Therapy Association. The Department will give consideration to the findings and recommendations of this group. Appeal procedures for this chapter are set forth in COMAR 10.09.36.09. The interpretive regulation for this chapter is set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: July 11, 1980 (7:14 Md. R. 1349) Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113) Regulation .07F amended effective October 1, 1982 (9:19 Md. R. 1895) Regulation .07F amended as an emergency provision effective July 1, 1982 (9:17 Md. R. 1698); emergency status expired September 30, 1982 Regulation .07F amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1171); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) Regulation .07F amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .07F amended as an emergency provision effective July 1, 1990 (17:14 Md. R. 1755); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .07G amended effective April 9, 1984 (11:7 Md. R. 625) Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07L amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07L amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Regulations .01—.05 and .07—.11 amended as an emergency provision effective December 2, 1992 (19:26 Md. R. 2282); amended permanently effective June 1, 1993 (20:10 Md. R. 851) Regulations .01, .04, and .05 amended as an emergency provision effective February 8, 1995 (22:5 Md. R. 364); emergency status expired May 31, 1995; amended permanently effective June 5, 1995 (22:11 Md. R. 821) Chapter revised effective October 24, 2005 (32:21 Md. R. 1708) Regulation .01B amended effective August 27, 2018 (45:17 Md. R. 803) Regulation .02 amended effective August 27, 2018 (45:17 Md. R. 803) Regulation .03 amended effective August 27, 2018 (45:17 Md. R. 803); August 7, 2023 (50:15 Md. R. 681) Regulation .04 amended effective August 27, 2018 (45:17 Md. R. 803) Regulation .04 amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .06D, F, I amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .06E amended effective November 14, 2011 (38:23 Md. R. 1421); February 27, 2017 (44:4 Md. R. 253) Regulation .06G amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .06H amended effective August 27, 2018 (45:17 Md. R. 803) The following terms have the meanings indicated. Terms Defined. “Concentrator” means a device which removes nitrogen from ambient air, thus increasing the percentage of oxygen, and delivers the resulting oxygen-enhanced air to the patient. “Current stable arterial blood gas results” means stable arterial blood gas results on room air within 1 month before the requested date of submission of the form designated by the Department. “Demurrage” means a charge imposed by a provider for the detention of an oxygen cylinder or other equipment. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Emergency services” means unscheduled deliveries or maintenance visits to the home or nursing home by the provider because of a threat to the patient's life caused by insufficient supply of oxygen or equipment malfunction. “Home” means the place of residence occupied by the recipient, other than a hospital or a nursing facility. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-301 et seq., Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the State in which the service is provided. “Intermittent Positive Pressure Breathing (IPPB) Equipment” means an apparatus designed to force a combination of ambient air or medication, or both, into a patient's respiratory system. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Nasal continuous positive airway pressure (NCPAP) system” means a noninvasive apparatus designed to maintain air or oxygen, or both, under constant positive pressure through the nose during sleep. “Nursing facility” means a Comprehensive Care Facility which falls within the jurisdiction of the Health-General Article, §19-301 et seq., Annotated Code of Maryland, or other applicable standards established by the State in which the service is provided. “Oxygen” means pure liquid or gaseous oxygen, not in combination with other medical gases, packaged in suitable safe containers for administration to patients. “Prepayment authorization” means the approval required from the Department or its designee before services can be rendered. “Prescriber” means a physician licensed to prescribe oxygen and related respiratory equipment in the state in which the service is provided. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual, association, partnership, or incorporated or unincorporated group of individuals who, through an appropriate agreement with the Department, has been identified as a Program supplier of oxygen and related respiratory equipment by the issuance of an individual account number. “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Related respiratory equipment” means accessories used to move, direct, measure, or control the flow of oxygen from its container, or from a concentrator, to the patient. To participate in the Program, the provider shall: Unless exempt from Medicare accreditation requirements: Be accredited by a Medicare-approved accreditation organization; Effective November 1, 2011, provide documentation of: Accreditation; or Having submitted an application for accreditation; and Effective April 1, 2012, be accredited or terminated from the Program; Apply for participation in the Program using the application form designated by the Department; If located more than 25 miles from the border of Maryland, shall provide to the Program documentation demonstrating that the enrollment and screening requirements of 42 CFR Part 455, Subpart E have been performed within the 12 months preceding the application for initial enrollment or revalidation of enrollment by: A Medicare contractor; or The Medicaid agency or the Children’s Health Insurance Program of another state; Be approved for participation by the Department; Verify the recipient's eligibility; Maintain for a minimum of 6 years adequate records which are sufficient in detail to support the invoices submitted for payment, and make these records available upon request to the Department or its designee; Provide service without discrimination as to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap; Not knowingly employ a former Medicaid provider, or a former employee of a Medicaid provider, to provide service to Medical Assistance patients after that provider or employee has been disqualified from the Program, unless prior approval has been received from the Department; Accept payment by the Department as payment in full for services rendered, and make no additional charge to any person for covered services; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the recipient; Agree that if the Program denies payment due to late billing, he may not seek payment from the recipient; Place no restriction on a recipient's right to select providers of the recipient's choice; Have emergency services available on a 24 hour-a-day basis; Be prepared to furnish necessary maintenance and repairs to oxygen and related respiratory equipment; Insure on every visit to the patient that all oxygen and related respiratory equipment functions properly; Provide suitable identification, including a recent photograph, which employees who visit patients at home will carry on their person and display on request; Agree to discontinue billing or remove equipment promptly, if the patient dies, is institutionalized, or otherwise ceases to require the oxygen; Provide an ancillary source of oxygen to last at least 24 hours when the primary source is a concentrator. The following medically necessary items and services are covered for pulmonary use in the patient's home or nursing facility pursuant to §§B, C, D, and E of this regulation: Rental or purchase for use in patient's home or nursing facility of: Oxygen, gaseous (tank contained); Oxygen, liquid. Rental of concentrators. Rental or purchase of the following related respiratory equipment: Rental of equipment included in complete oxygen set-up: Flow meter; Humidity jar; Nasal cannula; Oxygen face mask; Regulator; Safety stand; Tubing; Rental of portable oxygen unit; Rental or purchase of the following tracheostomy equipment: Trach tubes; Tracheostomy trays; Humidity system, complete set-up to include tracheostomy collar or T-tube, tubing, humidity jar, and compressor; Heater; Water trap; Other related equipment: Rental or purchase of aerosol compressor (complete set-up) to include compressor unit, medication cup, connector fitting, tubing, hand-held nebulizer, and mouthpiece, face mask, or tracheostomy collar or T-tube; Rental or purchase of ultrasonic nebulizer (complete set-up) to include ultrasonic aerosol chamber with blower, medication cup, connector fitting, corrugated tubing, and mouthpiece, face mask, or tracheostomy collar or T-tube; Resuscitator bag, manual. Rental or purchase of an intermittent positive pressure breathing (IPPB) machine (complete set-up) to include: Compressor; Medication cup; Nebulizer; Connector fitting; Corrugated tubing; Nebulizer hose; Exhalation hose; Exhalation valve; and Mouthpiece. Rental or purchase of a nasal continuous positive airway pressure (NCPAP) system (complete set-up) to include: Flow generating device; Valve mechanism to maintain pressure; Nasal mask and headgear; and Tubing and reservoir. Repairs to purchased respiratory equipment. Replacement items for purchased equipment. The items in §A(1), (2), and (3)(a) and (b) of this regulation are covered when: The patient's current stable arterial blood gas results (at rest, using room air) for PaO2 are 60 mm Hg or less after optimal treatment; or The patient’s saturation level is 88 percent or less on room air or less than 93 percent for patients younger than 21 years old; or The patient's: Baseline study demonstrates sleep apnea or disordered breathing events, or both, (hourly rates >30 episodes/hour) with oxygen desaturation (oxyhemoglobin desaturation <85 percent by ear oximetry which is the equivalent to PaO2 <50 mm Hg); and Repeat study on supplemental oxygen demonstrates either a 30 percent reduction in the number of apneic episodes or disordered breathing events, or both, or improved oxyhemoglobin saturation (>85 percent by ear oximetry which is equivalent to PaO2 >50 mm Hg) throughout the night. The items in §A(5) of this regulation are covered when the patient's: Baseline study demonstrates more than 30 episodes per hour of obstructive sleep apnea (OSA), each lasting 10 seconds or more, or other disordered breathing events (DBE's), with evidence of clinical impairment (that is, daytime hypersomnolence or cor pulmonale); and Study of NCPAP demonstrates a greater than 90 percent reduction in frequency of OSA or other DBE's, with improvement in clinical symptoms. The items in §A(4) of this regulation are covered when the patient's pulmonary function studies show: A vital capacity of less than 1.5 liters (with a normal FEV1; or An absolute FEV1 of 1.5 liters or less. The items in §A(3)(d)(i) and (ii) of this regulation are covered when: The patient's pulmonary function studies show an FEV1/FVC percentage of 45 or less (calculated as FEV1 divided by FVC); or Unable to test for §E(1), of this regulation, other objective signs/symptoms of severe airway obstruction. The items in §A(1)—(5) of this regulation are covered when they are ordered in writing, by a physician, including documentation that a face-to-face encounter occurred within 6 months before ordering prescribed services, as follows: The physician's initial order and plan of treatment shall include: When prescribing oxygen: Diagnosis and indication for oxygen use; Liter flow rate per minute (at rest, and when exercising if prescribing portable oxygen); Number of hours to be used during a 24-hour period; Description of equipment to include route of administration; Rehabilitative goals; Hospital discharge or clinical summary; Current stable arterial blood gas results to include PaO2, PaCO2, and Ph on room air and on oxygen at rest, and, if prescribing portable oxygen, when exercising, or sleep apnea study results. When prescribing aerosol equipment: Diagnosis and indication for use; Number of hours to be used during a 24-hour period; Description of equipment to include route of administration; Rehabilitative goals; Hospital discharge or clinical summary; Pulmonary function study results. When prescribing tracheostomy equipment: Diagnosis and indication for use; Description of equipment to include quantity requested, period of time required, and approximate cost; Rehabilitative goals. When prescribing an NCPAP system: Diagnosis and indication for use; Specification of NCPAP fixed level; Rehabilitative goals; Clinical summary, including appropriate sleep studies. The physician's subsequent orders shall include: When prescribing oxygen for other than sleep apnea, an update of the items listed in §F(1)(a) of this regulation if the patient's condition regarding the need for oxygen has changed since the previous orders; When prescribing oxygen for sleep apnea, an update of the items listed in §F(1)(a) of this regulation; When prescribing aerosol equipment, an update of the items listed in §F(1)(b) of this regulation; When prescribing tracheostomy equipment, an update of the items listed in §F(1)(c) of this regulation; When prescribing an NCPAP system, an update of the items listed in §F(1)(d) of this regulation. The physician's subsequent orders for oxygen when prescribing for sleep apnea shall be made within: One year of the effective date of the initial preauthorization; or At the time the patient's condition is changed by significant intervention, as follows, not to exceed that 1-year period: Significant weight loss of more than 10—15 percent; Surgical intervention on upper airway; Tracheostomy; Positive airway pressure. The Program does not cover: Any service or items not identified in Regulation .04 of this chapter; Demurrage; Charges for delivery; Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, air conditioners and room humidifiers; Items which are investigational or experimental in nature; Oxygen and related equipment not for pulmonary use; Pre-set oxygen for emergency use; Trach string or tape. The Program places the following limitations upon covered services: Reimbursement for aerosol equipment will only be provided if a hand held nebulizer has been tried and is not successful, as indicated in the clinical summary; Reimbursement for IPPB machine will only be authorized if the aerosol compressor with the nebulizer kit has been tried and is not successful, as indicated in the clinical summary; Reimbursement may not be made for: Repairs or replacement parts for rented items; Oxygen prescribed on an as-needed basis (PRN); Oxygen prescribed for stand-by purposes; Piped-in oxygen; Oxygen and related respiratory equipment and services provided in a facility or by a group when reimbursement is covered by another segment of the Program; and Payment for portable oxygen will be made only when: It is required in the pursuit of medical treatment; and The medical necessity is indicated for this type of system. The following items require a written prepayment authorization: Nasal continuous positive pressure (NCPAP) system; Custom made tracheostomy tubes; and Intermittent positive pressure breathing (IPPB) machine. Prepayment authorization is issued when: Program procedures are met; Program limitations are met; and The Prescriber submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. The prescriber shall submit requests for prepayment authorization in writing using the format and procedures designated by the Department. Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile of the completed prepayment authorization form shall be followed by a written request, using the original of the form, which shall be submitted immediately to the Department. Written prepayment authorization is valid for a period to be determined by the Program but not to exceed a maximum of 365 days beginning with the date of issue by the Program, and is contingent on the recipient's continuing eligibility. Prepayment authorization normally required by the Program is waived when the services are covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—E of this regulation. The provider shall submit request for payment on the forms designated by the Department, with attachments when applicable. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed and those submitted without required documentation. The provider shall charge the Program the provider’s customary charge to the general public for similar items. If the item is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §D of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. The Department shall reimburse providers for the purchase of covered services at the lowest of the provider’s customary charge: For items for which Medicare has established a rate: The Department shall pay providers 80 percent of the Medicare rates established on January 1 of each year for oxygen and respiratory equipment and supplies, which shall include all fitting, dispensing, and follow-up care; and For respiratory equipment for which Medicare has established a capped rental rate, the purchase price shall be 9 times the current Medicare monthly rental rate; and For items for which Medicare has not established a rate: Oxygen and respiratory supplies at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or the provider's wholesale cost plus 37.2 percent; Customized equipment or supplies at the provider's choice of the manufacturer's suggested retail price minus 30 percent or the provider's wholesale cost plus 40 percent; and Other oxygen and respiratory equipment at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or of the provider's wholesale cost plus 27.4 percent. The Department shall pay for repairs to purchased oxygen and respiratory equipment in accordance with the following: The provider's choice of wholesale cost plus 37.2 percent or manufacturer's suggested retail price minus 31.4 percent for all materials; and Reasonable charges for labor, not to exceed the customary charges for similar services in the provider’s area unless the service is free to individuals not covered by Medicaid; or Actual charges for repairs done by other than the provider as evidenced by an invoice attached to the bill. The Department shall only pay separately for the following replacement items for purchased respiratory equipment, and all other replacement items shall be included in repairs and will be reimbursed according to §E of this regulation: Mouthpiece; Face mask; Tracheostomy collar or T-tube. When any individual item or combination of items are provided as part of a complete setup, they may not be invoiced in the Program separately, but under complete setup procedure codes as listed in the fee schedule, except for replacement items as listed in §F of this regulation. The Program will approve for payment the least expensive mode of oxygen which is medically suited for the patient's condition. The Program will determine, based upon expected duration of medical need, whether oxygen related equipment will be purchased or rented. Once an item has been purchased and paid for in full, and if the Program has contributed in full or in part to the purchase, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered at the option of the Department. Supplemental payment on Medicare claims is made subject to the following provisions: Deductible insurance will be paid in full; Co-insurance will be paid in full; Services not covered by Medicare but by the Program will be paid in accordance with the limitations of §E of this regulation. The Department will authorize payment on Medicare claims if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department may not make direct payments to recipients. The provider may not bill the Program for: Services rendered by mail or telephone; Completion of forms or reports; or Broken or missed appointments. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Oxygen and respiratory equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing oxygen and respiratory equipment and supplies. Refills. For oxygen and respiratory equipment and supplies that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order. The provider shall contact recipient or designee regarding the refills no earlier than 7 days before the delivery and shipping date. For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product. If the recipient has insurance or other coverage, or if any other person is obligated either legally or contractually to pay for or to reimburse the recipient for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Department; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland Effective date: January 1, 1984 (10:25 Md. R. 2268) Regulation .01B amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109); April 5, 2010 (37:7 Md. R. 570) Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568) Regulation .03D amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .03H amended effective May 29, 1989 (16:10 Md. R. 1109) Regulation .03P, .05, .06F, and .07D, F, G amended effective November 5, 1984 (11:22 Md. R. 1899) Regulation .04 amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109) Regulation .04B amended effective September 11, 2017 (44:18 Md. R. 866) Regulation .04B, F amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .04F amended effective April 16, 2012 (39:7 Md. R. 492) Regulation .05B amended effective May 2, 1988 (15:9 Md. R. 1108); April 5, 2010 (37:7 Md. R. 570); September 11, 2017 (44:18 Md. R. 866) Regulation .06 amended effective October 27, 2003 (30:21 Md. R. 1529); April 5, 2010 (37:7 Md. R. 570) Regulation .07 amended effective April 5, 2010 (37:7 Md. R. 570) Regulation .07C, E, M amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 Regulation .07D amended effective August 12, 1985 (12:16 Md. R. 1606) Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129) Regulation .07D amended effective May 2, 1988 (15:9 Md. R. 1108); October 27, 2003 (30:21 Md. R. 1529); April 2, 2012 (39:6 Md. R. 408): February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 473) Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625) Regulation .07O amended effective September 10, 1984 (11:18 Md. R. 1584) Regulation .07O amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07O amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84) These regulations govern the administration of grants to counties, municipal corporations, and nonprofit organizations for the provision of safety-net transportation services to Medical Assistance Program recipients. The grant funds are to be used by grantees to: Screen requests for transportation by recipients; Arrange for transportation; Expand existing and develop new transportation resources; and Provide transportation services where no other transportation is available to the recipient. In this chapter, the following terms have the meanings indicated. Terms Defined. “Ambulance” means a specially designed vehicle used for transporting the sick or injured, which has necessary patient care equipment including a stretcher, clean linens, first aid supplies, oxygen equipment, and, in addition, other safety and lifesaving equipment which may be required by State or local laws to classify the vehicle as an ambulance. “Attendant” means an individual needed to accompany a recipient who is unable to travel alone. “Department” has the meaning stated in COMAR 10.09.36.01. “Emergency” means a situation requiring prompt diagnosis and treatment of conditions having the potential of causing imminent disability or death. “Emergency services” means services provided in hospital emergency facilities after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in: Placing health in jeopardy; Serious impairment to bodily functions; Serious dysfunction of any bodily organ or part; or Development or continuance of severe pain. “Grantee” means a recipient of grant funds from the Department pursuant to this chapter. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent individuals. “Medicare” has the meaning stated in COMAR 10.09.36.01. “Necessary” has the meaning stated in COMAR 10.09.36.01. “Nonambulatory” means a condition which renders a recipient physically unable to use a bus, taxicab, or private automobile in going to or from a hospital to receive needed medical treatment. “Program” has the meaning stated in COMAR 10.09.36.01. “Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Wheelchair van” means a van equipped with either a lift tailgate or side lift which is used for loading patients who are nonambulatory but who do not require the use of equipment found in an ambulance. The Secretary shall request proposals for the award of transportation grants. An applicant shall include in the applicant's proposal a description of how the applicant intends to carry out the duties required by these regulations. At a minimum, the applicant shall include the following items in the proposal: The criteria which the applicant will use to determine the recipient's need for transportation services; A discussion of how the applicant will arrange and provide transportation; If applicable, a description of how volunteers will be recruited and reimbursed; The reporting methodology that will be used by the grantee; and An itemized budget for administrative costs, including: A staffing plan; Descriptions of individual job responsibilities and salaries; A budget form; and Other pertinent material. If an applicant intends to enter into subcontracts for transportation services referred to in §B(2) of this regulation, the applicant shall provide the following information: The names of the subcontractors; The scope of services to be subcontracted; The payment arrangement and payment level; and The plan for monitoring the performance of the subcontractors. A grantee is responsible for arranging or providing nonemergency transportation to and from medically necessary covered services to Medical Assistance recipients and, when necessary, their attendants, who have no other means of transportation available. In carrying out this duty, a grantee: Shall screen recipients' requests for transportation in order to identify whether transportation is available to the recipients from other sources; When determining the appropriate means of transport for a recipient who appears to have a mental or physical disability which would prevent the recipient from using public transportation, shall request documentation prepared by the recipient's physician which indicates that the recipient's medical condition makes it medically contraindicated for the recipient to use public transportation; Shall refer recipients to organizations and programs which might be able to provide transportation and otherwise arrange for transportation when appropriate; Shall encourage the development and expansion of transportation resources such as churches and other community organizations; Shall provide transportation to recipients for whom there is no other transportation resource available, in the most efficient and cost-effective manner possible, including the use of volunteers and charitable organizations whenever possible; and May refuse to pay for transportation services if the recipient requests transportation less than 24 hours before the time the transportation is to be provided. Screening referred to in §A(1) of this regulation includes obtaining the information listed below, as appropriate: Whether a recipient or a member of the recipient's household owns a vehicle; Availability of vehicles owned by friends or relatives with whom a recipient does not share a household; Availability of a volunteer using a privately owned vehicle; Availability of a volunteer from a public or private agency; Availability of transportation services provided for free by any other city, county, or State agency programs; Methods by which a recipient previously reached medical services or currently reaches nonmedical services, such as the grocery store; Whether a recipient can walk to the medical service; Whether public bus transportation operates between a recipient's home and medical service; Whether a recipient is mentally or physically disabled; Whether a recipient is chronically ill or otherwise requires medical services on a frequent and ongoing basis; and Whether a recipient can reschedule an appointment to a time when transportation would be available. When the recipient is unable without assistance to obtain the documentation referred to in §A(2) of this regulation, and has no family member or other representative who can provide assistance, the grantee shall offer to contact the recipient's health care provider to request documentation of disability. Monies from a grant provided under these regulations may not be used to pay for the following: Emergency transportation services; Medicare ambulance services; Transportation to or from Veterans Administration hospitals unless it is to receive treatment for a non-military-related condition; Transportation to or from any correctional institutions; Transportation of recipients committed by the courts to mental institutions; Transportation between a nursing facility and a hospital, for routine diagnostic tests, nursing services, or physical therapy which can be performed at the nursing facility; Transportation services from a facility for treatment when the treatment is provided by the facility in which the recipient is located; Transportation to receive nonmedical services; Gratuities of any kind; Transportation between a medical day care facility and the recipient's home; Transportation to or from a State facility while the patient is a resident of that facility; Transportation of non-Medical Assistance recipients; Trips for purposes related to education, recreational activities, or employment; Transportation of anyone other than the recipient, except for an attendant accompanying a minor or when an attendant is medically necessary; Wheelchair van service for ambulatory recipients; Ambulance service for a recipient who does not need to be transported in a prone position; Transportation between a community rehabilitation program (CRP) and the recipient's home; Transportation between a day habilitation program and the recipient's home; Transportation to or from services that are not medically necessary. Whenever a grantee determines that the grantee will not arrange or provide transportation for a recipient who has requested transportation at least 24 hours in advance, even though the recipient has no available transportation resource, the grantee shall send the recipient a notice on a form, approved by the Department, that states the recipient has a right to a fair hearing pursuant to COMAR 10.09.24.13. A grantee shall document the following items and make the documentation available to the Department upon request: Whether the recipient had other transportation available or could reschedule the appointment to a time when transportation would be available; That any transportation paid for out of grant funds was to or from a medically necessary service for a recipient; and Which recipients the grantee denied transportation and the reason or reasons why. The Department shall: Follow all applicable policies required by COMAR 10.04.04 when approving grants; and Reconcile each grant on a yearly basis. A grantee is expected to meet the transportation needs of recipients in a grantee's county out of grant funds. In those circumstances when the grant funds are insufficient, the grantee shall contact the Program's staff specialist for transportation services, who shall evaluate and assist in resolving transportation requests. A grantee may not refuse services or assistance to a recipient who requests transportation on the basis that the grantee's grant funds have been exhausted. These regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: June 26, 1981 (8:13 Md. R. 1139) Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113) Regulation .07F amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .09A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .11 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .12 adopted effective October 25, 1982 (9:21 Md. R. 2106) Regulations .01—.12 repealed effective July 1, 1987 (14:4 Md. R. 418) Regulations .01—.12 adopted effective July 1, 1987 (14:4 Md. R. 418) Regulation .01B amended effective July 1, 1989 (16:12 Md. R. 1336) Regulations .01B and .05A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulations .01B and .05A amended, and .04G adopted as an emergency provision effective May 1, 1991 (18:7 Md. R. 765); amended permanently effective October 1, 1991 (18:15 Md. R. 1726) Regulation .03A—C amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .04A amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .05 amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .06A and B amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .07 amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .07A amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08C and D amended effective July 1, 1989 (16:12 Md. R. 1336) Regulations .01—.12, General Transportation, repealed effective May 24, 1993 (20:10 Md. R. 851) Regulations .01—.10, Transportation Grants, adopted effective May 24, 1993 (20:10 Md. R. 851) Regulation .02B amended effective July 1, 1994 (21:12 Md. R. 1060) Regulation .05 amended effective July 1, 1994 (21:12 Md. R. 1060) In this chapter, the following terms have the meanings indicated. Terms Defined. “Activities of daily living” means tasks or activities that include, but are not limited to: Bathing and completing personal hygiene routines; Dressing and changing clothes; Eating; Mobility, including: Transferring from a bed, chair, or other structure; Moving, turning, and positioning the body while in bed or in a wheelchair; and Moving about indoors or outdoors; and Toileting, including: Bladder and bowel requirements; Routines associated with the achievement or maintenance of continence; and Incontinence care. “Applicant” means an individual who is applying to receive services under this chapter. “Assistance” means that another individual: Physically performs the activity for the participant; Physically helps the participant to perform the activity; Monitors the participant’s performance of the activity in order to ensure health and safety; or Cues or encourages the participant to perform the activity. “Certified medication technician (CMT)” means an individual, regardless of title, who: Completes a course in medication administration approved by the Maryland Board of Nursing; Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. “Certified nursing assistant (CNA)” means an individual, regardless of title, who: Is certified by the Maryland Board of Nursing under COMAR 10.39.01; and Routinely performs delegated nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. Community Setting. “Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to: Seek employment and work in competitive integrated settings; Engage in community life; Control personal resources; and Receive services. “Community setting” does not mean: Hospitals; Nursing facilities; Institutions for mental diseases; Intermediate care facilities for individuals with intellectual disabilities; or Other institutions. “Conflicts of interest” means real or seeming incompatibility between one’s private interests and one’s public or fiduciary duties. “Delegated nursing functions” means nursing services provided to a participant by an enrolled personal assistance worker under the supervision of a: Registered nurse in accordance with COMAR 10.27.11; or Nurse practitioner in accordance with COMAR 10.27.07. “Department” means the Maryland Department of Health or its authorized agent acting on behalf of the Department. Home. “Home” means the participant’s place of residence in a community setting. “Home” does not mean: An assisted living program as defined in COMAR 10.07.14; A residential rehabilitation program licensed as a therapeutic group home under COMAR 10.21.07; An alternative living unit, group home, or individual family care home as defined in COMAR 10.22.01; Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; or Any other provider-owned or controlled residence. “Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. “Instrumental activities of daily living” means tasks or activities that include, but are not limited to: Preparing meals; Performing light chores that are incidental to the personal assistance services provided to the participant; Shopping for groceries; Nutritional planning; Traveling as needed; Managing finances and handling money; Using the telephone or other appropriate means of communication; Reading; and Planning and making decisions. “Medicaid” means the Program, administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy participants. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, ameliorative, palliative, or rehabilitative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, the participant’s family, the provider, or the worker. “Nurse” means an individual who is currently licensed to practice nursing in the State under COMAR 10.27.01. “Nurse monitor” means a registered nurse who completes nursing assessments on participants and evaluates the delivery of care. “Participant” means an individual who: Has been determined to meet the qualifications for participation in Community Personal Assistance Services as specified in Regulation .03 of this chapter; and Is enrolled with the Department to receive Medicaid services. “Personal assistance provider agency” means a public or private agency that: Employs or contracts with personal assistance workers; and Has been enrolled by the Program as a provider of personal assistance services. Personal Assistance Services. “Personal assistance services” means assistance specific to the functional needs of a participant with a chronic illness, medical condition, or disability. “Personal assistance services” includes: Assistance with activities of daily living and instrumental activities of daily living; and The performance of delegated nursing functions. “Plan of service” means the support plan that: Reflects what is important to the individual and what is important for the individual’s welfare; and Is developed with support from the supports planner with input from the individual and, when applicable, the individual’s representative. “Preauthorized” means approved by the Department or its designee before services can be rendered. “Program” means the Maryland Medicaid Program. “Provider” has the same meaning as defined in COMAR 10.09.36. “Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter. “Recommended plan of care” means the recommended service plan developed by a nurse after a face-to-face evaluation of an applicant or participant. “Representative” means: The person authorized by the individual to serve as a representative in connection with the provision of personal assistance services and supports; The individual who signs the plan of service on the participant’s behalf; Any individual who makes decisions on behalf of the participant related to the participant’s plan of service; A legal guardian of the individual for the participant; or The parent or foster parent of a dependent minor child. “Supports planner” means an individual who coordinates services, including: Supporting development of a plan of service; Interacting with third parties on behalf of, or in conjunction with, the applicant or participant; and Ensuring an accurate plan of service is provided to the Department. “Telephonic time-keeping system” means a system developed by the Department for workers to time stamp the start and finish of services provided to a participant. “Worker” means an individual who is employed by or contracts with a personal assistance provider agency to provide personal assistance services. The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered: Registered nurses; Licensed practical nurses; Certified medication technicians; and Certified nursing assistants. To participate in the Program, the participant shall: Be determined by the Department to need assistance with one or more activities of daily living; Be eligible for Medicaid under an eligibility coverage group described in COMAR 10.09.24, except for Regulations .03C, .03-1—.03-3, and .05-2; and Reside at home. To be eligible for participation, a participant shall have an active plan of service. The plan of service shall: Be based on: The evaluation and recommended plan of care; and Consultation with the applicant or participant; Address the applicant’s or participant’s health and safety needs; Specify the services needed to safely support the participant in the community, including a plan for receiving personal assistance services in case of an emergency; Specify the provider agency providing personal assistance services; and Include the signature of the: Participant or, when applicable, the individual’s representative; Supports planner; and Personal assistance provider agency listed within the plan of service. A participant’s eligibility for services shall be re-evaluated by the Department every 12 months, or more frequently if needed due to a significant change in the participant’s condition or needs. Participant eligibility shall be terminated if the participant: No longer meets the required level of care; No longer resides at home; Is without personal assistance services for 30 consecutive calendar days; Voluntarily chooses, or the participant’s legal representative chooses on the participant’s behalf, to disenroll from the Program; Moves to another state; Is an inpatient for 30 consecutive days or more in an institutional setting, including but not limited to a chronic hospital or nursing facility; or Dies. To participate as a provider of a service covered under this chapter, a provider: Shall meet all of the conditions for participation as a Medicaid provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; Shall verify the qualifications of all individuals who render services on the provider’s behalf and provide a copy of the current license or credentials on request; Shall implement the reporting and follow-up of incidents and complaints in accordance with the Department’s established policy by: Reporting incidents and complaints within 24 hours of knowledge of the event; Submitting a written report within 7 calendar days on a form designated by the Department; and Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subjected to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.02.16; Shall agree to cooperate with required inspections, reviews, and audits by authorized governmental agents; Shall agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter, for only those services covered under this chapter which have been: Preauthorized in the participant’s plan of service; Provided in a manner consistent with the participant’s plan of service; and Identified in the provider agreement as within the scope of the provider’s Medicaid participation; Shall agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years from the date of service, in a manner approved by the Department; Shall agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and only after consultation and input from the participant or, when applicable, the participant’s representative; Shall submit a transition plan to the case manager or supports planner and participant or, when applicable, the participant’s representative when suspending or terminating services; Shall verify Medicaid eligibility at the beginning of each month that services will be rendered; May not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; and Shall be free from conflicts of interest. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: Had a license or certificate suspended or revoked as a health care provider, health care facility, or direct care services worker; Been suspended or removed from participating as a Medicaid provider under COMAR 10.09.84; Undergone the imposition of sanctions under COMAR 10.09.36.08; Been subject to disciplinary action, including actions by the licensing board or any provider or principal of any provider agency; Been cited by a State agency for deficiencies which affect participants’ health and safety; or Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to: Failure to meet contractual obligations; or Fraudulent billing practices. A provider who renders health-related services to participants shall agree to: Periodically provide information about a participant in accordance with the procedures and forms designated by the Department; and Share and discuss the documented information at the request of the participant. Personal assistance service providers shall: Be licensed as a residential service agency under COMAR 10.07.05 to provide Level Two or Level Three home care services; Employ a registered nurse who shall: Assess each new participant who requires personal assistance services; Participate in developing the worker instructions and in assigning appropriate personnel; Delegate nursing tasks, as appropriate, to a CNA or a CMT in accordance with COMAR 10.27.11; and Participate in instructing the workers who will provide the assistance, when indicated; Employ workers who will accept instruction on the personal assistance services required in the participant’s plan of service from the following: The participant or, when applicable, the participant’s representative; The nurse monitor; A treating physician or nurse practitioner; or An individual from the Department; Provide services directly through their workers under the direction of the participant or, when applicable, the participant’s representative; Allow participants to have a significant role in the delivery of their specific care including: Directing the services and supports identified in their plan of service; and Exercising as much control as desired to select, train, schedule, determine duties of, and dismiss the personal assistance worker in their home; Notify the Department in writing at least 45 days in advance of any: Voluntary closure; Change of ownership; Change of location; Sale of the business; Change in the name under which the provider is doing business; or Change in provider tax identification number; Include in the notice to the Department the method for informing participants and representatives of its intent to close, change ownership, change location, or sell its business; Include in the notice to the Department, and inform participants and representatives, of the transition plan developed by the agency to ensure continuity of services to participants; If applicable, apply for a new license whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of services; Submit a Medicaid provider application to the Department if the new owner chooses to participate in the Program; and Conduct a criminal history records check on all direct service workers including nurses, in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland. A worker who performs delegated nursing services in accordance with COMAR 10.27.11 shall: If required to administer medications in accordance with the plan of service, be a certified medications technician; and If performing other delegated nursing functions, also be a certified nursing assistant. A personal assistance provider agency may not assign the participant’s representative to provide services to that participant. To participate in the Program as a supports planning provider under Regulation .10 of this chapter, a provider shall: Agree to be monitored by the Department; and Be: Identified by the Department through a solicitation process; or The area agency on aging that is enrolled to provide case management services under COMAR 10.09.54. To participate in the Program as a nurse monitoring provider under Regulation .11 of this chapter, a provider shall: Be designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act; Employ or contract with registered nurses who hold a current professional license to practice in Maryland; Agree to accept all referrals from the Department; and Agree to be monitored by the Department. The Program shall reimburse for the services specified in Regulations .09—.11 of this chapter, when, pursuant to the requirements of this chapter, these services have been preauthorized by the Department in the participant’s plan of service, billed in accordance with the payment procedures in Regulation .14 of this chapter, and documented as necessary to prevent institutionalization. The Program covers personal assistance services that are approved in the plan of service and rendered to a participant by a qualified provider in the participant’s home or a community setting. The Program covers the following services when provided by a personal assistance provider: Assistance with activities of daily living; Delegated nursing functions if this assistance is: Specified in the participant’s plan of service; and Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing; Assistance with tasks requiring judgment to protect a participant from harm or neglect; Assistance with or completion of instrumental activities of daily living, provided in conjunction with the services covered under §B(1)—(3) of this regulation; and Assistance with the participant’s self-administration of medications, or administration of medications or other remedies, when ordered by a physician. Personal assistance services may not include: Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant; The cost of food or meals prepared in or delivered to the home or otherwise received in the community; or Housekeeping services, other than those incidental to services covered under §B of this regulation. Supports planning services shall: Address the individualized needs of the participant; Be sensitive to the educational background, culture, and general environment of the participant; Support the participant to self-direct services and exercise as much control as desired to select, train, supervise, schedule, determine duties of, and dismiss the personal assistance provider; and Ensure freedom of choice among any willing provider for all services. Supports planning services include the following activities: Assisting the participant in developing a plan of service in consultation with the applicant or participant and any individual requested by the participant; Assisting the participant with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to: Behavioral health; Educational services; Disposable medical supplies and durable medical equipment; Housing; Medical services; and Social services; Monitoring the provision of services to determine if services are received in accordance with the plan of service; Using information technology systems developed by the Department; Coordinating with the fiscal intermediary to assist in managing budgeted resources; Providing guidance and support to help individuals self-direct their services; and Administering funds for transition services. The Program covers the following services when provided by a nurse monitor: Being available to give instruction and to answer questions; Complying with the Department’s reportable events policy; and Maintaining an up-to-date client profile in an electronic database designated by the Department. The Program covers nurse monitoring services according to the following schedule: Contact with the participant for the purpose of reviewing participant status at a minimum of every 6 months with at least one in-person home or workplace visit every 12 months; and Additional nurse monitoring services at a frequency established in conjunction with the participant or, when applicable, the participant’s representative, based on the participant’s medical condition or clinical status. Home and Workplace Visits. The nurse monitoring provider shall use the home or workplace visit for the following purposes: To assess the participant’s condition; To assess the quality of personal assistance services; and To determine the need for discharge from personal assistance services or referral to other services. The nurse monitor shall assess the quality of personal assistance services by: Reviewing documentation related to the provision of personal assistance services; and Observing the performance of the worker, as appropriate. The Program shall reimburse for the services specified in Regulations .09—.11 of this chapter, if provided in accordance with the requirements of this chapter, and if the service: Is recommended on the participant’s plan of service as necessary to assure the health and safety of an applicant or participant in the community; Has been preauthorized by the Department in the participant’s plan of service; Is provided to an enrolled participant; Is medically necessary; and Is provided by a Medicaid provider who meets the conditions for participation under this chapter. The Department shall establish a budget for personal assistance services that may be included in the participant’s plan of service, based on each participant’s assessed need. The Program does not cover the following services: Service primarily for the purpose of housekeeping unrelated to the participant’s activities of daily living, such as: Cleaning of the floor and furniture in areas not occupied by the participant; Laundry other than that incidental to the care of the participant; and Shopping for groceries or household items unless in the company of the participant; Meals delivered to the home; Services provided by providers not approved for participation by the Department; Expenses incurred while escorting participants: To obtain medical diagnosis or treatment; To or from the participant’s workplace; or For participation in social or community activities; Expenses related to room and board for either the participant or the worker; or Personal assistance services provided outside the State for more than 30 days per calendar year. Payment for supports planning and nurse monitoring services shall be limited to direct services to the participant and may not be made for: Administrative overhead; Travel; Internal quality monitoring activities; Staff supervision, training, or consultation; or Services rendered by an individual supports planner or nurse monitor in excess of 7 hours per day unless pre-authorized by the Department in writing. Request for Payment — Personal Assistance. To receive payment as a personal assistance provider agency under Regulation .09 of this chapter, a provider and its workers shall use the telephonic time-keeping system approved by the Department to: Document time; and Submit claims. Request for Payment — All Other Covered Services. To receive payment as a provider of services covered under Regulations .10 and .11 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department’s billing manual. Billing time limitations are set forth in COMAR 10.09.36.06. Payments. Payments for services rendered to a participant shall be made directly to a qualified provider. A provider shall be paid the lesser of: The provider’s usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate established according to the fee schedule published by the Department. Effective July 1, 2018, for personal assistance services up to 12 hours per day, payment will be made in 15-minute units of service. For individuals who are determined to need more than 12 hours of personal assistance per day, a daily rate for the service will be paid. Rates. The Department shall publish a fee schedule for services covered under this chapter which shall be publicly available and updated at least annually or upon any changes made by the Department. Effective July 1, 2018, the Program’s rates as specified in the Department’s fee schedule shall increase on July 1 of each year by 3 percent, subject to the limitations of the State budget. Recovery and reimbursement procedures shall be as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeal procedures shall be as set forth in: COMAR 10.09.36.09; and COMAR 10.01.03. Appeal procedures for applicants and participants are those set forth in: COMAR 10.09.24.13; and COMAR 10.01.04. Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. This chapter shall be implemented October 1, 2015. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: June 27, 1980 (7:13 Md. R. 1279) Regulation .01F-1—F-3 and .06E adopted, and Regulations .05B; .06B, D; and .07B, B-1, C amended as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); emergency status expired November 30, 1986 Regulation .01F-1—F-3 adopted effective December 1, 1986 (13:21 Md. R. 2321) Regulation .01F-4—F-6 adopted effective July 1, 1988 (15:13 Md. R. 1554) Regulation .01I-1 and J-1 adopted effective April 6, 1986 (13:7 Md. R. 795) Regulation .02B amended effective April 6, 1986 (13:7 Md. R. 795) Regulation .03A and B amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113); April 6, 1986 (13:7 Md. R. 795) Regulations .03A, B, .05, .07C amended as an emergency provision effective July 1, 1983 (10:13 Md. R. 1177); adopted permanently effective October 24, 1983 (10:21 Md. R. 1902) Regulation .03A-1 adopted effective April 6, 1986 (13:7 Md. R. 795) Regulation .03A-2 adopted effective July 1, 1988 (15:13 Md. R. 1554) Regulation .03B-1 adopted effective July 1, 1988 (15:13 Md. R. 1554) Regulations .04 and .05B, D amended effective April 6, 1986 (13:7 Md. R. 795) Regulation .04C amended effective October 22, 1984 (11:21 Md. R. 1813) Regulation .04D, E, F adopted effective July 1, 1988 (15:13 Md. R. 1554) Regulation .05B amended effective December 1, 1986 (13:21 Md. R. 2321); July 17, 1995 (22:14 Md. R. 1053) Regulation .06B and D amended, and E adopted effective December 1, 1986 (13:21 Md. R. 2321) Regulation .06F adopted effective July 1, 1988 (15:13 Md. R. 1554) Regulation .07A amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584); April 6, 1986 (13:7 Md. R. 795) Regulation .07B amended effective August 30, 1982 (9:17 Md. R. 1708); May 1, 1983 (10:8 Md. R. 726); December 1, 1986 (13:21 Md. R. 2321); December 28, 1998 (25:26 Md. R. 1925) Regulation .07B-1 adopted effective April 6, 1986 (13:7 Md. R. 795); amended effective December 1, 1986 (13:21 Md. R. 2321) Regulation .07B-2 adopted effective July 1, 1988 (15:13 Md. R. 1554) Regulation .07C amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1172); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) Regulation .07C amended effective December 1, 1986 (13:21 Md. R. 2321); December 28, 1998 (25:26 Md. R. 1925) Regulation .07D adopted effective July 1, 1988 (15:13 Md. R. 1554) Regulation .07D amended effective December 28, 1998 (25:26 Md. R. 1925) Regulation .08A, B amended effective April 6, 1986 (13:7 Md. R. 795) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulations .09A, C, D and .10A amended effective April 6, 1986 (13:7 Md. R. 795) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) Chapter revised effective February 20, 1989 (16:3 Md. R. 342) Regulations .01B and .05A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) Chapter revised as an emergency provision effective July 30, 1991 (18:17 Md. R. 1911); adopted permanently effective December 1, 1991 (18:23 Md. R. 2488) Regulations .01, .03, .05, and .07 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); emergency status expired December 31, 1998 Regulations .01, .03, .05, and .07 amended effective September 6, 1999 (26:18 Md. R. 1376) Regulation .01B amended effective January 31, 2005 (32:2 Md. R. 146); August 29, 2005 (32:17 Md. R. 1438) Regulation .01B amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) Regulation .01B amended effective November 14, 2011 (38:23 Md. R. 1421) Regulation .02 amended effective March 22, 2010 (37:6 Md. R. 477) Regulation .03 amended effective January 31, 2005 (32:2 Md. R. 146); August 29, 2005 (32:17 Md. R. 1438) Regulation .03A amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) Regulation .03A amended effective March 22, 2010 (37:6 Md. R. 477) Regulation .04 amended effective January 31, 2005 (32:2 Md. R. 146) Regulation .04B amended effective November 14, 2011 (38:23 Md. R. 1421) Regulation .04D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) Regulation .04E, F repealed effective August 29, 2005 (32:17 Md. R. 1438) Regulation .05 amended effective January 31, 2005 (32:2 Md. R. 146) Regulation .05A, F amended effective November 14, 2011 (38:23 Md. R. 1421) Regulation .05B amended effective August 29, 2005 (32:17 Md. R. 1438) Regulation .06B amended effective August 29, 2005 (32:17 Md. R. 1438) Regulation .06C amended effective November 14, 2011 (38:23 Md. R. 1421) Regulation .06D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) Regulation .07 amended effective August 29, 2005 (32:17 Md. R. 1438) Regulation .07 amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) Regulation .07 amended as an emergency provision effective July 1, 2008 (35:16 Md. R. 1389); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) Regulation .07 amended effective December 24, 2012 (39:25 Md. R. 1612) Regulation .07B, C amended effective May 4, 2009 (36:9 Md. R. 651); December 13, 2010 (37:25 Md. R. 1738) Regulation .07D amended effective March 22, 2010 (37:6 Md. R. 477) Regulations .01—.11, Personal Care Services, repealed and new Regulations .01—.20, Community Personal Assistance Services, adopted effective March 14, 2016 (43:5 Md. R. 385) Regulation .01B amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .04A amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .05A amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .09A amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .10 amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .10B amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .11 amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .13B amended effective December 31, 2018 (45:26 Md. R. 1242) Regulation .14 amended effective January 30, 2017 (44:2 Md. R. 84); May 20, 2019 (46:10 Md. R. 486) This chapter establishes requirements for individual pharmacists who enroll in the Program. In this chapter, the following terms have the meanings indicated. Terms Defined. “Board” means the Maryland Board of Pharmacy. “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. “Medication therapy management” services are defined as face-to-face consultations that are structured to reduce the risk of adverse events and ensure optimum therapeutic outcomes for targeted patients through improved medication use with disease-state specific education, counseling, and medication review related to treatments, including drug therapy, laboratory tests, or medical devices provided by licensed and practicing pharmacists. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Pharmacist” means an individual licensed in good standing to practice pharmacy in the state where the service is provided. “Program” means the Maryland Medical Assistance Program. The pharmacist shall meet: Licensure requirements set forth in COMAR 10.09.36.02; Conditions for participation set forth in COMAR 10.09.36.03; and Conditions for their license under the Board of Pharmacy as stated in Health Occupations Article, Title 12, Subtitle 3, Annotated Code of Maryland. The Program covers the following medically necessary services when rendered by a pharmacist: Services rendered within the pharmacist’s lawful scope of practice as defined by the Board and otherwise covered by the Program in accordance with COMAR 10.09.02.07D; and Medication therapy management for participants who meet the Department’s clinical criteria. The following are not covered: Pharmacist administered drugs obtained from manufacturers who do not participate in the federal Drug Rebate Program; Medical supplies usually included in an office visit; Services not medically necessary; Investigational and experimental drugs and procedures; Procedures solely for cosmetic purposes; and Services denied by Medicare as not medically justified. The provider shall adhere to general provider payment procedures established in COMAR 10.09.36.04. The provider shall be reimbursed in accordance with COMAR 10.09.02.07D. Effective January 1, 2024, medication therapy management shall be reimbursed at the following rates: For the first 8—15 minutes: For new patients, $49.67 per unit of service; or For established patients, $31.24 per unit of service; and For each additional 8—15 minute, $24.54 per unit of service. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-148(c), Annotated Code of Maryland Effective date: December 31, 2018 (45:26 Md. R. 1242) Regulation .02B amended effective May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187) Regulation .03 amended effective January 6, 2025 (51:26 Md. R. 1187) Regulation .03C, D adopted effective May 1, 2023 (50:8 Md. R. 337) Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187) Regulation .05 amended effective January 6, 2025 (51:26 Md. R. 1187) Regulation .06 amended effective June 14, 2021 (48:12 Md. R. 473); May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187) In this chapter, the following terms have the meanings indicated. Terms Defined. “CMS” means Centers for Medicare and Medicaid Services. “Continuous ambulatory peritoneal dialysis (CAPD)” means a dialysis treatment method performed manually during the day by patient in which the patient’s peritoneal membrane is used as a dialyzer. “Continuous cycling peritoneal dialysis (CCPD)” means a dialysis treatment method performed automatically during the night with a peritoneal dialysis cycler in which the patient’s peritoneal membrane is used as a dialyzer. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Dialysis” means a treatment method in which waste products are removed from the body by diffusion from one fluid compartment to another across a semi-permeable membrane. “Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Board of Dietetic Practice to practice dietetics in Maryland. “Free-standing dialysis facility” means a dialysis unit capable of providing staff-assisted dialysis, which is not located in an acute hospital setting. “Hemodialysis” means a dialysis treatment method in which blood passes through an artificial kidney machine and the waste products diffuse across a manmade membrane into a bath solution known as dialysate after which the cleansed blood is returned to the patient’s body. “Home dialysis” means hemodialysis or peritoneal dialysis performed regularly in the home with the assistance of a family member or the patient’s caregiver. "Home dialysis training” means instructions on how to perform dialysis services in a home setting. “Licensed practical nurse (LPN)” means an individual licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family or provider. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Nurse practitioner” means an individual who is licensed and certified to practice as a nurse practitioner as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. “Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Patient care policies” means written policies and protocols describing patient care practices and procedures established by a group of professional personnel (including one or more physicians affiliated with the free-standing dialysis facility) and approved in writing by the facility's medical director. “Peritoneal dialysis” means a dialysis treatment method in which waste products pass from the patient’s body through the peritoneal membrane into the peritoneal cavity where the bath solution (dialysate) is introduced and removed periodically. “Physician” means an individual who is authorized under the Maryland Medical Practice Act to practice medicine in this State as stated in Health-General Article §1-101, Annotated Code of Maryland. “Physician assistant” means an individual who is licensed to practice medicine with physician supervision as stated in Health Occupations Article, §§15-301(d) and (e) and 15-302, Annotated Code of Maryland. “Plan of care” means a written plan for evaluation, treatment, and follow-up of each participant documented in the participant’s medical record that should include, at a minimum, the following information: Patient identification data; Date of service; Reason for visit; Medical history; Plan for treatment; Results of all laboratory tests ordered and performed; and Interpretation of all diagnostic radiology procedures ordered and performed. “Program” means the Maryland Medical Assistance Program. “Registered nurse (RN)” means an individual licensed to practice registered nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. “Social worker” means a person who is licensed as a social worker in accordance with COMAR 10.42.01.05. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. A physician providing services in a free-standing dialysis facility shall be licensed and legally authorized to practice medicine in the state in which the service is provided. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02, or other applicable standards established by the state in which the service is provided. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or COMAR 10.10.06, as applicable; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. Specific requirements for participation in the Program as a free-standing dialysis facility include all of the following: Be approved by Medicare to furnish dialysis service to kidney disease patients and maintain documentation of certification by the Division of Survey and Certification of CMS. Verify the licenses and credentials of all professionals employed by, or under contract with, the free-standing dialysis facility to provide services. Meet the requirements of COMAR 10.30.01.05C, for a dialysis facility, home dialysis unit, or self-care dialysis facility, or all of the above. Have clearly defined, written, patient care policies. Maintain adequate documentation of each participant visit, as part of the plan of care, which, at a minimum, shall include: Date of service; Participant’s reason for visit; A brief description of service provided; A legible signature and printed or typed name of professional providing care, with the appropriate title. Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01. Maintain adequate administrative and medical records which are defined as having documentation sufficient in quantity, scope, and detail to confirm that the free-standing dialysis facility services are provided in accordance with this regulation. Not employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Medical Assistance participants. Be approved by the Medical Assistance Program in the state in which the service is provided. The Program covers medically necessary services described in §B of this regulation, rendered to participants in a free-standing dialysis facility, when these services are: Performed by a physician or by one of the following: A physician assistant; A nurse practitioner; An RN; An LPN; A social worker; or A dietitian-nutritionist; Provided by a non-physician listed in §A(1) of this regulation, when the following conditions are met: The individual performing the service is in the employ of, or under contract with, the free-standing dialysis facility; The individual performing the service is under a physician's direct supervision or written direction; The individual performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of the physician's services; and The services are provided according to the free-standing dialysis facility physician's written plan of care; Curative or rehabilitative services, when clearly related to the participant’s individual needs; Adequately described in the participant’s medical record and consistent with the physician’s written plan of care. Covered services include: Dialysis services furnished on an outpatient basis and provided by a free-standing dialysis facility, to include hemodialysis, peritoneal dialysis, CAPD, CCPD, and home dialysis training; and Laboratory tests, supplies, and prescription drugs as related to dialysis services. The Program does not cover the following: Services not specified in Regulation .04 of this chapter; Services not medically necessary; Investigational and experimental drugs and procedures; Drugs and supplies which are acquired at no cost; Injections and visits solely for the administration of injections, unless both the participant’s inability to take oral medications and medical necessity for the injections are documented in the participant’s medical record; Travel expenses; Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service; Laboratory or X-ray services performed by another facility; Completion of forms and reports; Broken or missed appointments; and Professional services rendered by mail or telephone. Reimbursement Principles. Reimbursement by the Program is for services described in Regulation .04B of this chapter provided at a free-standing dialysis facility which has been approved for Medicare by the Division of Survey and Certification of CMS. Reimbursement shall be consistent with the rates established by the Program for those services which are approved by Medicare. Physician services are not reimbursed under this regulation. Reimbursement for physician services are in accordance with COMAR 10.09.02.07. The provider shall submit a request for payment on the form designated by the Department. The Program reserves the right to return to the provider, any invoice that is not properly completed. A provider shall bill the program the established Medicaid rate for dialysis services. Payments on Medicare claims are authorized if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; Medicare has determined that the services are medically necessary; Services are covered by the program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department will make supplemental payment on Medicare claims subject to the following provisions: Deductible and coinsurance are to be paid in full; and Services not covered by Medicare are payable according to §D of this regulation. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail or telephone; or Home visits unless satisfactorily documented as an emergency. The Program will make no direct payment to a participant. The Program will make no separate direct payment to any person employed by or under contract to any free-standing dialysis facility for services covered under this regulation. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. If the participant has insurance or if any other person is obligated either legally or contractually to pay for, or to reimburse for, any service covered by this chapter, the provider shall seek payment from that source. If payment is made by both the Program and by the insurace or other source, the provider shall refund the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with all applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Recovery of overpayments as specified in Regulation .07 of this chapter; Withholding part or all of the payment by the Program; Suspension from the Program; Permanent removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action. The Department shall give to the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department shall: Establish the: Effective date of the proposed action; and Reasons for the proposed action; and Advise the provider of the right to appeal. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services which are provided without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: December 2, 1985 (12:24 Md. R. 2348) Regulation .01B amended effective February 17, 2014 (41:3 Md. R. 201) Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03B amended effective February 17, 2014 (41:3 Md. R. 201) Regulation .04B amended effective February 17, 2014 (41:3 Md. R. 201) Regulation .05 amended effective February 17, 2014 (41:3 Md. R. 201) Regulation .07 amended effective February 17, 2014 (41:3 Md. R. 201) Regulation .07G amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07J amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07J amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .09C adopted effective January 24, 2011 (38:2 Md. R. 84) Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84) Chapter revised effective March 26, 2018 (45:6 Md. R. 319) In this chapter, the following terms have the meanings indicated. Terms Defined. “American Academy of Pediatric Dentists” means the membership organization representing the specialty of pediatric dentistry. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program or its designee. “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means comprehensive and preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other diagnostic and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses in children younger than 21 years old. “EPSDT periodicity schedule” means the State-specified listing of the minimum required and recommended preventive health screening services that are to be performed at specified ages. “EPSDT screen” means the full scope of comprehensive well-child screening procedures, required by the State periodicity schedule that a participant receives at a given age. “EPSDT screening provider” means a physician, nurse practitioner, or physician assistant certified by the Department to provide EPSDT screens. “EPSDT treatment provider” means a health care provider that is enrolled to provide services that are not otherwise covered for individuals 21 years old or older. “EPSDT treatment services” means health care services that are covered for children younger than 21 years old that are not otherwise covered for individuals 21 years old or older. “Environmental lead investigation” means an inspection of the primary dwelling of a participant that results in a report characterizing the hazards associated with identified lead-containing substances. Foster Care Child. “Foster care child” means a participant who is in the care and custody of the Department of Human Services. “Foster care child” includes children who receive kinship care. “Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, or under the laws of the District of Columbia or another state, to provide health care services. “Health care service” has the meaning stated in Health-General Article, §19-132, Annotated Code of Maryland. “Healthy Kids Program” means the unit within the Maryland Medical Assistance Program that develops guidelines for and monitors EPSDT well-child screening services and certifies EPSDT screening providers. “Intermediate care facility” means a facility that provides a planned regimen of 24-hour professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting. “Jurisdiction” means a state or the District of Columbia. “Managed Care Organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Participant” means a person younger than 21 years old who is determined eligible for, and is receiving, Medical Assistance benefits as provided in COMAR 10.09.11 or 10.09.24. “Plan of treatment” means a written plan, updated at a minimum of every 6 months for ongoing care, to address identified problems to include: Diagnoses; Treatment goals; Frequency of visits; Duration of treatment; and Prognosis. “Preauthorization” means the approval required from the Department or its designee before services can be rendered. “Preventive services” means primary health care designed to: Promote normal growth and development; and Detect, ameliorate, or delay diseases at an early stage before complications or serious disabilities develop. “Program” means the Maryland Medical Assistance Program. “Screening services” means the EPSDT preventive health care and laboratory procedures required at specified ages by the State periodicity schedule. “Third-party payers” means insurers and other entities obligated either legally or contractually to pay for or to reimburse the participant for service covered in this chapter. “Vaccines for Children Program” means the federal program that provides specific childhood vaccines to health care providers, at no cost, for administration to participants younger than 19 years old. The Audiology, Physical Therapy, and Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual (Maryland Medical Assistance Program, Effective January 1, 2022) is incorporated by reference. EPSDT screening and treatment providers shall meet all of the licensure and certification requirements specified in this or any other applicable chapter of COMAR, statute, or policy for the service that the provider renders. In order for the Program to consider a health care practitioner for certification by the Healthy Kids Program as an EPSDT screening provider, the practitioner shall have a demonstrated history of providing services to children younger than 21 years old and shall also: Be a doctor of medicine or osteopathy who is: Licensed in good standing and legally authorized to practice medicine and surgery in the jurisdiction in which the service is provided; and Board-certified in one of the following: Pediatrics; Family practice; or Internal medicine; or Be a pediatric or family nurse practitioner or a physician assistant who is licensed in good standing and certified to practice in the jurisdiction in which services are provided. A freestanding clinic as defined in COMAR 10.09.08 shall be considered for certification by the Healthy Kids Program as an EPSDT screening provider if the clinic employs or contracts with one or more of the licensed health care practitioners listed in §B of this regulation. Any health care practitioner whose professional services are recognized in §1905(a) of the Social Security Act may apply to the Program to be an EPSDT treatment provider. EPSDT treatment providers that are covered by the Program include: The following provider types that are licensed in good standing to practice in the jurisdiction in which services are provided: Chiropractors; Nurse psychotherapists; Nutritionists or dietitians; Occupational therapists; Professional counselors; Psychologists; Social workers; Speech therapists; or An intermediate care facility that provides at least one of the following: Clinically managed high intensity residential treatment; and Medically monitored intensive inpatient treatment; Lead paint risk assessors who are accredited by the Maryland Department of the Environment in accordance with COMAR 26.16.01.16; Audiologists and hearing aid providers, as specified in COMAR 10.09.51.02; Dentists as specified in COMAR 10.09.05.02; Private duty nurses, as specified in COMAR 10.09.53.02; Residential treatment centers, as specified in COMAR 10.09.29.02; Therapeutic behavioral service providers, as specified in COMAR 10.09.34.02; and Vision care and optical providers, as specified in COMAR 10.09.14.02. Therapeutic nursery service providers, as specified in COMAR 10.21.18.03. In order to qualify as an EPSDT treatment provider, an intermediate care facility shall: Be licensed under COMAR 10.63.03 or certified under COMAR 10.47.02, whichever is appropriate; and If appropriate, provide separate social, residential, dietary, and recreational activities for children and adolescents. In order to receive payments as a Medicaid provider, providers shall meet the following general requirements: All conditions for participation set forth in COMAR 10.09.36; If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department; The licensure and provider qualification requirements in Regulation .02 of this chapter; and Verify the licenses and credentials of all professionals employed or contracted by the provider, and keep on file documentation of how that verification was completed. To be certified to participate in the Healthy Kids Program as an EPSDT screening provider, a provider shall agree to: Provide EPSDT comprehensive well-child services as outlined in the EPSDT periodicity schedule and in a manner prescribed by the Department; Provide or arrange for referral, diagnosis, treatment, and follow-up when the screening indicates a need for additional services; Inform the parent or guardian of the next preventive health care visit, and assist with scheduling; Cooperate with Departmental efforts to assure that children receive needed follow-up and treatment services; Conform to the equipment, facilities, and procedural standards set by the Department; Maintain a patient record system that is sufficiently detailed and current to allow another physician who is unfamiliar with the patient to properly continue treatment in the absence of the initial provider; Participate in the Vaccines for Children Program; Permit periodic on-site quality assurance visits by the Department or its designee following a protocol established by the Department to: Assure that the equipment necessary to perform required procedures is available; Review the charts of participants to assure delivery of EPSDT screens; Determine that required procedures are being performed correctly and that appropriate follow-up is provided; and Assess the need for any follow-up provider training, staff training, technical assistance, or in-service training; and Maintain a minimum score of 80 percent on all Healthy Kids Program quality assurance reviews. An MCO that has contracted with the Department shall ensure its enrollees have access to EPSDT comprehensive well-child services in accordance with COMAR 10.67.05.05A(3). The Program covers all medically necessary care, including all health care services to identify and correct physical and mental problems that are covered in the State Plan, or that are allowable under the federal Medicaid program as described in §1905(a) of the Social Security Act. For a foster care child, the Program also covers upon entry to or moving within the foster care system: A brief initial check-up; and A comprehensive EPSDT screen as described in §C of this regulation. The Program covers EPSDT comprehensive well-child services in accordance with the EPSDT periodicity schedule, which includes the following: EPSDT screening services which comprise the following: A comprehensive health and developmental history, including assessment of both physical and mental health and development; Age-appropriate immunizations; Age and risk appropriate laboratory tests, including blood lead levels that are required at specific ages regardless of risk; Comprehensive unclothed physical examination; and Health education and anticipatory guidance; Vision services that comprise: Vision screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule; Vision screening and vision services delivered by optometrists and opticians, including eyeglasses, as described in COMAR 10.09.14.04; Hearing services that comprise: Hearing screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule; and Hearing screening and hearing aid services, as described in COMAR 10.09.51.04; and Dental services, including: Oral health assessment by the EPSDT screening provider and referral to a dentist; and Dental services, as specified in COMAR 10.09.05.04. Additional Medically Necessary Plan of Treatment Services. The Program also covers the EPSDT treatment services listed in §D(2) of this regulation when the services are: Necessary to identify, correct, or ameliorate defects and physical and mental illnesses and conditions; Rendered in accordance with accepted professional standards; and Delivered in accordance with a plan of treatment. EPSDT services covered under §D of this regulation include: Chiropractic services; Mental health services or behavioral health services, or both, when the diagnosis of a participant is not included under the specialty mental health system, as described in COMAR 10.67.08.02; Nutritional counseling services; Occupational therapy services; Speech therapy services; Medically monitored intensive inpatient treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.14, whichever is applicable; Clinically managed high intensity residential treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable; Environmental lead investigations, as specified in COMAR 26.16.02.04 and .05 when there is a confirmed elevated blood lead level of the lower of the following values: 3.5 micrograms or greater per deciliter, the current Maryland elevated blood lead level; or The Centers for Disease Control and Prevention blood lead reference value; Private duty nursing services, as specified in COMAR 10.09.53.04; Residential treatment services, as specified in COMAR 10.09.29.04; and Therapeutic behavioral services, as specified in COMAR 10.09.34.03. Any Program limits on services or treatments identified in this regulation are not applicable for individuals younger than 21 years old if it is shown that the treatments or services are medically necessary to correct or ameliorate identified or suspected health problems. The dental covered services specified in COMAR 10.09.05.04, which follow the periodicity schedule issued by the American Academy of Pediatric Dentists, are limited to two dental examinations per participant per 12-month period. Vision services specified in COMAR 10.09.14.04, including eye examinations and eyeglasses or contact lenses, are limited to not more than once a year. Environmental lead investigations: Are limited to the child's primary dwelling; Are limited to one on-site inspection per dwelling; and Do not include testing of any substances sent to a laboratory for analysis. The provider covered by this chapter may not bill the Program for: Services that are: Provided while the participant is in an institution for mental disease, a hospital, or a residential treatment center, as bundled payment for institutional stays includes EPSDT services; Custodial or assist with activities of daily living; Not medically necessary; Beyond the provider's scope of practice; Rendered but not appropriately documented; Part of another service paid for by the State; or Rendered not in person, unless the services are provided in compliance with COMAR 10.09.49 and any subregulatory guidance issued by the Department; Respite services; Completion of forms or reports; Broken or missed appointments; Supplies, equipment, or items that are not medical in nature; or Services that are primarily cosmetic in nature. Preauthorization is required for: Certain audiology and hearing aid services, as specified in COMAR 10.09.51.06; Certain dental services, as specified in COMAR 10.09.05.06; Certain vision services, as specified in COMAR 10.09.14.06; Private duty nursing services, as specified in COMAR 10.09.53.06; Residential treatment services, as specified in COMAR 10.09.29.06; Therapeutic behavioral services, as specified in COMAR 10.09.34.05; and Intermediate Care Facilities, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable. Request for payment of services shall be submitted in accordance with COMAR 10.09.36.04. Billing time limitations for claims submitted pursuant to this chapter as set forth in COMAR 10.09.36.06. Rates for services provided by chiropractors, speech therapists, occupational therapists, and nutritionists covered under this chapter are included in the Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual. Reimbursement of Medically Monitored Intensive Inpatient Treatment Services Provided in an Intermediate Care Facility. The Department may not directly reimburse any State-operated intermediate care facility for participants. The Department shall claim federal fund recoveries from the Department of Health and Human Services for services to federally eligible Title XIX patients in these intermediate care facilities. The Department shall pay the intermediate care facility the lesser of: The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or The provider’s per diem costs for covered services according to the principles established under Title XVIII of the Social Security Act, up to a maximum of $400 per day. The maximum payment in §D(2)(b) of this regulation will be updated annually by the Centers for Medicare and Medicaid Service’s published federal fiscal year market basket increase percentage relating to hospitals excluded from the prospective payment system. Submitting Cost Reports. Facilities reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413.40, as amended, shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. If reports are not received within 3 months and the Department has not granted an extension, the Department shall withhold from the provider a maximum of 10 percent of the current interim payment for the calendar month in which the report is due and any subsequent calendar month until the report has been submitted. There may not be a refund or adjustment for withholding in cost settlement. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Department may grant an extension if: The provider makes a written request setting forth the specific reasons for the request; and The Department determines, taking into consideration the totality of the circumstances, that the request is reasonable. If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, and the provider has not received an extension, the Department, in addition to withholding percentages of payment pursuant to §D(3)(a) of this regulation, may impose one or more sanctions as provided for in Regulation .09 of this chapter. If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department, if applicable, shall make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established may not exceed the maximum per diem rates in effect when the facility's costs were last settled. For purposes of §D(3)(a)—(e) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department. Participant’s Contribution. The local department of social services or the State-operated facility’s fiscal agent shall determine the amount the participant has available to pay toward the cost of medical or remedial care for inpatient services, and so inform the provider. The provider shall collect from the participant that amount as shown available on the designated form. The provider may not collect a total amount, including the participant’s resource and the Department’s payment, which exceeds the provider’s rate established by the Department. The provider shall show to the Department sums collected from the participant. Reimbursement for environmental lead investigation is $333.29 per inspection. Reimbursement for services covered in Regulation .04 of this chapter shall be the lower of the provider's charge for the service, or the Program's fee schedule. Regardless of whether the participant has other third-party insurance coverage, EPSDT screening providers shall bill the Program directly for the following components of an EPSDT screen: Comprehensive unclothed physical examinations; Immunizations when the vaccine is not covered by the Vaccines for Children Program; Vaccine administration; and Objective screenings for: Developmental assessment; Hearing; and Vision. Upon submission of a claim for a EPSDT screening component, as described in §A of this regulation, the Department shall pursue third-party reimbursement when appropriate. Recovery and reimbursement for all other services in the chapter are set forth in COMAR 10.09.36.07. Cause for suspension or removal and impositions of sanctions are as set forth in COMAR 10.09.36.08. If during a quality assessment, the Department staff determines that the provider does not meet the standards established by the Department, the Department may decertify the provider as an EPSDT screening provider. Appeal procedures are as set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: January 1, 1983 (9:25 Md. R. 2483) Regulation .01 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .01B amended effective March 12, 1984 (11:5 Md. R. 463); October 1, 1985 (12:19 Md. R. 1849) Regulation .04A amended effective September 10, 1984 (11:18 Md. R. 1584) Regulation .04B amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .05 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .05B amended as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); amended permanently effective May 1, 1983 (10:7 Md. R. 634) Regulation .06 amended effective October 1, 1985 (12:19 Md. R. 1849); March 20, 1989 (16:5 Md. R. 629) Regulation .06A amended effective October 29, 1984 (11:21 Md. R. 1814) Regulation .07 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .07A-1 adopted effective February 13, 1984 (11:3 Md. R. 200) Regulation .07D amended effective October 1, 1985 (12:19 Md. R. 1849) Regulation .08 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .08F amended and .08G-1 adopted effective September 10, 1984 (11:18 Md. R. 1584) Regulation .08F amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulations .08F, J and .09A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); Regulation .08F, J amended permanently effective October 7, 1991 (18:18 Md. R. 2004) (Regulation .09A not amended permanently at this time—emergency status expired October 6, 1991) Regulation .08I amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .08J amended effective May 1, 1983 (10:8 Md. R. 725); February 13, 1984 (11:3 Md. R. 200); October 29, 1984 (11:21 Md. R. 1814); October 1, 1985 (12:19 Md. R. 1849) Regulation .08J amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 Regulation .08J amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .08L amended effective October 29, 1984 (11:21 Md. R. 1814) Regulation .09A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .11 amended effective June 6, 1983 (10:11 Md. R. 974); March 20, 1989 (16:5 Md. R. 629) Table 1 amended effective February 13, 1984 (11:3 Md. R. 200); June 3, 1985 (12:11 Md. R. 1049) Table 2A adopted as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); adopted permanently effective May 1, 1983 (10:7 Md. R. 634) Tables 1, 2, and 2A repealed effective March 20, 1989 (16:5 Md. R. 629) Table 3 recodified as Table 1 effective March 20, 1989 (16:5 Md. R. 629) Chapter revised effective July 19, 1993 (20:14 Md. R. 1169) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .07A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .08 amended effective June 21, 2004 (31:12 Md. R. 911) Regulations .01—.13 repealed and new Regulations .01—.12 adopted effective March 22, 2010 (37:6 Md. R. 477) Regulation .01B amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .01-1 adopted effective February 27, 2017 (44:4 Md. R. 253) Regulation .01-1 amended effective December 31, 2018 (45:26 Md. R. 1243); August 26, 2019 (46:17 Md. R. 726); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681) Regulation .02B, E amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .02E amended effective December 27, 2010 (37:26 Md. R. 1787); August 26, 2019 (46:17 Md. R. 726) Regulation .02F adopted effective December 31, 2018 (45:26 Md. R. 1243) Regulation .03A, B amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .03B amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .04D amended effective December 27, 2010 (37:26 Md. R. 1787); October 26, 2015 (42:21 Md. R. 1300); July 3, 2017 (44:13 Md. R. 621); December 31, 2018 (45:26 Md. R. 1243); August 7, 2023 (50:15 Md. R. 681); March 16, 2026 (53:5 Md. R. 243) Regulation .05B amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .05D amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .05E amended effective July 4, 2016 (43:13 Md. R. 712); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681) Regulation .06G adopted effective February 16, 2015 (42:3 Md. R. 315) Regulation .06G amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .07C amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .07C, E amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .07D amended effective September 30, 2013 (40:19 Md. R. 1544); February 1, 2016 (43:2 Md. R. 127); September 26, 2016 (43:19 Md. R. 1072); August 7, 2023 (50:15 Md. R. 681) Regulation .08A amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .12 repealed effective October 27, 2014 (41:21 Md. R. 1259) This chapter governs the determination of eligibility for the Maryland Medical Assistance Program. Eligibility may be established for the following coverage groups: The MAGI coverage groups whose income standard is based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014; and The MAGI Exempt coverage groups whose income standard is based on Title XIX of the Social Security Act. In this chapter, the following terms have the meanings indicated. Terms Defined. “Aged” means a person who is 65 years old or older. “Aid to the Permanently and Totally Disabled” means a former category of public assistance mandated under Title XIV of the Social Security Act, 42 U.S.C. §1351 et seq., and replaced by Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. “Appeal” means a process by which an applicant, recipient, or representative obtains review of a decision, action, or inaction of the Department or the local department of social services. “Applicant” means a person whose written application for Medical Assistance has been submitted to the local department of social services but has not received final action. This includes a person, who need not be alive at the time of application, whose application is submitted through a representative. “Application” means the filing of a written and signed application form for Medical Assistance at the local department of social services or its designee. “Application date” means the date on which a written, signed application is received by the local department of social services. “Application form” means the form designated by the Department to be completed, signed, and submitted to the local department of social services, or a designee, as an official application for Medical Assistance. “Assistance unit” means one person, or a group of persons whose eligibility for Medical Assistance benefits is determined in conjunction with each other. “Blindness” means a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of no greater than 20 degrees. Caretaker Relative. “Caretaker relative” means a parent or other person related by blood, marriage, or adoption and living with and caring for an unmarried child younger than 21 years old who is deprived of parental support due to death, continued absence from the home, incapacitation of a parent, or unemployment of the principal wage earner parent. A parent whose absence is occasioned solely by reason of the performance of active duty in the uniformed service of the United States is not considered absent from the home. The following relatives and their spouses meet this definition: father, mother, brother, sister, stepfather, stepmother, stepbrother, stepsister, uncle, aunt, first cousin, nephew or niece, and persons of preceding generations as denoted by the prefix of grand, great, and great-great; persons who legally adopt a child or his parent as well as the natural and other legally adopted children of these persons; and other relatives of adoptive parents in accordance with State law. A caretaker relative retains his status as a caretaker relative when the only child or children in his custody receives SSI benefits. This is the only instance when a caretaker relative without children in an assistance unit qualifies as a caretaker relative. “Continued absence from the home” means that the parent is out of the home, the nature of the absence either interrupts or terminates the parent's functioning as a provider of maintenance, physical care, or guidance for the child, and the known or indefinite duration of the absence precludes counting on the parent's performance of his function in planning for the present support or care of the child. “Incapacitation” means that a parent has a mental or physical defect, illness, or impairment which eliminates the parent's ability to support or care for the child and is expected to last for a period of at least 30 days. “Principal wage earner parent” means whichever parent, in a home in which both parents of a child are living, earned a greater amount of income in the period specified below: For initial eligibility, the 24 months immediately preceding the month in which application is filed on the basis of the unemployment of a parent; For eligibility for each subsequent month of the certification period, the 24 months immediately preceding the current month. Unemployed Parent. “Unemployed parent” means the principal wage earner parent who: Has been unemployed for at least 30 days before the receipt of Medical Assistance; and Has not left a job or refused to seek or accept employment without good cause within 30 days of the date of application. The condition of unemployment is met when the parent is employed less than 100 hours per month; or is employed 100 hours or more per month, if the parent's work is intermittent and the excess hours are of a temporary nature, as evidenced by the fact that the work hours were under the standard for the two previous months and are expected to be under the standard during the next month. “Carrier” means a: Health insurer; Non-profit health service plan; Health maintenance organization; Dental plan organization; and Any other person included as a third party in Section 1902(a)(25)(A) of the Social Security Act, as amended by the Federal Deficit Reduction Act of 2005. “Categorically needy” means aged, blind, or disabled persons, or families and children, who are otherwise eligible for Medical Assistance and who meet the financial eligibility requirements for FIP, SSI, or Optional State Supplement. “Child” means an unmarried person younger than 21 years old. “Chronic hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. “Comprehensive care facility” means a nursing facility licensed as a comprehensive care facility pursuant to COMAR 10.07.02. “Continuing care retirement community (CCRC)” means an entity that obtains certificate of registration issued by the Maryland Department of Aging in accordance with COMAR 32.02.01 and pursuant to its authority under Article 70B, Annotated Code of Maryland. “Corrective Managed Care Program” means the program administered by the Division of Utilization and Eligibility Review of the Medical Care Compliance Administration which limits recipients who have abused or misused Medical Assistance benefits to access most covered services through a single primary medical provider and a single pharmacy. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program. “Department of Human Services” means the department of State government which administers the FIP program. “Determination” means a decision regarding an applicant's eligibility for Medical Assistance. “Disabled” means the inability to perform any substantial gainful activity by reason of a medically determinable physical or mental impairment which can be expected to result in death, or which has lasted or can be expected to last for a continuous period of not less than 12 months. “Eligibility technician” means an employee of the local department of social services responsible for determining eligibility of applicants and recipients. “Emergency services” means services provided by a licensed medical practitioner after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in: Placing health in jeopardy; Serious impairment to bodily functions; Serious dysfunction of any bodily organ or part; or Development or continuance of severe pain. “Entrance fee” means a sum of money or other consideration, other than a surcharge that: Is paid by a resident to a CCRC initially or in deferred payments, pursuant to a written continuing care agreement between the CCRC and the resident, which governs the use, treatment, and refund of the entrance fee; Assures a resident of continuing care in the CCRC facility for a term of more than 1 year or for life; and Is at least three times the weighted average of the monthly cost of the periodic fees charged to independent living and assisted living units. “Extended care facility” means a nursing facility licensed as an extended care facility pursuant to COMAR 10.07.02. “Family Investment Program (FIP)” means a category of public assistance mandated under Title IV-A of the Social Security Act, 42 U.S.C. §601 et seq. “Guardian of the person” means a guardian appointed by a court pursuant to Estates and Trusts Article, Title 13, Subtitle 7, Annotated Code of Maryland, to serve the interests of a minor or disabled person under that subtitle. “Guardian of the property” means a guardian appointed by a court pursuant to Estates and Trusts Article, Title 13, Subtitle 2, Annotated Code of Maryland, to serve the interests of a minor or disabled person under that subtitle. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or is licensed according to applicable standards established by the state in which the hospital is located. Income. “Income” means any property or service received by a person in cash or in-kind which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. “Earned income” means payment received by a person in cash or in-kind as a result of employment, including self-employment. Earned income consists of wages, salaries, commissions, tips, and profit from self-employment. “In-kind income” means support or benefits in the form of food or shelter, or both, received by a person. “Unearned income” means all income which does not meet the definition of earned income. “Family Investment Administration” means the administrative unit of the Department of Human Services and its affiliated local departments responsible for determining an applicant's or recipient's eligibility for Public Assistance, Medical Assistance, and Medical Assistance, State-Only. “Incurred medical expenses” means those paid or unpaid bills for medical care which are recognized under State law and are or will be the obligation of the applicant. “Intermediate care facility” means a nursing facility which meets the standards for certification and participation in Title XIX and has entered into a provider agreement with the Department pursuant to COMAR 10.09.11. “Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID)” means a nursing facility for the intellectually disabled which meets the standards for certification and participation in Title XIX and has entered into a provider agreement with the Department pursuant to COMAR 10.09.11. “Living together” means sharing a common household. “Local department of social services (LDSS)” means the Baltimore City or a county social services department under the supervision of the Department of Human Services. “Long-term-care facility” means a skilled nursing facility, intermediate care facility, intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID), chronic hospital, tuberculosis hospital, or mental hospital. “Mandatory State Supplement” means a cash payment a state is required to make under Section 212, P.O. 93-66 to an aged, blind, or disabled person to provide him with the same amount of cash assistance he was receiving under Old Age Assistance, Aid to the Permanently and Totally Disabled, or Public Assistance to the Needy Blind if his SSI payment is less than that amount. “Maryland Medicaid Managed Care Program” means the Medicaid reform program established under COMAR 10.67.01—.10, as authorized by Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland. “Medicaid” means Medical Assistance provided under the State Plan approved under Title XIX of the Social Security Act. “Medical Assistance (MA)” means the program administered by the State under Title XIX which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons. “Medical Care Compliance Administration” means the administrative unit of the Department responsible for ensuring that health care services provided to recipients are appropriate and effectively utilized. “Medical Care Operations Administration” means the administrative unit of the Department responsible for maintaining a file of all eligible persons and paying providers of service. “Health Systems Financing Administration” means the administrative unit of the Department responsible for establishing regulations, policies, and procedures for the Medical Assistance program. “Medical institution” means an institution that: Is organized to provide medical care, including nursing and convalescent care; Has the necessary professional personnel, equipment, and facilities to manage the medical, nursing, and other health needs of patients on a continuing basis in accordance with accepted standards; Is authorized under State law to provide medical care; and Is staffed by professional personnel who are responsible to the institution for professional medical and nursing services. “Medically needy” means persons who are otherwise eligible for Medical Assistance, who are not categorically needy, and whose income and resources are within the limits set under the State Plan. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 et seq. “Mental hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.04. “Migrant worker” means a person who moves from place to place to harvest or process seasonal crops. “Old Age Assistance” means a former category of public assistance mandated under Title I of the Social Security Act, and replaced by Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. “One-time-only” means a time-limited certification. “Optional State Supplement” means a cash payment made by a state to an aged, blind, or disabled person, under §1616 of the Social Security Act. “Period under consideration” means the specified months which are assessed for determination of eligibility. “Postpartum period” means the period of time beginning on the date a pregnancy ends and ending on the last day of the 12th month following the end of pregnancy. “Public Assistance” means cash assistance payments, including state supplementary payments, made to persons who are eligible for programs administered under Title IV-A or Title XVI of the Social Security Act. “Public Assistance to the Needy Blind” means a former category of public assistance mandated under Title X of the Social Security Act and replaced by Title XVI of the Social Security Act, 42 U.S.C. §§1381 et seq. Public Institution. “Public institution” means an institution that is the responsibility of a governmental unit or over which a governmental unit exercises administrative control. “Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more persons unrelated to the proprietor. “Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves no more than 16 residents. Publicly Operated Community Residence that Serves No More Than 16 Residents. “Publicly operated community residence that serves no more than 16 residents” means a facility that is publicly operated, serves no more than 16 residents, and offers services beyond food and shelter. “Publicly operated community residence that serves no more than 16 residents” does not mean: Residential facilities located on or adjacent to any large institution or multipurpose center; Educational or vocational institutions that primarily provide an approved or accredited program to some or all of their residents; Medical treatment facilities which provide medical care or remedial service on an inpatient basis; or Correctional or holding facilities which provide for persons who are prisoners, have been arrested or detained, or are held under court order as material witnesses or juveniles. “Qualified alien” means an alien who: Has been fully admitted for permanent residence under the Immigration and Nationality Act (INA); Has been granted asylum under §208 of the INA; Has been admitted into the United States as a refugee under §207 of the INA; Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year; Has had deportation withheld under §243(h) of the INA; or Has been granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980. “Recipient” means a person who is certified as eligible for Medical Assistance. “Redetermination” means a determination regarding continuing eligibility of a recipient. “Remedial service” means any service, other than a physician's service, provided within the scope of practice as defined by State law by a person licensed as a practitioner under State law. “Resources” means accumulated personal wealth over which a person has the authority or power to liquidate his interest, including cash savings, savings accounts, certificates of deposit, money market certificates, checking accounts, stocks, bonds, cash value of life insurance, burial plots, prepaid burial plans, real property, personal property, mortgages, and mutual funds. “Retroactive coverage” means the availability of coverage for incurred medical expenses covered under the State Plan for a period not to exceed 3 months before the month of application. “Skilled nursing facility” means a nursing facility which: Is licensed as a comprehensive care facility (SNF/CCF), or as an extended care facility (SNF/ECF), or both; Meets the requirements for certification and participation in Title XIX of the Social Security Act as a skilled nursing facility; and Has entered into a provider agreement with the Department pursuant to COMAR 10.09.10. “Social Security Administration” means the administrative unit in the United States Department of Health and Human Services responsible for administering programs under Titles II, IV-A, IV-D, and XVI of the Social Security Act. “Spend-down” means a procedure by which an applicant who is ineligible for Medical Assistance due to excess income becomes eligible by deducting incurred medical expenses from excess income. “Spouse” means a person who has been determined to be the husband or wife of another person under State law or for the purposes of determining eligibility for Social Security benefits. “State Plan” means a comprehensive written commitment by a Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of a medical assistance program in accordance with federal requirements. “Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §§1381 et seq. “Third party” means a person, institution, corporation, public or private agency or organization who is or may be liable to pay all or part of the medical cost of injury, disease, or disability of an applicant or recipient. “Title XIX” means the title of the Social Security Act, 42 U.S.C. §§1396 et seq., which governs establishment of a medical assistance program for low income persons. “Tuberculosis hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. In this chapter, the following terms have the meanings indicated. Terms Defined. “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). Authorized Representative” has the meaning stated in COMAR 10.01.04.12. “Designee” means any entity designated to act on behalf of the Department such as: Baltimore City or a county social services department under the supervision of the Department of Human Services; Baltimore City Health Department and its subgrantees, or a county health department; and The Maryland Health Benefit Exchange. “Insurance Affordability Program” means a program that is one of the following: The Maryland State Medicaid program; The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; An optional State basic health program established under §1331 of the Affordable Care Act; A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; and A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act. “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. “MAGI exempt coverage group” means a coverage group as described under Regulation .03 of this chapter whose eligibility is not determined by MAGI or by the Maryland Health Benefit Exchange. “Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program. The following individuals, including recipients of Temporary Cash Assistance, may be determined eligible for the MAGI coverage groups: Parents and other caretaker relatives whose household income is equal to or less than 123 percent of the federal poverty level; Pregnant and postpartum women of any age whose household income is equal to or less than 250 percent of the federal poverty level; Adults 19 years old or older and younger than 65 years old who are not entitled to or enrolled in Medicare Part A or Part B, whose household income is equal to or less than 133 percent of the federal poverty level, including adults living with dependent children who have provided minimum essential health care coverage for those children; Children younger than 21 years old and whose household income is equal to or less than 133 percent of the federal poverty level; and Former Foster Care individuals who: For individuals who turned 18 years old before January 1, 2023: Are younger than 26 years old; Are not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and Were formerly in a Maryland out-of-home placement, including categorical Medical Assistance, during the foster care period in which they either turned 18 years old or attained a higher age during extended out-of-home placement as described under COMAR 07.02.11.04B; and For individuals who turned 18 years old on or after January 1, 2023: Are younger than 26 years old; Are not enrolled for coverage under an eligibility group described in §1902(a)(10)(A)(i)(I)—(VII) of the Act; and Were formerly in an out-of-home placement in any state, including categorical Medical Assistance, during the foster care period in which they either turned 18 years old or attained a higher age during extended out-of-home placement as described under COMAR 07.02.11.04B. An individual receiving SSI, Mandatory State Supplement, or Optional State Supplement is eligible for the MAGI Exempt coverage groups without having to file a separate application and covered as Categorically Needy. Transitional Medical Assistance. If a family loses Medical Assistance solely because of increased income from employment of the caretaker relative as defined under Regulation .02B(10)(a) of this chapter, all members of the family shall be eligible for Medical Assistance during the immediately succeeding 12-month period if the parents or caretaker relatives were eligible for Medical Assistance under §A(5) of this regulation in 3 or more months of the 6-month period immediately preceding the month in which they became ineligible for Medical Assistance. Termination of Transitional Medical Assistance. Transitional Medical Assistance during the 12-month period described under §C(1) of this regulation shall terminate at the close of the first month in which the family ceases to include a child younger than 21 years old. Termination of assistance may not become effective until the Department has provided the family with notice of the grounds for the termination. Continuation in Certain Cases until Redetermination. With respect to a person who would cease to receive Medical Assistance under §C(2) of this regulation but who may be eligible for Medical Assistance under this chapter, the Department may not discontinue Medical Assistance until the Department has determined that the person is not eligible for Medical Assistance under this chapter. The following individuals may be determined eligible for a MAGI Exempt coverage group after filing a separate application for Medical Assistance and, if determined eligible, are covered as Categorically Needy: An individual who would be eligible for SSI, or Optional State Supplement benefits except for a requirement of those programs that is specifically prohibited under Title XIX. A person who in December, 1973, was eligible for Medical Assistance as an essential spouse. Medical Assistance will continue if this person: Continues to meet the December, 1973, criteria of the State's approved Old Age Assistance, Aid to the Permanently and Totally Disabled, or Public Assistance to the Needy Blind plans to be considered an essential spouse; and Lives with an aged, blind, or disabled spouse who continues to meet the December, 1973, criteria of the State's approved Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled plans. A person who in the month of December, 1973, was eligible for Medical Assistance and was an inpatient in a long-term care facility qualified to receive Medical Assistance payments, and, if not institutionalized, would have been eligible for Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled. Medical Assistance will continue if this person: Needed and received inpatient care continuously since December, 1973; Continues to need and receive inpatient care; and Continues to meet the eligibility criteria of the Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled plan for December, 1973. A person who: Meets all current requirements for Medical Assistance eligibility except the criteria for blindness or disability; Was eligible for Medical Assistance in December, 1973, as a blind or disabled person, whether or not he was receiving cash assistance in December, 1973; and For each consecutive month after December, 1973, continues to meet the criteria for blindness or disability and the other conditions of eligibility used under the Medical Assistance plan in December, 1973. The following individuals may be determined eligible for a MAGI Exempt coverage group after filing a separate application, and if determined eligible, are covered as Medically Needy: A pregnant woman who has been denied AFDC solely because her income or resources exceed the cash assistance level; A person younger than 21 years old; A caretaker relative (and spouse); An aged, blind, or disabled person; and A person who was eligible as Medically Needy in December, 1973, on the basis of the blindness or disability criteria of Aid to the Permanently and Totally Disabled or Public Assistance to the Needy Blind and who continues to meet current requirements except for blindness or disability criteria. Continuous Eligibility for Pregnant Women. The Department will provide Medical Assistance through the last day of the month in which the postpartum period ends for a pregnant woman who: Was eligible and enrolled under §A(2) of this regulation; and Because of a change in household income, will not otherwise remain eligible. Purpose. The purpose of Regulations .03-1 and .03-2 of this chapter is to exercise the State's option under Title XIX of the Social Security Act to create a new Medical Assistance optional categorically needy coverage group for women who need treatment for breast cancer, cervical cancer, or precancerous conditions, in accordance with the Breast and Cervical Cancer Prevention and Treatment Act of 2000 (Public Law 106-354). Applications submitted under Regulations .03-1 and .03-2 of this chapter shall no longer be accepted after December 31, 2013. An individual who has submitted an application in accordance with §A(1) of this regulation and who has been determined eligible will receive benefits under Regulations .03-1 and .03-2 of this chapter after December 31, 2013. Effective July 31, 2024, any individual who was previously covered under §A(3) of this regulation will no longer receive benefits under Regulations .03-1 and .03-2 of this chapter. Definitions. In Regulations .03-1 and .03-2 of this chapter, the following terms have the meanings indicated: “Applicant” means an individual whose application for the Medical Assistance eligibility under the women's breast and cervical cancer coverage group has been submitted to the Department or its authorized representative, but has not received final action. “Application date” means the date on which a written, signed application for Medical Assistance eligibility under the women's breast and cervical cancer coverage group is received by the Department or its authorized representative. “Breast and Cervical Cancer Diagnosis and Treatment Program” means the State-funded program of cancer diagnosis and treatment services, which is: Governed by COMAR 10.14.02; and Administered by the Department's Center for Cancer Surveillance and Control. “Cancer treatment services” means active medical treatment for breast cancer, cervical cancer, or a precancerous condition, not including palliative care. “Categorically needy coverage group” means a category of Medical Assistance eligibility defined at Regulation .03A of this chapter. “Creditable health insurance coverage” means having one or more of the following types of coverage: A group health plan; Health insurance coverage with medical care benefits provided directly or through insurance, reimbursement, or otherwise and including items and services paid for as medical care, under any: Hospital or medical service policy or certificate; Hospital or medical service plan contract; or Health maintenance organization contract offered by a health insurance issuer; Medicare Part A or Part B; Medical Assistance; Armed forces insurance; or A state health risk pool. “Enrollee” means a woman who is determined eligible and is receiving Medical Assistance benefits under Regulations .03-1 and .03-2 of this chapter. “Health professional” means a licensed physician or certified registered nurse practitioner. “Institutionalized person” has the meaning specified at Regulation .08B of this chapter. “Mandatory Medical Assistance categorically needy coverage group” means a Medical Assistance categorically needy coverage group which the federal government requires a state to cover under the State Plan, in accordance with the Code of Federal Regulations. “Maryland Breast and Cervical Cancer Screening Program” means the National Breast and Cervical Cancer Early Detection Program in Maryland which: Is funded by the State or federal government; Is administered by the Department's Center for Cancer Surveillance and Control through the local jurisdictions; and Has income and other eligibility requirements. “National Breast and Cervical Cancer Early Detection Program (NBCCEDP)” means the program of the Centers for Disease Control (CDC), established under Title XV of the Public Health Service Act. “Needs treatment” means that, according to a written certification by a health professional, the individual needs cancer treatment services, such as chemotherapy, radiation, or surgery. “Precancerous condition” means for: Cervical cancer, a condition diagnosed as cervical intra-epithelial neoplasia I, II, or III; or Breast cancer, a condition diagnosed as atypical ductal hyperplasia or lobular carcinoma in-situ. “Screening services” means services provided by the Maryland Breast and Cervical Cancer Screening Program to screen for breast or cervical cancer, including clinical breast examinations, mammograms, pelvic examinations, Papanicolaou (Pap) tests, and diagnostic services such as breast ultrasound or colposcopically directed biopsy, to ensure that all women with abnormal screening results receive timely and adequate diagnostic and treatment services. “Uninsured” means: Not otherwise having creditable health insurance coverage for cancer treatment services; or Having creditable health insurance coverage, but the cancer treatment services ordered by a health professional are not covered due to one of the following reasons: The services are not included among the benefits covered by the individual's health insurance plan; A period of exclusion has been applied to the individual's health insurance coverage, such as for a preexisting condition; or The individual has exhausted the health insurance plan's covered benefits. “Women's breast and cervical cancer coverage group” means the Medical Assistance optional categorically needy coverage group covered under Regulations .03-1 and .03-2 of this chapter. Eligibility. The Department shall determine that an applicant or enrollee is eligible for Medical Assistance coverage under Regulations .03-1 and .03-2 of this chapter if the individual: Is a woman; Is 40—64 years old; Is uninsured, with the Department not requiring a waiting period of prior uninsurance; Received screening services, in accordance with Regulation .03-2A of this chapter; Had a biopsy through the: Maryland Breast and Cervical Cancer Screening Program which resulted in a diagnosis of cervical cancer or a precancerous condition; or Breast and Cervical Cancer Diagnosis and Treatment Program which resulted in a diagnosis of breast cancer or a precancerous condition; Needs treatment; Is not an institutionalized person; Meets the nonfinancial eligibility requirements for Medical Assistance, as specified in Regulation .05 of this chapter; and Is not eligible for a mandatory Medical Assistance categorically needy coverage group. The requirements in this chapter related to financial eligibility, income, and resources: Shall apply for assessing eligibility for a mandatory Medical Assistance categorically needy coverage group; and May not apply for determining eligibility for the WBCCHP under Regulations .03-1 and 03-2 of this chapter. Screening. A woman is considered to have received screening services if the: NBCCEDP funded all or part of the woman's screening services; or NBCCEDP did not fund all or part of the woman's screening services, but the screening services were rendered by a provider or entity funded at least in part by the NBCCEDP and the: Screening services were within the scope of a grant, subgrant, or contract under the State's NBCCEDP; or NBCCEDP grantee elected to include such screening services by that provider as screening services pursuant to the NBCCEDP. Assistance Unit. An applicant or enrollee shall be considered as an assistance unit of one person, including only the applicant or enrollee. Application Process. The requirements of Regulation .04 of this chapter shall apply, except for the following differences for the women's breast and cervical cancer coverage group: For the initial eligibility application, an individual shall apply through the Maryland Breast and Cervical Cancer Screening Program in the local jurisdiction; The applicant's or enrollee's written application for an initial determination or a redetermination shall be on the form designated by the Department for the women's breast and cervical cancer coverage group; The Department shall: Determine initial eligibility, retroactive or current, based on: A signed application received from the applicant; A form signed by a health professional, certifying that the enrollee needs treatment and, for a redetermination, specifying the anticipated length of treatment; Confirmation from the Maryland Breast and Cervical Cancer Screening Program that the applicant received screening services in accordance with §A of this regulation; Confirmation from the Maryland Breast and Cervical Cancer Screening Program or the Breast and Cervical Cancer Diagnosis and Treatment Program that the applicant had a biopsy which resulted in a diagnosis of breast cancer, cervical cancer, or a precancerous condition; and Additional information obtained by the Department to verify the applicant's eligibility in accordance with Regulation .03-1C of this chapter; Redetermine an enrollee's eligibility at least every 12 months, before the end of the certification period, based on the following: An application completed by the enrollee, verifying continuing eligibility under Regulations .03-1 and .03-2 of this chapter; and A certification form completed by a health professional, verifying that the enrollee needs treatment and specifying the expected length of treatment; Verify, before determining or redetermining eligibility, that the applicant or enrollee is not: Currently covered by Medical Assistance and does not have an application under consideration in a coverage group which covers all State Plan services without requiring spend down or payment of a premium; or Eligible for a mandatory Medical Assistance categorically needy coverage group; Determine or redetermine eligibility within 45 days after receipt of a signed application; Refer the applicant or recipient to the local department of social services or local health department for an eligibility determination or redetermination if the individual may be eligible for a mandatory Medical Assistance categorically needy coverage group; and Notify the applicant or enrollee of the eligibility decision and the rights for appeal and fair hearing, in accordance with Regulation .13 of this chapter; and Based on the application date, the Department shall establish a period under consideration, which shall be: For retroactive eligibility for an initial application, not more than 3 months immediately preceding the month of application, if as of this earlier date the applicant would have met the requirements at Regulation .03-1C of this chapter; For current eligibility for an initial application, a 12-month period beginning with the month of application; or For current eligibility for a redetermination, the lesser of: A 12-month period; or The number of months that the individual needs treatment. Certification Period. An enrollee's certification period shall begin: For retroactive eligibility with the initial determination, the first day of the month which is up to 3 months preceding the month of the application date if, as of this earlier date, the applicant would have met the requirements of Regulation .03-1C of this chapter, including having been screened for and diagnosed with breast cancer, cervical cancer, or a precancerous condition; For current eligibility with the initial determination, the first day of the month of the application date; or For a redetermination, the first day of the month immediately following the month in which the previous certification period ended. The effective date for retroactive or current coverage under Regulations .03-1 and .03-2 of this chapter shall be April 1, 2002 or later. An enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter shall end as of the: End of a certification period for a: 12-month period; or A period less than 12 months, based on how long the enrollee needs treatment; or Date when the enrollee is no longer eligible under Regulations .03-1 and .03-2 of this chapter due to: Death; Establishment of residency in another state; Becoming 65 years old; Becoming an institutionalized person; or No longer being uninsured, such as becoming eligible for another Medical Assistance coverage group which covers all State Plan services without requiring spend down or payment of a premium. Redetermination. Scheduled Redeterminations. The Department shall issue a redetermination package to an enrollee at least 60 days before the end of the certification period. Based on the information presented, the Department shall determine whether the enrollee: Qualifies for continuing eligibility under the women's breast and cervical cancer coverage group with a new 12-month certification period, because the enrollee needs treatment for at least 12 more months; Qualifies for continuing eligibility under the women's breast and cervical cancer coverage group with a new certification period of less than 12 months, based on the length of time that the enrollee needs treatment; Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group because the required information was not received by the Department by the specified deadline, but shall be considered for continuing eligibility under the women's breast and cervical cancer coverage group if the necessary information is received by the Department within 6 months of the date of termination; Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group and does not appear to qualify for a mandatory Medical Assistance categorically needy coverage group; or Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group because the enrollee may qualify for a mandatory Medical Assistance categorically needy coverage group, and shall be referred for an eligibility determination at the local department of social services. Unscheduled Redeterminations. An enrollee shall inform the Department within 10 days of a change in circumstances, which may impact the enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter. If the Department receives notice of a change in circumstances which may impact the enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter, the Department shall follow the procedures in §E(1)(b) of this regulation for redeterminations. If the Department determines as part of a scheduled or unscheduled redetermination that an enrollee does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group, the Department shall determine whether the individual qualifies for any other coverage groups under this chapter or COMAR 10.09.11. Covered Services. Enrollees shall be entitled to full coverage for all services covered under the State Plan, not limited to cancer treatment services, except for enrollment in: The HealthChoice Maryland Medicaid Managed Care Program, in accordance with COMAR 10.09.62 — 10.09.67; Rare and Expensive Case Management (REM), in accordance with COMAR 10.09.69; A home and community-based services waiver under §1915(c) of Title XIX of the Social Security Act; Medicare buy-in for Medical Assistance payment of Medicare premiums, copayments, and deductibles for Medicare eligible persons; Program of All-Inclusive Care for the Elderly; or Coverage for services in a long-term care facility exceeding 30 consecutive days. Non-Financial and Resource Eligibility for the Medicare Savings Programs. In order to be eligible for the Medicare savings program under §§E—H of this regulation, an individual: May not be enrolled in Medical Assistance or the Maryland Children's Health Program under this chapter or under COMAR 10.09.11; Shall be entitled to hospital insurance benefits under Medicare Part A, or medical insurance benefits under Medicare Part B, or both, with or without payment of premiums; Shall meet the non-financial eligibility requirements for Medical Assistance under this chapter; and Shall be part of an assistance unit whose countable resources do not exceed: For individuals eligible under §§E—G of this regulation, 3 times the maximum amount allowed by the Supplemental Security Income program, as adjusted from time to time by the Social Security Administration, for the number of persons in the assistance unit; or For individuals eligible under §H of this regulation, 2 times the maximum amount allowed by the Supplemental Security Income program for the number of persons in the assistance unit. Medicare Savings Program. The Medical Assistance benefits for individuals eligible under §§E—H of this regulation are limited to the Medicare savings program benefits described under those sections of this regulation. Current eligibility for Medicare savings program benefits shall continue until the recipient is determined ineligible. Application and Redetermination Procedures. The requirements under this chapter for applications and redeterminations shall apply for §§E—H of this regulation except as described in §C(2)—(5) of this regulation. Applications and re-applications for eligibility under this regulation shall be filed at: The Department or its designee; The Maryland Department of Aging; An area agency on aging; or A surrogate organization approved by the Department. The initial application may be made at a face-to-face interview or by mail with an agency defined under §C(2) of this regulation, as authorized by the Department. Redeterminations. Applications for redetermination of eligibility shall be mailed by the Department or its designee to the recipient or representative for completion at least once every 12 months. The recipient or representative shall return the application to the Department or its designee and indicate: Any changes that have occurred since the prior redetermination of eligibility, such as a new address; or That there is no new information to report, by marking “NO CHANGE” on the front of the application. Upon notice of a change in circumstances, a redetermination of eligibility under §§E—H of this regulation shall be completed by the Department or its designee. Eligibility under §§E—H of this regulation shall be initially determined and redetermined by the Department or its designee. Income and Resource Consideration. Assistance Unit. When financial eligibility is determined for an applicant or recipient under §§E—H of this regulation, the countable income and resources of the following individuals shall be considered and measured against the income and resource standards specified in this regulation for the number of persons in the assistance unit: The applicant or recipient; and The applicant's or recipient's spouse when living in the same household, whether or not the spouse is eligible for the same benefits under this regulation. Determining Countable Income and Resources. Income and resources shall be evaluated for §§E—H of this regulation in accordance with the provisions for aged, blind, or disabled adults residing in the community, as described under this chapter, in addition to the following resource exclusions: The cash value of life insurance; and An amount up to $1,500 for burial or funeral funds, unless included in the annual resource limit for the full Medicare Part D Low-Income Subsidy (LIS) program. Cost of Living Disregard. The annual cost of living increase in Social Security income under Title II of the Social Security Act shall be disregarded through the month following the month in which the annual federal poverty level update is published in the Federal Register. Qualified Medicare Beneficiary (QMB). An individual is eligible for QMB benefits if: All of the requirements of §A of this regulation are satisfied; and The assistance unit's net countable income does not exceed 100 percent of the federal poverty level for the number of persons in the assistance unit. Current eligibility for QMB benefits shall be effective the first day of the month after the month in which QMB eligibility is determined. Retroactive coverage before the month of application is not available for QMB benefits. Medicare savings program benefits for a QMB-eligible person shall include coverage of the following expenses by the Medical Assistance program: Monthly premium for Medicare Part B; Monthly premium for Medicare Part A, if the individual, due to insufficient working quarters, is not entitled to free coverage by the Social Security Administration; and Medicare Part A and Part B deductibles and co-insurance for services covered by Medicare, regardless of whether the services are covered under the Medical Assistance State Plan. Specified Low-Income Medicare Beneficiary (SLMB). An individual is eligible for SLMB benefits if: All of the requirements of §A of this regulation are satisfied; and The assistance unit's net countable income is greater than 100 percent but less than 120 percent of the federal poverty level for the number of persons in the assistance unit. Current eligibility for SLMB benefits shall be effective the first day of the month of application. An individual may qualify for retroactive SLMB benefits for up to 3 calendar months before the month of application, if the person meets the SLMB eligibility criteria for each of those prior months. Medicare savings program benefits for a SLMB-eligible person shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part B. Qualifying Individual QI. An individual is eligible for QI benefits if: All of the requirements of §A of this regulation are satisfied; The assistance unit's net countable income is at least 120 percent but less than 135 percent of the federal poverty level for the number of persons in the assistance unit; and The individual is not otherwise eligible for Medical Assistance under this chapter. Current eligibility for QI benefits shall be effective the first day of the month of application. An applicant may qualify for up to 3 calendar months before the month of application for retroactive QI benefits if: The individual meets the QI eligibility criteria for each of those prior months under consideration; and Each retroactive month is no earlier than January 1 of the calendar year in which the individual applied for QI benefits. Medicare savings program benefits for a QI eligible individual shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part B. Qualified Disabled and Working Individual (QDWI). An individual is eligible for QDWI benefits if: The individual: Meets all of the requirements under §A of this regulation; Is younger than 65 years old; Was determined disabled by the Social Security Administration (SSA) but lost Social Security benefits solely due to employment; Is entitled to enroll in Medicare Part A under §1818A of the Social Security Act; and Is not otherwise eligible for Medical Assistance under this chapter; and The assistance unit's net countable income does not exceed 200 percent of the federal poverty level for the number of persons in the assistance unit. SSA shall establish the effective date of QDWI coverage based on the: Individual's date of application for QDWI benefits; Date of potential QDWI eligibility, as specified in a letter from SSA to the individual; and Dates of the next Medicare open enrollment period. Medicare savings program benefits for a QDWI-eligible person shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part A. Only the individual who is identified by SSA as potentially eligible may be eligible for QDWI benefits in a QDWI assistance unit. Retroactive coverage before the month of application is not available for QDWI benefits. If an individual delays in applying for QDWI benefits after notification of potential QDWI eligibility by SSA, the individual may be required by SSA to pay a premium surcharge for Medicare Part A, unless the individual is covered by an employer-based group health plan. Eligibility for QDWI benefits shall continue until the earliest of the following dates: The end of the month after the Department: Determines that the individual is no longer eligible for QDWI benefits in accordance with this regulation; and Sends the recipient a notice of termination at least 10 days before the effective date; The end of the month before the month that the individual becomes: Re-entitled to premium-free Medicare Part A; or 65 years old; The date of death; or The end of the month following the month that the individual: Is notified by SSA that the individual no longer has a disabling impairment; or Files a request for termination of QDWI enrollment. If a recipient, who is determined federally eligible and enrolled in Medical Assistance or the Maryland Children’s Health Program according to the requirements of this chapter or COMAR 10.09.11, is entitled to hospital insurance benefits under Medicare Part A, or medical insurance benefits under Medicare Part B, or both, with or without payment of premiums, the Medical Assistance program shall provide the same coverage of Medicare savings program expenses as specified for a Qualified Medicare Beneficiary under Regulation .03-3E of this chapter. A qualified recipient is automatically made eligible by the Department or its designee for the Medicare buy-in benefits effective the first day of the: Second month after the month in which the individual is determined eligible for Medical Assistance or the first day of the third month of Medicare entitlement, whichever date is later, if the individual is eligible in a long-term care or spend down coverage group; or Month that the individual is eligible for both Medical Assistance and Medicare, if the individual is eligible under COMAR 10.09.24 or COMAR 10.09.11 for Medical Assistance in any coverage groups other than long-term care or spend down. A recipient's eligibility for Medicare buy-in benefits shall continue until the recipient is determined ineligible. The Department or its designee shall determine initial (retroactive and current) and continuing eligibility. The Department or its designee shall give oral, written, or electronic information about the Medical Assistance Program such as: Requirements for eligibility; Available services; An individual's rights and responsibilities; Information in plain English, supported by translation services; and Information accessible to disabled individuals requesting an application. An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply. The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means and in a manner accessible to disabled individuals requesting an application. A resident temporarily absent from the State but intending to return may apply for health coverage from an Insurance Affordability Program by telephone, mail, in-person, internet, and other available electronic means to the Department or its designee in any jurisdiction. The individual shall: Demonstrate continued residency in the State; and Meet all nonfinancial and financial requirements in order to be determined eligible. Application Filing and Signature Requirements. An individual who wishes to apply for health coverage under an Insurance Affordability Program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant shall be responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice. A signed application is required for all individuals for whom assistance is requested. If, after the completion of an eligibility determination, assistance is requested for additional family members, a signed application is required for those individuals. An exception to §F(2) of this regulation is that a child born to a mother eligible for and receiving Medical Assistance on the date of the child's birth shall be considered to have applied for Medical Assistance and to have been found eligible for Medical Assistance on the date of his birth, and to remain eligible for Medical Assistance for a period of 1 year. A deemed newborn is eligible for receiving Medical Assistance if, at the time of birth, the child’s mother was covered by Medicaid in another state, as a child under CHIP, or under an 1115 waiver. For the purpose of establishing eligibility, the applicant or an authorized representative shall complete and sign the application. In the case of a child applicant younger than 18 years old, a parent of the child shall sign the application, except in the following situations: When the child does not live with a parent, or the parent with whom the child lives is an unmarried minor younger than 18 years old, the caretaker relative other than parent shall sign the application form; An authorized representative who is 18 years old or older shall complete and sign the application form for an unmarried child younger than 18 years old who is not living with a parent or caretaker relative other than the parent. The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application; however, the application shall remain the property of the Department or its designee, and the withdrawal may not affect the requirements for establishing periods under consideration specified in §H of this regulation. Period under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established pursuant to §F(6) of this regulation. The period under consideration shall be for retroactive eligibility, the 1, 2, or 3 months immediately preceding the month of application for Medical Assistance, except as specified in §H(3) and §N of this regulation. For a deceased individual, the retroactive and current periods under consideration shall begin as stated in §H(1) and (2) of this regulation and may not extend beyond the month of death. Processing Applications — Time Limitations. When a written, telephonic, or electronic application is filed, a decision shall be made promptly but not later than: 10 days from the date of application when filed with the local health department; or 30 days from the date of application when filed with the Department or its designee, with the exception of the local health department. The time standards specified in §I(1) of this regulation cover the period from the date of application to the date the Department or its designee sends a written or electronic notice of its decision to the applicant. Information Required. The applicant shall report all required information. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. The Department or its designee shall inform the applicant or authorized representative in a written or electronic notice of the required information and verifications needed to determine eligibility, and the applicable pending time limit. The applicant or authorized representative shall provide all information and requested verification for the determination of nonfinancial and financial eligibility, including information relating to health insurance coverage or potential third-party payments, early enough for the Department or its designee to meet time limitations. When an applicant completes the application form and requests coverage for: The current period, verification of all elements of eligibility may be required for the current period; The retroactive period, verification of all elements of eligibility may be required for the retroactive period; or Both the retroactive and current periods, verification of all elements of eligibility may be required for both the retroactive and current periods. When an applicant fails to complete the application form, or fails to provide the required information and verification to determine eligibility within the applicable time frame, the applicant shall be determined ineligible. Extension of Time Standards. The time standards specified in §I(1) of this regulation shall be extended to allow the applicant sufficient time to complete provision of information when: The applicant is actively attempting to establish his eligibility but has been unable to provide the required information through no fault of his own; or There is an administrative or other emergency beyond the control of the Department or its designee. The Department or its designee shall document the reason for the delay in the applicant's written or electronic record. The extension of time will continue as long as the requirements of §I(4)(a) of this regulation are met. The Department or its designee shall deny Medical Assistance when these requirements cease to be met. When a subsequent application is made, eligibility and period under consideration shall be determined under §I(7), (8), (9), or (10) of this regulation. The standards of promptness for acting on applications may not be used to deny assistance except as provided in §I(4)(b) of this regulation. The standards of promptness for acting on applications may not be used as a waiting period for granting assistance to eligible persons. Disposition of Application Following a Decision of Ineligibility. If an applicant is determined ineligible for the current period under consideration: Due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, the process and the period under consideration shall be established under §I(9) of this regulation. Solely because of excess income, the application shall be preserved for the period under consideration. The applicant may subsequently establish eligibility for the period under consideration under the “spend-down” process described under Regulations .09C(4) and .10D(5) of this chapter. Solely because of failure to complete the application requirements, including voluntary withdrawal of the application, the application shall be disposed of. If the applicant reapplies, the process and period under consideration shall be established under §I (8), (9), or (10) of this regulation. Reactivation of an Application Following a Decision of Ineligibility for Reasons Other than Nonfinancial Factors or Excess Income. A request for current eligibility following the rejection of an application for reasons other than nonfinancial factors or excess income shall be considered a reactivation of the appropriate earlier application. The reactivation period shall: Apply to the earliest rejected application for which the period under consideration has not expired; Include the retroactive period associated with the current period. The applicant may establish eligibility for the current period, the retroactive period, or both, at any time during the reactivation period. Reapplication Following a Decision of Ineligibility Due to a Nonfinancial Factor. When an applicant reapplies following a decision of ineligibility due to a nonfinancial factor, a new period under consideration shall be established based on the date a new application is submitted. Coverage may not be provided for any month in which the applicant has not overcome the prior factor of ineligibility. The incurred medical expenses from a past period during which nonfinancial ineligibility or excess resources existed may be applied to excess income, if any, for the current period. Reapplication After the Period Under Consideration Has Expired. A request for eligibility and application filed after the expiration of the period under consideration shall be considered a new application, and a new period under consideration shall be established. A part of the expired current period under consideration may not be converted to a retroactive period for purposes of determining eligibility. A part of the expired current period under consideration may constitute part or all of the 3 months before the month of application for purposes of post-eligibility deductions. The incurred unpaid expenses from the expired period may, with the written consent of the applicant, be applied to excess income, if any, for the current period. The written consent shall be obtained on a form designated by the Department. An applicant or recipient may be assisted by an individual or individuals of the applicant's or recipient's choice in the application process and may be accompanied by this individual or individuals when in contact with the Department or its designee. Required Application for Income Benefits. Applicants and recipients shall apply for all income benefits to which there may be entitlement, except as specified in §K(3) of this regulation. Income benefits include, but are not limited to, Social Security, Unemployment Compensation, Railroad Retirement, Veterans' Administration, Civil Service annuities, federal, state, or local government and private pensions, and Workers' Compensation. Applicants and recipients determined by the Department or its designee to be unable to perform the required activity because of the applicant's or recipient's physical or mental condition and for whom there is no other individual to perform the activity are not required to apply for income benefits. Determination of initial eligibility may not be delayed pending the results of the application filed for income benefits. At the time of redetermination or reapplication, eligibility will be determined on the basis of the applicant's or recipient's documented reasonable and continuous efforts to establish entitlement to income benefits. Social Security Number. Eligibility may not be established until the applicant or recipient furnishes or applies for a Social Security number for any individual whose income is considered in determining financial eligibility. Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant or recipient complies with §L(1) of this regulation. If an applicant or recipient is physically or mentally incapable of acting for himself or herself or lacks the resources to meet the requirements, the Department or its designee shall assist the applicant or recipient in obtaining the necessary evidentiary documents required for application for a Social Security number, and any costs incurred by the Department or its designee shall be paid out of administrative funds. Third-Party Liability. Applicants and recipients shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for their medical expenses. Applicants and recipients shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. In accident situations, applicants and recipients shall notify the Department or its designee of the time, date, and location of the accident, the name and address of the attorney, the names and addresses of all parties and witnesses to the accident, and the police report number if an investigation is made. Retroactive Eligibility for Applicants or Recipients. An applicant or recipient who desires Medical Assistance coverage for a past period shall apply for retroactive coverage. The date of application for retroactive coverage shall be established in accordance with the requirements of Regulation .09B of this chapter. The Department or its designee shall explain the spend-down provision to an applicant determined ineligible because of excess income. The Department or its designee shall maintain a written or electronic record including documentation of all required elements of eligibility. The Department or its designee shall restrict disclosures of information concerning applicants and recipients to purposes directly connected with the administration of the Program, including: Establishing eligibility; Determining the extent of coverage under the Program; Providing services for recipients; and Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Program. The Department or its designee shall conduct a wage-screening inquiry to determine wages, benefits, and claimant history for each of the following applicants or recipients of Medical Assistance: Childless, adults older than 19 years old and younger than 65 years old; Parents and other Caretaker Relatives; Pregnant and postpartum women; Children younger than 21 years old; and Former Foster Care Children younger than 26 years old. An applicant or recipient shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic or electronic application. All of the requirements of Regulation .04 of this chapter shall apply with the exceptions stated in this chapter. Application Filing and Signature Requirements. An individual who wishes to apply for Medical Assistance shall submit a signed application to the Department or its designee in the jurisdiction where his residence is located. A deemed newborn is eligible for receiving Medical Assistance if at the time of birth the child’s mother was covered in another state as a child under CHIP or under a 1115 waiver. An individual who has filed an application may voluntarily withdraw that application; but the withdrawal may not affect the requirements for the penalty period associated with the transfer of a resource specified under Regulation .08I of this chapter. Period Under Consideration. Current eligibility shall have a period of consideration of a 6-month period beginning with the month of application for Medical Assistance, except as specified in Regulation .04H(3) of this chapter. Processing Applications. When a written or electronic application is filed, a decision shall be made promptly but not later than: 45 days from the date of application in the case of determination of aged and blind individuals; or 60 days from the date of application in the case of determination of disability. Extension of Time Standards. The time standards specified in Regulation .04I(1) of this chapter shall be extended to allow the applicant sufficient time to complete provision of information when the examining physician delays or fails to take a required action. Reactivation of an Application Following a Decision of Ineligibility for Reasons Other than Nonfinancial Factors, Excess Resources, or Excess Income. A request for current eligibility following the rejection of an application for reasons other than nonfinancial factors, excess resources, or excess income shall be considered a reactivation of the appropriate earlier application. The reactivation period shall: Apply to the earliest rejected application for which the period under consideration has not expired; and Include the retroactive period associated with the current period. The applicant may establish eligibility for the current period, the retroactive period, or both, at any time during the reactivation period. Disposition of Application Following a Decision of Ineligibility. If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor or excess resources, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, the process and the period under consideration shall be established under Regulation .04I(9) of this chapter. Interview. A face-to-face interview may be conducted at the request of the applicant or the Department or its designee. If it is determined that a face-to-face interview is necessary, the interview may be conducted with an individual other than the applicant in the following situations: When the Department or its designee determines that the applicant cannot participate in the interview because of unusual circumstances such as severely incapacitating disabilities, the interview shall be conducted with an authorized representative or individual acting responsibly on behalf of the applicant; or When the applicant is an unmarried child younger than 18 years old and is not living with a parent or other caretaker relative, the interview shall be conducted with one or more of the following individuals who is 18 years old or older: The parent or other knowledgeable relative of the child; The nonrelated individual with whom the child is living; or Another designated responsible individual who is knowledgeable about the child's circumstances. Required Application for Income Benefits. Eligibility may not be established until applicants, and recipients furnish proof that they have applied for and taken all other necessary steps to obtain and accept all income benefits to which there may be entitlement, except as specified in §N(3) of this regulation. Income benefits include, but are not limited to: Social Security; Unemployment Compensation; Railroad Retirement; Veterans’ Administration; Civil Service annuities; Federal, state, or local government and private pensions; and Workers’ Compensation. Applicants and recipients determined by the Department or its designee to be unable to perform the required activity because of the applicant’s or recipient’s physical or mental condition and for whom there is no other individuals to perform the activity are not required to apply for income benefits. Determination of initial eligibility may not be delayed pending the results of the application filed for income benefits. At the time of redetermination or reapplication, eligibility will be determined on the basis of the applicant’s or recipient’s documented reasonable and continuous efforts to establish entitlement to income benefits. An applicant who is 65 years old or older, or blind or disabled, is not eligible until the applicant furnishes proof that the applicant has applied for or is receiving Part A Medicare. Eligibility determination may not be delayed pending the results of the application filed for Part A Medicare. Periodic reviews of eligibility are necessary for those blind or disabled individuals initially determined ineligible for Medicare because of the required waiting period. Social Security Number. Eligibility may not be established until the applicant or recipient furnishes or applies for a Social Security number for each member of an assistance unit and any individual whose income and resources are considered in determining the financial eligibility of an assistance unit. An individual may not be added to an assistance unit until an application is completed for a Social Security number. Retroactive Eligibility for Cash Assistance Applicants or Recipients. A Public Assistance applicant or recipient who desires Medical Assistance coverage for a past period shall apply for retroactive coverage. The date of application for retroactive coverage shall be established as follows: The Medical Assistance application date shall be the: Same as that of the Public Assistance application date if the Medical Assistance application is filed within 3 months of the date of the Public Assistance application; or Date the Medical Assistance application is filed if the filing date is more than 3 months after the date of the Public Assistance application. Retroactive eligibility shall be determined in accordance with the requirements of Regulation .10C of this chapter. The Department or its designee shall conduct a wage-screening inquiry to determine wages, benefits, and claimant history for an Aged Blind Disabled applicants or recipients that: Resides in a long term care facility; or Is chronically ill and non-ambulatory. An applicant shall sign consent forms as needed authorizing the Department or its designee to verify from sources such as an employer, banks, and public or private agencies, information needed to establish eligibility. Obtaining Financial Records from Fiduciary Institutions Doing Business in the State as of October 1, 2017. The Department or its designee shall inform the applicant or authorized representative in a written or electronic document of the required information and verifications needed to determine financial eligibility for Medical Assistance and the time limit for submitting the required records. The applicant or authorized representative shall provide all of the required information and verifications needed to determine financial eligibility for Medical Assistance within the time period specified in the notice from the Department or its designee. The Department or its designee shall request financial records necessary to determine the applicant’s eligibility for Medical Assistance on behalf of the applicant when: The applicant or authorized representative is actively attempting to obtain financial documentation to establish eligibility but has been unable to provide the required financial information through no fault of his own from a certain fiduciary institution conducting business in the State; The applicant or authorized representative provides documentation to show their efforts to obtain the information; and The applicant or authorized representative provides a signed consent form designated by the Department or its designee to obtain the records. If the conditions set forth in §M(3) of this regulation are not met, the applicant or authorized representative remains responsible to provide the information. Reimbursement Schedule. The Department or its designee shall reimburse a fiduciary institution for providing copies of financial records in accordance with the Banks and Banking regulations found in 12 CFR §219.3, including the Reimbursement Schedule at Appendix A. Eligibility. To be eligible for federal coverage of full Medical Assistance benefits, an individual shall be: A citizen of the United States, including: An individual who was born in: One of the 50 states; The District of Columbia; Puerto Rico; Guam; The Northern Mariana Islands; or The Virgin Islands; A child born outside of the United States if: The federal requirements, including the requirements in the Child Citizenship Act of 2000 (Public Law 106-395), are met for the child to automatically acquire United States citizenship upon the child's lawful admission to the United States for permanent residence; At least one of the child's natural, adoptive, or stepparents is a United States citizen by birth or naturalization; The child is younger than 18 years old; The child is residing in the United States in the legal and physical custody of the citizen or naturalized parent; and The child is a lawful permanent resident of the United States; An individual who has been naturalized as a United States citizen; or A national from American Samoa or Swain's Island; A qualified alien, as specified in §C of this regulation, who is eligible in accordance with the requirements related to the 5-year bar specified at §D of this regulation; An honorably discharged veteran of the armed forces of the United States; An alien on active duty in the armed forces of the United States; The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an: Honorably discharged veteran of the armed forces of the United States; or Alien on active duty in the armed forces of the United States; or An alien who is: Eligible for and receiving Supplemental Security Income (SSI); A member of a state or federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or An American Indian born in Canada to whom §289 of the Immigration and Nationality Act (INA) applies. Veterans. Veterans of the following foreign armed forces are considered under this regulation to be veterans of the armed forces of the United States: Individuals who served in the Philippine Commonwealth Army during World War II or as Philippine scouts following World War II; and Hmong and other Highland Lao veterans who fought under United States' command during the Vietnam War and who were lawfully admitted to the United States for permanent residence. Qualified Aliens. According to §431 of the Personal Responsibility and Work Opportunity and Reconciliation Act of 1996 (PRWORA), qualified aliens admitted to the United States shall include: The following types of aliens, who may be subject to the 5-year bar specified at §D of this regulation, depending on their most recent date of entry and their date of qualified alien status: Aliens who were lawfully admitted to the United States for permanent residence or who since admission were granted lawful permanent resident status in accordance with the INA; Aliens granted parole for at least 1 year under §212(d)(5) of the INA; and A documented or undocumented immigrant who was battered or subjected to extreme cruelty by the individual's United States citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the immigrant, if: The spouse or parent consented to, or acquiesced in, the battery or cruelty; The abusive act or acts occurred in the United States; The individual responsible for the battery or cruelty no longer lives in the same household as the victim; A Violence Against Women Act immigration case or a family-based visa petition has been filed; and There is a substantial connection between the battery or cruelty and the need for Medical Assistance benefits; and The following types of aliens, who are not subject to the 5-year bar specified in §D of this regulation: Alien children and pregnant women who are lawfully residing in the United States, including legal permanent residents who have resided in the United States for less than 5 years as described under §214 of the Children's Health Insurance Program Authorization Act of 2009 (CHIPRA); Aliens who were lawfully admitted to the United States for permanent residence as Amerasian immigrants under §584 of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1988; Refugees admitted under §207 of the INA; Aliens granted asylum under §208 of the INA; Aliens whose deportation is being withheld under: §243(h) of the INA as in effect prior to April 1, 1997; or §241(b)(3) of the INA, as amended; Cuban or Haitian entrants, as defined at §501(e) of the Refugee Education Assistance Act of 1980; Aliens granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980; Children receiving federal payments for foster care or adoption assistance under Part B or E of Title IV of the Social Security Act, if the child's foster or adoptive parent is considered a citizen or qualified alien; and Victims of a severe form of trafficking, in accordance with §107(b)(1) of the Trafficking Victims Protection Act of 2000, who have been subjected to: Sex trafficking if the act is induced by force, fraud, or coercion, or the individual who was induced to perform the act was younger than 18 years old on the date that the visa application was filed; or Involuntary servitude. Five-Year Bar to Federal Medical Assistance for Qualified Aliens. Except for coverage of emergency medical services specified at Regulation .05-2 of this chapter, qualified aliens in the categories specified in §C(1) of this regulation who entered the United States on or after August 22, 1996, were not eligible for federally-funded Medical Assistance for 5 years from the date that the qualified alien: Entered the United States with the status of a qualified alien; or Obtained the status of a qualified alien, if the individual did not enter the United States as a qualified alien. The 5-year bar specified in §D(1) of this regulation shall also be applied to qualified aliens who entered the United States before August 22, 1996, but did not remain continuously present in the United States from the last date of entry before August 22, 1996 until the date of qualified alien status. An alien is not considered to be continuously present in the United States as specified in §D(2) of this regulation if, before the date of qualified alien status, the alien had: A single absence from the United States of more than 30 days; or Absences from the United States totaling more than 90 days. The 5-year bar to eligibility for federal Medical Assistance benefits, specified in §D(1) of this regulation, does not apply to: Qualified aliens in the categories specified at: §C(1) of this regulation, who are not subject to the 5-year bar in accordance with §D(1) or (2) of this regulation; or §C(2) of this regulation; A qualified alien who is: An honorably discharged veteran of the armed forces of the United States; On active duty in the armed forces of the United States; or The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an honorably discharged veteran or individual on active duty in the armed forces of the United States; and Lawful permanent residents who: Entered the United States under another exempt category specified at §D(4)(a)—(b) of this regulation; and Converted to lawful permanent resident status. Effective December 1, 2009, as authorized by the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), the 5-year bar will no longer apply to Medical Assistance or Children's Health Insurance Program eligibility for pregnant women and children who are qualified aliens. An applicant or recipient shall be required as a condition of eligibility to provide documentary evidence of identity as well as citizenship or nationality, to the Department's satisfaction, based on federal requirements, if the individual is: Declared to be a citizen or national of the United States; and Being determined for: Initial eligibility based on an application filed on or after September 1, 2006; or Continuing eligibility based on a redetermination with an end date on or after September 30, 2006. The requirements of this regulation shall be met for all Medical Assistance coverage groups except for: Supplemental Security Income beneficiaries; Newborns who are deemed eligible, for a period of 1 year, for Medical Assistance based on the mother's Medical Assistance eligibility for the newborn's date of birth; Newborns deemed eligible who are born to an otherwise eligible non-qualified alien woman meeting the requirements of Regulation .05-2 of this chapter who has filed an application and has been determined eligible for Medical Assistance for the newborn's date of birth; Individuals who are entitled to Medicare benefits or enrolled in any part of Medicare; Individuals receiving SSDI disability insurance benefits under §223 of the Social Security Act, or monthly benefits under §202 of the Act, based on the individual's disability; Children who are receiving foster care or adoption assistance under Title IV-B or Title IV-E of the Social Security Act; and Other categories of individuals who are considered by the federal government to have previously presented satisfactory documentary evidence of identity as well as citizenship or nationality. An applicant may not be determined eligible for Medical Assistance until the requirements of this regulation are met. An applicant may be determined eligible for Medical Assistance for a period of 90 days to provide requested documents. When an applicant fails to provide documentation of citizenship within the 90 day period, the applicant shall be determined ineligible. Continuing eligibility for a recipient may not be approved at redetermination until the requirements of this regulation are met. If an applicant or recipient fails to meet the requirements of this regulation within the time standards specified at Regulation .04I(1) of this chapter, and the time standards are not extended in accordance with Regulation .04I(4) of this chapter, the Department shall: Deny eligibility for an applicant; or Terminate eligibility for a recipient, in accordance with the requirements for timely notice in COMAR 10.01.04. The reactivation requirements in Regulation .04I(8) of this chapter shall apply to applicants and recipients deemed MAGI exempt. The documentation requirements of this regulation are subsequently met within the current period under consideration for the: Applicant's denied application; or Recipient's terminated period of continuing eligibility. If there is documentation in an applicant's or recipient's written or electronic record or a state or federal data system that demonstrates that the individual meets the requirements of this regulation, the individual shall be considered to meet the requirements of this regulation, unless the: Department or its designee has cause to question the documentation previously accepted; or Federal government requires additional documentation. An alien shall be eligible for federal Medical Assistance coverage of emergency medical services, as specified under §§B and C of this regulation, if the alien is determined by the Department to: Have received emergency medical services described under §§B and C of this regulation that are necessary for treatment of an emergency medical condition; and Meet all other requirements of Medical Assistance eligibility as specified in this chapter, including Maryland residency and financial eligibility, except the requirements related to: Social Security number; and Alien eligibility and declaration of immigration status. Emergency medical services, including labor and delivery services, are for the treatment of an emergency medical condition that, after a sudden onset, manifests itself by acute symptoms of sufficient severity, including severe pain, such that the absence of immediate medical attention can reasonably be expected to result in: Placing the individual's health in serious jeopardy; Serious impairment to bodily functions; or Serious dysfunction of any bodily organ or part. Emergency medical services extend from when the individual enters a hospital to receive the emergency medical services until the individual's emergency medical condition or other medical condition requiring the emergency medical services is stabilized, as determined by the Department. Emergency medical services do not include: An organ transplant and all services related to an organ transplant; or Routine prenatal or postpartum care. To be eligible for the Maryland Medical Assistance Program, an applicant or recipient shall be a Maryland resident. An individual is a Maryland resident if the individual resides in Maryland with the intent of remaining permanently or for an indefinite period, regardless of whether the individual maintains the residence permanently or at a fixed address. Residency in a state begins on the day that an individual: Enters the state with the intent to remain permanently or for an indefinite period; or Decides to remain in the state permanently or for an indefinite period after entering for another purpose. An individual is not a resident of a state if the individual: Is temporarily residing in or visiting the state without the intent of remaining, except as specified under §I(2)(b)(ii) or §I(3) of this regulation; Came into the state for a specific, time-limited purpose and does not intend to remain, except as specified under §I(2)(b)(ii) or §I(3) of this regulation; or Entered the state voluntarily to obtain noninstitutional medical care, such as for acute hospital inpatient services. Residency in a state established on any day in a calendar month shall constitute residency for the full month. Retaining Residency. Residency is retained until abandoned. Temporary absence from a state, with the intent to return to the state when the purpose of the absence is accomplished, does not interrupt continuity of residency, unless another state's Medical Assistance program determines that the individual is a resident of the other state. An individual who is routinely absent from a state for a protracted period of time retains residency in that state if the individual: Declares the intent to remain a resident of the state; Has an established residential address in the state; and Is not certified for Medical Assistance or receiving public assistance in another state. Residency in a state is not affected by an absence for: Unanticipated medical care; or Out-of-state medical treatment preauthorized by the state's Medical Assistance Program. An individual is ineligible for a state's Medical Assistance Program for any month in which the individual is not a resident of the state. State Supplementary Payment for a Recipient of Supplemental Security Income (SSI). Notwithstanding any other provisions of this regulation, the state of residence for a recipient of a state supplementary SSI payment is the state making the supplementary payment. An individual receiving a state supplementary payment from another state who moves to Maryland with the intent of remaining in Maryland is not eligible for Maryland Medical Assistance until: The individual's change of state residence is verified; and Changes, if any, in the individual's payment amount are made with the Social Security Administration. Additional Residency Criteria for Noninstitutionalized Individuals. Noninstitutionalized Child. Except as otherwise specified in this regulation, a noninstitutionalized, unmarried individual younger than 21 years old is considered a resident of the state where the child lives: With the child's parent or other caretaker relative; or In another living arrangement if the child is not living with the child's parent or other caretaker relative, and the child's parent or other caretaker relative is not responsible for the child's day-to-day care and supervision. For a child receiving federal payments for foster care or adoption assistance under Title IV-E of the Social Security Act, the child's state of residence is the state where the child lives, even if it is not the state making the payments. If a noninstitutionalized child's Medical Assistance eligibility is determined based on blindness or disability, the child's state of residence is the state where the child lives. Noninstitutionalized Adult. A noninstitutionalized adult, including an individual younger than 21 years old who is married or otherwise emancipated from the individual's parents, is considered a resident of the state where the individual lives: Voluntarily with the intent to remain permanently or for an indefinite period; or At the time of Medical Assistance application, if the individual is: Determined as incapable of indicating intent, in accordance with §K of this regulation; or Not receiving assistance from another state and entered the state with a job commitment or seeking employment, whether or not the individual is currently employed. The exclusion of Medical Assistance eligibility under §D of this regulation for individuals who temporarily reside in the state without the intent of remaining shall be waived for members of an assistance unit that includes a migrant worker, in MAGI Exempt coverage groups. Notwithstanding any other provision of this regulation, the state of residence for an individual placed by a state government in another state is the state that arranges or makes the placement for medical or other publicly funded services. Additional Residency Criteria for Institutionalized Individuals. For an institutionalized adult, including an individual younger than 21 years old who is married or otherwise emancipated from the individual's parents, the state of residence is the state where the individual is institutionalized, if the individual indicates the intent to remain in the long-term care facility indefinitely. If an institutionalized adult became incapable of indicating intent when the individual was 21 years old or older, the individual's state of residence is the state where the individual is institutionalized. An institutionalized child younger than 21 years old, or an institutionalized adult who became incapable of indicating intent when younger than 21 years old, is a resident of the state in which the: Individual's parent or other legal guardian resided at the time of the individual's placement in the long-term care facility; Individual's parent or other legal guardian currently resides, who applied for Medical Assistance on the individual's behalf; or Individual is institutionalized if the individual was abandoned by the individual's parents and does not yet have a legal guardian. Notwithstanding any other provision of this regulation, the state of residence for an individual institutionalized by a state government in an out-of-state facility is the state that arranges or makes the placement. The Department may not deny Medical Assistance eligibility to an institutionalized individual who satisfies the residency requirements of this regulation, on the grounds that the individual did not establish Maryland residency before entering the long-term care facility. An adult is considered incapable of indicating intent if the individual: Has an Intelligence Quotient of 49 or less, or a mental age of 7 years old or younger, based on tests acceptable to the Department's Developmental Disabilities Administration; Is judged legally incompetent; or Is found incapable of indicating intent based on medical documentation obtained from a physician, psychologist, or other person licensed by the state in the field of intellectual disabilities. Blindness. To be eligible for Medical Assistance as a blind individual, an applicant or a recipient shall be blind as defined at Regulation .02 of this chapter. Procedure for Determination of Blindness. If an applicant's or recipient's eligibility for Medical Assistance is determined on the basis of blindness, an ophthalmologist or a licensed optometrist shall examine the individual, unless: Both of the individual's eyes are missing; or The Social Security Administration has determined that the individual is currently blind. The ophthalmologist or licensed optometrist shall submit a report of the examination to the local department of social services or other entity designated by the Department. An ophthalmologist, contracted by the Department or its designee, shall review the report and determine, on behalf of the local department of social services or other entity designated by the Department: Whether the individual meets the definition of blindness; and The need and frequency of reexamination for periodic redetermination of blindness. Reexaminations for periodic redeterminations of blindness shall be conducted according to the procedures described under §B(2) of this regulation. The local department of social services or other entity designated by the Department shall accept the Social Security Administration's determination of blindness for an individual receiving a Social Security benefit based on blindness. Disability. In order to be eligible for Medical Assistance as a disabled individual, an applicant or recipient shall meet the definition of disabled in Regulation .02B of this chapter. Procedure for Determination of Disability. The Family Investment Administration shall determine disability. The local department of social services shall obtain a medical report and other nonmedical evidence for an individual applying for Medical Assistance on the basis of disability. The medical report and nonmedical evidence shall include a diagnosis and other information in accordance with the requirements for evidence applicable to disability determinations under the Supplemental Security Income Program (SSI), specified under 20 CFR Part 416, Subpart I. A Family Investment Administration review team shall review the medical report and other evidence obtained under §B(2)(b) of this regulation and determine whether the individual’s condition meets the definition of disability. The review team shall be composed of a medical or psychological consultant, and another individual who is qualified to interpret and evaluate medical reports and other evidence relating to the individual’s physical or mental impairments and, as necessary, to determine the capacities of the individual to perform substantial gainful activity as specified in 20 CFR Part 416, Subpart J. Disability Determination Made by the Social Security Administration. The Family Investment Administration may not make an independent determination of disability if the Social Security Administration has made a disability determination within 90 days of the date of the Medical Assistance application on the same issues presented in the Medical Assistance application. A determination by the Social Security Administration is binding on the Family Investment Administration until it is changed by the Social Security Administration. If the Social Security Administration determination is changed, the new determination is binding on the Family Investment Administration. The Department or its designee shall refer to the Social Security Administration for reconsideration or reopening of the determination all applicants who allege new information or evidence affecting previous Social Security Administration determinations of ineligibility based on disability, except as specified in §B(4)(d)(i) of this regulation. Disability Determination made by the Family Investment Administration. The Family Investment Administration shall make a determination of disability if any of the following circumstances exists: The individual applies for Medical Assistance and has not applied for SSI benefits; The individual applied for SSI benefits and was found ineligible for a reason other than disability; The individual has applied for both Medical Assistance and SSI benefits, and the Social Security Administration has not made an SSI determination within 90 days from the date of the individual’s application for Medical Assistance; The individual has applied for Medical Assistance and: Alleges a disabling condition different from, or in addition to, that considered by the Social Security Administration in making its determinations; Alleges more than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated since that determination and alleges a new period of disability that meets the durational requirements for disability, and has not applied to the Social Security Administration for a determination with respect to those allegations; Alleges less than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated and alleges a new period of disability that meets the durational requirements for disability, and has applied to the Social Security Administration for reconsideration or reopening of its disability decision but the Social Security Administration has refused to consider the new allegations; or Alleges less than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated, alleges a new period of disability that meets the durational requirements for disability, and no longer meets the nondisability requirements for SSI, but may meet the State’s nondisability requirements for Medical Assistance eligibility. Inmate of a Public Institution. To be eligible for Medical Assistance, an applicant or recipient may not be incarcerated as an inmate of a public institution. Inmate Status. An individual is considered incarcerated as an inmate of a public institution if the individual resides in a public institution involuntarily as a result of being accused or found guilty of a criminal offense, including the duration of time in which the individual is involuntarily residing in the public institution in a preadjudication or pretrial status awaiting criminal proceedings, penal dispositioning, or other involuntary detainment procedure. An individual may not be considered an inmate of a public institution if the individual resides in a public: Institution voluntarily and not as the result of a legal criminal process; Educational or vocational training institution for the purpose of receiving educational or vocational training; or Institution for the first partial month of residence or for a temporary period pending other arrangements appropriate to the individual's needs. Hospitalization as a Result of the Commission of a Crime. An individual who is hospitalized as a result of an injury sustained during the commission of a crime and has not yet been incarcerated because of the hospitalization may not be considered an inmate of a public institution. Retaining Inmate Status. Except as provided in §A(2)(f) of this regulation, an individual's inmate status continues until the criminal indictment against the individual is dismissed or the individual is released from the public institution. An individual who is not present at the correctional facility during the day, because the individual is attending a day treatment program or participating in day-time employment, but who resides in a correctional facility at night, shall be considered an inmate of a public institution. Inmate Admitted to Medical Institution. An inmate may be covered by Medical Assistance during the period when the inmate is admitted as an inpatient of a medical institution, such as a hospital, nursing facility, or juvenile psychiatric facility, and is receiving services covered by Medical Assistance. Individual Sent to an Institution for Mental Disease (IMD). Inmate status shall apply to an individual who is accused of a criminal offense and is sent directly to an IMD either for a mental examination or because the individual is determined mentally incompetent to stand trial. An individual committed by a court to an IMD based on a verdict of not guilty by reason of insanity may not be considered an inmate of a public institution. Children Younger than 21 Years Old Committed to a Correctional Facility. A child committed by a court to a correctional institution due to a violation of the law shall be considered incarcerated as an inmate of a public institution. A child committed to the custody of the Maryland Department of Juvenile Services shall be considered incarcerated as an inmate of a public institution if the child is placed in a State-owned and State-operated facility, and that status shall continue until the child is released from the facility. A child committed to the custody of the Maryland Department of Juvenile Services may not be considered an inmate of a public institution if the child is living: With the child's parent, caretaker relative, or legal guardian; In a group home serving no more than 16 residents; or In a privately operated facility under the jurisdiction of the Maryland Department of Juvenile Services. Institution for Mental Disease (IMD). An institutionalized individual younger than 65 years old who is admitted for residence in an institution for mental disease is not eligible for Medical Assistance, unless the applicant or recipient is: Younger than 22 years old; and Receiving inpatient psychiatric services for individuals younger than 21 years old. Inpatient psychiatric services for individuals younger than 21 years old may be provided: To individuals who are younger than 21 years old; or Until the earlier of the date that the individual: No longer requires the services; or Is 22 years old, if the individual was receiving the services immediately before reaching 21 years old. Except as provided in §B(4) of this regulation, when an individual is on conditional release or convalescent leave from an IMD, the individual may not be considered institutionalized in the IMD. An individual who is receiving inpatient psychiatric services for individuals younger than 21 years old shall be considered an institutionalized individual until the earlier of the date that the individual: Is unconditionally released from the IMD; or Is 22 years old. Purpose and Scope. This regulation establishes who shall be a member of an assistance unit, who may be excluded from an assistance unit, who will have separate eligibility determinations, and whose income and resources will be considered in determining financial eligibility for MAGI Exempt applicants and recipients of Medical Assistance. More Than One Assistance Unit Among Individuals Living Together. More than one assistance unit is permissible if: The parent or other caretaker relative chooses to have a child's eligibility determined as blind or disabled under Regulation .04J of this chapter; A caretaker relative chooses to have his eligibility determined as aged, blind, or disabled under Regulation .04J of this chapter; and There are individuals who would have been members of the assistance unit except for their status as automatically eligible Medical Assistance recipients under Regulation .03B of this chapter. Separate Eligibility Determinations for Certain Individuals. An individual eligibility determination shall be conducted for each individual identified in §A-1(1) of this regulation who requests Medical Assistance. For the aged, blind, or disabled individual identified in §A-1(2) of this regulation: If the person chooses to have eligibility determined as aged, blind, or disabled and either the person's spouse is non-aged, blind, or disabled or the aged, blind, or disabled spouse chooses to have eligibility determined as a caretaker relative, an individual eligibility determination shall be conducted; or If the person applies as aged, blind, or disabled and the person's spouse also applies as aged, blind, or disabled, the couple will be considered one unit. Aged, Blind, or Disabled. This section is applicable to the following: An aged, blind, or disabled person 21 years old or older who has no unmarried related children younger than 21 years old living with him; An aged, blind, or disabled person and spouse, with no unmarried related children younger than 21 years old living with the couple; A blind or disabled child younger than 21 years old who chooses to have his eligibility determined as blind or disabled; and An aged, blind, or disabled caretaker relative who chooses to have his eligibility determined as aged, blind, or disabled. Composition—Aged, Blind, or Disabled. The assistance unit shall include the following persons, except as provided in §B(2)(b)—(c) of this regulation: The aged, blind, or disabled person; and The aged, blind, or disabled spouse of the aged, blind, or disabled person, when living together. An aged, blind, or disabled caretaker relative who chooses to apply as caretaker relative will not be included in the unit. A non-aged, blind, or disabled parent or caretaker relative other than parent will not be included in the unit. Income and Resource Consideration. In determining financial eligibility, the income and resources of the following persons shall be considered: All persons included in the assistance unit; The spouse of the applicant, when living together, unless the spouse is an SSI recipient; and The parent of a blind or disabled child younger than 18 years old, when living together, unless the parent is an SSI recipient. Treatment of Income and Resources of Persons Not Living Together. When spouses cease to live together, their income and resources shall be considered available to each other throughout the month in which they cease living together. Beginning with the first full month of separate residence, only actually contributed income and resources from the spouse shall be counted. When a blind or disabled child younger than 18 years old ceases to live with his parent, the income and resources of the parent shall be considered available throughout the month in which they cease living together. Beginning with the first full month of separate residence, only actually contributed income and resources from the parents shall be counted. Blind and Disabled Children Living With Parents or Other Caretaker Relatives. This section applies to blind or disabled children living with a caretaker relative who chooses to have the child's eligibility determined as an individual younger than 21 years old and an aged, blind, or disabled individual who chooses to have his eligibility determined as a caretaker relative. Persons Living Together. The unit shall be established on the basis of persons living together, including persons who are temporarily absent from the home for purposes of attending school, or pursuing vocational or job training. Composition — Children Living With Parents or Other Caretaker Relatives. The assistance unit shall include, except as provided in §§A-1 and C(4) of this regulation, the parents, caretaker relatives other than parents, their unmarried children younger than 21 years old, and any other unmarried children younger than 21 years old (including second generation children who are parented by an unmarried person younger than 21 years old) who are related by blood, marriage, or adoption to the parent or caretaker relative other than parent. The relationship between children and caretaker relatives other than parents shall be limited to those specified in Regulation .02B(10)(a) of this chapter. Exclusion of a Child or Caretaker Relative Other Than Parent. The provisions of §C(3) of this regulation may not apply when: A parent or caretaker relative other than a parent chooses to exclude a child from the assistance unit provided at least one child is in the unit and the exclusion does not cause the applicant or recipient to lose Medical Assistance (Title XIX) status as a caretaker relative as defined in Regulation .02B(10)(a) of this chapter. A caretaker relative other than a parent chooses to be excluded from the assistance unit. The choice of exclusion includes the caretaker relative's spouse. An excluded aged, blind, or disabled person retains the option of selecting any federal category in which technical eligibility may be established upon subsequent application. An excluded non-aged, blind, or disabled person may not have a separate eligibility determination. Subsequent Application for an Excluded Person. A person excluded from the assistance unit may apply for Medical Assistance. If an excluded person applies as aged, blind, or disabled, the following conditions apply: A separate eligibility determination will be made in accordance with §A-1 of this regulation; and Income and resources of a spouse or parent will be considered in accordance with §B(3) of this regulation. If an excluded person does not apply as aged, blind, or disabled, the following conditions apply: The period under consideration will be the same as that of the currently eligible assistance unit; Eligibility for the new member shall be determined in conjunction with the currently eligible assistance unit established in §C(3) of this regulation; The income and resources of the new member shall be added to that of the currently eligible assistance unit beginning with the month for which coverage of the new member is requested; The income of the new member may not be averaged to include any months before the month for which coverage is requested; Certification may not begin earlier than the date the new member becomes eligible; and A decision of ineligibility for the new member will not affect the eligibility status of the currently eligible assistance unit for the remainder of the certification period. Income and Resource Consideration. In determining financial eligibility, the income and resources of the following persons shall be considered: All persons included in the assistance unit; The spouse of the applicant, when living together, unless the spouse is an SSI recipient; and The parent of a child younger than 21 years old, when living together, unless the parent is an SSI recipient. Treatment of Income and Resources When a Child Leaves the Home. The income and resources of a parent shall be considered throughout the month in which a child leaves the home for the purpose of establishing a new address, when the separation is for reasons other than placement in a foster home, group home, or drug or alcohol abuse treatment center. Beginning with the first full month of separate residence, only actually contributed income and resources from the parent shall be counted. Additions to the Household. A new member of the household will be considered in accordance with all applicable regulations of this chapter. Purpose and Scope. This regulation establishes who shall be a member of the MAGI household and who will be excluded from the MAGI household. The regulation applies to applicants and recipients of coverage groups described under Regulation .03A of this chapter. Household Composition. An individual, plus anyone for whom the individual claims a personal exemption, shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made. For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: Spouse; and Natural, adopted or step children. For a child applicant the household size shall consist of the child and the following individuals: Natural, adopted, or step parents; and Natural, adopted, or step siblings. In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return. In the case of determining the household size of a pregnant woman, the pregnant woman shall be counted as herself plus the number of children she is expected to deliver. This regulation contains the rules for considering earned and unearned income of: Members of the MAGI household unit and those individuals whose income is considered pursuant to Regulation .06-1 of this chapter in determining financial eligibility of individuals for retroactive and current eligibility for the period under consideration; or Members of the MAGI exempt assistance unit and those individuals whose income and resources are considered pursuant to Regulation .06 of this chapter in determining financial eligibility of an assistance unit for retroactive and current eligibility for the period under consideration. Definitions. “Disregard” means the amount of money specified by regulation that can be subtracted from countable income. “Excludable income” means income which is exempt from consideration as countable income. “Federal Supplemental Nutrition Assistance Program (SNAP)”, formerly the Food Stamp Program, has the meaning stated in COMAR 07.03.17.01. “Income tax” means federal, state, or local taxes either paid or withheld from income of a self-employed person not to exceed the tax table amount for the number of known dependents. “Modified Adjusted Gross Income (MAGI) based income” means income calculated using the same financial methodologies used to determine modified adjusted gross income as defined in 42 CFR 435.603 , with the following exceptions: An amount received as a lump sum is counted as income only in the month received; Scholarships, awards, or fellowship grants used for education purposes and not for living expenses are excluded from income; and American Indian or Alaska Native exceptions in accordance with 42 CFR 435.603. The applicant shall report all income. When there is evidence of regular expenditures which are inconsistent with reported income, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. The Department or its designee shall consider all income in accordance with this regulation. Retroactive Eligibility. The income to be considered is that which was actually available during the retroactive period under consideration. Current Eligibility. In considering income for current eligibility, the following rules apply: When an individual has regular income in the MAGI coverage group, the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application; When an individual has a regular income in the MAGI Exempt coverage group, the amount to be considered is that which is available, or can reasonably be expected to be available, for a projected period of 6 months including the month of application; For participants currently enrolled in both the Program and SNAP: The Program may renew the individual’s Medicaid eligibility using household income as determined by SNAP without conducting a separate income determination; and An individual is determined eligible when the participant is: Younger than 19 years old and has a SNAP verified income at or below 200 percent of the federal poverty level for individuals in a MAGI coverage group; Younger than 19 years old and has a SNAP verified income at or below 300 percent of the federal benefit rate for individuals in a MAGI exempt coverage group; or Between 19 to 64 years old and has a SNAP verified income at or below 138 percent of the federal poverty level for individuals in a MAGI coverage group; When a member of a MAGI exempt assistance unit works for less than 12 months but receives an annual salary, is self-employed, or has irregular or seasonal earning, the amount to be considered is one-half the expected annual income based on the prior year's gross income; and For a deceased individual, the income to be considered is that which was available up to and including the month of death. When there are other individuals in the assistance unit or MAGI household unit, the deceased individual's income will be averaged over the unit's established period under consideration. Treatment of Income. All earned and unearned income which is not designated as excludable income pursuant to §J of this regulation shall be counted to establish countable gross income. Countable gross income for MAGI Exempt coverage groups shall be reduced by subtracting appropriate income disregards as specified in §K of this regulation to determine countable net income. Countable gross income for MAGI coverage groups shall be the household income calculated according to MAGI. MAGI income limits shall be: Converted from traditional income limits to account for elimination of income disregards; and Increased by 5 percentage points of the federal poverty level for the following circumstances: When an individual’s income exceeds the Medicaid income standard; and The income standard is the highest income standard under which the individual can be determined eligible. Earned income includes the following: Wages. Commissions and fees. Salaries and tips. The value of in-kind goods and services received as a result of employment. Profit from self-employment income of MAGI exempt coverage groups, as described in §K(3)(a)of this regulation. Remuneration received for work or for activities performed as a participant in a program conducted by a sheltered workshop or activities center. The Earned Income Tax Credit (EITC) a person receives through the Tax Reduction Act of 1973. Sick pay which counts as earnings for deduction purposes under Title II of the Social Security Act. Work study earnings. Unearned income includes the following: Benefits and income from: Social Security; Veterans Administration; Workmen's Compensation Board; Black Lung Program; Railroad Retirement Board; Government, private, or company pensions and annuities; Unemployment benefit plans; Unemployment supplemental benefit plans; Payments from oil or mineral rights (leases); Government payments on land; Insurance benefits paid directly to a person; Trust funds; Individual Retirement Accounts (IRA's); Keogh Plans; Military allotments. Alimony, court-ordered and voluntary support payments received from an absent spouse, or an absent natural or adoptive parent. Financial contributions received from persons or public or private agencies. In-kind Support—Aged, Blind, or Disabled. One-third the appropriate medically needy income level for the number of persons in an aged, blind, or disabled assistance unit, when: A person receives in-kind support in the form of food and shelter while living in the household of another, and The person pays less than his pro rata share of the total household expenses for food and shelter, unless he documents otherwise. The value of actual payments for food, shelter, or both made by other persons on behalf of the assistance unit. The fair market value of free shelter received while living in an independent dwelling unit. When the person fails to present evidence of the fair market value of the dwelling unit, the presumed value shall be 1/3 the appropriate medically needy income level for the number of persons in the assistance unit. This provision may not apply to persons residing in public or private institutions, foster homes, group homes, or commercial establishments. Interest, dividends, royalties, or other income accrued to stocks, bonds, insurance, and savings certificates if the income is available to the person on a regular basis. Interest or dividends accrued to savings accounts. Mortgage payments. Lump sum benefits or other amounts of income received on a one-time-only basis including gifts, inheritances, retroactive benefit payments, lottery winnings, damage claims unless specifically excluded by other regulations, or any other lump sums or portions of them that are not excluded under §J or K of this regulation. Profit from Rental Income as described in §§L(3)(b) and M(2)(c)(ii) of this regulation. Cash assistance received from nongovernmental social agencies unless excluded under the provisions of §J or §K of this regulation. Grants, loans, scholarships, and fellowships for educational purposes, except as specified in §J(3) and (9) of this regulation. Cash assistance, including Public Assistance grants and SSI benefits, except as specified in Regulation .06B(3)(a)(ii) and .06C(4)(a)(ii) of this chapter. Sick pay which does not count as earnings for deduction purposes under Title II of the Social Security Act. Excludable Income—Aged, Blind, or Disabled. Income from the following sources shall be excluded in determining countable gross income: The value of the coupon allotment under the Food Stamp Program. Payment received under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, 42 U.S.C. §4601 et seq., excluding compensation received for the fair market value of the acquired real property. Grants or loans to an undergraduate student for educational purposes made or insured under any program administered by the Secretary, U.S. Department of Education. Work-study earnings, work-study stipends, and reimbursement for out-of-pocket expenses of a student. Benefits received under Title III C Nutrition Program for the Elderly of the Older Americans Act of 1965, as amended. Stipends, compensation, or expenses received by volunteers from a program existing or to be set up under the “Domestic Volunteer Service Act of 1973” sponsored by ACTION, such as but not limited to: (PLS) Demonstration Project Program for Local Services; VISTA (Volunteers in Service to America); UYA (University Year for Action); RSVP (Retired Senior Volunteer Program); Foster Grandparents; Older American Community Service Program; SCORE (Service Corps of Retired Executives); and ACE (Action Corps of Executives). The value of supplemental food assistance received under the Child Nutrition Act of 1966 as amended, and the special food service program for children under the National School Lunch Act, as amended. The value of livestock and home produce used for own consumption. Educational Expenses. The portion of educational grants, loans, scholarships, and fellowships that is designated and used solely for undergraduate and graduate educational pursuits such as tuitions, books, mandatory fees, transportation to and from educational institutions, and the cost of child care while in attendance. These expenses may be allowed to the extent that there are insufficient funds from those grants and loans specified under §J(3) of this regulation to cover these expenses. The earned income of a blind or disabled child who is younger than 22 years old and regularly attending school, including a college, university, or vocational training school, not to exceed $1,620 a calendar year. Payments received from providing foster care or subsidized adoption services to a child placed in the home by a public or private nonprofit child placement or child care agency. Assistance provided in cash or in-kind under the Emergency Energy Conservation Services Program, including plans for crisis intervention to prevent fuel cut-offs and assistance provided under the Low-Income Home Energy Assistance Act. The value of rent subsidies or other assistance received by a person for his dwelling unit under: The U.S. Housing Act of 1937, 42 U.S.C. §§1400 et seq.; The National Housing Act, 12 U.S.C. §§1701 et seq.; Section 101 of the Housing and Urban Development Act of 1965, 42 U.S.C. §§1400 et seq.; Title V of the Housing Act of 1949, 12 U.S.C. §§1601 et seq.; 42 U.S.C. §§1400 et seq. Infrequent or Irregular Earned Income. Infrequent or irregular earned income shall be excluded if: The total gross amount does not exceed $30 per quarter; and It is received less frequently than twice per quarter or cannot be reasonably anticipated. Infrequent or Irregular Unearned Income. Infrequent or irregular unearned income shall be excluded if: The total amount does not exceed $200 per 6 months; and It is received less frequently than twice per quarter or cannot be reasonably anticipated. The value of earned and unearned in-kind income. Third-party payments for food, clothing, shelter, or other goods and services made on behalf of an assistance unit or other persons whose income and resources are considered in determining eligibility, if the payment is not reimbursement for services rendered by a member of the assistance unit or other persons whose income and resources are considered. The Earned Income Tax Credit (EITC) a person receives through the Tax Reduction Act of 1973. Reparation payments made by the Federal Republic of Germany. For recipients of a VA pension who have neither spouse nor child, the VA payment not to exceed $90 per month beginning the month after the month of admission to a long-term care facility. Cash, including interest earned on the cash, or in-kind replacement received from any source for purposes of repairing or replacing an excluded resource that is lost, damaged, or stolen is not income but continues to be considered as an excluded resource in accordance with the provisions of Regulation .08G(7) of this chapter. Assistance, including any interest earned on the assistance, received under the Disaster Relief Act of 1974 (PL 93-288) or other assistance provided under a federal statute because of a catastrophe which is declared to be a major disaster by the President of the United States is not income but an excluded resource. Support and Maintenance (In-Kind Income) Provided as Replacement for an Excluded Home Because of a Casualty Loss or a Presidentially Declared Major Disaster. When an excluded home is damaged or destroyed and temporary housing is furnished to a person who owned an excluded home, the in-kind support and maintenance is not counted as income. This temporary housing is intended to replace the home pending repair or replacement of the excluded home. When an excluded home is damaged or destroyed as a result of a presidentially declared major disaster, the value of support and maintenance (in cash or in-kind) received by a person, or couple, is excluded, if: The person, or couple, was residing in the household as a home when a catastrophe occurred in the area in which the home was located; The catastrophe was declared by the President to be a major disaster for purposes of the Disaster Relief Act of 1974; The person, or couple, stopped living in the home because of the catastrophe and, within 30 days after the catastrophe, began to receive the support and maintenance; and The person, or couple, received the support and maintenance while living in a residential facility, including a private home, maintained by another person. Any amount refunded from any public agency, if paid on the purchase of food or the satisfaction of real property levies. One-third of support payments made to or for a blind or disabled child by an absent parent. Interest income accrued to a: Bank account during the period under consideration, such as a checking, savings, or money market account; Dedicated bank or other financial institution account that is considered an excludable resource because it is unavailable, such as an escrow account for a security deposit; or Keogh account, individual retirement account (IRA), or other private retirement account that is countable as a resource. Interest payments received for a mortgage, promissory note, or other loan. Refund of taxes on income, property, food, or other items already paid. Proceeds of a loan received by an individual as the borrower. Payments received from a trust, if the trust is countable as a resource. Income from the sale of an assistance unit member's blood or plasma. Cash donations based on need received from one or more charitable organizations. All income excluded by federal statute for medical assistance programs. Disregards — Aged, Blind, or Disabled. In order to determine countable net income, the following disregards shall be deducted from the countable gross income of an aged, blind, or disabled assistance unit: A general disregard of $20 per month for a person or a couple. An earned income disregard of $65 per month plus one-half of the remainder of the earned income of a person or a couple. A disregard of one-half of the gross income amount for the following types of income: Profit from self-employment income, unless an applicant or recipient can document a cost to produce in excess of the disregard of one-half of gross income; and Profit from rental property income and other income-producing property. The amount of earned income used to meet any expenses reasonably attributable to earning of income of a blind person younger than 65 years old in accordance with 20 CFR §416.1112(c)(5). Any wages, allowances, or reimbursement for transportation and attendant care costs, unless excepted on a case-by-case basis, when received by a blind or disabled handicapped person employed in a project under Title VI of the Rehabilitation Act of 1973 as added by Title II of Pub. L. No. 95-602 (92 Stat. 2992, 29 U.S.C. §795(b)(c)). Schedule MA-1. This regulation contains the rules for considering resources of members of the MAGI exempt assistance unit and those individuals whose income and resources are considered pursuant to Regulation .06 of this chapter in determining financial eligibility of an assistance unit for retroactive and current eligibility for the period under consideration. Definitions. “Account” means cash savings or any other form of liquid resource in a bank, credit union, savings and loan association, or any other financial institution in which the resource is subject to withdrawal by the owner or owners of the account. Automobile. “Automobile” means a passenger car or any other vehicle used to provide necessary transportation. “Automobile” does not mean an airplane, farm machinery, or a vehicle used solely for recreational purposes. “Burial funds” means a revocable burial contract, burial trust, or other burial arrangement or any other separately identifiable fund which is clearly designated as set aside for a person's burial expenses. “Burial spaces” means conventional gravesites, crypts, mausoleums, urns, and other repositories which are customarily and traditionally used for the remains of deceased persons. “Equity value” means the fair market value of property less any legal debt on the property. “Fair market value” means the amount for which property can be sold on the open market in a particular geographical area. “Funds in an irrevocable trust or other irrevocable arrangement that are available to meet burial expenses” means funds which are held in an irrevocable burial contract, an irrevocable burial trust, or an amount in an irrevocable trust which is specifically identified as available for burial expenses. “Home” means any shelter in which a member of the assistance unit or any person whose income and resources are considered in determining the financial eligibility of the assistance unit, has an ownership interest and uses as his principal place of residence. The home includes the parcel of land on which the shelter is situated and any related outbuildings necessary to its operation. Only one residence may be considered home property. “Immediate family” means a person's spouse or a person's minor and adult children, including adopted children and stepchildren, or a person's brothers, sisters, parents, adoptive parents, and the spouses of these persons. Neither dependency nor living in the same household are factors in determining whether a person is an immediate family member. “Institutionalized person” means a person who is: An inpatient in a nursing facility; An inpatient in a medical institution and with respect to whom payment is made based upon a level of care provided in a nursing facility; or Receiving services under a home and community-based services waiver under COMAR 10.09.27 or 10.09.31. “Joint account” means an account in which two or more persons are named as owners of the account and the funds in the account are subject to withdrawal by any of the persons named as owners. “Medicaid qualifying trust” means a trust or similar legal device established on or before August 10, 1993, other than by will, by an individual or an individual's spouse, under which the individual or the individual's spouse may be the beneficiary of all or part of the payments from the trust, and the distribution of payment is determined by one or more trustees who are permitted to exercise any discretion with respect to the distribution to the individual. “Nonapplicant” means a person who is neither an applicant nor the spouse of an applicant. Property. “Property” means any thing or things in which a person has a legal or equitable interest. “Personal property” means all property that is not real property. “Real property” means property which is fixed or immovable such as land or a building. “Uncompensated value” means the difference between the fair market value of a person's interest in a resource at the time it was disposed of and the amount of compensation received for the resource. The applicant shall report all resources to the Department or its designee with the exception of non-disabled children and their caretaker relatives who are not being considered as medically needy. Countable income that is retained at redetermination or reapplication shall be considered a resource unless specifically excluded by other regulations. The Department or its designee shall require an accounting and reasonable documentation, consisting of convincing testimony or other evidence, of the disposal of previously held resources within 30 months before the month of application to assure that the resources are no longer available and the disposal meets the requirements of this regulation. Excludable Resources for Aged, Blind, or Disabled Noninstitutionalized Individuals and Aged, Blind, or Disabled Institutionalized Individuals Who Intend to Return Home. The following resources are excluded in determining financial eligibility for aged, blind, or disabled noninstitutionalized individuals and for an aged, blind, or disabled institutionalized individual who intends to resume living in the individual's home: The home, as defined under §B(7) of this regulation, unless the person is institutionalized and has a life estate interest with full powers in the home. Income-Producing Property. Income-producing property associated with the home includes farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. The property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §F(2)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. Income-producing property not associated with the home includes land, buildings, farm machinery, business equipment, vehicles, special tools, farm animals and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §F(2)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. $6,000 Equity Value Exclusion. A $6,000 equity value exclusion applies to the combined equity value of resources in §F(2)(a) and (b) of this regulation. The exclusion does not apply to each individual property. Limitations on Equity Value Exclusion. The full equity value of each property not producing a net annual return of 6 percent will be a countable resource. The combined equity value in excess of $6,000 of all properties producing an individual net annual return of 6 percent will be a countable resource. Household Goods and Personal Effects. Household Goods. Household goods include those items of personal property customarily found in the home and used in connection with the maintenance, use, and occupancy of the premises as a home and in the functions and activities of home and family life, as well as those items which are for comfort and accommodation. Household goods necessary for the maintenance, use, and occupancy of the home shall be excluded regardless of value. The equity value of nonessential items shall be added to other countable resources and measured against the applicable resource standard. Personal Effects. Personal effects include those items of personal property which are worn or carried by a person or have an intimate relation to him. Personal effects shall be excluded except as specified in §F(3)(b)(iii) of this regulation. The equity value of nonessential personal effects of considerable value such as furs, and jewelry which is not excluded in §F(3)(c) of this regulation, shall be added to other countable resources and measured against the applicable resource standard. A wedding ring and an engagement ring shall be excluded from consideration as resources. Prosthetic devices, dialysis machines, hospital beds, wheelchairs, and similar equipment required because of a person's physical condition shall be excluded from consideration as resources. For an institutionalized person, household goods and personal effects remaining in the possession of the person at the long-term care facility shall be excluded from consideration as resources. Livestock and farm produce that is used only for home consumption. Automobiles. Life Insurance with a Maximum Face Value of $1,500 for Each Person. Life insurance policies such as term or burial insurance which do not have a cash surrender value may not be used in determining the total face value of all policies. Whenever the total face value of all policies on any person exceeds the allowable maximum face value, the entire cash surrender value of these policies shall be counted as a resource. Cash surrender value includes available accrued dividends and interest. Cash and In-Kind Replacement Received for Casualty Losses of Excluded Resources. Cash, including interest earned on the cash, or in-kind replacement received from any source for the purpose of replacing an excluded resource that is lost, damaged, or stolen, shall be an excluded resource for a period of 9 months, beginning with the date the cash or in-kind replacement was received. The initial 9-month exclusion period specified in §F(7)(a) of this regulation shall be extended for a reasonable period up to an additional 9 months if circumstances beyond the control of the individual prevent him from repairing, replacing, or contracting for the repair or replacement of the resource. Any of the cash and interest or in-kind replacement that is not used to repair or replace the excluded resource shall be counted as a resource beginning with the period under consideration after expiration of the initial 9-month period, or the extended period, if any. If an extension of the time period is made pursuant to §F(7)(b) of this regulation and the individual changes his intent to repair or replace the excluded resource, cash and interest, or in-kind replacement previously excluded, shall be counted as resources effective with the month the individual reports his change of intent. Assistance Received Because of a Major Disaster. Assistance, including any interest earned on the assistance, received under the Disaster Relief Act of 1974 (PL 93-288) or other assistance provided under a federal statute because of a catastrophe which is declared to be a major disaster by the President of the United States shall be excluded in determining countable resources for a period of 9 months from the date of receipt. The initial 9-month period for not counting the assistance specified in §G(8)(a) of this regulation shall be extended for a reasonable period up to an additional 9 months if circumstances beyond the control of the person prevented him from repairing, replacing, or contracting for repair or replacement of damaged or destroyed property. Burial spaces for a person and the person's immediate family. Proceeds from Sale of a Home. Proceeds from the sale of a home shall be excluded from consideration as a resource for a period not to exceed 3 months from the date the proceeds are received if the: Person indicates he intends to replace the home during that period; Home is in fact replaced during that period; and Replaced home itself was an excluded resource under the provision of §F(1) of this regulation. Payment received under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, 42 U.S.C. §4601 et seq. Compensation received for the fair market value of the acquired real property is not subject to this regulation. Assistance provided in cash or in-kind under the Emergency Energy Conservation Services Program, including plans for crisis intervention to prevent fuel cut-offs and assistance provided under the Low-Income Home Energy Assistance Act. Burial Funds. In determining the resources of a person and the person's spouse, if any, there shall be excluded an amount up to $1,500 per person of funds specifically set aside for burial arrangements of the person or the person's spouse. Interest earned on excluded burial funds and appreciation on the value of excluded burial arrangements shall be excluded from resources if left to accumulate and become a part of the burial fund. Funds or interest earned on funds and appreciation in the value of burial arrangements, which have been excluded from resources because they are burial funds, shall be used solely for that purpose. If any excluded funds, interest, or appreciated value set aside for burial expenses are used for any purpose other than the burial arrangements of the person or the person's spouse for whom the funds were set aside, the unit shall be determined ineligible until the unit spends for medical services an amount which is equal to the amount of burial funds used for some other purpose. §F(13)(d) of this regulation may not apply if countable resources, when added to the total excluded burial funds, including the amount misspent, were within the applicable amount in Schedule MA-2 during the month in which the use of burial funds for some other purpose occurred. An individual's $1,500 exclusion as described under §F(13)(a) of this regulation shall be reduced by: The face value of life insurance policies owned by the individual or the individual's spouse if the cash surrender value of those policies has been excluded from resources; and Amounts in an irrevocable burial fund as described under §F(14) of this regulation. An irrevocable burial fund of any amount, which has been set aside for the burial of the individual or the individual's spouse. Excludable Resources for Aged, Blind, or Disabled Institutionalized Individuals Who Do Not Intend to Return Home. The following resources are excluded in determining financial eligibility for an aged, blind, or disabled institutionalized individual who does not intend to resume living in the individual's home: The home as defined in §B(4) of this regulation, if it is occupied by the institutionalized person's spouse or any one of the following relatives who are medically or financially dependent: Son; Daughter; Grandson; Granddaughter; Stepson; Stepdaughter; In-laws; Mother; Father; Stepmother; Stepfather; Half sister; Half brother; Niece; Nephew; Grandmother; Grandfather; Aunt; Uncle; Sister; Brother; Stepbrother; Stepsister. Household Goods and Personal Effects Remaining in the Possession of the Person at the Long-Term Care Facility. Household goods include those items of personal property which are customarily found in the home and used in connection with the maintenance, use, and occupancy of the premises as a home and in the functions and activities of home and family life, as well as those items which are for comfort and accommodation. Personal effects include those items of personal property which are worn or carried by a person or have an intimate relation to him. Household goods and personal effects include, but are not limited to, items of personal clothing, toilet articles, prosthetic devices, an engagement ring, and a wedding ring. Life Insurance with a Maximum Face Value of $1,500 for Each Person. Life insurance policies such as term or burial insurance which do not have a cash surrender value may not be used in determining the total face value of all policies. Whenever the total face value of all policies exceeds the allowable maximum face value, the entire cash surrender value of these policies shall be counted as a resource. Cash surrender value includes all available accrued dividends and interest. Burial spaces for a person and the person's immediate family. Income-Producing Property. Income-producing property associated with the home includes farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §G(5)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. Income-producing property not associated with the home includes land, buildings, farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §G(5)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. $6,000 Equity Value Exclusion. A $6,000 equity value exclusion applies to the combined equity value of resources in §G(5)(a) and (b) of this regulation. The exclusion does not apply to each individual property. Limitations on Equity Value Exclusion. The full equity value of each property not producing a net annual return of 6 percent will be a countable resource. The combined equity value in excess of $6,000 of all properties producing an individual net annual return of 6 percent will be a countable resource. Burial Funds. In determining the resources of a person and the person's spouse, if any, there shall be excluded an amount up to $1,500 per person of funds specifically set aside for burial arrangements of the person or the person's spouse. Interest earned on excluded burial funds and appreciation on the value of excluded burial arrangements shall be excluded from resources if left to accumulate and become a part of the burial fund. Funds or interest earned on funds and appreciation in the value of burial arrangements, which have been excluded from resources because they are burial funds, shall be used solely for that purpose. If any excluded funds, interest, or appreciated value set aside for burial expenses are used for any purpose other than the burial arrangements of the person or the person's spouse for whom the funds were set aside, the unit shall be determined ineligible until the unit spends for medical services an amount which is equal to the amount of burial funds used for some other purpose. Section G(6)(d) of this regulation may not apply if countable resources, when added to the total excluded burial funds, including the amount misspent, were within the applicable amount in Schedule MA-2 during the month in which the use of burial funds for some other purpose occurred. An individual's $1,500 exclusion as described under §G(6)(a) of this regulation shall be reduced by: The face value of life insurance policies owned by the individual or the individual's spouse if the cash surrender value of those policies has been excluded from resources; and Amounts in an irrevocable burial fund as described under §G(7) of this regulation. An irrevocable burial fund of any amount, which has been set aside for the burial of the individual or the individual's spouse. Exclusion of the home under §§F(1) and G(1) of this regulation and exclusion of income-producing property under §§F(1) and G(5) of this regulation do not prevent a lien being attached to or executed on the home or property except as provided in Regulation .15A-2(3) of this chapter. Treatment of Joint Accounts. If a joint account exists between an applicant and a nonapplicant, all of the funds in the account are considered available to the applicant. If a joint account exists between the spouse of an applicant and a nonapplicant, all of the funds in the account are considered available to the spouse of the applicant. If a joint account exists between an applicant, the spouse of an applicant, and a nonapplicant, all of the funds in the account are considered available to the applicant and the spouse of the applicant. Rebuttal of Presumption of Full Ownership Interest. If the nonapplicant owner can demonstrate, to the Department's satisfaction, that the nonapplicant made regular and proportionate contributions of the nonapplicant's own funds to the account, a pro rata share of the funds is considered available to the nonapplicant. If either the applicant, the spouse of the applicant, or the nonapplicant owner of a joint account believes that the ownership interest attributed to him or her by the Department under §I(1)—(3) or (4)(a) of this regulation is incorrect and can demonstrate, under §I(5)(b)of this regulation, to the satisfaction of the Department, an ownership interest other than that attributed to him or her by the Department, the Department shall consider the amount established through rebuttal as the correct amount for the purpose of determining eligibility for Medical Assistance. Declaration of Ownership Interests. The applicant and the nonapplicant of a joint account shall declare their ownership interests on a form designated by the Department. The applicant shall provide adequate documentation to substantiate the declared ownership interests. If the nonapplicant owner withdraws funds from the account during or after the 30-month period immediately before the month of application, the withdrawal is considered a disposal by the applicant or the spouse of the applicant to the extent that the remaining funds are less than the amounts considered available to the applicant under §I(1)—(4) of this regulation. Medicaid Qualifying Trust. In the case of a Medicaid qualifying trust as defined under §B(12) of this regulation, the amount from the trust considered available to the person or the person's spouse establishing the trust is the maximum amount of payments that may be permitted under the terms of the trust to the beneficiary, assuming the full exercise of discretion by the trustee or trustees for the distribution of the maximum amount to the beneficiary. Section J of this regulation shall apply whether or not the: Medicaid qualifying trust is irrevocable or has been established for purposes other than to enable a person to qualify for Medical Assistance; or Discretion described under §J of this regulation is actually exercised. If the beneficiary of a trust is an intellectually disabled person who resides in an intermediate care facility for the intellectually disabled, the trust may not be considered a Medicaid qualifying trust if it was established before April 17, 1986 and is solely for the benefit of the intellectually disabled person. The Department may waive the application of §J of this regulation if the Department determines that to do so would work an undue hardship. Disposal of Resources for Less than Fair Market Value. In determining eligibility for Medical Assistance for any period under consideration beginning before October 1, 1993, an institutionalized individual shall be determined ineligible for nursing facility services, for a level of care in a medical institution equivalent to that of nursing facility services, and for waiver services under COMAR 10.09.27 and 10.09.31 if the individual or the individual's spouse: Disposes of a resource for less than fair market value at any time during or after the 30-month period immediately before or after the date the person becomes an institutionalized person if the person is entitled to Medical Assistance on that date; or If not entitled to Medical Assistance on that date, then on the date the person applies for Medical Assistance while an institutionalized person. If a person disposes of a resource for less than fair market value while in a period of ineligibility for an earlier disposal, the later disposal is considered a part of the earlier disposal for purposes of computing the total period of ineligibility. The period of ineligibility shall begin with the month in which the resource was transferred and the number of months in the period shall be equal to the lesser of: 30 months; or The total uncompensated value of the transferred resource, divided by the average cost, to a private patient at the time of application, of nursing facility services in the state in which the person is institutionalized. An institutionalized person may not be determined ineligible for Medical Assistance under §K(1) of this regulation if the resource transferred was a home and title to the home was transferred to: The spouse of the person; The person's child as defined under Regulation .02B(12) of this chapter or who is blind or disabled as determined under Regulation .05D and E of this chapter; A sibling of the person who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date the person became an institutionalized person; or A son or daughter of the person other than the person's child described under §K(4)(b) of this regulation, who: Is lawfully residing in the home, Was residing in the home for a period of at least 2 years immediately before the date the person became an institutionalized person, and Can establish, to the Department's satisfaction, that the son or daughter provided the care that permitted the person to reside at home rather than in an institution. A person may not be determined ineligible for Medical Assistance by reason of the transfer of any resource, excluded or nonexcluded, if the resource was transferred under any one of the conditions below: The resource was transferred to the community spouse, or to another for the sole benefit of the community spouse, as defined under Regulation .10-1B(1) of this chapter; The resource was transferred to the person's son or daughter who is blind or disabled as defined under Regulation .05D and E of this chapter; The resource was transferred to the person's spouse, or to another for the sole benefit of the person's spouse, if the spouse does not transfer the resource to another person for less than fair market value; The person furnishes convincing evidence, consisting of testimony or other corroborative evidence, that the person intended to dispose of the resource at fair market value or for other valuable consideration; The person furnishes convincing evidence that the resource was transferred exclusively for a purpose other than to qualify for Medical Assistance; or The Department determines that the denial of eligibility would work an undue hardship. A unit shall be ineligible for any month in which countable resources exceed the applicable standard, but may reapply for any following month in which countable resources are less than or equal to the applicable standard. Schedule MA-2. Schedule MA-2A. Definitions. In this regulation, the following terms have the meanings indicated: “Assets” means all income and resources of an individual and of an individual's spouse, including any income or resources which the individual or the individual's spouse is entitled to but does not receive because of action by: The individual; The individual's spouse; A person, including a court or administrative body: With legal authority to act in place of or on behalf of the individual or the individual's spouse, or Acting at the direction or upon the request of the individual or the individual's spouse. “Trust” means a legal instrument, which is either revocable or irrevocable, created, other than by will, by a grantor for the benefit of designated beneficiaries under the laws of the State and subject to the management of a trustee or trustees who have a fiduciary responsibility to manage the trust's resources and income for the benefit of the beneficiaries. Disposal of Assets. In determining eligibility for Medical Assistance for any period under consideration beginning on or after October 1, 1993, in the case of assets disposed of after August 10, 1993, a penalty period shall be established during which an individual is determined ineligible for nursing facility services, for a level of care in a medical institution equivalent to that of nursing facility services, and for home and community-based waiver services provided for under the authority of §1915(c) and (d) of the Social Security Act if the individual or the individual's spouse disposes of an asset for less than fair market value at any time during or after the time periods specified under §B(2) of this regulation. Time Periods for Evaluating Disposals. For assets other than trusts, the time period for evaluating disposals is the following: For disposals earlier than February 6, 2006, the 36-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance. For disposals on or after February 6, 2006, the 60-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance. In the case of payments from a trust or portions of a trust that are treated as a disposal of assets under Regulation .08-2B(4)(c), (5)(a)(ii), or (5)(b) of this chapter, the time period for evaluating disposals is the 60-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance. The penalty period begins: For a transfer before February 6, 2006, with the later of: The first day of the month in which the asset was transferred; or The date on which the individual is eligible for Medical Assistance and, but for the transfer, would be receiving institutional level of care; and For a transfer on or after February 6, 2006, with the later of: The first day of the month in which the individual is eligible for Medicaid and would be receiving Medicaid nursing facility services but for the application of this penalty; or The month during or after which assets have been transferred for less than fair market value. If the transfer occurs while the individual is in a penalty period for an earlier disposal, the penalty period begins on the first day of the first month following the end of the earlier penalty period. The number of months in the penalty period are equal to the total, cumulative, uncompensated value of all assets transferred, divided by the average monthly cost, to a private patient at the time of application for Medical Assistance, of nursing facility services in the State. Asset Transfers For Less Than Average Monthly Cost of Care. If the amount of a transfer is less than the average monthly cost of nursing facility services in the State, the length of the penalty period is calculated based on the proportion of the average monthly cost of nursing facility services that was transferred. If a series of transfers is made, each of which is less than the average monthly cost of nursing facility services, the penalty period is calculated based on the total, cumulative, uncompensated value of all assets transferred. Transfers Not Equally Divisible. If the amount of a single transfer or the amount of the total, cumulative, uncompensated value of all assets transferred is not equally divisible by the average monthly cost of nursing facility services in the State, the length of the penalty period is calculated based on the proportion of the average monthly cost of nursing facility services that was transferred. An institutionalized individual may not be determined ineligible for Medical Assistance under §B(1) of this regulation if the asset transferred was a home, and title to the home was transferred to: The spouse of the individual; The individual’s child as defined under Regulation .02B of this chapter or who is blind or disabled as determined under Regulation .05-4 of this chapter; A sibling of the individual who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date the individual became an institutionalized individual; or A son or daughter of the individual other than the individual’s child described under §B(8)(b) of this regulation, who: Is lawfully residing in the home, Was residing in the home for a period of at least 2 years immediately before the date the individual became an institutionalized individual, and Can establish, to the Department's satisfaction, that the son or daughter provided the care that permitted the individual to reside at home rather than in an institution. An individual may not be determined ineligible for Medical Assistance by reason of the transfer of any asset, excluded or countable, if the asset was transferred under one of the following conditions: The asset was transferred to the individual's spouse or to another for the sole benefit of the individual's spouse; The asset was transferred from the individual's spouse to another for the sole benefit of the individual's spouse; The asset was transferred to, or to a trust established for the sole benefit of, the individual’s son or daughter who is blind or disabled as defined under Regulation .05-4 of this chapter; The asset was transferred to a trust established for the sole benefit of a disabled individual, as defined under Regulation .05-4B of this chapter, younger than 65 years old; The individual furnishes convincing evidence, consisting of testimony or other corroborative evidence, that the individual intended to dispose of the asset at fair market value or for other valuable consideration; The individual furnishes convincing evidence that the asset was transferred exclusively for a purpose other than to qualify for Medical Assistance; or The full value of the asset transferred by an individual for less than fair market value has been returned to the individual. In the case of an asset held by an individual in common with another individual or individuals in a joint tenancy, tenancy in common, or similar arrangement, the asset, or the affected portion of the asset, shall be considered a transfer when any action is taken, either by the individual or by any other individual, that reduces or eliminates the individual's ownership or control of the asset. For the purpose of this regulation, “trust” has the meaning defined under Regulation .08-1A of this chapter. Treatment of Trusts Established after August 10, 1993. In determining eligibility for Medical Assistance for any period under consideration beginning on or after October 1, 1993, in the case of trusts established after August 10, 1993, an individual shall be considered to have established a trust if assets of the individual as defined under Regulation .08-1A of this chapter were used to form all or part of the corpus of the trust and if any of the following persons established the trust other than by will: The individual; The individual's spouse; A person, including a court or administrative body: With legal authority to act in place of or on behalf of the individual or the individual's spouse, or Acting at the direction or upon the request of the individual or the individual's spouse. In the case of a trust, the corpus of which includes assets of one of the individuals described under §B(1)(a) or (b) of this regulation and assets of any other individual or individuals, the provisions of this regulation apply to the portion of the trust attributable to the assets of the individual described under §B(1)(a) or (b) of this regulation. The provisions of this regulation apply without regard to: The purposes for which a trust is established; Whether the trustees have or exercise any discretion under the trust; Restrictions on when or whether distributions may be made from the trust; or Restrictions on the use of distributions from the trust. Revocable Trusts. In the case of a revocable trust: The corpus of the trust shall be considered resources available to the individual; Payments from the trust to, or for the benefit of, the individual shall be considered income of the individual; and Other payments from the trust shall be considered assets disposed of by the individual. Irrevocable Trust. In the case of an irrevocable trust, if there are any circumstances under which payment from the trust could be made to or for the benefit of the individual: The portion of the corpus from which, or the income on the corpus from which, payment to the individual could be made shall be considered resources available to the individual, and payments from that portion of the corpus or income: To or for the benefit of the individual, shall be considered income of the individual, and For any other purpose, shall be considered a transfer of assets; and A portion of the trust from which, or any income on the corpus from which, a payment could not, under any circumstances, be made to the individual shall be considered to be assets disposed of by the individual, as of the date of establishment of the trust or, if later, the date on which payment to the individual was foreclosed. The value of the trust shall be determined, for purposes of evaluating the disposal, by including the amount of any payments made from that portion of the trust after the date of establishment or foreclosure. The following trusts may not be counted in determining eligibility for Medical Assistance: Special needs trusts as defined in §C of this regulation; and A pooled special needs trust containing the assets of an individual who is disabled, and which meets all of the following conditions: The trust is established and managed by a nonprofit association, A separate account is maintained for each beneficiary of the trust but, for purposes of investment and management of funds, the trust pools these accounts, Accounts in the trust are established solely for the benefit of disabled individuals by the parent, grandparent, or legal guardian of the individuals, by the individuals, or by a court, and To the extent that amounts remaining in the beneficiary's account upon the death of the beneficiary are not retained by the trust, the trust pays to the Department from the amounts remaining in the account an amount equal to the total amount of Medical Assistance paid on behalf of the beneficiary. A nonprofit association that establishes and manages a trust consistent with the requirements of §B(6)(b) of this regulation may establish accounts for individuals for whom no governmental entity has made a determination of disability, provided that: The beneficiary of the account has submitted, or is actively engaged in preparing to submit, an application to: The Social Security Administration for Supplemental Security Income or Social Security Disability Insurance; or The Department of Human Services State Review Team for a disability determination using the Social Security Administration rules; and The account is closed immediately upon a determination, exclusive of appeals, by any State or federal governmental agency that the beneficiary of the account is not disabled. Special Needs Trust. The following criteria shall define a single, stand-alone special needs trust that is funded with assets that belonged to the beneficiary: The trust is irrevocable; The trust states that the beneficiary is disabled under Regulation .05-4B of this chapter; The beneficiary of the trust is younger than 65 years old at the time the trust is established and funded; The trust has been established by: The beneficiary; The beneficiary’s parent; The beneficiary’s grandparent; The beneficiary’s legal guardian; or A court; The trust does not contain provisions that conflict with the policies set forth under this regulation; The trust provides that all states which have provided medical assistance benefits to the beneficiary shall be paid their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states, up to the amount of assets remaining in the trust upon the death of the beneficiary; If the trust allows for the termination of the trust before the death of the beneficiary, the trust shall provide that: All states which have provided medical assistance benefits to the beneficiary shall be paid their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states, up to the amount of assets remaining in the trust at the time of termination, after administrative expenses related to the termination of the trust; Other than amounts paid to the states under §C(7)(a) of this regulation and payment of administrative expenses and reasonable compensation to the trustee for trust management, along with reasonable costs associated with investment, legal, or other services, no entity other than the trust beneficiary may benefit from early termination of the trust; and The power to terminate shall be held by someone other than the trust beneficiary; The trust does not permit distribution of trust assets upon termination of the trust that would hinder or delay reimbursement to the states under §C(6) and (7) of this regulation; The trust does not place time limits, or any other limits, on the states’ claim for reimbursement under §C(6) and (7) of this regulation; The trust contains the following provisions: Additions may not be made to the trust after the beneficiary is 65 years old; Expenditures from the trust shall be used for the sole benefit of the beneficiary and shall be directly related to the beneficiary's health care, education, comfort, or support; The trust beneficiary may not serve as trustee, cotrustee, trust protector, trust advisor, or in any other capacity that would allow the beneficiary to influence or exercise authority or control over distributions from the trust; The trustee shall administer the trust in accordance with the provisions of Estates and Trusts Article, §15-502, Annotated Code of Maryland, and may not: Except for the beneficiary’s relative, limited to the relatives defined at COMAR 10.09.24.02B(10)(a), who may have a contingent future interest in any trust funds remaining in the trust after the requirements of §C(6) of this regulation have been met, have an interest in trust assets; Have discretion to use trust assets for the trustee's own benefit; Self-deal by selling trust assets to the trustees or buying trust assets from the trustee; or Loan trust assets to the trustee; Compensation to the trustee shall be limited in accordance with the provisions of Estates and Trusts Article, §14.5-708, Annotated Code of Maryland; Any leases or mortgages that the trust may hold shall contain a provision that they either terminate or become due and payable upon the death of the beneficiary or termination of the trust; If the trust owns titled property that is valued at more than $500, the property shall be titled in the name of the trust, except for securities, which may be held in the name of a nominee; If the trust owns an asset jointly with another, the ownership shall be as tenants in common, and the ownership agreement shall provide that, upon termination of the trust, the property shall either be sold for fair market value or the other owners shall purchase the trust's interest in the property for fair market value; Trust assets may not be held as an ongoing business or enterprise, or as investments in new or untried enterprises; Trust distributions may not be used to supplement Medical Assistance payments to any health care provider delivering goods or services to the beneficiary; Trust assets may not be used to purchase gifts; Trust assets may not be used to purchase a life insurance policy on the life of the beneficiary; Trust assets may only be used to purchase a life insurance policy on the life of someone other than the trust beneficiary if the trust is the only beneficiary of the life insurance policy; Trust assets may not be used to purchase an annuity on the life of the beneficiary unless, upon the beneficiary’s death, all states which have provided medical assistance benefits to the beneficiary are paid, out of any remaining annuity payments, their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states. The trust may not loan trust assets without security, which may include an interest in real or personal property of at least equivalent value; The trust may only make loans if the loan agreement provides for immediate repayment in the event of the death of the beneficiary or termination of the trust for any other reason; The only real property in which the trust may invest is in a single home property, which is used as the residence of the beneficiary and is titled in the name of the trust; The trust may not disburse more than $100,000 for the purchase of property without the approval of the State circuit court in the jurisdiction in which the beneficiary resides; An annual accounting of the trust, including a listing of current assets, income, and itemized distributions during the previous year, shall be sent to the Maryland Medical Assistance Program, Division of Recoveries and Financial Services; Trust assets may not be used to pay funeral expenses of the beneficiary but may be used to purchase an irrevocable burial contract for the beneficiary to cover the beneficiary's funeral and burial expenses; The trust may not receive payments from a structured settlement or an annuity that was purchased by funds that are not part of the trust unless: Upon the beneficiary’s death, all states which have provided medical assistance benefits to the beneficiary are paid, out of any remaining annuity or settlement payments, their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states; and The beneficiary’s right to receive payments from the annuity or structured settlement has been assigned irrevocably to the trust and such assignment was made before the trust beneficiary attains the age of 65; A copy of the trust shall be sent to the Maryland Medical Assistance Program, Division of Recoveries and Financial Services, and if any amendments are made to the trust, the amendments shall comply with this section and a copy of the amendments shall be sent to the Division of Recoveries and Financial Services; If the trust agreement fails to comply with any provision of this section, the full value of the assets of the trust shall be considered available resources of the trust beneficiary for Medical Assistance eligibility purposes. Treatment of Entrance Fees before January 1, 2006. For Medical Assistance applications or requests for spousal resource assessments filed before January 1, 2006, the entrance fee shall be considered in accordance with the policies for exclusion of home property in this chapter. Treatment of Entrance Fees On or After January 1, 2006. For Medical Assistance applications or requests for spousal resource assessments filed on or after January 1, 2006, an entrance fee shall be considered available to the owner as a countable resource if the CCRC provides written verification, based on CCRC practice or policy, which satisfies the Department that all of the following criteria are met: The applicant or recipient or a designated beneficiary is eligible for a full refund of any amount remaining in the entrance fee, after subtracting any payments or transfers made by the individual in accordance with §B(1)(c)—(e) of this regulation, when the individual: Dies; or Terminates the continuing care agreement and leaves the CCRC facility; The entrance fee does not confer on the applicant or recipient a real property interest in the CCRC facility, in which case the entrance fee would be considered as excludable home property; The applicant or recipient has the ability to obtain funds from the entrance fee, without moving from the CCRC facility, to pay the CCRC or another entity for support and maintenance if the individual's income and other resources are insufficient to pay for the support and maintenance; If the Medical Assistance applicant or recipient has a son or daughter who is blind or disabled as defined under this chapter, the applicant or recipient has the ability to transfer unconditionally all or part of the entrance fee to the individual's blind or disabled son or daughter; and If the Medical Assistance applicant or recipient is institutionalized and married to a community spouse the: CCRC's entrance fee, if it is considered a countable resource in accordance with the requirements in §B of this regulation, shall be included in the assessment for the attribution of spousal resources, in accordance with Regulation .10-1 of this chapter; and CCRC shall permit the recipient to transfer unconditionally all or part of the entrance fee to the sole ownership of the community spouse according to the amount that is needed, after totaling other resources owned singly or jointly by the couple, for the community spouse resource allowance to total the protected amount calculated by the Department, in accordance with Regulation .10-1 of this chapter. The Department shall grant the applicant or recipient the opportunity to rebut the CCRC's written verification that all of the conditions in §B of this regulation are met for consideration of the entrance fee as a countable resource. If the applicant or recipient submits a rebuttal to the Department, the Department shall request additional documentation and evidence from the CCRC that support the basis for the CCRC's written verification of the availability of the entrance fee. The entrance fee may not be considered as a countable resource for determining the applicant's or recipient's Medical Assistance eligibility if the: Requirements in §B(1) of this regulation are not met; CCRC imposes limitations, conditions, penalties, or otherwise restricts the individual's right to reside in the CCRC facility when the individual uses funds from the entrance fee to make payments or transfers in accordance with §B(1)(c) — (e) of this regulation; or Applicant or recipient successfully rebuts, as determined by the Department in accordance with §B(2) of this regulation, the CCRC's written verification that all of the conditions in §B(1) of this regulation are met. This regulation establishes the rules for applicants and recipients who: Own a long-term care (LTC) partnership policy; and Meet all factors of Medicaid eligibility in accordance with MAGI Exempt coverage groups described in this chapter. Definitions. In this regulation, the following terms have the meanings indicated. Defined Terms. “Benefit payment amount” means the dollar value of LTC benefits which an insurance carrier has furnished on behalf of a partnership policyholder and which is disregarded from the resource amount when determining eligibility. “Insurance carrier” means an insurer who issues an insurance policy and makes benefit payment amounts on behalf of a partnership policyholder. “Partnership policy” means a LTC insurance policy that meets the requirements as described under COMAR 31.14.03.02 and whose benefit payment amount is disregarded from the resource amount when determining eligibility. “Partnership policyholder” means an individual who owns a partnership policy under the federal LTC partnership program. “Reciprocity compact” means an agreement among states having partnership programs that are approved under section 6021(b) of the Deficit Reduction Act of 2005, Public Law 109-171 (DRA). Partnership Policyholder Requirements. An applicant or recipient shall meet all factors of Medicaid eligibility in accordance with rules for MAGI Exempt coverage groups set forth in this chapter. An applicant or recipient shall have: A Maryland partnership policy approved on or after January 1, 2009, that meets all certification requirements, as described in COMAR 31.14.03; or A partnership policy approved in another state that has joined the national reciprocity compact under the federal LTC partnership program. An applicant or recipient shall provide documentation of the partnership policy benefit payments that have been issued by an insurance carrier. Subject to Regulation .10-2E of this chapter, an applicant or recipient who applies for LTC Medical Assistance in a nursing facility or through a waiver program shall be ineligible for payment for nursing facility services, or services under a home and community based waiver program, when the individual’s equity interest in home property exceeds the maximum allowable home equity amount as set forth in Regulation .10-2 of this chapter. Eligibility Determination for a Partnership Policyholder. When determining the resources of an individual in accordance with Regulation .08 of this chapter, there shall be disregarded a dollar value equal to the benefit payment amount. The benefit payment amount for purposes of the disregard set forth in §D(1) of this regulation shall: For purposes of initial application, equal the dollar amount of benefits paid to or on behalf of the partnership beneficiary at the time of application; and For purposes of redetermination, equal the benefit payment amount in §D(2)(a) of this regulation and the value of any additional benefits paid to or on behalf of the partnership beneficiary up to the time of redetermination, until all benefits under the partnership policy are exhausted. At the time of application and at each redetermination, the Department shall request documentation of the benefit payment amount. With the exception of an amount equal in value to the benefit payment amount applied at the most recent redetermination period, partnership policyholders will continue to be subject to a penalty for asset transfers for less than fair market value in accordance with Regulation .08 of this chapter. Estate recovery by the Department is limited as set forth in Regulation .15A-3(5) of this chapter. Basis. Financial eligibility is determined on the basis of the countable net income and resources of members of the MAGI exempt assistance unit and those individuals whose income and resource are considered pursuant to Regulations .06, .07, and .08 of this chapter for the period under consideration. For current eligibility under spend-down, a review to identify changes in the unit's financial and nonfinancial eligibility status shall be made before spend-down eligibility is established. The appropriate medically needy income level shall be the amount specified in Schedule MA-1 for the number of persons whose income is considered in determining financial eligibility. The appropriate medically needy resource level shall be the amount specified in Schedule MA-2 for the number of persons whose resources are considered in determining financial eligibility. Financial eligibility is determined on the basis of the countable income for members of the MAGI household unit and those individuals whose income are considered pursuant to Regulations .06-1 and .07 of this chapter for the period under consideration. For current eligibility under spend-down, a review to identify changes in the unit's financial and nonfinancial eligibility status shall be made before spend-down eligibility is established. Retroactive Eligibility. When the countable net income and resources are equal to or less than the medically needy income and resource levels, eligibility exists as medically needy. When the countable net income is greater than the medically needy income level and the countable resources are equal to or less than the medically needy resource level, retroactive eligibility may exist under the spend-down provision as specified in §B(4) of this regulation. Excess Resources. Retroactive eligibility does not exist when the countable resources are greater than the medically needy resource level. Retroactive Spend-Down Eligibility. In determining retroactive spend-down eligibility, documented medical and remedial expenses incurred during the 3 months before the month of application of any person whose income and resources are considered in determining eligibility shall be considered if the incurred expenses: Have not been paid for by any third party, including a family member or an insurer; and Are not required to be paid for by any third party, such as an insurer. The incurred medical expenses shall be considered on a month-by-month basis beginning with the earliest month in the period under consideration and shall be deducted from excess income in the following order: Medicare and other health insurance premiums, deductibles, or coinsurance charges; Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. Retroactive spend-down eligibility is established when the incurred medical expenses exceed the excess income. The medical expense used to establish retroactive spend-down eligibility may not be: Reimbursed by the Medical Assistance Program; or Used for any subsequent eligibility determination. Retroactive spend-down eligibility is not established when the incurred medical expenses are equal to or less than the excess income. Current Eligibility. When the countable net income and resources are equal to or less than the medically needy income and resource levels, eligibility exists as medically needy. When the countable net income is greater than the medically needy income level and the countable resources are equal to or less than the medically needy resource level, eligibility may exist under the spend-down provision as specified in §C(4) of this regulation. Spend-down eligibility is established when the amount of the incurred medical expenses equals or exceeds the excess income. Excess Resources. Eligibility does not exist when the countable resources are greater than the medically needy resource level. Spend-Down Eligibility. In determining spend-down eligibility, documented medical expenses incurred during the time periods and meeting the conditions specified in §C(4)(b)—(d) of this regulation shall be considered. Medical expenses incurred before the month of application shall be considered if: The expenses were not considered in any retroactive certification; The expenses were not used to establish spend-down eligibility for a prior certification; and The expenses are not paid for by any other person, remain the obligation of the person whose income and resources are considered in determining eligibility, and have not been forgiven by the provider of the services as evidenced by account statements dating up to 3 months before the month of application. Medical expenses incurred at any time during or after the month of application and before the end of the period under consideration by any person whose income and resources are considered in determining eligibility shall be considered if the medical expenses: Have not been paid for by any third party, including a family member or an insurer; and Are not required to be paid for by any third party, such as an insurer. Each medical bill verifying expenses shall include a statement of the service and the date the service was rendered. For purchases of medicines and medical supplies or equipment, the statement from the provider shall include the item purchased and the date and cost of the purchase. Medical expenses incurred during the time periods specified in §C(4)(b) and (c) of this regulation shall be deducted from the excess income beginning with the earliest time period and in the following order: Medicare and other health insurance premiums, deductibles, or coinsurance charges; Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. Spend-down eligibility is established for the remainder of the period under consideration when the incurred medical expenses equal or exceed the amount of excess income. The medical expenses used to establish spend-down eligibility may not be: Reimbursed by the Medical Assistance Program; or Used for any subsequent eligibility determination. When spend-down eligibility is not established during the application process, the applicant shall be notified of his ineligibility and advised of the spend-down provision. The application date shall be preserved for possible spend-down eligibility at any time during the established period under consideration. When the incurred medical expenses do not equal the amount of excess income during the period under consideration, eligibility does not exist. A new application date and period under consideration will be established when the applicant reapplies after the expiration of the established period under consideration. Scope. This section applies to persons who are institutionalized throughout a calendar month. Institutional status is presumed to begin on the first day of the first full calendar month in which the person is institutionalized and ends on the last day of the last full calendar month before discharge. Institutional status is not interrupted by a transfer from one long-term care facility to another or by a transfer from a long-term-care facility to a hospital. Presumed institutional status changes on the first day of the month of discharge to the community. Eligibility for noninstitutionalized persons shall be determined separately under Regulation .09 of this chapter. Basis. Financial eligibility shall be determined on the basis of the countable resources and income of members of the assistance unit. A person is categorically needy if his total income before deductions does not exceed 300 percent of the current SSI payment standard and his countable resources are within the applicable amount in Schedule MA-2A. A person is medically needy if his total income before deductions exceeds 300 percent of the SSI payment standard or if countable resources exceed the applicable amount in Schedule MA-2A. When calculating an institutionalized recipient's available income for the cost-of-care in a long-term care facility, in accordance with Regulations .10 and .10-1 of this chapter, guardianship fees may not be allowed as an income deduction, whether or not the recipient has a community spouse. Retroactive Eligibility. A retroactive eligibility determination shall be made for services incurred by an institutionalized person within 3 months before the month of application. Eligibility will be considered only for the month, or months, in which the expenses were incurred. The period under consideration shall be the month, or months, for which coverage is requested. Excess Resources. When the countable resources are greater than the medically needy resource standard, retroactive eligibility does not exist. Determination of Available Income for the Retroactive Period. The following amounts shall be deducted from the total income in the following order: For dates of service beginning July 1, 2003, a personal needs allowance of: $50 a month for an institutionalized person other than a person who meets the requirements of §C(4)(a)(iii) of this regulation. $100 a month for an institutionalized couple. $100 a month for a person who resided in an ICF/IID or mental hospital, participated in therapeutic work activities, and received remuneration for participation in these activities. An amount greater than $100 a month but not to exceed the MNIL may be deducted based on additional documented work-related need. For dates of service beginning July 1, 2004, a personal needs allowance of: $60 a month for an institutionalized person other than a person who meets the requirements of §C(4)(b)(iii) of this regulation; $120 a month for an institutionalized couple; and $100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and received remuneration for participation in these activities, and an amount greater than $100 a month but not to exceed the MNIL which may be deducted from available income based on additional documented work-related need. For dates of service beginning July 1, 2005, a personal needs allowance adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living. Spousal or Family Allowance or Both. For an institutionalized spouse as defined under Regulation .11B(6) of this chapter, an amount equal to the community spouse monthly income allowance as defined under Regulation .11B(2) of this chapter and, if applicable, an amount equal to the family allowance as determined under Regulation .11C(3)(c) of this chapter. For an institutionalized person without a spouse in the community, the amount needed to maintain an unmarried child or children younger than 21 years old living at home at a level which, based on verified need, equals the applicable medically needy income level. Residential Maintenance Allowance for a Single Person. For a person with no spouse or unmarried child younger than 21 years old at home, the amount not to exceed the medically needy income level that was needed to maintain the person's residence during the retroactive period shall be deducted beginning with the person's earliest first full month of institutionalization if, based on a medical review process established by the Department, it is determined that the person will be able to resume living in his community residence and that the person intends to do so. Institutional status is not interrupted by a transfer from one long-term care facility to another or by a transfer to a hospital. Incurred expenses for medical care or remedial service that have not been paid for by any third party, including a family member or an insurer, and are not required to be paid for by any third party, such as an insurer, including: Medicare and other health insurance premiums, deductibles or co-insurance charges; In the case of eligibility determinations before August 1, 2005, necessary medical care or remedial service recognized under State law but not covered under the State Plan; and In the case of eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, necessary medical care or remedial service recognized under State law but not subject to Medical Assistance reimbursement. Incurred expenses for necessary medical care or remedial service described under §C(4)(f)(iii) of this regulation as follows: For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, incurred expenses may not include medical expenses for dates of service more than 3 months before the month of the Medical Assistance application; and Incurred expenses shall be limited to the fees reimbursed by Medical Assistance in effect on the date of service and shall be for actual charges if no Medical Assistance fee exists. The maximum deduction for unpaid nursing facility bills incurred during a penalty period resulting from a transfer of assets shall be zero. Subject to the requirements of §C(6) of this regulation, effective October 1, 2016, the personal needs allowance set forth in §C(4) of this regulation shall be increased as follows: For a Medicaid recipient who has been assigned a guardian of the person, $50 per month; For a Medicaid recipient who has been assigned a guardian of the property, $50 per month; For a Medicaid recipient who has been assigned a single guardian serving all purposes, $50 per month; and For a Medicaid recipient who has been assigned one individual to serve as guardian of the person and one different individual to serve as guardian of the property, $100 per month. A guardian shall submit a monthly bill to the Medicaid recipient or authorized representative in order for a guardianship fee to be added to the recipient’s personal needs allowance set forth in §C(4) of this regulation. If the effective date cited in §C(4)(f)(ii) and (iii), and (g)(i) of this regulation is invalidated by final unappealable order of a court of competent jurisdiction, the effective date shall be April 1, 2009. When the available income as determined under §C(4) of this regulation is equal to or less than the person's incurred cost-of-care to the facility and countable resources are equal to or less than the medically needy resource standard, retroactive eligibility exists and begins on the first day of the period under consideration. Certification is established under Regulation .11D of this chapter. When the available income as determined under §C(4) of this regulation is greater than the person's incurred cost-of-care to the facility and countable resources are equal to or less than the medically needy resource standard, retroactive eligibility may exist under §C(10) of this regulation. Retroactive Spend-Down Eligibility. In determining retroactive spend-down eligibility, documented medical expenses incurred more than 3 months before the month of the Medical Assistance application shall be considered if the incurred expenses: Have not been paid for by any third party, including a family member or an insurer; Are not required to be paid for by any third party, such as an insurer; Were not incurred during a penalty period; and Were not forgiven by the provider. The incurred medical expenses shall be considered on a month-by-month basis beginning with the earliest month in the period under consideration and shall be deducted from excess available income in the following order: Medicare and other health insurance premiums, deductibles, or co-insurance charges; Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. The medical expenses used to establish retroactive spend-down eligibility may not be: Reimbursed by the Medical Assistance Program; Used for any subsequent eligibility determination; or Incurred before the period for which retroactive eligibility is requested. Retroactive spend-down eligibility is established on the day the incurred medical expenses considered under §C(10)(b) of this regulation equal or exceed the excess available income. Certification is established under Regulation .11D of this chapter. Retroactive spend-down eligibility is not established when the incurred medical expenses are less than the excess available income. Current Eligibility. Excess Resources. When the countable resources are greater than the medically needy resource level, eligibility does not exist. Determination of Available Income. The following amounts shall be deducted from total income in the following order: For dates of service beginning July 1, 2003, a personal needs allowance of: $50 a month for an institutionalized person other than a person who meets the requirements of §D(2)(a)(iii) of this regulation. $100 a month for an institutionalized couple. $100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and receives remuneration for participating in these activities. An amount greater than $100 a month but not to exceed the MNIL may be deducted based on additional documented work-related need. For dates of service beginning July 1, 2004, a personal needs allowance of: $60 a month for an institutionalized person other than a person who meets the requirements of §D(2)(b)(iii) of this regulation; $120 a month for an institutionalized couple; and $100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and received remuneration for participation in these activities, and an amount greater than $100 a month but not to exceed the MNIL which may be deducted from available income based on additional documented work-related need. For dates of service beginning July 1, 2005, a personal needs allowance adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living. Spousal or Family Allowance or Both. For an institutionalized spouse as defined under Regulation .11B(6) of this chapter, an amount equal to the community spouse monthly income allowance as defined under Regulation .11B(2) of this chapter and, if applicable, an amount equal to the family allowance as determined under Regulation .11C(3)(c) of this chapter. For an institutionalized person without a spouse in the community, the amount needed to maintain an unmarried child or children younger than 21 years old living at home at a level which, based on verified need, equals the applicable medically needy income level. Residential Maintenance Allowance for a Single Person. For a person with no spouse or unmarried child younger than 21 years old at home, an amount not to exceed the medically needy income level needed to maintain the person's residence during institutionalization shall be deducted for a period of up to 6 months beginning with the person's first full month of current institutionalization if, based on a medical review process established by the Department, it is determined that the person will be able to resume living in his community residence during this period and that person intends to do so. The maximum 6-month period is not interrupted by a transfer from one long-term care facility to another or by admission to a hospital. The following incurred medical expenses that are not subject to payment by a third party: Medicare and other health insurance premiums, deductibles or co-insurance charges; For eligibility determinations before August 1, 2005, necessary medical care or remedial service recognized under State law but not covered under the State Plan; and For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, necessary medical care or remedial service recognized under State law but not subject to Medical Assistance reimbursement. Incurred expenses for necessary medical care or remedial service described under §D(2)(f)(iii) of this regulation as follows: For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, incurred expenses may not include medical expenses for dates of service more than 3 months before the month of the Medical Assistance application; and Incurred expenses shall be limited to the fees reimbursed by Medical Assistance in effect on the date of service and shall be for actual charges if no Medical Assistance fee exists. The maximum deduction for unpaid nursing facility bills incurred during a penalty period resulting from a transfer of assets shall be zero. Subject to the requirements of §D(4) of this regulation, effective October 1, 2016, the personal needs allowance is increased as follows: For a Medicaid recipient who has been assigned a guardian of the person, $50 per month; For a Medicaid recipient who has been assigned a guardian of the property, $50 per month; For a Medicaid recipient who has been assigned a single guardian serving all purposes, $50 per month; For a Medicaid recipient who has been assigned one individual to serve as guardian of the person and one different individual to serve as guardian of the property, $100 per month. A guardian shall submit a monthly bill to the Medicaid recipient or authorized representative in order for a guardianship fee to be added to the recipient’s personal needs allowance set forth in §D(2) of this regulation. If the effective date cited in §D(2)(f)(ii) and (iii) and (g)(i) of this regulation is invalidated by final unappealable order of a court of competent jurisdiction, the effective date shall be April 1, 2009. If, after application of the disregards in §D(2) of this regulation, the person's income equals or is less than the projected cost-of-care, eligibility exists and may begin on the first day of the period under consideration. The amount remaining after application of the disregards in §D(2) of this regulation is available income to be applied to the person's cost-of-care. Certification is established under Regulation .11D of this chapter. If, after application of the disregards in §D(2) of this regulation, the person's income exceeds the projected cost-of-care, eligibility may be established under §D(8) of this regulation. Spend-down Eligibility. In determining spend-down eligibility, documented medical expenses incurred during the time periods and meeting the conditions specified in this section shall be considered. Medical expenses incurred before the month of application shall be considered if the expenses: Were not considered in any retroactive certification; Were not used to establish spend-down eligibility for a prior certification; Have not been paid for by any third party, including a family member or an insurer, and are not required to be paid for by any third party, such as an insurer; Were not incurred during a penalty period; Remain the obligation of any person whose income and resources are considered in determining eligibility; and Have not been forgiven by the provider of the services, as evidenced by account statements dating up to 3 months before the month of application. Medical expenses incurred at any time during or after the month of application and before the end of the period under consideration shall be considered if they: Were not paid for by any third party, including a family member or an insurer; Are not required to be paid for by any third party, such as an insurer; Were not incurred during a penalty period; and Have not been forgiven by the provider. Each medical bill verifying expenses shall include a statement of the service and the date the service was rendered. For purchases of medicines and medical supplies or equipment, the statement from the provider shall include the item purchased and the date and cost of the purchase. Medical expenses incurred during the time periods specified in §D(8)(b) and (c) of this regulation shall be deducted from the excess available income beginning with the earliest time period and in the following order: Medicare and other health insurance premiums, deductibles, or co-insurance charges; Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. Spend-down eligibility is established for the remainder of the period under consideration on the day the incurred medical expenses, considered under §D(8)(e) of this regulation, including projected private cost-of-care obligations, equal or exceed the amount of excess available income. Certification is established under Regulation .11D of this chapter. The medical expenses used to establish spend-down eligibility may not be: Reimbursed by the Medical Assistance Program; or Used for any subsequent eligibility determination. Eligibility exists on the day that incurred medical expenses equal or exceed the amount of excess available income. When spend-down eligibility is not established during the application process, the applicant shall be notified of his ineligibility and advised of the spend-down provision. The application date shall be preserved for possible spend-down eligibility at any time during the established period under consideration. Eligibility exists on the day during the preserved spend-down period that incurred medical expenses equal or exceed the amount of excess available income. Certification is established under Regulation .11D of this chapter. When the incurred medical expenses do not equal the amount of excess available income during the period under consideration, eligibility does not exist. A new application date and period under consideration will be established when the applicant reapplies after the expiration of the established period under consideration. Basis. Except as this regulation specifically provides, the provisions of this regulation may not affect: The determination of what constitutes income or resources; The methodology and standards for determining and evaluating income and resources; The criteria and standards for determining financial and nonfinancial eligibility for Medical Assistance; or Any other provision of this chapter. In determining the eligibility for Medical Assistance of an institutionalized spouse as defined under §B(6) of this regulation, the provisions of this regulation shall supersede any other provisions of this chapter which are inconsistent with them. Sections D and E of this regulation, which concern the treatment of resources, shall apply to a person who begins a continuous period of institutionalization on or after September 30, 1989. Section C of this regulation, which concerns the treatment of income, shall apply to a person who begins a continuous period of institutionalization before or after September 30, 1989 and who remains institutionalized for a continuous period on or after September 30, 1989. Continuity is broken by absence from an institution for 30 consecutive days. Definitions. “Community spouse” means a person who lives in the community outside an institution and who is married to an institutionalized spouse. “Community spouse monthly income allowance” means the amount by which the minimum monthly maintenance needs allowance established under §C(5) of this regulation exceeds the amount of monthly income otherwise available to the community spouse. “Community spouse resource amount” means the greatest of the amounts under §E(2)(a)—(d) of this regulation. “Continuous period of institutionalization” means 30 consecutive days of institutional care in a medical institution or nursing home. “Excess shelter allowance” means the amount by which the sum of the community spouse's expenses for shelter exceeds 30 percent of the amount described under §C(5)(a) of this regulation. Expenses for shelter include rent or mortgage payment, taxes and insurance for the community spouse's principal residence and the standard utility allowance used by the State under §5(e) of the Food Stamp Act of 1977. If the community spouse's principal residence is a condominium or cooperative, the required maintenance charge for the condominium or cooperative shall be included in the sum of the community spouse's expenses for shelter, and the standard utility allowance shall be reduced to the extent the required maintenance charge includes utility expenses. “Family member” means minor or dependent children, dependent parents, or dependent siblings of the institutionalized or community spouse who are residing with the community spouse. “Institutionalized spouse” means a person who is an inpatient in a nursing facility or who is an inpatient in a medical institution and with respect to whom payment is made based upon a level of care provided in a nursing facility, whose average length of stay exceeds 30 days and who is married to a person who is not in a medical institution or nursing facility. Treatment of Income. Separate Treatment of Income. During any month in which an institutionalized spouse is in the institution, except as provided under §C(2) of this regulation, income of the community spouse may not be deemed available to the institutionalized spouse. Attribution of Income. In determining the income of an institutionalized spouse or community spouse, after the institutionalized spouse has been determined to be eligible for Medical Assistance, the following apply: Non-Trust Property. Except as provided under §C(2)(c) and (d) of this regulation, unless the instrument providing the income otherwise specifically provides, if payment of income is made: Solely in the name of the institutionalized spouse or the community spouse, the income shall be considered available only to that respective spouse; In the name of the institutionalized spouse and the community spouse, 1/2 of the income shall be considered available to each of them; and In the names of the institutionalized spouse or the community spouse, or both, and to another person or persons, the income shall be considered available to each spouse in proportion to the spouse's interest or, if payment is made with respect to both spouses and no such interest is specified, 1/2 of the joint interest shall be considered available to each spouse. Trust Property. In the case of a trust, income shall be considered available to each spouse as provided in the trust or, in the absence of a specific provision in the trust, if payment of income is made: Solely to the institutionalized spouse or the community spouse, the income shall be considered available only to that respective spouse; To both the institutionalized spouse and the community spouse, 1/2 of the income shall be considered available to each of them; and To the institutionalized spouse or the community spouse, or both, and to another person or persons, the income shall be considered available to each spouse in proportion to the spouse's interest; or To both spouses and if the interest is not specified, 1/2 of the joint interest shall be considered available to each spouse. In the case of income not from a trust in which there is an instrument establishing ownership, except as provided under §C(2)(d) of this regulation, 1/2 of the income shall be considered to be available to the institutionalized spouse and 1/2 to the community spouse. Section C(2)(a) and (c) of this regulation shall be superseded to the extent that an institutionalized spouse can establish, by a preponderance of the evidence, that the ownership interests in income are other than as provided under these sections. Protecting Income for the Community Spouse. After an institutionalized spouse is determined to be eligible for Medical Assistance, in determining the amount of the spouse's income that is to be applied monthly to payment for the cost of care in the institution, there shall be deducted from the spouse's monthly income the following amounts in the following order: A personal needs allowance of: $50 a month for dates of service beginning July 1, 2003; $60 a month for dates of service beginning July 1, 2004; and For dates of service beginning July 1, 2005, an amount adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living. A community spouse monthly income allowance as defined under §B(2) of this regulation, but only to the extent income of the institutionalized spouse is made available to, or for the benefit of, the community spouse; A family allowance, for each family member defined under §B(5) of this regulation, equal to 1/3 of the amount by which the amount described under §C(5)(a) of this regulation exceeds the amount of the monthly income of that family member; and Incurred expenses for medical care or remedial service for the institutionalized spouse that are not subject to payment by a third party, including: Medicare and other health insurance premiums, deductibles or co-insurance charges, and Necessary medical care or remedial service recognized under the State law but not covered under the State plan. Incurred expenses for necessary medical care or remedial service described under §C(3)(d)(ii) of this regulation shall be limited to the fees reimbursed by Medical Assistance which are in effect on the date of service. Establishment of Minimum Monthly Maintenance Needs Allowance. The minimum monthly maintenance needs allowance for a community spouse is the sum of: The applicable percent, described under §C(6) of this regulation, of 1/12 of the income official poverty line for a family unit of two members; and An excess shelter allowance as defined under §B(5) of this regulation. Applicable Percent. For purposes of §C(5)(a) of this regulation, the applicable percent, effective as of the following dates, is: September 30, 1989, 122 percent; July 1, 1991, 133 percent; and July 1, 1992, 150 percent. Cap on Minimum Monthly Maintenance Needs Allowance. The minimum monthly maintenance needs allowance established under §C(5) of this regulation may not exceed $1,500, subject to adjustment under §G of this regulation, except as provided under §F(3) of this regulation. Court Ordered Support. If a court has entered an order against an institutionalized spouse for monthly income for the support of the community spouse, the community spouse monthly income allowance as defined under §B(2) of this regulation shall be not less than the amount of the monthly income ordered. Treatment of Resources. Computation of Spousal Share at the Time of Institutionalization. Total Joint Resources. There shall be computed, as of the beginning of the first continuous period of institutionalization of the institutionalized spouse: The total value of the resources to the extent either the institutionalized spouse or the community spouse has an ownership interest; A spousal share which is equal to 1/2 of the total value. Assessment. At the request of an institutionalized spouse or community spouse, as of the beginning of the first continuous period of institutionalization of the institutionalized spouse and upon receipt of the relevant documentation of resources, the Department shall: Promptly assess and document the total value of the resources; Provide a copy of the assessment and documentation to each spouse; and Retain a copy of the assessment for use under this regulation. Request for Assessment When Not Part of the Medical Assistance Application. If the request is not part of an application for Medical Assistance, the Department may not include a notice indicating that the spouse has the right to a fair hearing as provided for under §F(1)(c) of this regulation, but shall require payment of a fee not to exceed the reasonable expense of providing and documenting the assessment. Attribution of Resources at the Time of Initial Eligibility Determination. In determining the resources of an institutionalized spouse at the time of application for benefits under this chapter, regardless of any State laws relating to community property or the division of marital property, all the resources held by either the institutionalized spouse, the community spouse, or both, shall be considered to be available to the institutionalized spouse, but only to the extent that the amount of the resources exceeds the greatest of the amounts computed under §E(2)(a)—(d) of this regulation at the time of application for benefits. Assignment of Support Rights. The institutionalized spouse may not be ineligible by reason of resources determined under §D(2) of this regulation when: The resources are unavailable to the institutionalized spouse; Payments are not being made for the care of the institutionalized spouse; The institutionalized spouse, or that person's guardian or attorney in fact or representative, agrees to cooperate with the State in bringing a criminal action for nonsupport under Family Law Article, §§10-201 and 10-202, Annotated Code of Maryland; and The institutionalized spouse, if capable of executing an assignment, has assigned all support rights from the community spouse to the State. Resources may not be considered to be unavailable to the institutionalized spouse under §D3(a) of this regulation if the institutionalized spouse, or: That spouse's guardian or attorney in fact has the legal authority to withdraw, liquidate, or otherwise access those resources; or The institutionalized spouse's guardian or attorney in fact, has assisted in making those resources unavailable unless it can be demonstrated, to the Department's satisfaction, that the: Action was primarily for a purpose unrelated to Medical Assistance eligibility, and Denial of eligibility would work an undue hardship. Resources shall be considered to be unavailable to the institutionalized spouse under §D(3)(a) of this regulation only if the community spouse has willfully failed to, and refuses to, pay for care of the institutionalized spouse or cannot be located. Section D(3)(c) or (d) of this regulation may not be considered to be satisfied if the institutionalized spouse, or the institutionalized spouse's guardian or attorney in fact, has taken any action or otherwise assisted in limiting his or her support rights from the community spouse. The Department shall waive the requirements of §D(3)(c) or (d) of this regulation if the Department determines that denial of eligibility would work an undue hardship. Separate Treatment of Resources After Eligibility for Benefits Established. During the continuous period in which an institutionalized spouse is in an institution and after the month in which an institutionalized spouse is determined to be eligible for benefits under this chapter, resources of the community spouse may not be deemed available to the institutionalized spouse. Permitting Transfer of Resources to the Community Spouse. In General. An institutionalized spouse may, without regard to Regulation .08K of this chapter, transfer to the community spouse, or to another for the sole benefit of the community spouse, an amount equal to the community spouse resource allowance as defined under §E(2) of this regulation, but only to the extent the resources of the institutionalized spouse are transferred to, or for the sole benefit of, the community spouse. The transfer shall be made as soon as practicable after the date of the initial determination of eligibility, taking into account such time as may be necessary to obtain a court order under §E(3) of this regulation. Community Spouse Resource Allowance Defined. The community spouse resource allowance is the amount by which the greatest of the following amounts exceeds the amount of resources otherwise available to the community spouse: $12,000, subject to adjustment under §G of this regulation; The lesser of the spousal share computed under §D(1)(ii) of this regulation or $60,000, subject to adjustment under §G of this regulation; The amount established under §F(4) of this regulation; or The amount transferred under a court order under §E(3) of this regulation. Transfers Under Court Orders. If a court has entered an order against an institutionalized spouse for the support of the community spouse, Regulation .08K of this chapter may not apply to amounts of resources transferred under the order for the support of the spouse or a family member as defined under §B(5) of this regulation. Fair Hearing. The spouse is entitled to a fair hearing as provided for under Regulation .14 of this chapter if either the institutionalized spouse or the community spouse is dissatisfied with the determination of any of the following: Minimum monthly maintenance needs allowance as established under §C(5) of this regulation; Determination of the amount of monthly income otherwise available to the community spouse; Computation of the spousal share of resources under §D(1) of this regulation; Attribution of resources under §D(2) of this regulation; or Determination of the community spouse resource allowance as defined under §E(2) of this regulation. Any hearing respecting the determination of the community spouse resource allowance shall be held within 30 days of the date of the request for the hearing if an application for benefits under this chapter has been made on behalf of the institutionalized spouse. Revision of Minimum Monthly Maintenance Needs Allowance. If either the institutionalized spouse or the community spouse establishes that the community spouse needs income above the level provided by the minimum monthly maintenance needs allowance due to exceptional circumstances resulting in significant financial duress, the Department shall substitute, for the minimum monthly maintenance needs allowance established under §C(5) of this regulation, an amount adequate to provide the additional income as is necessary. Revision of Community Spouse Resource Amount. If either the institutionalized spouse or the community spouse establishes that the community spouse resource amount, in relation to the amount of income generated by that amount, is inadequate to raise the community spouse's income, which shall include the amount of the community spouse monthly income allowance, to the minimum monthly maintenance needs allowance, the Department shall substitute, for the community spouse resource amount, an amount adequate to provide a minimum monthly maintenance needs allowance. For services furnished during a calendar year after 1989, the dollar amounts specified under §§C(7) and E(2)(a) and (b) of this regulation shall be increased by the same percentage as the percentage increase in the consumer price index for all urban consumers between September, 1988 and the September preceding the calendar year involved. Subject to §E of this regulation, an institutionalized individual is not covered by Medical Assistance for long-term care services in a nursing facility, medical institution with a level of care equivalent to a nursing facility, or home and community-based services waiver if: The individual’s equity interest in the individual’s home property, reduced by any bona fide, legally binding, documented encumbrances secured by the home, exceeds the amount specified in §D of this regulation; and The individual does not have, lawfully residing in the home, the individual’s spouse or the individual’s son or daughter who is: Younger than 21 years old; or Blind or disabled as determined under Regulation .05-4 of this chapter. For all applications received on January 1, 2007 or after, the Department shall evaluate the institutionalized individual’s equity interest in the individual’s home property if the individual is determined eligible for Medical Assistance based on: An initial determination of nursing facility or waiver eligibility; A reapplication for nursing facility or waiver eligibility after a break in nursing facility or waiver eligibility; or A redetermination after an initial determination or reapplication in accordance with §B(1) or (2) of this regulation. The institutionalized individual’s equity interest in the individual’s home property shall be evaluated by the Department, in accordance with §§A and B of this regulation, at: The determination of nursing facility or waiver eligibility; and Each subsequent redetermination of nursing facility or waiver eligibility. The maximum allowable equity interest specified at §A(1) of this regulation shall be $543,000 in calendar year 2014, adjusted annually as set forth in section 6014 of the Deficit Reduction Act of 2005, Pub. L. 109-171 (DRA) by the percentage increase in the consumer price index for all urban consumers, rounded to the nearest $1,000. Reductions to Equity Interest. If the individual has ownership interest in no property other than the home, the benefit payment amount shall be applied to reduce an equal amount of home equity. A mortgage, reverse mortgage, home equity loan, lien, or other bona fide encumbrance received by the individual and secured by the home property may be considered by the Department to reduce the individual’s equity interest in the home. An exclusion of long-term care coverage, in accordance with §A of this regulation, shall be applied even if there is a legal impediment to transferring or selling the home property. The Department may waive the application of §F of this regulation if the Department determines that denial of eligibility for long-term care coverage would work an undue hardship. This regulation specifies the time periods for certifying eligible members of an assistance unit. Certification periods for retroactive and current coverage will be based on consideration periods established in accordance with the provisions of Regulations .09 and .10 of this chapter. Certification of Eligible Noninstitutionalized Persons. The following eligible noninstitutionalized persons shall be certified for a one-time-only period of 6 months or less and scheduled redetermination for continued eligibility may not be made: Those who are certified for a retroactive period only, including retroactive spend-down; Those who are certified under the spend-down provision; and Those whose anticipated circumstances preclude eligibility beyond the current period. Section B(1)(c) of this regulation is limited to: A person who dies before the completion of the eligibility determination; A migrant worker whose date of departure or expected date of departure from the State is known; and A coverable inmate of a public institution who leaves the institution solely for admission to a medical facility. Eligible persons not certified under §B(1) of this regulation shall be certified for a one-time-only period of 6 months and scheduled redetermination of eligibility shall be made. Date for Certification to Begin and End for Noninstitutionalized Persons. Persons Eligible for Retroactive Coverage Under Spend-Down. Certification begins on the day in the period under consideration on which retroactive spend-down eligibility was met. Certification ends on the last day of the most recent month in the retroactive period in which coverable expenses were incurred. Only persons who have coverable medical expenses during the period under consideration shall be certified. Certification under this provision shall cover only those incurred medical bills that are not subject to third-party payment and remain the liability of persons in the assistance unit. Persons Eligible for Retroactive Coverage Without Spend-Down. Certification begins on the first day of the earliest month of the retroactive period under consideration in which coverable medical expenses were incurred. Certification ends on the last day of the most recent month in the retroactive period in which coverable medical expenses were incurred. Only persons who have coverable medical expenses during the period under consideration shall be certified. Certification under this provision shall cover only those incurred medical bills that are not subject to third-party payment and remain the liability of persons in the assistance unit. Persons Eligible for Current Coverage Under Spend-Down. Certification begins on the day in the period under consideration on which medical expenses for services already received equal or exceed the amount of excess income. The beginning date of the certification period shall be established to exclude from coverage any full day after the application date and before the certification date for which all expenses for medical services were used to establish spend-down eligibility. Certification ends on the last day of the period under consideration. Individuals Eligible for the Maryland Medicaid Managed Care Program. Initial certification shall be a period of 6 months. Section C(4)(a) of this regulation applies only if the individual: Has not been eligible for Medical Assistance any time during the calendar month immediately before the month of application; and Has no private health insurance. An individual certified under §C(4)(a) of this regulation is not subject to the unscheduled redetermination requirements of Regulation .12C(2) of this chapter. Subsequent certification periods shall be consistent with the provisions of this subsection. All Other Persons. Certification begins on the first day of the month of application. Certification ends on the last day of the period under consideration. Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of a deceased person may not continue beyond the date of death. Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of an eligible new member of the assistance unit pursuant to Regulation .06D of this chapter may not precede the date he becomes a member of the household. Date for Certification to Begin and End for Eligible Institutionalized Persons. Persons Eligible for Retroactive Coverage Under Regulation .10C(5) of this chapter. Certification begins on the first day of the period under consideration. Certification ends on the last day of the period under consideration. Persons Eligible for Retroactive Coverage Under Regulation .10C(7) of this chapter. Certification begins on the day the incurred medical expenses less health insurance and other third-party coverage equal or exceed the excess available income. Certification ends on the last day of the period under consideration. Persons Eligible for Current Coverage Under Regulation .10D(3) of this chapter. Certification begins on the first day of the period under consideration or, at the option of the person or the person's representative, on the first day of the following month if coverage is not needed in the month of application. Certification continues until the person is determined ineligible and scheduled redetermination of eligibility shall be made at least once every 12 months. Persons Eligible for Current Coverage Under Regulation .10D(5) of this Chapter. Certification begins on the day the incurred medical expenses less health insurance and other third-party coverage equal or exceed the excess available income. Eligibility ends on the last day of the period under consideration or, if it is known that eligibility should terminate before the end of the period under consideration, on the appropriate earlier date, and scheduled redetermination of eligibility may not be made. Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of a deceased person may not continue beyond the date of death. Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following: For eligible individuals in MAGI coverage groups: The basis and effective date for eligibility; Instructions for reporting changes that may affect the recipients eligibility; and The right to request a hearing. For eligible individuals in MAGI Exempt coverage groups: A finding of eligibility, the beginning and ending dates for coverage; and The right to request a hearing. For ineligible individuals in MAGI coverage groups: A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; Information regarding application for MAGI exempt coverage groups; and The right to request a hearing. For ineligible individuals in MAGI exempt coverage groups: A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; and The right to request a hearing. Recipient Responsibility. A recipient or his representative shall notify the Department or its designee within 10 working days of changes that may affect eligibility. A recipient or his representative shall limit use of the Medical Assistance card to the person whose name appears on the card. Third-Party Liability. A recipient or his representative shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of any accident or other occurrence in which a third party might be liable. Recipients shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information that would assist the Department or its designee in seeking reimbursement. In accident situations, recipients shall notify the Department or its designee of the time, date, and location of the accident, the name and address of the attorney, the names and addresses of all parties and witnesses to the accident, and the police report number if an investigation is made. When written notice of cancellation is received, a recipient shall discontinue use of the Medical Assistance card on the first day of ineligibility and return it to the Department or its designee. Failure to comply with the provisions of §B(1), (2), and (3) of this regulation may result in the termination of assistance. Failure to comply with the provisions of §B(1)—(4) of this regulation may result in legal action, referral to the Department or its designee for reimbursement, fraud investigation, or both, for illegal use of the Medical Assistance card. Recipients shall cooperate with the Department’s quality control and audit review process, including provision and verification of all information pertinent to eligibility determination. Failure to cooperate may result in the termination of coverage. Redeterminations. Redetermination for Former SSI Recipients. The Department or its designee shall promptly redetermine eligibility when notice has been received from the Social Security Administration that an individual's SSI benefits have been terminated. When notice of SSI termination is received, Department or its designee shall notify the person that redetermination is required to establish continuing eligibility and shall make the application available to him. When the written or electronic, signed application is received by the Department or its designee, a new period under consideration will be set. The new period will be related to the date the application is received but may not include any months in which the individual was entitled to coverage under the current certification period. The Department or its designee shall notify the individual or his representative of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. All non-financial and financial factors for continuing eligibility shall be met. The following applies when the individual is determined ineligible for Medical Assistance: When the SSI termination is received by the tenth day of the month, the Department or its designee shall cancel certification effective the end of the month, unless the recipient requests a hearing in accordance with COMAR 10.01.04. When the SSI termination notice is received after the tenth day of the month, the Department or its designee shall cancel certification effective the end of the following month unless the recipient requests a hearing in accordance with COMAR 10.01.04. The following applies when the person is determined ineligible for Medical Assistance: When SSI termination is received by the tenth day of the month, the local department of social services shall cancel certification effective the end of the month, unless the recipient requests a hearing in accordance with Regulation .13 of this chapter. When the SSI termination notice is received after the tenth day of the month, the local department of social services shall cancel certification effective the end of the following month unless the recipient requests a hearing I accordance with Regulation .13 of this chapter. Notice of Eligibility Decisions. Eligible Individuals. Individuals who are determined eligible for a new period under consideration shall be sent notice in accordance with §A(1) and (2) of this regulation. Ineligible Individuals. Individuals determined ineligible shall be sent notice in accordance with §A(3) and (4) of this regulation. When ineligibility is due to excess income only, the person will be provided with an explanation of the spend-down provision. Spend-down eligibility may be established at any time during the new period under consideration. Unscheduled Redetermination. The Department or its designee shall promptly make unscheduled redetermination when: The person's circumstances suggest future changes which may affect eligibility before the due date of a scheduled redetermination; Relevant facts or changes in circumstances are reported by the recipient or someone on his behalf; or Relevant facts or changes are brought to the attention of the Department or its designee from other responsible sources. The Department or its designee shall notify the recipient that redetermination is required to establish continuing eligibility. Notification will be sent in a timely manner so that a decision of eligibility will be made within 30 days from the date of change. The Department or its designee shall notify the recipient of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. The Department or its designee may not require the recipient or his representative to appear in unless the Department or its designee has determined that a face-to-face contact is necessary to make an accurate eligibility determination, or the recipient requests a face to face interview. All non-financial and financial factors for continuing eligibility shall be met. Eligibility Decisions. Eligibility Continued for the Remainder of the Certification Period. Recipients who are determined eligible for the remainder of the certification period will be sent notice in accordance with §A(1) and (2) of this regulation. Recipients Determined Ineligible for the Remainder of the Certification Period. Recipients determined ineligible for the remainder of the certification period because of a change in circumstances or failure to establish eligibility following a change in circumstances, shall be sent notice in accordance with §A(3) and (4) of this regulation. A person may reapply at any time after the cancellation of current eligibility and a new period under consideration will be established. Scheduled Redetermination. The Department or its designee shall make scheduled redeterminations at least once every 6 months for noninstitutionalized individuals certified under Regulation .11B(3) of this chapter and at least once every 12 months for institutionalized individuals certified under Regulation .11D(3) of this chapter. The Department or its designee shall notify the recipient that redetermination is required to establish continuing eligibility. The notice and application will be sent at least 45 days before expiration of the current certification period. When the written, telephonic, or electronic, signed application is received by the Department or its designee, a new period under consideration will be set. The new period will be related to the date the application is received but may not include any months in which the individual was entitled to coverage under the current certification period. A recipient shall be treated the same as an applicant at the time of scheduled redetermination. All nonfinancial and financial factors of eligibility shall be met. The local Department or its designee shall make timely decisions in accordance with the provisions of Regulation .04H of this chapter. Eligibility Decisions. Eligibility Established. Applicants who are determined eligible for a new period under consideration shall be sent notice in accordance with §A(1) and (2) of this regulation. Ineligibility Established. Applicants determined ineligible for the new period under consideration shall be sent notice in accordance with §A(3) and (4) of this regulation. When ineligibility is due to excess income only, the applicant will be provided with an explanation of the spend-down provision. Spend-down eligibility may be established at any time during the new period under consideration. Subsequent Application. A person may reapply when eligibility is not met during the periods established in §C(1) and (3) of this regulation. Continuous Eligibility for Children. The Department shall establish continuous eligibility periods for individuals who are: Younger than 19 years old; and Eligible and enrolled for mandatory or optional coverage. Individuals who are in a period of continuous eligibility shall, with the exception of the circumstances in §E(4) of this regulation, maintain coverage despite any change in circumstance that would otherwise preclude eligibility. The period of continuous eligibility shall: Begin on the first day of the month in which initial eligibility was determined or a renewal of eligibility is approved as a result of redetermination; and Remain in effect for a 12-month period or for individuals covered under COMAR 10.09.62, until birth. An individual’s eligibility may be redetermined during their continuous eligibility period if one or more of the following changes in circumstances occur: The individual attains the maximum age specified in §E(1)(a) of this regulation; The individual or the individual’s representative requests a voluntary termination of eligibility; The individual ceases to meet the residency requirements established in Regulation .05-3 of this chapter; The individual dies; or The Department or its designee determines that eligibility was erroneously granted at the most recent determination, redetermination, or renewal of eligibility due to one or more of the following: Agency error; or Fraud, abuse, or perjury attributed to the individual or the individual’s representative. The procedures for the Department or its designee granting a hearing to an applicant or a recipient and the status of benefits pending a hearing are set forth in COMAR 10.01.04. “Medicaid fraud” means: Knowingly and willfully making or causing to be made any false statement or representation of a material fact in any application for any benefit or payment under a State plan established by Title XIX of the Social Security Act of 1939; Knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to those benefits or payments; Having knowledge of the occurrence of any event affecting: The initial or continued right to those benefits or payments, or The initial or continued right to those benefits or payments to any other individual in whose behalf an application has been made or in whose behalf benefits or payments are being received, and concealing or failing to disclose that event with an intent to secure fraudulently those benefits or payments either in a greater amount or quantity than is due or when benefits or payments are not authorized; Having made application to receive or having received any of those benefits or payments for the use and benefit of another, and knowingly and willfully converting any part of the benefit or payment to a use other than for the use and benefit of that other person; Fraudulently obtaining, attempting to obtain, or aiding another person in obtaining or attempting to obtain any drug product or any medical care, the benefit or payment of any part of which is or may be made from federal or state funds under a state Medical Assistance program, by use of: Fraud, deceit, misrepresentation, or subterfuge; Forgery or alteration of a Medical Assistance prescription; or Concealment of any material fact or by the use of false names or addresses; Possession of a blank Medical Assistance prescription, unless possession is authorized by: A contract or other power, right, or permission to manufacture, store, transport, or distribute blank prescriptions; A grant of a rendering privilege as evidenced by the issuance of a rendering number by a state Medical Assistance program by which one is authorized to prescribe pharmaceutical products for Medical Assistance recipients if the authorization: To possess a blank Medical Assistance prescription terminates 30 days after notice of suspension or termination of provider status in a state Medical Assistance program or exhaustion of final appeal rights, whichever is later; and Does not extend to possession of blank Medical Assistance prescriptions which have been obtained from a source not authorized to distribute blank Medical Assistance prescriptions under §S(6)(a) of this regulation; or Performance of one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program; Possession of a Medical Assistance card without the authorization of the individual to whom the card is issued, unless: Possession is obtained by a provider without knowledge that the presenting party lacked authorization; or Possession is pursuant to one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program; Manufacture, distribution, or possession of a counterfeit Medical Assistance card, or prescription blank except when possession is obtained: By a provider without knowledge that the card or prescription blank is counterfeit; or Pursuant to one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program; and Manufacture, distribution, or possession of a provider identification plate used or capable of use to imprint Medical Assistance prescriptions unless authorized by: A contract or other power, right, or permission to manufacture, transport, distribute, handle, or possess the plates; Issuance by a state Medical Assistance program to the party in possession; or Performance of one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program. Examples. The following are examples of circumstances that may be Medicaid fraud: Failure to report income, resources, if applicable, and family composition at the time of application or reapplication; Failure to report within 10 working days any changes in income, resources, if applicable, and circumstances during any period of eligibility; Lending a Medical Assistance card to another person; Using or attempting to use a Medical Assistance card with intent to secure fraudulently benefits which are not authorized. LDSS Reporting. All cases of suspected Medicaid fraud that are discovered by personnel of a local department of social services shall be reported to the Department or its designee. Other Reporting. All cases of suspected Medicaid fraud that are discovered by agencies other than a local department of social services, that is, other state or federal agencies, providers, or concerned citizens, may be reported to the Department or its designee. Review and Investigation. The Department or its designee shall review and, when appropriate, investigate all referrals when an allegation is made that a misrepresentation of a material fact has been made or is suspected to have been made. Disposition of Referrals. Each referral shall be processed by the Department or its designee for appropriate resolution which includes, but is not limited to: Referral for prosecution; Filing of charges at District Court; Recovery of incorrect benefit payments; A finding that the allegation has not been sustained; Referral to the appropriate agency; and Other administrative action. Penalties. A person convicted of the crime of Medicaid fraud is subject to penalties as described in Criminal Law Article, §§8-510—8-512, Annotated Code of Maryland. Forms of Abuse. Recipient abuse exists when: A recipient utilizes an inappropriate type of provider for care; A recipient utilizes an appropriate type of provider at an inappropriate frequency for care; A recipient utilizes an appropriate provider in an inappropriate manner; or A recipient utilizes a Medical Assistance card in an inappropriate manner. Examples. The following are examples of circumstances that may be recipient abuse: Misrepresenting to a provider material facts regarding symptoms, circumstances, or treatment by other providers; Failing to affirmatively disclose to a provider any treatment or services being provided by another provider; Losing or failing to maintain security sufficient to prevent loss or theft of more than one Medical Assistance card during a certification period; Utilizing an emergency room of a hospital or a specialty outpatient clinic of a hospital as a primary care provider when primary care providers are available in the service area in which the recipient resides; Underutilizing the appropriate providers for the proper care and management of an existing health condition; Obtaining medications that require close physician monitoring while not appropriately using the physician services which could provide the monitoring; Using or maintaining custody or possession of a Medical Assistance card in such a manner that it is used for an unauthorized or illegal purpose. Procedures. The Department or its designee, shall determine whether recipient abuse exists using the procedures in §C(2)—(8) of this regulation. Cases may be reviewed on the basis of statistical reports, outside complaints, referrals from other agencies, or other appropriate sources. A preliminary review shall be conducted to determine whether the recipient's alleged or noted behavior is of the form specified under §A(1)—(3) of this regulation or is of the form specified under §A(4) of this regulation. If the alleged or noted behavior is one of the types listed in §A(1)—(3) of this regulation, all relevant and available information shall be forwarded for medical review as specified under §B(5) of this regulation. If the alleged or likely behavior is of the type listed in §A(4) of this regulation, all relevant and available information shall be forwarded for administrative review as specified under §C(7) of this regulation. When a case is referred for medical review, a medical professional employed by the Department or its designee shall determine whether the recipient's use of medical services constitutes abuse, as defined under §A(1), (2), or (3) of this regulation. The medical reviewer shall consider all relevant and available information including Medical Assistance payment records and information secured from interviews, if conducted, in making a decision. The reviewer may, when appropriate, obtain records from other sources, including providers of medical services. When a case is referred for administrative review, a determination shall be made by the Department or its designee, regarding whether the recipient's use of benefits constitutes abuse as defined under §A(4) of this regulation. If a recipient has been convicted of a crime involving use of Medical Assistance benefits, as defined in §A of this regulation, the Department or its designee may consider the recipient to have committed abuse as described under §A(4) of this regulation. Notice. A recipient determined to have abused the Medical Assistance entitlement shall receive notice to that effect. Notice includes the following: A statement of the reason or reasons why the recipient was found to have abused the Medical Assistance entitlement; If applicable, a statement that the recipient will be enrolled in the Corrective Managed Care Program and the effective date and duration of that enrollment; A statement regarding an opportunity to provide additional information which will be considered before enrollment becomes effective; If applicable, a statement regarding an opportunity to identify a preference for an assigned primary medical care provider or pharmacy; and A statement of appeal rights under Regulation .13 of this chapter. Consideration of Recipient Information. Additional information received from the recipient under §D(3) of this regulation is considered relative to the appropriateness of the recipient's enrollment in the Corrective Managed Care Program. Notice of the determination of the Department or its designee regarding the additional information shall be sent to the recipient. The notice shall either confirm or reverse the decision to enroll the recipient. Information received from the recipient under §D(4) of this regulation is considered relative to the designation of a primary medical provider or pharmacy in accordance with §G(7) of this regulation. Corrective Managed Care Program. A recipient determined to have abused the Medical Assistance entitlement shall be enrolled in the Corrective Managed Care Program in which the recipient shall be required to meet the requirements of §F(1)—(3) of this regulation. The recipient shall obtain all covered physician, hospital outpatient and inpatient, and clinic services, except methadone clinic and all other drug and alcohol abuse services and emergency services, from, or upon written referral by, a single primary medical provider. The recipient shall obtain prescribed drugs only from a single designated pharmacy provider, except in an emergency or pursuant to hospital inpatient treatment. Provider Selection. The Department or its designee shall select primary medical and pharmacy providers for the recipient according to the requirements of §G(2)—(7) of this regulation. The primary medical provider may be any physician who participates in the Medical Assistance Program and whose practice is chiefly in one of the following specialties which include general practice, family practice, pediatrics, obstetrics-gynecology, or internal medicine. The Department or its designee may also designate a physician group, community health center, or clinic which participates in the Program as a physician provider and which assigns practitioners in one or more of the specialties named under §G(2) of this regulation to be the designated primary medical provider for the recipient. The Department or its designee may designate a provider which delivers limited or specialty services if the designation is in the recipient's best interest and the provider agrees to deliver or manage the recipient's primary care and refer the recipient for other services as necessary. The pharmacy provider may be any pharmacy, or any single branch of a pharmacy chain, which participates in the Medical Assistance Program. The recipient shall be afforded an opportunity to suggest primary medical and pharmacy providers. However, the Department or its designee is not bound by the recipient's suggestion and may designate other providers if, in its sole discretion, the recipient's choice of provider would not serve the recipient's best interest in achieving appropriate use of the health care system and of Medical Assistance benefits. The Program may designate a new primary medical or pharmacy provider if the: Recipient moves out of the service area of the provider; Provider originally selected refuses to serve as the recipient's provider; Program determines that the provider is not reasonably accessible to the recipient or does not meet accepted standards of medical or pharmacy practice; Recipient has not responded affirmatively to the imposition of restrictions; or Recipient's best interest in achieving appropriate use of the health care system and of Medical Assistance benefits would, in the Program's sole discretion, be better served by an alternative designation. Time of Period of Enrollment for the Corrective Managed Care Program. The period of enrollment is 24 months. A recipient who has completed the period of enrollment and who is subsequently found, through the procedures specified under §C of this regulation, to have resumed abusive practices, shall be enrolled for an additional period of 36 months. A recipient found to have abused Medical Assistance benefits while enrolled in the Corrective Managed Care Program shall have the enrollment period extended for 24 months. A recipient who has been found on three separate determinations under §C(5)—(7) of this regulation to have abused Medical Assistance benefits shall be enrolled for a period of 60 months. If an enrolled recipient loses and regains eligibility for Medical Assistance benefits, the recipient shall be re-enrolled at the resumption of eligibility for a full enrollment period. The final determination of abuse, the decision to enroll the recipient for the Corrective Managed Care Program, and the designation of primary medical and pharmacy providers shall be the responsibility of the Department or its designee. The recipient shall be given notice of an opportunity for a hearing in conformity with COMAR 10.01.04. Definitions. In this regulation, the following terms have the meanings indicated: “Dependent” means a: Child of the decedent, or the decedent's descendants; Sibling, including half or step, of the decedent; or Parent of the decedent, or the decedent's ancestors. “Discharge from a long-term care facility and return home” means the release of a person from that facility for the purpose of returning to the home for permanent residence. “Equity interest in the home” means co-ownership of the home which is not the result of a transfer of the property for less than the fair market value within 2 years before institutionalization. “Estate” means all real and personal property and other assets included within an individual's estate, as defined for purposes of State probate law. “Group health plan” means any plan, including a self-insured plan, of or contributed to by an employer to provide health care, directly or otherwise, to the employer's employees, former employees, or their families. “Incorrect payment of benefits” means payment of benefits to which a recipient is not entitled. “Lawfully residing in the home” means residing in the home with the permission of the owner or, if under guardianship, the owner's legal guardian. “Real property” means property which is fixed or immovable, such as land or a building. “Residing in the home on a continuous basis” means using the home as the principal place of residence. “Substantial hardship” means the Department's estate claim will result in the sale or transfer of the real property owned by the decedent and that the sale or transfer will result in the removal from the property of a dependent who: Resided in the property on the date of the decedent's death; Has resided in the property continuously for a period beginning at least 2 years before the decedent's death; and Cannot provide an alternate residence. The Department shall make a claim against income or resources, or both, of a recipient for benefits correctly paid, or to be paid, under the following circumstances: Under a court order; In any situation in which a recipient has a cause of action against any person for medical expenses arising from that cause of action; or As a result of payment by the Department for services for which health care coverage was available to a recipient. Liens. Incorrect Payments. Following a court judgment which has determined that benefits were incorrectly paid for a person, the Department shall impose a lien against the person's property, both personal and real, before the person's death, on account of Medical Assistance claims paid or to be paid on the person's behalf. Correct Payments. Except as provided under §A-2(3) of this regulation, the Department shall impose a lien against the real property of a person, before the person's death, on account of Medical Assistance claims paid or to be paid on that person's behalf under the following circumstances: The person owns real property, is a patient in a long-term care facility, and is required, as a condition of receiving Medical Assistance services, to spend for costs of medical care all but a minimal amount of his income required for personal needs; and The Department has determined, after notice and opportunity for a hearing, that there is no reasonable expectation that the person can be discharged from the long-term care facility and return home. Restrictions on Placing a Lien. The Department may not impose a lien on the home of an institutionalized individual under §A-2(2) of this regulation if any of the following individuals lawfully reside in the home. The institutionalized individual's: Spouse; Child as defined in Regulation .02B of this chapter; Son or daughter who is blind or disabled as defined in Regulation .05D and E of this chapter; or Sibling, who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date of the institutionalized person's admission to a long-term care facility. Termination of a Lien. Any lien imposed on a person's real property under §A-2(2) of this regulation will dissolve if the person is discharged from a long-term care facility and returns to the home. Delay in the Imposition of a Lien. When the imposition of a lien against a person's property is delayed because of the person's mental incompetence, eligibility may be granted pending the appointment of a legal representative for the person. The effective date of the lien shall be the date eligibility was granted. Adjustments and Recoveries. The Department shall seek recovery of Medical Assistance benefits correctly paid: From the estate of any individual who was 55 years old or older when the individual received Medical Assistance benefits; and From the estate or upon sale of the property on which a lien was imposed and which was owned by an individual described under §A-2(2) of this regulation. The Department shall seek recovery under §A-3(1) of this regulation of Medical Assistance benefits correctly paid only: After the death of the person's surviving spouse; When the individual has no surviving child as defined in Regulation .02B of this chapter; When the person has no surviving son or daughter who is blind or disabled as defined in Regulation .05D and E of this chapter; and In the case of liens imposed on a person's home under §A-2(2) of this regulation, when there is no: Sibling of the person lawfully residing in the home, who has resided there for a period of at least 1 year immediately before the date of the person's admission to a long-term care facility and who has lawfully resided there on a continuous basis since that time, or Son or daughter of the person lawfully residing in the home, who has resided there for a period of at least 2 years immediately before the date of the person's admission to a long-term care facility, who has lawfully resided there on a continuous basis since that time, and who can establish to the Department's satisfaction that he or she provided the care that permitted the person to reside in the home rather than in the facility. The Department may not seek recovery from the estate of a deceased individual under §A-3(1) and (2) of this regulation if, in the Department's judgment, substantial hardship exists. The Department may not seek recovery from the estate of a deceased individual for Medical Assistance payments of Medicare premiums, copayments, or deductibles. The Department may not seek recovery from the estate of a deceased individual to the extent of the value of LTC partnership policy benefits furnished to the individual up to the time of death. The Department shall accept reimbursement when voluntarily offered by a current or former recipient or someone acting on his behalf. Repealed. Extended Benefits Pending a Hearing Decision. The Department or its designee shall consider reimbursement in all cases in which: A recipient received extended benefits pending a hearing and decision by an administrative law judge at the Office of Administration Hearings; and The administrative law judge affirmed the original decision of the Department or its designee. The Department or its designee shall institute procedures to recover the cost of any expenditures made on behalf of a recipient in cases identified in §D(1) of this regulation. This provision may not apply to a individual who requested a hearing and extended benefits resulting from a bona fide belief that the Department or its designee has taken an adverse action erroneously. The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or person acting responsibly for the recipient. Assignment of Benefits, Release of Information, and Requirement of Cooperation by Recipient in Recovery Procedures. A recipient of Medical Assistance is deemed to have created an authorization for the release to the Department of all data, records, and information by insurance companies, nonprofit health service plans, providers of medical care, employers, unions, governmental agencies, and any other agencies, organizations, or individuals necessary for the Department's pursuit of third-party reimbursement. The authorization extends to all information relevant to third-party reimbursement or third-party health care coverage. The local department of social services shall take reasonable measures to identify and report to the Department on a form designated by the Department all possible third-party benefits available to persons determined eligible for Medical Assistance. The Department shall collect available benefits from third parties determined liable to pay for services received under Medical Assistance. An individual who receives medical services that was or will be paid for by Medical Assistance is deemed to have made assignment to the Department of: His own rights to any medical care support available under an order of a court or an administrative agency, and any third-party payments for medical care; and The rights of any other individual eligible under the plan, for whom he can legally make an assignment. Assignment of rights to benefits does not include assignment of rights to Medicare benefits. An applicant or recipient of Medical Assistance shall cooperate in: Establishing paternity for a child born out of wedlock for whom he can legally assign rights; and Obtaining medical care support and payments for himself and any other individual for whom he can legally assign rights. Waiver. The Department shall waive the requirements in §G(6) of this regulation if the Department, through the local department of social services, determines that the individual has good cause for refusing to cooperate. With respect to establishing support paternity of a child born out of wedlock or obtaining medical care and payments for a child for whom the individual can legally assign rights, the Department, through the local department of social services, shall find that cooperation is against the best interests of the child if it is reasonably anticipated that cooperation will result in: Physical harm to the child for whom support is to be sought; Emotional harm to the child for whom support is to be sought; Physical harm to the parent or caretaker relative with whom the child is living which reduces the person's capacity to care for the child adequately; or Emotional harm to the parent or caretaker relative with whom the child is living, of such nature or degree that it reduces the person's capacity to care for the child adequately. If at least one of the following circumstances exists, and the Department, through the local department of social services, believes that because of the existence of that circumstance, in the particular case, proceeding to establish paternity or secure support would be detrimental to the child for whom support would be sought, the Department, through the local department of social services, shall find that cooperation is against the best interests of the child: The child for whom support is sought was conceived as a result of incest or forcible rape; Legal proceedings for the adoption of the child are pending before a court of competent jurisdiction; or The applicant or recipient is currently being assisted by a public or licensed private social agency to resolve the issue of whether to keep the child or relinquish him for adoption, and the discussions have not gone on for more than 3 months. If the Department of Human Services has made a finding that good cause for refusal to cooperate does or does not exist, the Department shall adopt that finding as its own for this purpose. With respect to obtaining medical care support and payments for an individual in any case not covered by §G(7)(b) or (c) of this regulation, the Department, through the local department of social services, shall find that cooperation is against the best interests of the individual or other person to whom Medical Assistance is being furnished, if it is reasonably anticipated that cooperation will result in reprisal against, and cause physical or emotional harm to, the individual or other person. The Department or its designee shall: Deny or terminate eligibility for any applicant or recipient who refuses to cooperate as required under §G(6) of this regulation unless cooperation has been waived; Provide Medical Assistance to any individual who: Cannot legally assign his own rights, and Would otherwise be legally eligible for Medical Assistance but for the refusal by a person legally able to assign his rights or to cooperate as required by this regulation. The assignment created by this regulation shall be effective as long as the recipient is eligible for Medical Assistance and remains effective for all services paid by the Program during this period of eligibility, and for those services which were erroneously provided to ineligible persons and paid for by the Program. Except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. A carrier shall: Provide, at the request of the Department, information about individuals who are eligible for benefits under the Program or are Program recipients so that the Department may determine: Whether an individual, the spouse of an individual, or the dependent of an individual is receiving health care coverage from a carrier; and The nature of that coverage; Provide the information required under §A of this regulation in a manner prescribed by the Department; and Accept the Program's right of recovery and the assignment to the Program of any right of an individual or other entity to payment from the carrier for an item or service for which payment has been made under the Program if the carrier has a legal obligation to make payment for the item or service. Subject to §A of this regulation, a carrier may not reject, deny, limit, cancel, refuse to renew, increase the rates of, affect the terms or conditions of, or otherwise affect a health insurance policy or contract for a reason based wholly or partly on the: Eligibility of the individual for receiving benefits under the Program; or Receipt by an individual of benefits under the Program. A carrier shall comply with the provisions of Health-General Article, §15-144, Annotated Code of Maryland, pertaining to health maintenance organizations. Estates and Trusts Article, §14.5-1002; Health-General Article, §§2-104(b), 2-105(b), 15-103, 15-105, 15-121, and 15-401—15-407; Annotated Code of Maryland; Annotated Code of Maryland Effective date: May 1, 1983 (10:6 Md. R. 558) Regulations .01, .02, and .06 amended as an emergency provision effective December 1, 1992 (19:25 Md. R. 2198); amended permanently effective June 1, 1993 (20:10 Md. R. 852) Regulation .02B amended effective May 1, 1986 (13:8 Md. R. 898); August 8, 1988 (15:16 Md. R. 1914); May 1, 1989 (16:8 Md. R. 910); December 1, 1992 (19:23 Md. R. 2041); March 24, 1997 (24:6 Md. R. 485); June 2, 1997 (24:11 Md. R. 793) Regulations .02B; .03C; .04; .07B, I, J, L; .08G, H; .09B; .10C, E, F; .11D, E; .12B; .14A; and .15D amended as an emergency provision effective May 1, 1983 (10:11 Md. R. 962); adopted permanently effective September 1, 1983 (10:17 Md. R. 1521) Regulations .02B and .05A amended as an emergency provision effective October 3, 1997 (24:22 Md. R. 1550); amended permanently effective January 12, 1998 (25:1 Md. R. 16) Regulation .02B amended effective November 24, 2005 (32:23 Md. R. 1826); December 31, 2007 (34:26 Md. R. 2262); October 14, 2013 (40:20 Md. R. 1652) Regulation .03 amended as an emergency provision effective May 4, 1990 (17:11 Md. R. 1339); amended permanently effective August 13, 1990 (17:15 Md. R. 1858) Regulation .03-1 adopted effective April 1, 2002 (29:6 Md. R. 567) Regulation .03-1B amended effective June 9, 2003 (30:11 Md. R. 735) Regulation .03-2 adopted effective April 1, 2002 (29:6 Md. R. 567) Regulation .03-2F amended effective January 6, 2003 (29:26 Md. R. 2027) Regulation .03-3 adopted effective June 7, 2004 (31:11 Md. R. 856) Regulation .03-3 amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03-4 adopted effective June 7, 2004 (31:11 Md. R. 856) Regulation .03-4A amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .04 amended effective May 1, 1986 (13:8 Md. R. 898); May 1, 1989 (16:8 Md. R. 910); June 30, 2008 (35:13 Md. R. 1179); April 19, 2010 (37:8 Md. R. 615) Regulation .04J amended as an emergency provision effective October 1, 2001 (28:24 Md. R. 2125); emergency status expired March 29, 2002 Regulations .04J, .07B, G—N, and .08B, G—L amended as an emergency provision effective March 1, 1984 (11:5 Md. R. 449); emergency status extended at 11:14 Md. R. 1247 (July 6, 1984) Regulations .04J, .07B, G—N, and .08B, G—L amended effective October 15, 1984 (11:20 Md. R. 1742) Regulation .04J amended effective September 20, 2010 (37:19 Md. R. 1284) Regulation .05 repealed and new Regulation .05 adopted effective September 24, 2007 (34:20 Md. R. 1737) Regulation .05A amended effective April 14, 2003 (30:7 Md. R. 487) Regulation .05C amended effective April 19, 2010 (37:8 Md. R. 614) Regulation .05D amended effective March 11, 1985 (12:5 Md. R. 482); April 19, 2010 (37:8 Md. R. 614) Regulation .05E amended effective March 11, 1985 (12:5 Md. R. 482); March 24, 1997 (24:6 Md. R. 485) Regulation .05H amended effective June 2, 1997 (24:11 Md. R. 793) Regulation .05-1 adopted effective September 24, 2007 (34:20 Md. R. 1737) Regulation .05-1B amended effective April 19, 2010 (37:8 Md. R. 614) Regulation .05-2 adopted effective September 24, 2007 (34:20 Md. R. 1737) Regulation .05-2 amended effective April 19, 2010 (37:8 Md. R. 614) Regulation .05-3 adopted effective September 24, 2007 (34:20 Md. R. 1737) Regulation .05-3K amended effective October 14, 2013 (40:20 Md. R. 1652) Regulation .05-4 adopted effective September 24, 2007 (34:20 Md. R. 1737) Regulation .05-5 adopted effective September 24, 2007 (34:20 Md. R. 1737) Regulations .06, .07M, .08, .10, .11, .12C, and .15 amended effective May 1, 1986 (13:8 Md. R. 898) Regulation .07 amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .07D, M amended effective June 30, 2008 (35:13 Md. R. 1179) Regulation .07J amended effective October 8, 1991 (18:18 Md. R. 2005) Regulation .07M amended as an emergency provision effective September 30, 1989 (16:21 Md. R. 2258); adopted permanently effective February 1, 1990 (17:1 Md. R. 69) Regulation .07N amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1173); amended permanently effective September 10, 1984 (11:18 Md. R. 1584) Regulation .07N amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1628); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020) Regulation .07N amended effective August 10, 1987 (14:16 Md. R. 1774); July 1, 1988 (15:13 Md. R. 1554) Regulations .07N and .10E amended as an emergency provision effective July 1, 1985 (12:13 Md. R. 1274); adopted permanently effective November 4, 1985 (12:22 Md. R. 2104) Regulation .07N amended as an emergency provision effective July 1, 1989 (16:14 Md. R. 1565); amended permanently effective October 30, 1989 (16:21 Md. R. 2261) Regulation .07N amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1851); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .07N amended as an emergency provision effective December 10, 1991 (18:26 Md. R. 2827); amended permanently effective April 1, 1992 (19:5 Md. R. 577) Regulation .07N amended as an emergency provision effective November 25, 1992 (19:25 Md. R. 2199); amended permanently effective March 29, 1993 (20:4 Md. R. 371) Regulation .07N amended as an emergency provision effective July 22, 1993 (20:16 Md. R. 1275); amended permanently effective November 1, 1993 (20:21 Md. R. 1654) Regulation .07N amended as an emergency provision effective August 10, 1994 (21:18 Md. R. 1506); amended permanently effective November 7, 1994 (21:22 Md. R. 1876) Regulation .08 amended as an emergency provision effective May 15, 1992 (19:11 Md. R. 1012); emergency status extended at 19:19 Md. R. 1702; amended permanently effective September 14, 1992 (19:18 Md. R. 1656) Regulation .08 amended as an emergency provision effective April 8, 1994 (21:9 Md. R. 744); emergency provision rescinded retroactively to April 8, 1994 (21:14 Md. R. 1226) Regulation .08 amended effective June 30, 2008 (35:13 Md. R. 1179) Regulation .08B amended effective September 1, 1993 (20:17 Md. R. 1346); January 12, 1987 (14:1 Md. R. 31); August 22, 1988 (15:17 Md. R. 2049); July 3, 1995 (22:13 Md. R. 967) Regulation .08G, H amended effective June 2, 1997 (24:11 Md. R. 793) Regulation .08G, H, and H-1 amended effective January 12, 1987 (14:1 Md. R. 31) Regulation .08G, H, and I amended effective August 22, 1988 (15:17 Md. R. 2049) Regulation .08G, H, and K amended effective July 3, 1995 (22:13 Md. R. 967) Regulation .08G, I amended as an emergency provision effective October 1, 2001 (29:4 Md. R. 413); emergency status extended at 29:8 Md. R. 696; amended permanently effective April 29, 2002 (29:8 Md. R. 700) Regulation .08J-1 adopted effective September 1, 1993 (20:17 Md. R. 1346) Regulation .08J-1 amended effective October 14, 2013 (40:20 Md. R. 1652) Regulation .08L amended effective June 29, 1987 (14:13 Md. R. 1474); January 25, 1988 (15:2 Md. R. 121) Regulation .08L amended as an emergency provision effective July 1, 1989 (16:14 Md. R. 1565); amended permanently effective October 30, 1989 (16:21 Md. R. 2261) Regulation .08M amended effective June 29, 1987 (14:13 Md. R. 1474) Regulations .08 and .10 amended, and new Regulation .10-1 adopted as an emergency provision effective September 30, 1989 (16:21 Md. R. 2259); adopted permanently effective February 1, 1990 (17:1 Md. R. 69) (Regulation .10-1 originally adopted as Regulation .11) Regulations .08-1 and .08-2 adopted effective July 3, 1995 (22:13 Md. R. 967) Regulation .08-2 amended effective April 29, 2002 (29:8 Md. R. 700) Regulation .08-3 adopted effective November 24, 2005 (32:23 Md. R. 1826) Regulation .09B, C amended effective September 20, 2010 (37:19 Md. R. 1284) Regulation .10 amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .10C and D amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1628); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020) Regulation .10C, D amended effective July 1, 1987 (14:13 Md. R. 1474) Regulation .10C, D amended as an emergency provision effective March 13, 2009 (36:8 Md. R. 591); emergency status expired July 30, 2009 Regulation .10C, D amended effective July 27, 2009 (36:15 Md. R. 1165); September 20, 2010 (37:19 Md. R. 1284); October 14, 2013 (40:20 Md. R. 1652) Regulation .10E amended as an emergency provision effective May 1, 1983 (10:7 Md. R. 632); adopted permanently effective May 9, 1983 (10:9 Md. R. 791) Regulation .10-1 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1382); amended permanently effective November 1, 1992 (19:21 Md. R. 1891) Regulation .10-1C amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .10-1C, E amended and G adopted effective November 12, 1990 (17:21 Md. R. 2529) Regulation .10-1D amended effective October 8, 1991 (18:18 Md. R. 2005) Regulation .11C amended effective September 10, 1994 (11:8 Md. R. 1584) June 2, 1997 (24:11 Md. R. 793) Regulation .11E amended effective September 10, 1984 (11:18 Md. R. 1584) Regulation .12B amended effective August 8, 1988 (15:16 Md. R. 1914) Regulation .12C amended effective September 10, 1984 (11:18 Md. R. 1584) Regulation .13 repealed and new Regulation .13 adopted effective March 19, 2012 (39:5 Md. R. 382) Regulation .13C amended effective August 8, 1988 (15:16 Md. R. 1914) Regulation .14 amended effective August 8, 1988 (15:16 Md. R. 1914) Regulation .14 amended and recodified to Regulations .14 and .14-1 effective December 1, 1992 (19:23 Md. R. 2041) Regulation .14B amended as an emergency provision effective May 1, 1984 (11:10 Md. R. 858); emergency status expired August 28, 1984 Regulation .14B amended effective August 29, 1984 (11:17 Md. R. 1492) Regulation .15 amended effective August 8, 1988 (15:16 Md. R. 1914); July 3, 1995 (22:13 Md. R. 967) Regulation .15 amended as an emergency provision effective October 13, 1992 (19:22 Md. R. 1979); amended permanently effective February 1, 1993 (20:2 Md. R. 113) Regulation .15 amended as an emergency provision effective April 8, 1994 (21:9 Md. R. 744); emergency provision rescinded retroactively to April 8, 1994 (21:14 Md. R. 1226) Regulation .15A-3 amended as an emergency provision effective November 12, 2002 (29:24 Md. R. 1915); amended permanently effective February 17, 2003 (30:3 Md. R. 179) Regulation .17 adopted effective December 31, 2007 (34:26 Md. R. 2262) Chapter revised effective January 6, 2014 (40:26 Md. R. 2162) Regulation .02B amended effective September 11, 2017 (44:18 Md. R. 866); May 20, 2019 (46:10 Md. R. 486); April 4, 2022 (49:7 Md. R. 465); April 13, 2026 (53:7 Md. R. 328) Regulation .03A amended effective August 5, 2024 (51:15 Md. R. 706) Regulation .03A, C amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .03A, F amended effective April 4, 2022 (49:7 Md. R. 465) Regulation .03F adopted effective May 20, 2019 (46:10 Md. R. 486) Regulation .03-1 amended effective July 21, 2025 (52:14 Md. R. 712) Regulation .04F amended effective March 28, 2016 (43:6 Md. R. 406) Regulation .04-1D amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .04-1M adopted effective May 7, 2018 (45:9 Md. R. 461) Regulation .05-4B amended effective July 4, 2016 (43:13 Md. R. 713) Regulation .07B, F amended effective April 13, 2026 (53:7 Md. R. 328) Regulation .08-1B amended effective February 1, 2016 (43:2 Md. R. 127) Regulation .08-2B, C amended effective April 10, 2017 (44:7 Md. R. 355); May 20, 2019 (46:10 Md. R. 486) Regulation .08-2C amended effective August 29, 2016 (43:17 Md. R. 954) Regulation .08-4 adopted effective April 13, 2015 (42:7 Md. R. 568) Regulation .10C, D amended effective September 11, 2017 (44:18 Md. R. 866) Regulation .10-2 adopted effective April 13, 2015 (42:7 Md. R. 568) Regulation .12E adopted effective April 13, 2026 (53:7 Md. R. 328) Regulation .15A-3 amended effective April 13, 2015 (42:7 Md. R. 568) In this chapter, the following terms have the meanings indicated. Terms Defined. “Child's family” means those individuals with whom a participant resides, who are responsible for the participant, and who are the primary nurturing caregivers. “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. “Early intervention services (EIS)” means services which are consistent with COMAR 13A.13.01.02. “Individualized education program (IEP)” means a written description of special education and related services developed by a multidisciplinary team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.09. “Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.02. “Individuals with Disabilities Education Act (IDEA)” means the federal statute which provides for a free appropriate public education (FAPE) for children with disabilities from ages 3 to 21 and early intervention services for infants and toddlers with developmental delay, from birth to age 3. “Infants and toddlers with disabilities” means children from birth through 2 years old who are eligible for early intervention services, as documented by appropriate qualified personnel as defined in COMAR 13A.13.01.02. “Local education agency (LEA)” means a local public school district. “Local lead agency (LLA)” means the agency designated by the local governing authority in each county and Baltimore City to administer the interagency system of early intervention services under the direction of the Office for Children. “Maryland State Department of Education (MSDE)” means the Department established by Education Article, Title 2, Annotated Code of Maryland. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Multidisciplinary” means the involvement of two or more disciplines or professions in the provision of integrated and coordinated services, including evaluation and assessment activities and the development of the individualized family service plan or individualized education program. “Multidisciplinary team” means a group convened and conducted by the provider to develop the participant's IEP, which is composed of the child's parent or parents, the child's teacher, and relevant service providers as indicated in COMAR 13A.05.01.08A. “Office for Children” means the Office for Children established under Executive Order 01.01.2006.03. “Parent” means a biological or adoptive parent, a legal guardian, another individual responsible for a child's welfare, or a surrogate parent for those cases when: A public agency, after reasonable efforts, cannot discover the whereabouts of a biological or adoptive parent; An individual cannot be identified with responsibility for a child's welfare; or The child is a ward of the State. “Participant” means a Medical Assistance recipient who is eligible for Medical Assistance reimbursement for transportation services under IDEA. “Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Provider” means a local education agency, local lead agency, State-operated education agency, or State-supported education agency which meets the conditions for participation stated in Regulation .03 of this chapter, to provide transportation services under IDEA. “State-operated education agency” means a State agency that operates education programs for children with disabilities in accordance with COMAR 13A.05.01. “State-supported education agency” means an entity accredited by the Maryland State Board of Education to operate a school in accordance with COMAR 13A.09.10. “Transportation” means transportation services provided pursuant to COMAR 13A.06.07. Providers shall meet the requirements of COMAR 13A.06.07. Providers shall meet all the requirements of the jurisdiction in which they operate. Providers shall meet all requirements for participation in the Program stated in COMAR 10.09.36.03 and COMAR 13A.06.07. The Program covers the services listed in §B of this regulation when the services are provided to a child: Eligible for services under IDEA; Who is an eligible Medicaid recipient; Who was transported to or from a Medicaid-covered service under IDEA; Whose transportation and Medicaid-covered service or services are included on the child's IEP or IFSP. The following services are covered under this chapter: Transportation to or from a school where a Medicaid-covered IDEA service is provided; Transportation to or from a site where a Medicaid Early Intervention-covered IDEA service is provided; and Transportation between a school and a Medicaid-covered IDEA service. To participate in the Program as a provider of transportation services under IDEA, a provider shall be a local education agency, a local lead agency, a State-operated education agency, or State-supported education agency. Providers shall only bill the Program for transportation services on dates when other Medicaid covered services are provided. Request for Payment. An enrolled provider shall submit a request for payment of services rendered and completed under this chapter according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all payment requests not properly prepared or submitted. The provider shall submit a request for payment in the manner specified by the Department. The completed form shall indicate the: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, location, and provider number; and Nature, unit or units, and procedure code or codes of covered services provided. The Program may not make direct payment to the participant. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Reimbursement for transportation services shall be $12.50 per one way trip, of which the State portion is certified by the Maryland State Department of Education. Recovery and reimbursement is as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are those set forth in COMAR 10.09.36.09. Interpretive regulations are those set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.10 adopted as an emergency provision effective February 12, 1997 (24:5 Md. R. 391); adopted permanently effective May 19, 1997 (24:10 Md. R. 710) Regulation .01B amended effective December 18, 2006 (33:25 Md. R. 1951) In this chapter, the following terms have the meanings indicated. Terms Defined. “Alternative living unit” means a residence that: Provides residential services for individuals who, because of developmental disabilities, require specialized living arrangements; Admits not more than 3 individuals; and Provides 10 or more hours of supervision per unit per week. “Appropriate evaluation” means the assessment of an individual by qualified developmental disabilities professionals using accepted professional standards to document the presence of a: Developmental disability as defined in Health-General Article, §7-101(e), Annotated Code of Maryland; or Severe, chronic disability that qualifies the individual for support services as defined in Health-General Article, §7-403(c), Annotated Code of Maryland. “Chronic care facility” means an institution which: Falls within the jurisdiction of Health-General Article, §19-307(a)(1)(ii), Annotated Code of Maryland; and Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. “Day habilitation services” means a program of habilitation and health-related services which is routinely provided during the day in a community setting for a minimum of 30 hours per week, not less than 5 days per week, according to an individually designed and implemented plan of services. On one of the 5 days the program may be provided for not less than 4 hours. The habilitation program may include scheduled training or skills development activities which are conducted at sites away from the day habilitation services center. “Day habilitation services center” means a facility or a site which provides day habilitation services to individuals with developmental disabilities who do not require 24-hour inpatient care, but who, due to the degree of disability, are not capable of full-time independent living. “Department” has the meaning Maryland Department of Health as stated in COMAR 10.09.36. “Developmental Disabilities Administration (DDA)” means that agency of the Maryland Department of Health which, under Health-General Article, Title 7, is charged with the responsibility for providing services to persons who are developmentally or otherwise disabled. “Developmental disability” means a severe chronic disability of an individual that: Is attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; Is manifested before the individual attains the age of 22; Is likely to continue indefinitely; Results in an inability to live independently without external support or continuing and regular assistance; and Reflects the need for a combination and sequence of special interdisciplinary or generic care, treatment, or other services that are individually planned and coordinated for the individual. “Environmental modifications” means physical adaptation to a community residence, when documented in the Individualized Service Plan as being necessary to make the residence accessible and to meet the needs of the waiver participant being served in that setting. “Group home” means a residence that: Provides residential services for individuals who, because of developmental disability, require specialized living arrangements; Admits at least 4 but not more than 8 individuals; and Provides 10 or more hours of supervision per home, per week. “Habilitation services” means a program which assists an individual to acquire and maintain those life skills that enable the individual to cope more effectively with the demands of the individual's own person and environment, and to raise the level of the individual's physical, mental, social, and vocational functioning including, but not limited to, programs of treatment with training in self-help, daily living, and survival skills. Home. “Home” means a house or apartment: Which is rented or owned by the waiver participant or the waiver participant's family or proponent; Which may be held in trust for the waiver participant, or the waiver participant may be a roommate without appearing on a lease or title; and Where the waiver participant lives with not more than two other unrelated waiver participants. “Home” does not mean a house or apartment that is owned or rented by a provider, although the provider may be a guarantor of rental or mortgage payments. “Home and Community Based Services Waiver for the Developmentally Disabled” means the document and any amendments to it submitted by the single State agency for Title XIX and approved by the Secretary of Health and Human Services which authorize the waiver of statutory requirements limiting coverage for home and community based services under the Medical Assistance Program's State Plan. “Individual family care home (IFC)” means a private, single family residence licensed by the Department which: Under supervision, provides a home for individuals with developmental disabilities in a family atmosphere; and Provides habilitation services for one to three individuals who are not related to the caregiver. “Individual Habilitation Plan (IHP)” means the written plan of specific action as specified in COMAR 10.22.05, which is developed and modified by an appropriately constituted interdisciplinary team. “Individualized Service Plan (ISP)” means the document serving as the basis for effective and efficient services coordination for the client, developed by an interdisciplinary team with the input and approval of the client, or the client's representative, as appropriate, focusing upon the broad service areas needed by the client, and recorded and managed by the client's service coordinator. “Intensive behavior management” means a specialized program designed to serve waiver participants who have been identified as having emotional disturbance or maladaptive behavior of sufficient severity to prevent or jeopardize community living. “Interdisciplinary team” means a group convened by the waiver participant's service coordinator, which meets to design effective, efficient individualized plans and programs, with membership comprised of, but not limited to, the waiver participant, the waiver participant's family or representative, the waiver participant's service coordinator, representatives of providers, individuals with various professional skills which are relevant to the needs of the waiver participant, and other human services staff. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36. “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, because of their degree of impairment, need health maintenance and restorative services supportive to their community living. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Nursing facility” means a facility or a distinct part of a facility which is participating in the Medical Assistance Program as a nursing facility provider under COMAR 10.09.10 or 10.09.11. “Physician” means an individual licensed to practice medicine in the state in which services are provided. “Plan of care” means the written, individualized plan of care developed for a waiver participant in accordance with the requirements under COMAR 10.09.48, 10.22.09, or 10.22.11. “Program” has the meaning stated in COMAR 10.09.36. “Provider” means an agency which is licensed or certified to furnish covered services under these regulations through an appropriate agreement with the Department. “Provider agreement” means the contract between the Department and the provider specifying the services to be performed, methods of operation, financial and legal requirements which shall be in force before Program participation is allowed. “Qualified developmental disabilities professional (QDPP)” means an individual who: Is a registered nurse, physician, or an individual with a bachelor's degree in a relevant discipline which may include, but not be limited to: Occupational therapy, Physical therapy, Psychology, Social work, Recreation, Education; and Has a minimum of 1 year full-time or equivalent experience working directly with persons with an intellectual disability or other developmental disability. “Recipient” has the meaning stated in COMAR 10.09.36. “Residential habilitation services” means that training provided in a group home, alternative living unit, or individual family care home to a waiver participant which promotes skills necessary for maximum independence in daily activities of living. “Residential option services” means one or more of the services described in Regulation .08-2 of this chapter which are intended to assist eligible waiver participants, regardless of the nature and severity of their disability, to live independently and successfully in the community by assisting them to perform activities of daily living and enabling them to live in homes of their choice, receive services from providers of their choice, and take into account the use of community resources and natural supports. “Respite care” means a service for waiver participants designed to provide time-limited and temporary relief for primary informal caregivers from the ongoing responsibility of providing care for waiver participants, as well as to provide a back-up service system in the event of a crisis or emergency involving a primary informal caregiver. “Room and board” means rent or mortgage, utilities, and food. “Service coordinator” means a case management professional who is a qualified developmental disabilities professional (QDDP) selected by the client and employed by a service coordination provider under this chapter to assist the client in gaining more efficient and effective access to the service delivery system. “Services coordination” means a service that consists of the following 3 major functions that are designed to assist an individual in obtaining the needed services and programs that the individual desires in order to gain as much control over the individual's own life as possible: Planning services; Coordinating services; and Monitoring service delivery to the individual. “State residential center” means a place that: Is owned and operated by this State; Provides residential services for individuals with an intellectual disability and who, because of an intellectual disability, require specialized living arrangements; and Admits 9 or more individuals with a diagnosis of an intellectual disability. “Supported employment” means paid work in a variety of regular work settings in which persons without disabilities are employed, and which are especially designed for individuals with developmental disabilities facing severe impediments to employment due to the nature and complexity of their disabilities, irrespective of age or vocational potential. “Waiver participant” means a recipient who meets the eligibility requirements of these regulations. Providers of residential habilitation services shall be licensed pursuant to COMAR 10.22.03 or 10.22.14. Providers of day habilitation or supported employment services shall be licensed pursuant to COMAR 10.22.12 or 10.22.13. Providers of services coordination services shall be licensed by the Department pursuant to COMAR 10.22.09. Providers of residential option services shall be licensed pursuant to COMAR 10.22.11.04. Providers of intensive behavior management shall be: Licensed by the Department to provide services for developmentally disabled individuals; or Approved by the DDA as qualified to render services in accordance with COMAR 10.22.10. Providers of any service covered under this chapter, with the exception of medical day care services, may be issued a deemed status license by the Director of DDA, in accordance with the deemed status provisions in Health-General Article, §7-903(b), Annotated Code of Maryland. Providers of medical day care services shall be licensed pursuant to COMAR 10.12.04. DDA shall comply with all applicable provisions of COMAR 10.21 when: Enrolling providers for services covered under this chapter; Authorizing a provider to serve greater numbers of waiver participants; or Transferring authorized positions for waiver participants from one provider to another provider. General requirements for participation in the Medical Assistance Program are that the providers: Meet all conditions for participation specified in COMAR 10.09.36, except as otherwise specified in this regulation; Meet the licensure requirements as provided in Regulation .02 of this chapter; Have a provider agreement in effect with the Developmental Disabilities Administration and the Medical Assistance Program; Verify the licenses of all service agencies with whom they contract and have a copy of the same available for inspection; Verify the licenses and credentials of all professionals whom they employ or with whom they contract and have a copy of same available for inspection; Maintain a written clinical record for each waiver participant which includes: A copy of the waiver participant's signed statement indicating the alternatives of care locations offered to him or her, and his or her choice; Date of: Discharge from a State residential center or a nursing or chronic care facility into the services covered under this chapter; or Diversion from a State residential center or chronic care facility into the services covered under this chapter; and Have waiver participants reevaluated annually by the interdisciplinary team. Services coordination providers shall submit individualized service plans to the DDA or its designee. Environmental Modifications. Residential habilitation or residential option services providers shall provide environmental modifications as necessary to meet the needs of waiver participants after receiving prior authorization from DDA. Environmental modifications shall be: Provided by the residential habilitation or residential option services provider in getting a residence ready to be occupied; and Performed in accordance with applicable codes of the locality. Respite Care. Residential habilitation or residential option services providers shall provide respite care as necessary to meet the needs of waiver participants. Respite care services shall be received in a: State residential center; or Community residence: Operated by a provider of residential habilitation services; and Licensed by the State, in accordance with COMAR 10.22.03.02A(9)(b) and (c), to provide respite care. Medical day care providers: Shall meet the requirements of COMAR 10.09.07; and Are exempt from meeting the requirements of Regulation .18D of this chapter. The Department shall reimburse for services coordination which shall include the following: Convening the interdisciplinary team and conducting the team meeting for the development and revision of the ISP; Assisting the waiver participant in identifying, negotiating, and obtaining needed services that are agreed upon and specified in the ISP; Arranging, coordinating, and monitoring the delivery of services specified in the ISP; Reassessing or arranging for the periodic reassessment of the waiver participant's needs and services; Participating in the development of the waiver participant's initial IHP; Participating in reviews of the waiver participant's IHP; and Assisting the waiver participant in maximizing the use of the following sources of services and equipment in an effort to achieve the least costly, yet appropriate, delivery of services to the waiver participant: Services provided at no cost by governmental or charitable agencies, such as the Department of Social Services or the Department of Vocational Rehabilitation, Services covered by the Program or other third-party payors, Generic services covered by other programs, Services that can be paid for with the waiver participant's funds. The Department shall reimburse residential habilitation services providers for those services listed below, exclusive of room and board. These regulations do not limit payments, within the fiscal guidelines of the Department, for room, board, and normal living expenses for waiver participants. Habilitation. The services shall be provided as required and recommended in the IHP. Residential habilitation services providers shall provide, as a minimum, the following: A program of habilitation which shall: Be specified in the IHP, Provide training in the development of self-help, daily living, self-advocacy, and survival skills, and Use the principles of the Developmental Model; Mobility training to maximize use of public transportation in traveling to and from work training or day programs, work sites, community services, and recreational sites; Training and assistance in developing appropriate social behaviors which are normative in the surrounding community such as conducting one's self appropriately in restaurants, on public transportation vehicles, in recreational facilities, and in stores and other public places; Training and assistance in developing patterns of living, activities, and routines which are appropriate to the waiver participant's age and the practices of the surrounding community and which are consistent with the waiver participant's interest and capabilities; Training and assistance in developing basic safety skills; Training and assistance in developing competency in housekeeping skills including, but not limited to, meal preparation, laundry, and shopping; Training and assistance in developing competency in personal care skills such as bathing, toileting, dressing, and grooming; Training and assistance in developing health care skills, including but not limited to, maintaining proper dental hygiene, carrying out the recommendations of the dentist or physician, appropriate use of medications, application of basic first aid, arranging medical and dental appointments, and summoning emergency assistance; Training and assistance to waiver participants in developing money management skills which include recognition of currency, making change, bill paying, check writing, record keeping, budgeting, and saving; Supervision of individuals as appropriate. Medical. Medical services provided shall be under the direction of a physician and shall include the following: Evaluation, diagnosis, and treatment; Consultation with the waiver participant and his or her family, staff members, and personal physician, if any; Participation in the development of the initial IHP; Monitoring, reevaluation and follow-up of medical services as appropriate; Referral of waiver participants who require additional medical treatment and services which are not available at the residential services site. Occupational Therapy. Occupational therapy services shall be provided that are required and recommended in the IHP and shall include: Specifications of the treatment to be rendered, the frequency and duration of that treatment, and the expected results; Evaluation and reevaluation of the waiver participant's level of functioning through the use of standardized or professionally accepted diagnostic methods; Development and delivery of appropriate treatment programs which are designed to significantly improve a waiver participant's level of functioning within a reasonable period of time; Selection and teaching of task-oriented therapeutic activities designed to restore physical functioning; Improvement of mobility skills. Psychiatric. Psychiatric services shall be provided as recommended in the IHP, under the direction of a board certified psychiatrist, and shall include: Treatment and prevention of behavioral or emotional disorders which result from psychiatric or neurological conditions; Written assessment of the waiver participant's mental and emotional status; Consultation with the waiver participant's personal physician, and other individuals involved in the care of the waiver participant as appropriate; Periodic monitoring and follow-up of waiver participant's progress. Psychological. Psychological services shall be provided as required and recommended in the IHP and shall include: A written evaluation that includes use of psychometric data, provided that there is a significant change in the waiver participant's level of functioning, or behavior, or both; Interviews and consultations with the waiver participant, family, and other pertinent individuals; Participation in the development of the initial IHP, monitoring, reevaluation, and follow-up of specific individual programs as appropriate; Assessment and treatment related to the emotional needs of the waiver participant; Consultation with staff; Development and implementation of behavior modification programs. Physical Therapy. Physical therapy services shall be provided as required and recommended in the IHP which specify: Part or parts of the body to be treated; Type of modalities or treatments to be rendered; Expected results of physical therapy treatments; Frequency and duration of treatment. The needs assessment shall indicate services which are of a diagnostic, habilitative, therapeutic, or maintenance nature to prevent further deterioration. Services shall meet accepted standards of medical practice, with developed time frames for effective professional treatment. Social. Social services shall be provided as required and recommended in the IHP and shall include: Identification of the waiver participant's social needs; Individual counseling to assist the waiver participant's adaption to the environment; Family and group counseling to assist and facilitate the waiver participant's adjustment. Speech Pathology and Audiology. Speech pathology and audiology services shall be provided as required and recommended in the IHP and shall include: Maximization of communication skills; Screening, evaluation, counseling, treatment, habilitation, or rehabilitation of waiver participants with hearing, language, or speech handicaps; Coordination of interdisciplinary goals related to hearing and speech needs; Consultation with staff regarding the waiver participant's programs. Nursing. Nursing services shall be provided which: Are preauthorized by DDA as being medically necessary and not otherwise covered by the Program; Are rendered under the direction of a physician; Are required and recommended in the waiver participant's ISP; and May include: Meeting with provider's staff to discuss how the medical services that are identified in the ISP will be implemented, Education, supervision, and training of waiver participants in health-related matters, and Short-term or intermittent skilled or unskilled nursing services. Day habilitation services shall be provided that are required and recommended in the waiver participant's IHP by licensed day habilitation programs and shall include the services listed in Regulation .05 of this chapter and in §B—D of this regulation. Transportation. Transportation services shall be arranged for participants by the day habilitation services center staff. The center shall maximize the use of the following types of transportation services in an effort to achieve the least costly, yet appropriate, means of transportation for its participants: Persons who live within walking distance of the day habilitation services center, and who are sufficiently mobile, shall be encouraged to walk; Transportation supplied by family, friends, neighbors, or volunteers; Free community transportation services. After every effort made by the center to procure the types of transportation mentioned above has failed, the Department shall reimburse the day habilitation services provider for the waiver participant's traveling costs, to and from the center, by car, van, or specially equipped vehicles. It shall be the responsibility of the center to: Arrange for use of public transportation, when appropriate; Arrange special low-cost contract agreements with transportation providers to meet the transportation needs of the participants; Group participants, when possible, not to exceed the seating capacity, in the same van or specially equipped vehicle, to minimize the cost of transportation. Records shall clearly indicate both a primary transportation plan and an alternate plan. The center shall keep accurate records which include the type of transportation used by each participant. Nutrition. Arrangements shall be made for participants to eat well balanced, palatable, properly prepared meals of sufficient quality and quantity. Dietary counseling and education shall be available to all participants. Nutrition services do not include a full meal regimen. Prevocational Services. “Prevocational services” means those plans and interventions to assist a waiver participant in acquiring and maintaining basic work and work-related skills. The services are designed to prepare the waiver participant for unpaid or paid employment, but are not job task oriented. Prevocational services have habilitative objectives rather than explicit employment objectives. Prevocational services include: Training the waiver participant to follow directions, adapt to work routines, and carry out assigned duties in an effective and efficient manner; Helping the waiver participant to acquire appropriate attitudes and work habits, including instruction in socially appropriate behaviors on and off the job site; Assisting the waiver participant to adjust to the productive and social demands of the workplace; Familiarizing the waiver participant with job production and performance requirements; Providing transportation between the waiver participant's place of residence and the workplace when other forms of transportation are unavailable or inaccessible; Providing mobility training, including the use of public transit and para-transit systems; and Instructing waiver participants in appropriate use of job-related facilities such as break areas, lunch rooms or cafeterias, and restrooms. Prevocational services are covered by the Program if: The waiver participant previously resided in a State residential center or nursing facility and has a demonstrated earning capacity of less than 50 percent of the federal minimum wage, as determined in accordance with certification standards promulgated by the U.S. Department of Labor; The services are an essential component of the waiver participant's IHP; Work productivity is a secondary or tertiary goal of these services, subordinate to the acquisition and retention of work and work-related skills; The provider's program is certified by the U.S. Department of Labor as a “work activity center”, in accordance with the Fair Labor Standards Act, §14(c); and The waiver participant is engaging in compensable work as a necessary but subordinate part of the receipt of habilitation services. Environmental modifications shall be provided on a limited, one-time-only basis to the extent necessary to enable waiver participants with physical infirmities or disabilities to live safely in community homes as an alternative to institutionalization. The environmental modifications are limited to: Installation of bathing and toilet-area grab bars in the home of a waiver participant who has physical infirmities or disabilities, when these mechanisms are not already installed; Minor remodeling of the home to make it physically accessible for a waiver participant; Construction of access ramps and railings for a waiver participant who uses a wheelchair or who has limited ambulatory ability; Installation of detectable warnings on walking surfaces; Adaptations to the electrical, telephone, and lighting systems; Life-saving equipment for waiver participants; Widening of doorways and halls for wheelchair use; and Installation of chair glides along stairways. The services in this regulation are covered only if prior authorization is received from DDA, to assure that the proposed modifications are necessary to meet the waiver participant's needs and that the modifications conform with the requirements in these regulations. Respite care may only be provided to waiver participants who receive residential habilitation or residential option services in their home or in an individual family care home. When respite care is received in a: State residential center, it is limited to a total of 45 days within any 12-month period; Community residence, it is limited to 14 consecutive days at a time and to a total of 28 days within any 12-month period. Room and board is included in the residential habilitation or residential option services provider's reimbursement for respite care. Supported employment services are available to waiver participants: Who previously resided in a State residential center or nursing facility; For whom competitive employment at or above the minimum wage is unlikely; and Who, because of their disability, need ongoing post-employment support to perform in a work setting. Supported employment services are designed to assist a waiver participant with accessing and maintaining paid employment. The services shall be provided as required and recommended in the waiver participant's ISP, as an alternative model of day habilitation. Supported employment services include: Individualized assessment and development of employment-related goals and objectives; Individualized and group counseling; Individualized job development, placement, and work adjustment services that produce an appropriate job match between the waiver participant and the waiver participant's employer; On-the-job training in work and work-related skills required to perform the job; Ongoing evaluation, supervision, and monitoring of the waiver participant's performance on the job which are required because of the waiver participant's disabilities, but which do not include supervisory activities rendered as a normal part of the business setting; Ongoing support services necessary to assure job retention; Training in related skills essential to obtaining and retaining employment, such as the effective use of community resources and break or lunch areas, and transportation and mobility training; Transportation between the waiver participant's place of residence and the workplace, when other forms of transportation are unavailable or inaccessible; Adaptive equipment necessary to obtain and retain employment; and Community integration activities. Residential option services are available as an alternative to residential habilitation for those waiver participants who: Have followed DDA's application procedures according to COMAR 10.22.11; Are determined by DDA to be able to live safely in a home of the waiver participant's choosing and who are in need of at least one residential option service; and Elect, or have an authorized representative elect in the waiver participant's behalf, to receive residential option services. These services shall be provided, as required and recommended in the waiver participant's ISP, as being appropriate and necessary to assist the waiver participant in living successfully in a home of the waiver participant's choosing. Residential option services include the services specified in Sec. C--E of this regulation. Personal Assistance. Services under COMAR 10.09.20 may not be reimbursed for a waiver participant receiving personal assistance under this chapter. Personal assistance services provide necessary assistance for waiver participants living in their own homes or family homes to meet their daily living needs and to ensure adequate functioning in the community. They include the following services, when they do not have a habilitative objective: Housekeeping assistance which is directly related to the waiver participant's developmental disability and which is necessary for the waiver participant's health and well-being in the home, such as: Changing bed linens, Straightening the area used by the waiver participant, Doing the waiver participant's personal laundry and linens, and Maintenance of kitchen area if food preparation is necessary; Menu planning, food shopping, meal preparation, and assistance with eating; Personal hygiene and grooming, including oral and denture care, shaving, and care of skin, nails, and hair; Cleaning and maintaining adaptive devices such as wheelchairs; and Assurance of health and safety. Support Services. Support services are necessary to aid the waiver participant to participate in community life as is typical in the community. Support services include the following: Guidance to optimize the waiver participant's capability of living in the community at home; Facilitating community participation by assisting with linkages to community activities, organizations, or associations; Assisting with budgeting, banking, tax preparation, and financial management; Assisting with accessing and managing government and community resources; and Assisting the waiver participant with securing and maintaining housing. 24-Hour Emergency Assistance. These emergency assistance services are utilized to provide a waiver participant with access to a highly responsive form of back-up services in the event of an emergency, without dictating that the waiver participant be subject to on-site 24-hour supervision. The access to 24-hour emergency assistance shall be adapted to the skills and needs of the waiver participant and may include the use of an emergency telephone number, a pager, or other appropriate technology. This technology and equipment includes the assistive technology and adaptive equipment necessary to enable a waiver participant to live in the community and to participate in community activities, when this technology and equipment is not otherwise covered by the Program. The following items or services are included: Equipment needed to adapt the waiver participant's or family's vehicle; Purchase or rental of certain types of medical equipment to allow greater independence for a waiver participant; A prompted assisted living system for a waiver participant; and Assessments, specialized training, and upkeep and repair needed in conjunction with the use of these devices and equipment. Services shall be provided in accordance with COMAR 10.22.10. Unit of service means a day of care in which the participant is certified present at the medical day care center for a minimum of 4 hours. Medical day care services shall be provided in accordance with COMAR 10.09.07. Medical day care services may be covered for not more than 5 days per week. The Department shall reimburse for services in Regulations .04—.08-5 of this chapter when they are: Provided to waiver participants; With the exception of medical day care services, contained in the waiver participant's plan of care, approved initially and within 12 months after that by a: Licensed physician; Licensed physician's assistant or licensed nurse practitioner in accordance with applicable law; or Qualified developmental disabilities professional; and With the exception of medical day care services, adequately described in the progress notes in the waiver participant's record, signed and dated by a qualified developmental disabilities professional. These regulations do not cover the following services: Services available to waiver participants through programs funded under the Rehabilitation Act of 1973, §110, Public Law 94-142, or Education of the Handicapped Act, §602(16) and (17); Services which are not part of a waiver participant's plan of care as established by a: Licensed physician; Licensed physician's assistant or licensed nurse practitioner in accordance with applicable law; or Qualified developmental disabilities professional; Services which are not included in Regulations .04—.08-5 of this chapter; and Medical day care services which are not provided in accordance with COMAR 10.09.07. Providers are not entitled to reimbursement from the Program unless the waiver participant served by that provider is certified for medical eligibility by the Department or its designee and for financial eligibility by the Department of Human Services or its designee. Providers of services coordination services pursuant to these regulations may not be providers of any other service covered under this chapter for waiver participants. If the Program denies payment or requests repayment on the basis that an otherwise covered service was not programmatically necessary, the provider may not seek payment for that service from the recipient. Payment may not be made for the same date of service for respite care, personal assistance, and residential habilitation services rendered to a waiver participant. Payment may not be made for the same date of service to a residential habilitation services provider, a residential option services provider, and a personal care services provider under COMAR 10.09.20 for services rendered to a waiver participant. Qualified participants shall be given the option of residential habilitation or residential option services when they are determined to need residential services and qualify for both options. Payment may not be made for the same date of service for day habilitation services, supported employment services, and medical day care services under COMAR 10.09.07 rendered to a waiver participant. The following services shall be reimbursed only if preauthorized by DDA, or authorized by DDA after the fact in emergency situations: Environmental modifications as covered under Regulation .07 of this chapter; Assistive technology and adaptive equipment as covered under Regulation .08-3 of this chapter; and Nursing services as covered under Regulations .05 or .06 of this chapter. Waiver participants shall meet the eligibility conditions of §B of this regulation, as well as Regulation .12 of this chapter. To be eligible for services under the Home and Community Based Services Waiver for the Developmentally Disabled, a person shall: Be a recipient who, immediately before placement pursuant to these regulations, is residing in a: State residential center; Nursing facility and who is determined through the Preadmission Screening Annual Resident Review (PASARR) process to: Have a developmental disability, and Be in need of specialized services pursuant to 42 CFR §483.136; or Chronic care or nursing facility bed at a chronic care facility; or Community setting and who is determined by DDA to be at risk of placement in a State residential center or in a chronic care or nursing facility bed at a chronic care facility, in accordance with DDA's process for eligibility determinations and for determination of service priority categories; Be given a comprehensive evaluation as defined in Health-General Article, §7-104, Annotated Code of Maryland; Have an approved plan of care; Be selected by the DDA based on professionally accepted assessment measures, as appropriate to participate in the waiver program; Choose, during an interpretive interview, between institutional or home and community based services; Be certified for an ICF/IID level of care and have need for active treatment pursuant to 42 CFR §435.1009. Definitions. In this regulation, the following terms have the meanings indicated: “Aged” means a person who is 65 years old or older. “Blind” means having a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of not greater than 20 degrees. “Child” means an individual who is younger than 21 years old. “Community spouse” means an individual who: Lives in the community outside a medical institution; Is not determined to meet the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of Title XIX of the Social Security Act; and Is married to an institutionalized spouse. “Continuous period of institutionalization” means: At least 30 consecutive days of institutional care in a nursing facility or other medical institution; or A determination that a spouse meets the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of Title XIX of the Social Security Act. “Disabled” means the inability to perform any substantial gainful activity by reason of a medically determinable physical or mental impairment which is expected to result in death, or which has lasted or can be expected to last for a continuous period of not less than 12 months. “Institutionalized spouse” means an individual who is married to a community spouse and who: Is an inpatient in a nursing facility or other medical institution with a length of stay exceeding 30 days; or Is determined to meet the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of the Social Security Act. Financial eligibility for waiver participants is determined according to this regulation and COMAR 10.09.24, as cited in §§C—F of this regulation. Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as a: Recipient of Supplemental Security Income (SSI); or Member of a low income family with children, as described in §1931 of the Social Security Act. Medically Needy. An individual is eligible for waiver services as medically needy if the individual is receiving Medical Assistance as a medically needy person in accordance with COMAR 10.09.24.03D. Optionally Categorically Needy. An individual is eligible for waiver services as optionally categorically needy, in accordance with 42 CFR §435.217, if the individual's countable income does not exceed 300 percent of the applicable payment rate for SSI, and the individual's countable resources do not exceed the SSI resource standard for one person. For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one person. For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income rules set forth in COMAR 10.09.24 which are applicable to a child or an aged, blind, or disabled individual who is institutionalized, with the exceptions specified at §E(9) of this regulation. For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource rules set forth in COMAR 10.09.24, which are applicable to a child or an aged, blind, or disabled person who is institutionalized, with the exceptions specified at §E(9) of this regulation. An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires. The spousal impoverishment rules at COMAR 10.09.24.10-1 are applicable, with the differences specified in this regulation. Medical Assistance eligibility shall be redetermined at least every 12 months. As part of the determination and redetermination of Medical Assistance eligibility as optionally categorically needy, the Department of Human Services shall determine whether the applicant or recipient is eligible as a disabled person in accordance with COMAR 10.09.24.05E, unless the applicant or recipient is aged, blind, or a child, or has been determined as disabled by the Social Security Administration. All provisions of COMAR 10.09.24 which are applicable to a child or an aged, blind, or disabled individual who is institutionalized are applicable to waiver applicants and participants who are considered as optionally categorically needy, with the following exceptions: COMAR 10.09.24.04J(1), (2), and (3); COMAR 10.09.24.04K; COMAR 10.09.24.06B(2)(a)(ii); COMAR 10.09.24.08G(1); COMAR 10.09.24.08H; COMAR 10.09.24.09; COMAR 10.09.24.10; COMAR 10.09.24.10-1; and COMAR 10.09.24.15A-2(2). Home Exclusion. The home, as defined in COMAR 10.09.24.08B, is not considered a countable resource under §E of this regulation if it is occupied by the waiver applicant or participant, the applicant's or participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or participant: Child; Parent; or Sibling. Post-Eligibility Determination of Available Income for Optionally Categorically Needy. The countable monthly income considered for the post-eligibility determination is calculated in accordance with rules at §E of this regulation and at COMAR 10.09.24 for institutionalized aged, blind, or disabled individuals, except that the income disregards specified at COMAR 10.09.24.07L are not applied. For individuals eligible under §E of this regulation who reside in a residential habitation facility, the Department shall reduce its monthly payment for residential habilitation services by the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: A personal needs allowance of $170 and the residential habilitation provider's monthly charge of at most $375 to the participant for room and board, as of the effective date of this amendment, either or both of which may be adjusted based on a schedule issued by the Department; A spousal maintenance allowance in accordance with COMAR 10.09.24.10D(2)(b); and Incurred medical expenses as specified at COMAR 10.09.24.10D(2)(d) and (e). The Department shall determine the amount of available income to be paid by a participant towards the cost of care in a residential habilitation facility, based on the countable income remaining after deducting the amounts specified at §F(2) of this regulation. The residential habilitation provider shall collect the participant's available income, in an amount which may not exceed the cost of residential habilitation services as determined by the Department for the participant. The sum of the participant's cost of care contribution and the Department's payment may not exceed the total cost of residential rehabilitation services as determined by the Department for the participant. Request for Payment. All requests for payment of services rendered shall be submitted according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider. Requests for payment shall be submitted as set forth in COMAR 10.09.36.04A. Requests for payment shall include all units of service rendered to a waiver participant during the billing period. Billing Time Limitations. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Payments. Payments shall be made only to a qualified provider. Payment may not be made to a waiver participant, to individual professionals, or to other Program providers in connection with the provision of services specified in Regulations .04—.08-5 of this chapter. Payments to service coordination providers shall be made according to a monthly waiver participant fee negotiated with the DDA. Payments to residential habilitation service providers or to day habilitation service providers during their first year of operation, to most intensive behavior management providers, to some residential option providers, and to most supported employment providers which are licensed under COMAR 10.22.13 shall be made on a cost-related basis. This includes the following: The Department shall pay these providers an interim payment based on allowable costs included in the human services agreement between DDA and the provider. The final cost settlement shall be actual allowable cost as determined by the Department through the audit and post-audit settlement process specified in COMAR 10.04.03 and 10.04.04. Tentative cost settlements may be made using unaudited annual reports submitted by providers to the Department. Allowable costs are those costs incurred in the delivery of the covered services delineated in this chapter. Return on equity is not an allowable cost. A provider fee as specified in COMAR 10.09.41 is an allowable cost. Room and board is an allowable cost only for respite care provided under Regulation .08 of this chapter. Payments to these providers shall be on a quarterly basis. Providers shall submit quarterly reports of expenditures and requests for payment in the prescribed form to the Division of Program Cost and Analysis of the Maryland Department of Health. Providers shall receive funds in advance of expenditures anticipated in the ensuing quarter of the fiscal year. Payments to most residential habilitation and day habilitation service providers, some intensive behavior management providers, and some supported employment and residential option providers shall be made according to the prospective payment system specified in COMAR 10.22.17. Payments to medical day care service providers shall be in accordance with COMAR 10.09.07 and the waiver participant's approved plan of care. Notwithstanding any other provision of these regulations, payment may not be made under these regulations for respite care or environmental modifications, as defined in Regulation .01B of this chapter, until the §1915(c) waiver amendment authorizing coverage of these services has been approved by the Health Care Financing Administration (HCFA). Once HCFA has approved the waiver amendment, payments may be made for respite care and environmental modifications retroactive to the effective date of the waiver amendment, but not earlier than April 1, 1991. Notwithstanding any other provision of these regulations, payment may not be made under these regulations for residential option or intensive behavior management services, as defined in Regulation .01B of this chapter, or for services delivered to an individual being discharged or diverted from a chronic care facility, until the waiver amendment under the Social Security Act, Title XIX, §1915(c), authorizing coverage of these services has been approved by the Health Care Financing Administration (HCFA). Once HCFA has approved the waiver amendment, payments may be made retroactive to the effective date of the waiver amendment. Cost Reporting. The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. This system of accounts shall provide at a minimum: Maintenance of a chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements. Proper reference to supporting invoices, voucher, or other form of original evidence. Maintenance of an appropriate time reporting system for all personnel and proper payroll authorizations and vouchers. Provision for payment by check. When financial transactions involve numerous small expenditures an imprest petty cash fund shall be established, provided adequate supporting vouchers are maintained. Maintenance of records of all assets. Maintenance of records on a cash or accrual basis. Maintenance of records as required by the Department. Maintenance of all records concerning financial expense and income allocations shall be sufficiently documented by supporting data. Generally accepted accounting principles and the allocation principles of cost accounting theory shall be used for allocation of costs and income. Maintenance of separate records of financial expense and income allocation applicable to: Room and board; Covered services as specified in Regulations .05—.08-4 of this chapter. The provider shall keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours. Records shall be maintained for 6 years after the period the cost report to which the materials apply is filed with the Department. The provider shall: Report direct and indirect costs applicable to recipient care. These reports shall clearly identify those direct and indirect costs and income applicable to: Room and board; Covered services as specified in Regulations .05—.08-4 of this chapter. Submit to the Division of Program Cost and Analysis of the Department a year-end reconciliation report of financial data in the prescribed form within 30 days of the end of the fiscal year unless the Department grants the provider an extension. Application of Recipient Income to Cost of Care. The Department of Human Services shall determine the application of Optional Categorically Needy recipient's income toward the cost of services specified in Regulations .05 and .08 of this chapter pursuant to Regulation .12B of this chapter. The residential habilitation services provider shall collect the Optional Categorically Needy recipient's available income as certified by the Department of Human Services. The total of an Optional Categorically Needy recipient's available income to be applied to the cost of care and the Department's payment may not exceed the total cost of services specified in Regulations .05 and .08 of this chapter for that individual. Recovery and reimbursement are as specified in COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions is as specified in COMAR 10.09.36. Appeal procedures for providers are as specified in COMAR 10.09.36. Persons filing appeals contending that they were not informed of their choice of services or that they were denied the service of their choice may file an appeal requesting a fair hearing under provisions contained in 42 CFR Part 431, Subpart E. State regulations shall be interpreted as specified in COMAR 10.09.36. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective February 13, 1984 (11:5 Md. R. 455); emergency status extended at 11:7 Md. R. 621; adopted permanently effective August 12, 1984 (11:15 Md. R. 1330) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Chapter revised effective February 20, 1989 (16:3 Md. R. 343) Chapter revised as an emergency provision effective April 1, 1990 (17:8 Md. R. 969); amended permanently effective July 30, 1990 (17:14 Md. R. 1758) Regulations .03A, .09B, .11B amended as an emergency provision effective November 19, 1990 (17:24 Md. R. 2835); emergency status extended at 18:4 Md. R. 444 (February 22, 1991); amended permanently effective February 18, 1991 (18:3 Md. R. 305) Chapter revised as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 6, 1991 (18:13 Md. R. 1482) Regulations .01—.03, .05—.11, and .13 amended and .08-1—.08-4 adopted as an emergency provision effective June 8, 1992 (19:12 Md. R. 1130); emergency status extended at 19:19 Md. R. 1702; adopted permanently effective September 28, 1992 (19:19 Md. R. 1707) Regulations .01, .04—.08-3, .09—.11, and .13 amended effective February 28, 1994 (21:4 Md. R. 277) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) Regulation .01B amended effective October 14, 2013 (40:20 Md. R. 1652) Regulations .02, .06, .08-2, .09, and .13 amended as an emergency provision effective November 4, 1992 (19:24 Md. R. 2124); amended permanently effective February 15, 1993 (20:3 Md. R. 258) Regulation .02 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) Regulation .03E adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) Regulation .05J amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .08-5 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) Regulation .09 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) Regulation .10A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) Regulation .11B amended effective October 14, 2013 (40:20 Md. R. 1652) Regulation .12 repealed and new Regulation .12 adopted effective February 17, 2003 (30:3 Md. R. 179) Regulation .13C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) In this chapter, the following terms have the meanings indicated. Terms Defined. “Certified nursing assistant” means an individual who: Is certified by the Maryland Board of Nursing; and Performs nursing tasks delegated by a registered nurse or licensed practical nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland. “Department” means the Maryland Department of Health as defined in COMAR 10.09.36. “Disabled child” means a chronically ill or severely impaired child, younger than 22 years old, whose illness or disability may not require 24-hour inpatient care, but which, in the absence of home care services, may precipitate admission to or prolong stay in a hospital, nursing facility, or other long term care facility. “Face-to-face” means contact with a participant that occurs in-person or via audio-visual telehealth in accordance with COMAR 10.09.49. “Home care” means a comprehensive package of medical and health-related services provided under the Program, pursuant to the authority of a model waiver for certain disabled children, as an alternative to institutionalization. “Home care case management” means locating, coordinating, and monitoring home care services for disabled children and includes: Screening of referrals and identification of individuals requiring home care services; Completing a comprehensive assessment to determine the appropriateness of home care services; Convening the multidisciplinary team and coordinating the development of a comprehensive plan of care; Determining individual case cost effectiveness; Identifying and maximizing informal sources of care; Ongoing monitoring of the delivery of services specified in the plan of care to determine the appropriateness of the type, amount, and duration of services rendered; Completing the semiannual utilization review procedure specified in Regulation .03B(1)(c)(ii) of this chapter; and Providing in-home assessments as specified in Regulation .04A(2)(e) of this chapter. “Home care case manager” means the agency administering a program of services for disabled children authorized under Title V of the Social Security Act, or the agency's designee, which provides or arranges for the provision of home care case management services for participants, develops training and community education programs, and establishes standards and procedures for quality assurance and monitoring. “Home care provider” means the principal physician or the individual or agency providing nursing, home health aide services, medical supplies and equipment, or home care case management services to disabled children. “Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10. “Home health aide” means an individual who meets all the conditions of participation specified in: 42 CFR §484.36; and Health Occupations Article, Title 8, Annotated Code of Maryland. “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36. “Medical day care” has the meaning stated in COMAR 10.09.07. “Medical day care center” has the meaning stated in COMAR 10.09.07. “Medicare” means Medicare as defined in COMAR 10.09.36. “Model Waiver” means the document and any amendments to it submitted by the Department to, and approved by, the Department of Health and Human Services which authorize the waiver of certain statutory requirements limiting eligibility and covered services under the Medicaid State plan pursuant to §1915(c) of the Social Security Act. “Multidisciplinary team” means the group consisting of the participant or the participant's legal representative or representatives, or all of these, home care providers, and the participant's principal physician or the physician designated by the principal physician, and other providers of health-related services, as appropriate, that establishes and updates the plan of care under the overall direction and coordination of the home care case manager and assesses the appropriateness of the participant's discharge to or continuation of home care. “Necessary” means necessary as defined in COMAR 10.09.36. “Nurse” means a person who is licensed as a registered nurse or licensed practical nurse in the jurisdiction in which services are provided. “Nursing care plan” means a plan developed by a registered nurse that identifies: The patient's diagnoses and needs; The goals to be achieved; and The interventions required to meet the patient's medical condition. “Participant” means a recipient: Whose initial eligibility for services under this chapter is established as a disabled child certified by the Department or its designee as requiring nursing home care under the Program pursuant to COMAR 10.09.10 or COMAR 10.09.11, or inpatient hospital care pursuant to COMAR 10.09.92—10.09.95, but whose medical condition does not require 24-hour inpatient care unless home care services are not available; Who, once eligibility is established, remains eligible for services under this chapter as long as he or she continues to meet the certification and care requirements of §B(15)(a) of this regulation, regardless of age; Who, but for the services listed in Regulation .04 of this chapter, requires and would be receiving institutional care reimbursed under the Program; Who, before receipt of services under this chapter, was: A patient in a hospital, nursing facility, or other long-term care facility; or Formerly a patient in a hospital, nursing facility, or other long-term facility who, upon discharge, has continuously received other insurance reimbursement for skilled nursing or home health aide services which has precluded the need for admission to the waiver; Whose disabilities and needs for home care cannot be adequately and appropriately addressed through provider services otherwise available under the Program; and Who meets the eligibility requirements of these regulations or was receiving services under this chapter as of December 1, 1988 or under COMAR 10.09.31 as of December 31, 1990 and continues to meet the certification and care requirements specified in this chapter. “Plan of care” means the written home care plan which is: Composed of a comprehensive assessment of the participant's health status including: All pertinent diagnoses; Prognosis; Functional status; Level of activity permitted; Type, frequency, and duration of services required; Treatment goals for each type of service; Medications; and Treatments; Established by the multidisciplinary team; Approved, signed, and dated by the participant's principal physician; Approved, signed, and dated by the participant or the participant's legally authorized representative, or both; Approved, signed, and date by the Department; and Revised 90 days after approval of the initial plan of care and semiannually thereafter, unless the home care case manager decides that a different review period is appropriate. “Principal physician” means the specialty physician who is part of the interdisciplinary team and who approves the plan of care for the participant. “Program” means the Program as defined in COMAR 10.09.36. “Progress note” means a dated written notation by a home care provider which: Summarizes facts about the care given and the patient's responses during a given period of time; Specifically addresses the established goals of treatment; Is consistent with the participant's plan of care; Is written and signed during the course of care; and Is provided to the home care case management agency to become a part of the agency's permanent record for the participant. “Provider” means a provider as defined in COMAR 10.09.36. “Provider agreement” means a contract between the Department and the provider of home care, specifying the services to be performed, methods of operation, and financial and legal requirements which shall be in force before Program participation. “Recipient” means a recipient as defined in COMAR 10.09.36. “Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05. “Secretary” means the Secretary of Health. “Specialty physician” means a licensed physician who meets one of the following criteria: Has been declared board certified, or board eligible, by a member board of the American Board of Medical Specialties, and has demonstrated experience in the care of disabled children; or Has been declared board certified, or board eligible, by a specialty board approved by the Advisory Board of Osteopathic Specialists and the Board of Trustees of the American Osteopathic Association, and has demonstrated experience in the care of disabled children. “Supervision” means: Authoritative procedural guidance by a licensed registered nurse for the accomplishment of a function or activity; and The process of critical watching, directing, and evaluating an individual's performance. “Telehealth” has the meaning stated in COMAR 10.09.49.02. “Waiver enrollment process” means those procedures necessary to establish participant eligibility pursuant to Regulation .05 of this chapter. “Witness” means the recipient or an individual who, on behalf of the recipient, is able to personally verify that the recipient received private duty nursing services, home health aide services, or certified nursing assistant services. Providers shall meet all licensing requirements specified in COMAR 10.09.36. General requirements for participation in the Medical Assistance Program are that providers shall meet all conditions for participation specified in COMAR 10.09.36. Specific requirements for participation in the Program as a provider of home care services are as follows: The home care case management provider shall: Have a written agreement with each participant which includes the following: A description of the types, amount, frequency, and duration of home care services to be provided to the participant as ordered by the principal physician and specified in the approved plan of care; A statement that the participant or responsible representatives shall have access to the individual plan of care and shall be involved in its development and periodic review; The name, address, telephone number, and Medical Assistance number of the participant; The dated signatures of the participant or legally authorized representative, and the provider representative; A statement that utilization of available services and selection among approved enrolled providers is subject to participant choice; A statement that services will at all times be provided without discrimination with regard to race, color, age, sex, national origin, marital status, or physical or mental handicap. Be available to participants in-person at least 8 hours a day, 5 days a week with established hours of operation. Have written and implemented formalized policies and procedures developed before participation in the Program concerning the following areas: Medical records for each participant which include at a minimum the application for home care, plan of care, orders for home care services, documentation of nursing observations at least every 30 days, social history, and home care cost worksheets establishing initial participant eligibility and continued eligibility on a quarterly basis; Utilization review which includes the development of a home care review procedure completed every 6 months for all participants to evaluate the appropriateness of home care, the efficiency, adequacy, and coordination of home care services, with the objective of achieving the least costly yet appropriate delivery of services under the Program. Convene the multidisciplinary team which: Upon receipt of the principal physician's orders assesses the appropriateness of home care for the participant; Determines the medical, psychological, social, and functional status of each participant; Develops an individual plan of care in conjunction with the principal physician's orders; Coordinates at least one in-person meeting annually, unless otherwise authorized by the Department; Unless otherwise excepted in §B(1)(d)(iv) of this regulation, may meet in-person or via telehealth; and Reviews and updates the individual plan of care in accordance with Regulation .01B(16) of this chapter. Provide for in-home assessments, via an in-person visit or telehealth, on a quarterly basis or as determined necessary by the principal physician. Conducts at least two in-person visits annually, unless otherwise authorized by the Department. Not be a provider of medical supplies and equipment or nursing services. Shift private duty nursing, certified nursing assistant, and home health aide providers shall: Meet all conditions for participation set forth in: COMAR 10.09.53.03; or COMAR 10.09.69; Participate in interdisciplinary team meetings; Ensure timesheets are signed by the individual rendering services; Ensure a nurse, a certified nursing assistant, or a home health aide is not scheduled to work for more than 16 consecutive hours and the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department; Provide for in-home assessments by the principal physician, on a quarterly basis or as determined necessary by the principal physician. Either be a: Residential service agency licensed in accordance with COMAR 10.07.05; or Home health agency licensed in accordance with COMAR 10.07.10 which meets the conditions of participation specified in 42 CFR §484.36; Demonstrate the capacity to arrange for the provision of home health aide services in the amount and level required in the participant's plan of care including the establishment of a contingency plan to assure coverage as specified in the plan of care; Demonstrate sufficient specialized training and experience in the care of individuals with disabilities necessary to deliver the level of services required by participants; and Demonstrate, on a continuing basis, the ability to competently carry out services in the plan of care subject to review by the home care case manager or the home care case manager's designee. Medical day care providers shall meet all conditions for participation set forth in COMAR 10.09.07. The provider of home care services shall: Deliver services in-person unless expressly authorized to render services via telehealth; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. The Program reimburses for home care services which include the following: Shift nursing services provided by a licensed registered nurse or a licensed practical nurse if: The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a licensed nurse for a shift of 4 or more continuous hours; The services are delivered to the participant in the participant's home or other setting when normal life activities take the participant outside the home; Services are provided to a model waiver participant who is 21 years old or older; Services are rendered in accordance with COMAR 10.09.53; Services are rendered in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland; Sufficient documentation concerning the services provided is maintained by the registered nurse or licensed practical nurse, including: Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and Signed and dated progress notes which are reviewed monthly by the nurse supervisor; The nurse is not scheduled to work for more than 16 consecutive hours and is off 8 or more hours before starting another shift; Services are rendered by a licensed registered or practical nurse certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; Services are preauthorized in accordance with the criteria set forth in COMAR 10.09.53.06; and Supervisory visits are conducted at least monthly in the participant's home or another site where the participant is receiving nursing services with a minimum of two visits per year with the primary nurse present; Home care case management which includes: Arranging, monitoring, and coordinating the health-related services necessary to meet the identified needs of the participant as specified in the participant's plan of care; Establishing, in conjunction with the other members of the multidisciplinary team, the plan of care necessary to deinstitutionalize or maintain, or both of these, the participant at home; Reviewing the plan of care for appropriateness of the level, amount, type, quality, and frequency of services provided as well as monitoring the cost effectiveness of home care for each participant; Arranging for scheduled reviews and approval of the plan of care by the principal physician; and Providing for in-home assessments, via an in-person visit or telehealth as authorized by the Department, on a quarterly basis, or as determined necessary by the principal physician; Participation by the principal physician in the plan of care meetings including: Prescribing home care services; and Approving and signing the plan of care; Home health aide services which include: The performance of simple procedures as an extension of therapy services; Ambulation and exercise; Household services essential to health care at home; Assistance with medications that are ordinarily self-administered; Assistance with activities of daily living when performed in conjunction with other delegated nursing services; Other health care services properly delegated by a licensed nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, if: The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a home health aide for a shift of 4 or more continuous hours; Services are provided by an unlicensed individual who meets all the conditions of participation specified by the Medicare program in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland; Services are rendered by a home health aide certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; The home health aide is not scheduled to work for more than 16 consecutive hours and has 8 hours or more off before starting another shift; Sufficient documentation is maintained by the home health aide including verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and signed and dated progress notes which are reviewed every 2 weeks by the nurse supervisor; Supervisory visits are conducted every 2 weeks and documented by a registered nurse with a minimum of two visits with the primary aide present; The services are included in the model waiver participant's plan of care developed by the case manager; and Services are preauthorized by the Department; Certified nursing assistant services if: The certified nursing assistant is certified by the Maryland Board of Nursing and meets all the requirements to render services pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a certified nursing assistant for a shift of 4 or more continuous hours; The services provided include but are not limited to: Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or Other health care services properly delegated by a licensed nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; Services are rendered by a certified nursing assistant certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; The certified nursing assistant is not scheduled to work for more than 16 consecutive hours and has 8 hours or more off before starting another shift; Sufficient documentation concerning the services provided is maintained by the certified nursing assistant including: Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and Signed and dated progress notes which are reviewed every 2 weeks by the nurse supervisor; Supervisory visits are conducted every 2 weeks and documented by a registered nurse with a minimum of two visits with the primary aide present; The services are included in the model waiver participant's plan of care developed by the case manager; and Services are preauthorized by the Department; Delegated nursing services provided by a certified nursing assistant or home health aide who is also a certified medical technician when: The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of the certified nursing assistant or home health aide for at least 2 or more continuous hours; The services provided include but are not limited to: Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or Other nursing services properly delegated by a nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11; Sufficient documentation is maintained by the certified nursing assistant or home health aide, including signed and dated progress notes which are reviewed by the nurse supervisor; and Supervisory visits are conducted and documented by a registered nurse supervisor in accordance with COMAR 10.27.09 and 10.27.11; and Medical day care when services are: Included in the Model Waiver participant's approved and signed plan of care; and Rendered in accordance with COMAR 10.09.07. The Department will reimburse for the services listed in §A(1)—(2) and (4)—(6) of this regulation when they are: Ordered by the participant's principal physician as part of a written home care plan, which is included in the provider's permanent record for the participant and is reviewed by the principal physician in accordance with Regulation .01B(16) of this chapter; Medically necessary; Adequately described in progress notes in the participant's medical record, signed, and dated by the individual providing care; Provided instead of institutional care to recipients certified and annually recertified as requiring nursing facility care under the Program as specified in COMAR 10.09.10 or 10.09.11; and Provided in the amount, duration, and frequency specified in the plan of care subject to approval by the Program. Requirements. Model waiver participants shall meets the financial eligibility requirements under §B, C, or D of this regulation and the nonfinancial requirements of §§E and F of this regulation. Categorically needy eligibility recipients of supplemental security income benefits under Title XVI of the Social Security Act are eligible for medical assistance benefits as categorically needy individuals as specified in COMAR 10.09.24. Optional Categorically Needy Eligibility. Individuals who do not qualify for supplemental security income benefits may apply for eligibility under the provision of this section and applicable sections of COMAR 10.09.24, as follows: COMAR 10.09.24, exclusive of Regulations .06, .08L, .09, and .10, applies for the purpose of determining eligibility as an optional categorically needy individual. An individual is eligible for medical assistance benefits as an optional categorically needy individual if they comply with the requirements of §C(1) of this regulation, including the requirement that resources not exceed the applicable standard for supplemental security income eligibility, and if the income of the individual before the disregards specified in §C(3) of this regulation does not exceed 300 percent of the supplemental security income benefit amount payable under §1611(b)(i) of the Social Security Act to an individual in their own home who has no income or resources. Disregards. The following disregards are subtracted from income computed according to COMAR 10.09.24.07A—K in order to determine the amount of the income of recipients qualifying under this section to be applied toward the cost of services specified in Regulation .04 of this chapter. The amount of the medically needy income standard for one person established under COMAR 10.09.24.07; Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party, including: Medicare and other health insurance premiums, deductibles, or co-insurance charges, and Necessary medical or remedial care recognized under State law but not covered under the Program. Medically Needy Eligibility. Financial eligibility for individuals who do not qualify as categorically needy recipients as specified in §B, or optional categorically needy recipients as specified in §C of this regulation is determined according to provisions of COMAR 10.09.24 relating to determinations of medically needy eligibility. To be eligible to receive services under the model waiver for disabled children a person shall: Be certified and annually recertified as requiring nursing home care under the Program pursuant to COMAR 10.09.10 or COMAR 10.09.11; Be approved by the Department or its designee as appropriate for home care based on a comprehensive assessment of the participant's health status as set forth in Regulation .01B(15) of this chapter; Choose between institutional or home care services under the Program; Be a recipient: For whom it can reasonably be expected that the cost of home care services would not exceed the cost of the level of care provided in an institution, and Whose plan of care meets the requirement of §F of this regulation relating to cost effective coverage of home care services. Eligibility for coverage of home care services for disabled children is limited to individuals for whom the projected total cost that would be incurred by the Program if the coverage and services specified in this chapter were not available is greater, on an annual basis, than the projected total cost that would be incurred by the Program for the services listed in Regulation .04 of this chapter and all other services available under the Program based on the following formula: Payment procedures as set forth in COMAR 10.09.36 apply. Payments. Payments shall be made directly to a qualified provider. Providers shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate established according to the fee schedule published by the Department. Rates. The Department shall publish a fee schedule for services covered under this chapter that shall be publicly available and updated at least annually or upon any changes made by the Department. Effective July 1, 2022, rates for services governed by this chapter are as follows: For home health aide or certified nursing assistant services provided to one participant: $5.0809 per 15 minutes of services; or If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $6.1208 per 15 minutes of services; For home health aide or certified nursing assistant services provided to two or more participants in the same residence: $3.5044 per 15 minutes of services per participant; or If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $4.2232 per 15 minutes of service per participant; and Payments for home care case management services shall be made as follows: Waiver enrollment process — $1,181.61; First month of home care case management — $1,181.61; and The second and any subsequent month of home care case management — $590.80. Effective January 1, 2024 through June 30, 2024, rates for services governed by this chapter are as follows: For home health aide or certified nursing assistant services provided to one participant: $5.4874 per 15 minutes of services; or $6.6105 per 15 minutes of service if the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician; For home health aide or certified nursing assistant services provided to two or more participants in the same residence: $3.7848 per 15 minutes of services per participant; or $4.5611 per 15 minutes of service per participant if the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician; and Payments for home care case management services shall be made as follows: Waiver enrollment process — $1,276.14; First month of home care case management — $1,276.14; and The second and any subsequent month of home care case management — $638.06. Effective July 1, 2024, rates for services governed by this chapter are as follows: For home health aide or certified nursing assistant services provided to one participant: $5.6520 per 15 minutes of services; or If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $6.8088 per 15 minutes of services; For home health aide or certified nursing assistant services provided to two or more participants in the same residence: $3.8983 per 15 minutes of services per participant; or If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $4.6979 per 15 minutes of service per participant; and Payments for home care case management services shall be made as follows: Waiver enrollment process — $1,314.42; First month of home care case management — $1,314.42; and The second and any subsequent month of home care case management — $657.21. Subject to the limitations of the State budget, the Program’s rates as specified in this regulation shall increase by 4 percent each year through Fiscal Year 2026. Recovery and reimbursement shall be as specified in COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions shall be as specified in COMAR 10.09.36. Appeal procedures shall be as specified in COMAR 10.09.36. State regulations shall be interpreted as specified in COMAR 10.09.36. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: Regulations .01—.10 adopted as an emergency provision effective May 10, 1985 (12:11 Md. R. 1041); emergency status extended at 12:19 Md. R. 1843 and 13:6 Md. R. 669; adopted permanently effective March 10, 1986 (13:5 Md. R. 543) Regulations .01—.10 amended as an emergency provision effective March 11, 1991 (18:7 Md. R. 765); amended permanently effective July 1, 1991 (18:12 Md. R. 1339) Regulation .01B amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .03B amended effective August 25, 1986 (13:17 Md. R. 1922); July 1, 1989 (16:12 Md. R. 1336) Regulation .04A amended effective August 25, 1986 (13:17 Md. R. 1922); July 1, 1989 (16:12 Md. R. 1336) Regulation .04B amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .06A—C amended effective July 1, 1989 (16:12 Md. R. 1336) Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .06C amended effective August 25, 1986 (13:17 Md. R. 1922) Regulation .07A amended effective August 25, 1986 (13:17 Md. R. 1922) Chapter revised effective July 1, 1991 (18:12 Md. R. 1339) Regulation .01B amended effective July 17, 2006 (33:14 Md. R. 1163) Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077); September 25, 2017 (44:19 Md. R. 896) Regulation .01B amended effective August 21, 2023 (50:16 Md. R. 725) Regulation .03B amended effective July 17, 2006 (33:14 Md. R. 1163) Regulation .03B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) Regulation .03B amended effective August 21, 2023 (50:16 Md. R. 725) Regulation .04A amended effective July 17, 2006 (33:14 Md. R. 1163); August 21, 2023 (50:16 Md. R. 725) Regulation .04A, B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) Regulation .05C amended effective August 21, 2023 (50:16 Md. R. 725) Regulation .06 amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .06A, C amended effective July 17, 2006 (33:14 Md. R. 1163) Regulation .06A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) Regulation .06A, C amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .06C amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1346); amended permanently effective October 8, 2007 (34:20 Md. R. 1739) Regulation .06C amended effective April 6, 2009 (36:7 Md. R. 523); February 8, 2010 (37:3 Md. R. 175); August 21, 2023 (50:16 Md. R. 725); November 24, 2025 (52:23 Md. R. 1139) In this chapter, the following terms have the meanings indicated. Terms Defined. Applied Behavior Analysis (ABA). “Applied behavior analysis (ABA)” means the design, implementation, and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvements in human behavior. “Applied behavior analysis (ABA)” includes the direct observations, measurement, and functional analysis of the relations between environment and behavior. “ABA program” means an association, partnership, corporation, or unincorporated group that includes: A licensed psychologist or an LBA; and A BCaBA, RBT, or a BT. “Autism spectrum disorder (ASD)” means a group of developmental disorders: Characterized by persistent deficits in social communication and social interaction across multiple contexts; Characterized by restricted, repetitive patterns of behavior, interests, or activities; and Whose symptoms cause clinically significant impairment in social, occupational, or other important areas of current functioning. “Behavior Analyst Certification Board (BACB)” means the Board accredited by the National Commission for Certifying Agencies that credentials and certifies an LBA or BCaBA, or registers an RBT. “Behavior technician (BT)” means a paraprofessional in the process of obtaining BACB certification who delivers ABA services that are provided to participants with ASD under the supervision of a licensed: Psychologist; BCBA-D; or BCBA. “Board certified assistant behavior analyst (BCaBA)” means a paraprofessional who: Delivers ABA treatments that are provided to participants with ASD under the supervision of: A licensed psychologist; or An LBA; and Obtained a BACB certification. “Board certified behavior analyst (BCBA)” means a licensed professional who: Renders and provides direction for ABA services that are provided to participants with ASD; and Obtained a BACB certification. “Board certified behavior analyst-doctoral (BCBA-D)” means a licensed professional who: Renders and provides direction for ABA treatments that are provided to participants with ASD; and Obtained a BACB certification with a doctoral-level credential. “Caregiver” means a willing and able individual who is trained in providing care to the participant. “Comprehensive diagnostic evaluation” means an assessment performed by a qualified health care professional with the help of validated instruments, which includes: A direct observation of the participant; Interviews with the participant’s parent or caregiver; Documentation of developmental history, psychosocial history, and current functioning across major domains of development; and A confirmed diagnosis of Autism Spectrum Disorder (ASD). “Custodial care” means care that is provided: To assist in the activities of daily living, such as bathing, dressing, eating, and maintaining personal hygiene; For maintaining the participant's safety; and By individuals without professional skills or training. “Department” means the Maryland Department of Health. “Designee” means the entity designated by the Department to manage the public behavioral health system on behalf of the Department. “Direction of a technician” means the in-person monitoring of a BCaBA, RBT, or BT, performed by a licensed psychologist or an LBA. “Early and periodic screening, diagnosis, and treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects, physical and mental illnesses, and conditions discovered by EPSDT screening services. “Family” means an adult who: Lives with or provides care to the participant; and Is not paid to provide the care. “HIPAA” means the Health Insurance Portability and Accountability Act, a federal law enacted on August 21, 1996, whose purpose is to improve the efficiency and effectiveness of the health care system by standardizing the electronic exchange of administrative and financial data, provide security requirements for transmitted information, and protect the privacy of identifiable health information. “Individualized education program (IEP)” means a written description of special education and related services to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.03B and 13A.05.01.09. “Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.03B. “Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that provides health-related services or health rehabilitative services for individuals with intellectual disabilities or related conditions. “Licensed behavior analyst (LBA)” means a licensed professional who is certified by the Behavior Analyst Certification Board (BACB) to be a: BCBA; or BCBA-D. Maladaptive Behavior. “Maladaptive behavior” means behavior that interferes with the participant's activities of daily living or ability to adjust or participate in particular settings. “Maladaptive behavior” includes behaviors such as self-injurious behavior, aggression, tantrums, stereotypies, and rituals. “Maryland Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not for the convenience of the participant, family, or provider. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., as amended. “Parent” means the adult representative of a participant and includes: A biological or adoptive parent; A legal guardian; An individual acting in the place of a parent, such as a grandparent or stepparent with whom the participant lives, including those relatives or stepparents who are foster parents; An individual appointed as the parent surrogate in accordance with Education Article, §8-412, Annotated Code of Maryland, for matters within the scope of the Individuals with Disabilities Education Act; or Another individual responsible for a participant's welfare. “Participant” means an eligible individual who is enrolled in the Program. “Plan for generalization” means a component of the treatment plan whose goal is the expansion of a participant's performance ability beyond the initial conditions set for acquisition of a skill that can occur across people, places, and materials used for teaching. “Preauthorized” means the approval required from the Department, or its designee, before a provider renders services in order to receive reimbursement for services. “Program” means the Maryland Medical Assistance Program. “Provider” means a person certified to provide ABA services to participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. “Psychologist” means an individual who is: Licensed and legally authorized to practice psychology under Health Occupations Article, Title 18, Annotated Code of Maryland; or Licensed and legally authorized to practice psychology in the state where the service is rendered. “Qualified health care professional” means a developmental pediatrician, pediatrician, pediatric neurologist, child psychiatrist, clinical psychologist, neuropsychologist, or a nurse practitioner with training and experience to diagnose ASD. “Registered behavior technician (RBT)” means a paraprofessional certified by the BACB who delivers ABA services that are provided to participants with ASD under the supervision of: A licensed psychologist; or An LBA. “Remote access technology” means the use of HIPAA compliant technological methods to provide auditory and visual connection between a licensed psychologist or an LBA, who is not directly present, and a BCaBA, RBT, or BT when services are being provided at the participant’s home. “Remote direction of a technician” means the monitoring of a BCaBA, RBT, or BT, who is physically with the participant, performed via synchronous two-way audio-visual remote access technology by a licensed psychologist or an LBA. “Treatment plan” means an individualized written plan for ABA services which includes the components specified in Regulation .03 of this chapter.. To participate in the Program, a provider shall: Meet all conditions for participation as set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. An ABA provider shall be licensed, certified, or otherwise legally authorized to provide ABA services in the jurisdiction in which the services are provided. An ABA provider may not have current sanctions or current disciplinary actions imposed by: The jurisdictional licensing or certification authority; Medicare Program; Maryland Medical Assistance Program; or Other federally funded healthcare program. An ABA provider shall have a completed Criminal Justice Information System's criminal background check. A licensed psychologist who renders ABA services shall: Be licensed by the Maryland Board of Examiners of Psychologists; and Act within the licensee's scope of practice. A BCBA-D provider who renders ABA services shall: Be licensed by the Maryland Board of Professional Counselors and Therapists; and Have a current certification of BCBA-D by the BACB. A BCBA provider who renders ABA services shall: Be licensed by the Maryland Board of Professional Counselors and Therapists; and Have a current certification of BCBA by the BACB. A BCaBA provider who renders ABA services shall: Have a current certification of BCaBA by the BACB; Work under the direction of: A licensed psychologist; or An LBA; and Have the supervisory relationship documented in writing. An RBT provider who renders ABA services shall: Be 18 years old or older; Be currently registered by the BACB; Have a high school degree or national equivalent; Work under the direction of: A licensed psychologist; or An LBA; and Have the supervisory relationship documented in writing. A BT provider who renders ABA services shall: Be 18 years old or older; Obtain BACB registration within 90 days of enrollment with Maryland Medicaid; Have a high school degree or national equivalent; Work under the direction of: A licensed psychologist; or An LBA; and Have the supervisory relationship documented in writing. A participant shall meet the eligibility conditions set forth in §B of this regulation. To qualify for ABA services, a participant shall: Be younger than 21 years old; Live in the community; Be diagnosed with an ASD by a qualified health care professional; Exhibit the presence of maladaptive behavior or developmental skills deficits that significantly interferes with home, school, or community activities; Be medically stable and not require 24-hour medical or nursing monitoring or procedures provided in a hospital or an ICF-IID; Have a comprehensive diagnostic evaluation by a qualified health care professional; Be referred for ABA services by a licensed health care professional; and Have a completed ABA treatment plan that shall: Be participant-centered and family-centered, culturally competent, and based on individualized goals; Consider the participant's age, school attendance requirements, and other daily activities; Be developed by: A licensed psychologist; or An LBA; Ensure that the interventions are consistent with ABA techniques; Delineate both the frequency of baseline targeted behaviors and the behavior intervention plan to address the behaviors; Identify long-term goals, short-term goals, and objectives that: Are behaviorally defined; Are customized to the participant; Are measurable; and Are based upon clinical observations; Identify the methods that will be used to measure achievement of behavior goals, objectives, and estimated timeframes; Identify the schedule of services planned, including number of hours per week and the providers responsible for delivering the services; Include: Care coordination involving the participant's parent or caregiver and other professionals as applicable; Support and training of the participant's parent or caregiver; A plan for generalization; and Measurable discharge criteria. The Program covers the ABA services set forth in §B of this regulation when the services are: Medically necessary; Preauthorized by the Program or its designee; Delivered in accordance with the participant's treatment plan; and Supported by documentation of consent to treatment from the participant or the participant’s parent or guardian. The Program covers the following ABA services: An ABA assessment, which is a behavior identification assessment that: Is administered in person with a participant and the participant's parent or caregiver by: A licensed psychologist; or An LBA; Addresses the behavioral needs for ABA services; and Includes: An interview, direct observation, record review, data collection, and analysis; An assessment of the participant's current level of functioning, skills deficits, and maladaptive behaviors using validated instruments; Analysis of past data; Scoring and interpreting the assessment; Preparing the treatment plan and report; and Discussion of the findings; A behavior identification supporting assessment which is a follow-up assessment that is administered: In person, by an RBT, BT, or BCaBA, with a participant present; and Under the direction of a licensed psychologist or an LBA; An exposure behavior identification supporting assessment which is a follow-up assessment that: Is conducted on a participant with specific, severe destructive behaviors in a structured, safe environment; Is administered in person by a licensed psychologist or an LBA with the assistance of two or more BCaBAs, RBTs, or BTs; Exposes the participant to a customized series of social and environmental conditions associated with the destructive behaviors; and Uses structured testing to examine events, cues, responses, and consequences associated with the behaviors; An adaptive behavior treatment with protocol modification which is an in-person service that: Is conducted on a participant with specific, severe destructive behaviors in an environment that is: Customized; Structured; and Safe; Is administered in-person by a licensed psychologist or an LBA with the assistance of two or more BCaBAs, RBTs, or BTs; Includes in-person direction of two or more technicians eliciting behavioral effects or exposing the participant to specific environmental conditions and treatment; and Refines and modifies ineffective components of the treatment; Group adaptive behavior treatment by protocol which is an in-person service provided to a group of two or more participants by: A licensed psychologist; An LBA; or A BCaBA, RBT, or BT under the direction of a licensed psychologist or an LBA utilizing a behavioral intervention protocol designed in advance by the psychologist or an LBA who may or may not provide in-person direction of a technician during the treatment; Multiple-family group adaptive behavior treatment guidance that: Is provided in person with parents or caregivers of multiple participants without the presence of the participants by: A licensed psychologist; or An LBA; Identifies maladaptive behaviors and skills deficits; Instructs parents or caregivers on how to utilize ABA treatments to reduce maladaptive behaviors and skill deficits; and Is performed in person for at least 25 percent of the session time each month; Family adaptive behavior treatment guidance which: Is provided in person or remotely with a participant’s parent or caregiver, with or without the presence of the participant by: A licensed psychologist; An LBA; or A BCaBA; Identifies maladaptive behaviors and skills deficits; Instructs the parent or caregiver on how to utilize ABA strategies to reduce maladaptive behaviors and skill deficits; and Is performed in person for at least 25 percent of the session time each month; A behavior identification reassessment which is a follow-up assessment that: Is performed in person with a participant and a participant's parent or caregiver every 180 days by: A licensed psychologist; or An LBA; Evaluates the progress toward each behavior treatment goal using objective, quantifiable measures and includes the results of validated instruments; Includes a revision of the treatment plan based on progress; and Includes a clinical recommendation as to whether ABA services continue to be medically necessary; Group adaptive behavior treatment with protocol modification which is a service that is: Provided in person to multiple participants by: A licensed psychologist; or An LBA; Focused on social skills training; and Aimed at identifying and targeting individual participants social deficits and maladaptive behaviors; Adaptive behavior treatment direction of a technician which is the clinical direction and oversight of a BCaBA, RBT, or a BT by a licensed psychologist or an LBA that: Requires the licensed psychologist or the LBA to directly or remotely observe the BCaBA, RBT, or BT administering ABA services to the participant, group of participants, parent, or caregiver; Is performed on an ongoing basis, equal to at least 10 percent of the amount of hours that the BCaBA, RBT, or BT is providing direct ABA services to the participant, or group of participants; and Is performed in person for at least 25 percent of the session time each month; Adaptive behavior treatment by protocol which is an in-person service provided to a participant by: A licensed psychologist or an LBA; or A BCaBA, RBT, or BT under the direction of a licensed psychologist or an LBA utilizing a behavioral intervention designed in advance by the licensed psychologist or an LBA, who may or may not provide in-person or remote direction during the treatment; and Adaptive behavior treatment planning which is an ongoing indirect service that: Is performed by a licensed psychologist or an LBA; and Includes: Development and revision of the treatment plan and goals; Data analysis; and Real-time, direct communication and coordination with the participant's other service providers. ABA services shall only be provided by a licensed psychologist, LBA, BCaBA, RBT, or BT. ABA services shall be initially preauthorized for a period not to exceed 180 days. Additional preauthorization beyond the initial preauthorization shall be requested every 180 days, in advance of the expiration of the previous preauthorization. The provider shall maintain documentation of each service delivered under the participant's treatment plan, which, at a minimum, includes: The location, date, start time, and end time of the service; A brief description of the service provided, including reference to the treatment plan; A description of the participant's behaviors or symptoms in measurable terms; A description of the participant’s parent or caregiver’s participation in the ABA treatment sessions, including the parent or the caregiver’s name and relationship to the participant, date, and time of participation or notification of the participant’s parent or caregiver’s consent to be absent; and A legible signature, along with the printed or typed name of the individual providing care, with the appropriate title. ABA services are only available to participants under the EPSDT program. ABA services shall be delivered in a home or community setting, including a clinic, when medically necessary. The provider may not bill the Program for: Services that are: Provided in: A hospital; An institution for mental disease; An ICF-IID; A crisis residential program; A residential treatment center; A 24-hour, 365-day residential program funded with federal, State, or local government funds; or Nonconventional settings, including but not limited to resorts, spas, and camps; Rendered when measurable functional improvement or continued clinical benefit is not met, and treatment is not deemed necessary; Not preauthorized by the Department or its designee; Beyond the provider's scope of practice; Rendered but not documented in accordance to Regulation .04 of this chapter; Rendered by mail or telephone; Services whose purpose is vocationally based or recreationally based; Respite services; Custodial care; Completion of forms and reports; Broken or missed appointments; Travel to and from site of service; and Services which duplicate a service that a participant is receiving under another medical care program. The participant’s parent or caregiver shall be trained to reinforce ABA services for the participant in a clinically effective manner. Services shall be discontinued if no longer medically necessary because: Long-term treatment goals and objectives are achieved; or Participant is not demonstrating progress towards treatment goals and objectives and measurable functional improvement is no longer expected. The provider shall obtain approval by the Department or its designee for remote supervision. The provider shall follow all procedures in accordance with COMAR 10.09.36. The Program shall provide fee-for-service reimbursement for covered ABA services to the following ABA providers who meet the conditions for participation set forth in Regulation .02 of this chapter: ABA program; Individual licensed psychologist; and Individual LBA. Reimbursement for ABA services may not be made directly to a BCaBA, RBT, or BT rendering ABA services. Reimbursement for ABA services may not be made to, or on behalf of services rendered by, the participant's parent or caregiver. The Program shall pay for covered services: At the lesser of the provider's customary charge to the general public unless the services are free to the individuals not covered by Medicaid; or In accordance with COMAR 10.09.36.06. Effective July 1, 2022 through June 30, 2023, reimbursement for ABA services covered under this chapter is as follows: Behavior identification assessment at a rate of $33.46 per 15 minutes; Behavior identification assessment follow-up at a rate of $16.73 per 15 minutes; Exposure behavior identification supporting assessment at a rate of $45.63 per 15 minutes; Adaptive exposure behavior treatment with protocol modification at a rate of $45.63 per 15 minutes; Group adaptive behavior treatment by protocol at a rate of: $9.13 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; $7.30 per 15 minutes, per participant, when provided by a BCaBA; and $6.08 per 15 minutes, per participant, when provided by an RBT or BT; Adaptive behavior treatment with protocol modification at a rate of $33.46 per 15 minutes; Multiple-family group adaptive behavior treatment guidance at a rate of $11.26 per 15 minutes per family; Family adaptive behavior treatment guidance with the participant present at a rate of: $33.46 per 15 minutes when provided by a licensed psychologist or an LBA; and $18.25 per 15 minutes when provided by a BCaBA; Family adaptive behavior treatment guidance without the participant present at a rate of: $18.25 per 15 minutes when provided by a licensed psychologist or an LBA; and $10.65 per 15 minutes when provided by a BCaBA; Behavior identification reassessment at a rate of $33.46 per 15 minutes; Group adaptive treatment with protocol modification at a rate of $9.13 per 15 minutes per participant; Adaptive behavior treatment direction at a rate of $33.46 per 15 minutes; Adaptive behavior treatment by protocol at a rate of: $21.30 per 15 minutes when provided by a licensed psychologist or an LBA; $18.25 per 15 minutes when provided by a BCaBA; and $16.73 per 15 minutes when provided by an RBT or BT; and Adaptive behavior treatment planning: At a rate of $33.46 per 15 minutes; and For a maximum of 4 hours per month. Effective July 1, 2023 through December 31, 2023, reimbursement for ABA services covered under this chapter is as follows: Behavior identification assessment at a rate of $34.46 per 15 minutes; Behavior identification assessment follow-up at a rate of $17.23 per 15 minutes; Exposure behavior identification supporting assessment at a rate of $47.00 per 15 minutes; Adaptive exposure behavior treatment with protocol modification at a rate of $47.00 per 15 minutes; Group adaptive behavior treatment by protocol at a rate of: $9.40 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; $7.52 per 15 minutes, per participant, when provided by a BCaBA; and $6.26 per 15 minutes, per participant, when provided by an RBT or BT; Adaptive behavior treatment with protocol modification at a rate of $33.46 per 15 minutes; Multiple-family group adaptive behavior treatment guidance at a rate of $11.60 per 15 minutes per family; Family adaptive behavior treatment guidance with the participant present at a rate of: $34.46 per 15 minutes when provided by a licensed psychologist or an LBA; and $18.80 per 15 minutes when provided by a BCaBA; Family adaptive behavior treatment guidance without the participant present at a rate of: $18.80 per 15 minutes when provided by a licensed psychologist or an LBA; and $10.97 per 15 minutes when provided by a BCaBA; Behavior identification reassessment at a rate of $34.46 per 15 minutes; Group adaptive treatment with protocol modification at a rate of $9.40 per 15 minutes per participant; Adaptive behavior treatment direction at a rate of $34.46 per 15 minutes; Adaptive behavior treatment by protocol at a rate of: $21.94 per 15 minutes when provided by a licensed psychologist or an LBA; $18.80 per 15 minutes when provided by a BCaBA; and $17.23 per 15 minutes when provided by an RBT or BT; and Adaptive behavior treatment planning: At a rate of $34.46 per 15 minutes; and For a maximum of 4 hours per month. Effective January 1, 2024 through June 30, 2024, reimbursement for ABA services covered under this chapter is as follows: Behavior identification assessment at a rate of $37.22 per 15 minutes; Behavior identification assessment follow-up at a rate of $18.61 per 15 minutes; Exposure behavior identification supporting assessment at a rate of $50.76 per 15 minutes; Adaptive exposure behavior treatment with protocol modification at a rate of $50.76 per 15 minutes; Group adaptive behavior treatment by protocol at a rate of: $10.15 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; $8.12 per 15 minutes, per participant, when provided by a BCaBA; and $6.76 per 15 minutes, per participant, when provided by an RBT or BT; Adaptive behavior treatment with protocol modification at a rate of $37.22 per 15 minutes; Multiple-family group adaptive behavior treatment guidance at a rate of $12.53 per 15 minutes per family; Family adaptive behavior treatment guidance with the participant present at a rate of: $37.22 per 15 minutes when provided by a licensed psychologist or an LBA; and $20.30 per 15 minutes when provided by a BCaBA; Family adaptive behavior treatment guidance without the participant present at a rate of: $20.30 per 15 minutes when provided by a licensed psychologist or an LBA; and $11.85 per 15 minutes when provided by a BCaBA; Behavior identification reassessment at a rate of $37.22 per 15 minutes; Group adaptive treatment with protocol modification at a rate of $10.15 per 15 minutes per participant; Adaptive behavior treatment direction at a rate of $37.22 per 15 minutes; Adaptive behavior treatment by protocol at a rate of: $23.70 per 15 minutes when provided by a licensed psychologist or an LBA; $20.30 per 15 minutes when provided by a BCaBA; and $18.61 per 15 minutes when provided by an RBT or BT; and Adaptive behavior treatment planning: At a rate of $37.22 per 15 minutes; and For a maximum of 4 hours per month. Effective July 1, 2024, reimbursement for ABA services covered under this chapter is as follows: Behavior identification assessment at a rate of $38.34 per 15 minutes; Behavior identification assessment follow-up at a rate of $19.17 per 15 minutes; Exposure behavior identification supporting assessment at a rate of $52.28 per 15 minutes; Adaptive exposure behavior treatment with protocol modification at a rate of $52.28 per 15 minutes; Group adaptive behavior treatment by protocol at a rate of: $10.45 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; $8.36 per 15 minutes, per participant, when provided by a BCaBA; and $6.96 per 15 minutes, per participant, when provided by an RBT or BT; Adaptive behavior treatment with protocol modification at a rate of $38.34 per 15 minutes; Multiple-family group adaptive behavior treatment guidance at a rate of $12.91 per 15 minutes per family; Family adaptive behavior treatment guidance with the participant present at a rate of: $38.34 per 15 minutes when provided by a licensed psychologist or an LBA; and $20.91 per 15 minutes when provided by a BCaBA; Family adaptive behavior treatment guidance without the participant present at a rate of: $20.91 per 15 minutes when provided by a licensed psychologist or an LBA; and $12.21 per 15 minutes when provided by a BCaBA; Behavior identification reassessment at a rate of $38.34 per 15 minutes; Group adaptive treatment with protocol modification at a rate of $10.45 per 15 minutes per participant; Adaptive behavior treatment direction at a rate of $38.34 per 15 minutes; Adaptive behavior treatment by protocol at a rate of: $24.41 per 15 minutes when provided by a licensed psychologist or an LBA; $20.91 per 15 minutes when provided by a BCaBA; and $19.17 per 15 minutes when provided by an RBT or BT; and Adaptive behavior treatment planning: At a rate of $38.34 per 15 minutes; and For a maximum of 4 hours per month. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeal procedures are as set forth in COMAR 10.09.36.09. This chapter shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: November 7, 2016 (43:22 Md. R. 1218) Regulation .01B amended effective March 12, 2018 (45:5 Md. R. 285); June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049); December 11, 2023 (50:24 Md. R. 1041) Regulation .02A amended effective December 12, 2022 (49:25 Md. R. 1049) Regulation .02H, I amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049) Regulation .02J adopted effective December 11, 2023 (50:24 Md. R. 1041) Regulation .03B amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049) Regulation .04 amended effective December 12, 2022 (49:25 Md. R. 1049) Regulation .04B amended effective March 12, 2018 (45:5 Md. R. 285); June 17, 2019 (46:12 Md. R. 542); December 11, 2025 (52:24 Md. R. 1197 Regulation .04B, C amended effective December 11, 2023 (50:24 Md. R. 1041) Regulation .05B, C amended effective March 12, 2018 (45:5 Md. R. 285) Regulation .05D amended effective December 12, 2022 (49:25 Md. R. 1049) Regulation .05F adopted effective March 12, 2018 (45:5 Md. R. 285) Regulation .06 amended effective March 12, 2018 (45:5 Md. R. 285); December 11, 2023 (50:24 Md. R. 1041); December 11, 2025 (52:24 Md. R. 1197) Regulation .06B amended effective December 12, 2022 (49:25 Md. R. 1049) Regulation .06F amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049) Regulation .06G adopted effective December 12, 2022 (49:25 Md. R. 1049) In this chapter, the following terms have the meanings indicated. Terms Defined. “Active treatment” means inpatient psychiatric services which involve implementation of a professionally developed and supervised individual plan of care described in 42 CFR §441.155, that is: Developed and implemented no later than 14 days after admission; and Designed to achieve the recipient's discharge from inpatient status at the earliest possible time. “Acute psychiatric services” mean psychiatric services rendered in response to a severe psychiatric condition requiring intervention in order to bring the patient's symptoms under control. “Admissions team” means an independent team that certifies the need for services (as specified in 42 CFR §§441.152 and 441.153). The certification shall be made by an independent team that: Includes a physician; Has competence in diagnosis and treatment of mental illness, preferably in child psychiatry; and Has knowledge of the individual's situation. “Children's residential treatment center” means a residential treatment center that admits patients 12 years old and younger. “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Department of Human Services” means the department of State government encompassing the Family Investment Administration, the Social Services Administration, and the Child Support Enforcement Administration. “Family Investment Administration” means the administrative unit of the Department of Human Services and its affiliated local departments responsible for determining a person's eligibility for Medical assistance. “Individual plan of care” means a written plan developed for each recipient in accordance with 42 CFR §§456.180—456.181, and §§456.280—456.281, and defined in 42 CFR §441.155 (individual plan of care). The plan of care shall: Be based on a diagnostic evaluation that includes examination of the medical, psychological, social, behavioral, and developmental aspects of the recipient's situation and reflects the need for inpatient psychiatric care; Be developed by a team of professionals in consultation with the recipient and the recipient's parents, legal guardians, or others in whose care the recipient will be released after discharge; State treatment objectives; Prescribe an integrated program of therapies, activities, and experiences designed to meet the objectives; and Include, at an appropriate time, post-discharge plans and coordination of inpatient services with partial discharge plans and related community services to ensure continuity of care with the recipient's family, school, and community upon discharge. “Local department of social services” means that unit of the Baltimore City or county social services department under the supervision of the Family Investment Administration. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Mental health services” means those services described in COMAR 10.09.59.06 rendered to treat an individual for a diagnosis set forth in COMAR 10.67.08.02M. “Physician” means an individual who is currently licensed to practice medicine in the state in which his practice is located. “Preauthorization” means an approval required from the Department or its designee and transmitted to the provider before services can be rendered. “Program” means the Maryland Medical Assistance Program, which administers comprehensive medical and health-related benefits to indigent and medically indigent persons. “Provider” means a residential treatment center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Recipient under 21 years old” means a recipient who is either: Under 21 years old; or Twenty-one years old and received residential treatment center services immediately before the recipient reached age 21. The recipient continues to be recognized as a recipient under 21 years old until the earlier of the date the recipient either: No longer requires inpatient psychiatric services; or Reaches 22 years old. “Residential treatment center” means any institution which falls within the jurisdiction of Health-General Article, §19-308, Annotated Code of Maryland, and is licensed as required by COMAR 10.07.04 or other applicable standards established by the state in which the service is provided. “Secretary” means the Secretary of Health. In order to participate in the Program a provider shall: Be licensed by the Department in accordance with requirements of Health-General Article, §19-308, Annotated Code of Maryland; Meet the standards established by COMAR 10.07.04; and Obtain other licenses as may be required by applicable State and local laws. A physician providing services in a residential treatment center shall be licensed and legally authorized to practice medicine in the state in which the service is provided. To participate in the Program as a residential treatment center for emotionally disturbed children and adolescents, a provider shall: Meet the requirements for participation as defined in 42 CFR §440.160 (inpatient psychiatric services for individuals under 21 years old) and have acute psychiatric services that meet the requirements of 42 CFR Part 441, Subpart D (inpatient psychiatric services for individuals under 21 years old in psychiatric facilities or programs). Be accredited by the Joint Commission on Accreditation of Healthcare Organizations. Meet the applicable conditions and requirements of Regulation .04 of this chapter. Apply for participation in the Program by completing the application form designated by the Program. Be approved for participation and be assigned a provider account number by the Department. Have a current written agreement with the Program. Verify the licenses and credentials of all professionals employed by or under contract with the residential treatment center to provide services. Verify the recipient's eligibility. Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap, unless limitations are those specifically required by 42 CFR Subpart D. Place no restriction on a recipient's right to select providers of the recipient's choice. Have a written individual plan of care for each recipient as specifically defined by 42 CFR §441.155, and developed by an interdisciplinary team of physicians and other personnel as required in 42 CFR §441.156. The plan shall be reviewed every 30 days by the team to determine that services being provided are or were required on an inpatient basis, and recommend changes in the plan as indicated by the recipient's overall adjustment as an inpatient. The team shall be capable of: Assessing the recipient's immediate and long-range therapeutic needs, developmental priorities, and personal strengths and liabilities; Assessing the potential resources of the recipient's family which includes the recipient's parents, legal guardians, or others in whose care the recipient will be released after discharge; Setting treatment objectives; and Prescribing therapeutic modalities to achieve the plan's objectives. Employ for purposes of developing an individual plan of care an interdisciplinary team which shall: Include as a minimum: A Board-eligible or Board-certified psychiatrist, A clinical psychologist who has a doctoral degree and a physician licensed to practice medicine or osteopathy, or A physician licensed to practice medicine or osteopathy with specialized training and experience in the diagnosis and treatment of mental diseases, and a psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association; Include one of the following: A psychiatric social worker, A registered nurse with specialized training or 1 year's experience in treating mentally ill individuals, An occupational therapist who is licensed, if required by the State, and who has specialized training or 1 year of experience in treating mentally ill individuals, A psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association. Maintain adequate administrative and medical records for a minimum of 6 years and make them available upon request to the Department or its designee. Adequate administrative and medical records are defined as having documentation sufficient in quantity, scope, and detail to confirm that the residential treatment center services are provided in accordance with this regulation. Not knowingly contract or employ a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance recipients unless prior written approval has been received from the Department. Accept payment by the Department as payment in full for services rendered and make no additional charge to any person for covered service. Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the recipient or his family. Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient or his family. Meet the requirements for admission to regional institutes for children and adolescents, established by COMAR 10.21.06. Agree that if the Program denies payment due to the provider's failure to satisfy mandatory federal requirements as specified in 42 CFR Part 441, Subpart D—Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs, the provider may not seek payment from the recipient or his family. Comply with all requirements for the delivery of mental health services contained in COMAR 10.67.08. The Program covers inpatient psychiatric services for the diagnosis, active treatment, and care of recipients under 21 years old with mental disease when the services are: Medically necessary; Performed under the direction of a physician; Certified as necessary by an admissions team before the recipient's admission to the residential treatment center; In the case of a recipient already residing in the residential treatment center, certified as necessary by the team developing the individual plan of care in accordance with 42 CFR §441.153(b); For the treatment of a mental illness listed in COMAR 10.67.08.02M. The Program does not cover the following: Services not specified in Regulation .04 of this chapter; Services not medically necessary; Investigational and experimental drugs and procedures; A day of inpatient care solely for the purpose of performing diagnostic tests that can be performed on an outpatient basis; Admissions with a primary diagnosis of alcoholism, drug addiction, or severe brain damage, or the following diagnoses in the ICD-9-CM, 294.0—Amnestic syndrome, 294.8—Other specified organic brain syndromes (chronic), 294.9—Unspecified organic brain syndromes (chronic), 299.00—299.8—Psychoses with origin specific to childhood, 301.7—Antisocial personality disorder, 302.70—302.79—Psychosexual dysfunction, 306.0—306.9—Physiological malfunction arising from mental factor, 307.0—Special symptoms or syndromes, not elsewhere classified (NEC), 307.2 —Tics, 307.40—307.49—Specific disorders of sleep of nonorganic origin, 307.9—Other and unspecified special symptoms or syndromes (NEC), or 316—Psychic factors associated with disease classified elsewhere; Days of care for recipients remaining in the residential treatment center beyond the length of stay certified by the team which develops the individual plan of care; Psychiatric services to recipients over 21 years old except as specified in Regulation .01B(16) of this chapter. The following procedures or services require preauthorization: Out-of-State admissions. Adequate documentation shall be provided demonstrating that the placement meets one of the conditions as follows: Effective services at an in-State facility are not available; For similar services, an inpatient placement is not currently available in Maryland; or The recipient resides out-of-State and the cost for the out-of-State service is comparable to the cost of similar services in Maryland. Services which are determined by Medicare to be ineffective, unsafe, or without proven clinical value are generally presumed to be not medically necessary, but will be preauthorized if the provider can satisfactorily document sufficient medical necessity except as specified in Regulation .05C of this chapter. All admissions, which shall comply with the requirements under COMAR 10.09.59.08 for preauthorization. Reimbursement Principles. The Department will make no direct reimbursement to any State-operated residential treatment center for recipients. The Department will claim federal fund recoveries from the Department of Health and Human Services for services to federally eligible Title XIX patients in these residential treatment centers. The Department will pay the residential treatment center the lesser of the provider’s customary charge or the provider’s per diem costs for covered services according to the principles established under Title XVIII of the Social Security Act, as required in 42 CFR 413, or on the basis of charges not to exceed $750 per day effective July 1, 2021 through December 31, 2022, or $850 per day effective January 1, 2023. The average increase in the Department’s reimbursement to the provider per inpatient day for each fiscal year over the cost-settled rate for the previous fiscal year, State Fiscal Year 2019 final cost per diem effective July 1, 2021, may not exceed the rate of increase of the Hospital Wage and Price Index plus 1 percentage point, described in 42 CFR §413.40. The target rate percentage increase for each calendar year will equal the prospectively estimated increase in the Hospital Wage and Price Index (market basket index) for each year, plus 1 percentage point. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with the provisions of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. An in-State children’s residential treatment center shall be reimbursed the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; The provider’s per diem cost for covered services established in accordance with Medicare principles of reasonable cost reimbursement as described in 42 CFR 413; Effective July 1, 2021, $750 per day; or Effective January 1, 2023, $850 per day. The Department rebases prices in §A(2) and (3) of this regulation between every 2 and 4 years. Prices may be rebased more frequently if the State determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. In years in which rates are not rebased, rates are subject to annual indexing. For purposes of §A(3)(b) of this regulation, the percentage increase in the Department's cost reimbursement to the provider, per inpatient day for each cost reporting year over the cost-settled payment rate for the previous cost reporting year, State Fiscal Year 2019 final cost per diem effective July 1, 2021, may not exceed the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, plus 1 percent. The rate stated in §A(2) and (3)(c) of this regulation shall be updated annually for each provider's cost reporting period by the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system. Effective July 1, 2021, the rate stated in §A(2) and (3)(c) of this regulation shall be updated annually for each provider's cost reporting period by the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, plus 1 percent. Out-of-State Providers. To be reimbursed for services provided to Maryland Medical Assistance recipients, an out-of-State provider shall be licensed or formally approved as a psychiatric facility or as an inpatient program in a psychiatric facility, either of which is accredited by the Joint Commission on Accreditation of Healthcare Organizations. Recipient's Contribution. The local department of social services or the State-operated facility's fiscal agent shall determine the amount the recipient has available to pay toward the cost of medical or remedial care for inpatient services, and so inform the provider. The provider shall collect from the recipient that amount as shown available on the designated form. The provider may not collect a total amount, including the amount the recipient has available and the Department's payment, which exceeds the provider's rate established by the Department or its designee. The provider shall show to the Department sums collected from the recipient. The provider shall submit request for payment on the form designated by the Department. The provider shall submit, with invoices, properly completed attachments as requested by the Department. A provider may not bill the Program a charge exceeding that charged the general public for similar services. The provider may not bill the Department for: Completion of forms and reports; Broken or missed appointments; or Professional services rendered by mail or telephone. The Department will make no direct payment to the recipient. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. If the recipient has insurance, or if any other person is obligated either legally or contractually to pay for, or to reimburse, the recipient for any services covered by this chapter, the provider shall seek payment from that source. If payment is made by both the Program and the insurance or other source, the provider shall report, within 15 days after the close of each month, on a form designated by the Department, the amount paid by the Program, and the insurance or the other source, whichever is less, and refund the total amount of the lesser of the two payments reported to the Program at that time. If refund of a payment as specified in §A, of this regulation, is not made, the Department will have the right to reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that it no longer honors Medical Assistance cards before it renders additional services. The Department shall give to the provider reasonable written notice of the Department’s intention to impose sanctions. In the notice, the Department shall: Establish the: Effective date of the proposed action; and Reasons for the proposed action; and Advise the provider of the right to appeal. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. The provider shall: Include, for purposes of cost finding, direct and indirect costs applicable to recipient care; In the cost report, specifically identify costs associated with related organizations; Maintain adequate financial records and statistical data, according to generally accepted accounting principles and procedures, which shall provide, as a minimum: Maintenance of: A chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements, An appropriate time reporting system for all personnel and proper payroll authorizations and vouchers, Records on all assets capitalized and depreciation on the assets, Appropriate records of client days, Records on an accrual basis, A daily midnight bed census by recipient name in a form prescribed by the Department, although use of the prescribed form may be waived by the Department or its designee when a provider demonstrates the ability to maintain a superior system of census information, Other records as required by the Department, and A Maryland Medical Assistance log on forms prescribed by the Department; Proper reference to supporting invoices, vouchers, or other forms of original evidence; and A provision for payment by check, although when financial transactions involve numerous small expenditures, an imprest petty cash fund may be established, provided adequate supporting vouchers are maintained; Keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours, with records for each fiscal year's cost report to be retained for 6 years after the filing date of the cost report specified in §A(5) of this regulation; Submit financial and statistical cost reports to the Department or its designee: In a prescribed form; and Within 3 months after the end of the provider's fiscal year unless the: Department grants the provider an extension, or Provider discontinues participation in the Program; Be considered for an extension as cited in §A(5)(b)(i) of this regulation, which may be granted upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; and If it discontinues participation, submit financial and statistical data to the Department within 45 days after the effective date of termination. The Department shall: For cost reports requested in §A(5) of this regulation, which have not been received within the 3-month time period and when an extension has not been granted: Withhold from the provider a maximum of 5 percent of the current interim payment starting at the beginning of the second calendar month after the month in which the report is due, Continue withholding as described in §B(1)(a) of this regulation in any subsequent calendar months, and Retain all withholdings until final cost settlement is completed; When a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, impose one or more sanctions as provided for in Regulation .09 of this chapter; and When a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, make final cost settlement for that fiscal year at the last final per diem rates for which the Department has verified costs for that facility, if the rates established do not exceed the maximum per diem rates in effect when the facility was last field verified. For purposes of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. The Program may not make an initial retroactive adjustment when cost reports are received, and tentative settlements may not be made before final settlement. When a provider receives notification of final settlement as set forth in Regulation .14A(4) of this chapter and an appeal is filed, undisputed amounts of settlement may not be paid to the appropriate recipients until final findings of the appeal. A provider shall have its interim rate updated annually. A provider's interim rate shall be adjusted at the beginning of each fiscal year, by applying the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, subject to the limitations in Regulation .07A of this chapter, to the provider's interim rate in effect on the last day of the preceding fiscal year. The rate established in §B of this regulation is in effect until such time as a new rate can be calculated as specified in §§D—F of this regulation. The provider shall submit annually, with the cost report described in Regulation .12 of this chapter, schedules detailing projected increases/decreases from the year just ended to the current year. The provider shall submit a calculation reflecting the rate being requested for the current year. The Department or its designee shall use the submitted cost report, schedules, calculations, and other information as appropriate to calculate an updated interim rate for the current year. The rate established in accordance with §F of this regulation shall be implemented for the remainder of the fiscal year with no retroactive supplemental billing or payment for differences in rates. Providers may request an interim rate revision: If the revised interim rate exceeds the current rate by 7 percent; and Not more than two times during a fiscal year. A request for a revised interim rate shall include, at a minimum: A completed cost report based on a minimum of 3 months of recent actual cost and statistics; An adjusted trial balance covering the cost report period in §I(1) of this regulation; and A calculation reflecting the revised rate being requested. A new provider seeking payment for services shall submit to the Department or its designee a projected budgeted cost report and other appropriate information for the period from the beginning of its operations as a provider to the end of its first fiscal year, along with a projected charge rate schedule, for establishment of an initial interim rate by the Department or its designee, subject to the limitations in Regulation .07A of this chapter. The Department or its designee shall: Conduct a field verification, at least every 3 years, of the reported costs of each facility participating in the Program, if the amount of the facility's reimbursement would justify the expense of a field verification; Desk review the reported costs of the facility in those years when a field verification is not conducted; Notify each provider participating in the Program of the results of the field verification or desk review; and Calculate final settlements by comparing the verified allowable reimbursement to the interim reimbursement. Appeal Findings. After the Department receives the findings of an appeal filed under Regulation .10 of this chapter, the Department shall determine the amount that is due either to the Program or to the provider, and notify the provider of that amount. If the provider has accepted the determination made under §B(1) of this regulation, and within 60 days after the provider receives the notification under §B(1) of this regulation, the Program shall pay the amount the Department has determined is due the provider, if any. Subject to the provisions of §B(5) and (6) of this regulation, within 60 days after the provider receives the notification under §B(1) of this regulation, the provider shall pay the amount due the Program, if any. After the expiration of the 60-day period in §B(3) of this regulation, the Department may, in addition to the sanctions provided for in Regulation .09 of this chapter, recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule. The Department shall establish a longer payment schedule if, in the Department's reasonable judgment, failure to grant a longer payment schedule would: Result in financial hardship to the provider; or Have an adverse effect on the quality of patient care furnished by the facility. The current owner of a residential treatment center shall: Notify the Program of the contemplated sale of a facility or controlling interest in it not less than 30 days before the date of the change of ownership; and Before the date of the change of ownership, post an indemnity bond or standby letter of credit, or provide some assurance satisfactory to the Program that the purchaser will assume and be responsible for all financial obligations of the current owner. The bond or standby letter of credit under §A(2) of this regulation shall be in the amount of 1 month's Program billings for each unsettled fiscal period outstanding. This amount shall equal the median monthly payment for each unsettled fiscal period. The new owner of a residential treatment center shall: Notify the Program of the intent to purchase an existing facility or controlling interest in it, and the desire to enroll in the Program, not less than 30 days before the date of the change of ownership; and Enter into a provider agreement with the Department before being assigned new interim per diem rates. Interim Per Diem Rates. For the purpose of establishing interim per diem rates, the new owner in an arm's length change of ownership shall be treated as a new provider under the provisions of Regulation .13J of this chapter. The Department shall establish new interim per diem rates within 90 days after the date of the change of ownership, applicable retroactively to the date of the change of ownership, if the information specified in Regulation .13J of this chapter is submitted to the Department or its designee within 60 days after the date of the change of ownership. Until the new interim per diem rates are established, the new provider may be reimbursed at the interim per diem rates that existed before the date of the change of ownership. Failure by the provider to provide data for interim rate determination within 60 days after the change of ownership may result in temporary withholding of the interim per diem payments. Failure to comply with §§A and B of this regulation shall result in all unsettled fiscal periods to be immediately settled at 90 percent of the rates used for the most recently settled fiscal period, and amounts due shall be paid immediately. If the provider elects to file an appeal against any action taken under the provisions of §E of this regulation, any amount due to the Department shall be escrowed pending the final outcome of the appeal. The Department, in its sole discretion, may waive any of the requirements of this regulation based on exceptional circumstances. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective July 1, 1986 (13:13 Md. R. 1474); adopted permanently effective December 1, 1986 (13:24 Md. R. 2559) Regulation .01 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1150); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) Regulation .01B amended effective April 5, 2010 (37:7 Md. R. 571); April 4, 2022 (49:7 Md. R. 465) Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159) Regulations .03—.06 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1150); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) Regulations .03, .04, .07 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1383); amended permanently effective November 1, 1992 (19:21 Md. R. 1891) Regulation .04E amended effective April 4, 2022 (49:7 Md. R. 465) Regulation .05 amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .06C amended effective April 4, 2022 (49:7 Md. R. 465) Regulation .07A amended effective February 6, 1989 (16:2 Md. R. 159) Regulation .07A amended as an emergency provision effective November 17, 1995 (22:25 Md. R. 1958); adopted permanently effective April 8, 1996 (23:7 Md. R. 552) Regulation .07A amended effective February 12, 2007 (34:3 Md. R. 298); April 5, 2010 (37:7 Md. R. 571); July 4, 2016 (43:13 Md. R. 712); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 682) Regulation .07F amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07H amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07H amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .09D adopted effective January 24, 2011 (38:2 Md. R. 84) Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84) Regulations .12—.14 adopted effective November 23, 1992 (19:23 Md. R. 2041) Regulations .12B and .13 amended as an emergency provision effective November 17, 1995 (22:25 Md. R. 1958); adopted permanently effective April 8, 1996 (23:7 Md. R. 552) Regulation .13B, C amended effective February 12, 2007 (34:3 Md. R. 298) Regulation .15 adopted effective February 12, 2007 (34:3 Md. R. 298) The purpose of this chapter is to codify policy regarding comprehensive evaluations performed for the purpose of determining eligibility for services or informing individuals of available services or as required for Geriatric Evaluation Services (GES) or Preadmission Screening and Resident Review (PASRR). The following terms have the meanings indicated. Terms Defined. “Comprehensive evaluation” means the assessment performed by a nurse or social worker, or both, using the tools designated by the Department, of a participant’s medical, social, and functional status by: Direct observation of the participant; Contact, as appropriate, with the participant's representative; and Financial eligibility screening. “Department” means Maryland Department of Health. “Financial eligibility screening” means the determination of whether an individual qualifies financially as a participant. “Geriatric Evaluation Services (GES)” means the assessment that is required to admit an individual to a State facility or Veteran’s Administration hospital. “Nurse” means a person who is licensed as a registered nurse in the jurisdiction in which services are provided. “Nurse practitioner” means a person who is licensed as a nurse practitioner in the jurisdiction in which services are provided. “Participant” means a Medicaid recipient or an individual who would be able to establish financial eligibility under the Program within 6 months of admission to a nursing facility, whose needs may not be adequately met in an episodic ambulatory care setting, and who may require continuing institutional or community based long-term care services. “Plan of care” means the written long term care plan composed of a comprehensive evaluation of the participant’s health status including: Pertinent diagnoses; Psychosocial status; Functional status; and Type of services recommended. “Preadmission Screening and Resident Review (PASRR)” means the screening or reviewing of all individuals with mental illness or intellectual disability who apply to or reside in Medicaid-certified nursing facilities. “Program” has the same meaning as defined in COMAR 10.09.36. “Provider” means a local health department, or when necessary, a contracted agency: Providing the comprehensive evaluation through an appropriate agreement with the Department and identified as a Program provider by the issuance of an individual account number; Employing nurses and social workers to provide the comprehensive evaluation; and Demonstrating experience in providing assessment and evaluation services and in developing plans of care. “Provider agreement” means a contract between the Department and the provider of STEPS specifying the: Services to be performed; Methods of operation; and Financial and legal requirements which shall be in force before Program participation. “Psychiatrist” means a person who is licensed as a psychiatrist in the jurisdiction in which services are provided. “Psychologist” means a person who is licensed as a psychologist in the jurisdiction in which services are provided. “Social worker” means a person who is licensed as a social worker in the jurisdiction in which services are provided. The following health professionals providing services under this regulation shall be licensed to practice in the jurisdiction in which services are rendered: Nurses; Nurse practitioners; Psychiatrists; Psychologists; and Social workers. Specific requirements for participation in the Program are that providers shall: Ensure that all individuals performing services under Regulation .05 of this chapter meet the licensure requirements as provided in Regulation .03 of this chapter; Have existing policies and procedures concerning the completion of comprehensive evaluations, and expedition of those evaluations when necessary, that the provider has agreed to perform; Develop, as appropriate, agreements in order to facilitate access to services and coordinate with local public agencies and other providers; If approved as a provider of comprehensive evaluations, inform participants of the results of the comprehensive evaluation and of available services; and Ensure completion, at least every other year, of training on the tools designated by the Department for the purposes of the comprehensive evaluation, by all nurses and social workers providing services under this chapter. The Program reimburses for completed comprehensive evaluations, which include assessment by a nurse, social worker, or both. The comprehensive evaluation or designated form is to be completed within the following time frames: 3 business days for all Geriatric Evaluation Services (GES) and Preadmission Screening and Resident Review (PASRR) for individuals transferring from a hospital to a nursing facility; 5 business days for all other PASRR; and 15 calendar days for all other purposes. The comprehensive evaluation shall be completed in-person. The Department will reimburse for the services listed in §A of this regulation when they are: Rendered to participants as defined in Regulation .02 of this chapter; Completed within the time frame specified in §B of this regulation, unless the Department is notified, in writing, of circumstances that prevent completion within the specified time frame and a temporary, alternative schedule has been approved by the Department; Adequately performed as reflected on the completed form specified by the Department and submitted to the Program as a condition for payment; and Rendered by a provider approved to perform comprehensive evaluations. The comprehensive evaluation is advisory in nature and is designed to assist individuals in identifying and using appropriate long term care services. A restriction may not be placed on the qualified recipient’s option to receive the comprehensive evaluation. The comprehensive evaluation does not restrict or otherwise affect: Eligibility for Title XIX benefits or other available benefits or programs; The freedom of a recipient to select from all available services, including nursing home care, for which the individual is found to be eligible; or The participant's free choice of qualified providers. Request for Payment. Requests for payment of services rendered shall be submitted according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider. Requests for payment shall be submitted on the form specified by the Department. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Effective July 1, 2022, payments for comprehensive evaluations shall be made in accordance with the fee schedule below: Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Interpretive regulatory requirements are as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective October 21, 1986 (13:23 Md. R. 2477); emergency status extended at 14:2 Md. R. 125; adopted permanently effective January 27, 1987 (14:2 Md. R. 129) Regulation .01B amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129) Regulation .02 amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129) Regulation .03 amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129) Regulation .04 amended effective July 12, 1987 (14:14 Md. R. 1571); July 25, 1988 (15:15 Md. R. 1809); January 9, 1989 (15:27 Md. R. 3129) Regulation .05 amended effective January 9, 1989 (15:27 Md. R. 3129) Regulation .05D amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) Regulation .06 amended effective July 12, 1987 (14:14 Md. R. 1571); July 25, 1988 (15:15 Md. R. 1809); January 9, 1989 (15:27 Md. R. 3129) Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .06C amended as an emergency provision effective December 4, 1990 (17:26 Md. R. 2973); emergency status extended at 18:4 Md. R. 444; amended permanently effective March 18, 1991 (18:5 Md. R. 594) Regulation .06C amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) Regulation .06C amended effective December 26, 2011 (38:26 Md. R. 1697) Regulation .09 amended effective January 24, 2011 (38:2 Md. R. 84) Chapter revised effective December 11, 2023 (50:24 Md. R. 1041) In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” has the meaning stated in COMAR 10.09.36. “Emergency medical services (EMS) provider " has the meaning stated in Education Article, §13–516, Annotated Code of Maryland. “Emergency service transporter” means a public entity or volunteer fire, rescue, or emergency medical service that provides emergency medical transportation services. “EMS Board” means the State Emergency Medical Services Board established by Education Article, §13-503, Annotated Code of Maryland. “Facility” means a hospital or nursing facility including an intermediate care facility, skilled nursing facility, comprehensive care facility, or extended care facility. “Free-standing urgent care center” means a location, distinct from a hospital emergency room, a physician's office, or a free-standing clinic, whose purpose is to diagnose and treat illness or injury for unscheduled, ambulatory patients seeking immediate medical attention. “Mobile integrated health” means a community-based preventive, primary, chronic, pre-admission, or post-admission health care service provided by an emergency medical services provider to a participant. “Participant” has the meaning stated in COMAR 10.09.36. “Program” has the meaning stated in COMAR 10.09.36. “Provider” has the meaning stated in COMAR 10.09.36. A provider shall meet all licensing requirements: Set forth in COMAR 10.09.36; and In the jurisdiction where the service is provided. To participate in the Program, the provider shall: Comply with the conditions for participation set forth in COMAR 10.09.36; Certify that all third-party payers are routinely billed for services; Retain all documentation, including but not limited to run sheets, for 6 years; and When delivering mobile integrated health, render services in accordance with the MIH services medical protocols adopted by the EMS Board. Emergency Medical Transportation Services. The Program covers the following services when provided by an enrolled emergency service transporter to an eligible participant in response to a 911 call: Medical services delivered at the scene of a 911 response consistent with EMS Board protocols, with or without subsequent transportation; Medical services provided while transporting the participant to a facility, free-standing urgent care center, or other Department-approved destination; and Transportation to a facility, free-standing urgent care center, or other Department-approved destination. Mobile Integrated Health Services. The Program covers the following medically necessary mobile integrated health services when delivered by an EMS provider or any team member in the participant’s home or another community-based setting permitted by the EMS Board’s medical protocols: Health assessments; Remote medical diagnostics; Chronic disease monitoring and education; Medication compliance; Immunizations and vaccinations; Laboratory specimen collection; Hospital discharge follow-up care; and Minor medical procedures. Under this chapter, the Program does not cover: Services not rendered in response to a 911 call unless delivered as part of a mobile integrated health visit; Services performed or billed by an emergency services transporter that is not enrolled in the Program; Services rendered by an emergency services transporter in response to a 911 call when the participant refuses medical services and transport of the participant does not occur; Services rendered to anyone other than an eligible participant; Services for which proper documentation, including but not limited to run sheets, cannot be provided on request of the Department or its designee; Services not indicated by the medical protocols adopted by the EMS Board; Mobile integrated health services delivered to participants younger than 18 years old; and Services delivered in any setting other than the eligible participant’s home or any community-based site permitted under the medical protocols adopted by the EMS Board. Payment procedures for this chapter are set forth in COMAR 10.09.36. Emergency Medical Transportation Services Reimbursement. Payment for covered services provided in response to each 911 call incident is the lesser of: The amount billed; or Effective July 1, 2022, $150. Effective January 1, 2023, payment for covered services provided in response to each 911 call incident that does not result in a transport is the lesser of: The amount billed; or $150. Mobile Integrated Health Reimbursement. Payment for a mobile integrated health visit is the lesser of: The amount billed; or Effective January 1, 2023, $150. The provider shall bill one mobile integrated health service, regardless of the number of clinical services rendered to a participant during the visit. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36. Appeal procedures under this chapter are set forth in COMAR 10.09.36. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-114.1, Annotated Code of Maryland Effective date: June 14, 1999 (26:12 Md. R. 925) Regulation .01B amended effective May 1, 2023 (50:8 Md. R. 337) Regulation .03B, C amended effective May 1, 2023 (50:8 Md. R. 337) Regulation .03D adopted effective May 1, 2023 (50:8 Md. R. 337) Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337) Regulation .05 amended effective May 1, 2023 (50:8 Md. R. 337) Regulation .06 amended effective May 1, 2023 (50:8 Md. R. 337) The following terms have the meanings indicated. Terms Defined. “Case management” means services which will assist participants in gaining access to the full range of Medical Assistance services, as well as to any additional needed medical, social, housing, financial, counseling, and other support services. “Case manager” means a physician, nurse, or social worker (refer to Regulation .02 of this chapter) employed by the HIV ongoing case management provider and chosen by the participant or the participant’s legally authorized representative. “Department” means Department as defined in COMAR 10.09.36.01. “Entity” means a facility, agency, organization, department, office, corporation, partnership, group or individual. “HIV diagnostic evaluation services” means a bio-psychosocial assessment of a participant and development or revision of an individualized plan of care by a multidisciplinary team convened by an approved HIV diagnostic evaluation services provider. “HIV diagnostic evaluation services provider” means an entity approved by the Department as a provider of HIV diagnostic evaluation services, as defined in Regulation .03 of this chapter. “HIV-infected individual” means a person determined as positive for human immunodeficiency virus (HIV) infection by the enzyme-linked immunosorbent assay (ELISA) and confirmed by the Western Blot, or another generally accepted diagnostic testing algorithm for HIV infection. “HIV ongoing case management” means the activities involved in developing, revising, implementing, and monitoring the plan of care, as performed by a case manager through an approved HIV ongoing case management provider. “HIV ongoing case management provider” means an entity, as defined in Regulation .03 of this chapter, approved by the Department as a provider of ongoing case management services to participants. “HIV-targeted case management” means the provision of HIV diagnostic evaluation services and HIV ongoing case management. “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Multidisciplinary team” means the members convened by the HIV diagnostic evaluation services provider to perform a bio-psychosocial assessment of the participant and develop or revise an individualized plan of care. “Nurse” means a person who is licensed as a registered nurse in the jurisdiction in which services are provided. “Ongoing case management” means the activities involved in developing, revising, implementing, and monitoring the plan of care, as performed by a case manager through an approved HIV ongoing case management provider. “Participant” means a recipient who: Has been diagnosed as HIV-infected or is a child less than 2 years old born to a woman diagnosed as HIV-infected; Elects, or has a legally authorized representative elect in the recipient's behalf, to receive the services available under these regulations; and Is not receiving the same case management services under the Social Security Act, §1915(b), 1915(c), or 1915(g). “Physician” means a doctor of medicine or osteopathy who is licensed to practice medicine in the jurisdiction in which services are rendered. “Plan of Care” means a goal-directed treatment plan developed and revised by the HIV diagnostic evaluation service provider’s multidisciplinary team that is based on the bio-psychosocial assessment. “Program” means the Program as defined in COMAR 10.09.36.01. “Provider” means the HIV diagnostic evaluation services provider or HIV ongoing case management provider, which offers covered case management services to participants through a provider agreement signed with the Department and which is identified as a Program provider by issuance of an individual account number. “Provider agreement” means a contract between the Department and the provider. “Recipient” means recipient as defined in COMAR 10.09.36.01. “Social worker” means a person who is in compliance with the social work licensing requirements of the jurisdiction in which services are provided. Registered nurses participating in targeted case management for HIV-infected individuals shall be licensed pursuant to Health Occupations Article, Title 7, Annotated Code of Maryland, or pursuant to comparable licensing requirements of the jurisdiction in which services are rendered. Social workers participating in targeted case management for HIV-infected individuals shall be licensed pursuant to Health Occupations Article, Title 18, Annotated Code of Maryland. Physicians participating in targeted case management for HIV-infected individuals shall be licensed to practice medicine in the jurisdiction in which services are rendered. General requirements for participation in the Medical Assistance Program are that providers shall meet all the conditions for participation as set forth in COMAR 10.09.36.03. Specific requirements for participation in the Program as a provider of services covered under this chapter are that the provider shall maintain a record on each participant which meets the Program’s requirements and which includes: Verification of the participant’s HIV-infected status; Verification of the participant’s eligibility for services; A signed consent form by the participant to participate in HIV ongoing case management; The completed bio-psychosocial assessment; The completed plan of care signed by all members of the multidisciplinary team; Documentation for each contact made by the case manager including: Date and subject of contact; Person contacted; Person making the contact; Nature, extent, and unit or units of service provided; and Place of service; and A signed case closure form when HIV ongoing case management services are ended. Specific requirements for participation in the Program as an HIV diagnostic evaluation services provider are that the provider shall: Be a physician or a health or social services entity which employs or has a written agreement with physicians, nurses, or social workers for provision of its diagnostic evaluation services who are experienced or trained in the provision of services to HIV-infected individuals; Have a written plan for the implementation of HIV diagnostic evaluation services; Be available to participants at least 8 hours a day, 5 days a week, except on State holidays; Have existing policies and procedures concerning the performance of HIV diagnostic evaluation services; Develop procedures to expedite bio-psychosocial assessments when necessary; Have access to specialty physicians experienced and trained in the provision of services to HIV-infected individuals for consultation, as necessary, concerning a participant’s medical assessment and the medical services recommended in the plan of care. Present a qualified recipient with the option of receiving HIV diagnostic evaluation services and HIV ongoing case management services. If the recipient elects to receive HIV ongoing case management, the provider shall ask the recipient to select from a list of qualified HIV ongoing case management providers. Establish a written agreement with any entity approved as an HIV ongoing case management provider which a participant selects as his or her case manager and agrees to allow the case manager chosen by the participant to: Participate as a member of the multidisciplinary team; Assist with performance of the bio-psychosocial assessment; Assist with the development and revision of the plan of care; and Monitor the participant’s need for a revised bio-psychosocial assessment. Convene a multidisciplinary team for each participant, to perform the bio-psychosocial assessment and develop or revise an individualized plan of care. The team shall be composed of: The participant; The participant’s legally authorized representative or representatives; Any additional representatives chosen by the participant, if desired; A representative from the HIV diagnostic evaluation services provider which may include any of the following as necessary and appropriate: The participant’s primary care physician; Nurse; Current service provider or providers; Specialty physician; or Social worker; and The participant’s case manager. If employed by the HIV diagnostic evaluation services provider, the case manager may also act as the representative from the provider. Inform the participant or the participant’s legally authorized representative or representatives of: Recommendations for the plan of care in the bio-psychosocial assessment; and Availability of needed services. Have the capacity to conduct, at minimum, an annual bio-psychosocial assessment of the participant, unless an earlier assessment is recommended by the case manager or multidisciplinary team. Specific requirements for participation in the Program as an HIV ongoing case management provider are that the provider shall: Be a health or social services entity employing registered nurses, social workers, or physicians, who are trained and have at least 1 year experience in the provision of services as a case manager. Experience may have been acquired as volunteer work or field placement; Have a written agreement: With any entity approved as an HIV diagnostic evaluation services provider from whom the ongoing case management provider is accepting referrals, and Which permits the case manager to participate as a member of the multidisciplinary team, to have access to the plan of care, and to request a bio-psychosocial assessment and plan of care revision as necessary; Have a written plan for the implementation of HIV ongoing case management services; Have existing policies and procedures concerning the performance of HIV ongoing case management; Provide HIV ongoing case management services to participants who: Are assessed by an HIV diagnostic evaluation services provider; Are recommended for HIV ongoing case management services in the plan of care; and Elect to receive ongoing case management services; Be available to participants at least 8 hours a day, 5 days a week, except on State holidays; Have established alternatives for managing participants’ medical and social crises during off-hours that will be specified in participants’ individualized plans of care; Have the capacity to meet with the participant face-to-face; Be knowledgeable of the eligibility requirements and application procedures of applicable federal, State, and local government assistance programs; and Maintain a current listing of medical, social, housing assistance, mental health, financial assistance, counseling, and other support services available to HIV-infected individuals. The Program covers the following services when they have been documented as medically necessary: HIV Diagnostic Evaluation Services. These services shall include, as a unit of service, performance of a bio-psychosocial assessment and development or revision of a recommended plan of care, as well as all other necessary covered services described in §A(2) of this regulation. A bio-psychosocial assessment shall be completed within 6 weeks of the participant’s referral for case management services. The assessment shall be performed by the HIV diagnostic evaluation services provider representative on the multidisciplinary team and include: A review of relevant medical and other records, with the participant’s or legal representative’s written consent; A consult with the participant’s attending physician and current providers of medical, social, or other support services, as appropriate; A face-to-face assessment of the participant, preferably at the participant’s residence, to determine: Medical, psychiatric, and substance abuse history, including current medications; Nutritional status; Emotional and behavioral status; Health care coverage; Living situation; Personal support systems; Employment and income status; Health education; Social support; and Any additional service needs; A consult, as appropriate, with the participant or the participant’s legally authorized representative or representatives; and All areas listed on the Department’s approved sample bio-psychosocial assessment form. Documentation of the results of the assessment shall be kept in the participant’s record. The multidisciplinary team will develop a written, individualized plan of care which reflects both the needed and available services being recommended for delivery. The plan of care shall: Be participant-centered and goal-oriented; Be developed and written in collaboration with the participant and other members of the multidisciplinary team; Incorporate findings from the bio-psychosocial assessment; Incorporate findings and recommendations from the multidisciplinary team; Establish a plan for after-hours crises, including medical and social crises, and other emergency situations; Document the proposed frequency of contact with a minimum of 1 face-to-face meeting every 6 months; and Address all areas listed on the Department’s approved sample plan of care form. HIV Ongoing Case Management Services. The case manager shall assist with the bio-psychosocial assessment and with development or revision of the plan of care by: Conducting a face-to-face assessment of the participant’s psychosocial status and health care needs and briefing the multidisciplinary team on the findings; Participating in the development or revision of an individualized plan of care for the participant; Encouraging the participant’s and representative’s participation in the multidisciplinary team process; and Linking the participant with any services needed on an emergency basis before the plan of care or revision is finalized. The HIV ongoing case management provider may be reimbursed for the case manager’s participation as a member of the multidisciplinary team, convened to review the participant’s case by the HIV diagnostic evaluation services provider. The case manager: Participates as a member of the multidisciplinary team convened by the HIV diagnostic evaluation services provider; Assumes responsibility for providing case management services to the participant; Acts as a point of contact for the case; and Implements and monitors the plan of care recommended by the HIV diagnostic evaluation services provider’s multidisciplinary team and approved by the participant. HIV ongoing case management services shall be provided to participants who: Are recommended in the plan of care as needing case management; and Who elect to receive case management services. The plan of care shall be implemented as follows: The case manager shall make initial contact with the participant to assure that medical and support referrals were completed and followed-up on; The case manager shall maintain regular contact that will occur at intervals agreed on by the participant and case manager in the plan of care; The case manager or HIV ongoing case management provider, when necessary, shall respond to participant-initiated non-emergency contact within 2 working days; The participant or the participant’s representative or representatives shall be offered a copy of the plan of care; The case manager shall document every direct and indirect contact, including assessing the progress of implementation of the plan of care in the participant’s record; The case manager shall assist the participant with each action plan to reach the goals outlined in the plan of care; The case manager shall advise the participant about available services and service providers, by making referrals to and arrangements with service providers selected by the participant, and by assisting the participant in gaining access to services for which the participant is eligible and which the participant chooses, to include: The full range of Medical Assistance services; and Other available support services such as medical, social, housing, financial, and counseling; The case manager shall provide the participant with any necessary counseling concerning: Government entitlement programs; Health programs; Social programs; Educational programs; Psychological programs; Financial programs; Housing programs; and Other resources; The case manager shall follow up with referral sources; and The case manager shall examine the actual service delivery against the plan of care. The case manager shall monitor and evaluate the participant’s plan of care as follows: Review and check the status of each activity outlined in the plan of care; Modify the action plan or goals to accommodate the participant’s changing needs or changes in service availability; Monitor the plan of care at regular intervals that have been predetermined at the time of the plan of care or more often depending on participant need; Evaluate the plan of care, in collaboration with the participant, at least every 6 months, with input from any members of a multidisciplinary team who have been involved with the participant’s care. The case manager shall document the following in the participant’s record regarding case closure: Participant notification, including date of closure, reason, and explanation of closure; Participant’s notification of right to re-enter services at a later time; Documentation of coordination and referral to a new provider if desired by the participant; and Documentation of a participant’s non-response to case manager attempts to reach the participant over a 6-month period of time with at least 3 attempts to contact the participant. HIV-targeted case management shall be advisory in nature. A restriction may not be placed on qualified recipients' option to receive HIV case management services. HIV-targeted case management does not restrict or otherwise affect: Eligibility for Title XIX benefits or other available benefits or programs; The freedom of a recipient to select from all available services for which the individual is found to be eligible; or The participant's free choice of qualified providers. HIV-targeted case management may not be: Provided as an integral and inseparable part of another covered Program service; Provided as an administrative function; Rendered in connection with the implementation of the Social Security Act, §1915(b) or 1915(c); or Part of institutional discharge planning. Reimbursement may not be made for HIV-targeted case management services if the participant is: Eligible to receive services under the Maryland Medicaid Managed Care Program, as defined in COMAR 10.09.62; or Receiving comparable case management services under: The Rare and Expensive Case Management Program, as defined in COMAR 10.09.69; or Under another Program authority. A participant's case manager may not be a direct services provider for the participant. Request for Payment. Requests for payment of HIV-targeted case management services rendered shall be submitted by an approved provider according to procedures as set forth in COMAR 10.09.36.04. Requests for payment shall be submitted on the invoice form specified by the Department. The completed form shall indicate the: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, identification number, and location; and Nature, procedure code or codes, and unit or units of covered service provided. Providers shall bill the Program for the appropriate fee specified in §C of this regulation. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Payments shall be made: Only to 1 provider for a specific type of HIV-targeted case management services rendered to a participant during a specified time period; To an HIV ongoing case management provider that shall be reimbursed in 15-minute increments, which is equal to 1 unit of service. Reimbursement for HIV ongoing case management may not exceed 96 units of service per year following the date of service for the HIV diagnostic evaluation services; and To a provider of HIV-targeted case management services that may not exceed the following fee schedule: For the completion of a bio-psychosocial assessment and development or revision of the plan of care performed by an HIV diagnostic evaluation services provider — $200; For the participation by the case manager in the completion of the bio-psychosocial assessment and development or revision of the plan of care, as specified in Regulation .04B of this chapter up to 6 units of service at a rate of $17.86 per unit of service For HIV ongoing case management, up to 96 units of service, at a rate of $17.86 per unit of service, may be reimbursed per year following completion of the bio-psychosocial assessment and development or revision of the plan of care by a qualified provider of HIV diagnostic evaluation services. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeal procedures shall be as set forth in COMAR 10.09.36.09. State regulations shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: July 11, 1988 (15:14 Md. R. 1655) Regulations .01—.06 amended as an emergency provision effective December 26, 1988 (15:27 Md. R. 3123); adopted permanently effective April 25, 1989 (16:7 Md. R. 811) Regulations .01—.06 amended as an emergency provision effective August 28, 1990 (17:19 Md. R. 2318); emergency status expired November 11, 1990; amended permanently effective November 26, 1990 (17:23 Md. R. 2732) Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Chapter revised effective September 30, 1991 (18:19 Md. R. 2100) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); April 2, 2012 (39:6 Md. R. 408) Regulation .03 amended effective April 2, 2012 (39:6 Md. R. 408) Regulation .04 amended effective August 27, 2007 (34:17 Md. R. 1507); April 2, 2012 (39:6 Md. R. 408) Regulation .05D, E amended effective April 2, 2012 (39:6 Md. R. 408) Regulation .06A, C amended effective April 2, 2012 (39:6 Md. R. 408) In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrative service organization (ASO)” has the meaning stated in COMAR 10.09.59.01. “ASO system” means the electronic system available to providers which the ASO utilizes to manage Maryland’s Public Behavioral Health System as defined in COMAR 10.09.59.01. “Care management tool” means a system that helps accomplish administrative tasks of the health home, including maintaining a list of health home participants and scheduling and tracking participants clinical appointments. “Care plan” means a written plan of action that is developed and modified to address a patient's specific behavioral, somatic, and social service needs, which is maintained in the individual's medical record and satisfies the following conditions: Meets the requirements of COMAR 10.47.01.04C; or Meets the requirements of COMAR 10.21.21.06C. “Caregiver” means a family member, guardian, or other individual who is not paid to provide care to the participant and who helps the participant achieve and maintain wellness. “Chesapeake Regional Information System for Our Patients (CRISP) means the electronic notification system health home providers are required to use in order to access participant hospital encounter data. “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C §1396 et seq. “Full-time equivalent (FTE)” means an employee who works 40 hours per week. “Health home” means a provider designated to offer enhanced care coordination and management services to individuals affected by, or at risk for, chronic conditions, operating under the conditions of this chapter. “Health Information Technology” means electronic systems equipped for the exchange of health data to link services, facilitate communication between health team members and individuals and family caregivers, and enable quality reporting and the review of health outcomes. “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Mental health case management” means services covered under COMAR 10.09.45 and COMAR 10.09.90 which assist participants in gaining access to the full range of mental health services, and necessary medical, social, financial assistance, counseling, educational, housing, and other support services. “Minor” means an individual who is younger than 18 years old. “Mobile treatment services (MTS) program” means a program approved under COMAR 10.63.03.04. “Opioid treatment program (OTP)”, formerly referred to as opioid maintenance therapy (OMT) programs, means a program approved to provide opioid maintenance therapy under COMAR 10.63.03.19. “Participant” means an individual enrolled in a health home funded by the Medical Assistance Program. “Provider” means an individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide health services. “Psychiatric rehabilitation program (PRP)” means a program approved under COMAR 10.63.03.09 for adults, COMAR 10.63.03.10 for minors, or both. A PRP serving adults and participating as a health home shall be approved pursuant to COMAR 10.63.03.09. A PRP serving minors and participating as a health home shall be approved pursuant to COMAR 10.63.03.10. An MTS program participating as a health home shall be approved pursuant to COMAR10.63.03.04. An OTP participating as a health home shall be approved to provide opioid maintenance therapy pursuant to COMAR 10.63.03.19. An individual is eligible for health home services if the individual: Is a recipient of Maryland Medical Assistance; and Meets the following criteria: Receives outpatient mental health rehabilitation or treatment services with a PRP or MTS program for a serious and persistent mental illness or serious emotional disturbance, and is not currently receiving: 1915(i) waiver services; or Mental health case management; or Receives treatment with an OTP for an opioid substance use disorder and is at risk for additional chronic conditions based on: Current alcohol use, tobacco use, or other non-opioid use; or A history of alcohol, tobacco, or other non-opioid substance dependence. A health home participant that is no longer receiving services from their PRP, MTS program, or OTP provider may continue to receive health home services for up to 6 months for the purposes of reengagement or transition to another level of care. To be eligible as a health home, a provider shall: Meet the conditions for provider participation in the Medical Assistance Program, as set forth in COMAR 10.09.36.03; Meet the approval requirements set forth in Regulation .02 of this chapter; Be accredited by, or demonstrate evidence of having started the accreditation process from, an approved accrediting body as a health home; For PRP and MTS health homes serving minors, demonstrate a minimum of 3 years of experience serving minors, which may be achieved as an independent practice or as a member of a broader agency, with exceptions designated by the Department; At the time of enrollment as a health home, be registered or be able to provide documentation of starting the process of registration with CRISP in order to receive hospital encounter alerts; At the time of enrollment as a health home, be registered or be able to provide documentation of starting the process of registration with one of the following organizations in order to receive access to real-time pharmacy data for participants: CRISP; or The State’s ASO; At the time of enrollment as a health home, have an internal protocol for reviewing and responding to hospital encounter alerts and pharmacy use data; Directly provide, or subcontract for the provision of, health home services to all participants; Maintain an electronic database with the ability to, at minimum: Maintain an up-to-date list of all health home participants and their contact information; and Record and review clinical appointments; Maintain a file for each participant that includes: A form signed by the participant consenting to participate in the health home, including the program’s data-sharing elements; An initial assessment of the participant’s health and social services needs, as described in Regulation .06B(1)(a) of this chapter; and A care plan, updated every 6 months, which may be combined with the existing MTS, PRP, or OTP care plan, and includes, at a minimum: The participant’s health home goals; Time frames for meeting the health home goals; Proposed interventions for meeting the health home goals; Relevant community networks and supports; Optimal clinical outcomes for the participant; and Signatures of: The participant or the participant’s parent or guardian; and The nurse care manager to whom the participant has been assigned in the health home; Safeguard the confidentiality of the participants’ records in accordance with State and federal laws and regulations; Provide on-call and crisis intervention services by telephone 24 hours a day, 7 days a week to participants and, as appropriate, their caregivers, or if the participant is a minor, the minor’s parent or guardian; Be responsible for meeting all health home service requirements, including services performed by a business or individual subcontracted to provide such services; Convene health home staff meetings every 6 months, at minimum, to plan and implement goals and objectives of functioning as a health home; Collaborate with MCOs and the ASO to improve participant outcomes; and Agree to participate in federal and State-required evaluation activities, including: Using the ASO system to: Submit encounters documenting participants’ services at least monthly; Generate monthly reports documenting: Health home service delivery; and Participants’ health and social outcomes; and Update participant diagnoses and outcomes every 6 months; and Completing and submitting to the Department a program assessment every 6 months to demonstrate that: All staffing and other regulatory requirements are being met; and A quality improvement plan is being implemented. Health Home Staffing Requirements. Health Home Care Manager. At minimum, the health home shall maintain health home care manager staff at a ratio of .5 FTE per 125 participants. Up to a staffing level of 1 FTE, the health home care manager shall be a: Nurse practitioner meeting the conditions of COMAR 10.27.07; or Registered nurse licensed pursuant to COMAR 10.27.01 and meeting the conditions of COMAR 10.27.09. A health home employing more than 1 FTE health home care manager may employ a physician’s assistant licensed pursuant to COMAR 10.32.03.04 to fulfill the additional care manager roles. Health Home Director. At minimum, the health home shall maintain a health home director at a ratio of .5 FTE per 125 health home participants. A health home requiring a health home director and health home care manager of .5 FTE each may employ 1 FTE individual to serve in both roles, provided that individual meets the requirements for both positions. A health home requiring more than .5 FTE health home director, may choose to designate a lead health home director and fulfill the additional FTE requirement with key management staff who meet the requirements of §A(2)(d)(i) or (ii) of this regulation. The health home director shall: Possess a Bachelor’s degree from an accredited university and 2 years experience in health administration; Possess a Master’s degree from an accredited university in a related field; Be licensed as a Registered Nurse with the Maryland Board of Nursing; or Be licensed as a Physician or be licensed as a Nurse Practitioner. Physician or Nurse Practitioner Consultant. At minimum, the health home shall maintain physician or nurse practitioner services at a ratio of one and one half (1.5) hours per health home participant per 12-month period. The physician shall meet the conditions of COMAR 10.32.01. The nurse practitioner shall meet the conditions of COMAR 10.27.07. Administrative Support Staff. The health home shall maintain administrative support at a level sufficient to meet the service provision and reporting requirements of the health home. Administrative support for the health home may be one or a combination of the following: Administrative support staff; or An electronic care management tool that addresses the administrative health home tasks. A health home with fewer than 125 participants may form a consortium to share health home staff and costs, contingent upon geographic proximity and Department approval of a plan detailing the proposed collaboration. Should staffing levels drop below the levels required by this regulation for more than 60 days, the health home shall: Report this to the Department; and Demonstrate that steps have been taken to reach the required staffing levels. Health home staff members shall be dedicated to health home duties at a level of .5 FTE minimally, and staffing requirements may not be divided among staff at levels below .5 FTE each. To begin offering health home services, a provider shall have in place a health home director and health home care manager at levels of .5 FTE each, minimally. Additional staff required to meet the staffing levels specified in §§A—D of this regulation shall be hired within 30 days of beginning service provision. The Department covers the services in §§B—G of this regulation when these services have been documented, pursuant to the requirements in this chapter, as necessary. Comprehensive Care Management. The health home shall collaborate to provide comprehensive care management services including: An initial assessment performed prior to the patient's enrollment, which includes: A comprehensive assessment of the participant's physical health, mental health, chemical dependency, and social service needs, signed off on by a physician or nurse practitioner, if no such assessment has been performed in the preceding 6-month period; and Requesting records from the participant's primary care physician and other providers; Development of a care plan within 30 days following enrollment, in accordance with Regulation .04J(3) of this chapter; Delineation of roles, which includes: Assigning each staff member clear roles and responsibilities; and Ensuring that participant care plans identify providers and specialists involved in the participant's care; and Monitoring and reassessment, which includes: Monitoring and documenting participant health status and progress toward care plan goals; Monitoring population health status and service use to determine adherence to or variance from treatment guidelines; and Outcomes evaluation and reporting, which includes using eMedicaid and other available HIT tools such as electronic health records. Care Coordination and Health Promotion. The health home shall coordinate and provide access to: High-quality health care services; Preventive and health promotion services, including education regarding: Mental illness; Substance use disorders; and Chronic physical health conditions; Mental health and substance abuse services; Chronic disease management services; and Long-term care supports and services. The health home shall coordinate services and support, including: Appointment scheduling; Referrals and follow-up monitoring; Hospital discharge processes; and Communication with other providers and supports, including school service providers. The health home shall assign each participant a health home care manager who is responsible for coordinating the participant's care and ensuring implementation of the care plan. The health home shall develop policies and procedures to facilitate collaboration between primary care, specialist, and behavioral health providers, community-based organizations, and, for minors, school-based providers. The health home shall follow security protocols to protect confidential health information. The health home shall assist participants with the implementation of their care plan, including: Health education specific to a participant's chronic conditions; Development of a plan for self-management; Medication review and education; and Substance use prevention, smoking cessation, obesity reduction, improved nutrition, and increased physical activity. A health home serving minors shall actively involve parents and families in providing services in accordance with §C(6) of this regulation, including: Identifying conditions for which the minor may be at risk due to family, physical, or social factors; and Working with the minor and parents and families to address the identified conditions. The health home shall use the ASO system to document, review, and report health promotion services delivered to each participant. Comprehensive Transitional Care. The health home shall provide services designed to: Streamline plans of care; Reduce avoidable hospital admissions; Ease the transition to long-term services; Interrupt patterns of frequent hospital emergency department use; and Ensure timely and proper follow-up care across settings, including from: An acute care setting to other settings; and A pediatric system of care to an adult system of care. The health home shall increase participants' and caregivers' ability to manage care and live safely in the community. The health home shall utilize CRISP to receive alerts of hospital admissions, discharges, or transfers among their health home participants. The health home shall follow up with participants within 2 business days of discharge with a home visit, phone call, or scheduling an on-site appointment. Individual and Family Support Services. Services shall include, but are not limited to: Advocating for individuals and families; Supporting participants in obtaining and adhering to medications and other prescribed treatments; Accessing resources that support participants, including providing referrals for: Community services; Social support services; Recovery services; and Transportation to medically necessary services; Improving participants' health literacy; Increasing the participant's ability to self-manage care; Facilitating participation in the ongoing revision of the treatment plan; and Providing information on advance directives and health care power of attorney. The health home shall utilize peer supports, support groups, and self-care programs to: Increase participants' and caregivers' knowledge of the participants' diseases; Increase caregivers' care-management capabilities; Promote participants' adherence to their plan of care; and Increase participants' self-management capabilities. The health home shall ensure that all communication shared with the participant, the participant's family, and caregivers is language, literacy, and culturally appropriate. Referral to Community and Social Support Services. The health home shall provide assistance in accessing and coordinating, as appropriate: Medical assistance; Disability benefits; Subsidized or supported housing; Personal needs support; Peer support; or Legal services. The health home shall assist in coordinating these services. Use of HIT to Link Services. The provider shall use HIT, including CRISP and the ASO system to: Facilitate communication between health home staff members, the participant, and their caregivers; and As appropriate, provide feedback to participants' other providers. Health home services provided by PRP, MTS, or OTP staff qualify as covered services. Enrollment. The health home shall enroll an individual only after the individual has been enrolled in the health home provider's applicable PRP, MTS, or OTP services. During enrollment, an OTP established as a health home shall identify eligible individuals under the OTP’s care and report the diagnoses related to qualifying risk factors set forth in Regulation .03A(2)(b) of this chapter in the ASO system. The health home shall provide the individual with a brief description of health home services, including: Explaining the data-sharing elements of the program; and Describing how the individual may opt out if desired. Following the provision of information in accordance with §A(3) of this regulation, the health home shall obtain the individual's consent to participate in the health home. Following consent to participate in accordance with §A(4) of this regulation, the health home shall complete the individual's online intake report through the ASO system thereby enrolling the individual into the health home. The health home shall: Notify a participant's other treatment providers about health home services; and Encourage other providers' participation in care coordination efforts. Participation. A health home participant shall receive a minimum of two health home services per month, as defined in Regulation .06 of this chapter and to be documented in the ASO system. An assigned health home care manager shall monitor the participant's care and health status and coordinate with other staff to provide appropriate health home services. Discharge. In the event of discharge, the health home shall create a discharge plan that includes referrals to appropriate services and providers. The health home shall report all discharges and completion of discharge plans in the ASO system. An eligible individual may not receive services from a health home provider that is not the individual’s PRP, MTS, or OTP provider. Health home services do not restrict or otherwise affect: Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation; The freedom of a participant to select from all available services for which the participant is found to be eligible; or A participant’s free choice among providers in the Medical Assistance Program. The Department may not reimburse the health home provider for: Activities that have already been billed to or counted towards a service requirement for another Medical Assistance Program or other program; Activities not consistent with the definition of health home services under this chapter; Activities delivered as part of institutional discharge planning that are not comprehensive transitional care services delivered by the health home; A participant’s health home monthly rate more than once per month; A participant’s health home monthly rate when the intake encounter is utilized by the provider as one of the two required monthly service encounters; A participant’s health home monthly rate when the provider counts two encounters as having the same date of service, unless: The modality of the two encounters is different because one was an individual encounter and one was a group encounter; or The encounters are distinguishable by both the time at which they were rendered and the subject matter discussed; or The health home monthly rate when the two required services were both rendered as group services. The Department may not reimburse for monthly health home services unless the individual receiving health home services: Is Medicaid eligible at the time of service delivery and engaged in treatment or rehabilitation with either OTP or PRP or MTS services; Is enrolled as a health home member at the billing health home provider; and Has received a minimum of two health home services in the stated month that has been documented in the ASO system. Reimbursement will not be made for health home services if the participant is receiving a comparable service under another Medical Assistance Program or other program. A participant’s health home provider may not be the participant’s family member. The Department shall reimburse the health home for covered services according to the requirements in this chapter and the rate established in §C of this regulation. Request for Payment. The health home provider is authorized to bill for the intake and ongoing monthly rate for a participant when: The participant is receiving PRP, MTS, or OTP services; and The intake portion of the participant's ASO system file has been submitted and initial services have been delivered. After completing the required health home service provision reporting in the ASO system, the health home provider shall, within 30 days from the end of the month during which health home services were provided, submit a request for payment for all participants who received two health home services during that month. A health home provider shall bill the Department for the appropriate rate specified in §C of this regulation. The Department shall reimburse according to the following fee schedule: For dates of service from July 1, 2023 through December 31, 2023, at a monthly rate of $131.03 per participant; For dates of service from January 1, 2024 through June 30, 2024, at a monthly rate of $141.51; and For dates of service beginning July 1, 2024, at a monthly rate of $145.76. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Cause for suspension or removal from the Medical Assistance Program and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. If the Department determines that a health home provider has failed to comply with the provisions of this chapter, the Department may initiate one or more of the following actions against the health home provider: Recovery of overpayment made by the Department; Withholding of payment by the Department; Reduction in payment by the Department, including a 10 percent reduction in reimbursement for services that are not billed within the time frame required by Regulation .09B(2) of this chapter; Suspension from being a health home provider; Removal from being a health home provider; or Disqualification from being a health home provider at any future time. Appeal procedures shall be as set forth in COMAR 10.09.36.09. State regulations shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 7.5-204, 7.5-205(d), 7.5-402, 8-204(c), 15-103, and 15-105(b), Annotated Code of Maryland Effective date: September 30, 2013 (40:19 Md. R. 1544) Regulation .01B amended effective July 7, 2014 (41:13 Md. R. 752); November 13, 2023 (50:22 Md. R. 973); May 11, 2026 (53:9 Md. R. 412) Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .04 amended effective November 24, 2014 (41:23 Md. R. 1372) Regulation .04P amended effective May 11, 2026 (53:9 Md. R. 412) Regulation .06B amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .06C, H amended effective May 11, 2026 (53:9 Md. R. 412) Regulation .07 amended effective May 11, 2026 (53:9 Md. R. 412) Regulation .07A amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .08C amended effective April 4, 2022 (49:7 Md. R. 465), May 11, 2026 (53:9 Md. R. 412) Regulation .08D amended effective May 11, 2026 (53:9 Md. R. 412) Regulation .09 amended effective April 4, 2022 (49:7 Md. R. 465) Regulation .09B amended effective May 11, 2026 (53:9 Md. R. 412) Regulation .09C amended effective October 24, 2016 (43:21 Md. R. 1166); January 1, 2018 (44:26 Md. R. 1215); December 30, 2019 (46:26 Md. R. 1164); November 13, 2023 (50:22 Md. R. 973); September 16, 2024 (51:18 Md. R. 808); November 10, 2025 (52:22 Md. R. 1095) In this chapter, the following terms have the meanings indicated. Terms Defined. “Behavioral plan” means an individualized written plan for therapeutic behavioral services which includes the components specified in Regulation .03B(1) of this chapter. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396(a)—(v). “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) provider” means any health care provider acting within the scope of the provider's practice who: Screens, evaluates, or identifies a condition; and Recommends treatment. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits. “Preauthorization” means the approval required from the Department, or its designee, before services may be rendered. “Prescribed” means ordered in writing and signed by an EPSDT provider who has examined the participant and diagnosed the [recipient's] participant’s medical condition. “Program” means the Maryland Medical Assistance Program. “Rehabilitative service” means a medical or remedial service prescribed by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland, or the jurisdiction where services are rendered for: Maximum reduction of physical or mental disability; and Restoration of a participant’s best possible functional level. “Therapeutic behavioral aide” means an individual who is: A health care professional or a nonprofessional who is supervised by an individual who is licensed, certified, or otherwise legally authorized to provide mental health services independently in the state where the service is rendered; Trained and supervised by a therapeutic behavioral service provider to implement a behavior plan; and Available on-site to provide one-to-one behavioral assistance and intervention to accomplish outcomes specified in the behavioral plan. “Therapeutic behavioral assessment” means a comprehensive assessment of a participant and, if applicable, a participant’s family that: Is performed by a licensed or certified health care professional; Addresses the medical and behavioral needs for therapeutic behavioral services; Includes the risk of needing placement in a more restrictive living arrangement because of the behavior; and Includes development of a behavioral plan. “Therapeutic behavioral service” means an intensive, rehabilitative service that is documented in the written behavioral plan and is intended to: Provide the participant with behavioral management skills to effectively manage the behaviors or symptoms that place the participant at risk for a higher level of care; and Restore the participant’s previously acquired behavior skills and enable the participant to develop appropriate behavior management skills. “Therapeutic behavioral service provider” means: A Developmental Disabilities Administration provider meeting criteria set forth in COMAR 10.22.02; An outpatient mental health clinic approved under COMAR 10.21.20; A mental health mobile treatment unit meeting criteria set forth in COMAR 10.09.59; or A psychiatric rehabilitation program approved under COMAR 10.21.29. A therapeutic behavioral service provider shall: Ensure that therapeutic behavioral aides are trained and supervised in: Principles of behavior change and childhood development; Clinically accepted techniques for decreasing or eliminating maladaptive behaviors; Implementing a behavioral plan; Identifying the needs and characteristics of the participant; and Documenting interventions and outcomes; If the therapeutic aide is not licensed or certified by a health practice licensure board to practice independently, ensure that a licensed healthcare practitioner shall: Meet at least once every 2 weeks with the aide and review the progress and develop a plan of care for each participant assigned to the aide; and At least once a month, observe the participant’s progress and needs with the participant’s parent or guardian; and Provide a written progress note that is completed for each time period that a therapeutic behavioral aide spends with the participant and includes: The location, date, start time, and end time of the service; The name of the parent, guardian, or individual who customarily provides care present during the service; A brief description of the service provided, including reference to the behavioral plan; A description of the participant’s behaviors or symptoms; and The signature of the behavioral aide. General requirements for provider participation in the Program are set forth in COMAR 10.09.36. The Program covers the services listed in this chapter when the services are: Diagnosed, identified, and prescribed by an EPSDT provider to be medically necessary; Preauthorized by the Department or its designee; and Delivered in accordance with the behavioral plan. The following services are covered: Therapeutic behavioral assessment and reassessment that includes: Development of a behavioral plan with the participant and parent, guardian, or individual who customarily provides care which specifically: Identifies the target behaviors or symptoms that are placing the current living arrangement at risk or presenting a barrier to transition to a less restrictive living arrangement; Defines specific interventions to be used to resolve the behaviors or symptoms, including how a therapeutic aide will implement therapeutic behavioral services; Defines outcome measures that can be used to demonstrate the decreasing frequency of targeted behaviors; Defines alternative behaviors; Defines the clinically accepted techniques for behavior change, including where, when, and the frequency of the techniques to be used and the risks and benefits of each; Details the strategies and skills for the participant and parent, guardian, or individual who customarily provides cares to provide continuity of care when therapeutic behavioral services are discontinued; Details emergency procedures to be implemented when the participant exhibits behaviors that pose harm to self or others; Contains written informed consent before implementation, of the parent or legal guardian, or if the participant is 18 years old or older, written informed consent of the participant; and Identifies the level or type of licensed healthcare professional responsible for monitoring the behavioral plan; and Determination if therapeutic behavioral services are needed; Therapeutic behavioral services that: Provide one-to-one intervention for a specified period of time at the appropriate site in accordance with the behavioral plan; and May include, but are not limited to: Assisting the participant to engage in or remain engaged in appropriate activities; Minimizing the participant’s impulsive behavior; Providing immediate behavioral reinforcements; Providing time structuring activities; and Collaboration with and support for parent, guardian, or individual who customarily provides care in the effort to provide ongoing behavioral support. To be eligible for therapeutic behavioral services the: Participant shall be younger than 21 years old and enrolled in the Program; Participant shall be assessed as having behaviors or symptoms related to a mental health diagnosis that places the individual's current living arrangement at risk and creates a risk for a more restrictive placement, or prevents transition to a less restrictive placement; Participant’s behaviors or symptoms shall be safely and effectively treated in the community; and Participant’s parent, guardian, or individual who customarily provides care shall be present during the provision of all therapeutic behavioral services to participate in the behavioral plan, unless there are clinical goals specifically addressed in the behavior plan that need to be achieved requiring that the parent, guardian, or individual who customarily provides care not be present. Therapeutic behavioral services shall meet the definition of rehabilitation services. Therapeutic behavioral services shall be: Decreased proportionally when indicated by the participant’s progress; Discontinued when the targeted outcomes have been reached; or Reassessed for new targeted outcomes if progress on the current outcomes is not being achieved. A therapeutic behavioral service provider may not bill the Program for: Services that are: Provided in: An intermediate care facility; An institution for mental disease; A hospital; or A crisis residential program; Habilitative, custodial, or activities of daily living; Not authorized by the Department or its designee; Provided by a therapeutic behavioral aide who is a member of the participant’s immediate family or who resides in the participant’s home; Not medically necessary; Beyond the provider's scope of practice; Not performed under the supervision of a licensed health care provider; Rendered but not appropriately documented; Part of another service paid for by the State; or Rendered by mail, telephone, or otherwise not one-to-one, in person; Services that duplicate the care and custody provided by another State agency pursuant to a court order or a voluntary placement agreement; Respite services; Seclusion or restrictive techniques; Completion of forms or reports; Broken or missed appointments; or Travel to and from site of service. The Department or its designee shall require preauthorization for therapeutic behavioral services. The initial authorization shall be given for not more than 60 calendar days. Additional authorization beyond the initial authorization shall be requested at a minimum, every 60 days and in advance of the expiration of the previous authorization. Authorization may only be given if the therapeutic behavioral service continues to be effective and progress towards the specified goals is documented. Request for payment of services shall be submitted in accordance with COMAR 10.09.36.04. Billing time limitations for claims submitted pursuant to this chapter as set forth in COMAR 10.09.36.06. Reimbursement for services covered under this chapter is as follows: For dates of service from November 1, 2021 through June 30, 2022: Initial therapeutic assessment and reassessment at a rate of $136.12; and Therapeutic behavioral services at a rate of: $29.50 for the first 30 minutes; and $14.75 for each additional 15 minutes. Effective July 1, 2022: Initial therapeutic assessment and reassessment at a rate of $145.99; and Therapeutic behavioral services at a rate of: $31.64 for the first 30 minutes; and $15.82 for each additional 15 minutes. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09. This chapter shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: November 24, 2005 (32:23 Md. R. 1827) Regulation .01B amended effective May 2, 2011 (38:9 Md. R. 552); December 12, 2022 (49:25 Md. R. 1050) Regulation .02A amended effective February 15, 2016 (43:3 Md. R. 273); December 12, 2022 (49:25 Md. R. 1050) Regulation .03B amended effective December 12, 2022 (49:25 Md. R. 1050) Regulation .04 amended effective December 12, 2022 (49:25 Md. R. 1050) Regulation .04D amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .06C amended effective February 15, 2016 (43:3 Md. R. 273); December 12, 2022 (49:25 Md. R. 1050); August 21, 2023 (50:16 Md. R. 726) In this chapter, the following terms have the meanings indicated. Terms Defined. “Attending physician” means: A doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State; or A nurse practitioner who meets the qualifications set forth in COMAR 10.27.07. “Bereavement counseling” means counseling services provided to the participant's family after the participant's death. “Cap period” means the 12-month period beginning November 1 of each year and ending October 31 of the following year, which is used in the annual application of the limitation on reimbursement at the general inpatient and inpatient respite care rates. “Core services” means the hospice services that must routinely be provided directly by hospice employees, that is, nursing care, physician services, medical social services, and counseling. “Department” means the Department as defined in COMAR 10.09.36.01. “Election period” means a period for which a recipient may elect to receive hospice care in accordance with Regulation .04 of this chapter. “Health Maintenance Organization (HMO)” means an organization which has contracted with the Department to deliver specific health care services to recipients in accordance with COMAR 10.09.16. “Home” means that place of residence occupied by a participant. For purposes of hospice care, home may include a nursing facility. “Hospice” means a public agency or private organization or subdivision of either of these that: Is primarily engaged in providing care to terminally ill individuals; Meets all applicable State and local licensing and regulatory requirements; and Is participating in Medicare as a hospice care provider. “Hospice nurse practitioner” means a nurse practitioner who: Is an employee of the hospice; and Meets the qualifications set forth in COMAR 10.27.07. “Hospice physician” means a doctor of medicine or osteopathy who is: Employed by or contracted by the hospice; and Legally authorized to practice medicine and surgery by the State. “Hospital” means an institution which is participating in Medicare or in a Medical Assistance Program as a hospital. “Interdisciplinary group” means a group of provider employees who provide or supervise hospice care, and include at least a: Doctor of medicine or osteopathy; Registered nurse; Social worker; and Pastoral or other counselor. “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons, jointly financed by the federal and State governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Medicare” means Medicare as defined in COMAR 10.09.36.01. “Nursing facility” means a facility or a distinct part of a facility which is participating in a Medical Assistance Program as a nursing facility provider. “Participant” means a recipient who is eligible, has elected, and is receiving hospice care in accordance with the provisions of this chapter. “Plan of care” means a written, individualized care plan established and maintained for each recipient enrolled by a hospice provider. “Program” means the Maryland Medical Assistance Program. “Provider” means a hospice that meets the requirements of Regulation .03 of this chapter and which, through a provider agreement signed with the Department, has been identified as a Program provider by the issuance of an individual account number. “Provider agreement” means a contract between the Department and the provider. “Recipient” means recipient as defined in COMAR 10.09.36.01. “Representative” means a person who is, because of the recipient's mental or physical incapacity, authorized, in accordance with the State law to execute or revoke an election for hospice care, to advise concerning the plan of care, or to terminate medical care on behalf of the terminally ill individual. “Respite care” means short-term care furnished to a participant for the purpose of providing rest or relief for family members or other individuals routinely furnishing at-home care to the participant. “Room and board” means services provided to a participant who is a nursing facility resident. “Skilled nursing facility” means a nursing facility or a distinct part of a nursing facility which is participating in Medicare as a skilled nursing facility. “Terminally ill” means that the individual has a medical prognosis of a life expectancy of 6 months or less if the illness runs its normal course. In order to participate in the Program, a provider shall be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland, or shall be legally authorized to provide hospice care in the jurisdiction in which the services are provided, and shall obtain other licenses as may be required by applicable State and local laws. Employees of the provider who provide hospice care services must be licensed, certified, or registered in accordance with applicable federal, State, and local laws. General requirements for participation in the Program are that providers shall: Meet all conditions for participation as set forth in COMAR 10.09.36.03, except as otherwise specified in this regulation; and Ensure that the licensure requirements as provided in Regulation .02 of this chapter are met. Specific requirements for participation in the Program as a hospice care provider are that the provider shall: Meet the requirements of §A of this regulation. Be a participating Medicare hospice. Provide information about a participant's election, continuation, and termination of hospice care in accordance with procedures established by the Program. Provide directly or make available through arrangements the covered services in Regulation .06 of this chapter. Make nursing services, physician services, and drugs and biologicals routinely available on a 24-hour basis. Make all other covered services available on a 24-hour basis to the extent necessary to meet a participant's needs for care as specified in the participant's plan of care. Have a written policy, approved by the Program, which assures that the release of information from the participant's record is handled in accordance with applicable State and federal laws and regulations governing confidentiality. Ensure that all core services are routinely provided directly by the provider's employees. Volunteers under the jurisdiction of the provider are considered provider employees. Contracted staff may be used to supplement employees only when necessary during periods of peak patient loads, under extraordinary circumstances, or to obtain physician specialty services. Provide bereavement counseling, even though it is not a reimbursable service. An individual may elect to receive hospice care during one or more of the following election periods: An initial 90-day period; A subsequent 90-day period; or An unlimited number of subsequent 60-day periods. The periods of care indicated in §A of this regulation are available in the order listed and may be elected separately at different times. An election period or an extended election period shall terminate before expiration when one of the following conditions is met: The participant dies; The election of hospice care is revoked in accordance with Regulation .05D of this chapter; The participant's eligibility for Medical Assistance is cancelled; The Program determines that the election period or extended election period shall be terminated for cause. Cause for termination may include, but shall not be limited to: A change in the participant's prognosis as being terminally ill; Relocation by the participant to a place of residence where a hospice care provider is not available; or Action or behavior of the participant that makes continuation of hospice care inappropriate, such as misconduct, fraud, or repeated instances of willfully and knowingly seeking services related to the terminal illness from other than the designated provider. When a participant revokes the election of hospice care, in accordance with Regulation .05D of this chapter, during an election period, any remaining days in that election period shall be forfeited. Thereafter, the participant may elect hospice coverage for any remaining election periods for which the participant is eligible. When a participant revokes the election of hospice care during an extended election period, further Program coverage of hospice care shall be forfeited. The waiver of rights to Program payments described in Regulation .05B(5) of this chapter shall expire as of the effective date of termination of the election period or extended election period. To be eligible for hospice care, written certification of terminal illness shall be obtained by the hospice for each of the election periods listed in Regulation .04 of this chapter. Procedures for certification of terminal illness are as follows: The hospice shall obtain the written certification before the hospice submits a claim for payment; If the hospice is unable to obtain written certification within 2 calendar days after an election period begins, an oral certification shall be obtained within 2 calendar days and a written certification shall be obtained before the hospice submits a claim for payment; Certifications shall be completed not more than 15 calendar days before the start of the election period; For the initial election period, the hospice shall obtain written certification statements and shall document oral certification statements in accordance with §A(2) of this regulation from: The medical director of the hospice or the physician member of the hospice interdisciplinary team; and The attending physician, if there is an attending physician; For subsequent election periods, certification by one of the physicians listed in §A(4) of this regulation is required; All certifications shall: Be signed and dated by the certifying physician; and Include the date of the election for which the certification applies; Certifications shall be based on the certifying physician’s clinical judgment regarding the normal course of the recipient’s illness and conform to the following requirements: Document that the participant’s prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course; Clinical information documenting the prognosis of a terminal illness shall accompany the certification and shall be filed in the medical record; Clinical information for the initial election period may be provided orally and shall be documented in the medical record and included as part of the hospice’s eligibility assessment; A brief narrative written by the certifying physician: Shall be included in the certification; Shall be located immediately before the certifying physician’s signature or included as an addendum signed by the certifying physician; Shall include a statement inserted directly above the certifying physician’s signature and based on a review of the participant’s medical record or examination of the participant; Shall reflect the participant’s individual clinical circumstances; and May not contain checkboxes or standard language used for all participants; To determine continued eligibility for hospice care, a face-to-face encounter by the hospice physician or the hospice nurse practitioner shall occur: When a stay across all hospices is anticipated to reach the third election period; and Not more than 30 days before the third election period and any subsequent election period; and A narrative associated with an election period requiring a face-to-face encounter shall include: An explanation of why the clinical findings support a prognosis of a terminal illness; and A written attestation of the date of the encounter and that the clinical findings were provided to the certifying physician. A recipient 21 years old or older meeting the eligibility requirements and electing to receive hospice care shall file a signed election declaration with the provider which shall contain the following: A statement that the recipient or the representative elects hospice care for the recipient; Identification of the provider that will furnish hospice care to the recipient; The effective date of the election, which may not be earlier than the date that the election is made; A statement that the recipient or representative acknowledges being given a full description of hospice care and of its palliative rather than curative nature as it relates to the recipient's terminal illness and related conditions; A statement that the recipient or representative understands that the recipient waives all rights to Program payments for the duration of the election of hospice care for the following services: Hospice care provided by a hospice other than the provider designated by the recipient or representative, unless provided under arrangements made by the designated provider; and Any services covered by the Program that are related to treatment of the terminal condition or a related condition, or that are equivalent to hospice care, except for services provided by: The designated provider; Another hospice under arrangements made by the designated provider; The recipient's attending physician if that physician is not an employee of the designated provider or receiving compensation from the provider for those services; or A nursing facility as room and board, if the recipient is a resident of a nursing facility and would be eligible under the Program for nursing facility services if hospice care was not elected; and The signature of the recipient or representative. A recipient younger than 21 years old meeting the eligibility requirements and electing to receive hospice care shall file a signed election declaration with the provider which shall contain the following: A statement that the recipient or the representative elects hospice care for the recipient; Identification of the provider that will furnish hospice care to the recipient; The effective date of the election, which may not be earlier than the date that the election is made; A statement that the recipient or representative acknowledges being given a full description of hospice care and of its palliative nature as it relates to the recipient's terminal illness and related conditions; A statement that the recipient or representative understands that hospice services shall be made available without forgoing Program payments for curative treatment for the terminal illness; and The signature of the recipient or representative. The election of hospice care shall be considered to continue uninterrupted through the first election period and through any subsequent election periods and any extended election periods, as long as the participant: Remains in the care of a provider; and Does not have the hospice care terminated under the provisions of Regulation .04D of this chapter. The election of hospice care may be revoked by the participant or representative at any time for any reason during an election period or an extended election period. Revocation requires the following: The participant or representative shall file a statement with the provider that includes the following information: A statement that the participant or representative revokes the election of Program coverage of hospice care and understands that the participant forfeits the remaining days in the election period; The date that the revocation is to be effective, which may not be earlier than the date the revocation is made; and The signature of the participant or representative. As of the effective date of the revocation of the election of hospice care, the recipient: Is no longer covered under the Program for hospice care; Resumes Program coverage of services waived under §B(5) of this regulation; and Forfeits Program coverage of hospice care for any days remaining in the election period, but may at a future time elect hospice care for any remaining election period for which the recipient is eligible. A participant may designate a new provider of hospice care not more than once during an election period. Designation shall be as follows: The designation of a new provider is not a revocation of the election of hospice care under §D of this regulation. To designate a new provider, the participant or representative shall file with the previously designated provider and with the newly designated provider, a statement that includes the following information: The names of the previously designated provider and the new provider; The effective date of the change of providers; and The signature of the participant or representative. A change in ownership of the provider is not considered a change in the participant's designation of a provider and requires no action on the participant's part. The provider shall maintain the statements described in this regulation and provide copies or related information to the Program on request. Hospice care includes the services listed in §B of this regulation when the services are: Provided to an eligible recipient who elects hospice care, in accordance with Regulation .05 of this chapter; Reasonable and necessary for the palliation or management of the participant's terminal illness and related conditions; Consistent with the plan of care established before the services are provided; Provided by appropriately qualified personnel; Administered according to accepted standards of practice; and Routinely provided directly by provider employees, when they are the core services listed in §B(1)—(4) of this regulation, except that the provider may contract for supplemental services during peak patient loads, under extraordinary circumstances, or to obtain physician specialty services. The following are covered hospice care services: Nursing care provided by a nurse licensed as a registered nurse in the jurisdiction in which services are provided or by an individual under the supervision of a registered nurse; Medical social services provided by a social worker who is: In compliance with the social work licensing requirements of the jurisdiction in which service is provided; and Working under the direction of a physician; Physician services performed by a physician as described in 42 CFR §§410.20—410.25, except that the services of the provider's medical director or physician member of the interdisciplinary group shall be performed by a doctor of medicine or osteopathy; Counseling services provided to the participant and the family members or other persons caring for the participant at home, including: Dietary counseling; Counseling to train the participant's family or other caregivers in providing care; Spiritual counseling to help the participant and the family or other caregivers in the home to adjust to the participant's approaching death; Bereavement counseling for the family after the participant's death; and Additional counseling provided by interdisciplinary group members, as well as by other qualified professionals as necessary; Short-term inpatient care subject to the following conditions: General inpatient care may be provided to meet the participant's needs for pain control or for acute or chronic symptom management that cannot be met in other settings; Inpatient respite care may be furnished to provide rest or relief for family members or other individuals routinely furnishing at-home care to the participant; and General inpatient care and inpatient respite care shall be provided in a: Hospice that meets the conditions of participation for providing inpatient care directly as set forth in 42 CFR §418.100; or Hospital, skilled nursing facility, or nursing facility that meets the special hospice standards regarding 24-hour nursing service and patient areas as set forth in 42 CFR §418.100(a) and (e); Medical appliances and supplies, including drugs and biologicals, which are needed for the palliation and management of the terminal illness and related conditions; Home health aide and homemaker services furnished by qualified individuals, who are under the general supervision of a registered nurse; and Physical therapy, occupational therapy, and speech-language pathology services provided by qualified individuals for purposes of symptom control or to enable the participant to maintain activities of daily living and basic functional skills. When a recipient is enrolled in Medicare Part A, Program payment for hospice care shall be limited to payment of the recipient's Medicare hospice care co-insurance amounts for drugs and biologicals and for respite care and, where applicable, room and board for residents of a nursing facility under Regulation .08E of this chapter. Reimbursement Principles. The Program shall pay the provider at one of four rate categories for each day that the participant is under the provider's care, subject to the conditions, limitations, and exceptions set forth in this chapter. The payment rates for providers shall be those established by the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services for hospice care under a Medical Assistance Program. The daily rates are prospective rates, and there shall be no retroactive adjustment of payment other than the limitation on payment for inpatient care set forth in §C of this regulation. Categories of Hospice Care for Reimbursement. Routine Home Care. The provider shall be paid the routine home care rate for each day the participant is under the care of the provider and another rate is not payable under §B(2)—(4) of this regulation. The routine home care rate is paid without regard to the volume or intensity of covered services provided on a given day. The routine home care rate is paid at one of the following levels, whichever is applicable: An enhanced rate for the first 60 days in which the participant is enrolled in hospice; or A lesser rate for day 61 and thereafter. Continuous Home Care. The provider shall be paid the continuous home care rate for each day the participant is at home, under the care of the provider, and all of the following requirements are met: There is a brief period of crisis during which the participant requires continuous care, which is primarily nursing care to achieve palliation or management of acute medical symptoms. Nursing care shall be provided by either a registered nurse or a licensed practical nurse, and a nurse must be providing care for more than half the period. Homemaker or home health aide services may be provided to supplement the nursing care. A minimum of 8 hours of care must be provided during a 24-hour day which begins and ends at midnight, but the hours of care need not be continuous. The continuous home care rate is divided by 24 hours to arrive at an hourly rate. For every hour or part of an hour of continuous home care furnished, the hourly rate shall be paid to the provider, up to 24 hours a day. If less skilled care is needed on a continuous basis to maintain the patient at home during a period of crisis, or if less than 8 hours of continuous home care is provided during a day, payment shall be made at the routine home care rate. Inpatient Respite Care. The provider shall be paid the inpatient respite care rate for each day the participant is in a qualified inpatient facility for the purpose of respite care, subject to the following requirements: Payment shall be made at the inpatient respite care rate for a maximum of 5 consecutive days at a time, including the day of admission but not counting the day of discharge; Payment for the sixth and any subsequent day of inpatient respite care shall be made at the routine home care rate; For the day of discharge, payment shall be made at the routine or continuous home care rate, as appropriate, unless the participant dies as an inpatient; and Payment shall be made at the inpatient respite care rate for the day of discharge if the participant is discharged deceased. Inpatient respite care may not be provided when the participant is a resident of a nursing facility. General Inpatient Care. The provider shall be paid the general inpatient care rate for each day the participant is in a qualified inpatient facility for care, subject to the following requirements: The inpatient care is required for procedures necessary for pain control or for acute or chronic symptom management which cannot be provided in other settings; Payment shall be made at the general inpatient rate for the day of admission and for all subsequent inpatient days, except for the day of discharge; For the day of discharge, payment shall be made at the routine or continuous home care rate, as appropriate, unless the participant dies as an inpatient; and Payment shall be made at the general inpatient rate for the day of discharge if the participant is discharged deceased. Limitation on Payment for Inpatient Care. Payment to a provider for inpatient care shall be limited according to the total number of days of inpatient care the provider furnished to participants during a specific cap period, excluding the days of inpatient care furnished to participants diagnosed with Acquired Immune Deficiency Syndrome (AIDS). For the cap period, the aggregate number of inpatient days reimbursed for general inpatient and inpatient respite care (excluding inpatient days reimbursed for participants with AIDS) may not exceed 20 percent of the aggregate total number of days of hospice care the provider furnished to all participants (excluding days of hospice care furnished to participants with AIDS) during the same period. The limitation on payment for inpatient care days is calculated as follows: Subtract the days of care furnished to participants with AIDS from the total days of care furnished by the provider to all participants during the cap period; Subtract the days of inpatient care furnished to participants with AIDS from the total days of inpatient care furnished by the provider to all participants during the cap period; The maximum allowable number of reimbursable inpatient days is determined by multiplying by 0.2 the adjusted total number of days of hospice care the provider furnished to participants during the cap period, as determined in §C(3)(a) of this regulation; If the adjusted total number of inpatient care days the provider furnished to participants during the cap period, as determined in §C(3)(b) of this regulation, is less than or equal to the maximum allowable number of reimbursable inpatient days, no payment adjustment is necessary; and If the adjusted total number of inpatient care days the provider furnished to participants during the cap period exceeds the maximum allowable number of reimbursable inpatient days, the payment limitation and the refund to the Program shall be determined by: Calculating a ratio of the maximum allowable number of reimbursable inpatient days to the adjusted total number of inpatient care days, and multiplying this ratio by the total reimbursement to the provider during the cap period for general inpatient and inpatient respite care days (minus the reimbursement for inpatient care days furnished to participants with AIDS); Multiplying excess inpatient care days by the routine home care rate; Adding together the amounts calculated in §C(3)(e)(i) and (ii) of this regulation; and Refunding to the Program the difference between the interim reimbursement made for non-AIDS inpatient care during the cap period and the amount determined in §C(3)(e)(iii) of this regulation. This limitation shall be applied once a year, at the end of the cap period. Service Intensity Add-On. In addition to the routine home care rate paid under §B(1) of this regulation, the provider shall be paid for visits made by a social worker or a registered nurse, when provided during routine home care in the last 7 days of the participant’s life. The service intensity add-on payment is equal to the continuous home care hourly rate divided by four. The provider shall be paid in 15-minute increments for a maximum of four hours daily. Payment for Physician Services. The per diem rates are designed to reimburse for those administrative and general supervisory activities performed by physicians who are employees of or are working under arrangements with the provider. These activities are generally performed by the physician serving as the medical director or the physician member of the provider's interdisciplinary group. The included activities consist of participation in establishment of care plans, supervision of service delivery, periodic review and updating of care plans, and establishment of governing policies. In addition to the daily rates, the Program shall make separate payment to the provider for physician services, subject to the following requirements: The services shall be direct patient care services furnished to a participant under the care of the provider; The services shall be furnished by an employee of the provider or furnished under arrangements made by the provider; The provider shall have a liability to reimburse the physician for the services rendered; The provider shall bill for the physician services in accordance with procedures established by the Program; A payment may not be made for physician services furnished on a volunteer basis; and Payment to the provider for physicians' services shall be made in accordance with the fee schedule contained in COMAR 10.09.02. A physician who is designated as the attending physician by a participant and who also volunteers services to the provider is considered an employee of the provider, whose direct patient care services furnished to the participant on a nonvolunteer basis shall be reimbursed to the provider in accordance with §D(2) of this regulation. A physician who is designated as the attending physician by a participant and who is not an employee of the provider or receiving compensation from the provider shall be paid by the Program in accordance with COMAR 10.09.02. The attending physician may bill the Program only for personal professional services. When a participant resides in a nursing facility, the Program shall pay an additional per diem amount for room and board to the provider, subject to the following requirements: The additional amount shall be paid only for those days that the provider is reimbursed at the routine or continuous home care rate for hospice care furnished to the participant; The amount shall be the per diem reimbursement established by the Program to pay for room and board in the facility; The amount shall be paid to the provider only when the provider and the facility have a written agreement under which the provider is responsible for the professional management of the participant's hospice care and the facility agrees to provide room and board to the participant; While the provider is being reimbursed for hospice care furnished to a participant residing in a nursing facility, Program payment to the facility shall be discontinued; and The Department of Human Services shall determine the application of a recipient's resource to the cost of hospice care pursuant to COMAR 10.09.24 and COMAR 10.09.25. The provider: Shall collect a recipient's resource available for hospice care as certified by the Department of Human Services, May not collect a total payment, including the recipient's resource and the Department's payment, which exceeds the amount the provider would be paid in accordance with this regulation for a day of hospice care, and Shall show sums collected from a recipient's available resource as patient collection. Requests for Payment. Requests for payment for hospice care services rendered shall be submitted as set forth in COMAR 10.09.36.04. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeal procedures for providers shall be as set forth in COMAR 10.09.36.09. State regulations shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: October 1, 1989 (16:16 Md. R. 1751) Regulation .08G amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .08G amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Chapter revised effective September 16, 1991 (18:18 Md. R. 2005) Regulation .01B amended effective July 22, 2013 (40:14 Md. R. 1174) Regulation .04 amended effective July 22, 2013 (40:14 Md. R. 1174) Regulation .05 amended effective July 22, 2013 (40:14 Md. R. 1174) Regulation .07B, C amended effective July 22, 2013 (40:14 Md. R. 1174) Regulation .08 amended effective July 21, 2025 (52:14 Md. R. 712) The following terms apply to Medical Assistance providers. Additional defined terms, unique to Medical Assistance provided services, are found in Medical Assistance service-specific chapters. Terms Defined. “Abandoned” means failing to appear for a hearing on the established date without good cause. “Administrative law judge” means an individual appointed by the Chief Administrative Law Judge under State Government Article, §9-1604, Annotated Code of Maryland, or designated by the Chief Administrative Law Judge under State Government Article, §9-1607, Annotated Code of Maryland, to: Adjudicate contested cases at the Maryland Office of Administrative Hearings; and Render a proposed decision for purposes of COMAR 28.02.01.22. “Care manager” means a: Primary medical provider under the Diabetes Care Program, in accordance with COMAR 10.09.43, or the Maryland Access to Care Program, in accordance with COMAR 10.09.44; Primary care provider under the corrective managed care program, in accordance with COMAR 10.09.24.15B and 10.09.25.14B; or Hospice provider under the hospice care program, in accordance with COMAR 10.09.35. “Claim” means: A bill for services; A line item of service; or All services for one participant within a bill. Clean Claim. “Clean claim” means a claim that can be processed consistent with applicable regulations without obtaining additional information from the provider of the service or from a third party. “Clean claim” includes a claim with errors originating in a State's claims system; “Clean claim” does not include a claim: From a provider who is under investigation for fraud or abuse; or “Current Procedural Terminology (CPT)” means the American Medical Association’s uniform nomenclature for coding medical procedures and services. “Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific item or service, excluding token charges for charity patients and substandard charges for welfare and other low-income patients. “Department” means the Maryland Department of Health, which is the single state agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Emergency services” means those services which are provided in hospital emergency facilities after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in: Placing health in jeopardy; Serious impairment to bodily functions; Serious dysfunction of any bodily organ or part; or Development or continuance of severe pain. “Healthcare Common Procedure Coding System (HCPCS)” means the specified code set for procedures and services, according to the Health Insurance Portability and Accountability Act (HIPAA). “Managed care" means the care manager's provision of comprehensive primary care and referral services to an enrollee in a managed care program. “Managed care program” means: Maryland Access to Care Program under COMAR 10.09.44; Diabetes Care Program under COMAR 10.09.43; Corrective managed care under COMAR 10.09.24.15B or 10.09.25.14B; or Hospice care under COMAR 10.09.35. “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medical Care Programs" means the unit of the Department responsible for the administration of the Medical Assistance Program. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. Overpayment. “Overpayment” means any payment made by the Medicaid Program to a provider for medical care provided to a participant which at the time of payment, or at a subsequent date, is determined to be: A duplicate payment; A payment for services for which reimbursement is claimed when all or any part of the claim submitted to the Department is for services that were provided in violation of one or more regulations; Excessive in amount; or The primary obligation of a health insurance carrier or any other person, including the participant, who is legally or contractually obligated to pay for that medical care. “Overpayment” does not include an amount recovered as part of a routine cost settlement process. “Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Primary care” means that medical care which addresses a patient's general health needs including the coordination of the patient's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, and referral to other specialists for more intensive care when appropriate. “Program" means the Medical Assistance Program. “Provider” means: An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Program participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number; An agent, employee, or related party of a person identified in §B(19)(a) of this regulation; or An individual or any other person with an ownership interest in a person identified in §B(19)(a) of this regulation. “State Department of Assessments and Taxation (SDAT)” means the State Department of Assessments and Taxation as described in COMAR Title 18. “Withhold payment” means the Program's decision to not pay or suspend payment to a provider as a sanction for failure to comply with applicable federal or State laws or regulations or because of a credible allegation of fraud. Medical Assistance Program providers shall, to the extent required by law, be licensed, certified, or otherwise legally authorized to practice or deliver services in the state in which the service is provided. To participate in the Program, the provider shall: Ensure compliance with all the Medical Assistance provisions listed in the Code of Maryland Regulations (COMAR) designated for their provider type; Apply for participation in the Program using the application form designated by the Department; Obtain and maintain in good standing the appropriate SDAT identification number in accordance with §I of this regulation; Be approved for participation by the Department; Allow the Department or its agents to conduct unannounced on-site inspections of any and all provider locations; Allow the Department or its agents to require all providers to consent to criminal background checks, including fingerprinting; Have a current provider agreement with the Program in effect and fully comply with the terms and conditions stated in the provider agreement; Comply with all standards of practice, professional standards and levels of service as set forth in all applicable federal and State laws, statues, rules, and regulations as well as all administrative policies, procedures, transmittals, and guidelines issued by the Department; Charge the Program the provider's customary charge to the general public for similar items or services. If the item or service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with the Department's rate provisions; and The provider's reimbursement is not limited to the provider's customary charge. Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee; Accept payment by the Program as payment in full for covered services rendered and make no additional charge to any person for covered services; Provide services without regard to race, color, age, sex, national origin, religion, sexual orientation, gender identity, marital status, or physical or mental disability; Verify the participant’s eligibility by: Viewing the participant’s Medical Assistance card and another identification card; and Calling the Program's Eligibility Verification Interactive Voice Response System (EVS/IVR) or accessing the web-based participant eligibility system; Place no restriction on a participant’s right to select health care providers of the participant’s choice, except that a participant in a managed care program shall be required to obtain certain specified Program services from or through the participant's care manager, in accordance with the restrictions imposed by the managed care program; Not knowingly employ or contract with a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance participants unless prior written approval has been received from the Department; Notify the Department or its designee of patient activity or circumstance that affects placement, eligibility, or reimbursement, on the form and at the time specified by the Department; Maintain the confidentiality of all participant information by not releasing the information without authorization by the participant or as authorized by law; Have an individual rendering number for practitioners recognized by the Program; Obtain a referral from a participant’s care manager in a manner prescribed by the Department before rendering services, when: The participant is enrolled in a managed care program; and The service is included under the managed care program's referral requirements. Supply a signed service order or prescription that includes the individual rendering number of the ordering or prescribing practitioner, as well as the full name and Medical Assistance number of the participant, when ordering services to be supplied by other providers, such as hospital admission, diagnostic testing, supplies, or pharmacy services; Ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed; Provide a participant’s medical records at no charge when the records are requested by another physician or licensed provider on behalf of the participant; and Comply with the requirements of COMAR 10.01.04.12 regarding the designation of an authorized representative; Place no restriction on a participant’s fair hearing appeal rights as a condition of rendering services; and Comply with provider audits authorized by State and federal law to ensure compliance with Program requirements. Enrollment Effective Date. Unless a provider is enrolled under the provisions of §B(2) of this regulation, the effective date of a provider’s enrollment is the date the Program completes all screenings required by State and federal law, which may include a site visit, following the Program’s receipt of the provider’s submission of a complete application with all required supporting documents. If an out-of-State emergency transportation services or emergency services provider meets provider enrollment requirements, the enrollment effective date is the date the provider renders the emergency services. A provider may not seek payment from more than one State agency for the same service. If the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the participant. If the Program denies payment for covered services for any reason, the provider may not seek payment for the denied service from the participant. The Program may pay for a covered service rendered by a provider to a participant under any of the following circumstances: The provider charges for nonparticipants who receive the same service by: Charging the individual in full for services rendered; Using a sliding fee scale based on the individual's income; Waiving all or part of the fee for a specific individual; or Agreeing to accept what a third party pays as payment in full, whether or not the provider bills individuals who lack this coverage; The State, using its own funds, pays for services rendered to a targeted group of nonparticipants, and the provider charges nontargeted users of the services; The provider bills all individuals with third party coverage, whether or not the provider bills individuals who lack this coverage; The service is offered by or through the State agency which administers the program of services authorized under Title V of the Social Security Act; or The service is offered to a handicapped child receiving services under the Education for the Handicapped Act (EHA) under an individualized education plan (IEP). The following types of providers shall comply with the requirements of 42 CFR Part 489, Subpart I, Advance Directives: Acute hospitals under COMAR 10.09.92; Chronic hospitals under COMAR 10.09.93; Special pediatric hospitals under COMAR 10.09.94; Special psychiatric hospitals under COMAR 10.09.95; Nursing facilities under COMAR 10.09.10 and COMAR 10.09.11; Home health agencies under COMAR 10.09.04; Personal care case monitors under COMAR 10.09.20; Model waiver nursing services providers under COMAR 10.09.27; and Hospices under COMAR 10.09.35. For services that are funded under the Substance Abuse and Mental Health Services Administration and related federal funding sources, specifically for providers that bill the public behavioral health system for specialty mental health services described in COMAR 10.09.59 and community-based substance use disorder services described in COMAR 10.09.80 shall provide data elements per Federal requirements set forth in 42 U.S. Code §300x–9 and 42 USC 300x-35, to the State in the frequency required by the Department. State Department of Assessments and Taxation (SDAT) Identification Number. A provider shall obtain an SDAT identification number that: Identifies their organizational structure as either: An individual provider, classified with a prefix of the letter L; or A business entity; and Is maintained in good standing as described in COMAR 18.04.03.01. Each provider practice location shall: Be individually enrolled with the Program; Have an individualized provider agreement as described under §A(6) of this regulation; Maintain a unique NPI number as described under §K of this regulation. National Provider Identification (NPI) Number. Unless specifically excepted under §K(2) of this regulation, each provider shall maintain a unique NPI number that: Correctly classifies the provider as either: An individual provider with a Type 1 NPI number; or An organizational provider with a Type 2 NPI number; and For Type 2 organizational providers, is individualized to a specific service or practice location. The following enrollment types are exempt from the individualized Type 2 NPI number requirement in §K(1)(b) of this regulation: Skilled nursing facility therapy groups with an affiliated nursing facility provider; Pharmacies with an affiliated durable medical equipment and disposable medical supplies provider; and Hospitals. Providers may not request or require that a participant waive, revoke, or otherwise forgo Medicaid coverage as a condition for receiving covered services. Providers of services under COMAR 10.09.84 shall comply with the provisions of §§D—F of this regulation and 42 CFR 441.301(c)(4). Effective January 1, 2018, to be enrolled as a provider of services authorized under §§1915(c) or 1915(i) of the Social Security Act, the provider shall comply with the provisions of §§D—F of this regulation and 42 CFR 441.301(c)(4). Providers of services authorized under §§1915(c) or 1915(i) of the Social Security Act that are enrolled Maryland Medicaid providers before January 1, 2018, shall comply with the provisions of §§D—F of this regulation on or before March 17, 2022. The setting in which services are provided shall: Be integrated in and support full access to the greater community for individuals receiving Medicaid home and community-based services to the same degree of access as individuals not receiving Medicaid home and community-based services; Be selected by the individual from among setting options, including nondisability specific settings; Be identified and documented in the person-centered service plan and is based on the individual’s needs and preferences; Ensure an individual’s rights of: Privacy; Dignity and respect; and Freedom from coercion and restraint; Optimize, but not regiment, individual initiative, autonomy, and independence in making life choices, including but not limited to: Daily activities; Physical environment; and With whom to interact; and Facilitate individual choice regarding services and supports, and who provides them. In addition to the provisions of §D of this regulation, provider-owned or controlled settings shall meet the following conditions: The unit or dwelling is a specific physical place that can be owned, rented, or occupied under a legally enforceable agreement by the individual receiving services and the individual has, at a minimum, the same responsibilities and protections from eviction that tenants have under the landlord tenant law of the State, county, city, or other designated entity; Each individual has privacy in their sleeping or living unit, as evidenced by the following: Units have entrance doors lockable by the individual, with only appropriate staff having keys to doors; Individuals sharing units have a choice of roommates; and Individuals have the freedom to furnish and decorate their sleeping or living units within the lease or other agreement; Individuals have the freedom and support to control their own schedules and activities; Individuals have access to food at any time; Individuals are able to have visitors of their choosing at any time; and The setting is physically accessible to the individual. Any modification of the conditions under §§D and E of this regulation shall be supported by a specific assessed need and justified in the person-centered services plan in accordance with 42 CFR 441.301(c)(2)(xiii). This regulation establishes standards for providers using Data Management systems. Definitions. In this regulation, the following terms have the meanings indicated. Terms Defined. “Data management system” means a health information technology solution used by the Maryland Department of Health (Department), its agents, providers, and Program participants that stores provider or participant protected health information (PHI) or personally identifiable information (PII) and related business processes. “Electronic visit verification (EVV)” means an electronic service entry method used to record service details, including but not limited to service type, provider and participant information, date of service, service delivery location, and beginning and ending times of service that meets the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines. Electronic visit verification (EVV) services means services that are: Covered Medicaid services, according to the respective authority, including but not limited to the Medicaid State Plan, a Medicaid waiver program, or regulations; and Required to be electronically recorded in the Department’s EVV system or approved financial management and counseling services contractors’ EVV solutions pursuant to 42 U.S.C. §1396b(l) and other State and federal laws, regulations, or guidance except in circumstances when the services, provided under the agency, traditional, or self-directed delivery model, are provided by a live-in caregiver or worker and exempted by the Department, or otherwise exempted by the Department and the participant elects to forego the electronic process. “Financial management and counseling services (FMCS) contractors” means agencies that provide financial management and counseling services to support individuals who choose the self-direction delivery model. “Live-in caregiver” means a paid personal caregiver who permanently, or for an extended period of time approved by the Department, resides in the same residence as the Medicaid participant for whom they are providing services and supports. “Preauthorized” means approved by the Department or its designee before services are rendered. “Worker” means an individual, who may be referred to as a caregiver, who is employed by or contracts with a provider or self-directing participant. Requirements for Using Data Management Systems. Providers shall: Register and credential all system users in the manner specified by the Department with valid and accurate information; Properly train all workers registered as system users on proper protocols for conducting system activities, including: Accurate entry of information into the system; Proper use of hardware and equipment required to use the system; EVV, including but not limited to recording and modifying billing entries, participant and provider information, or other records, in accordance with the policies and procedures issued by the Department, unless otherwise exempted by the Department; and Protection of protected health information in compliance with State and federal law, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA); Comply with the laws and regulations concerning the privacy and security of protected health information under State and federal law, including HIPAA; and Ensure that any provider-owned systems and devices responsible for sending, retrieving, or storing data from a State-operated data management system comply with all Department, State and federal regulations, policies, and procedures regarding information technology privacy and security. Requirements for EVV Use. Agency providers and workers shall use the EVV method and data management system approved by the Department, unless otherwise exempted by the Department, to: Meet the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines; and Submit claims. The Department shall reimburse for EVV services if the service is: Electronically recorded through the EVV method and data management system approved by the Department in accordance with Department regulations, policies, and procedures; Recorded using a manual or alternate electronic timekeeping process and data management system approved by the Department in accordance with Department regulations, policies, and procedures when the live-in caregiver exemption is applicable and elected; Preauthorized in the manner designated by the Department for the service type; Directly provided to the participant in-person, unless otherwise authorized by the Department; and Delivered in accordance with all applicable Department regulations, policies, and procedures for the service type. The Program does not cover services, even those exempted from EVV, provided: During periods of participant ineligibility; During time periods that overlap with the worker’s time period for the same or another participant unless otherwise authorized by the appropriate program authority for the service type; or During time periods that overlap with the same or another worker’s time period for the same participant unless otherwise authorized by the appropriate program authority for the service type. The provider shall submit the request for payment of services rendered according to procedures established by the Department and in the format designated by the Department. The Department reserves the right to return to the provider, before payment, all claims not properly signed, completed, and accompanied by properly completed forms required by the Department. The Program will make no direct payment to recipients. All payments are contingent upon a provider’s full compliance with the requirements of its enrollment and applicable conditions of participation. Unless the service is free to the general public, the provider shall charge the Program its customary charge to the general public for similar services. Unless otherwise excepted, the provider shall be paid the lesser of: The provider’s customary charge unless the service is free to individuals not covered by the Program; or The Department’s applicable rate. Unless otherwise excepted, if a service is free to individuals not covered by the Program: The provider: May charge the Program; and Shall be reimbursed in accordance with §F of this regulation; and The provider's reimbursement is not limited to the provider's customary charge. Providers may not bill the Department, the Program, or participants for: Completion of forms and reports; Broken or missed appointments; Covered professional services rendered by: Mail; Email; or Fax; or Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. Unless otherwise excepted, payments on Medicare claims are authorized, if: Services are covered by the Medicare Program; The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; and Initial billing is made directly to Medicare according to Medicare guidelines. Unless otherwise provided by regulation, supplemental payments on Medicare claims are made subject to the following provisions: Deductible insurance will be paid in full; Beginning with August 1, 2010 dates of service and subject to the limitations of the State budget, coinsurance shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare are payable according to §F of this regulation. An individual or entity who is employed by or under contract to any group provider, clinic, or hospital may not bill for any service for which reimbursement is sought by the group provider, clinic, or hospital. Providers who are reimbursed on the basis of cost reports shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. An extension shall be granted upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable. Availability of Records. The provider shall keep all records available for inspection or audit by the Department or the Department's designee at any reasonable time during normal business hours. Documentation of Costs. Upon request by the Department or the Department's designee, the provider shall make documentation of costs available during the course of verification. The provider shall have 30 days from the date of the request to provide this documentation. Costs for which documentation is not provided within the 30 days shall be considered not allowable. Upon written demonstration by the provider of good cause, the Department may grant, in writing, an extension of time to provide the requested documentation. Records shall be retained for 6 years after the month in which the cost report to which the materials apply is filed with the Department or the Department's designee. Definition. In this regulation, the following term has the meaning indicated. Term Defined. “Received” means: The Program taking delivery of a claim after the Program signs a certified mail, return receipt requested parcel from the United States Postal Service; or The claim is reported on the provider’s remittance advice. Unless specified in Regulation .03A(1) of this chapter, the following apply: The Department may not reimburse the claims received by the Program for payment more than 12 months after the date of service. Medicare Claims. For any claim initially submitted to Medicare and for which services have been: Approved, requests for reimbursement shall be submitted and received by the Program within 12 months of the date of service or 120 days from the Medicare remittance date, as shown on the Explanation of Medicare Benefits, whichever is later; and Denied, requests for reimbursement shall be submitted and received by the Program within 12 months of the date of service or 120 days from the Medicare remittance date, as shown on the Explanation of Medicare Benefits, whichever is later. Fee for Service Claims. Fee for service claims shall be submitted and received by the Program within 12 months of: The date of service; The date of discharge, if the service was a hospital inpatient service; or The month of service, if the service was provided in a nursing or rehabilitation facility or is a hospice service. The Program shall only pay claims for services provided on different dates and submitted on a single claim if the single claim form is received by the Program within 12 months of the earliest date of service. The Program shall only pay a claim that was initially rejected, denied, or not acted upon within reasonable promptness after being received by the Program, if the claim is: Complete according to Program billing instructions and the 837 HIPAA compliant and companion guidelines; Resubmitted; and Received by the Program within the later of 12 months from the date of service or 60 days from the date last received by the Program or last rejected by the Program. A claim for services provided on different dates and submitted on a single form shall be paid only if it is received by the Program within 12 months of the earliest date of service. The Program shall only pay a claim that was initially rejected, denied, or not acted upon within reasonable promptness after being received by the Program, if the claim is: Complete according to Program billing instructions and the 837 HIPAA compliant and companion guidelines; Resubmitted; and Received by the Program within the later of: 12 months from the date of service; or 60 days from the date last received by the Program or last rejected by the Program. Claims submitted after the time limitations because of a retroactive eligibility determination shall be considered for payment if received by the Program within 12 months of the date on which eligibility was determined. Late Charge Billing. The Program shall only accept additional or supplemental claims that were not included with a larger primary claim paid by the Program if all of the additional or supplemental claims are: Submitted together; Submitted in accordance with the requirements of §B(3) of this regulation; and Received within 60 days of the original paid claim date. The Program shall only accept one additional or supplemental claim under §B(7)(a) of this regulation for each: Date of service; Date of discharge; or Month of service billed. Adjustment Requests. Requests by providers to adjust information in claims already paid, including but not limited to changing the days billed, the amount charged, the units of service, or the rate of the service, shall be submitted to the Program in accordance with §B(3) and (5) of this regulation. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, covered services, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The Program shall pay the difference between what was paid by the insurance carrier and the Program's maximum fees. Total payment cannot exceed the Program's maximum fee. The provider shall submit a copy of the insurance carrier's notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. The Department may conduct provider audits as authorized by State and federal law to ensure compliance with Program requirements. For audits commencing on or after July 1, 2004, if the provider fails to reimburse the Department in accordance with §§A and B of this regulation, the provider shall be responsible for reimbursing the Department for the amount of the overpayment and any audit costs incurred by the Department in seeking recovery of the overpayment. An audit is considered to have commenced upon the initial written notification by the Department or the Department's agent to the provider. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider or related party of the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from the Program; Withholding of payment by the Program; Recovery of an overpayment; Removal from the Program; and Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department shall take similar action. The Department may report to the federal Secretary of Health and Human services any providers removed from participation with the Program for failure to comply with applicable federal or State laws and regulations in accordance with 42 CFR §455.416. The Department shall give the provider reasonable notice of its intention to impose sanctions. In the written notice, the Department shall establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants, before rendering additional services, that the provider no longer honors Medical Assistance cards. Source of Appeals. A provider may file an appeal from a proposed Program action to: Suspend the provider from the Program; Withhold payment by the Program; Recover an overpayment; Remove the provider from the Program; or Disqualify the provider from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. A provider shall submit an appeal according to: COMAR 10.01.03; State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; Health-General Article, §§2-201—2-207, Annotated Code of Maryland; and COMAR 28.02.01. A provider may not file an appeal from a Program action to terminate the provider when that action is the result of either: Termination of the provider or an owner by the federal government or another state Medicaid agency pursuant to 42 CFR §445.416; or Suspension or termination of the provider’s license or certificate by their respective licensing or certification authority. Request for a Hearing. An appeal of a proposed Program action shall be filed in writing with the Program within 30 days of the date of the notice of the proposed Program action. The Program shall make reasonable accommodation if a provider cannot submit a written request because of a disability. The Program shall immediately forward a written appeal request to the Office of Administrative Hearings. The Office of Administrative Hearings shall: Promptly acknowledge any appeal; and Notify the provider and the Program in writing of the date, time, and place of the hearing. Effective Date. The proposed Program action shall be effective on: The date of the proposed Program action notice if the Program: Determines that the provider poses an imminent threat to public health, safety, or welfare that requires emergency action; and Notifies the provider of this determination in the proposed Program action notice; The date specified in the proposed Program action notice if the provider: Does not request a hearing within 30 days of the date of the notice of the proposed Program action; or Withdraws in writing or abandons a request for a hearing before the effective date of the proposed Program action; The first payment date following the date of the Program action notice if the Program action involves withholding payment to the provider because the Program discovered an overpayment to the provider; The date the administrative law judge renders a decision in favor of the Program if the provider: Fails to timely file exceptions to the administrative law judge's decision with the Secretary pursuant to §D of this regulation; or Withdraws in writing or abandons a request for an exceptions hearing before the date of the exceptions hearing; or The date the Secretary renders a decision in favor of the Program pursuant to COMAR 10.01.03 if any party files exceptions with the Secretary in accordance with §E(1) of this regulation. A Program determination to suspend payments due to a credible allegation of fraud shall be effective immediately unless the Department determines, consistent with 42 CFR §455.23, that a good cause exception to immediate suspension exists. Exceptions and Outcomes. A party may seek additional administrative review of the administrative law judge's decision by filing in writing exceptions with the Secretary within 30 days of the date of the administrative law judge's decision pursuant to COMAR 10.01.03. If the Secretary's decision is favorable to the Program, the Program may: Immediately implement the proposed Program action; and Institute recovery procedures against the provider to recoup the cost of any payments made to the provider to the extent the payments were made solely because the provider was permitted to continue to submit claims to the Department because of §C(5) of this regulation. If the proposed Program action was effective on the date of the notice as provided for in §B(1) of this regulation, the Program shall authorize corrected payments or relief retroactive to the date of the notice if: The Secretary's decision is favorable to the provider; or The Program grants the provider the relief the provider requests before the Secretary's decision. Further Appeals. The provider may seek additional administrative review of the Secretary's decision as provided in Health-General Article, §§2-206 and 2-207, Annotated Code of Maryland, and subsequent judicial review as provided in State Government Article, §10-215, Annotated Code of Maryland. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Providers participating in the Program shall have the right to: Be treated professionally with courtesy, dignity, and respect regardless of the individual's: Race; Color; Religion; Gender; Sexual orientation; National origin; Political affiliation; Disability; Marital status; Age; or Union affiliation; File a complaint with the appropriate State agency when the provider believes that the provider has been discriminated against because of: Race; Color; Religion; Gender; Sexual orientation; National origin; Political affiliation; Disability; Marital status; Age; or Union affiliation; Have the information in the provider's Program file kept confidential except as otherwise stated by State or federal law; Be reimbursed for covered services provided to Program participants; and Participate in an impartial grievance and appeals process as outlined in COMAR 10.09.36.09. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.10 adopted as an emergency provision effective July 1, 1990 (17:15 Md. R. 1851); adopted permanently effective October 1, 1990 (17:18 Md. R. 2201) Regulations .01A and .03A amended, and .03D adopted as an emergency provision effective February 27, 1992 (19:6 Md. R. 669); adopted permanently effective June 22, 1992 (19:11 Md. R. 1015) Regulations .01A, .06A, B amended, and .06C—E adopted as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulations .01A and .06 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .01B amended effective May 9, 2005 (32:9 Md. R. 849); August 27, 2007 (34:17 Md. R. 1507); January 24, 2011 (38:2 Md. R. 84); July 4, 2016 (43:13 Md. R. 712); June 14, 2021 (48:12 Md. R. 473); September 18, 2023 (50:18 Md. R. 794); August 5, 2024 (51:15 Md. R. 707); July 21, 2025 (52:14 Md. R. 713) Regulation .02 amended effective September 18, 2023 (50:18 Md. R. 794) Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03 amended effective January 1, 2018 (44:26 Md. R. 1215); September 18, 2023 (50:18 Md. R. 794); July 21, 2025 (52:14 Md. R. 713) Regulation .03A amended effective June 14, 2010 (37:12 Md. R. 800); December 10, 2012 (39:24 Md. R. 1577); November 11, 2013 (40:22 Md. R. 1877); February 16, 2015 (42:3 Md. R. 316); March 28, 2016 (43:6 Md. R. 407); July 4, 2016 (43:13 Md. R. 712) Regulation .03-1 adopted effective February 26, 2018 (45:4 Md. R. 206) Regulation .03-2 adopted effective April 4, 2022 (49:7 Md. R. 466); amended effective August 5, 2024 (51:14 Md. R. 707) Regulation .04 amended effective August 5, 2024 (51:15 Md. R 707) Regulation .04H amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .05D adopted effective August 12, 1996 (23:16 Md. R. 1175) Regulation .06 amended effective June 1, 1993 (20:10 Md. R. 852); January 12, 2009 (36:1 Md. R. 21); June 27, 2011 (38:13 Md. R. 755) Regulation .07 amended effective September 18, 2023 (50:18 Md. R. 794) Regulation .07C, D adopted effective May 9, 2005 (32:9 Md. R. 849) Regulation .08A, D amended effective June 14, 2021 (48:12 Md. R. 473) Regulation .08C adopted effective July 21, 2025 (52:14 Md. R. 713) Regulation .09 repealed and new Regulation .09 adopted effective January 24, 2011 (38:2 Md. R. 84) Regulation .09 amended effective June 14, 2021 (48:12 Md. R. 473) Regulation .09A amended effective September 18, 2023 (50:18 Md. R. 794) Regulation .10 amended effective September 18, 2023 (50:18 Md. R. 794) Regulation .11 adopted effective June 27, 2011 (38:13 Md. R. 755) Regulation .11D amended effective September 18, 2023 (50:18 Md. R. 794) This chapter governs the determination of eligibility for the Family Planning Program. In this chapter, the following terms have the meanings indicated. Terms Defined. Applicant. “Applicant” means an individual whose written, signed application for the Family Planning Program has been submitted to the Department but has not received final action. “Applicant” includes a non-pregnant individual whose application is submitted through an authorized representative. “Application” means the filing of a written and signed application form for the Family Planning Program at the Department or its designee. “Application date” means the date on which a written, signed application is received by the Department. “Application form” means the form designated by the Department to be completed, signed, and submitted to the Department, or its designee, as an official application for the Family Planning Program. “Authorized representative” means a spouse, legal guardian, parent, individual with power of attorney, relative or other individual designated in writing to the Department, authorized concerning the applicant’s or participant’s eligibility under this chapter to: Act on an applicant’s or participant’s behalf; and Assist with the application or redetermination process and in other communication with the Department. “Continuing eligibility” means a participant’s eligibility for a subsequent certification period after the current certification period, based on the Department’s redetermination of eligibility with respect to an individual who is enrolled in Family Planning on the application date. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Determination” means a decision regarding an applicant's eligibility for the Family Planning Program. “Family Planning Program” means the program established in Health–General Article, §15-103 et seq., Annotated Code of Maryland to provide services related to contraceptive care to individuals who meet the eligibility requirements specified in Regulation .03 of this chapter. “Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2). “Household” means a MAGI household unit as set forth in COMAR 10.09.24.06-1. “Income” has the meaning stated in COMAR 10.09.24.02B. “Inmate in a public institution” has the meaning stated in COMAR 10.09.24.05-5. “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility under the Affordable Care Act. “MAGI coverage groups” has the meaning stated in COMAR 10.09.24.03A. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq. “Participant” means an individual who is determined eligible for the Family Planning Program. Public Institution. “Public institution” means an institution that is the responsibility of a governmental unit or over which a governmental unit exercises administrative control. “Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves no more than 16 residents. “Redetermination” means a determination regarding the eligibility of a participant. In order to be determined eligible for benefits under the Family Planning Program, an applicant: Shall: Have a household income that does not exceed 250 percent of the federal poverty level; and Meet the following requirements: Citizenship requirements in COMAR 10.09.24.05; Identity requirements in COMAR 10.09.24.05-1AF and H; and Residency requirements in COMAR 10.09.24.05-3. May not be: Pregnant; Determined eligible for another Medical Assistance Program; or An incarcerated inmate in a public institution as defined in COMAR 10.09.24.05-5A. An applicant whose income does not exceed 250 percent of the federal poverty level and is determined eligible for pregnancy or postpartum coverage under COMAR 10.09.24 shall be: Enrolled for 1 year without filing a separate application after pregnancy related period of eligibility ends; and Redetermined for eligibility based on the criteria in §A of this regulation. Definitions. In this regulation, the following terms have the meanings indicated. Terms Defined. “Applicant” means an individual who has applied for presumptive eligibility at a participating family planning clinic. “Application” means the presumptive eligibility application. “Authorized representative” has the meaning stated in COMAR 10.01.04.01. “Determination” means a decision regarding an applicant’s presumptive eligibility. “Family planning clinic” means an entity that: Provides family planning services under a written agreement with the Maryland Department of Health, Prevention and Health Promotion Administration; and Is approved to perform family planning presumptive eligibility determinations. “Former foster care” means an individual who: Is younger than 26 years old; Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance, upon attaining age 18 and leaving out-of-home placement or upon attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B. “Income” means property or a service received by an individual in cash or in-kind, which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. “Maryland Family Planning Program Delegate Service Site” means an entity that provides family planning services under a written agreement with the Department. “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals. “Presumptive eligibility” means temporary eligibility for Family Planning Program services as determined by family planning clinics in accordance with this regulation. Requirements. A family planning clinic qualified to make presumptive eligibility decisions shall: Participate as a Medical Assistance Program provider in good standing; and Sign an agreement prepared by the Department. The agreement under §B(1)(b) of this regulation shall require that the family planning clinic: Comply with Departmental policies and procedures supplied by the Department at the time of application and training; Meet accuracy and timeliness standards established by the Department; Submit a list to the Department of family planning clinic employees who will attend presumptive eligibility training developed by the Department; Prohibit employees who have not attended required trainings from making presumptive eligibility decisions; and Report all requested information on a form designated by the Department. Before assisting an applicant in filing a presumptive eligibility application, the family planning clinic employee shall: Check the Department’s eligibility verification system to make sure the individual is not actively enrolled in the Medical Assistance Program; Provide information concerning the full Medical Assistance application process to the individual applying for presumptive eligibility and assist or refer the applicant to an individual who can assist the applicant in completing a full Medical Assistance application; and Determine that the applicant: Has not had a prior family planning presumptive eligibility period within the last 12 months; Is not pregnant; or Is not actively enrolled in the Medical Assistance Program. The family planning clinic employee shall fill out the presumptive eligibility application based on information supplied by the applicant. The family planning clinic employee shall make a presumptive eligibility decision and submit the presumptive eligibility application by applying §D of this regulation and the following information obtained pursuant to §C of this regulation: Residency; Citizenship; Family size and composition; and Gross family income. The family planning clinic employee shall inform the individual in writing of the family planning clinic’s presumptive eligibility decision, which shall include an explanation of the presumptive eligibility period. The family planning clinic shall submit the presumptive eligibility application to the Department on the date of application completion to allow the individual to have temporary Medical Assistance coverage. The family planning clinic shall: Keep all written and signed presumptive eligibility applications on file for 6 years; and Make the file available to the Department upon request. Presumptive Eligibility Criteria. An individual shall apply for presumptive eligibility through a participating family planning clinic. An individual who applies for presumptive eligibility shall attest to: The citizenship requirements in COMAR 10.09.24.05; The residency requirements in COMAR 10.09.24.05-3; The individual’s pregnancy status; The individual’s family size; and The gross monthly income of the individual’s household. Presumptive eligibility may be established for individuals who meet the Family Planning Program eligibility requirements in Regulation .03 of this chapter. Limitations. Presumptive eligibility may not be granted to an individual who: Is pregnant; Is currently enrolled in the Medical Assistance Program; Had a prior presumptive eligibility period during the last 12 months; Does not meet the income requirements stated in Regulation .03 of this chapter ; Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or Does not meet the citizenship requirements stated in COMAR 10.09.24.05. Coverage Span. Presumptive eligibility begins on the day the presumptive eligibility worker determines the individual is presumptively eligible. Presumptive eligibility ends on the earlier of: The day the individual is determined eligible for Medical Assistance; or The last day of the month following the month in which the family planning clinic determined presumptive eligibility, if an individual: Is found ineligible for Medical Assistance; or Failed to apply for Medical Assistance. Presumptive Eligibility Appeal Rights. An individual or an organization does not have appeal rights for presumptive eligibility determinations. For individuals not described in .03B of this chapter, application for Family Planning Program services will be conducted pursuant to the provisions of COMAR 10.09.24.04. Determination of an applicant’s income for purposes of the Family Planning Program shall be determined under the household provisions of COMAR 10.09.24.06-1 and the income provisions applicable to MAGI household units of COMAR 10.09.24.07. An applicant is financially eligible for the Family Planning Program if the applicant's MAGI household income as determined under COMAR 10.09.24.06-1 and .07 does not exceed 250 percent of the federal poverty level. For a participant, certification for initial eligibility begins not sooner than the first day of the month of application. A participant’s eligibility under Regulation .03 of this chapter will end as of the: End of a 12 month certification period; Date eligibility is determined in another Medicaid coverage group; Date the participant ceases to qualify under the requirements of Regulation .03A of this chapter; Beginning of the month in which the participant is enrolled in Medicare; or Date a participant becomes an inmate in a public institution. A Family Planning Program recipient shall be entitled to services as stated in COMAR 10.09.58. Post-eligibility requirements for the Family Planning Program are set forth at COMAR 10.09.24.12. The procedures for the Program granting a hearing to an applicant or a recipient and the status of benefits pending a hearing are set forth in COMAR 10.01.04. The requirements relating to fraud and abuse under COMAR 10.09.24.14 and COMAR 10.09.24.14-1 shall apply to this chapter. The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, excluding COMAR 10.09.24.15A(2)—(3) and COMAR 10.09.24.15A(3), shall apply to this chapter. State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103(a), and 15-140, Annotated Code of Maryland Effective date: Regulations .01—.15 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686) Chapter revised effective January 6, 2014 (40:26 Md. R. 2163) Regulation .02B amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1243) December 31, 2018 (45:26 Md. R. 1243) Regulation .09 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .11 amended effective December 31, 2018 (45:26 Md. R. 1243) Chapter revised effective January 13, 2020 (47:1 Md. R. 12) Regulation .03A amended effective June 9, 2025 (52:11 Md. R. 532) Regulation .03-1 adopted effective February 22, 2021 (48:4 Md. R. 176) In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Dietitian or nutritionist” means an individual who: Meets the licensing requirements in Regulation .02D of this chapter; Meets the conditions of participation in Regulation .03A and D of this chapter; and Has a provider agreement with the Department as a Program provider of dietary and nutrition services. “Enriched maternity service” means direct counseling, educational, case coordination, and referral services provided to a pregnant or postpartum recipient by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife during the prenatal or postpartum visit. “Family support center” means a community-based and operated center which provides parenting education, health education, child development assessment services, education and job skill development services, and social support services to families. “Healthy Start High-Risk Nutrition Instrument” means the form designated by the Department for the purpose of identifying pregnant participants in need of high-risk nutrition counseling services. “Healthy Start Prenatal Risk Assessment Instrument” means the form furnished by the Department to the provider for the purposes of documenting the results of the prenatal risk assessment and developing the participant's plan of care. “Healthy Start Program” means a program designed to identify and address medical, nutritional, and psychosocial predictors of poor birth outcomes and poor child health by providing enhanced prenatal and postpartum services to pregnant and postpartum recipients. “High-risk nutrition counseling services” means educational services provided to nutritionally high-risk pregnant participants by a dietitian or nutritionist. “Local health department” means the local agency responsible for ensuring the availability of basic public health services in each local jurisdiction, and for administering and enforcing certain State and local health laws and regulations. “Maternal and Child Health Services Block Grant” means funds allotted by the federal government under Title V of the Social Security Act. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Nurse” means an individual who is licensed as a registered nurse in the state in which services are provided. “Nurse midwife” means an individual who: Meets the licensing requirements of Regulation .02A of this chapter; Meets the conditions of participation in Regulation .03A—C of this chapter; and Has a provider agreement with the Department as a Program provider of nurse midwife services. “Participant” means a pregnant or postpartum recipient who: Enters the Healthy Start Program during a medically verified pregnancy, or up to 60 days after delivery; May continue in the program receiving postpartum family planning services up to 60 days after the delivery; and Elects to receive the services available under these regulations. “Physician” means a doctor of medicine or osteopathy who: Is licensed to practice medicine in the state in which services are provided; Has a provider agreement with the Department as a Program provider of physician services; and Meets the conditions of participation in Regulation .03A—C of this chapter. “Program” means the Maryland Medical Assistance Program. “Provider” means a qualified provider of services under the Healthy Start Program who meets the conditions of participation in Regulation .03 of this chapter. “Provider agreement” means a contract between the Department and the provider. “Recipient” means an individual who is certified for and is receiving Medical Assistance benefits. “Risk assessment—plan of care” means a package of services provided to a pregnant participant by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife, to include: A comprehensive risk assessment appraising the participant's medical history and current health, nutritional, psychological, and social status; and An individualized plan of care developed by the provider in consultation with the participant. “Social worker” means a person who is licensed as a social worker in the state in which services are provided. “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)” means the federally funded program authorized under an amendment to the Child Nutrition Act of 1966 (PL 94-105) to provide supplemental foods and nutrition education to pregnant and postpartum women, infants, and young children from families with low incomes who are at risk by reason of inadequate nutrition or health care. “Tertiary care maternity center” means a facility with all necessary equipment and personnel specifically trained to care for high-risk obstetrical patients and with the capability to perform all necessary tests and obstetrical procedures 24 hours a day. A certified nurse midwife providing Healthy Start services shall be: Licensed as a registered nurse in the state in which services are provided; Certified as a nurse midwife by the American College of Nurse-Midwives; and In compliance with requirements to practice nurse midwifery in the state in which services are provided. Physicians providing Healthy Start services shall be licensed and legally authorized to practice medicine in the state in which the services are provided. Dietitians or nutritionists providing Healthy Start Program services shall be licensed in the state in which the services are provided. General requirements for participation in the Medical Assistance Program are that providers shall: Meet the licensure requirements in Regulation .02 of this chapter, and verify the licenses and credentials of all professionals employed by the provider; Apply for participation in the Program using an application form designated by the Department; Be approved for participation by the Department; Have a provider agreement with the Department in effect; Be identified as a Program provider by issuance of an individual provider number; Verify the eligibility of recipients; Accept payment by the Program as payment in full for services rendered and make no additional charge to any person for the covered services specified in Regulation .04 of this chapter; Provide services without discrimination on the basis of race, color, sex, national origin, marital status, physical or mental handicap; Maintain adequate records concerning service provision for a minimum of 6 years and make them available, upon request, to the Department or its designee; Not knowingly employ or contract with any person, partnership, or corporation which has been disqualified from the Program to provide or supply service to Medical Assistance recipients, unless prior written approval has been received from the Department; Agree that claims rejected for payment due to late billing may not be billed to the participant; Not place a restriction on the recipient's right to choose the provider; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or has not been preauthorized, the provider may not seek payment for that service from the participant; and Be selected by the participant from among qualified providers. Specific requirements for providers of risk assessment-plan of care services are that providers shall: Be physicians or nurse midwives; Provide the covered services as specified in Regulation .04A of this chapter in conjunction with the pregnant participant's initial clinical prenatal visit or, otherwise, as early as possible in the pregnancy; Maintain the participant's consolidated medical record; and Agree to on-site visits by Department staff to monitor adherence to Regulation .04A of this chapter. Specific requirements for providers of enriched maternity services are that providers shall: Be physicians or nurse midwives or be under the supervision of a physician or nurse midwife; Provide the covered services as specified in Regulation .04B of this chapter in conjunction with each prenatal clinical visit of the pregnant participant and each postpartum clinical visit of the postpartum participant up to 60 days after the delivery; and Agree to on-site visits by Department staff to monitor adherence to Regulation .04B of this chapter. Specific requirements for participation in the provision of high-risk nutrition counseling services are that providers shall: Be a dietician or nutritionist as specified in Regulation .02C of this chapter; Contact the recipient within 10 working days of the receipt of a referral from a local health department or private prenatal care provider, unless client-related extenuating circumstances are documented; and Agree to on-site visits by Department staff to monitor adherence to Regulation .04C of this chapter. Effective July 1, 2006, the Program shall reimburse for the following services: Risk Assessment — Plan of Care. One unit of service is to be reimbursed for each pregnancy. A risk assessment is an appraisal of the participant's medical history and current health, nutritional, psychological, and social status, as specified in the Healthy Start Risk Assessment Instrument. It results in the identification of problems having an impact on the outcome of the pregnancy and the subsequent health care status of the child. Based on the assessment, an appropriate plan of care is drafted and appropriate referrals are made. A copy of the completed Healthy Start Risk Assessment Instrument will be sent by the provider to the participant's local health department within 10 working days of the risk assessment. A plan of care is a description of the services and resources required to meet the participant's needs identified through the risk assessment. An individual participant's plan of care: Includes a description of the specific action steps necessary to address each identified need; Matches the risk status of the participant to the appropriate intensity and breadth of care; Describes the elements of care, provider or providers, and facilities to be utilized by the participant; Is subject to modification as new information arises during the course of care, including information communicated from the provider of home-visiting services; Is individualized and is developed in consultation with the participant; and Encompasses the continuum of care from the prenatal period through postpartum. Enriched Maternity Service. A maximum of one unit of service is to be reimbursed in conjunction with each prenatal and postpartum clinical visit of the participant. The following components comprise enriched maternity service: Prenatal and postpartum counseling and education. This component shall include, but not be limited to, the following topics: The benefits and recommended schedule of prenatal visits, including routine laboratory and radiological services; Danger signs of pre-term labor, including how to differentiate between normal and abnormal signs and symptoms related to pregnancy and what actions the individual should take; Preparation for labor and delivery, including hospital registration procedures; The risks of using prescription and over-the-counter medicines during pregnancy; The risks of alcohol, tobacco, and controlled substance use; The benefits of proper dental care; The benefits of seat belt and infant car seat use; The importance of postpartum care and continuing family planning services; and Arrangements for pediatric care. Nutrition education for pregnant and postpartum participants. This component shall include, but not be limited to, the following topics: The relation of proper nutrition to a healthy pregnancy and to a successful pregnancy outcome; Kinds and amounts of foods needed to meet nutritional requirements during pregnancy; Appropriate weight gain during pregnancy, and components of gain; Early decisions about infant feeding practices; Benefits of, and preparation for, breastfeeding; Appropriate use of nutritional supplements, if prescribed; A postpartum woman's nutritional needs; and The benefits of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Case coordination and referral for pregnant participants. This component shall include, but not be limited to, the following activities: Telephone reminders before prenatal and postpartum appointments and follow-up telephone contact if the participant misses an appointment; Referral of the participant to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); Referral of the participant to specialty services as indicated; Referral of the participant to high-risk nutrition counseling as indicated; Referral of the participant to high-risk obstetrician-gynecologist specialists, perinatologists, or other specialists based on the client's medical needs; Arrangements for hospital delivery, including delivery at a tertiary care maternity center as indicated; Arrangements for pediatric care; and Assistance in arranging for transportation to and from clinical services. High-Risk Nutrition Counseling Services. These services are provided to nutritionally high-risk pregnant participants. Nutritionally high-risk pregnant participants are identified to the high-risk nutrition counseling services provider through the Healthy Start High-Risk Nutrition Instrument. The services include, but are not limited to, the following: Making a nutritional assessment including the recording and interpretation of anthropometric measurements, clinical and laboratory findings, medical conditions, nutrient and drug interactions, diet history, and psychological, social, cultural, religious, and economic factors affecting food intake; Developing a nutritional care plan based on problems identified through the assessment and integrated into the total plan of care; Determining appropriate interventions to achieve care plan goals consistent with the participant's culture, family composition, and restrictions imposed by income, transportation availability, and neighborhood food resources, including, but not limited to, counseling for food habit and behavior change, diet modifications for medical conditions, and referral for food assistance; and Monitoring and recording participant's progress toward goal achievement. The Healthy Start Program may not restrict or otherwise affect: Eligibility for benefits under Title XIX of the Social Security Act or other available benefits or programs; and The provider's right to bill the Program for other covered program services. Request for Payment. Requests for payment of Healthy Start Program services rendered and completed shall be submitted by an approved provider according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider. Requests for payment shall be submitted on the invoice form specified by the Department. A separate invoice shall be submitted for each participant. The completed form shall indicate the: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, location, and provider number; and Nature, unit or units, and procedure code or codes of covered services provided. Providers shall bill the Program for the appropriate fee specified in §C of this regulation. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Payments shall be made: Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; According to the applicable rate under COMAR 10.09.02 or 10.09.21 for risk assessment—plan of care, and enriched maternity service; According to methodology described in the memorandum of understanding between the Program and each local health department for risk assessment—plan of care; For high-risk nutrition counseling as follows: To federally qualified health centers, according to COMAR 10.09.08.05; To each local health department, according to the methodology described in the memorandum of understanding between the Program and each local health department; To Maryland qualified health centers, according to COMAR 10.09.08.06; and To all other eligible providers, according to COMAR 10.09.02.07D. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08. Appeal procedures are as set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: July 1, 1989 (16:12 Md. R. 1337) Regulations .01—.05 amended as an emergency provision effective August 1, 1989 (16:16 Md. R. 1745); amended permanently effective November 29, 1989 (16:22 Md. R. 2364) Regulation .01B amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulation .02 amended effective July 20, 1992 (19:14 Md. R. 1283); November 23, 2006 (33:23 Md. R. 1795) Regulation .02G adopted effective September 3, 1990 (17:17 Md. R. 2080) Regulation .03 amended effective November 23, 2006 (33:23 Md. R. 1795) Regulation .03A, E amended effective June 2, 1997 (24:11 Md. R. 794) Regulation .03D, E amended effective July 20, 1992 (19:14 Md. R. 1283) Regulation .03F adopted effective September 3, 1990 (17:17 Md. R. 2080) Regulation .04 amended effective July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulation .04F adopted effective September 3, 1990 (17:17 Md. R. 2080) Regulation .04G, H adopted effective July 20, 1992 (19:14 Md. R. 1283) Regulation .05 amended effective June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulation .05B amended, C adopted effective July 20, 1992 (19:14 Md. R. 1283) Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .06C amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) Regulations .07—.10 repealed and new Regulations .07—.10 adopted effective June 2, 1997 (24:11 Md. R. 794) Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02D repealed effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03D amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .03E repealed effective December 27, 2010 (37:26 Md. R. 1787) Regulation .04D repealed effective December 27, 2010 (37:26 Md. R. 1787) Regulation .06C amended effective December 27, 2010 (37:26 Md. R. 1787); February 27, 2017 (44:4 Md. R. 252) In this chapter, the following terms have the meanings indicated. Terms Defined. “Birthing parent” means the participant giving birth, who is receiving doula services throughout their pregnancy, including the prenatal, labor, and postpartum periods. “Certified doula” means a trained nonmedical professional who provides continuous physical, emotional, and informational support to the birthing parent throughout the prenatal and postpartum periods and who has received a certification as approved by the Program to perform doula services. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Doula services” means continuous physical, emotional, and informational support to the birthing parent throughout the prenatal and postpartum periods, provided by a certified doula, including: Information about the childbirth process; Emotional and physical support provided at perinatal visits and during labor and delivery, which may include: Prenatal coaching; Providing person-centered care that honors cultural and family traditions; and Teaching and advocating on behalf of the birthing parent during appointment visits, hospitalization, and delivery; Provision of evidence-based information on general health practices pertaining to pregnancy, childbirth, postpartum care, newborn health, and family dynamics; Provision of emotional support, physical comfort measures, and information to the birthing parent to enable the birthing parent to make informed decisions pertaining to childbirth and postpartum care, and other issues throughout the perinatal period; Provision of support for the whole birth team including a birthing parent’s partner, family members, and other support persons; Provision of evidence-based information on infant feeding; Provision of general breastfeeding guidance and resources to supplement, but not in lieu of, the services of a lactation consultant; Provision of infant soothing and coping skills for the new parents; and Facilitation of access to resources that can improve birth-related outcomes, including ongoing home visiting services, transportation, housing, alcohol, tobacco and drug cessation, WIC, SNAP, and intimate partner violence resources. “Home” means the birthing parent’s place of residence in a community setting. “Labor and delivery” means the period during which the fetus, membranes, umbilical cord, and placenta are expelled from the uterus through vaginal birth or through the surgical delivery by a cesarean section. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Perinatal period” means the period that encompasses both the prenatal and postpartum periods. “Postpartum period” means the period that begins immediately after childbirth up to 180 days following childbirth. “Prenatal period” means the developmental period between conception and birth. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual doula or an association, partnership, or incorporated or unincorporated group of doulas certified to provide doula services that, through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. A provider shall be certified as described in the Professional Services Provider Manual and Fee Schedule under COMAR 10.09.02.07D. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. Specific requirements for participation in the Program as a certified doula provider require that the provider: Maintain up-to-date certification through a doula certification program as specified in Regulation .02 of this chapter; and Shall have adequate liability insurance. Effective January 1, 2022, the Program covers doula services as defined in Regulation .01 of this chapter when the services: Are medically necessary; Are rendered during a birthing parent’s prenatal period, labor and delivery, and postpartum period; and If rendered via telehealth, comply with the requirements established in COMAR 10.09.49 and any other subregulatory guidance. The Program shall cover up to: Eight prenatal or postpartum visits; and One labor and delivery service. Doula services covered under this chapter are subject to the following limitations: One of the following providers shall be present while doula services are provided during the delivery: An obstetrician-gynecologist; A family medicine practitioner; or A certified nurse midwife. Doula services furnished during labor and delivery may not be rendered via telehealth. Payment for doula services shall be limited to direct services provided. Expenses may not be reimbursed for items related to: Travel; Administrative overhead; or Ongoing certification, training, or consultation. Multiple visits are not allowed in the same day except in the following instances: A prenatal visit occurs earlier in the day, and a labor and delivery visit later in the day; or A labor and delivery visit occurs earlier in the day, and a postpartum doula later in the day. The provider shall submit the request for payment in the format designated by the Program. The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program. The provider shall charge the Program the provider's customary charge to the general public. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §H of this regulation; and The provider's reimbursement is not limited to the provider's customary charge. The Program will pay for covered services, the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The Program's fee schedule. The provider may not bill the Program or the participant for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; Professional services rendered via telehealth when services are indicated as an exclusion; or Providing a copy of a participant's medical record when requested by another provider on behalf of the participant. Payments for services rendered to a birthing parent shall be made directly to a qualified provider. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Reimbursement. Unless otherwise specified, payments shall be made in 15-minute units of service. The provider shall be reimbursed in accordance with COMAR 10.09.02.07D. Recovery and reimbursement regulations are set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. This chapter shall be implemented on January 1, 2022. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: February 21, 2022 (49:4 Md. R. 300) Regulation .02 amended effective June 24, 2024 (51:12 Md. R. 618) Regulation .06H amended effective June 24, 2024 (51:12 Md. R. 618) In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Department as defined in COMAR 10.09.36.01. “Developmental areas” means cognitive development, physical development (including fine and gross motor and sensory development), speech and language development, psychological development, and self-help skills. “Developmental delay” has the meaning stated in COMAR 13A.13.01.03B. “Early intervention services” means services defined in COMAR 13A.13.01.03B(15) that: Are designed to meet the developmental needs of infants and toddlers with disabilities; Are provided under public supervision and in conformity with an IFSP; and Meet applicable State and federal standards. “Early intervention service coordination” means the coordination of services covered under this chapter. “Family” means those individuals with whom a participant resides, who are responsible for the participant, are the primary nurturing caregivers, and have assumed major, long-term roles in the infant or toddler's daily life. “Individualized Family Service Plan (IFSP)” means a participant's written plan for early intervention services which is developed or revised by a multidisciplinary team based on the results of a multidisciplinary assessment or reassessment and is documented in accordance with guidelines issued by the Maryland Infants and Toddlers Program. “Local health department” means the public health services agency in each county and Baltimore City, which receives State and local government funding to ensure that basic public health services in the areas of personal and environmental health are available in each jurisdiction. “Maryland Infants and Toddlers Program” means the program designated by the Governor under Executive Order 01.01.1988.15 to plan, develop, and implement a Statewide, coordinated, comprehensive, multidisciplinary, interagency plan for early intervention services in Maryland. “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Multidisciplinary assessment or reassessment” means the process used by a participant's multidisciplinary team to review the child's unique needs, the family's ability to assist in meeting needs related to the child's development, and the nature and extent of early intervention and other services needed by the child. “Multidisciplinary team” means the involvement of two or more disciplines or professions in the provision of integrated and coordinated services, including evaluation and assessment activities and the development of the IFSP. “Parent” has the meaning stated in COMAR 13A.13.01.03B. “Participant” means a federally qualified recipient: Who is aged birth to the beginning of the school year following the child’s fourth birthday; Whose parents have provided written consent for the use of public benefits consistent with COMAR 13A.13.01.12; Who is not receiving the same service coordination services under another Program authority; and Who is defined as a child with a developmental delay as defined in COMAR 13A.13.01.03. “Program” means the Program as defined in COMAR 10.09.36.01. “Provider” means an early intervention service coordination provider. “Service coordination” means the services provided, as part of the Maryland Infants and Toddlers Program, which assists participants in gaining access to the full range of Medical Assistance services, as well as to any additional needed medical, social, mental health, financial assistance, counseling, educational, and other support services. “Service coordinator” means an individual who: Is utilized by the provider and chosen by the participant’s parent; Is designated to carry out the IFSP service coordination activities; Meets the requirements in Regulation .03C of this chapter; and Provides the services specified in Regulation .04 of this chapter. “Telehealth” has the meaning as stated in COMAR 10.09.49.02. Social workers participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 18, Annotated Code of Maryland, or meet the social worker licensure and regulatory requirements of the state in which the services are provided. Registered nurses participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 7, Annotated Code of Maryland, or meet the registered nurse licensure and regulatory requirements of the state in which the services are provided. Audiologists participating as service coordinators shall be licensed pursuant to COMAR 10.41.03.03, or meet the audiologist licensure and regulatory requirements of the state in which the services are provided. Nutritionists or dietitians participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 4, Annotated Code of Maryland, or meet the corresponding licensure and regulatory requirements of the state in which the services are provided. Occupational therapists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 9, Annotated Code of Maryland, or meet the occupational therapist licensure and regulatory requirements of the state in which the services are provided. Physical therapists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 13, Annotated Code of Maryland, or meet the physical therapist licensure and regulatory requirements of the state in which the services are provided. Clinical psychologists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 16, Annotated Code of Maryland, or meet the clinical psychologist licensure and regulatory requirements of the state in which the services are provided. School psychologists participating as service coordinators shall be certified pursuant to COMAR 13A.12.03.08, or meet the school psychologist regulatory requirements of the state in which the services are provided. Special educators participating as service coordinators shall be certified pursuant to COMAR 13A.12.01.04, or meet the special educator regulatory requirements of the state in which services are provided. Speech language pathologists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 19, Annotated Code of Maryland, or meet the speech language pathologist licensure or certification and regulatory requirements of the state in which the services are provided. Professional counselors participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 15, Annotated Code of Maryland, or meet the professional counselor licensure and regulatory requirements of the state in which services are provided. Physicians participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 14, Annotated Code of Maryland, or meet the physicians’ licensure and regulatory requirements of the state in which the services are provided. General requirements for participation in the Program are that providers shall do the following, either directly through staff or by agreement: Meet all conditions for participation as set forth in COMAR 10.09.36.03; and Maintain a file on each participant which meets the Program’s requirements and which includes for each contact made by the service coordinator: Date and subject of contact, Person contacted, Person making the contact, Nature, content, and unit or units of service provided; Place of service; and Signature and printed name of the service coordinator. Specific requirements for participation in the Program as an early intervention service coordinator are that the provider shall do the following, either directly or indirectly by agreement: Use qualified individuals as service coordinators; Have demonstrated expertise in providing family-centered, community-based, coordinated care to children with disabilities, with an emphasis on early intervention services; Develop the IFSP within 45 working days of referral, unless client-related extenuating circumstances are documented in accordance with COMAR 13A.13.01.07B. Have formal written policies and procedures, approved by the Department, which specifically address the provision of early intervention [services case management] service coordination to participants in accordance with the requirements of this chapter; Designate specific qualified individuals as early intervention service coordinators; Maintain on file an initial Individualized Family Service Plan for each participant, and any subsequent revised IFSPs; Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants; Maintain a current listing of medical, social, mental health, financial assistance, education, training, counseling, and other early intervention and support services available to infants and toddlers with disabilities; and Strictly safeguard the confidentiality of a participant's records, so as not to endanger the participant's and the family's legal rights, family relationships, and status in the community. A service coordinator shall meet the following requirements: Be a professional who: Has a current license or certification, according to Regulation .02 of this chapter, in the profession most immediately relevant to a participant’s needs; and Has demonstrated training or experience in providing service coordination or other early intervention services to infants and toddlers with disabilities; or Be a nonprofessional who: Has a high school diploma or its equivalency who meets Personnel Standards described in COMAR 13A.07.01.02; Has demonstrated training or experience in providing service coordination or other early intervention services to infants and toddlers with disabilities; and Participates in ongoing training offerings as specified in the interagency plan for early intervention services. The Program shall reimburse for the services in §§B, C, and D of this regulation, when they have been documented as necessary. Initial Service Coordination. A unit of service is defined as a completed initial Individualized Family Service Plan (IFSP) and at least one contact with the participant or the participant’s family, on the participant’s behalf. The covered services include convening and conducting a multidisciplinary team to: Perform a multidisciplinary assessment; and Develop an initial IFSP for a participant that identifies the: Participant’s needs for early intervention, medical, mental and behavioral health, social, educational, financial assistance, counseling, and other support services; Responsibilities and rights of the participant and the family, Provider's responsibilities, and Resources available to provide the needed services. Administrative, supervisory, and monitoring services associated with the initial service coordination are included as a part of the service. Ongoing Service Coordination. Ongoing service coordination is provided following the initial service coordination. A unit of service includes all necessary covered services and at least one monthly contact with the participant’s family on the participant’s behalf via: Telephone call; Telehealth or in-person visit; or Written communication. These services include: Maintaining contact with a participant and the family through home visits, office visits, telephone calls, and follow-up services as necessary; Referring the participant to direct service providers, assisting the participant in gaining access to services specified in the IFSP, and providing linkage to agreed-upon direct service providers of early intervention services; Discussing with direct service providers of early intervention services the services needed and available for the participant, determining the quality and quantity of service being provided, following up to identify any obstacles to a participant's utilization of services, coordinating the service delivery, and performing ongoing monitoring to determine whether the recommended services are being delivered and meet the participant's current needs; Providing a participant's family with information and direction that will assist the participant in successfully accessing and using the services recommended in the IFSP; Informing a participant's family of the participant's and the family's rights and responsibilities in regard to specific programs and resources; Conducting, with a participant's family, a periodic review of the participant's IFSP every 6 months, or more frequently if conditions warrant or the family requests a review; A periodic review accomplished at a meeting or by other means acceptable to the family and others involved in the review process, and which determines the following: The degree of a participant's progress toward achieving the goals established in the IFSP, and Whether the goals or recommended services need to be revised; and Being available to the participant and the family on a nonscheduled basis as necessary for problem resolution and crisis management related to the participant's needs. Administrative, supervisory, and monitoring services associated with the ongoing case management services are included as part of the service. Annual IFSP Review. A unit of service is defined as a completed annual IFSP review and at least one contact with the participant or the participant’s family, on the participant’s behalf. The covered services include convening and conducting a multidisciplinary team to: Perform a multidisciplinary reassessment of the participant's status and service needs; and Review and revise, as necessary, the participant's IFSP. Early intervention service coordination is advisory in nature. A restriction may not be placed on a qualified participant’s option to receive early intervention service coordination. Early intervention service coordination does not restrict or otherwise affect: Eligibility for Title XIX benefits or other available benefits or programs; The freedom of a participant's parent or family to select from all available services for which the participant is found to be eligible; A participant's parent or family's free choice among qualified providers, in the participant's behalf; or A provider's right to bill the Program for other covered Program services. Early intervention service coordination may not be: Provided as an integral and inseparable part of another covered Program service; Provided as an administrative function necessary for the proper and efficient operation of the State's Medical Assistance plan; Rendered in connection with the implementation of §1915(b) or (c) of the Social Security Act; or Delivered as part of institutional discharge planning. Reimbursement may not be made for early intervention service coordination if a participant is receiving a comparable case management service under another Program authority. A participant’s service coordinator may not be the participant’s parent. Request for Payment. Requests for payment of early intervention service coordination shall be submitted by an approved provider according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all claims not properly signed and completed. A provider shall submit a request for payment on the claim form designated by the Department. A separate claim shall be submitted for each participant. The completed claim form in §A(2)B of this regulation shall indicate the: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, location, and provider number; and Nature, unit or units, and procedure code or codes of covered services provided. Providers shall bill the Program for the appropriate fee specified in §C of this regulation. The Program may not make direct payment to participants. Billing Time Limitations. Billing time limitations shall be as set forth in COMAR 10.09.36.06. Payment shall be made: Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; Only to one provider of early intervention service coordination rendered to a participant during a billing period; and According to the following fee-for-service schedule for early intervention service coordination: Initial service coordination (only one unit of service may be reimbursed per participant) ... $500; Ongoing service coordination (only one unit of service per month may be reimbursed for a participant after completion of initial service coordination or the annual IFSP review) ... $150; Annual IFSP review ... $275 per review. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeal Procedures shall be as set forth in COMAR 10.09.36.09. State regulations shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105,, Annotated Code of Maryland Effective date: Regulations .01—.10 adopted as an emergency provision effective November 19, 1990 (17:24 Md. R. 2835); emergency status extended at 18:4 Md. R. 445 (February 22, 1991); adopted permanently effective February 18, 1991 (18:3 Md. R. 305) Chapter revised as an emergency provision effective August 1, 1991 (18:17 Md. R. 1911); amended permanently effective November 1, 1991 (18:21 Md. R. 2308) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); November 13, 2023 (50:22 Md. R. 973) Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .03 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .04 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .06A, C amended effective November 13, 2023 (50:22 Md. R. 973) The purpose of this chapter is to increase employment opportunities by making Medical Assistance coverage available to employed individuals with disabilities who meet: The disability criteria under Title II or XVI of the Social Security Act; and The nonfinancial and financial eligibility requirements established in this chapter. Applicability of COMAR 10.09.24.02 Definitions. Except as provided in §A(2) of this regulation, terms used in this chapter that are not defined in §C of this regulation have the meanings stated for the same terms in COMAR 10.09.24.02. If a term's definition in COMAR 10.09.24.02 references a “local department of social services” in the context of a determination of eligibility, the words “local department of social services” in the COMAR 10.09.24.02 definition shall be replaced, for purposes of the term's meaning in this chapter, with “the Department” . In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicant” means an individual: Who is not a recipient; Who has submitted to the Department an application for the Employed Individuals with Disabilities coverage group; and Whose application has not received final action. “Application” means the filing with the Department of a written and signed application form for the Employed Individuals with Disabilities (EID) coverage group to establish eligibility for Medical Assistance benefits. “Application date” means the date a written and signed application form for determination or redetermination of eligibility for the EID coverage group is received by the Department. “Assistance unit” means an applicant or recipient and, when living together, the applicant's or recipient's spouse, whose eligibility for Medical Assistance benefits is determined in conjunction with each other. “Certification period” means a period of time of up to 12 months, beginning on the first day of the month in which the Department receives the application, for which the EID applicant’s or recipient’s eligibility to receive Medical Assistance benefits is certified. “Chronic hospital” has the meaning stated in COMAR 10.09.06.01B. “Continuing eligibility” means a recipient's EID eligibility for a subsequent certification period after the current certification period, based on the Department's redetermination of eligibility with respect to an individual who is enrolled in the EID coverage group on the application date. “Days” has the meaning stated in Article I, §36, Annotated Code of Maryland. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. “Determination” means a decision by the Department regarding an applicant's or recipient's eligibility for the EID coverage group. “Disability” means an individual's medically determinable impairment that is the basis of a determination that the individual is disabled, according to the standards set forth in §1614(a)(3) of the Social Security Act, except substantial gainful activity is not considered in determining disability. “Disabled” means having a disability. “Disregard” means a fixed monetary amount or documented expense that is deducted from countable gross income to determine countable net income. “Employed” means being engaged in employment: That is verifiable; That yields earnings during the period under consideration; and The earnings from which are subjected to reporting, withholding, and payment as required by law, including but not limited to individual income tax, payroll tax, estimated income tax, and withholding or payments required by the Federal Insurance Contribution Act. “Employed Individuals with Disabilities (EID)” means the Medical Assistance coverage group for employed individuals with disabilities, which is: Operated under the regulations of this chapter; Funded jointly by the State and the federal governments; and Administered by the Department. “Employer-sponsored insurance (ESI)” means group health insurance coverage provided wholly or partly at the expense of an applicant's, recipient's, or spouse's employer. “Employment” means working for payment either for an employer or on a self-employed basis. “Excludable” means the types of income and resources that are specified in this chapter as not countable in the determination of eligibility for the EID coverage group. “Family unit size” means the number of individuals included in an assistance unit, which is used to determine the applicable income or resource standard. “Grace period” means a period of time not longer than 6 months during which an unemployed EID recipient pays premiums and remains eligible to receive EID benefits despite failing to meet the requirement that EID recipients be employed. “Hardship” means financial adversity or misfortune significant enough that it reasonably can be expected to compromise an applicant's or recipient's ability to obtain and provide basic food, shelter, and clothing for the applicant or recipient, another member of the assistance unit, or any dependents of the applicant or recipient. “Health insurance” has the same meaning as “health insurance coverage”, as stated in COMAR 10.09.43.02B. “Initial eligibility” means the EID eligibility of an individual who is not enrolled in the EID coverage group on the application date. “Long-term care facility services” means services delivered to patients admitted to a nursing facility, chronic hospital, or a rehabilitation hospital. “Medical criteria for disability” means the criteria applied by the Social Security Administration (SSA) to determine disability under Title XVI of the Social Security Act, except for the disability criteria that consider an individual's earnings as evidence of an ability to perform substantial gainful activity. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Notice of eligibility” means the written notice issued by the Department informing an applicant or recipient of: The Department's finding of eligibility or ineligibility; and The legal rights and obligations of the applicant or recipient associated with the Department's determination. “Nursing facility” has the meaning stated in COMAR 10.09.10.01B. “Period under consideration” means a period of 6 months, beginning on the first day of the month of the application date, for which an assistance unit's income is assessed for a determination of eligibility under this chapter. “Premium” means the monthly amount an applicant or recipient is required to pay, absent a successful claim of hardship pursuant to Regulation .07C of this chapter, as a condition of eligibility for the EID coverage group and Medical Assistance benefits. “Provider” has the same meaning as “health care provider”, as stated in Health-General Article, §19-132, Annotated Code of Maryland. “Recipient” means an individual who has been determined eligible for the EID coverage group. “Redetermination” means a determination by the Department, at least every 12 months, regarding the continuing eligibility of a recipient, in accordance with the requirements of this chapter. “Rehabilitation hospital” has the same meaning as “special rehabilitation hospital”, as stated in COMAR 10.07.01.02C. “Social Security Disability Insurance (SSDI)” means a federally administered program that provides benefits to individuals with disabilities who have paid sufficient Social Security taxes to be eligible for disability insurance payments under Title II of the Social Security Act, 42 U.S.C §423 et seq. “Substantial gainful activity” has the meaning stated in 20 CFR §416.910, which the Social Security Administration applies in determining disability under Title XVI of the Social Security Act. The Department shall determine whether an applicant or recipient meets the nonfinancial eligibility requirements for Medical Assistance benefits under this regulation. An applicant or participant meets the nonfinancial eligibility requirements for Medical Assistance benefits under this regulation if the applicant or participant: Is 16 years old or older, but younger than 65 years old; Is employed, except when an unemployment grace period described under Regulation .07 of this chapter applies, and verifies employment and compliance with all applicable requirements relating to FICA, income tax reporting, withholding, and payment requirements, including, if self-employed, payment of estimated taxes, by submitting documentation such as: Pay stubs; A letter from the employer verifying the applicant's or recipient's employment; Bank statements showing deposits of earnings; Income tax returns; Evidence of payment of estimated taxes; or Business ledgers; Except for the consideration of substantial gainful activity, meets the definition of disability in §1614(a)(3) of the Social Security Act, as determined by: The Department pursuant to a disability determination process for applicants who have not had a disability determination completed by the Social Security Administration within the time period prescribed in §C(2) of this regulation; or The Social Security Administration, if the applicant or recipient: Receives SSDI benefits; or Has lost eligibility for SSDI or SSI for any reason other than medical improvement; As specified in COMAR 10.09.24: Meets the eligibility requirements for Medical Assistance as to: Citizenship; and Residency; and Is not: An institutionalized person; An inmate of a public institution; or An inpatient in an institution for mental disease; and Is not a current recipient of: Comprehensive Medical Assistance benefits pursuant to COMAR 10.09.24; or Benefits under the Maryland Children's Health Program pursuant to COMAR 10.09.11 or 10.09.43. Periodic Redetermination of Disability. The Department shall periodically review a recipient's impairments to determine continuing disability status, consistent with §C(2) of this regulation. Frequency of Continuing Disability Reviews. The Department may schedule the periodic disability reviews required by §C(1) of this regulation at a frequency that is consistent with the time frames set forth in federal law and regulations as specified in 20 CFR §416.989, as amended, and 20 CFR §416.990, as amended, which are incorporated by reference. Assistance Unit. An applicant's or recipient's assistance unit shall include the: Applicant or recipient; and Applicant's or recipient's spouse when living in the same household, whether or not the spouse is eligible for the same benefits under this chapter. Consideration of Income. Except as provided in §B(2) or C of this regulation, the Department shall determine, in accordance with the policies and procedures for aged, blind, or disabled coverage groups specified at COMAR 10.09.24, the countable net income of an EID applicant or participant for purposes of determining the applicable premium amount under Regulation .07 of this chapter. To determine the countable net income of an EID assistance unit, the Department shall subtract from the assistance unit's total gross income: The general income exclusions and disregards and the specific income exclusions and disregards for aged, blind, or disabled coverage groups specified at COMAR 10.09.24; and An amount equal to the applicant's, recipient's, or spouse's documented out-of-pocket cost of premium payments to secure current employer-sponsored insurance coverage that includes coverage of the applicant or recipient. As a condition of eligibility for Medical Assistance benefits under this chapter, unless good cause for not doing so is shown, applicants and recipients, shall take all necessary steps to obtain any annuities, pensions, retirement, and disability benefits to which they are entitled, including, but not limited to: Veterans' compensation and pensions; Old Age and Survivors' Disability Insurance (OASDI) benefits; Railroad retirement benefits; Unemployment compensation; or Social Security Disability Income (SSDI). Income Standards. Effective January 1, 2024, no income standard applies to applicants or participant under this chapter. Consideration of Resources. Except as provided in this section, whether an applicant meets the resource standards for eligibility for the EID coverage group shall be determined according to the policies and procedures for aged, blind, or disabled coverage groups specified in COMAR 10.09.24. To determine the total countable resources of an applicant, the Department shall apply the general resource exclusions and specific resource exclusions for aged, blind, or disabled coverage groups specified in COMAR 10.09.24 to the total gross resources of the applicant. From the total countable resources of the applicant determined pursuant to §C(1) and (2) of this regulation, the Department shall subtract the aggregate current cash value of the applicant’s or participant’s ownership interest in any of the following types of accounts: 401(k) retirement account; 403(b) retirement account; Pension plan; Keogh plan; Individual retirement account (IRA); Independence Account; or Other retirement accounts as defined by the IRS. For an applicant or participant to be eligible for Medical Assistance benefits under this chapter, the countable resources attributed to the applicant’s or participant’s assistance unit pursuant to §§C and D of this regulation may not exceed $10,000 for an individual. Independence Accounts. Account Provisions. Contributions to any of the participant’s registered Independence Accounts are subject to the rules described in this section and to any policies of the respective financial institution governing the account. All contributions to the participant’s Independence Account or accounts, including interest, dividends, or other gains from the principal, shall be treated as an exempt asset for the purpose of calculating eligibility for Medical Assistance and the EID program. The purpose of an Independence Account is to allow the participant to purchase any items or services that may aid in the participant’s pursuit of personal or financial independence. The EID participant shall be the sole owner of any account registered as an Independence Account. The Department shall assess the participant’s Independence Account as a part of the verification process at redetermination for Medical Assistance. The review process shall include verifying all contributions to the participant’s Independence Account with the financial institution holding the participant’s account. The total amount a participant deposits in all independence accounts during an annual certification period may not exceed the participant’s gross earned income for that annual certification period. Independence Account Registration. A person shall complete an account registration form to register an applicable account as an Independence Account with the Department. A person shall re-register the Independence Account with the Department if the financial institution or other information for the Independence Account changes. The applicant or participant shall report any changes in personal or financial status that may affect the applicant’s or participant’s eligibility for Medical Assistance as described in COMAR 10.09.24. For all registered Independence Accounts, the date of account creation may be no earlier than the date an EID participant is determined eligible for Medical Assistance under this section. For all registered Independence Accounts, the funds in the Independence Account shall be held separate from the participant’s non-exempt assets. Application. To any individual requesting information, the Department shall provide oral or written information about: EID eligibility requirements; The coverage, scope, and related services of the Medical Assistance Program; and Applicants' and recipients' rights and obligations under the Medical Assistance Program. The Department shall issue an EID application form to any individual upon request. An applicant or recipient may apply for a determination or a redetermination of eligibility for the EID coverage group by submitting to the Department: The application form designated by the Department and signed in accordance with the signature requirements of COMAR 10.09.24; The social security numbers of each member of the assistance unit, in accordance with §A(5) of this regulation; and Signed consent forms as specified in §A(4) of this regulation. Consent Forms. An applicant or recipient, or, if necessary and consistent with the signature requirements specified in COMAR 10.09.24, a representative or other individual acting on behalf of the applicant or recipient, shall sign consent forms as needed to authorize the Department's verification of information needed to establish eligibility through sources such as employers, banks, and public or private agencies. Social Security Number. As required in COMAR 10.09.24 for each assistance unit member requesting benefits under this chapter, an applicant or recipient shall: Provide the Department with the individual's Social Security number; or Verify that the individual has applied to the Social Security Administration for a Social Security card. An applicant's or recipient's failure to meet the requirements of §A(5)(a) of this regulation shall result in a determination of ineligibility under this chapter. An applicant or recipient shall provide to the Department information and verifications needed for the determination of all elements of nonfinancial, income, and resource eligibility, including but not limited to information relating to health insurance coverage or potential third-party payments. Additional Information Requirements. An applicant or recipient shall, at the Department's request: Be available for and participate in an interview; and Answer questions and provide information relevant to: The applicant's eligibility for the EID coverage group; or The recipient's continuing eligibility for the EID coverage group. An individual temporarily absent from the State who intends to return to the State: May apply to the Department by mail for the EID coverage group; and To establish eligibility for the EID coverage group, shall: Demonstrate continued residency in the State; and Meet all technical and financial requirements of eligibility under this chapter. An applicant or recipient shall cooperate and assist with the Department's eligibility determination or redetermination process under this chapter, including but not limited to the requirements of §A of this regulation. The Department shall: Maintain a case record for the applicant or recipient, including documentation of all required elements of eligibility; Conduct a wage-screening inquiry to determine wages, benefits, and claimant history for each assistance unit member; Verify all factors of eligibility under this chapter for each assistance unit member applying for the EID coverage group; and Restrict disclosures of information concerning applicants and recipients to purposes directly connected with the administration of the EID coverage group of the Medical Assistance program. Time Standards for the Department. Disability Determined by Social Security Administration. With respect to an application submitted by an individual determined to be disabled as provided in Regulation .03B(3)(b) of this chapter, unless the time standard is extended pursuant to §D of this regulation, the Department shall, not later than 30 days from the application date: Complete its determination or redetermination of eligibility, subject to any premium payment required by Regulation .07 of this chapter, and issue a written notice that satisfies the requirements of Regulation .08B of this chapter; or Determine that it cannot complete its eligibility determination without additional information or verifications, and issue a written notice that informs the applicant or recipient of: The information and verifications required to determine or redetermine eligibility; and The due dates for the Department's eligibility determination and for the applicant's or recipient's provision of the additional information and verifications requested by the Department. No Disability Determination by Social Security Administration. Unless the time standard is extended pursuant to §D of this regulation with respect to an applicant who has had no determination of disability or continuing disability completed by the Social Security Administration within the time frame prescribed by Regulation .03C(2) of this chapter, the Department shall complete the requirements specified in §A(1)(a) or (b) of this regulation not later than 90 days from the application date. Time Standard for Redeterminations. Before the beginning of a new certification period, the Department shall: Issue a redetermination form to a recipient at least 60 days before the end of the current certification period; and Perform a redetermination of a recipient's eligibility, subject to any premium payment required by Regulation .07 of this chapter, for the EID coverage group. Time Standards for Applicants and Recipients. Unless the time standard is extended pursuant to §D of this regulation, the applicant or recipient shall, within the time standards specified in §B(2)—(4) of this regulation, provide to the Department: The completed and signed application required by Regulation .05A(3) of this chapter; and The information and verifications, if any, requested by the Department pursuant to §A(1)(b) of this regulation. If the Department's request for information or verification is part of the application packet, an applicant or recipient shall provide the signed and completed application and supporting information and materials specified in Regulation .05A(3) of this chapter to the Department early enough for the Department to meet the 30-day time standard specified in §A of this regulation for completion, subject to any premium payment required by Regulation .07 of this chapter, of an eligibility determination or redetermination. If the Department's request is made after the application date, an applicant or recipient shall provide the requested information and verifications to the Department within 10 days of the date of the Department's notice pursuant to §A(1)(b) of this regulation. For redeterminations, the recipient shall provide to the Department, by the last day of the current certification period, all materials and information required by §B(1)—(3) of this regulation. Time for Payment of Premium. Unless a claim of hardship is raised pursuant to Regulation .07C of this chapter, an applicant or recipient shall submit, within the time allowed by §B of this regulation, the premium required by Regulation .07A of this chapter. If a claim of hardship raised pursuant to Regulation .07C of this chapter is denied by the Department, the applicant or recipient to whom Regulation .07C(3) of this chapter applies shall pay the premium required by Regulation .07A of this chapter within 10 days of the date of the Department’s notice pursuant to Regulation .07C(2) of this chapter. Extension of Time Standards. The Department shall extend the time standards specified in §B of this regulation if: The applicant or recipient is actively attempting to establish eligibility but has been unable to provide the required information or verifications due to circumstances beyond the applicant's or recipient's control; or There is an administrative delay or emergency beyond the control of the Department. If the circumstances described in §D(1) of this regulation are present: The Department shall document in the applicant's or recipient's record the reason for the delay; and The extension of time shall continue as long as the requirements of §D(1) of this regulation are met. Effect of Noncompliance with Time Standards. The Department shall deny the application for the EID coverage group and issue a notice of ineligibility or termination pursuant to Regulation .08C of this chapter if: The applicant or recipient fails to meet the timeliness requirements of §B of this regulation without the circumstances set forth in §D(1) of this regulation being present; or The time standard for the applicant's or recipient's submission of information and verifications set forth in §B of this regulation initially was extended pursuant to §D(1) of this regulation, but the requirements of §D(1) of this regulation are no longer met. The standards of timeliness for acting on applications may not be used: To deny eligibility except as provided in §E of this regulation; or As a waiting period for EID enrollment of eligible individuals. Withdrawal and Reactivation of Application. An individual who has filed an application for the EID coverage group with the Department may voluntarily withdraw the application at any time. An individual who has withdrawn an application for the EID coverage group may not reactivate the application except as provided in COMAR 10.09.24. If an applicant or recipient withdraws a pending application, the application form shall remain the property of the Department. Submission of Premium. Unless an exception under §A(2) of this regulation applies or a timely claim of hardship is raised pursuant to §C of this regulation, an applicant or recipient shall, as a condition of eligibility for the EID coverage group, pay the premium specified in §A(3) of this regulation. Limitation of Premium Requirement. An applicant or recipient with income at or below the federal poverty level is not required to pay a premium as a condition of eligibility in the EID coverage group. With respect to an applicant determined eligible subject to the requirements of §A(3) of this regulation, the Department shall waive the premium payment before the notice of eligibility for a period not to exceed 6 months if such notice of eligibility is delayed by factors beyond the applicant's control. An applicant or participant whose assistance unit has income: Above the federal poverty level, but at or below 200 percent of the federal poverty level, shall pay a monthly premium of $25; Above 200 percent, but at or below 250 percent of the federal poverty level, shall pay a monthly premium of $40; Above 250 percent, but at or below 300 percent of the federal poverty level, shall pay a monthly premium of $55; Above 300 percent, but at or below 450 percent of the federal poverty level, shall pay a monthly premium of 4 percent of the monthly net countable income determined under Regulation .04B of this chapter; Above 450 percent, but at or below 600 percent of the federal poverty level, shall pay a monthly premium of 5 percent of the monthly net countable income determined under Regulation .04B of this chapter; or Above 600 percent of the federal poverty level, shall pay a monthly premium of 7.5 percent of the monthly net countable income determined under Regulation .04B of this chapter. Request for Payment. With respect to an applicant or recipient determined eligible subject to the requirements of §A(3) of this regulation, the Department shall issue a request for payment of the applicable premium, indicating that the applicant or recipient shall pay the amount specified within 30 days of the date the Department mailed the request for payment. An applicant or recipient to whom §A(3) of this regulation applies shall, within 30 days of the Departments request for payment pursuant to Regulation §A(4) of this regulation: Pay the full premium due as specified in the request for payment issued pursuant to §A(4) of this regulation; or Submit a claim of hardship as authorized by §C of this regulation. Upon request by the recipient, the Department shall approve an unemployment grace period, not to exceed 6 months within a 12-month period, provided the recipient: Has unemployment due to medical reasons or involuntary job loss; Is otherwise eligible for EID; and Continues to pay the premium during the unemployment grace period. Nonpayment of Premium. If an applicant who is required to pay a premium under §A(3) of this regulation, and is the subject of a request for payment issued by the Department pursuant to §A(4) of this regulation, does not pay the premium or submit a hardship claim within 30 days of the Department's notice, the Department shall: Determine the applicant is not eligible for the EID coverage group; and Issue a denial notice as required by Regulation .08C(1) of this chapter. If recipient who is required to pay a premium under §A(3) of this regulation, and is the subject of a request for payment issued by the Department pursuant to §A(4) of this regulation, does not pay the premium or submit a hardship claim within 30 days of the Department's notice, the Department shall: Determine the recipient is not eligible for the EID coverage group; Issue a termination notice as required by Regulation .08C(2) of this chapter; and Refer the recipient to the Central Collection Unit. An applicant or recipient whose eligibility is denied or terminated due to failure to pay the premium as specified in §A(4) of this regulation may not be reenrolled in the EID coverage group until the applicant or recipient pays all monies due to the Department in full. Hardship. If the applicant or recipient suffers financial adversity or misfortune so severe that payment of the premium would compromise the applicant's or recipient's ability to obtain and provide basic food, shelter, and clothing for members of the assistance unit or other legal dependents of the applicant or recipient, the applicant or recipient may submit a claim of hardship, specifying the underlying circumstances, to the Department. The Department shall evaluate the claim of hardship and notify the applicant or recipient of its decision within 30 days of the Department's receipt of the written claim of hardship. If the Department determines that the applicant or recipient's claim of hardship is without merit, the applicant or recipient shall pay the applicable premium within 10 days after the date the Department's notice is issued pursuant to §C(2) of this regulation. Department's Determination. Based on the information presented, the Department shall determine whether an applicant or recipient is or is not eligible for the EID coverage group under this chapter. Finding of Eligibility or Continuing Eligibility. Notice of Initial Eligibility. If the Department determines that an applicant is eligible, subject to the requirements of Regulation .07A of this chapter, for the EID coverage group, the Department shall issue to the applicant written notice that includes: A statement of the finding of eligibility, as applicable, indicating the beginning and ending dates of coverage, in accordance with §E of this regulation; and Notice of the right to request a hearing pursuant to Regulation .13 of this chapter. Notice of Continuing Eligibility. If the Department determines that a recipient qualifies for continuing eligibility for the EID coverage group, the Department shall issue to the recipient a written notice that includes: A statement of the finding of continuing eligibility, indicating the beginning and ending dates of coverage, in accordance with §E of this regulation; and A notice of the right to request a hearing pursuant to Regulation .13 of this chapter. Denial or Termination. Applicant—Denial Notice. If the Department determines that an applicant is not eligible for the EID coverage group, the Department shall issue to the applicant a written denial notice that includes: A statement of the Department's finding for the EID coverage group; The reason for the finding; The regulation supporting the finding; and Notice of the right to request a hearing pursuant to Regulation .13 of this chapter. Recipient—Notice of Termination. If the Department finds that a recipient is no longer eligible for the EID coverage group, the Department shall issue to the recipient a written notice of termination that includes: A statement of the Department's finding that the recipient is no longer eligible for the EID coverage group; The reason for the finding; The regulation supporting the finding; and Notice of the right to request a hearing pursuant to Regulation .13 of this chapter. Grounds for Department's Denial or Termination. If the Department finds one or more of the reasons for denial or termination listed in §D(2) of this regulation with respect to an applicant or recipient, the Department shall determine that: An applicant is not eligible for the EID coverage group and issue a notice of denial as specified in §C(1) of this regulation; or A recipient is no longer eligible for the EID coverage group and issue a notice of termination as specified in §C(2) of this regulation. Grounds for denial or termination from the EID coverage group shall include that an applicant or recipient: Does not meet, or no longer meets, the EID eligibility criteria for: Nonfinancial eligibility, as specified in Regulation .03 of this chapter; or Financial eligibility, as specified in Regulation .04 of this chapter; Did not submit, within the time standard specified in Regulation .06B of this chapter: A complete application, signed by the applicant as required by Regulation .05A(3) of this chapter; and All information and verifications requested by the Department pursuant to Regulation .05A(3)—(7) of this chapter, to determine the applicant’s or recipient’s eligibility for the EID coverage group; Did not cooperate with the Department’s eligibility determination process as required by Regulation .05A(9) of this chapter; Did not: Pay the premium required by Regulation .07A of this chapter; or Submit a claim of hardship that was approved by the Department pursuant to Regulation .07C of this chapter; Did not comply with the posteligibility requirements specified in Regulation .09B and C of this chapter; or Died. Certification Period. A recipient's certification period for initial eligibility shall begin on the first day of the month in which the Department receives the application. For a recipient approved by the Department for continuing eligibility, the next certification period shall begin on the first day of the month immediately following the month in which the previous certification period ends. Unless the recipient is terminated before the end of the certification period due to a change in circumstances or other reason for ineligibility, a recipient’s certification period ends, except as provided in §§D(2)(f) and E(4) of this regulation, on the last day of the current 12-month eligibility period. A recipient's certification period may be extended if the Department requires additional time to complete its redetermination of the recipient's eligibility. Department's Responsibility. If it makes a determination as described in Regulation .08A of this chapter, the Department shall: Inform the applicant or recipient of the applicant's or recipient's legal rights and obligations; and Provide to the applicant or recipient written notice of the findings, rights, and obligations as specified in COMAR 10.09.24.12A(2) and (4) and Regulation .08B or C of this chapter. Recipient Responsibility. A recipient or the recipient's representative shall: Notify the Department within 10 business days of changes that may affect the recipient's eligibility for EID; Limit use of the Medical Assistance card to the individual whose name appears on the card; Cooperate with the Department by completing forms to report all pertinent information that would assist the Department in seeking reimbursement for expenditures made on the recipient's behalf; If services covered under the State Plan are provided for injuries resulting from an accident, provide to the Department: Notice as to the time, date, and location of the accident; The name and address of the attorney; The names and addresses of all parties and witnesses to the accident; and The police report number if an investigation is made; If written notice of cancellation is received, discontinue use of the Medical Assistance card on the first day of ineligibility; and Cooperate with the Medical Assistance Quality Control—Program Integrity. A recipient's failure to comply with the provisions of §B(1) of this regulation may result in the adverse consequences specified in COMAR 10.09.24, including: Termination of benefits under this chapter; and Legal action. Additional Recipient Responsibilities Concerning Third Party Reimbursement. A recipient of Medical Assistance in the EID coverage group: Is considered, as specified in COMAR 10.09.24, to have created an authorization for the release of data, records, and information necessary for the Department's pursuit of third-party reimbursement; Shall assign benefits to the Department and cooperate in the Department's recovery procedures as required in COMAR 10.09.24; and Shall assist and cooperate with the Department's efforts to collect available health insurance benefits and other third party payments as specified in this regulation and Regulation .12 of this chapter. Except as provided in §§B and C of this regulation, a recipient in the EID coverage group is covered for medically necessary services required by the recipient, if the services are: Furnished by a provider who, with respect to the services rendered, is approved by the Department to participate in the Medical Assistance Program; Covered under the State Plan; Not covered under ESI or any other health insurance coverage besides Medical Assistance; and Not the subject of any third party liability. Copayments, Deductibles, and Coinsurance. Medical Assistance does not cover any copayments, deductibles, or coinsurance applicable to the ESI coverage of a recipient in the EID coverage group. An EID recipient is not entitled to: Enrollment in the Maryland Medicaid Managed Care Program (HealthChoice) in accordance with COMAR 10.09.62—10.09.75; Enrollment in Rare and Expensive Case Management (REM), in accordance with COMAR 10.09.69; Enrollment in the Program of All-Inclusive Care for the Elderly (PACE) under COMAR 10.09.44; or Long-term care facility services exceeding 30 consecutive days. The requirements for provider participation and reimbursement for services furnished to Medical Assistance recipients in the EID coverage group are governed by the same authorities that apply to services furnished to Medical Assistance recipients in other coverage groups, including: General Medical Assistance Provider Participation Criteria, as specified in COMAR 10.09.36; and Service-specific provisions included within regulations applicable to individual service categories. The provisions of COMAR 10.09.24.14 concerning fraud apply to this chapter. The Department shall make a claim against income or resources, or both, of a recipient for benefits correctly paid, or to be paid, under the circumstances specified in COMAR 10.09.24.15A-1. The Department may impose a lien on the property of a recipient under the circumstances specified in COMAR 10.09.24.15A-2(1). The Department shall seek recovery of Medical Assistance benefits correctly paid as provided in COMAR 10.09.24.15A-3. The Department shall accept reimbursement if voluntarily offered by a current or former recipient or by someone acting on behalf of the current or former recipient. Extended Benefits Pending a Hearing Decision. The Department shall refer for reimbursement consideration all cases in which: A recipient received extended benefits pending a hearing and decision by the hearing officer; and The hearing officer affirmed the decision of the Department that was the subject of the appeal. The Department: Shall institute procedures to recover the cost of any expenditures made on behalf of a recipient in cases identified in §F(1) of this regulation; and May not apply §F(2)(a) of this regulation to an individual who requested a hearing and extended benefits based on a bona fide belief that the adverse action was erroneous. The Department shall refer for investigation and other appropriate action all cases in which a recipient has received coverage erroneously as a result of the action or inaction of the recipient, representative, or individual acting responsibly for the recipient. The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or individual acting responsibly for the recipient. Providers. If a recipient has ESI or other coverage, or if any other individual is obligated, either legally or contractually, to pay for, or to reimburse the recipient for, services covered by this chapter, a provider of covered services shall seek payment from that source before submitting a claim to the Medical Assistance Program. If an insurance carrier rejects the provider's claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Medical Assistance Program, which shall be accompanied by a copy of the insurance carrier's notice or remittance advice. If payment is made by both the Medical Assistance Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Medical Assistance Program or the insurance or other source, whichever is less. A provider shall reimburse the Department for any overpayment. Recipients. A recipient shall assist and cooperate with the Department's efforts to collect available health insurance benefits and other third party payments by: Completing a form designated by the Department to report all pertinent information to assist the Department in seeking reimbursement for services provided; Notifying the Department within 10 days if medical treatment has been provided as a result of any accident or other occurrence in which a third party may be liable for health care services provided to the recipient; and Providing to the Department, as set forth in §J(2) of this regulation, the information required under such circumstances pursuant to COMAR 10.09.24.12 and Regulation .09B(1)(d) of this chapter. An EID applicant or recipient shall have the hearing rights specified in COMAR 10.01.04, subject to the qualification set forth in §B of this regulation. To apply the terms of COMAR 10.01.04 to the hearing rights of an EID applicant or recipient, substitute “the Department” for references therein to the “local department of social services”. Health-General Article, §15-138, Annotated Code of Maryland Effective date: Regulations .01—.13 adopted as an emergency provision effective April 1, 2006 (33:9 Md. R. 795); adopted permanently effective July 3, 2006 (33:13 Md. R. 1063) Regulation .01A amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .02C amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .02C amended effective May 27, 2013 (40:10 Md. R. 917); February 16, 2015 (42:3 Md. R. 316) Regulation .03 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .03B amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087) Regulation .04 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .04 amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087) Regulation .04D amended effective May 27, 2013 (40:10 Md. R. 917) Regulation .05 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .06 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .06C amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .07 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .07 amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .07A amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087) Regulation .08 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .08 amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .09A amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .10C amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .12J amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) Regulation .12J amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .13 amended effective February 16, 2015 (42:3 Md. R. 316) In this chapter, the following terms have the meanings indicated. Terms Defined. “Covered surgical procedures” means those surgical and other medical procedures which meet the criteria specified in 42 CFR Part 416, Subpart F, §416.166(a) and (b), and which are published by the Centers for Medicare and Medicaid Services (CMS) in the Federal Register. “Dental Benefits Administrator (DBA)” means an entity that administers the dental program for the Maryland Department of Health. “Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession. “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. “Free-standing Ambulatory Surgery Center (ASC)” means an entity capable of providing ambulatory surgical services, which is not located in a hospital setting, and which is Medicare-certified to furnish ambulatory surgical services. “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Medicare” means Medicare as defined in COMAR 10.09.36.01. “Medicare-certified facility” means a facility which: Is certified for Medicare by the regional office of the Centers for Medicare and Medicaid Services (CMS) to furnish ambulatory surgical services directly to patients; Has an agreement with (CMS) under Medicare to participate as an ASC; and Meets the conditions set forth by (CMS) in 42 CFR Part 416, Subparts B, C, and F, §416.163. “Patient” means a recipient awaiting or undergoing health care or treatment. “Physician” means an individual legally licensed to practice medicine in the state in which the physician's practice is located. “Podiatrist” means a Doctor of Podiatry (D.P.M.) who is licensed to practice podiatry by the Board or by the state in which the service is rendered. “Program” means Program as defined in COMAR 10.09.36. “Provider” means a free-standing ambulatory surgical center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number. “Recipient” means recipient as defined in COMAR 10.09.36.01. License requirements under this chapter are referenced in COMAR 10.09.36.02. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of the Maryland Radiation Act, Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02 or other applicable standards established by the state in which the service is provided. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or 10.10.06, as applicable; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03 and 42 CFR, Part 416, Subpart B. Specific requirements for participation in the Program are that the provider shall meet all specific conditions for participation as set forth in 42 CFR, Part 416, Subpart C, to include the following: Be approved by Medicare to furnish ambulatory surgical services to patients and maintain documentation of certification by the Department of Health and Human Services and the Centers for Medicare and Medicaid Services; Have clearly defined, written, patient care policies; Maintain adequate documentation of each recipient visit as part of the plan of care, which at a minimum, shall include: Date of service; Recipient's reason for visit; A brief description of service provided, and A legible signature and printed or typed name of the professional providing care, with the appropriate title; Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01; Be approved by the state in which the service is provided, except where a Certificate of Need is not required; Provide for in-house Program evaluation and clinical record review which assess use of services for appropriateness in meeting a recipient's needs; Refer laboratory testing only to independent medical laboratory providers. The Program covers the following: Medically necessary facility services rendered to recipients in a free-standing Medicare-certified ambulatory surgical center; Diagnostic, curative, palliative, or rehabilitative services, when clearly related to the recipient's individual needs; Surgical procedures which meet the standards described in 42 CFR Part 416, Subpart D, §416.65, and as published by the Centers for Medicare and Medicaid Services; and Dental services that have been pre-authorized by the Dental Benefits Administrator (DBA). The Program does not cover the following: Services not specified in Regulation .04 of this chapter; Services not medically necessary; Investigational and experimental drugs and procedures; Services denied by Medicare as not medically justified; Separate billing of services which are included in the composite Medicare rate for an ambulatory surgical center; Surgical procedures which: Generally result in extensive blood loss; Require major or prolonged invasion of body cavities; Directly involve major blood vessels; Are generally emergency or life-threatening in nature; Commonly require systemic thrombolytic therapy; Are designated as requiring inpatient care (overnight); Can only be reported using a CPT unlisted surgical procedure code; or Are otherwise excluded under 42 CFR §411.15(a)—(h) and (j)—(s); Physicians' services, including surgical procedures and all preoperative and postoperative services performed by a physician; Anesthesia services; Radiology services other than those integral to performance of a covered surgical procedure; Diagnostic procedures other than those directly related to a covered surgical procedure; Ambulance services; Leg, arm, back, and neck braces other than those that serve the function of a cast or splint; Artificial limbs; or Non-implantable prosthetic devices and durable medical equipment (DME). The Program reimburses a facility fee when the free-standing Medicare certified ambulatory surgery center provides a covered surgical procedure, in accordance with 42 CFR §416.166 to an eligible Medicaid recipient. Reimbursement for the facility fee includes, but is not limited to the following: Nursing, technician, and related services; Use of the facility; Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances, and any equipment directly related to the provision of surgical procedures; Administrative costs; Materials including supplies and equipment for the administration and monitoring of anesthesia; Radiology services for which separate payment is not allowed and other diagnostic tests or interpretive services that are integral to a surgical procedure; Supervision of the services of a nurse anesthetist by the operating surgeon; Ancillary items and services that are integral to a covered surgical procedure as defined in 42 CFR §416.166; and Any laboratory testing performed under a Clinical Laboratory Improvement Amendment of 1988 (CLIA) certificate of waiver. Reimbursement Methodology: Reimbursement fees equal 80 percent of the current Medicare-approved ASC facility fee for services furnished to Medicaid recipients in connection with covered surgical procedures. If one covered surgical procedure is furnished to a recipient, payment is at the Maryland Medicaid Program payment amount which is 80 percent of the current Medicare approved facility fee for that procedure. If more than one covered surgical procedure is provided to a recipient in a single operative session, payment is made at 100 percent of the Maryland Medicaid Program payment amount for the procedure with the highest reimbursement rate. Other covered surgical procedures furnished during the same session are reimbursed at 50 percent of the Maryland Medicaid Program payment amount for each procedure. When a covered surgical procedure is terminated before the completion due to extenuating circumstances or circumstances that threaten the well-being of the patient, the Medicaid Program payment amount is based on one of the following: If the covered procedure for which the anesthesia is planned is discontinued after the induction of anesthesia or after the procedure is started, the reimbursement amount is 80 percent of the current Medicare approved facility fee; or If the patient is prepared for surgery and the surgery is then cancelled before the induction of anesthesia, reimbursement shall be 50 percent of Maryland Medicaid payment amount. Dental services rendered in an ASC on or after December 1, 2014, shall be reimbursed as follows: For covered dental services that have a reimbursement amount of $1,000 through $2,999.99, the ASC facility fee will be $600; For covered dental services that have a reimbursement amount of $3,000 through $4,999.99, the ASC facility fee will be $1,250; For covered dental services that have a reimbursement amount of $5,000 through $7,999.99, the ASC facility fee will be $2,500; and For covered dental services that have a reimbursement amount of $8,000 and over, the ASC facility fee will be $3,000. The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. The Program reserves the right to return to the provider, before payment, all invoices not properly completed, including but not limited to, diagnostic and procedure codes and description of services provided. The Program shall authorize payment on Medicare cross-over claims only if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; and Medicare has determined that the services are medically justified, excludes dental services. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: Deductible is paid in full; Coinsurance shall be paid lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of Regulation .04C of this chapter. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail or telephone; or Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. The Program shall make no direct payment to a recipient. The Program shall make no separate direct payment to any person employed by or under contract to any free-standing Medicare-certified ambulatory surgical center facility for services covered under this regulation. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. Appeal procedures under this chapter are set forth in COMAR 10.09.36.09. Interpretive regulations under this chapter are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: September 2, 1991 (18:17 Md. R. 1918) Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) Regulation .02B amended effective March 16, 2015 (42:5 Md. R. 485) Regulation .02C amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03 amended effective March 16, 2015 (42:5 Md. R. 485) Regulation .03B amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .04C amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) Regulation .04D adopted effective March 16, 2015 (42:5 Md. R. 485) Regulation .05 amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .05F amended effective March 16, 2015 (42:5 Md. R. 485) Regulation .06 amended effective April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) Regulation .06B amended effective April 12, 2004 (31:7 Md. R. 584) Regulation .06H amended effective July 4, 2016 (43:13 Md. R. 712) This chapter governs the determination of eligibility and the conditions of participation for MCHP Premium with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014. In this chapter, the following terms have the meanings indicated. Terms Defined. “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). “Applicant” means a child or the child's representative who has filed a written, telephonic, or electronic application for health coverage in an Insurance Affordability Program to the Department or its designee but has not received final action. “Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an Insurance Affordability Program to the Department or its designee. “Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. “Authorized representative” has the meaning stated in COMAR 10.01.04.12. “Department” means the Maryland Department of Health. “Designee" means any entity designated to act on behalf of the Department such as: Baltimore City or a county social services department under the supervision of the Department of Human Services; Baltimore City Health Department and its subgrantees, or a county health department; and The Maryland Health Benefit Exchange “Determination” means a decision regarding an applicant's eligibility for MCHP Premium. “Eligible individual” means a child who meets all nonfinancial eligibility requirements to participate in MCHP under COMAR 10.09.11 and whose family income is above 200 percent but at or below 300 percent of the federal poverty level. “Family contribution” means the portion of the premium cost paid for an eligible individual to enroll and participate in MCHP Premium. “Family member” means an individual living with the applicant whose income is counted, or would be counted as family income under Regulation .07 of this chapter. “Federal poverty level (FPL)” means the non-farm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981. “Group health plan” has the meaning stated in 42 U.S.C. §300gg-91. “Hardship” means unreasonable financial adversity or misfortune. “Health insurance coverage” has the meaning stated in 42 U.S.C. §300gg-91. “Inpatient services” means services received by a recipient while in a medical institution, birthing center, or clinic for which Medical Assistance is provided. “Institution for mental disease (IMD)” has the meaning stated in COMAR 10.09.62.01B(78)(a). “Insurance Affordability Program” means a program that is one of the following: The Maryland State Medicaid program; The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; An optional State basic health program established under §1331 of the Affordable Care Act; A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; or A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act. “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. “MAGI Exempt Coverage Group” means coverage groups such as Aged, Blind, Disabled; Categorically Needy; and Medically Needy as defined under COMAR 10.09.24.02, whose eligibility is not determined by MAGI. “Managed care organization (MCO)” means: A certified health maintenance organization that is authorized to receive Medical Assistance prepaid capitation payments; or A corporation that: Is a managed care system that is authorized to receive Medical Assistance prepaid capitation payments; Enrolls only program recipients, individuals, or families served under the Maryland Medicaid Managed Care Program; and Is subject to the requirements of Health-General Article, §15-102.4, Annotated Code of Maryland. “Maryland Children's Health Program (MCHP)” means the program established in Health-General Article, §15-301(b)(1), Annotated Code of Maryland, to provide comprehensive medical care and other health care services to certain children. “Maryland Health Benefits Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program. “Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.09.62.01B(88). “MCHP Premium” means the program established in Health-General Article, §15-301.1 et seq., Annotated Code of Maryland, to provide access to health coverage to eligible individuals through managed care organizations (MCOs) under MCHP. “Medical institution” means an institution that: Is organized to provide medical care, including nursing and convalescent care; Has the necessary professional equipment and facilities to manage the medical, nursing, and other health needs of a patient on a continuing basis in accordance with accepted standards; Is authorized under State law to provide medical care; and Is staffed by medical and nursing professionals. “Period under consideration” means the specific months that are assessed in order to determine eligibility for MCHP Premium. Public Institution. “Public institution” means an: Institution that is the responsibility of a government unit or over which a government unit exercises administrative control; or Establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. “Public institution” does not include a medical institution, a skilled nursing facility, or a publicly operated community residence that serves fewer than 17 residents. “Qualified alien” means an individual who: Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA); Has been granted asylum in the United States as a refugee under §208 of the INA; Has been admitted into the United States as a refugee under §207 of the INA; Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year; Has had deportation withheld under §243(h) of the INA; Has been granted conditional entry into the United States under §203(a)(7) of the INA which was in effect before April 1, 1980; Is a documented or undocumented immigrant who has been battered or subjected to extreme cruelty by the individual's U.S. citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the alien, if: The spouse or parent consented to, or acquiesced in, the battery or cruelty; The immigrant has filed a Violence Against Women Act (VAWA) immigration case or a family-based visa petition with INS; and In the opinion of the agency providing benefits, there is a substantial connection between the battery or cruelty and the need for the benefits to be provided; Is a victim of a severe form of trafficking who has been subjected to: Sex trafficking, if the act is induced by force, fraud, or coercion, or if the individual induced to perform the act is younger than 18 years old; or Involuntary servitude; Is a member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or Is an American Indian born in Canada to whom §289 of the Immigration and Nationality Act applies. “Recipient” means a child younger than 19 years old who is certified as eligible for MCHP Premium. “Redetermination” means a determination regarding the continuing eligibility of a recipient. “Representative” means: A parent or parents living with the applicant; The applicant's guardian; or The applicant's authorized representative. “Title XXI” means the title of the Social Security Act through which funding is provided, in part, for MCHP Premium. Eligibility may be established for the MCHP Premium Program for children younger than 19 years old whose household income is above 200 percent but at or below 300 percent of the Federal Poverty Level. The Department or its designee shall determine eligibility for children. The Department or its designee shall give oral, written, or electronic information about MCHP Premium such as: Requirements for eligibility; Available services; An individual's rights and responsibilities; Information in plain English, supported by translation services; and Information accessible to disabled individuals requesting an application. An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply. The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means, and in a manner accessible to disabled individuals requesting an application. Applicant Temporarily Absent from the State. If an applicant is temporarily absent from the State, the applicant or the applicant's representative may apply for assistance by telephone, mail, in person, internet, and other electronic means to the Department or its designee in any jurisdiction. To establish eligibility for MCHP Premium for an applicant temporarily absent from the State, the applicant or the applicant's representative shall: Affirm that: The applicant intends to return to the State; or The applicant's parent or guardian intends to return the applicant to the State; Demonstrate the applicant's continued residency in the State; and Meet other technical and financial requirements. Application Filing and Signature Requirements. An individual who wishes to apply for health coverage under Insurance Affordability Program shall submit a written, telephonic, or electronic application, signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice. A signed application is required for all applicants who request assistance. If, after the completion of an eligibility determination, assistance is requested for additional family members, a signed application is required for those persons. The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee. The following individuals shall complete and sign a written or electronic application: An applicant; An applicant’s parents living with the child applicant; or If the applicant does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application form. An applicant who has filed a written, telephonic, or electronic application may voluntarily withdraw that application, but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §H of this regulation. Period Under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established under §F(3) of this regulation, for a 12-month period beginning with the month of application. Processing Applications — Time Limitations. When a written, telephonic or electronic application is filed, a decision shall be made promptly, but not later than 60 calendar days from the application date. The time period specified in §I(1) of this regulation covers the period from the application date to the date the Department or its designee sends a written or electronic notice of its decision to the applicant or the applicant's representative. The Department or its designee shall inform the applicant by written or electronic notice of the missing information needed to determine eligibility, and the applicable time limit. When an applicant fails to complete the application or to provide the required information needed to determine eligibility within the 60 calendar day limit provided under §I(1) of this regulation, the applicant shall be determined ineligible. The Department or its designee shall provide notice of delay for extenuating circumstances within 60 calendar days of the delay, stating the reason for the delay and the anticipated date of decision. If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, a new period under consideration shall be established based on the date the new application is filed. Information Required. All information needed to determine eligibility for the MCHP Premium shall be reported. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. The applicant shall provide the additional information within a reasonable time limit as established by the Department. If the applicant fails to provide required information within the 60 calendar days, the applicant shall be determined ineligible. Social Security Number. As a condition of eligibility, an applicant shall furnish to the Department or its designee a Social Security number for the applicant. If the applicant cannot furnish a Social Security number, the applicant shall apply for a number. Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant complies with this subsection. Eligibility may not be established until the applicant: Furnishes a Social Security number; or Requests the assignment of the number through the Social Security Administration. Failure to provide the required Social Security number shall result in ineligibility for the applicant. If an applicant lacks the resources to meet the requirements of this regulation, the Department or its designee services shall assist the applicant in obtaining the necessary documents, and any costs incurred shall be paid for out of administrative funds. If the application indicates that a Social Security number was issued previously, the Department or its designee shall request validation of the number by the Social Security Administration. Third-Party Liability. An applicant shall notify the Department or its designee within 10 working days if medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party may be liable for the recipient's medical expenses. An applicant shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. In accident situations, a representative shall notify the Department or its designee of the: Time, date, and location of the accident; Name and address of the attorney; Names and addresses of all parties and witnesses to the accident; and Police report number if an investigation is made. Consent Forms. An applicant shall give consent to verify information to establish eligibility to the Department or its designee, by submitting a written, telephonic, or electronic application. Citizenship. In order to be eligible for full benefits under MCHP Premium, an applicant shall be one of the following: A citizen of the United States; A person residing in the United States who is: A qualified alien as defined under Regulation .02B of this chapter; An honorably discharged veteran of the armed forces of the United States; An alien on active duty in the armed forces of the United States; or The spouse, including a surviving spouse who has not remarried, or unmarried dependent child of an honorably discharged veteran of or alien on active duty in the armed forces of the United States; An individual residing in the United States who is: An alien who has been granted asylum under §208 of the Immigration and Nationality Act; A refugee admitted into the United States under §207 of the Immigration and Nationality Act; An alien whose deportation has been withheld under §243(h) of the Immigration and Nationality Act; A Cuban or Haitian entrant; An alien admitted to the country for permanent residence as an Amerasian immigrant under Title II of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1989; A legal permanent resident who first entered the country under another exempt category, that is, as a refugee, asylee, Cuban or Haitian entrant, trafficking victim, or alien whose deportation was being withheld, and who later converted to legal permanent resident status; A victim of a severe form of trafficking who has been subjected to: Sex trafficking, if the act is induced by force, fraud, or coercion, or if the individual induced to perform the act is younger than 18 years old; or Involuntary servitude; An honorably discharged veteran of the armed forces of the United States; An alien on active duty in the armed forces of the United States; or A spouse, including a surviving spouse who has not remarried, or unmarried dependent child of an honorably discharged veteran or alien on active duty in the armed forces of the United States; or An individual residing in the United States who is a qualified alien as defined under Regulation .02B of this chapter. Residency. The requirements relating to residency under COMAR 10.09.24.05-3 apply to this chapter. Age. In order to be eligible for benefits, under this chapter a child shall be younger than 19 years old. Inmate of a Public Institution. In order to receive benefits under this chapter, an applicant may not be an inmate of a public institution. Institution for Mental Diseases or Mental Hospital. An applicant who is a patient in an institution for mental diseases or mental hospital is not eligible for benefits under this chapter. Access to or Coverage under Other Health Benefit Plans. Current Coverage. Except for coverage purchased in the context of participating in MCHP Premium, an applicant or recipient is not eligible for MCHP Premium if the applicant or recipient is covered: As a dependent under an employer-sponsored group health plan; or Under health insurance coverage. Past Coverage. In order to be eligible for benefits under this chapter, an applicant may not be covered by employer-sponsored insurance or have been voluntarily terminated from an employer-sponsored insurance within 6 months before the date of the application, except for coverage purchased in the context of participating in MCHP Premium. Voluntary termination does not include: Loss of employment due to factors other than voluntary termination; Change to a new employer that does not provide an option for dependent coverage; Change of address so that no employer-sponsored health benefit plan is available; Discontinuation of health benefits to all dependents of employees of the parent's or guardian's employer; or Expiration of the applicant's continuation of coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA). Duration of Eligibility. After an individual has been determined to be eligible for MCHP Premium and is enrolled in MCHP Premium: The Department shall periodically redetermine the recipient's eligibility for MCHP Premium as specified in Regulation .15D of this chapter; and The recipient or the recipient's representative shall, within 10 days of the occurrence, notify the Department if there is a change in the recipient's, the recipient's parent's, or the recipient's guardian's: Income; Employment; Address; or Health insurance coverage status. The applicant shall report the income of each family member, except for the income of members that do not file a federal tax return and are not claimed as a federal tax dependent. Determining Countable Household Income. In determining an applicant's financial eligibility for MCHP Premium, the applicant's current household income shall be considered. For the child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the applicant and the applicant's parent or parents, if living with the applicant. For the married child applicant, household income shall consist of the income of the married child applicant and the married child applicant's spouse. When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application. Treatment of Income. Countable gross income for the Maryland Children’s Health Program shall be the household income calculated according to MAGI. MAGI income limits shall be: Converted from traditional income limits to account for elimination of income disregards; and Increased by 5 percentage points of the federal poverty level for the following circumstances: When an individual’s income exceeds the Medicaid income standard; and The income standard is the highest income standard under which the individual can be determined eligible. Household Composition. For purposes of determining the income standard applicable to an applicant the following rules apply: An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made. For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: Spouse; and Natural, adopted or step children. In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals: Natural, adopted, or step parents; and Natural, adopted, or step siblings. In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made. No resources or assets test may be applied to applicants or recipients who are subject to a MAGI-based income test. Current and New Enrollees. An applicant is financially eligible for MCHP Premium if, for the period under consideration, the applicant's countable household income as determined under Regulation .06 of this chapter, is greater than 200 percent but not greater than 300 percent of the federal poverty level for the number of persons in an applicant’s tax-dependent unit equal to the size of the applicant's family. The certification period begins the first day of the month in which the eligible child is enrolled in a MCO. Duration of Certification Period. The initial certification period, or the certification period beginning after a period of ineligibility for MCHP Premium, shall end not later than 1 year from the beginning month of certification for MCHP Premium. Notwithstanding §B(1) of this regulation, the certification period may be shortened: If a determination of ineligibility is made; or At the request of the representative. A child who, on the day the child becomes 19 years old, is receiving acute inpatient services under MCHP Premium and who, but for attaining that age, is otherwise eligible for MCHP Premium, shall remain eligible for MCHP Premium until the end of the stay for which acute inpatient services are furnished. Individuals may be certified for a period of continuous eligibility as described in COMAR 10.09.24.12. A child enrolled in MCHP Premium is eligible for all health benefits included in the Maryland Medicaid Managed Care Program, as set forth in COMAR 10.09.67, the school-based health centers program as set forth in COMAR 10.09.68, and the rare and expensive case management. An eligible individual who is enrolled in MCHP Premium shall be covered through a Maryland Medicaid Managed Care MCO. Timely Enrollment. The representative shall: Send to the Department or its designee the first month's family contribution within 30 days of receiving notice of eligibility for MCHP Premium, before enrollment can be completed; and Complete and submit to the Department's enrollment broker a MCO selection and enrollment form within 28 days of receiving notice of eligibility for each eligible child. Family Contribution Required. As a requirement of enrollment and participation in MCHP Premium, the representative of an eligible individual shall agree to pay the following annual family contribution: For an eligible individual whose family income is above 200 percent but at or below 250 percent of the FPL, an amount equal to 2 percent of the annual income of a family of two at 200 percent of the FPL; and For an eligible individual whose family income is above 250 percent, but at or below 300 percent of the FPL, an amount equal to 2 percent of the annual income of a family of two at 250 percent of the FPL. The family contribution amounts required under §A of this regulation apply on a per family basis regardless of the number of eligible individuals each family has enrolled in MCHP Premium. American Indians and Alaskan Natives are exempt from a family contribution requirement. Payment Procedures. The representative shall send the initial month's payment to the Department or its designee by electronic transfer, money order, or check. For months following the initial month of coverage: The Department or its designee shall bill at the start of each month for the next month's family contribution and shall provide a self-addressed stamped envelope for return of the family contribution; The representative shall make the family contribution payment in full to continue coverage, unless the representative claims that payment will cause hardship as defined in Regulation .02B of this chapter; The Department or its designee shall notify the applicant of the amount due and instruct on the manner of payment and date due, if timely payment has not been made; and The applicant shall make payment in full of amounts due to the Department or its designee no later than 30 days after the date of issuance of a request for payment, to ensure continuing eligibility unless the representative claims that payment will cause hardship as defined in Regulation .02B of this chapter. Hardship. The applicant shall submit the claim of hardship in writing within 10 days of receipt of the Department's request for payment. The Department shall evaluate claims of hardship and notify the applicant of the decision within 30 days of receipt of the written claim of hardship. The applicant shall report any change in family status or family composition within 10 days of the change. Change in family status includes increase or decrease in the number of family members through birth, death, marriage, adoption, separation, divorce, or the voluntary or involuntary removal of a family member from residence with the family. The applicant shall complete a written, telephonic, or electronic application and file it with the Department or its designee in any jurisdiction to apply for coverage for a child added to the family, including a newborn child, unless the newborn child's mother was eligible for Medicaid when the child was born. For all changes except addition of a child, the Department or its designee shall evaluate the effect of the change on continued eligibility for MCHP Premium and notify the applicant of its determination within 60 days of the report of the change. Notice of Eligibility Determination. The Department or its designee shall inform the applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following: For eligible individuals: The basis and effective date for eligibility; Instructions for reporting changes that may affect the recipient’s eligibility; and The right to request a hearing; and For ineligible individuals: A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; Information regarding application for MAGI excluded coverage groups; and The right to request a hearing. Applicant Responsibility. The applicant shall notify the Department within 10 working days of changes affecting the applicant’s eligibility. Only an applicant that has been determined eligible by the Department or its designee shall use MCHP Premium benefits. If written or electronic notice of cancellation is received, the applicant shall discontinue use of MCHP Premium benefits on the first day of ineligibility. Failure to comply with the provisions of §B(1)—(3) of this regulation may result in: The termination of assistance; or Referral to the Department for fraud investigation, or for criminal or civil prosecution. The applicant shall cooperate with the Department’s quality control review process, including verification of all information pertinent to the determination of eligibility. If the applicant refuses to cooperate, the applicant’s coverage shall be terminated. Unscheduled Redetermination. The Department shall: Promptly make an unscheduled redetermination of a recipient's eligibility if changes in circumstances or relevant facts are: Reported by someone on the applicant’s behalf; or Brought to the attention of the Department from other responsible sources; and Notify the applicant of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. Eligibility Decisions. Recipients who are determined: Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or Ineligible for the remainder of the certification period because of a change in circumstances or failure to establish eligibility following a change in circumstances, shall be sent notice in accordance with §A(2) of this regulation. A recipient whose eligibility has been canceled may reapply for MCHP at any time. Scheduled Redetermination. Redetermination is required to establish continued eligibility. Redetermination shall be scheduled annually. Completion of the application and determination of eligibility for MCHP by the Department or its designee is required for renewal for program eligibility. The requirements relating to hearings under COMAR 10.01.04 apply to this chapter. The requirements relating to fraud and recipient abuse under COMAR 10.09.24.14 apply to this chapter. A person convicted of fraud under this chapter is subject to penalties as described in Criminal Law Article, §§8-516 and 8-517, Annotated Code of Maryland. In all cases where MCHP Premium benefits have been incorrectly paid, the Department shall seek recovery pursuant to COMAR 10.09.24.15. State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services for MCHP Premium recipients without regard to the availability of federal financial participation. Health-General Article, §§2-104(b), 15-101(f), 15-103(a)(2), 15-301.1, and 15-302—15-304;Insurance Article, §§15-1208, 15-1213, 15-1406, and 27-220;Annotated Code of Maryland; Ch. 202, Acts of 2003 Effective date: Regulations .01—.19 adopted as an emergency provision effective July 1, 2001 (28:12 Md. R. 1102); adopted permanently effective September 3, 2001 (28:17 Md. R. 1556) Regulation .02B amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .02B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) Regulation .03 amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .03 amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) Regulation .04E amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .05A amended effective November 10, 2003 (30:22 Md. R. 1580); April 19, 2010 (37:8 Md. R. 614) Regulation .05F, G amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .09 amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .09 amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) Regulation .10A and B amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .11 amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .12 amended as an emergency provision effective July 1, 2002 (29:16 Md. R. 1284); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .12 amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .13 amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .13A amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) Regulation .14 amended effective November 10, 2003 (30:22 Md. R. 1580) Regulation .15D amended effective November 10, 2003 (30:22 Md. R. 1580) Chapter revised effective January 6, 2014 (40:26 Md. R. 2162) Regulation .10D adopted effective April 13, 2026 (53:7 Md. R. 328) Regulation .13F amended effective April 13, 2026 (53:7 Md. R. 328) In this chapter, the following terms have the meanings indicated. Terms Defined. “Amount that would otherwise have been paid (AWOP)” means the amount the Program expects to have paid for services for a PACE participant under the State Plan had the participant not enrolled under the PACE program. “Community spouse” means an individual who: Lives in the community outside a long-term care facility; Is not determined to meet the criteria for participation for: PACE under this chapter; or A waiver under §1915(c) of the Social Security Act; and Is married to an institutionalized spouse. “Continuous period of institutionalization” means at least 30 consecutive days of institutional care in a long-term care facility. “Contract” means a written agreement between a PACE provider and a third party under which the third party agrees to perform one or more of the PACE provider's obligations under this chapter or the PACE agreement. “Capitation payment” means the sum of money paid in advance on a monthly per capita basis to a PACE provider by the Department on a participant's behalf for the PACE provider benefit package specified in the PACE Program Agreement. “Centers for Medicare and Medicaid Services (CMS)” means the federal administering agency for the Medicare and Medicaid program benefits in PACE. “Contractor” means an entity with which the PACE provider has a contract agreement. “Contract year” means the term of a PACE Program Agreement, which is a calendar year, except that a PACE provider's initial contract year may be from 12 to 23 months, as determined by CMS. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01B, or its authorized agents acting on its behalf. “Eligible person” means any person who meets the eligibility requirements for enrollment in the PACE program as specified in the PACE program agreement and Regulation .05 of this chapter. “Emergency medical condition” means a medical condition characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in: Placing the individual's health in serious jeopardy; Serious impairment to bodily functions; or Serious dysfunction of any bodily organ or part. “Emergency services” means health care services that are: Covered under the PACE provider benefit package; Provided to a PACE participant with an emergency medical condition; Rendered by entities who are not employees or agents of the PACE provider and with whom the PACE provider does not have a contract; and Provided in a hospital emergency facility or a free-standing urgent care center as defined in COMAR 10.09.77.01. “Insolvency” means that the entity's net tangible equity or fund balance is negative and results from total program expenditures exceeding total program revenues to date. “Institutionalized spouse” means an individual who is married to a community spouse and who is: An inpatient in a long-term care facility with a length of stay exceeding 30 days; or Determined to meet the criteria for participation for: PACE under this chapter; or A waiver under §1915(c) of Title XIX of the Social Security Act. “Long-term care facility” means a nursing facility, intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID), chronic hospital, tuberculosis hospital, or psychiatric hospital. “Medicaid Provider Agreement” means the agreement between Medicaid providers, including PACE providers, and the Department that allows providers to provide services to Medicaid participants “Medical Assistance Program” means the Maryland Medical Assistance Program, as defined in COMAR 10.09.36.01B. “Medically necessary” means directly related to diagnostic, preventive, curative, palliative, or rehabilitative treatment. “Medicare” means the federal program that provides benefits to aged or disabled individuals under Title XVIII of the Social Security Act. “PACE enrollment limit” means the maximum number of Medicaid participants permitted to the PACE provider as declared in the State Certification Page of the CMS PACE provider application. “PACE benefit package” means a prepaid, comprehensive package of all the health care services to which a PACE provider's participants are entitled under the State Plan when the services are medically necessary and appropriate. “PACE center” means a facility operated by a PACE provider where primary care is furnished to participants. “PACE Organization Provider Agreement” is the agreement between the PACE Provider and the Department that contains provisions to provide additional protections to PACE participants. “PACE participant” means an eligible person who voluntarily enrolls and enters into an agreement with a PACE provider or an eligible person who is enrolled by a legal representative. “PACE provider” means an entity that is approved by the Department and CMS to provide the PACE benefit package covered under this chapter to Medical Assistance participants. “PACE Program Agreement” means a written, signed agreement between the Department, CMS, and the PACE provider, which specifies the terms of the relationship between the Department and the PACE provider and authorizes the PACE provider to operate in the State. “Participant” means an individual who is certified by the Department as eligible to receive Medical Assistance Program benefits. “Primary care” means health care services that address an individual's general health needs, including the coordination of the individual's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, maintenance of the individual's health records, and referral for medically necessary and appropriate specialty care. “Primary care provider” means a practitioner who provides a participant's primary care services and is the primary coordinator of all other health care services for the participant, responsible for providing or assuring access to continuous, comprehensive, and coordinated health care services covered in the PACE benefit package. “Professional standards” means professional requirements set forth in the Annotated Code of Maryland or by the national accrediting body for a practitioner's profession. “Program” means the Medical Assistance Program, as defined in COMAR 10.09.36. “Programs of All-Inclusive Care for the Elderly (PACE)” means a jointly administered capitated Medicare/Medicaid program providing medical and long term care services to nursing home eligible, frail, elderly participants. “Quality Assurance and Performance Improvement Plan (QAPI)” means a document or series of documents that set forth a PACE provider's strategy for systematically monitoring, evaluating, and improving all facets of operations including, but not limited to, clinical health care delivery, participant assistance and outreach services, and administrative services. “Secretary” means the Secretary of Health. “Service area” means a defined geographic area selected by the PACE provider and approved by the Department in the PACE program agreement, in which the complete PACE benefit package is available to all the PACE provider's participants, and beyond which the PACE provider is restricted from directly marketing its services. “Services” includes both items and services. “State Plan” means the plan for the Medical Assistance Program as submitted by the Department and approved by the Secretary of the U.S. Department of Health and Human Services pursuant to Title XIX of the Social Security Act, as modified or amended. “Trial period” means the first 3 contract years in which a PACE organization operates under a PACE program agreement, including any contract year during which the entity operated under a PACE demonstration waiver program. “Urgent care” means health care services for a medical condition that manifests itself by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent layperson who possesses an average knowledge of health and medicine, to result in an emergency medical condition. An applicant for participation in the Program as a PACE provider shall submit to the Department and CMS a complete PACE application that describes how the entity meets all requirements in 42 CFR 460 et seq. The PACE provider shall comply with: 42 CFR 460 et seq.; This chapter; The Medicaid provider agreement and the PACE Organization Provider Agreement signed with the Department; COMAR 10.09.36; Standards in P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; Any other applicable regulations, transmittals, and guidelines issued by the Department that are in effect; and All other requirements of applicable federal and State law. The PACE provider shall have a signed PACE program agreement with the Department and CMS which establishes the terms of the relationship between the PACE provider and the Department. The PACE provider shall obtain approval by the Department before establishing additional care sites. The PACE provider shall obtain approval by the Department before expanding its service area. Professional and Administrative Standards. The PACE provider shall have the professional and administrative ability and staffing to carry out its duties and responsibilities according to the PACE Program Agreement and PACE Organization Provider Agreement, which shall include the following: A full-time administrator; Sufficient allied health, medical social work, clerical, and support staff to provide proper medical care within acceptable professional standards; A demonstrated ability to deliver health services within the service area according to standards established by the Department; A management information system, which shall: Meet the requirements of Regulations .14 and .15 of this chapter; and Maintain medical and financial records for 10 years; An acceptable PACE participant grievance and appeals procedure and system for reporting the disposition of grievances and appeals to the Department, as specified in Regulation .19 of this chapter; A procedure established to provide PACE participants an ability to participate in matters of policy and operation; and A sufficient quality assurance and performance improvement system, as specified in Regulation .13 of this chapter. Nondiscrimination. In connection with the performance of its obligations under this chapter, the PACE provider shall comply with all applicable federal and State laws, regulations, or orders which prohibit discrimination on grounds of race, age, creed, sex, color, national origin, marital status, physical or mental handicap, health status, or need for health services. Provision of Services and Health Care Delivery. A PACE provider shall provide: The services set forth in Regulation .09 of this chapter and covered under the PACE provider benefit package: Promptly and continuously, consistent with accepted medical practice and community professional standards; and Through its own employees and agents or through contractors, except for emergency services; and Written notice to PACE participants if there is a significant change in the nature, location, or provider of services provided. The PACE provider may not knowingly have as a director, officer, partner, or owner of more than 5 percent of the entity's equity, a person or an affiliate of a person who is or has been debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued pursuant to federal Executive Order No. 12549 or under guidelines implementing such an order. The PACE provider may not knowingly have an employment, consulting, or other agreement with a person described in §H of this regulation, for the provision of items and services that are significant and material to the PACE provider's obligations under this chapter. The PACE provider and its agents and employees, in the performance of the services covered under this chapter, shall act in an independent capacity and may not act as officers, employees, or agents of the Department. An individual employed by the State or any department, commission, agency, or branch of the State, whose duties include matters relating to or affecting the subject matter of this chapter, may not be an employee of a PACE provider. Any obligations of the PACE provider set forth in this chapter may be waived by the Department, but the waiver extends only to the particular case, time, and manner specified by the Department and is not a waiver of any other provision of this chapter. If the PACE Program Agreement exempts the PACE provider from financial responsibility for any services available under the State Plan, the PACE provider shall be required by the PACE Organization Provider Agreement to provide for these services. Liability. The PACE provider shall be wholly at risk for all medically necessary and appropriate services covered under the PACE provider benefit package. The Department may not make additional payment for services under this section. The PACE provider may not collect any payment from a PACE participant except as specified in Regulation .05 of this chapter. The PACE provider is solely responsible for ensuring that it does not issue payments for services for which it is not liable in its PACE Organization Provider Agreement, and the Department may not accept responsibility for refunding to the PACE provider any excess payments made by the PACE provider. The duration or term of the agreement between the Department and the PACE provider is specified in the PACE Organization Provider Agreement. The PACE Organization Provider Agreement shall provide for automatic amendment, renegotiation, or termination, or all of the above, of the PACE Organization Provider Agreement by either party if any part of the PACE Organization Provider Agreement's provider benefit package is changed under the State Plan. Termination. The Department may terminate immediately the PACE Organization Provider Agreement upon notification: By the U. S. Department of Health and Human Services, that it is withdrawing federal financial participation in all or part of the cost of the PACE benefit package; By the Department of Budget and Management, of the unavailability of sufficient State funds for the PACE benefit package; or That the owners or managers of the PACE provider, or other persons with substantial Medicaid Provider Agreement relationships with the PACE provider, have been convicted of certain crimes or received certain sanctions as specified in §1128 of the Social Security Act. The Department may, at its sole discretion, offer to renegotiate any provision of the PACE Organization Provider Agreement if renegotiation would remove any of the causes of termination specified in §C(1) of this regulation. This offer is not a waiver of the Department's right of immediate termination. The PACE Organization Provider Agreement may be terminated by either the Department or the PACE provider if the other party fails to meet a provision of: This chapter; The PACE Organization Provider Agreement; or Applicable laws, rules, regulations, or guidelines effective as of the date of the PACE Organization Provider Agreement or enacted or established during the PACE Organization Provider Agreement's term. A PACE Organization Provider Agreement's termination is effective only after the terminating party has notified the breaching party in writing of the cause or causes of termination and has allowed 60 days for the correction or alleviation of the cause or causes by the breaching party. Termination of Agreement by PACE. The PACE provider may terminate an agreement after timely notice to CMS, the Department, and PACE participants, as follows: To CMS and the Department, 90 days before termination; and To PACE participants, 60 days before termination. Default by PACE. The Department may immediately terminate the PACE Organization Provider Agreement if the PACE provider defaults, as specified in §D(3) of this regulation. If the PACE provider defaults, the Department may recover any capitation payments issued to the PACE provider for periods after the termination effective date of the PACE Organization Provider Agreement. The following are defaults by the PACE provider: Inability to provide the services described in the PACE provider benefit package and in Regulation .09 of this chapter; or Insolvency. Nonexclusivity of Remedy. This regulation's provisions supplement, rather than replace, any other sanctions or remedies available to the Department under the provisions of Regulation .24 of this chapter, the PACE Organization Provider Agreement, the Medicaid Provider Agreement, or applicable law or regulations. If the PACE Program Provider Agreement is terminated under this regulation, the PACE provider shall furnish to the Department, within 45 days of the termination's effective date, all information necessary for the reimbursement of any outstanding claims for services rendered to the PACE provider's participants, including claims of its contractors. An eligible person shall: Reside in the PACE approved service area upon enrollment; Be 55 years old or older; Be able to be maintained in a community-based setting with the assistance of PACE at the time of enrollment without jeopardizing the PACE participant's health or others' health or safety; Be determined by the Department to need the level of care required under the State Plan for coverage of nursing facility services for longer than 4 months; and Be willing to abide by the provision that requires PACE participants to receive all health and long-term care services exclusively from the PACE provider and its contracted or referred providers. Medical Assistance Eligibility Services. Medical Assistance eligibility for services under this chapter is determined under this regulation and applicable sections of COMAR 10.09.24, as cited in §B(2)—(4) of this regulation. Categorically Needy. An individual is eligible for services under this chapter as categorically needy if the individual is receiving Medical Assistance as: A recipient of Supplemental Security Income (SSI); A member of a low income family with children, as described in §1931 of the Social Security Act; or Any other type of categorically needy person in accordance with COMAR 10.09.24.03. Optionally Categorically Needy. An individual is eligible for services under this chapter as optionally categorically needy in accordance with 42 CFR §435.217, if the individual's countable: Income does not exceed 300 percent of the applicable payment rate for SSI; and Resources do not exceed the SSI resource standard for one individual. For the purpose of determining Medical Assistance eligibility for the optionally categorically needy: The individual is treated as an assistance unit of one individual; and Countable income and resources are determined based on the rules for income and resources set forth in COMAR 10.09.24 as applicable to an aged, blind, or disabled individual who is institutionalized, with the exceptions in §B(3)(g) of this regulation. An individual is not eligible under §B(3) of this regulation if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires. The spousal impoverishment rules in §1924 of the Social Security Act and COMAR 10.09.24.10-1 are applicable, except for the differences specified in this regulation. Medical Assistance eligibility shall be redetermined at least every 12 months. If the applicant or participant is not aged, blind, or determined disabled by the Social Security Administration, the Department of Human Services shall determine whether the applicant or participant is technically eligible for Medical Assistance as a disabled person, in accordance with COMAR 10.09.24.05-4B. All provisions of COMAR 10.09.24 which apply to an aged, blind, or disabled individual who is institutionalized are applicable to applicants and PACE participants under this chapter who are considered optionally categorically needy, with the following exceptions in full or in part: COMAR 10.09.24.04-1D and E; COMAR 10.09.24.04-1F; COMAR 10.09.24.06B(2)(a)(ii); COMAR 10.09.24.08F(1); COMAR 10.09.24.08G; COMAR 10.09.24.09; COMAR 10.09.24.10; and COMAR 10.09.24.10-1. Home Exclusion. The home, as defined in COMAR 10.09.24.08F(1), is not a countable resource under §B(3) of this regulation if it is occupied by the applicant or PACE participant, the applicant's or PACE participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or PACE participant: Child; Parent; or Sibling. Medical Assistance eligibility shall be determined by the Department within 45 days after the Department or its representative receives a signed application according to COMAR 10.09.24.04-1D. Post-Eligibility Determination of Available Income for Optionally Categorically Needy. The countable monthly income considered for the post eligibility determination is calculated in accordance with §B(3) of this regulation and COMAR 10.09.24 for institutionalized aged, blind, or disabled individuals, except that the income disregards specified in COMAR 10.09.24.07L are not applied. For individuals eligible under §B(3) of this regulation who reside in a licensed assisted living facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: A personal needs allowance of $60; A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d); and Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g). For individuals who reside in an assisted living facility whose contribution toward the cost of service is calculated under §B(4)(b) of this regulation, the provider shall collect the PACE participant's available income. The amount collected under this paragraph may not exceed the monthly capitation amount under this chapter for the PACE participant. For individuals eligible under §B(3) of this regulation who reside in a long-term care facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: A personal needs allowance in accordance with COMAR 10.09.24.10D(2)(c); A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d); A residential allowance in accordance with COMAR 10.09.24.10D(2)(e); and Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g). For individuals who reside in a long-term care facility whose contribution toward the cost of service is calculated under §B(4)(d) of this regulation, the provider shall collect the PACE participant's available income. Enrollment shall be on a voluntary basis, without respect to race, age greater than the lower limit required, creed, sex, color, national origin, marital status, or physical or mental handicap. An individual is not eligible for enrollment in PACE, regardless of whether the individual is otherwise eligible for benefits under the Program, if the individual is: Living outside the PACE provider's service area; Not included in the PACE provider's target population specified in the PACE Program Agreement; or Enrolled in: A managed care organization contracting with the Department; A Medicaid home and community-based services waiver under §1915(c) of the Social Security Act; Rare and expensive case management (REM) under COMAR 10.09.69; or A Medicaid capitated program that includes nursing facility or community-based long term care services. The Department shall enroll eligible persons who have chosen to enroll in the PACE provider. The PACE provider shall enter into an enrollment agreement with an eligible participant on the form approved by the Department. The PACE provider shall enroll eligible participants in the order in which they apply, and may not discriminate on the basis of health status in its enrollment, re-enrollment, or disenrollment procedures. Signature on Enrollment Forms. Except as indicated under §D(2) of this regulation, a participant 55 years old or older shall sign and submit the enrollment form; A legal guardian or legal representative shall sign enrollment forms for eligible persons determined to be incapacitated or incompetent to sign the form. Because the PACE provider is responsible for ensuring that participants whose primary language is not English understand the benefits and restrictions associated with enrollment in PACE, the PACE provider shall give to such a participant at the time of enrollment a: Notice that translation services are available; or List of primary care providers who speak foreign languages. Subject to verification of eligibility, enrollment shall be effective on the first day of the calendar month following the date the PACE organization receives the signed enrollment agreement. An individual eligible for enrollment under Regulation .05 of this chapter, may enroll at any time during the term of the PACE Provider Agreement, unless: Enrollment under the PACE Organization Provider Agreement has been suspended pursuant to Regulation .23 of this chapter; or The PACE provider exceeds the enrollment limit established by the Department. The PACE provider shall: Maintain a list of all individuals denied enrollment in the order in which they applied for enrollment; and Promptly offer enrollment to denied individuals when permitted. The PACE provider shall provide to each PACE participant an identification card, clearly indicating the bearer is enrolled with the PACE provider. The PACE provider shall provide in writing and explain to a new participant, at a minimum, the following: Notification of the PACE participant's right to terminate enrollment, the time frame required, and explanation of the required process; and Information about the proper utilization of pharmacy services including the requirement to use one pharmacy within the PACE provider network to fill all prescriptions. Termination of a PACE participant's enrollment may be initiated by the: PACE provider; Department; PACE participant; or PACE participant’s legal guardian or legal representative. All enrollment terminations require prior approval by the Department. General Requirements for Processing Disenrollments. The Department shall establish a timeline for the receipt of disenrollment forms as follows: A PACE participant’s involuntary disenrollment occurs after the PACE provider meets the requirements set forth in 42 CFR §460.164 and is effective on the first day of the next month that begins 30 days after the day the PACE organization sends notice of the disenrollment to the PACE participant; or A PACE participant’s voluntary disenrollment is effective on the first day of the month following the date the PACE organization receives the PACE participant’s notice of voluntary disenrollment. Disenrollment requests shall be submitted to the Department by the PACE provider within 3 working days from completion, except if the PACE participant requests that the form be mailed to the PACE participant's home address for completion. The PACE provider shall send the PACE participant a copy of the completed disenrollment forms, regardless of who initiated the disenrollment process. Voluntary Disenrollment by PACE Participant. In general, PACE participants may disenroll from the PACE provider at their discretion at any time without cause, by completing or having completed by a legal guardian or legal representative a disenrollment form provided by the Department. The PACE provider shall act to facilitate disenrollment, including mailing disenrollment request forms to PACE participants desiring to disenroll but having difficulty accessing the PACE provider's office. The PACE provider shall date-stamp PACE participants' disenrollment requests upon receipt. Disenrollment Initiated by the PACE Provider. The PACE provider shall have a written policy regarding termination of a PACE participant's enrollment by the PACE provider which shall address, at a minimum: Under what conditions a PACE participant is to be disenrolled by the PACE provider; and The time elements involved in processing terminations. A disenrollment initiated by the PACE provider shall require prior approval by the Department. A disenrollment may not occur because of an adverse change in the PACE participant's health status. The PACE participant's complete medical and utilization history shall be provided by the PACE provider to the Department, upon request, in order to determine an appropriate disenrollment date. The PACE provider shall notify the PACE participant within 14 days of when the disenrollment is approved, and the PACE participant may appeal the decision under the terms of COMAR 10.01.04. Disenrollment may be requested by the PACE provider by providing to the Department acceptable documentation that the: PACE participant's domicile was relocated outside the PACE provider's service area; PACE participant is no longer eligible in accordance with Regulation .05 of this chapter; PACE participant is discovered to be an individual for whom there existed legal documentation at the time of enrollment that the individual was mentally incompetent, but the PACE participant signed the enrollment form; PACE participant commits fraudulent or illegal acts, such as permitting use of the PACE participant's medical identification card by others, altering a prescription, theft or other criminal acts committed in any provider's or PACE provider's premises; PACE participant fails to complete and submit consents, releases, or assignments and other documents reasonably requested by the PACE provider in order to obtain or assure payment by Medicare, Medicaid, or other third party payers; or PACE participant has died. A PACE provider requesting disenrollment based on documentation under §E(6)(d) of this regulation shall report any illegal acts to law enforcement authorities or to the Medicaid Fraud Control Unit of the Department's Recipient Fraud Unit as appropriate. If a request for disenrollment is approved, the PACE provider shall facilitate a PACE participant's enrollment into other programs by: Making appropriate referrals; and Ensuring clinical records are made available to new providers within 10 days of disenrollment. Disenrollment by the Department. The Department shall disenroll a PACE participant if the: PACE Organization Provider Agreement between the PACE provider and the Department is terminated; PACE participant dies; PACE participant becomes ineligible for enrollment in accordance with Regulation .05 of this chapter; or PACE participant loses eligibility for Medical Assistance Program benefits or changes to a category of assistance not eligible for enrollment in PACE. Effective Date of Termination. The Department shall approve or disapprove requests for voluntary disenrollment within 5 working days of the date the request is received. A disenrollment initiated by either the Department or the PACE provider because the participant died or became ineligible for enrollment for one of the other reasons specified in this regulation is effective the day after the event causing the ineligibility. For disenrollments initiated by the Department, the Department shall provide the PACE provider with written notice. A disenrollment resulting from the PACE participant's loss of Program eligibility shall be effective on the day following the PACE participant's last date of eligibility. The Department may recover any capitation payments made on behalf of the PACE participant for periods following the effective date of the PACE participant's termination of enrollment or loss of eligibility, but not for a retroactive period greater than 3 months except in the case of: The PACE participant's death; or The PACE participant's relocation of domicile outside the PACE provider's service area. The Department may determine a retroactive disenrollment date based on the conditions present when the disenrollment is requested or indicated. The PACE provider shall ensure notification and protection of the rights of enrollees according to 42 CFR §460.110 and 42 CFR §460.112. Except as limited or expanded by the PACE benefit package specified in the PACE program agreement, the PACE provider shall directly provide, arrange, purchase, or otherwise make available, as medically necessary and appropriate, the services specified in the State Plan and the PACE benefit package. The PACE benefit package for all PACE participants, regardless of the source of payment, shall include the following: All Medicaid-covered services, as specified in the State Plan; Multidisciplinary assessment and treatment planning; Social work services; Nutritional counseling; Recreational therapy; Certain meals; Medical specialty services; Prosthetics, orthotics, corrective vision devices, such as eyeglasses and lenses, hearing aids, dentures, and repair and maintenance of these items; Assisted living; and Other services determined necessary by the multidisciplinary team to improve and maintain the PACE participant's overall health status. For access, including access to emergency services, the PACE provider shall comply with 42 CFR §460.100. Limitations on coverage are as specified in the PACE program agreement and 42 CFR §460.96. The PACE provider shall obtain approval by the Department before any changes in the following: Service contract agreements; PACE provider benefit package; PACE provider's service area; PACE provider's enrollment limit; PACE Organization Provider Agreement; or PACE provider structure. The PACE Organization Provider Agreement shall specify the methods by which the PACE provider will assure the Department that its marketing plans, procedures, and materials are accurate and do not mislead, confuse, or defraud the Department or potential PACE participants. The PACE provider's marketing plan and all marketing procedures and materials require approval by the Department before implementation and utilization. The PACE provider may not participate in: Activities described in 42 CFR §460.82(e); or Face-to-face or telephone contact with a participant, or otherwise soliciting a participant who is not a PACE provider’s participant, unless authorized by the Department or initiated by the participant. Subject to prior approval by the Department, a PACE provider may engage in marketing activities designed to make [recipient] participants aware of the PACE provider's availability as well as any special services offered. Addressee-blind informational mailings to an entire zip code may be used. Enrollment Agreement and PACE Participant Enrollment Materials. The PACE provider shall distribute the enrollment agreement within 14 days of the PACE participant's effective date of coverage with the PACE Program. At a minimum the information in the enrollment agreement shall contain the following PACE participant enrollment materials which shall remain with the PACE participant: Location or locations and office hours of the PACE providers; Telephone number or numbers to call for more information; Choice and use of primary care providers and policies on changing primary care providers; How to access urgent care services and advice; How and when to use emergency services including ambulance; Information on the grievance and appeals process, including confidentiality and requesting an administrative hearing; How to access interpreter services including sign interpreters; PACE participant rights and responsibilities; PACE participant's possible responsibility for charges including Medicare deductibles and coinsurances if the participant goes outside of the PACE Program for nonemergency care, or obtains noncovered services or services not authorized by the interdisciplinary team; A clear statement that plan of care decisions are determined by the participant's interdisciplinary team; Information on the availability of social services and assistance in placement in community-based housing and facilities; Information on advance directives and physician order for life sustaining treatment; How to obtain copies of the PACE participant's records; How to obtain nonemergency ambulance services and other medical transportation to appointments, as appropriate; Explanation of covered and noncovered services; How to obtain prescriptions; and Confidentiality policy. The PACE provider shall review the enrollment agreement for accuracy at least yearly and update it with new or corrected information as needed to reflect the PACE provider's internal changes and regulatory changes. If changes impact the PACE participants' ability to use services or benefits, the PACE provider shall distribute the updated materials to all PACE participants after approval by the Department. The provider shall offer orientation to the PACE program to new participants in person within 30 days of enrollment. The PACE provider shall comply with 42 CFR Part 460, Subpart H (Quality Assessment and Performance Improvement). The PACE provider shall comply with requirements designated by the Department. The PACE provider shall comply with 42 CFR §460.210. The PACE provider shall collect and submit to the Department service-specific encounter data by service type in the format and at the frequency designated by the Department and in conformance with the Department's computer coding requirements. Encounter data submitted by PACE providers under §A of this regulation shall include, at a minimum: PACE participant and provider identifying information; Service, procedure, and diagnosis codes; Allowed, paid, and third-party liability amounts; and Service, claims submission, adjudication, and payment dates. The PACE provider shall prepare and submit to the Department reports related to third-party liability as required by Regulation .20 of this chapter. The PACE provider shall immediately notify the Department if it has knowledge of a PACE participant's death. The PACE provider shall have an effective procedure for reporting to the Department the following information: Patterns of utilization; Health status of PACE participants; and Appeals and grievances made by PACE participants. Quarterly Reports. A PACE provider shall submit to the Department quarterly, within 30 days of the close of each calendar quarter, and in a format designated by the Department: Financial reports specified by the PACE program agreement; Quality assurance reports including, but not limited, to quality assurance committee meeting minutes reflecting major quality assurance corrective action plans, initiatives, and activities; Grievance reports, including emergency room based grievances, as specified in Regulation .19 of this chapter that contain An analysis of PACE participant appeal and grievance records; Identification of significant trends or anomalies; The root causes of the trend or anomaly; and Actions taken to address the trend or anomaly; A list of all pre-service denials or reduction of services or benefits issued by the PACE provider or subcontractors during the preceding quarter; and A report of the PACE provider’s participant advisory committee outlining the committee’s activities and recommendations. Annual Reports. The PACE provider shall submit to the Department annually, within 90 days after the end of the calendar year: An annual summary of the information required by §E of this regulation; Any revisions to the PACE provider's quality assurance or utilization management plans; A copy of any changes in contractor agreements; On-site proof that the PACE provider has obtained adequate insurance coverage, issued by an insurer authorized by the Maryland Insurance Administration to engage in the insurance business in the State, to protect its financial viability, and its ability to carry out its PACE program agreement obligations, including at a minimum: Malpractice coverage for all professional and related employees of the PACE provider, as well as for the PACE provider itself; Bonding of all employees and officers who have any responsibilities for the accounting and financial management activities of the PACE provider; and Workers' compensation, fire, theft, casualty, and other coverage as required by State and local laws; A proposed budget and financial plan for the PACE provider's operation, including: An annualized cash flow chart; The cost of operations; Information demonstrating that the PACE provider has a fiscally sound operation; and A statement of policy and procedures for accounting, capitation collection, methods of reimbursing providers and contractors, and method of payment for emergency and out-of-area claims; and Financial monitoring reports, including any supplemental schedules required by the Department, prepared according to the criteria and reporting instructions and in the format and pursuant to the schedule required by the Department. For the purposes of Program administration or monitoring of the PACE provider's performance pursuant to this chapter, given a reasonable period of notice, the PACE provider shall supply other information the Department may request from time to time. Subject to the requirements of 42 CFR Part 431 Subpart F, the PACE provider and its contractors may not release or disclose any information concerning a PACE participant to anyone other than the Department except with the written permission of the: PACE participant; or PACE participant's attorney, legal representative, or legal guardian. For all information, records, data, and data elements collected and maintained by the PACE provider to facilitate operations under this chapter, the PACE provider shall: Protect this information, records, data, and data elements from unauthorized disclosure, in accordance with the provisions of applicable federal and State laws and regulations; and Assure that access is limited by the PACE provider to persons or agencies requiring the information to perform their duties in accordance with this chapter or other duties authorized by the Department. The PACE provider shall comply with 42 CFR §460.80 and 42 CFR §460.208. Consistent with this chapter, the PACE provider, in performing its obligations under this chapter and the PACE program agreement, may either engage its own employees and agents or utilize the services of persons, firms, and other entities by means of contractual relationships. The PACE provider shall have a contractor agreement for all services which are not provided directly by the PACE provider through its own employees and agents. A contractor agreement may not diminish or alter the legal responsibility of the PACE provider to the Department to assure that all obligations under this chapter and the PACE program agreement are carried out. All service contractor agreements require preapproval by the Department. If there are proposed changes in a contractor agreement with any contractor, the full contractor agreement shall be submitted to the Department for prior approval. If the Department determines that termination or expiration of a PACE provider's contractual relationship materially affects the PACE provider's ability to carry out its responsibilities under the PACE [provider agreement] Organization Provider Agreement, the Department may terminate the PACE Organization Provider Agreement. The PACE provider may contract for any health care services not furnished directly by PACE in its benefit package to a health care provider that is licensed, certified, and meets Medicaid and Medicare participation requirements. Contractors shall be legally and professionally qualified to furnish the services set forth in the contractor agreement in return for the compensation set forth in the contractor agreement. The PACE provider shall comply with the grievance procedures described at 42 CFR §460.120—124. The PACE provider shall identify and collect money owed from responsible third parties liable for the cost of health care services furnished by the PACE provider to its PACE participants. Upon request from the Department, the PACE provider shall convey any information regarding third-party liability to the Department and the U.S. Department of Health and Human Services. If both the Department and the PACE provider have a right of subrogation, the Department and the PACE provider shall coordinate settlement negotiation, ensuring that the funds available are prorated to allow sufficient compensation to settle each party's claim amount. For insurance coverage identified by the PACE provider with a retroactive effective date, the PACE provider shall ensure that procedures are in place for the collection of funds from either the provider or the insurance carrier for claims paid by the PACE provider during the coverage period, for up to 2 years from the date of health care services provided to the participant. The Department shall: Pay the PACE provider for each PACE participant based on the fixed capitation payment or payments specified in §E of this regulation; and Calculate the capitation payment or payments for the PACE provider using the methodology described in §B of this regulation. Calculation of PACE Capitation Payments. PACE capitation payments are calculated on a per-member per-month basis. Capitation payments are specific to both the regional service area, as described in §C of this regulation, and the participant age and coverage status, as described in §D of this regulation. Capitation payments are calculated using an AWOP analysis, which is determined using a base period of Medicaid fee for service participant data that: Spans two State fiscal years; Is specific to the PACE eligible population; Is weighted by the expected ratio of participants receiving long-term care services in institutional and community-based settings; and Excludes participants enrolled in the following programs: Medicaid managed care programs; PACE; and Home and community-based services waivers operated by the Developmental Disabilities Administration. The Department shall set the PACE capitation rate as 98 percent of the calculated AWOP. The Department shall recalculate PACE capitation rates annually by trending forward the base period by 1 year. Certain categories of costs not associated with a PACE-eligible, nursing facility-certified population are excluded from the claims data. Capitation rates shall be categorized by regional service area as follows: Baltimore Metro — Baltimore City and Anne Arundel, Baltimore, Carroll, Cecil, Harford, and Howard counties; Washington Metro — Calvert, Charles, Frederick, Montgomery, Prince George’s, and St. Mary’s counties; and Rural Regions — Allegany, Caroline, Dorchester, Garrett, Kent, Queen Anne’s, Somerset, Talbot, Washington, Wicomico, and Worcester counties. Capitation rates shall be categorized by participant age and coverage status as follows: Ages 55—64, Medicaid-only; Ages 65 and over, Medicaid-only; Ages 55—64, dual eligibility; and Ages 65 and over, dual eligibility. For services provided on or after January 1, 2024, the Department shall pay the PACE provider at the following per-member per-month capitation rates: The capitation rate paid by the Department to the PACE provider for a participant shall be accepted as payment in full for the PACE provider benefit package provided by the PACE provider according to its PACE Organization Provider Agreement, and additional charge may not be made to the participant, the Department, or any other entity except as provided under Regulation .05 of this chapter. The Department shall recover any overpayments made to the PACE provider. A capitation payment may not be made to the PACE provider on behalf of a participant for whom fee-for-service or a capitation payment for the same period has been made by the Department to any other provider, HMO, or managed care organization. Capitation payment may not be made to the PACE provider on behalf of a participant if the Department's eligibility verification system indicates that the participant is not eligible for Medicaid benefits. The Department shall provide retroactive capitation to the PACE provider on behalf of a participant when: The Department's eligibility verification system indicates that the participant has established a retroactive eligibility period to a previous PACE enrollment period; and Services were provided by the PACE provider and no other fee-for-service provider. Program Changes. Amendments, revisions, or additions to the State Plan or the State or federal regulations, guidelines, or policies shall, insofar as they affect the scope or nature of Program benefits available to eligible persons, be considered as amendments to the PACE provider benefit package, unless the Department shall otherwise notify the PACE provider. The Department or PACE may determine that a change in the PACE provider benefit package, or in the Program's reporting or other administrative requirements, is a substantial modification of the financial or other responsibilities of the PACE provider, and so may request an adjustment in the PACE provider's capitation payment. Refusal of an adjustment in the PACE provider's capitation payment by the other party shall, at the discretion of the party making the request, be grounds for termination of the PACE Organization Provider Agreement. The PACE provider shall be responsible for prompt payment for all emergency services received by PACE participants. If a claim is submitted to the PACE provider within 9 months of the date of service, the PACE provider shall reimburse a hospital emergency facility and provider or free-standing urgent care center, without requiring prior authorization or approval for payment from the PACE provider, for: Emergency services; Medical screening services rendered at an emergency facility to meet the requirements of the federal Emergency Medical Treatment and Active Labor Act; and Medically necessary and appropriate services if: The PACE provider authorized, referred, or otherwise allowed the PACE participant to use the emergency facility; and The services are related to the condition for which the PACE participant was allowed to use the emergency facility. Cause for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider or related party of the provider has failed to comply with applicable federal or State laws or regulations, the Department may: Impose one or more of the actions under COMAR 10.09.36.08A; and Suspend the PACE provider’s ability to enroll new PACE participants. The PACE provider shall comply with 42 CFR §460.122. PACE provider appeal procedures under this chapter are set forth in COMAR 10.09.36.09. PACE participant appeals are set forth in COMAR 10.01.04. Interpretation of this regulation is subject to COMAR 10.09.36. Health-General Article, §2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.25 adopted as an emergency provision effective November 1, 2002 (29:25 Md. R. 1979); adopted permanently effective April 28, 2003 (30:8 Md. R. 540) Regulation .01B amended effective October 14, 2013 (40:20 Md. R. 1652); August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) Regulation .03 amended effective January 29, 2018 (45:2 Md R. 68); July 21, 2025 (52:14 Md. R. 713) Regulation .04 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .05A, B amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .06 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .07 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .09B amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .11E amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .12 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .15 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) Regulation .16A amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .18F amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .20A amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .21 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) Regulation .22 amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .23 amended effective August 19, 2024 (51:16 Md, R. 742) Regulation .23B amended effective July 21, 2025 (52:14 Md. R. 713) Regulation .24C amended effective July 21, 2025 (52:14 Md. R. 713) This chapter applies to providers organized to deliver mental health case management services to adults. The purpose of mental health case management is to assist participants in gaining access to needed medical, mental health, social, educational, and other services. In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrative services organization (ASO)” means the entity with which the Mental Hygiene Administration may contract to provide the services described in COMAR 10.09.70 for the public mental health system. “Adult” means an individual 18 years and older. “Care plan” means the plan prepared according to the requirements outlined in this chapter that delineate the plan of care for a specific participant. “Case manager” means a community support specialist. “Community support specialist” means an individual who is employed by a mental health case management provider to deliver case management services to participants. “Community support specialist associate” means an individual who is employed by a mental health case management provider to assist community support specialists in the provision of mental health case management services to participants. “Community support specialist supervisor” means an individual who is employed or under contract to supervise case management services. “Core service agency (CSA)” has the meaning stated in COMAR 10.21.17. “Department” has the meaning stated in COMAR 10.09.36.01. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Mental health case management provider” means a provider that: Is approved under this chapter to provide mental health case management services to adults 18 years or older; and Utilizes a collaborative process of assessment, planning, implementation, coordination, monitoring, and evaluation of the options and services required to meet an individual's health needs through communication and available resources to promote quality cost-effective outcomes. “Mental health case management services” means services covered under this chapter which assist participants in gaining access to the full range of mental health services, as well as to any additional needed medical, social, financial assistance, counseling, educational, housing, and other support services. “Mental health professional” has the meaning stated in COMAR 10.21.17. “Mental health services” means those services described in COMAR 10.09.70.10C rendered to treat an individual for a diagnosis set forth in COMAR 10.09.70.10A. “Mental Hygiene Administration (MHA)” means the Department's administration that is charged with the responsibility for providing services to mentally ill individuals, as defined in Health-General Article, Title 10, Annotated Code of Maryland. “Nonparticipant” means an individual who does not meet the qualifications for participation in mental health case management that are specified in Regulation .03 of this chapter. “Participant” means an individual who meets the qualifications for participation in mental health case management that are specified in Regulation .03 of this chapter. “Program” has the meaning stated in COMAR 10.09.36.01. “Provider” means the mental health case management services provider. “Recipient” has the meaning stated in COMAR 10.09.36.01. “Serious and persistent mental disorder” means a disorder that is: Manifested in an individual 18 years old or older; and Diagnosed, according to a current diagnostic and statistical manual of the American Psychiatric Association that is recognized by the Secretary as: Schizophrenic disorder; Major affective disorder; Other psychotic disorder; or Borderline or schizotypal personality disorders, with the exclusion of an abnormality that is manifested only by repeated criminal or otherwise antisocial conduct. “Unit of service” means a per day rate for a minimum of 1 hour per day for contacts, including face-to-face contacts with a participant, and non-face-to-face contacts on behalf of the participant with nonparticipants, that are directly related to identifying the needs and supports for helping the individual to access services. A recipient is eligible for mental health case management services if the recipient: Is in a federal eligibility category for Maryland Medical Assistance according to COMAR 10.09.24, which governs the determination of eligibility for the Maryland Medical Assistance Program; and Has a serious and persistent mental health disorder and is: In, at risk of, or needs continued community treatment to prevent, inpatient psychiatric treatment; At risk of, or needs continued community treatment to prevent, being homeless; or At risk of incarceration or who will be released from a detention center or prison. Waiver of Specific Diagnostic Criteria. The specific diagnostic criteria may be waived if an individual is: Committed as not criminally responsible and is conditionally released from a Mental Hygiene Administration (MHA) facility, according to the provisions of Health-General Article, Title 12, Annotated Code of Maryland; or In a MHA facility, or is a MHA-funded individual in a psychiatric inpatient hospital who requires community services, excluding individuals who are eligible for Developmental Disabilities Administration's residential services. Eligible individuals transitioning from institutions as described in either §B(1) or (2) of this regulation to a community-based setting may receive case management services for up to 180 consecutive days of the covered stay in the institution. Levels of Care. In addition to meeting the eligibility criteria outlined under §§A and B of this regulation, participants shall be classified according to the levels of care listed in §D(2) or (3) of this regulation. Level I—General. For a maximum of 2 units of service per month and based on the severity of the participant's mental illness, the participant shall meet at least one of the following conditions: The participant is not linked to mental health and medical services; The participant lacks basic supports for shelter, food, and income; The participant is transitioning from one level of care to another level of care; or The participant needs case management services to maintain community-based treatment and services. Level II—Intensive. For a maximum of 5 units of service per month and based on the severity of the participant's mental illness, the participant shall meet two or more of the following conditions: The participant is not linked to mental health and medical services; The participant lacks basic supports for shelter, food, and income; The participant is transitioning from one level of care to another level of care; or The participant needs case management services to maintain community-based treatment and services. A participant may not be enrolled in Mental Health Case Management for Adults while receiving services under COMAR 10.09.90 or 10.09.33. The local core service agencies shall select mental health case management providers through a competitive procurement process, at least once every 5 years. Mental health case management services may be provided by local health departments according to COMAR 10.04.04, which allows the Director of the MHA to utilize the local health departments as vendors unless the health officer believes the service provided by alternate vendors would be preferable. Providers of mental health case management shall: Be approved or licensed in Maryland as a community mental health provider under COMAR 10.21.19, 10.21.20, 10.21.21, or 10.21.29, or have 3 years experience as a mental health case management provider; and Have at least 3 years experience providing mental health services, including serving high risk populations, to adults with serious mental illness. General Requirements. To be eligible to be approved as a mental health case management service provider, an entity shall meet all of the: Conditions for participation as set forth in COMAR 10.09.36.03; and Medical Assistance provisions listed in COMAR designated for their provider type. Specific Requirements. A mental health case management service provider: May not place restrictions on the qualified recipient's right to elect to or decline to: Receive mental health case management as authorized by the Department or the Department's designee; and Choose a community support specialist or associate, as approved by the Department or the Department's designee, and other medical care providers; Shall employ appropriately qualified individuals as community support specialists, community support specialist associates, and community support specialist supervisors with relevant work experience, including experience with the target population, including but not limited to adults with a serious and persistent mental disorder; Shall assure that: A participant's initial assessment is completed within 20 days after the participant has been authorized by the ASO and determined eligible for, and has elected to receive, mental health case management services; and An initial care plan is completed within 10 days after completion of the initial assessment; Shall maintain a file for each participant which includes all of the following: An initial referral and intake form with identifying information, including, but not limited to, the individual's name and Medicaid identification number; A written agreement for services signed by the participant or the participant's legally authorized representative and by the participant's community support specialist; An assessment as specified in Regulation .06 of this chapter; A care plan, updated at a minimum of every 6 months, which contains at a minimum: A description of the participant's strengths and needs; The diagnosis established as evidence of the participant's eligibility for services under this chapter; The goals of case management services, with expected target dates; The proposed intervention; Designation of the community support specialist with primary responsibility for implementation of the care plan; and Signatures of the community support specialist, participant, or the participant's legally authorized representative, and significant others, if appropriate; An ongoing record of contacts made on the participant's behalf, which includes all of the following: Date and subject of contact; Individual contacted; Signature of community support specialist or community support specialist associate making the contact; Nature, content, and unit or units of service provided; Place of service; Whether goals specified in the care plan have been achieved; The timeline for obtaining needed services; The timeline for reevaluation of the plan; and The need for and occurrences of coordination with other case managers; and Monthly summary notes, which reflect progress made towards the participant's stated goals; Shall have formal written policies and procedures, approved by the Department, or the Department's designee, which specifically address the provision of mental health case management services to participants in accordance with the requirements of this chapter; Shall be available to participants and, as appropriate, their families for 24 hours a day, 7 days a week in order to refer: Participants to needed services and supports; and In a psychiatric emergency, participants to mental health treatment and evaluation services in order to prevent the participant from accessing a higher level of care; Shall document in the participant's case management records if the participant declines case management services; May not provide other services to participants which would be viewed by the Department as a conflict of interest; Shall be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants; Shall maintain information on current resources for mental health, medical, social, financial assistance, vocational, educational, housing, and other support services; Shall safeguard the confidentiality of the participant's records in accordance with State and federal laws and regulations governing confidentiality; Shall comply with the Department's fiscal reporting requirements and submit reports in the manner specified by the Department; Shall provide services in a manner consistent with the best interest of recipients and may not restrict an individual's access to other services; and Shall assure the amount, duration, and scope of the case management activities are documented in a participant's care plan, which includes mental health case management activities before discharge and after discharge when transitioning from an institution, to facilitate a successful transition into the community. Required Staff. The mental health case management provider shall have staff that is sufficient in numbers and qualifications to provide appropriate services to the participants served and shall include, at a minimum: A community support specialist supervisor who: Is a mental health professional who is licensed and legally authorized to practice under the Health Occupations Article, Annotated Code of Maryland, and who is licensed under Maryland Practice Boards in the profession of: Social work; Professional Counseling; Psychology; Nursing; Occupational Therapy; or Medicine; Has 1 year of experience in mental health working as a supervisor; Provides clinical consultation and training to community support specialists or associates regarding mental illness; and Is employed or contracted to supervise case management services at a ratio of one supervisor to every eight community support specialists or associates; A community support specialist who: Has at least a: Bachelor's degree in a mental health field and 1 year of mental health experience, including mental health peer support; or Bachelor's degree in a field other than mental health and 2 years of mental health experience, including mental health peer support; Is chosen as the case manager by the participant or the participant's legally authorized representative; and Is employed by the mental health case management provider to provide case management services to participants; and A community support specialist associate who: Has at least a high school degree or the equivalent, and 2 years of experience with individuals with mental illness, including mental health peer support; Is employed by the mental health case management provider to assist community support specialists in the provision of mental health case management services to participants; and Works under the supervision of a community support specialist who delegates specific tasks to the associate. The Department shall reimburse for the services in §§C—I of this regulation under mental health case management when these services have been documented, pursuant to the requirements in this chapter, as necessary. Case management services shall be coordinated with, and may not duplicate activities provided as part of, institutional services and discharge planning activities. Comprehensive Assessment and Periodic Reassessment. Assessment or reassessment involves the participant's stated needs and review of information concerning the participant's mental health, social, familial, cultural, medical, developmental, legal, vocational, and economic status to assist in the formulation of a care plan. The assessment or reassessment of the participant’s stated needs and service needs is conducted by the community support specialist and incorporates input from the participant, family members, and friends of the participant, as appropriate, and community service providers, such as mental health providers, medical providers, social workers, and educators, if necessary. A home visit, or visit at another location suitable to the participant's needs, by the community support specialist or community support specialist associate is required every 90 days. After an initial assessment, each participant shall be reassessed every 6 months. Development and Periodic Revision of a Specific Care Plan. After the initial assessment is completed, a care plan shall be developed. After the care plan is developed, it shall be updated every 6 months in conjunction with the participant's schedule for reassessments, to ensure that all services being provided remain sufficient. The participant, a legal guardian, the participant’s family or any significant others with the participant’s consent, shall participate with the community support specialist, to the extent practicable, in the development and regular updating of the participant’s care plan. The specific care plan shall: Be developed with the participant and based on the assessment; Specify the goals and actions to address the mental health, medical, social, educational, and other services needed by the participant; Include the active participation and agreement of the participant, the participant’s authorized health care decision maker, if applicable, and others designated by the participant; and Identify strategies to meet the goals and needs of the participant. The care planning process may include, as necessary and appropriate: The care planning meeting, which includes the participant, and with the participant's consent, providers, family members, other interested persons, as appropriate, for the purpose of establishing, revising, and reviewing the care plan; The development and periodic updating of the written, individualized care plan based on the participant's needs, progress, and stated goals; Transitional care planning that involves contact with the participant or the staff of a referring agency, or a service provider who is responsible to plan for continuity of care from inpatient level of care or an out-of-home placement to another type of community service; and Discharge planning from mental health case management services, when appropriate and when goals for mental health case management have been achieved. Referral and Related Activities. The community support specialist or associate, under the direction of a community support specialist, shall assure that the participant has applied for, has access to, and is receiving the necessary services available to meet the participant’s needs, such as mental health services, resource procurement, transportation, or crisis intervention. The community support specialist shall take the necessary action when the services identified under §D of this regulation have not occurred. The linkage process shall include: Community support development by contacting, with the participant’s consent, members of the participant’s support network, for example, family, friends, and neighbors, as appropriate, to mobilize assistance for the participant; Crisis intervention by referral of the participant, to services on an emergency basis when immediate intervention is necessary; Arranging for the participant's transportation to and from services; Outreach in an attempt to locate service providers which can meet the participant’s needs; and Reviewing the care plan with the participant and with the participant’s family and friends, as appropriate, so as to enable and facilitate their participation in the plan’s implementation. Monitoring and Follow-Up Activities. A mental health case management provider shall monitor, as frequently as necessary, the activities and contacts that are considered necessary to ensure the care plan is implemented and adequately addresses the participant’s needs, and include: The participant; and With proper consent: Family members and friends, if appropriate; and Other service providers, if any. In addition to the requirements outlined in §E of this regulation, the case management provider shall conduct, every 6 months, a reassessment to determine whether: Services are being furnished in accordance with the participant's care plan; Services in the care plan are adequate; and If the needs of the participant change, and if applicable, necessary adjustments are made to the care plan, including referrals for services. The mental health case management provider shall: Follow up any service referral to determine whether the participant made contact with the service provider that the participant was referred to; and Monitor service provision on an ongoing basis, to ensure that the agreed-upon services are provided, are adequate in quantity and quality, and meet the participant’s needs and stated goals. The mental health case management provider may revise the care plan to reflect changing needs identified from the service monitoring. Mental health case management may include contacts with non-participants that are directly related to identifying the needs and supports for helping the participant to access services. The mental health case management provider shall engage in participant advocacy, including: Empowering the participant to secure needed services; Taking any necessary actions to secure services on the participant's behalf; and Encouraging and facilitating the participant’s decision making and choices leading to accomplishment of the participant’s goals. Service Provision. Mental health case management services shall be provided in accordance with the following: For participants in Level I—General, a mental health case management provider shall provide a minimum of 1 and a maximum of 2 days of service each month; For participants in Level II—Intensive, a mental health case management provider shall provide a minimum of 2 and a maximum of 5 days of service each month; and One additional unit of service above the monthly maximum may be billed during the first month of service to a participant in order to complete the comprehensive assessment. Mental health case management services are advisory in nature. A restriction may not be placed on a qualified recipient's option to receive mental health case management services. Mental health case management services do not restrict or otherwise affect: Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation; The freedom of a participant to select from all available services for which the participant is found to be eligible; or A participant’s free choice among qualified providers. Mental health case management providers may not bill the Program for: The direct delivery of an underlying medical, educational, social, or other service to which a participant has been referred; Activities integral to the administration of foster care programs; Activities not consistent with the definition of case management services under Section 6052 of the federal Deficit Reduction Act of 2005 (P.L. 109-171); Activities for which third parties are liable to pay; or Activities delivered as part of institutional discharge planning. Reimbursement may not be made for mental health case management services if the participant is receiving a comparable case management service under another Program authority. A participant's case manager may not be the participant's family member or a direct service provider for the participant. All covered services under this chapter shall be preauthorized and comply with the requirements of COMAR 10.09.70.07. The Program shall reimburse the provider according to the requirements in this chapter and the fees established under COMAR 10.21.25. Request for Payment. Requests for payment of mental health case management services shall be submitted by an approved provider according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed. A provider shall submit a request for payment on the invoice form designated by the Department. A separate invoice shall be submitted for each participant. The completed form shall indicate the: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, location, and provider number; and Nature, unit or units, and procedure code or codes of covered services provided. A provider shall bill the Program for the appropriate fee or fees specified in COMAR 10.21.25. The Program may not make direct payment to recipients. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Payment shall be made: Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; and According to the requirements of this chapter and the fees established in COMAR 10.21.25. The Department may reimburse providers for service delivery beyond the maximum units stated in COMAR 10.21.25 only if pre-authorized by the ASO based on a review of medical necessity. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are those set forth in COMAR 10.09.36.09. State regulations are interpreted as those set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: January 20, 1992 (19:1 Md. R. 32) Regulations .01—.06 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1383); amended permanently effective October 26, 1992 (19:21 Md. R. 1891) Regulations .01B and .02B amended as an emergency provision effective June 1, 1993 (20:12 Md. R. 995); adopted permanently effective September 1, 1993 (20:17 Md. R. 1346) Regulations .01 and .02 amended as an emergency provision effective February 8, 1995 (22:5 Md. R. 365); emergency status expired May 31, 1995; amended permanently effective June 5, 1995 (22:11 Md. R. 821) Regulations .01—.06 amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1288); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .04A, C amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .05-1 adopted as an emergency provision effective July 1, 1997 (24:18 Md. R. 1288); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) Regulations .01—.10 repealed and new Regulations .01—.13 adopted as an emergency provision effective August 21, 2009 (36:19 Md. R. 1433); adopted permanently effective December 14, 2009 (36:25 Md. R. 1954) Regulation .01A amended effective October 1, 2014 (41:19 Md. R. 1077) Regulation .02B amended effective October 1, 2014 (41:19 Md. R. 1077) Regulation .03A amended effective October 1, 2014 (41:19 Md. R. 1077) Regulation .03E adopted effective October 1, 2014 (41:19 Md. R. 1077) Regulation .04C, E amended effective October 1, 2014 (41:19 Md. R. 1077) Regulation .06 amended effective October 1, 2014 (41:19 Md. R. 1077) Regulation .07C amended effective October 1, 2014 (41:19 Md. R. 1077) Regulation .09E adopted effective October 1, 2014 (41:19 Md. R. 1077) In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicant” means an individual who is applying as a participant in the BI waiver. “Behavior intervention” means services designed to assist individuals who exhibit challenging behaviors in acquiring skills, gaining social acceptance, and becoming full participants in the community, consistent with behavior support services program service plans set forth in COMAR 10.22.10. “Behavioral Health Administration (BHA)” means the administration of the Department that: Is charged with the responsibility for providing services to individuals with behavioral health conditions as defined by Health-General Article, Title 10, Annotated Code of Maryland; Is designated as the State’s lead agency for service delivery to individuals with brain injury; and Manages the BI waiver, in collaboration with the Program and in accordance with a memorandum of agreement signed with the Program. “Brain injury (BI)” means an insult to the brain caused by an external or internal mechanism that occurs after birth and is not related to congenital or degenerative disease, which results in cognitive, physical, behavioral, or emotional disability that is documented in the medical record. “CARF” means the Commission on Accreditation of Rehabilitation Facilities, a nonprofit accrediting body which promotes quality, value, and optimal outcomes of services through a consultative accreditation process that centers on enhancing the lives of individuals receiving services. Case Management. “Case management” means the services provided by a case manager who assists an individual in gaining access to needed medical, social, educational, and other services. “Case management” includes assessment, referral, coordination, and monitoring of the plan of care. “Case manager” means an individual who provides administrative case management services for BI waiver participants. “Day habilitation” means assistance with acquisition, retention, or improvement in self-help, socialization, and adaptive skills which takes place in a nonresidential setting, separate from the home or facility in which the individual resides, normally furnished 4 or more hours per day. “Department” means the Maryland Department of Health as stated in COMAR 10.09.36.01B, or its authorized agents acting on behalf of the Department. “Eligible individual” means an individual who is determined to meet the qualifications for participation in the BI waiver as specified in Regulation .03 of this chapter. “Health care professional” means an individual who is licensed and authorized by the Health Occupations Article to provide the health service for which the individual is privileged. Home and community-based services waiver for individuals with brain injury (BI waiver) means the program implemented under this chapter. “Individual support services (ISS)” means assistance with acquisition, retention, or improvement in skills related to self-help, socialization, and/or adaptive skills furnished in the participant's home or community by a provider who does not have round-the-clock responsibility for the participant's health and welfare. “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped individuals who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living in accordance with COMAR 10.09.07. “Nursing facility level of care” means an assessment that an individual needs the level of services provided in a nursing facility, as defined in COMAR 10.09.10.01. “Participant” means an eligible individual who is enrolled in the BI Waiver. “Program” means the Medical Assistance Program, as stated in COMAR 10.09.36.01B, which exercises administrative discretion in the administration and supervision of the BI waiver and issues policies, rules, and regulations related to the BI waiver. “Provider” means an individual or an agency that: Is approved by the BHA and the Program as meeting the conditions for waiver participation specified in Regulations .05 and .06 of this chapter; and Has enrolled with the Program to provide one or more of the waiver services described under Regulations .07—.09 of this chapter. “Provider agreement” means a contract between the Program and a provider to provide services to waiver participants. “Residential habilitation” means assistance with acquisition, retention, or improvement in skills related to activities of daily living and the social and adaptive skills necessary to enable the individual to live in a noninstitutional setting. “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in or associated with an individual's place of residence. “State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of Title XIX of the Social Security Act and approved by the federal Centers for Medicare and Medicaid Services, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements. “Supported employment” means activities needed to support paid work by individuals receiving waiver services, including supervision and training. “Utilization control agent” means the organization responsible for reviewing services to determine medical necessity according to professional standards and for conducting patient assessments. “Virtual supports” is an electronic method of service delivery used to maintain or improve a participant’s functional abilities, enhance interactions, support meaningful relationships, and promote their ability to live independently and meaningfully participate in their community. “Waiver plan of care” means a participant's written, individualized care plan as specified in Regulation .04 of this chapter. Financial eligibility for waiver participants is determined according to the provisions of this regulation and applicable sections of COMAR 10.09.24 Medical Assistance Eligibility, as cited in this section. Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as: A recipient of Supplemental Security Income (SSI); A member of a low income family with children, as described in §1931 of the Social Security Act; or A recipient eligible in another mandatory or optional categorically needy coverage group with full Medical Assistance benefits, covered in the community under the State Plan. Optionally Categorically Needy. An individual is eligible for waiver services as optionally categorically needy in accordance with 42 CFR §435.217, if the individual's countable income does not exceed 300 percent of the applicable payment rate for SSI, and the individual's countable resources do not exceed the SSI resource standard for one person. For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one person. For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income rules set forth in COMAR 10.09.24, which are applicable to an aged, blind, or disabled individual who is institutionalized, with the exceptions specified in §C(9) of this regulation. For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource rules set forth in COMAR 10.09.24, which are applicable to an aged, blind, or disabled person who is institutionalized, with the exceptions specified in §C(9) of this regulation. An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until the penalty time expires. The spousal impoverishment rules at COMAR 10.09.24.10-1 are applicable, except for the following differences in definitions: “Community spouse” means an individual who: Lives in the community outside a medical institution; Is not determined to meet the criteria for participation in the Waiver for Individuals with Brain Injury or any other waiver under §1915(c) of Title XIX of the Social Security Act; and Is married to an institutionalized spouse. “Continuous period of institutionalization” means: At least 30 consecutive days of institutional care in a nursing facility or other medical institution; or A determination that a spouse meets the criteria for participation in the waiver for individuals with brain injury or any other waiver under §1915(c) of Title XIX of the Social Security Act. “Institutionalized spouse” means an individual who is married to a community spouse and who is: An inpatient in a nursing facility or other medical institution with a length of stay exceeding 30 days; or Determined to meet the criteria for participation in the waiver for individuals with brain injury or any other waiver under §1915(c) of the Social Security Act. Medical Assistance eligibility shall be redetermined at least every 12 months. As part of the determination and redetermination of Medical Assistance eligibility as optionally categorically needy, the Department of Human Services shall determine whether the applicant or recipient is eligible as a disabled person in accordance with COMAR 10.09.24.05E, unless the applicant or recipient is aged, blind, or has been determined as disabled by the Social Security Administration. All provisions of COMAR 10.09.24 which are applicable to an aged, blind, or disabled individual who is institutionalized are applicable to waiver applicants and participants who are considered as optionally categorically needy, with the following exceptions in full or in part: COMAR 10.09.24.04J(1)—(3); COMAR 10.09.24.04K; COMAR 10.09.24.06B(2)(a)(ii); COMAR 10.09.24.08G(1); COMAR 10.09.24.08H; COMAR 10.09.24.09; COMAR 10.09.24.10; COMAR 10.09.24.10-1; and COMAR 10.09.24.15A-2(2). Home Exclusion. The home, as defined in COMAR 10.09.24.08B, is not a countable resource under §C of this regulation if it is occupied by the waiver applicant or participant, the applicant's or participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or participant: Child; Parent; or Sibling. Posteligibility Determination of Available Income for Optionally Categorically Needy. Participants in the waiver for individuals with brain injury are not required to pay towards their cost of care, and therefore they are not subject to a posteligibility determination of available income. Medically Needy. An individual is not eligible for waiver services if the individual is receiving Medical Assistance as a medically needy person in accordance with COMAR 10.09.24.03D. Medical Eligibility for the Waiver. To be medically eligible for the services covered under this chapter, an applicant shall be certified by the Program's utilization control agent to need nursing facility level of care or special hospital level of care. Every 12 months, or more frequently if determined necessary by the BHA or Program due to a significant change in the participant's condition or need, a participant's medical need for nursing facility level of care or special hospital level of care shall be reevaluated by the Program's utilization control agent. Technical Eligibility for the Waiver. An applicant or participant shall be determined by the BHA, using the form for determination of eligibility for BI waiver services, to meet the waiver's technical eligibility criteria if the individual: Is 22 years old or older but younger than 65 years old at the time of initial admission to the waiver; Is diagnosed with brain injury as defined in Regulation .01B(4) of this chapter by a qualified physician; Was 18 years old or older when the brain injury was sustained; Is receiving: Care in a State psychiatric hospital that is determined to be inappropriate because the individual does not need that level of care; Brain injury community placement funded by the BHA with all-State funds; Care in a nursing facility owned and operated by the State or an out-of-State rehabilitation institution funded by the Program; or Care in a Maryland licensed special hospital for chronic disease accredited by CARF in brain injury inpatient rehabilitation; Is not enrolled in another waiver program under §1915(c) of Title XIX of the Social Security Act; Is clinically appropriate to be served in the waiver program and the waiver plan of care can serve the individual safely in the community; Chooses directly, or a legal representative chooses on the individual's behalf, to receive waiver services as an alternative to services in a nursing facility or special hospital, and documents that choice on the consent form for BI waiver services included in the approved waiver proposal; Costs the Program no more in the community than what the individual would have cost the Program in the alternative institutional placement at the nursing facility level of care or special hospital level of care, as demonstrated on the waiver plan of care and by the Program's paid claims; and Uses at least one waiver service in a 12 month period. Financial Eligibility for Medicaid. Waiver participants shall qualify for one of the categories of assistance set forth in Regulation .02 of this chapter. During a 12-month waiver year, as defined in the approved waiver proposal, eligible individuals shall be enrolled in the waiver up to the maximum number of unduplicated participants established for that waiver year in the approved waiver proposal. Overall Waiver Eligibility. Using the form for determination of eligibility for BI waiver services, if an applicant is determined by the BHA: To meet all of the criteria specified in §§A—C of this regulation, the BHA or its authorized representatives shall sign and date the form to certify waiver eligibility and establish the effective date for waiver enrollment; or Not to meet all of the criteria specified in §§A—C of this regulation: The BHA or its authorized representatives shall sign and date the form to certify waiver ineligibility determination and specify in writing the reason or reasons for the determination; and The applicant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E. Every 12 months, or more often if there is a significant change in the participant's condition or needs: The BHA and the Program's utilization control agent shall reevaluate whether the participant remains eligible for the waiver by meeting all of the criteria specified in §§A—C of this regulation; The BHA or its authorized representatives shall sign and date the form for determination of eligibility for BI waiver services to certify the redetermination of waiver eligibility; and If the BHA determines that the participant no longer meets all of the eligibility criteria specified in §§A—C of this regulation, the: Participant's eligibility shall be terminated, as of the effective date established by the BHA; and The participant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E. Cause for Termination of a Participant's Waiver Enrollment. A participant shall be disenrolled from the waiver, as of the date established by the Department, if the participant: No longer meets all of the criteria for waiver eligibility specified in §§A—C of this regulation; Voluntarily chooses, or the participant's legal representative chooses on the participant's behalf, to disenroll from the waiver; Is an inpatient for more than 30 days in a State psychiatric hospital, nursing facility, or intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID); Moves to another state; or Dies. Reentering the Waiver. If a participant is discharged from the waiver, the same individual may reenter the waiver during the same waiver year, if the individual meets all eligibility requirements of the waiver. The participant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E. The program services and supports shall: Maximize the level of functioning of an individual with BI through assistance and support with independent living, self care skills, and social skills in an environment which encourages the participant's ability to make decisions about the individual's life and create opportunities for choice regarding home, school or work, and community activities; Promote the use of community resources to integrate the individual into the community; Provide services that are: Appropriate to the age of the populations being served; Offered at times and places suitable to the individuals served; and Coordinated by BHAs administrative case manager with other medical rehabilitation, mental health, and primary care services that the individual is receiving; and Assure that staff are available, on call, 24 hours per day, 7 days per week. Development of the Initial Waiver Plan of Care. Before the start of waiver services: A case manager shall meet with the participant or the participant's legal representative, in person or remotely, to develop the initial waiver plan of care; The case manager, the participant, or the participant's legal representative shall sign the waiver plan of care to indicate approval of its recommendations; and The BHAs authorized representative shall review the initial waiver plan of care and sign to indicate approval if the plan of care is determined to be: Sufficient to assure the participant's health and safety and meet the participant's needs in a community-based setting; Feasible according to the specifications in the waiver plan of care; and Individually cost-neutral by costing the Program no more for the participant's waiver and other Program services than the participant would have cost the Program in the alternative nursing facility or special hospital setting. Waiver Plan of Care. The participant's waiver plan of care: Preauthorizes the specific waiver services to be provided to the participant, as covered under Regulations .07—.09 of this chapter; Is documented on the waiver plan of care form included in the approved waiver proposal; Specifies for each preauthorized waiver service the following information, as appropriate: Description of the specific service to be provided; Level of service; Service start date; Estimated duration; Approved frequency and units of service to be delivered; Approved service delivery mode; The provider for that service, if known; and Estimated unit costs and monthly costs; Describes other Program services recommended for the participant; Evaluates the participant's total costs to the Program, to ensure the participant's cost-neutrality as compared to the cost to the Program for the individual in the alternative nursing facility or special hospital setting; and Is subject to the BHAs approval. A participant shall be given freedom of choice among all qualified and available providers for each service included in the participant's waiver plan of care. Periodic Review of the Waiver Plan of Care. At least every 12 months or more frequently if determined necessary by the BHA: A case manager and the participant or the participant's legal representative shall review the waiver plan of care and revise it as necessary; The case manager and the participant or the participant's legal representative shall sign the waiver plan of care, as revised, to indicate approval of its recommendations; and The BHA or its authorized representative shall review the revised waiver plan of care, and if the plan of care is determined to meet all of the criteria specified in §C(3) of this regulation, sign to indicate approval. Periodic reviews and updates shall take place to: Determine the appropriateness and adequacy of the participant's services; and Ensure that the furnished services are consistent with the services needed for the participant's disability. General requirements for participation in the Medical Assistance Program as a provider of BI waiver services are that the provider, with the exception of a medical day care provider, shall: Be approved by the BHA as meeting the requirements and able to provide the services specified in this chapter; Have a provider agreement in effect; Meet all the conditions for participation in COMAR 10.09.36, except as otherwise specified in this chapter; Have demonstrated experience in the provision of services to individuals with BI as evidenced by: Having: A history of serving individuals with brain injury for at least the past 2 years; A program of specialized services appropriate for the needs of individuals with brain injury; and Availability of licensed healthcare professionals with experiences in the provision of services to individuals with brain injury to supervise, train, or consult with program staff regarding the needs of waiver participants; or Accreditation by CARF for the provision of brain injury services; Verify the licenses or credentials of all agencies and individuals who render services on the provider's behalf under this chapter, and have a copy of the licenses or credentials available for inspection; Assure that direct care workers who render services under this chapter: Receive oversight from an appropriately licensed or certified health care professional; and Are determined by the provider as qualified to meet the participants' needs; Provide an annual continuing education program approved by BHA for all staff working with waiver participants on the needs of individuals with BI that may include: Types of brain injury; Behavioral, emotional, cognitive, and physical changes after brain injury; and Strategies for compensation and remediation of deficits caused by a brain injury; Provide services in accordance with the requirements of Regulation .04 of this chapter and all applicable federal, State, and local laws and regulations; Agree to provide and bill BHA or its authorized representative for only those services covered under this chapter which have been preauthorized in the participant's waiver plan of care; Be ineligible to participate in the BI Waiver if the provider or any of its current or previous principals have overpayments that remain due and owing to the Department; Provide services in person, except as authorized by the Department; and If providing services via virtual supports, comply with the requirements established in Regulation .09-1 of this chapter. Provider of Residential Habilitation or Rehabilitation Services. To provide the services covered under Regulation .07 of this chapter, the provider agency shall: Operate a community-based program of residential habilitation or rehabilitation services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.08 for the Community Residential Services Program; Meet the participant's needs for room and board and clothing, although these services are not reimbursed by the Program; and If the facility is covered by §1616(e) of the Social Security Act, comply with applicable State standards that meet the requirements of 45 CFR Part 1937 for board and care facilities. Provider of Day Habilitation Services. To provide the services covered under Regulation .08 of this chapter, the provider agency shall operate a community-based program of day habilitation services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.07, Vocational and Day Services Program Service Plan. Provider of Supported Employment Services. To provide the services covered under Regulation .09 of this chapter, the provider agency shall operate a community-based program of supported employment services that is: Licensed by the Department's Office of Health Care Quality under COMAR 10.22.07, Vocational and Day Services Program Services Plan; or Approved by the Department's Office of Health Care Quality under COMAR 10.21.28, Mental Health Vocational Programs. Provider of Individual Support Services. To provide the services covered under Regulation .09-1 of this chapter, the provider agency shall operate a community-based program of individual support services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.06 for Family and Individual Support Services. Provider of Medical Day Care Services. To provide the services covered under Regulation .09-2 of this chapter, the provider shall meet the: Licensure requirements as provided in COMAR 10.12.04; and Requirements of COMAR 10.09.07. Medical day care providers are not required to meet the conditions of Regulation .05 of this chapter. The residential habilitation services covered under this regulation shall be provided in a community-based residential facility. The covered services shall include: Habilitative services to assist a participant in acquiring, regaining, retaining, or improving the self-help skills related to activities of daily living and the socialization and adaptive skills which are necessary to reside successfully in home and community-based settings; Supervision and support, up to 24 hours a day, in a residence, based on the individual's plan of care; and Any of the following additional services which are medically necessary to prevent the participant's institutionalization and are not otherwise covered for the participant by the Program or another payer: Nursing supervision, in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11 for any medication administration or other delegated nursing functions provided to the participant in the residence by a direct care worker; and Behavior intervention services. The residential habilitation services provider shall provide daily coordination of the participant's clinical treatment, rehabilitation, health, and medical services with the other providers of BI waiver services and the BI waiver case manager. Levels of Service. Services provided in a residential program shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA. Level 1 requires a minimum of 1:3 staff to participant ratio during day and evening shifts and nonawake supervision during overnight shift or an awake staff person covering more than one site during the overnight shift. The participant shall meet nursing facility or special hospital level of care. Level 2 requires a minimum of 1:3 staff to participant ratio during day and evening shifts and awake, on-site supervision during overnight shift. The participant shall meet nursing facility or special hospital level of care. Level 3 requires a 1:1 staff to participant ratio during day and evening shifts and awake on-site supervision during overnight shift. The participant shall meet special hospital level of care. The day habilitation services covered under this regulation shall be provided in a nonresidential setting, separate from the home or facility in which the participant resides. The covered services, as defined in this chapter shall include: Habilitative or rehabilitative services to assist a participant in acquiring, regaining, retaining, or improving the self-help skills related to activities of daily living and the social and adaptive skills, which are necessary to reside successfully in home and community-based settings; Meals furnished as part of the program; Any of the following additional services which are provided at the provider's site, are medically necessary to prevent the participant's institutionalization, and are not otherwise covered for the participant by the Program or another payer: Nursing supervision, in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11 for any medication administration or other delegated nursing functions provided to the participant by a qualified direct care worker; and Behavior intervention services; and Transportation between a participant's residence and the provider's site, or between habilitation sites if the participant receives habilitation services in more than one place. Day habilitation services shall regularly be provided 4 or more hours per day on a regularly scheduled basis for 1 or more days per week, unless provided as an adjunct to other day activities included in the participant's waiver plan of care. Day habilitation services shall focus on enabling the participant to regain, attain, or maintain the participant's maximum functional level. The provider shall provide services in collaboration with the participant's other BI waiver services, clinical treatment, rehabilitation, and health and medical services. Levels of Service. Services provided in a day habilitation program shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA. Level 1 requires a minimum of 1:6 staff to participant ratio. The participant shall meet nursing facility or special hospital level of care. Level 2 requires a minimum of 1:4 staff to participant ratio. The participant shall meet nursing facility or special hospital level of care. Level 3 requires a minimum of 1:1 staff to participant ratio. The participant shall meet special hospital level of care. The program under this regulation does not cover recreational activities which are not related to specific treatment goals or are solely diversional. The supported employment services covered under this regulation shall be provided in nonresidential community settings, separate from the home or facility in which the participant resides. The covered services shall: Include a work program that includes supports necessary for the participant to achieve desired outcomes established in the waiver plan of care; Include rehabilitation activities needed to sustain the participant's job including support and training; Consist of training, skill development, and paid employment for participants: For whom competitive employment at or above the minimum wage is unlikely; and Who, because of disabilities, need intensive ongoing support to perform in a work setting; Be provided to help individuals obtain and maintain paid work in integrated community settings; and Include transportation or the coordination of transportation between a participant's residence and the supported employment job site. Levels of Service. Services shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA. Level 1 requires that staff members provide daily contacts to the waiver participant. The participant shall meet nursing facility or special hospital level of care. Level 2 requires that staff members provide a minimum of 1 hour of direct support per day. The participant shall meet nursing facility or special hospital level of care. Level 3 requires that staff members provide continuous support for a minimum of 4 hours of service per day. The participant shall meet special hospital level of care. When provided at a work site where individuals without disabilities are employed, services shall only include the adaptations, supervision, and training required by the participants as a result of their disabilities, not the supervisory activities rendered as a normal part of the business setting. The Program may not reimburse for the following: Incentive payments, subsidies, or unrelated incentive payments made to an employer to encourage or subsidize the employer's participation in a supported employment program; Payments that are passed through to participants in a supported employment program; or Payments for vocational training that is not directly related to a participant's supported employment program. Individual support services, as defined in Regulation .01B of this chapter, shall be provided in a participant's own home or their community. The service involves the training and development of compensatory strategies and skills such that a waiver participant may learn to initiate and complete activities on their own to fully engage in their community, live independently, and compensate for cognitive and behavioral deficits related to short term memory, planning, attention, concentration, impulse control, and judgment, with the intended goal of minimizing the level of staff support the individual needs over time and preventing institutionalization. The provider shall provide services in collaboration with the participant's other BI waiver services, clinical treatment, and health and medical services. Individual support services shall be provided as pre-authorized by BHA and included in the waiver plan of care and provided in 15-minute units. Services may be provided in-person or via virtual supports as determined appropriate by the Department. Providers delivering services via virtual supports: Shall ensure the participant's rights of privacy, dignity, and respect, and freedom from coercion and restraint; and May provide direct support via virtual supports according to the following requirements and restrictions: Virtual supports do not isolate the participant from integration in the community or interacting with people without disabilities; The use of virtual supports is based on the participant’s preferences, has been agreed to by the participant and their team, and is outlined in the Plan of Service (POS); Virtual supports may not be used for the provider's convenience; The use of virtual supports and the service delivery method shall be documented per State requirements, policies, and guidance; Text messaging and emailing do not constitute virtual supports; The virtual supports shall comply with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and their applicable regulations to protect the privacy and security of the participant’s protected health information; ISS may not be provided entirely via virtual supports; Virtual supports shall allow flexibility of service delivery and supplement in-person direct supports as recommended and monitored by the case manager; The provider shall develop, maintain, and enforce written policies, approved by BHA, which address their procedures for ensuring: The participant’s rights of privacy, dignity, and respect, and freedom from coercion and restraint; The virtual supports meet applicable information security standards; and Their provision of virtual supports complies with applicable laws governing individuals’ right to privacy; The provider shall train direct support staff on their policies and advise participants and their person-centered planning teams regarding the policies that indicate how a participant’s needs, including health and safety, will be addressed safely via virtual supports; The virtual supports shall meet all federal and State requirements, policies, guidance, and regulations; The provider shall ensure that virtual supports are accessible to the participant and provide in-person trainings, prior to the initiation of virtual services, to help the participant learn to use the required technology independently; and Video cameras/monitors are not permitted in bedrooms and bathrooms. Covered medical day care services are those set forth in COMAR 10.09.07. A unit of service is a minimum of 4 hours present at the medical day care center. The Department shall reimburse for services covered under this chapter if the services are: Provided to a participant who meets the qualifications for eligibility specified in Regulations .02 and .03 of this chapter; Preauthorized in the participant's waiver plan of care by the BHA, as being reasonable and medically necessary to prevent institutionalization; Provided by an approved provider which meets the conditions for participation in Regulations .05 and .06 of this chapter; and Rendered pursuant to: The relevant definition of covered services in Regulation .01 of this chapter; All other requirements specified in this chapter and COMAR 10.09.36; and The waiver proposal and any amendments to it approved by the Secretary of the U.S. Department of Health and Human Services. Reimbursement shall be made by the Program only if all of the requirements of this chapter are met. Reimbursement may not be made by the Program for a waiver service furnished before: Enrollment of the participant in the waiver; Development of the participant's waiver plan of care; and Inclusion of the specific service in the participant's approved waiver plan of care. The Program shall reimburse for a participant not more than: One unit of residential habilitation services for a date of service; One unit of day habilitation per day; One unit of supported employment per day; A combined maximum of seven units of supported employment and day habilitation per week; or 32 units of individual support services for a date of service. The Program does not cover the following: Room and board for the participant; Room and board for an unrelated personal caregiver who lives with the participant; Direct payments to the participant's family; Respite care for a participant residing in an out-of-home facility; Activities or supervision reimbursed by a source other than Medicaid; Payment for day habilitation on the same date of service as medical day care under COMAR 10.09.07; Payment for day habilitation on the same date of services as on-site psychiatric rehabilitation as defined in COMAR 10.21.21 and COMAR 10.21.25; Payment for residential habilitation on the same date of service as personal care under COMAR 10.09.20; Payment for residential habilitation on the same date of service as residential rehabilitation services as defined in COMAR 10.21.22; Payment for supported employment on the same date of service as mental health vocational supported employment as defined in COMAR 10.21.28; Payment for individual support services on the same day as residential habilitation services as defined in Regulation .01B of this chapter; or Payment for individual support services on the same day as family and individual support services as defined in Regulation .01B of this chapter. Request for Payment. An approved provider, with the exception of a medical day care provider, shall submit requests for payment to BHA or its authorized representative for the services covered under this chapter, according to procedures set forth in COMAR 10.09.36.04 or otherwise established by the Department. Medical day care providers shall submit requests for payment to the Department in accordance with COMAR 10.09.07.08. The provider shall: Bill the Department in accordance with the payment methodology specified in §C of this regulation; Accept payment from the Department as payment in full for the services covered under this chapter and make no additional charge for the covered services to the participant or any other party; and Submit a request for payment in a manner approved by the Department, which includes the: Date or dates of service; Participant's name and Medicaid number; Provider's name, location, and Program identification number; Type, procedure code or codes, and unit or units of covered services provided; and Amount of reimbursement requested. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Payments. Payments shall be made only to a qualified provider for services covered under this chapter which are rendered to a participant. The Program shall pay according to the following fee-for-service schedule: Residential habilitation reimbursed at: $305.51 per day for Level 1 effective July 1, 2024; $404.52 per day for Level 2 effective July 1, 2024; and $559.63 per day for Level 3 effective July 1, 2024; Day habilitation reimbursed at: $78.88 per day for Level 1 effective July 1, 2024; $137.59 per day for Level 2 effective July 1, 2024; and $193.57 per day for Level 3 effective July 1, 2024; Supported employment reimbursed at: $46.80 per day for Level 1 effective July 1, 2024; $78.88 per day for Level 2 effective July 1, 2024; and $193.57 per day for Level 3 effective July 1, 2024; and Individual support services (ISS): reimbursed at the rate of $9.5666 per 15 minutes effective July 1, 2024; and Individual support services—virtual: reimbursed at the rate of $9.5666 per 15 minutes effective July 1, 2024. The Program shall pay for medical day care services in accordance with COMAR 10.09.07 and the participant's approved plan of care. Program rates specified in this regulation shall increase each fiscal year through FY 2026, subject to the limitations of the State budget. Recovery and reimbursement under this chapter are as set forth in COMAR 10.09.36.07 and COMAR 10.09.07.09. Cause for suspension or removal and imposition of sanctions under this chapter are as set forth in COMAR 10.09.36.08. Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and COMAR 10.01.04. Provider appeal procedures under this chapter are set forth in COMAR 10.09.36.09. Interpretation of this regulation is subject to COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: Regulations .01—.16 adopted as an emergency provision effective July 1, 2003 (30:14 Md. R. 933); adopted permanently effective December 11, 2003 (30:24 Md. R. 1740) Regulation .01B amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) Regulation .01B amended effective January 6, 2014 (40:26 Md. R. 2163); May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338) Regulation .02B amended effective January 25, 2010 (37:2 Md. R. 67) Regulation .02C, D amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .03 amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .03B, E amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .03B, F amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .03F amended effective October 14, 2013 (40:20 Md. R. 1652) Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 516); May 18, 2020 (47:10 Md. R. 516) Regulation .04A amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .04B amended effective April 9, 2007 (34:7 Md. R. 698); May 1, 2023 (50:8 Md. R. 338) Regulation .04C amended effective May 1, 2023 (50:8 Md. R. 338) Regulation .05 amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .05 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) Regulation .05 amended effective January 6, 2014 (40:26 Md. R. 2163); May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338) Regulation .06 amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .06E adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); adopted permanently effective October 6, 2008 (35:20 Md. R. 1774) Regulation .07C amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .07D amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .08E amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .08F amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .09C amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .09-1 adopted effective April 9, 2007 (34:7 Md. R. 698) Regulation .09-1 amended effective May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338) Regulation .09-1C amended effective January 6, 2014 (40:26 Md. R. 2163) Regulation .09-2 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); adopted permanently effective October 6, 2008 (35:20 Md. R. 1774) Regulation .10B amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .11C amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .11C, D amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .12A amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .12A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) Regulation .12C amended effective May 1, 2023 (50:8 Md. R. 338); March 3, 2025 (52:4 Md. R. 218); June 8, 2026 (53:11 Md. R. 485) Regulation .13 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.06.01 are applicable to this chapter. Terms Defined. “Charity care” means hospital care for which the costs are not reimbursed through any patient or third party. “Charity care inpatient costs” means hospital costs that are not reimbursed through any patient or third party, reduced by the amount of gifts, restricted grants, or income from endowments. For the purposes of this chapter, third party payments include Medicaid payments for the cost of care, but do not include disproportionate share payments. “Low-income hospital costs” means the sum of a hospital's: Inpatient Medicaid costs; State and local government inpatient cash subsidies; and Charity care inpatient costs. “Low-income utilization rate” means, for a hospital, the sum of: A fraction, expressed as a percentage: The numerator of which is the sum, for a fiscal year, of the total revenues paid the hospital for patient services under a Medical Assistance Program, and the amount of cash subsidies for patient services received directly from State and local governments, and The denominator of which is the total amount of revenues of the hospital for patient services, including the amount of the cash subsidies in the fiscal year; and A fraction, expressed as a percentage: The numerator of which is the total amount of the hospital's charges for inpatient hospital services that are attributable to charity care in a fiscal year, less the portion of any cash subsidies described in §B(4)(a)(i) of this regulation in the period reasonably attributable to inpatient hospital services, and The denominator of which is the total amount of the hospital's charges for inpatient hospital services in the hospital in the period reasonably attributable to inpatient hospital services. “Medicaid cost” means an amount equal to Medicaid payments by the Medicaid program. “Medicaid inpatient utilization rate” means a fraction, expressed as a percentage: The numerator of which is the hospital's number of inpatient days attributable to patients who were eligible for Medical Assistance benefits under Title XIX of the Social Security Act for a fiscal year; and The denominator of which is the total number of the hospital's inpatient days for the fiscal year in §B(6)(a) of this regulation. “State and local government inpatient cash subsidies” means the payments for hospital costs from State or local government health agencies that are not intended as reimbursement for costs directly associated with particular patients, but are provided more generally for operating costs of the institution. These subsidies do not include Medicaid payments or disproportionate share payments. A Maryland hospital is considered a disproportionate share hospital for purposes of a disproportionate share payment if the hospital's: Medicaid inpatient utilization rate is at least one standard deviation above the mean Medicaid inpatient utilization rate for Maryland hospitals that are Medicaid providers; or Low-income utilization rate exceeds 25 percent. To be considered a disproportionate share hospital, a hospital shall have at least two obstetricians with staff privileges who have agreed to provide obstetrical services to individuals who are entitled to Medical Assistance for services under Title XIX of the Social Security Act. The requirements set forth in §B of this regulation do not apply to a hospital if: Inpatients are predominately individuals younger than 18 years old; or The hospital did not provide nonemergency obstetric services as of December 22, 1987. Data for §A(1) and (2) of this regulation relate to the State fiscal year occurring 2 years before the fiscal year during which payments are made. Free-Standing Acute General, Chronic, or Pediatric/Rehabilitation Hospitals. Except as set forth in §A(2) of this regulation, the disproportionate share payment for disproportionate share hospitals that are free-standing hospitals licensed as acute general, chronic, or jointly as pediatric and rehabilitation equals an amount determined in accordance with 42 CFR §412.106, but only if the hospital qualifies as a disproportionate share hospital under 42 CFR §412.106. Free-standing hospitals that are approved by the Program for reimbursement according to rates established by the HSCRC receive a bad debt allowance, which is recognized as a disproportionate share payment equal to or greater than the amount set forth in §A(1) of this regulation, and an additional payment may not be made under this chapter. The disproportionate share payment rate relating to Program payments on or after October 1, 1992 for free-standing hospitals licensed exclusively as: Psychiatric with charity care inpatient costs: Exceeding 40 percent of total inpatient hospital costs equals the greater of the: Hospital's annual low income costs divided by its annual inpatient Medicaid costs, minus 1, all multiplied by 2, and then multiplied by its inpatient Medicaid payment, or Minimum payment required by federal law; Less than or equal to 40 percent of total inpatient hospital costs equals the minimum payment required by federal law; Rehabilitation with charity care inpatient costs: Exceeding 20 percent of total inpatient hospital costs equals the greater of the: Hospital's annual low income costs divided by its annual inpatient Medicaid costs, minus 1, multiplied by its inpatient Medicaid payment, or Minimum payment required by federal law; Less than or equal to 20 percent of total inpatient hospital costs equals the minimum required by federal law. If a hospital qualifies under both §§A(2) and B of this regulation, it is governed by §A(2) of this regulation. Payments according to §A or B of this regulation shall be: Based on data on annual low-income hospital costs, annual inpatient Medicaid costs, and data pertaining to 42 CFR §412.106 from the complete State fiscal year occurring 2 years before the fiscal year during which payments are made; Made in one or more payments covering the complete fiscal year; and Made to appropriate hospital providers that comply with all regulations set forth in COMAR 10.09.92—10.09.95. Out-of-State hospitals determined by the host state Medicaid Program to be a disproportionate share hospital shall be paid a disproportionate share adjustment as determined by the host state Medicaid Program, with a hospital's total adjustment not to exceed 1 percent of the total Maryland Medical Assistance payments to that hospital in a fiscal year. Qualification Requirements. Except as set forth in §F(2) of this regulation, to qualify as a disproportionate share hospital, a hospital shall supply to the Program, 6 months before the start of the applicable fiscal year: Information necessary to determine if the hospital qualifies as a disproportionate share hospital; and Data required under §D(1) of this regulation. For payments in fiscal year 93, the information required in this section shall be presented to the Department within 10 days of the effective date of these regulations. A free-standing hospital licensed exclusively as psychiatric or rehabilitation for at least 2 years, that has not been a Maryland Medicaid provider for at least 2 years, shall receive a disproportionate share payment, for any year, not greater than the hospital's low-income hospital costs in the complete State fiscal year occurring 2 years before the fiscal year during which payments are made. If it is determined that a payment made to any hospital under this regulation exceeds the actual amount of uncompensated care and would result in reverting funds to CMS, the overpayment shall be used for another provider that received less than that provider was eligible to receive. The redistribution shall be available to all providers that are eligible for disproportionate share payments except those whose rates are set by HSCRC. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.04 adopted as an emergency provision effective June 1, 1992 (19:12 Md. R. 1131); adopted permanently September 1, 1992 (19:17 Md. R. 1607) Regulation .03 amended as an emergency provision effective February 17, 1993 (20:5 Md. R. 511); amended permanently effective May 24, 1993 (20:10 Md. R. 852) Regulation .03D amended effective September 25, 2017 (44:19 Md. R. 896) Regulation .03H adopted effective June 24, 2013 (40:12 Md. R. 1042) In this chapter, the following terms have the meanings indicated. Terms Defined. “Annually” means within 365 days. “Applicant” means the individual who files an application for services with the DDA. “Community Coordination Services” means provision of core services to individuals receiving ongoing DDA funding for comprehensive community services. “Community resources” means generic, local, State, or federal programs, services, benefits, and supports. “Comprehensive assessment” means an assessment of the applicant’s needs and supports to enable the DDA to determine the applicant’s eligibility for DDA funding of comprehensive community services. Comprehensive Community Services. “Comprehensive community services” means services funded by the DDA for residential, day, employment, or supports services. “Comprehensive community services” does not mean funding for low intensity support services or coordination of community services. “Contact” means a face-to-face meeting, phone conversation, or written correspondence related to the covered services in this chapter. “Coordination of community services” means the provision of targeted case management services that assist participants in gaining access to the full range of medical assistance services, as well as access to any additional needed generic, medical, social, habilitative, employment, recreational, housing, financial, counseling, legal, educational, and other support services. “Coordinator of community services” means an individual employed by the coordination of community services agency to assist participants in selecting, obtaining, and monitoring the most responsive and appropriate services and supports. “Coordination of community services supervisor” means an individual who is employed to oversee coordination of community services and performance of coordinators of community services. “Core services” means the following community services: Comprehensive assessment; Development of the person-centered plan; Referrals and related activities; and Monitoring and follow-up. “Critical incident” means a reportable event that presents an immediate and serious threat of injury, harm, impairment, or death of an individual. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Developmental Disabilities Administration (DDA)” means that agency of the Department which, under Health General Article, Title 7, Annotated Code of Maryland, is charged with the responsibility for providing services to individuals with developmental disability. “Developmental disability” has the same meaning as set forth in Health-General Article, §7-101, Annotated Code of Maryland. “Entity” means a facility, agency, organization, department, office, corporation, partnership, group, or individual. “Generic” means programs, services, or supports which are available to the community at large. “Goal” means measurable activity that is required to achieve progress toward an outcome. “Medicaid waiver programs” means any program under §1915(c) of the Social Security Act. “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Most integrated setting” means a setting that enables a participant with a disability to interact with nondisabled individuals other than staff to the fullest extent possible. “Outcome” means tangible results of goals that reflect the desired quality of life as defined by the individual. “Participant” means an individual who meets the qualifications for participation in coordination of community services as specified in Regulation .03 of this chapter. Person-Centered Plan. “Person-centered plan” means a written plan that is developed through a planning process driven by the participant with a developmental disability to: Identify the participant’s goals and preferences; Identify services to support the participant in pursuing the participant’s personally defined outcomes in the most integrated community setting; Direct the delivery of services that reflect the participant’s personal preferences and choice; and Identify the participant’s specific needs that must be addressed to ensure the participant’s health and welfare. “Person-centered plan” includes an individual plan as referenced in COMAR 10.22. “Person-directed supports” means service and supports that empower the participant, and the legally authorized representative on the participant’s behalf, to direct the development and implementation of a plan of supports and services that meet the participant’s personal goals. Place of Service. “Place of service” means the place where participants receive services. “Place of service” includes but is not limited to the participant’s home, day program, group home, alternate living arrangement, or place of employment. “Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Provider” means an entity that meets the conditions for participation specified in Regulation .04 of this chapter, and is authorized by DDA to provide coordination of community services. “Reportable events” means specified incidents and complaints noted in the DDA Policy on Reportable Incidents and Investigations (PORII), as required under COMAR 10.22.02.01 and established to ensure the health, safety, and welfare of participants receiving services from DDA-funded providers. “Representative” means a person who: Is chosen by the participant to represent the participant’s needs and may include: A family representative; An informal caregiver; or Any other individual chosen by the participant; or Is recognized by the DDA as a legally appointed guardian qualified to act on the participant’s behalf with respect to services covered under this chapter. “Service record” means all past and current health, eligibility, request for service change, service funding plan, person-centered plan, and coordination of community services documents and records. “State programs” means programs, services, or supports offered by the State. Targeted Case Management. “Targeted case management” means an optional service allowed under federal Medicaid rules which includes services to assist target populations of Medicaid participants to gain access to needed medical, social, educational, and other services. “Targeted case management” includes: Performance of a comprehensive assessment and periodic reassessment of participant needs, to determine the need for any medical, educational, social, or other services; Provision of waiting list coordination services; Provision of community coordination services; and Provision of transition coordination services. “Transition Coordination Services” means provision of core services to participants transitioning to the community from an institution. “Unit of service” means 15 minutes of services covered under this chapter, excluding the comprehensive assessment. “Waiting list” means participants found eligible for services in the crisis resolution, crisis prevention, or current request priority category as set forth in COMAR 10.22.12.07B. “Waiting List Coordination Services” means provision of core services to participants on the DDA waiting list. The provider shall meet all applicable certification requirements as set forth in COMAR 10.22.02 unless otherwise authorized by the Developmental Disabilities Administration. To be eligible for services covered under this chapter, a participant or applicant shall: Apply to be a Medical Assistance Program participant or be Medical Assistance Program eligible; and Either: Have applied for services from the Developmental Disabilities Administration but not yet had their eligibility determined; or Be eligible for funding from the DDA as set forth in COMAR 10.22.12, and meet one of the following conditions: Be determined to have a developmental disability and currently on the DDA waiting list; Be receiving comprehensive community services funded by the DDA; or Be determined to have a developmental disability and in the process of transitioning to the community. In this chapter, targeted case management services are referred to as coordination of community services. Providers shall meet all the conditions for participation as set forth in COMAR 10.09.36.03. Administrative and Professional Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall: Be incorporated in the State in good standing with the Maryland Department of Assessments and Taxation unless operating as a local health department; Have a board of directors or local advisory board in accordance with COMAR 10.22.02; Be selected by DDA as an approved provider of coordination of community services, as evidenced by an executed DDA-approved contract; Participate in all transition and rollout processes as determined by the DDA; Maintain a standard 8-hour operational day Monday through Friday and have flexible staffing hours that include nights and weekends to accommodate the needs of participants receiving coordination of community services; Maintain a toll-free number, unless otherwise authorized by the DDA, and an accessible communication system in accordance with the Americans with Disabilities Act of 1990; Maintain a communication system that is accessible for participants with limited English proficiency; Provide alternative communication methods to serve the needs of participants receiving coordination of community services and their family members; Have a means for participants, their families, community providers, and DDA staff to contact the coordination of community services designated staff directly in the event of an emergency and at times other than standard operating hours; Annually advise participants of their right to choose among qualified providers of services including coordination of community services; Comply with all State and federal statutes and regulations; Maintain a participant’s record for a minimum of 6 years after the record is made; Notify the DDA immediately in writing of any critical incidents that affect the health, safety, and welfare of a participant, as well as administrative and quality of care complaints as required by the DDA Policy on Reportable Incidents and Investigations; and Submit required documents and forms to the Department as requested. Operational Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall: Submit a program service plan that includes: Scope of work; and Proposed staffing plan, including staff and staff-to-participant ratios; Complete and submit an initial and annual written quality assurance plan to the DDA which meets the requirements in COMAR 10.22.02.14 and includes the following: Customer service plan that includes strategies and services to meet the needs of participants, their families or caretakers, and providers; and Self-assessment, remediating, monitoring, reporting, and system improvements strategies, or other quality and compliance actions related to coordination of community services; Submit monthly service delivery statistical reports as defined by the Department by the 15th of each month unless otherwise directed by the Department; Submit quarterly updates, as defined by the Department, on progress on quality assurance plans by October 15, January 15, and April 15 of each year unless otherwise directed by the Department; Submit to the Department annually by July 15th the final quality plan summary reports unless otherwise directed by the Department; Maintain a thorough understanding and knowledge of: Eligibility requirements, application procedures, and scope of services of local, State, and federal resources and programs which are applicable to participants eligible for DDA services; Medicaid, Medicaid waiver programs, and DDA eligibility requirements, application procedures, and service delivery systems; and Person-centered planning methodology and person-centered plan development and monitoring; Coordinate services with multiple long-term service and support systems; Maximize resources to the greatest possible extent; and Obtain authorization from the DDA before providing any coordination of community services to any participant; In providing coordination of community services, meet the following requirements: All participants referred for coordination of community services by the DDA shall be contacted within 3 business days of receipt of referral unless otherwise authorized by the DDA; A face-to-face meeting with the referred participant shall be arranged at a time and location convenient for the referred individual during the first contact; A face-to-face meeting shall occur within 7 business days of the initial contact unless the participant’s health or schedule conflicts; If applicable, the provider shall document in the case record reasons why face-to-face meetings did not occur within the required timeframe and share the document as requested by the DDA or its designee; Authorization for specific coordination of community services shall be based on referrals from the DDA regional office; and In the event of emergencies, the participant referred for coordination of community services by the DDA shall be contacted by the coordinator of community services as circumstances require or as requested by the DDA. Participant Record. The provider shall maintain a record on each participant which meets the Program’s requirements and which includes: The name of the participant; The dates of the coordination of community services; The name of the provider agency and the name of agency employee providing the coordination of community service; The name, address, and telephone number of the individual or individuals to be contacted in case of emergency; A completed person-centered plan; The comprehensive assessment as applicable; Documentation that the coordinator of community services provided the participant with a choice among qualified providers of services, including coordination of community services; Documentation that indicates whether the participant has declined services in the person-centered plan and the reason for declining; Documentation that includes: A schedule for obtaining needed services; A timeline for re-evaluation of the person-centered plan not less than annually; and The name and position of the individual responsible for completing tasks related to the person-centered plan; Status of progress on participant-intended outcomes identified in the person-centered plan; Documentation of coordination with other service systems, including: Demonstrated need for other services systems; and Dates of occurrences of coordination with other service systems; and Documentation for each contact made by the coordinator of community services including: Date and subject of contact; Individual contacted; Individual making the contact; Contact method; Nature and extent of coordination of community services provided; Number of unit or units of service provided; Place of service; and Services referred. Technology Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall: Utilize an electronic information system which, at a minimum: Maintains confidential individual case and billing records; Provides documentation of coordination of community services and number of units provided for participants receiving services; Maintain a permanent history log of all entries made to the record; and Adheres to applicable State and federal laws; and Adhere to the following information technology requirements: Use the DDA’s designated data system unless another data system is approved annually by the DDA; Ensure that all management information systems: Are secure from improper use, alteration, or disclosure; Utilize industry best practices for secure connection to management information systems; Secure network connections with logon only from a secured location; Prohibit users from sharing user accounts; Limit access to the system and related information based on job function; and Adhere to DDA information technology data security policies, standards, and procedures when using DDA managed systems; Report security violations and actual or attempted security breaches affecting the managed systems with participant information immediately but not later than 48 hours after the violation or breach; Maintain and update as necessary all electronic data systems to be compatible with those of the State and, if required, work with DDA to develop a system for developing protocols for data sharing and read-only access for the DDA and its designees; and Obtain written approval from the DDA before posting on any public website information that describes DDA services. Billing. To receive payment for services covered under this chapter, the provider shall: Comply with Department’s requirements for submitting, processing, and reconciling claims for payment for services rendered under this chapter; Be in good standing with the Maryland Department of Assessments and Taxation, and with its equivalent in every state in which the applicant provides services; Permit the DDA or the Department or its agent, or any State or federal entity operating within its statutory authority to conduct audits and provide immediate access to all records upon request; and Comply with audit requirements. Freedom of Choice. The provider shall place no restrictions on the participant’s freedom of choice among: Providers of coordination of community services; Providers of community-based services for which the participant qualifies; and Service delivery models available under the DDA’s Medicaid waiver programs. Transfer of Service Records. For participants changing from one DDA-authorized coordination of community services provider to a different DDA-authorized coordination of community services provider, the outgoing provider shall: Transfer the service record to the new provider; and Share with the new provider the participant’s demographic information and the most recent person-centered plan within 5 business days of notification of transfer for the continued coordination of services. Provision of Services. The provider may not exercise the agency’s authority to authorize or deny DDA or other State funded services. Staff Capability Requirements. The provider shall: Employ only personnel who are appropriately qualified as set forth in this regulation; Maintain sufficient staff required to meet the needs of the participants whom the provider serves; Have administrative and supervisory staff to ensure the quality of coordination of community services provided by the provider; Have a management capability team, each member of which has at least 3 years of experience providing coordination of community services or management experience in human services; and Maintain personnel files for each employee which includes documentation of staff qualifications as set forth in this regulation. Staff Training Requirements. All DDA-certified coordination of community services providers shall ensure through appropriate documentation that coordination of community services staff, supervisors, and quality assurance staff receive training, as required by DDA. All coordination of community services staff shall receive training on procedures, protocols, processes, and regulations as required by the DDA. Coordination of community services staff shall: Receive required training as specified in COMAR 10.22, unless otherwise directed by the DDA, which shall be documented and made available upon request; Comply with all State and federal statutes, regulations, and policies; and Demonstrate competency-based skills and working knowledge in the following areas: Negotiation and conflict management; Crisis management; Community resources including generic programs, local programs, State programs, and federal programs and resources; Determining the most integrated setting appropriate to meet the participant’s needs; Coordinating and facilitating planning meetings; Assessing, planning, and coordinating services; Assisting participants in gaining access to services and supports; Monitoring the provision of services to participants; Allied service delivery systems, including Medicaid, mental health, substance abuse, social services, juvenile justice, vocational rehabilitation, and corrections; and Regulations governing services for participants with developmental disabilities. Coordination of Community Services Supervisor. The coordination of community services supervisor shall: Except as stated in §F of this regulation, meet one or more of the following education requirements: An advanced degree from an accredited education program in human services and 1 year of experience as set forth in §C of this regulation; or A bachelor’s degree from an accredited education program in human services with 3 years experience as set forth in §C of this regulation; Demonstrate experience in one or more of the following: Coordinating services for participants in Medicaid or waiver programs; or Coordinating services for participants with intellectual or developmental disabilities; Demonstrate experience in all of the following: Social services intake and referral services; Data collection, analysis, and reporting; Staff supervision; and Management or leadership; Supervise the work of coordinators of community services; and Monitor the quality of services. Coordinator of Community Services. The coordinator of community services shall: Except as stated in §F of this regulation, have: A bachelor’s degree from an accredited education program in a human services field; An associate’s degree with 2 years’ experience in a human services field; or 7 years’ experience in a human services field; Use all communication methodologies, strategies, devices, and techniques necessary, including sign language, assistive technology, or language interpreter services, to facilitate the involvement of the participant in the assessment, development, and monitoring of services and supports; Ensure that each participant receives a person-centered plan that is designed to meet the individual’s needs in the most cost-effective manner; and Annually advise participants of their right to choose among qualified providers of services including coordination of community services. Education and Experience Waiver. Coordination of Community Services Supervisor. Education and experience requirements may be waived if an individual has been employed as a coordination of community services supervisor for at least 1 year as of January 1, 2014. Coordinator of Community Services. Education and experience requirements may be waived if an individual has been employed as a coordinator of community services for at least 1 year as of January 1, 2014. An individual is ineligible for employment by a coordination of community services provider, agency, or entity in Maryland if the individual: Is simultaneously employed by any MDH-licensed or MDH-certified provider agency; Is on the Maryland Medicaid exclusion list; Is on the federal List of Excluded Individuals/Entities (LEIE); Is on the federal list of excluded parties as maintained by the System of Award Management (SAM.GOV); Has been convicted of a crime of violence in violation of Criminal Law Article, §14-101, Annotated Code of Maryland; Violates or has violated Health-General Article, §7-1102, Annotated Code of Maryland; or Has been found guilty or been given Probation Before Judgment for a crime which would indicate behavior potentially harmful to individuals receiving services, as documented either through a criminal history records check or a criminal background check, pursuant to: Health-General Article, §19-1902, et seq., Annotated Code of Maryland; and COMAR 12.15. Only core services shall be authorized for payment by DDA as covered coordination of community services. The coordinator of community services shall provide the core services listed in this regulation to every participant assigned to the coordinator. Comprehensive Assessment. Coordination of community services shall include a comprehensive assessment of the participant’s needs and supports to determine eligibility, in accordance with COMAR 10.22.12. The assessment shall be completed within 45 days after referral by the DDA and include: A review of relevant medical and other records with the applicant or legal representative’s written consent; A review of current providers of medical, social, or other support services, as appropriate; Unless otherwise authorized by the DDA, a face-to-face assessment of the participant, preferably at the participant’s residence, to review: Medical, developmental, and mental history, including current medications; Nutritional status; Emotional and behavioral status; Health care coverage; Living situation; Personal support systems; Participant goals and preferences; Environmental, social, and functional status; Educational history; Employment and income status; Health education; Social support; The most integrated setting appropriate to meet the participant’s needs; and Any additional service needs; Assistance with information-gathering such as obtaining professional evaluations and assessments necessary to document and recommend eligibility and priority for services; and A completed assessment form as required by the DDA. Person-Centered Plan. The coordinator of community services shall facilitate the person-centered plan that is designed to meet the participant’s needs, preferences, goals, and outcomes in the most integrated setting and in the most cost effective manner. The person-centered plan shall: Be participant-centered, outcome-oriented, and person directed, as selected by participant; Comply with the requirements set forth in COMAR 10.22.05; Establish a plan for emergencies; Be completed within 30 business days after initial contact with the participant, and, if necessary, updated or modified within 30 business days after service initiation; Be developed and written in collaboration with the participant and his or her identified representatives as appropriate; Provide services in the most integrated setting; Identify services needed to accomplish intended outcomes and preferences; Address risks and needs identified in the comprehensive assessment; and Be updated or revised: As the conditions or circumstances of the participant change or as requested by the participant; and Within 365 days of the initial person-centered plan or annually. Specific requirements for the person-centered plan developed for participants receiving transition coordination services are that the person-centered plan shall: Address challenges related to transitioning; Focus on transition from the institutional setting to the community; Identify services and supports that may be available; Be outcome-oriented; and Include the provision of services and supports. Referral and Related Activities. At the time of the initial meeting and any follow-up contacts, coordinators of community services shall provide information, make referrals, and assist participants with applications for services provided by: Community organizations; State programs; and Federal programs. Referral and related activities may include: Assisting the participant with the completion of applications for services and programs; Providing the participant with contact or other information for services provided by self-advocacy groups, recreation organizations, or social groups; Assisting the participant with transitioning to new services, providers, or supports; Assisting the participant with referrals, as needed; and Providing education to participants and their families concerning: The range of most integrated setting service and support options that may be appropriate to meet the participant’s needs and preferences; How to access services; and How to coordinate and advocate for services. Monitoring and Follow-Up. The coordinator of community services shall provide monitoring and follow-up activities, which shall include: Assessment of: Services being rendered as specified in the person-centered plan; The participant’s current circumstances; Progress toward goals and intended outcomes; The participant’s referral status; and The participant’s needs and supports to maintain eligibility for Medicaid, Medicaid waiver programs, DDA services, and any other relevant benefits or services; Identification of new medical, health services, or other needs; Recommendation of new DDA priority category as the conditions or circumstances of the participant changes, or as requested by the DDA; Requests for service change and modifications of the person-centered plan as necessary to meet health and safety needs, preferences, and goals; Identification of new support or resource options; Review and, if necessary, revision of the plan for emergencies; Monitoring of any and all reportable incidents as defined in DDA’s reportable incident policy; and Application or re-application for necessary programs or services to prevent or remedy a gap in eligibility. Frequency of Monitoring and Follow-up Contact. For participants receiving waiting list coordination services, monitoring and follow-up contact activities shall meet the following requirements: For participants who meet the criteria for the crisis resolution priority category as set forth in COMAR 10.22.12.07, minimum monthly face-to-face contacts shall be made for the first 90 days, after which face-to-face contacts will be made quarterly; For participants who meet the criteria for the crisis prevention priority category as set forth in COMAR 10.22.12.07, minimum quarterly face-to-face contacts shall be made; and For participants who meet the criteria for the current request priority category as set forth in COMAR 10.22.12.07, minimum annual face-to-face contacts shall be made. Participants on the DDA waiting list shall be monitored in accordance with §F(2)(a) of this regulation unless: The participant’s priority category changes; or Additional units are authorized by DDA. For participants receiving community coordination services, monitoring and follow-up activities shall be performed: On a minimum quarterly basis; Face to face with the participant; In different services delivery settings; and At least one time in each service delivery setting. For participants receiving transition coordination services, monitoring and follow-up activities shall be performed face-to-face at least once a month for the first 90 calendar days, after which face-to-face contacts shall be made quarterly. Records of monitoring activities shall: Be completed in a format approved by the DDA; Include descriptions of the participant’s current circumstances, progress toward goals, intended outcomes, preferences, and referral status; Document new support and resource options for intake and referral; Be submitted using the electronic system provided by the Department; and Document all reportable events as set in the DDA’s policy on reportable incidents and investigations. Restrictions may not be placed on a participant’s option to receive coordination of community services. Coordination of community services provided under this chapter does not restrict or otherwise affect eligibility for Title XIX benefits or other available benefits or programs. Coordination of community services may not be: Provided as an integral and inseparable part of another covered Program service; Provided as an administrative function; Rendered in connection with the implementation of another service authorized under §1915(b) or 1915(c) of the Social Security Act; or Provided as a substitute or in duplication of another service or support. Unless otherwise approved by the Department, reimbursement may not be made for coordination of community services if the participant is receiving comparable case management services under any other State program. A participant’s coordination of community services provider may not also provide DDA-funded direct services, including meaningful day, support, and residential services for the participant. Service Exclusions. Unless an individual is transitioning into the community, coordination of community services may not be provided to: Individuals between the ages of 22 and 64 who are served in institutions for mental disease; or Inmates or residents of public institutions. Services of more than 180 consecutive days of a covered stay in a medical institution will not be reimbursed unless an individual is transitioning from another Medicaid program into a DDA waiver program as authorized by the DDA. An applicant is ineligible to be a provider if, within the preceding 10 years, the entity, its owner, or any member of its board of directors has had a provider license or certification revoked or suspended for more than 30 days, pursuant to Maryland or another state’s regulations, or has been found by a court of law to have committed fraud, abuse, intentional or negligent tort, or a criminal act. Request for Payment. Requests for payment for the services covered under this chapter shall be submitted by a provider according to procedures set forth in COMAR 10.09.36.04. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Payment Rates. The Department shall publish a fee schedule for services covered under this chapter, which shall be publicly available and updated at least annually or upon any changes made by the Department. The Department's rates set forth in its fee schedule will apply to services covered under this chapter that are provided under either the traditional services delivery model or the self-directed services delivery model. The Program's rates for covered services under this chapter shall increase on July 1 of each year, subject to the limitations of the State budget. Providers shall be reimbursed within 45 business days of approved invoice for services rendered based on the rates set forth in §C(1) and (2) of this regulation. For a comprehensive assessment, providers shall be reimbursed $450 per assessment. For all other services rendered to Maryland Medicaid participants residing in counties other than those listed in §B(7) of this regulation, providers shall be reimbursed: For dates of service January 1, 2023 through June 30, 2023, $24.56 per unit; For dates of service July 1, 2023 through December 31, 2023, $25.54 per unit; For dates of service January 1, 2024 through June 30, 2024, $27.50 per unit; and For dates of service July 1, 2024 through June 30, 2025, $28.33 per unit. Providers rendering services to Maryland Medicaid participants residing in Calvert, Charles, Frederick, Montgomery, and Prince George’s counties shall be reimbursed: For dates of service January 1, 2023 through June 30, 2023, $25.86 per unit; For dates of service July 1, 2023 through December 31, 2023, $26.89 per unit; For dates of service January 1, 2024 through June 30, 2024, $28.96 per unit; and For dates of service July 1, 2024 through June 30, 2025, $29.83 per unit. Changes in Rates. The rates are subject to the limitations of the State budget. Unless otherwise authorized, the rates may be changed on July 1 of each year beginning July 1, 2015, based on legislative action, and subject to limitations of the State budget. Payment Limitations. Payment shall be made only to one provider for covered services rendered to a participant on a particular date of service. Payment for the services covered under this chapter: Shall be considered as payment in full; and May not supplement or be supplemented by payment from other sources, such as the participant, family, a public program, or private agency. For a comprehensive assessment, only one assessment may be reimbursed per participant, unless otherwise authorized by DDA. Ongoing coordination of community services shall be billed on a scheduled determined by the Department. Units of Services and Limitations. All coordination of community services other than the initial comprehensive assessment shall be billed to DDA in units of service. DDA shall provide payment for only those coordination of community services that were authorized by DDA before the provision of the service. Each fiscal year, the coordinator of community services shall complete the core services for each participant. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08 and 10.22.03. Appeal procedures for providers shall be as set forth in COMAR 10.09.36.09. Appeal procedures for participants shall be as set forth in COMAR 10.01.04. State regulations shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.18 adopted as an emergency provision effective June 23, 1992 (19:14 Md. R. 1276); adopted permanently effective October 12, 1992 (19:20 Md. R. 1815) Regulations .01—.03 and .06 amended and Regulation .12 repealed as an emergency provision effective December 9, 1994 (21:26 Md. R. 2183); adopted permanently effective March 27, 1995 (22:6 Md. R. 474) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .09A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .10A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulations .01—.18 under Case Management for Individuals with Developmental Disability repealed and new Regulations .01—.12 under Targeted Case Management for People with Intellectual and Developmental Disabilities adopted effective July 8, 2013 (40:13 Md. R. 1074) Chapter name, Targeted Case Management for People with Intellectual and Developmental Disabilities amended to be Targeted Case Management for People with Developmental Disabilities effective June 8, 2015 (42:11 Md. R. 723) Regulation .01B amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) Regulation .02 amended effective December 27, 2021 (48:26 Md. R. 1111) Regulation .03 amended effective December 27, 2021 (48:26 Md. R. 1111) Regulation .03B amended effective June 20, 2016 (43:12 Md. R. 666) Regulation .04 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) Regulation .05 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) Regulation .06 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) Regulation .07 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) Regulation .08 amended effective June 8, 2015 (42:11 Md. R. 723); June 20, 2016 (43:12 Md. R. 666); December 27, 2021 (48:26 Md. R. 1111) Regulation .08B amended effective August 14, 2017 (44:16 Md. R. 809); February 12, 2018 (45:3 Md. R. 156); December 31, 2018 (45:26 Md. R. 1243); December 30, 2019 (46:26 Md. R. 1164); August 21, 2023 (50:16 Md. R. 276); September 16, 2024 (51:18 Md. R. 809); November 24, 2025 (52:23 Md. R. 1139) Regulation .10 amended effective June 8, 2015 (42:11 Md. R. 723) This chapter applies to covered services delivered via synchronous telehealth and eligible for reimbursement by the Maryland Medicaid Program. The purpose of providing medically necessary services via telehealth is to improve: Access to services, thus reducing preventable hospitalizations and barriers to health care access; Access to outpatient and inpatient subspecialty services, thus improving diagnostic clarification, treatment recommendations, and planning for the individual; Health outcomes through timely disease detection and treatment options; and Capacity and choice for ongoing treatment in underserved areas of the State. In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrative services organization (ASO)” means an entity that manages the Public Behavioral Health System on behalf of the Department. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Distant site” means a site at which the licensed, certified, or otherwise authorized distant site provider is located at the time the service is provided via technology-assisted communication. “Distant site provider” means the licensed, certified, or otherwise authorized provider at the distant site who provides medically necessary services via telehealth to the patient. “GT modifier” means the Healthcare Common Procedure Coding System service code modifier indicating that the provider rendered a healthcare service via an interactive audio and video telecommunications system. “Medically necessary" means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, family, or provider. “Originating site means the location of an eligible Medicaid participant at the time the service being furnished via technology-assisted communication occurs. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Provider” means: An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Medical Assistance participants and who, through appropriate agreement with the Department, has been identified as a Maryland Medical Assistance Provider by the issuance of an individual account number; An agent, employee, or related party of a person identified in §B(12)(a) of this regulation; An individual or any other person with an ownership interest in a person identified in §B(12)(a) of this regulation. Store and Forward Technology. “Store and forward technology" means the transmission of medical images or other media captured by the originating site provider and sent electronically to a distant site provider, who does not physically interact with the patient located at the originating site. “Store and forward technology” does not mean dermatology, ophthalmology, or radiology services according to COMAR 10.09.02.07. “Technology-assisted communication” means multimedia communication equipment permitting two-way real-time interactive communication between a patient at an originating site and a distant site provider at a distant site. “Telehealth” means the synchronous delivery of medically necessary services to a patient at an originating site by distant site provider, through the use of technology-assisted communication. “Telehealth Program” means the program by which medically necessary services are authorized to be delivered via technology-assisted communication between originating and distant site providers. “UB modifier” means the Healthcare Common Procedure Coding System service code modifier indicating that the provider rendered a healthcare service via an interactive audio-only telecommunications system. Under the Telehealth Program, the Department shall cover: Medically necessary services covered by the Maryland Medical Assistance Program rendered via telehealth that shall be: Distinct from services provided in person; Able to be delivered using technology-assisted communication; and Clinically appropriate to be delivered via telehealth; Services provided via telehealth to the same extent and standard of care as services provided in person; As determined by the provider’s licensure or credentialing board, services performed via telehealth within the scope of a provider’s practice; and Services permitted to be provided via telehealth as set forth in the COMAR chapter defining the covered service being rendered.. To render or bill for services delivered via telehealth, the provider shall meet the requirements as set forth in: COMAR 10.09.36.02; COMAR 10.09.36.03; and The COMAR chapter defining the covered service being rendered. The provider shall obtain the participant’s consent to services via telehealth, unless there is an emergency that prevents obtaining consent, which shall be documented in the participant’s medical record. Medical Record Documentation. The provider shall: Maintain documentation in the same manner as during an in-person visit, using either electronic or paper medical records; Retain telehealth records according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland; and Include the participant's consent to participate in telehealth or an explanation as to why consent was not available. An originating site may be any secure location, approved by the participant and the provider, for the delivery of telehealth services. Distant Site Providers may render services via telehealth within the provider's scope of practice. A provider of services delivered through telehealth shall adopt and implement technology in a manner that supports the standard of care to deliver the required service. A service delivered through synchronous audio-visual telehealth shall, at a minimum, meet the following technology requirements: Cameras at both the originating and distant sites that provide clear, synchronous video of the patient and provider, respectively, with the ability to meet the clinical requirements of the service; Unless engaging in a telehealth with a participant who is deaf or hard of hearing, microphones and speakers at both the originating and distant sites, respectively, that provide clear, synchronous, two-way audio transmission; Network connectivity and bandwidth at both the originating and distant site sufficient to provide clear, synchronous two-way video and audio for the full duration of the service; Display monitor size sufficient to support diagnostic needs used in the telehealth services; and Utilize technology that meets the standards required by State and federal laws governing the privacy and security of protected health information (HIPAA compliant). The provider: Shall comply with all State and federal laws and regulations concerning the privacy and security of protected health information, including but not limited to: Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended; Shall ensure that all interactive video technology-assisted and audio-only communication comply with HIPAA patient privacy and security regulations throughout the transmission process; Shall occupy a space or area that meets the minimum standards for privacy expected for a patient-provider interaction; May not disseminate any participant images or information to other entities without the participant's consent, unless there is an emergency that prevents obtaining consent; and May not store the video images or audio portion of the service delivered via telehealth for future use. A service delivered via telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage that exist for services delivered in person. A service delivered via telehealth does not include: An electronic mail message between a health care provider and a patient; A facsimile transmission between a health care provider and a patient; or A telephone conversation, electronic mail message, or facsimile transmission between providers without direct interaction with the patient. Store and forward technology does not meet the Maryland Medical Assistance Program's definition of telehealth. The Maryland Medical Assistance Program covers services such as dermatology, ophthalmology, and radiology according to COMAR 10.09.02.07. The provider may not bill the Maryland Medicaid Assistance Program for services delivered via telehealth when technical difficulties preclude the delivery of all or part of the telehealth session. The Department may not reimburse for services that: Require in-person evaluation; or Cannot be reasonably delivered via telehealth as specified in provider specific COMAR chapters, and subregulatory guidance issued by the Department. A provider may not bill for facility, room, or board charges for telehealth visits if a professional fee can be billed separately. To receive reimbursement for services delivered via telehealth, a provider shall: Be actively enrolled with Maryland Medical Assistance on the date the service is rendered; and Comply with payment procedures as set forth in COMAR 10.09.36. Distant Site Reimbursement. The distant site provider shall be reimbursed as set forth in the COMAR chapter defining the covered service being rendered. Services delivered via audio-visual telehealth shall be billed with the telehealth GT modifier. Services delivered via audio-only telehealth shall be billed with the UB modifier. Services delivered via telehealth shall be within the provider's scope of practice as determined by its governing licensure or credentialing board. A service provided through telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage that exist for the service when provided in person. A telehealth service does not include: An audio-only telephone conversation between a health care provider and a patient; An electronic mail message between a health care provider and a patient; A facsimile transmission between a health care provider and a patient; or A telephone conversation, electronic mail message, or facsimile transmission between the originating and distant site providers without interaction between the distant site provider and the patient. Store and forward technology does not meet the Maryland Medical Assistance Program’s definition of telehealth. The Maryland Medical Assistance Program covers services such as dermatology, ophthalmology, and radiology according to COMAR 10.09.02.07. Telehealth-delivered services may not bill to the Maryland Medical Assistance Program or to the ASO when technical difficulties preclude the delivery of part or all of the telehealth session. The Department may not reimburse a provider for the following: Services that occur during an ambulance transport; Communications between providers where the participant is not physically present at the originating site; Telehealth services delivered where the originating site is not a permitted originating site provider as set forth in Regulation .06 of this chapter; or Mental health and substance use disorder services that did not receive prior authorization from the Department or its ASO. The Department may not reimburse for services that: Require in-person evaluation; or Cannot be reasonably delivered via telehealth. The Department may not reimburse distant site providers for a facility fee. The Department may not reimburse for home health monitoring services. To receive reimbursement for telehealth services, a provider shall: Be actively enrolled with Maryland Medical Assistance; Participate with a telehealth partner that meets provider conditions for participation as set forth in Regulation .06 of this chapter; and If a provider is a behavioral health service provider, be registered as a provider through the ASO on the date the service is rendered. Distant Site Reimbursement. The distant site shall be reimbursed: For somatic services provided via telehealth, as set forth in COMAR 10.09.02.07D; For mental health services provided via telehealth, as set forth in COMAR 10.09.59.09; or For substance use disorder services provided via telehealth, as set forth in COMAR 10.09.80.08. Services delivered via telehealth shall be billed with the telehealth GT modifier. Services delivered via telehealth shall be within the provider’s scope of practice as determined by its governing licensure or credentialing board. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-105.2(b), Annotated Code of Maryland; Ch. 280, Acts of 2013; Ch. 366, Acts of 2016; Ch. 367, Acts of 2016 Effective date: September 30, 2013 (40:19 Md. R. 1546) Regulation .01 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .01A amended effective December 22, 2014 (41:25 Md. R. 1479) Regulation .02B amended effective April 28, 2014 (41:8 Md. R. 471); December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300); April 11, 2016 (43:7 Md. R. 449) Regulation .03 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300) Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .04D amended effective December 22, 2014 (41:25 Md. R. 1479) Regulation .05 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300) Regulation .05B, D amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .06B amended effective December 22, 2014 (41:25 Md. R. 1479) Regulation .07 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300) Regulation .07B amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471); October 26, 2015 (42:21 Md. R. 1300) Regulation .09 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .10A, B amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .11 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .11I, J adopted effective December 22, 2014 (41:25 Md. R. 1479) Regulation .12A, B amended effective December 22, 2014 (41:25 Md. R. 1479) Regulation .12 repealed and new Regulation .12 adopted effective October 26, 2015 (42:21 Md. R. 1300) Chapter revised effective October 24, 2016 (43:21 Md. R. 1166) Regulation .02B amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .04D amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .05 amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .06 amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .07C, D amended effective March 26, 2018 (45:6 Md. R. 319) Regulation .07D amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .09 amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .10 amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .11 amended effective October 23, 2017 (44:21 Md. R. 983) Regulation .11C, D amended effective February 27, 2017 (44:4 Md. R. 252) Chapter revised effective October 7, 2019 (46:20 Md. R. 844) Chapter revised effective July 24, 2023 (50:14 Md. R. 593) Regulation .02B amended effective June 8, 2026 (53:11 Md. R. 485) Regulation .07B, F amended effective June 8, 2026 (53:11 Md. R. 485) Regulation .08B amended effective June 8, 2026 (53:11 Md. R. 485) In this chapter, the following terms have the meanings indicated. Terms Defined. “Audiological evaluation” means identification, evaluation, and treatment of auditory impairments necessary to develop and implement an IFSP or an IEP pursuant to COMAR 13A.13.01.03B and 13A.05.01.03B. “Audiologist” means an individual licensed by the Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech Language Pathologists to practice audiology in Maryland. “Audiology service” means treatment of auditory impairments necessary to develop and implement an IFSP or an IEP pursuant to COMAR 13A.13.01.03B and 13A.05.01.03B. “Dietitian-Nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Maryland State Board of Dietetic Practice to practice dietetics in Maryland. “Aversive technique” means the use of painful or noxious stimuli to the body, which is intrusive to the individual's physical, mental, or emotional well-being, used to terminate challenging or maladaptive behavior. “Child's family” means those individuals with whom a participant resides, who are responsible for the participant, and who are the primary nurturing caregivers. “Crisis intervention services” means the therapeutic response that provides immediate care or referral for an individual with an urgent mental health need. “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. “Early intervention services (EIS)” means services which are consistent with COMAR 13A.13.01.03B. “Individualized education program (IEP)” means a written description of special education and related services developed by an IEP team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.03B and 13A.05.01.09. “IEP team” means a group convened and conducted by a provider to develop a participant’s IEP, which is composed of a child’s parent or parents, the child’s teacher, and relevant service providers as indicated in COMAR 13A.05.01.03B and 13A.05.01.07. “Individualized Family Service Plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child’s family developed by an IFSP team pursuant to COMAR 13A.13.01.03B. “IFSP team” means a group convened and conducted by a provider to develop a participant’s IFSP, which is composed of a child’s parent or parents, the child’s service coordinator, and relevant service providers as indicated in COMAR 13A.13.01.06. “Infants and toddlers with disabilities” means children from birth to the beginning of the school year following the child’s 4th birthday who are eligible for early intervention services, as described in COMAR 13A.13.01.03B and documented by appropriate licensed personnel as defined in COMAR 13A.13.01.03B. “Jurisdiction” means a state or the District of Columbia. “Local School System (LSS)” means any of the 24 public school systems in Maryland responsible for providing public elementary or secondary education. “Local lead agency” means the agency designated by the local governing authority in each county and Baltimore City to administer the interagency system of early intervention services under the direction of the State Department of Education in accordance with Education Article, §8-416, Annotated Code of Maryland. “Maladaptive behavior” means behavior that is: Harmful to oneself or others; Developmentally inappropriate; and Disruptive or dangerous. “Maryland State Department of Education” has the meaning stated in COMAR 13A.01.03. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Mental health professional” has the meaning stated in COMAR 10.21.17.02B. “Nurse” means an individual who is licensed to practice as a registered nurse (RN) or licensed practical nurse (LPN) in the jurisdiction in which services are provided. “Nursing care plan” means a plan developed by a registered nurse that identifies the patient’s diagnoses and needs, the goals to be achieved, and the interventions required to meet the patient’s medical condition as defined in COMAR 10.09.53.01B. Nursing Services. “Nursing services” means skilled nursing services performed by a licensed nurse for a participant, which are necessary for the participant to benefit from educational or early intervention services pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. “Nursing services” includes an initial assessment. “Nursing services” does not include: Routine assessments of recipients whose medical condition is stable, unless the assessment leads to an intervention or change in the nursing care plan; Administration of medications; Supervision of interventions which the child is able to perform independently; Health screens; Health education, except one-on-one training regarding self-management of the child's medical condition; First aid interventions; Services not directly related to the nursing care plan; and Services not deemed medically necessary at the initial assessment or the most recent nursing care plan review. Nutrition Services. “Nutrition services” means services delivered by a licensed dietitian nutritionist. “Nutrition services” includes: Nutrition assessments and evaluations; Developing and monitoring appropriate plans to address the nutritional needs of eligible children; and Making referrals to appropriate community resources to carry out nutrition goals in an IFSP pursuant to COMAR 13A.13.01.03B. “Occupational therapist” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice occupational therapy in Maryland. “Occupational therapy assistant” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice limited occupational therapy in Maryland. “Occupational therapy services” means occupational therapy evaluations or treatments delivered by a licensed occupational therapist, or treatments delivered by a licensed occupational therapy assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. “Parent” means the parent of a child and includes: A biological or adoptive parent; A legal guardian; Another person responsible for a child's welfare; or A parent surrogate for those cases when: A public agency, after reasonable efforts, cannot discover the whereabouts of a biological or adoptive parent, An individual cannot be identified with responsibility for a child's welfare, or A child is a ward of the State. “Participant” means a Medical Assistance recipient who is eligible for and receives school-based health-related services. “Physical therapist” means an individual licensed by the Maryland Board of Physical Therapy Examiners to practice physical therapy in Maryland. “Physical therapist assistant” means an individual licensed by the Maryland Board of Physical Therapy Examiners to practice limited physical therapy in Maryland. “Physical therapy services” means physical therapy evaluations or treatments, delivered by a licensed physical therapist, or treatments delivered by a licensed physical therapy assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. “Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Provider” means a local school system, local lead agency, State-operated education agency, or State-supported education agency which meets the conditions for participation as defined in Regulation .03 of this chapter to provide school-based health-related services. “Psychological services” means the delivery of services by a qualified licensed mental health professional, including administering psychological and developmental tests and other assessment procedures, interpreting assessment results, obtaining, integrating, and interpreting information about child behavior and child and family conditions related to learning, mental health, and development, and planning and managing a program of psychological services including psychological counseling for children and families. “Rehabilitative service” means the medical or remedial service recommended by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland within the scope of the practice under §B(36) of this regulation, for the reduction of maladaptive behavior and restoration of a recipient to the best possible functional level. “School psychologist” means an individual certified by the Maryland State Department of Education to provide psychological services in a school-based setting. “Special health needs” means those temporary or long-term health problems arising from physical, emotional, or social factors, or any combination of these. “Speech-language pathologist” means an individual licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice speech language pathology in Maryland. “Speech-language pathology assistant” means an individual licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to assist in the practice of speech language pathology in Maryland. “Speech-language pathology” means speech language evaluations, diagnoses or treatments delivered by a licensed speech-language pathologist, or treatments delivered by a licensed speech-language pathology assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. “Therapeutic behavioral aide” means an individual who has been trained to implement a behavior plan as specified in the IEP or IFSP under the supervision of a licensed physician or authorized practitioner pursuant to Health Occupations Article, Annotated Code of Maryland. “Therapeutic behavioral service” means a one-to-one individualized rehabilitative service, rendered by a therapeutic behavioral aide, using appropriate methods of preventing or decreasing maladaptive behaviors for a Medicaid recipient who is eligible for and receives health-related services in an IEP or health-related early intervention services in an IFSP. A provider shall ensure that the provider's employees who render school health-related services meet the licensure or certification requirements for their profession, as specified in §B of this regulation. A professional employed by a provider shall have the following qualifications: An audiologist shall be licensed to practice in the jurisdiction in which services are provided; A professional counselor shall be licensed to practice in accordance with Health Occupations Article, Title 17, Annotated Code of Maryland, in the jurisdiction in which services are provided; A nurse shall be a registered nurse or a practical nurse licensed to practice in the jurisdiction in which services are provided: A nurse psychotherapist shall be licensed to practice in the jurisdiction in which services are provided; A dietitian-nutritionist shall be licensed to practice in the jurisdiction in which services are provided; An occupational therapist shall be licensed to practice in the jurisdiction in which services are provided; An occupational therapy assistant shall be licensed to practice in the jurisdiction in which services are provided under the direction of a licensed occupational therapist; A physical therapist shall be licensed to practice in the jurisdiction in which services are provided; A physical therapy assistant shall be licensed to practice in the jurisdiction in which services are provided under the direction of a licensed physical therapist; A psychiatrist shall be a physician licensed to practice in the jurisdiction in which services are provided who is certified by the American Board of Psychiatry and Neurology or who has completed the minimum educational and training requirements to take the Board examination; A psychologist shall be licensed to practice in the jurisdiction in which services are provided; A school psychologist shall be certified in accordance with COMAR 13A.12.04.09 to practice in the jurisdiction in which services are provided; A social worker shall be licensed as: A master social worker in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided; A certified social worker in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided; or A certified social worker-clinical in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided; A speech language pathologist shall be licensed to practice in the jurisdiction in which services are provided; A speech language pathology assistant shall be licensed to practice in the jurisdiction in which services are provided under the supervision of a licensed speech language pathologist; and A therapeutic behavioral provider shall be approved by the Department in accordance with COMAR 10.09.50.05A. General requirements for participation in EPSDT school health-related or health-related early intervention services are that a: Provider shall: Meet all the requirements for participation in the Program as set forth in COMAR 10.09.36.03; and Collaborate in the provision of covered services with local health departments in accordance with Education Article, §7-401, Annotated Code of Maryland; and Therapeutic behavioral aide shall be: Trained in the principles of behavioral management and appropriate methods of preventing or decreasing maladaptive behaviors relevant to the recipient's behavioral needs; and Supervised by a licensed physician or an authorized practitioner under Health Occupations Article, Annotated Code of Maryland. Specific requirements for participation in the Program require that the provider maintain adequate documentation of all services provided, which at a minimum, includes: The location, date, start, and end time of the service; A brief description of the service; and A legible signature, along with the printed or typed name of the individual providing care, with the appropriate title. The Program covers the services listed in §B and C of this regulation when the services are: Necessary to identify the need for a health-related service or health-related early intervention service; Necessary to: Prevent disease, disability, and other health conditions or their progression; and Promote physical and mental health and efficiency; Necessary for the maximum reduction of physical or mental disability and restoration of a participant to the participant's best possible functional level; and; Rendered in accordance with accepted professional standards. The following services are covered under this chapter when delivered in accordance with an IEP or an IFSP, which is developed at the time of referral for health-related services or health-related early intervention services: Audiology services, which include the identification, evaluation, and treatment of auditory impairments; Nursing services, which: Are related to an identified health problem; Except for nursing assessments, are ordered by a licensed prescriber; Are indicated in the nursing care plan, which is reviewed at least every 60 days and more frequently when the child's medical condition changes; and Require the judgment, knowledge, and skills of a licensed nurse; Nutrition services which include conducting assessments of nutritional history and dietary intake and developing and monitoring appropriate plans to address a participant’s nutritional needs; Occupational therapy services, which include any screening, evaluations, or treatments necessary to implement a program of activities, with the goal to develop or maintain the adaptive skills necessary to achieve a participant’s adequate and appropriate physical and mental functioning; Physical therapy services, which include screening and evaluations necessary to determine a participant’s level of functioning, as well as any treatment, which may use therapeutic exercises for the purpose of preventing, restoring, or alleviating a movement dysfunction and related functional problems; Psychological services, which include the evaluation, diagnosis, and treatment of emotional or behavioral problems in order for a participant to benefit from an educational or early intervention program including the counseling of parents and parent training when the participant is present; Speech-language pathology services, which include, diagnosis, evaluation, or treatment; and Therapeutic behavioral services which: Includes one-to-one services by a trained therapeutic behavior aide; and Is supervised by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland. Psychological services, as described in §B(6) of this regulation, are covered under this chapter even if the services are not delivered in accordance with an IEP or an IFSP. To participate in the Program as a provider of health-related services or health-related early intervention services, the provider shall be a local school system, a local lead agency, a State-operated education agency, or State-supported education agency. Health-related services or health-related early intervention services outlined in the IEP or the IFSP shall be approved by the IEP or IFSP team for continued treatment. Therapeutic behavioral services may only be provided if: Preauthorized through the IEP or IFSP process and directly related to the IEP or IFSP; Services are not custodial; Services are considered medically necessary by the IEP or IFSP team, which develops the recipient’s IEP or IFSP; Delivered in the recipient's home, school, or other setting if normal activities are disrupted; The therapeutic behavioral aide is not a member of the recipient's immediate family or an individual who ordinarily resides in the recipient's home; and The recipient has: Maladaptive behavior; Warrants a behavioral plan; Behavior that is deviant from developmentally appropriate behavior for the individual’s chronological age as determined by the IEP or IFSP team; A behavior plan that does not include aversive techniques, restraints, and seclusion, or any of these; and No insurance coverage for therapeutic behavior services when compensated as an individual service covered by another third party insurance or part of a package of benefits covered by either another third party insurance or another public agency. Therapeutic behavioral services shall be preauthorized through the IEP or IFSP process. Psychological services that are not delivered in accordance with an IEP or IFSP shall be preauthorized by the Administrative Services Organization in accordance with COMAR 10.09.59.08. Request for Payment. An approved provider shall submit a request for payment of services rendered and completed under this chapter as set forth in COMAR 10.09.36.04. The Department reserves the right to return to the provider, before payment, all payment requests not properly prepared or submitted. A provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. The completed form shall indicate the: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, location, and provider number; and Nature, unit or units, and procedure code or codes of covered services provided. Providers may not bill the Program for: Services not rendered in person, unless the services are provided in compliance with COMAR 10.09.49 and any guidance issued by the Department: Completion of forms or reports; Broken or missed appointments; Services which duplicate a service that a recipient is receiving under another medical care program. The Program may not make direct payment to a participant. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Reimbursement for health-related services and health-related early intervention services is contained in COMAR 10.09.02.07D. The State portion of reimbursement is provided by the Maryland State Department of Education. Psychological services not delivered in accordance with an IEP or IFSP are reimbursable when they are: Rendered by a school psychologist or school social worker that: Meets the qualifications of this chapter; and Is enrolled with the Medicaid Program in accordance with COMAR 10.09.36; and Billed by a local education agency in accordance with COMAR 10.09.59.09. Recovery and reimbursement is as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are set forth in COMAR 10.09.36.09. Interpretive regulations are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-124, Annotated Code of Maryland Effective date: Regulations .01—.10 adopted as an emergency provision effective February 2, 1993 (20:4 Md. R. 369); adopted permanently effective June 1, 1993 (20:10 Md. R. 852) Regulations .01—.04 and .06 amended as an emergency provision effective September 19, 1997 (24:21 Md. R. 1445); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) Regulations .01, .02, .04, and .05 amended effective June 25, 2001 (28:12 Md. R. 1106) Regulations .01B, .02B, and .04—.06 amended as an emergency provision effective September 2, 1994 (21:20 Md. R. 1729); amended permanently effective December 19, 1994 (21:25 Md. R. 2105) Regulation .05B amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1083); amended permanently effective November 4, 1996 (23:22 Md. R. 1497) Chapter revised as an emergency provision effective December 17, 2002 (30:1 Md. R. 22); emergency status extended at 30:14 Md. R. 933; revised permanently effective August 4, 2003 (30:15 Md. R. 991) Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 386); May 12, 2025 (52:9 Md. R. 405) Regulation .02 amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .02B amended effective March 14, 2016 (43:5 Md. R. 386) Regulation .03 amended effective March 14, 2016 (43:5 Md. R. 386) Regulation .03A amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .04 amended effective March 14, 2016 (43:5 Md. R. 386) Regulation .04A, B amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .04C adopted effective May 12, 2025 (52:9 Md. R. 405) Regulation .05 amended effective March 14, 2016 (43:5 Md. R. 386) Regulation .05C amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .06 amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .07B amended effective September 26, 2016 (43:19 Md. R. 1072); April 4, 2022 (49:7 Md. R. 466) Regulation .07E, F amended effective November 14, 2011 (38:23 Md. R. 1421) Regulation .07E amended effective March 14, 2016 (43:5 Md. R. 386); February 27, 2017 (44:4 Md. R. 252) Regulation .07F repealed effective March 14, 2016 (43:5 Md. R. 386) Regulation .07F adopted effective May 12, 2025 (52:9 Md. R. 405) In this chapter, the following terms have the meanings indicated. Terms Defined. “Audiologist” means a professional who is licensed in accordance with Regulation .02 of this chapter who treats hearing disorders and communication problems. “Audiology assessment” means procedures performed by an audiologist to evaluate and monitor the status of the peripheral auditory system, auditory nerve, and central auditory system, or to establish the site of the auditory disorder by using procedures to quantify and qualify hearing loss by site of lesion, on the basis of perceptual, physiological, or electrophysiological responses to acoustic stimuli, and to describe any communicative disorders. Audiology Center. “Audiology center” means a multispecialty setting with all necessary equipment for audiology services that operates for the purpose of providing preventive, diagnostic, therapeutic, and rehabilitative audiology services, and other multispecialty services by or under the direction of a licensed physician or audiologist. “Audiology center” does not include the office of one or more private audiologists. “Audiology services” means services delivered by an audiologist to eligible participants in order to diagnose and treat hearing problems. “Auditory osseointegrated device” means a device implanted in the skull that replaces the function of the middle ear and provides mechanical energy to the cochlea via a mechanical transducer. “Bilateral” means relating to or involving both ears. “Cochlear implant” means a device that is implanted under the skin that picks up sounds and converts them to impulses transmitted to electrodes placed in the cochlea, restoring some hearing to people with a hearing impairment. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Designee” means any entity designated to act on behalf of the Department. “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision of preventive health care under 42 CFR §441.50 et seq., including medical and dental services, in order to assess growth and development and to detect and treat health problems in Medical Assistance eligible individuals under 21 years old. “EPSDT screening provider” means a physician, audiologist, or an authorized practitioner under Health Occupations Article, Annotated Code of Maryland. “Hearing aid” means an instrument or device that is designed for improving or correcting impaired human hearing, or any part or accessory of the instrument or device. “Hearing aid dispenser” means a person who is licensed in accordance with Regulation .02 of this chapter to sell hearing aids or provide other hearing aid services. “Hearing aid evaluation” means services provided to a participant by an audiologist for determining the benefit of hearing aids and, upon the audiologist’s recommendation, the dispensing of hearing aids. “Maryland Medical Assistance Program (Program)” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. “Program” has the meaning stated in COMAR 10.09.36.01. “Provider” means an audiologist, audiology center, or hearing aid dispenser that is licensed and that, through an agreement with the Department, has been identified as a Program provider by the issuance of a provider number. “Unilateral” means relating to, involving, or affecting one ear. In order to provide services as an audiologist under this chapter, an audiologist shall be licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice audiology, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland, or by the appropriate licensing body in the jurisdiction in which the audiology services are performed. In order to provide services as a hearing aid dispenser under this chapter, a hearing aid dispenser shall be licensed by the: State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to dispense hearing aids and hearing aid accessories, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland; or Appropriate licensing body in the jurisdiction in which the hearing aids are dispensed. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. Specific requirements for participation in the Program as an audiologist, audiology center or group, or hearing aid dispenser are that the provider: Shall meet the licensure requirements in accordance with Regulation .02 of this chapter; and May not knowingly employ another person to provide services to Maryland Medical Assistance Program participants after that person has been disqualified from the Program unless prior approval has been received from the Department. The Program covers the following medically necessary services: Audiology services, as follows: For participants who are at risk for or have a hearing impairment, audiology assessments using procedures appropriate for the participant’s developmental age and abilities; and Hearing aid evaluations and routine follow-up for participants with an identified hearing impairment, who currently use or are being considered for hearing aids; and Hearing amplification services, as follows: Unilateral or bilateral hearing aids which are medically necessary and are: Not used or rebuilt, and which meet the current standards set forth in 21 CFR §§801.420 and 801.421, which are incorporated by reference; Recommended and fitted by an audiologist in conjunction with written medical clearance from a physician who has performed a medical examination within the past 6 months; Sold on a 30-day trial basis; and Fully covered by a manufacturer’s warranty for a minimum of 2 years, at no cost to the Program; Hearing aid accessories and services, as listed below: Ear molds; Batteries; Routine follow-ups and adjustments; Repairs after all warranties have expired; Replacement of unilateral or bilateral hearing aids every 5 years when determined to be medically necessary; and Other hearing aid accessories determined to be medically necessary; Cochlear implants and related services, as listed below: Unilateral or bilateral implantation of cochlear implant or implants which are medically necessary including the cost of the device; Post-operative evaluation and programming of the cochlear implant or implants; Aural rehabilitation services; and Repair or replacement of cochlear implant device components subject to the limitations in Regulation .05 of this chapter; and Auditory osseointegrated device or devices and related services, as listed below: Unilateral or bilateral implantation of auditory osseointegrated devices which are medically necessary including the cost of the device; Non-implantable or softband device or devices which are medically necessary; Evaluation and programming of the auditory osseointegrated device or devices; and Repair or replacement, or both, of auditory osseointegrated device components subject to the limitations in Regulation .05 of this chapter. Covered audiology services, including hearing aids, cochlear implants, and auditory osseointegrated devices are limited to: Unless the time limitation is waived by the Program, one audiology assessment per year; The initial coverage of unilateral or bilateral hearing aids, cochlear implants, or auditory osseointegrated devices when the Department’s medical necessity criteria have been met; One replacement of unilateral or bilateral hearing aids: Every 5 years for participants younger than 21 years old, unless the Program approves more frequent replacement; or Every 5 years for participants 21 years old or older, unless the Program approves more frequent replacement, but no more than 1 replacement extraneous to the devices’ warranty; Replacement of hearing aids, cochlear implants and auditory osseointegrated device components that have been lost, stolen, or damaged beyond repair, after all warranties have expired; Repairs and replacements that take place after all warranties have expired; A maximum of 76 batteries per participant per 12-month period for a unilateral hearing aid or osseointegrated devices, or 152 batteries per participant per 12-month period for bilateral hearing aids or osseointegrated devices purchased from the Department not more frequently than every 6 months, and in quantities of 38 or fewer for a unilateral hearing aid, or 76 or fewer for a bilateral hearing aid; A maximum of 238 disposable batteries for a unilateral cochlear implant per participant per 12-month period or 476 disposable batteries per 12-month period for a bilateral cochlear implant purchased not more frequently than every 6 months, and in quantities of 119 or fewer for a unilateral cochlear implant, or 238 or fewer for a bilateral cochlear implant; Four replacement cochlear implant component rechargeable batteries per 12-month period for bilateral cochlear implants, and a maximum of two replacement rechargeable batteries for a unilateral cochlear implant per 12-month period; Two cochlear implant replacement transmitter cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitter cable for a unilateral cochlear implant per 12-month period; Two cochlear implant replacement headset cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement headset cable for a unilateral cochlear implant per 12-month period; Two replacement cochlear implant transmitting coils per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitting coil for a unilateral cochlear implant per 12-month period; Charges for routine follow-ups and adjustments which occur more than 60 days after the dispensing of a new hearing aid; and A maximum of two unilateral earmolds or four bilateral earmolds per 12-month period unless a larger number is determined to be medically necessary. Services which are not covered are: Services not medically necessary; Hearing aids and accessories not medically necessary; Cochlear implant services and external components not medically necessary; Cochlear implant services and external components provided less than 90 days after the surgery which are covered through the initial reimbursement; Spare or backup cochlear implant components; Spare or back-up auditory osseointegrated device components; Replacement of hearing aids, equipment, cochlear implant components, and auditory osseointegrated device components if the existing devices are functional, repairable, and appropriately correct or ameliorate the problem or condition; Spare or backup hearing aids, equipment, or supplies; Repairs to spare or backup hearing aids, cochlear implants, auditory osseointegrated devices, equipment, or supplies; Investigational or experimental services or devices, or both; Replacement of improperly fitted earmold or earmolds unless the: Replacement service is administered by someone other than the original provider; and Replacement service has not been claimed before; Additional professional fees and overhead charges for a new hearing aid when a dispensing fee claim has been made to the Program; and Loaner hearing aids. The Department requires preauthorization for the following services: All hearing aids; Certain hearing aid accessories; All cochlear implant devices and replacement components except microphone, transmitter cables, and transmitting coils; All auditory osseointegrated devices; and Repairs for hearing aids, cochlear implants, and auditory osseointegrated components exceeding $500. Preauthorization is valid: For services rendered or initiated within 6 months from the date the preauthorization was issued; and If the patient is an eligible participant at the time the service is rendered. The following written documentation shall be submitted by the provider to the Department or its designee with each request or preauthorization of hearing aids, cochlear implants, or auditory osseointegrated devices: Audiology report documenting medical necessity of the hearing aids, cochlear implants or auditory osseointegrated devices; Interpretation of the audiogram; and Medical evaluation by a physician supporting the medical necessity of the initial hearing aids, cochlear implants, or auditory osseointegrated devices within 6 months of the preauthorization request. To obtain compensation from the Department for covered services, the provider shall submit a request for payment using the format designated by the Department. Audiology services are reimbursed in accordance with COMAR 10.09.23.01-1. The provider shall be paid the lesser of: The provider’s customary charge to the general public, unless the service is free to individuals not covered by Medicaid; or The rate in accordance with the Department’s fee schedule. The provider may not bill the Department or participant for: Completion of forms and reports; Broken or missed appointments; or Professional services rendered by mail or telephone. Audiology centers licensed as a part of a hospital may charge for and be reimbursed according to rates approved by the Health Services Cost Review Commission (HSCRC), set forth in COMAR 10.37.03. The provider shall refund to the Department payment for hearing aids, supplies, or both, that have been returned to the manufacturer within the 30-day trial period. The provider shall give the Department the full advantage of any and all manufacturer’s warranties and trade-ins offered on hearing aids, equipment, or both. Unless preauthorization has been granted by the Department or its designee, the Department is not responsible for any reimbursement to a provider for any service provided which requires preauthorization. The Department may not make direct payment to participants. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Recovery and reimbursement requirements are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are as set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: August 16, 1993 (20:16 Md. R. 1277) Chapter revised effective June 21, 2004 (31:12 Md. R. 911) Regulation .01B amended effective July 18, 2005 (32:14 Md. R. 1275); January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973) Regulation .02A amended effective January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973) Regulation .03 repealed and new Regulation .03 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .04 amended effective April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973) Regulation .04A amended effective January 16, 2006 (33:1 Md. R. 36) Regulation .05 amended effective July 18, 2005 (32:14 Md. R. 1275); October 22, 2018 (45:21 Md. R. 973) Regulation .05A amended effective December 27, 2021 (48:26 Md. R. 1111) Regulation .05B amended effective January 16, 2006 (33:1 Md. R. 36) Regulation .06 amended effective October 22, 2018 (45:21 Md. R. 973) Regulation .06A amended effective July 18, 2005 (32:14 Md. R. 1275) Regulation .06B, C amended effective January 16, 2006 (33:1 Md. R. 36) Regulation .06B, D amended effective April 4, 2011 (38:7 Md. R. 431) Regulation .07 amended effective January 16, 2006 (33:1 Md. R. 36); April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973) Regulation .07B amended effective April 21, 2008 (35:8 Md. R. 805); February 27, 2017 (44:4 Md. R. 253) Regulation .07C, G, K amended effective July 4, 2016 (43:13 Md. R. 712) In this chapter, the following terms have the meanings indicated. Terms Defined. “Autism” has the meaning stated in COMAR 10.09.56.01C. “Autism Waiver” or “Waiver” means the Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder. “Autism Waiver Service Coordination” means the coordination of waiver services covered under this chapter. “Autism Waiver Service Coordinator” means an individual who meets the requirements specified in Regulation .03-1 of this chapter and provides the autism waiver services specified in Regulations .04-1—04.2 of this chapter to a waiver participant. “Department” has the meaning stated in COMAR 10.09.36.01. “Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder” means the program implemented under COMAR 10.09.56 in accordance with the document and any amendments to it submitted by the Department to, and approved by, the Secretary of the U. S. Department of Health and Human Services, which authorizes the waiver, pursuant to Section 1915(c) of Title XIX of the Social Security Act, of certain specified statutory requirements limiting coverage for home and community-based services under the Medical Assistance Program. “IEP service coordination” means the coordination of services which assists a participant in gaining access to the services recommended in the participant’s IEP. “IEP service coordinator” means an individual who meets the requirements in Regulation .03C of this chapter. “Individualized Education Program (IEP)” means a written, individualized plan of care for a participant, that: Is developed by an IEP team on a form approved by MSDE; Recommends the special education and related services to meet a participant's needs; and Conforms with the requirements in COMAR 13A.05.01 and 34 CFR §§300.320—300-324. “Individualized education program (IEP) team” means the multidisciplinary team convened by a provider in accordance with COMAR 13A.05.01 to review a participant’s needs, develop the participant’s IEP, and determine the placement of the participant in the least restrictive environment. “Individualized family service plan (IFSP)” means a written, individualized plan for providing early intervention and other services for an infant, toddler, or preschool-age child, in accordance with COMAR 13A.13.01. “Local lead agency” means the agency designated by the local governing authority in each jurisdiction to administer the interagency system of early intervention services under the direction of the Maryland State Department of Education. “Local school system (LSS)” means any public school system in Maryland responsible for providing public elementary or secondary education. “Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.67.01.01. “Maryland State Department of Education (MSDE)” is the agency responsible for ensuring that all children with disabilities residing in the State are identified, assessed, and provided with a free, appropriate public education consistent with State and federal laws. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Parent” has the meaning stated in COMAR 13A.13.01.03. “Participant” means an individual who meets the qualifications for participation in the services covered under this chapter, as specified in Regulation .02 of this chapter. “Program” has the meaning stated in COMAR 10.09.36.01. “Provider” means an agency which meets the conditions for participation, as specified in Regulation .03 of this chapter. “Qualified diagnostician” means an individual whose license or certification permits diagnosis of Autism Spectrum Disorder. “Rare and expensive case management (REM)” has the meaning stated in COMAR 10.09.69.02. “Telehealth” has the meaning as stated in COMAR 10.09.49.02. “Waiver eligible person” means an individual who meets the qualifications, as specified in COMAR 10.09.56, for participation in the Autism Waiver. “Waiver multidisciplinary team” means the team, consistent with the Individuals with Disabilities Education Act (IDEA), which is convened for a waiver applicant or waiver participant. “Waiver participant” means a waiver eligible person who is enrolled in the Autism Waiver. “Waiver plan of care” means the written, individualized treatment plan which preauthorizes the specific Autism Waiver services to be provided to a waiver participant, as covered under COMAR 10.09.56. A participant is eligible for Service Coordination if: The individual is enrolled as a waiver participant in accordance with the requirements of COMAR 10.09.56 and this chapter; or The following requirements are met: The participant, for whom free and appropriate education is provided under the Individuals with Disabilities Education Act, is aged 3 through 20 years old; An IEP team determines that the participant is a child with disabilities who: Is eligible for special education and related services, and Needs an IEP; The participant elects, or the participant’s parent elects on the participant’s behalf, to receive the services available under this chapter; and The participant is not a resident of any of the facilities that receive Medicaid reimbursement for residential services. General requirements for participation in the Program are that a provider shall: Meet all the conditions for participation as set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. IEP service coordination providers shall: Be an agency within the State that: Operates programs with special education and related services for children with disabilities, in accordance with COMAR 13A.05.01; and Is eligible to receive, through MSDE, funding from Assistance to States for the Education of Children with Disabilities under Part B of the Individuals with Disabilities Education Act; Convene or participate on an IEP team or teams, in accordance with COMAR 13A.05.01; Designate specific, qualified individuals as service coordinators, and verify their credentials for providing the services covered under this chapter; Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants; Maintain a file on each participant which meets the Program’s requirements which shall include: Copies of the participant's IEP with any revisions; Written parental consent to initiate services covered under this chapter; Written parental consent prior to accessing the student’s public benefits or insurance the first time, and annually thereafter, in accordance with 34 CFR §300.154(d)(2); Approval from a participant’s parent of the participant’s IEP before implementation of the IEP service coordination; and A record of IEP service coordination encounters including: A brief description of the service; The location; The name of the contact (parent/guardian or student); The date of the service; and The IEP service coordinator’s printed name and signature; and Employ or have under contract qualified personnel who convene or participate on IEP teams, convene or participate on multidisciplinary teams as necessary, and develop participants’ IEPs. IEP Service Coordinator Requirements. An IEP service coordinator shall: Be employed by or under contract with a provider; Be identified by the IEP team ; Participate with the IEP team in the development or revision of a participant’s IEP and in the IEP review; Assist the participant in gaining access to the services recommended in the IEP; and Collect and synthesize evaluation reports and other relevant information about a participant that might be needed by an IEP team. An IEP service coordinator shall have the following qualifications and be a: Professional who has a current license or certification, in accordance with §C(3) of this regulation, in the profession most immediately relevant to a participant's needs; or Nonprofessional who meets the requirements in §C(4) of this regulation. A professional who is chosen as a participant's service coordinator shall meet the following licensing or certification requirements, as appropriate, and be: An audiologist licensed pursuant to COMAR 10.41.03.03 and certified pursuant to COMAR 13A.12.03.09; A guidance counselor with at least a master's degree and certified pursuant to COMAR 13A.12.03.02; A professional counselor licensed to practice in accordance with Health Occupations Article, Title 17, Annotated Code of Maryland; A registered nurse licensed pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; An occupational therapist licensed pursuant to Health Occupations Article, Title 10, Annotated Code of Maryland; A physical therapist licensed pursuant to Health Occupations Article, Title 13, Annotated Code of Maryland; A psychologist with at least a master's degree in psychology and certified pursuant to COMAR 13A.12.03.08; A pupil personnel worker with at least a master's degree and certified pursuant to COMAR 13A.12.03.04; A social worker licensed at the master's level as a licensed certified social worker or licensed graduate social worker, pursuant to Health Occupations Article, Title 19, Annotated Code of Maryland; A speech-language pathologist: With at least a master's degree in speech pathology; or Certified pursuant to COMAR 13A.12.03.09 or licensed pursuant to Health Occupations Article, Title 2, Annotated Code of Maryland; An education professional who is: Certified as a teacher pursuant to COMAR 13A.12.02; or Certified as an administrator or supervisor pursuant to COMAR 13A.12.04. A nonprofessional who is chosen as a participant’s IEP service coordinator shall meet the following requirements: Have at least a high school diploma or the equivalent; Have demonstrated training or experience in providing IEP service coordination to students with disabilities; and Participate in ongoing IEP service coordination training offerings as specified in the interagency plan for special education services. General requirements for participation in the Program are that a provider shall: Meet all the conditions for participation as set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. Specific requirements for participation in the Program as a provider of Autism Waiver Service Coordination are that a provider shall: Be an agency within the State that employs or has under contract qualified personnel who convene or participate on waiver multidisciplinary teams as necessary, develop participant’s waiver plans of care, and provide service coordination services for waiver participants; Designate specific, qualified individuals as Autism Wavier service coordinators and verify their credentials for providing the services covered under this chapter; Convene or participate on a waiver multidisciplinary team or teams for waiver participants, in accordance with the requirements of COMAR 10.09.56 and this chapter; Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs that are applicable to participants; and Maintain a file on each participant that meets the Program’s requirements and includes the waiver participant’s: Technical eligibility form approved by MSDE, reviewed and signed at least annually; Determination of eligibility for level of care in an intermediate care facility for the intellectually disabled and persons with related conditions (ICF/IID) — initial determination and redetermination, at least annually; Autism Waiver Risk Assessment pursuant to 10.09.56; Consent Form for Autism Waiver Services, signed before Autism Waiver enrollment and annually thereafter; Form for determination of Medicaid eligibility for Autism Waiver services — initial determination and redetermination, at least annually; Initial waiver plan of care, reviewed at least annually, and any plan revisions; Parental Rights and Responsibilities form reviewed and signed at least annually; Preauthorization by MSDE of any environmental accessibility adaptations reimbursed through the Autism Waiver, if applicable; Reportable Event forms concerning the waiver participant, if applicable; Record of ongoing Autism Wavier service coordination encounters, including: A description of the service; The location of the service; Date of contact and name of the parent/guardian or participant; Type of contact; Supportive documentation of the service; and The Autism Wavier service coordinator’s printed name and signature; Monthly tracking logs with Technical Eligibility Exemption Request Forms as applicable; and A copy of the treatment plans for each applicable service provided or Reportable Event form, as applicable, if a treatment plan was not submitted. Autism Waiver Service Coordinator Requirements. An Autism Waiver service coordinator shall: Be employed by or under contract with a provider; Be approved by the participant’s parent or parents; Participate with the waiver multidisciplinary team in the development, or revision, of a participant’s waiver plan of care and in the waiver plan of care review; Assist the participant in gaining access to the services recommended in the waiver plan of care; and An Autism Waiver service coordinator who is chosen to provide services for a waiver participant shall have at least: 1 year of relevant training or experience; and A bachelor’s degree. An Autism Waiver service coordinator shall complete at least 5 hours of training on the Autism Waiver, offered by the Department and MSDE, prior to rendering Autism Waiver service coordination in accordance with Regulations .04-1 and .04-2 of this chapter. Autism Waiver service coordinators shall attend one Statewide training for Autism Waiver service coordinators per fiscal year. The Program shall reimburse for the services in §§B—D of this regulation when the services have been documented, pursuant to the requirements of this chapter, as medically necessary. Initial IEP. Definition. “Unit of service” means: A completed initial IEP, signed by all members of the IEP team; and At least one contact by the participant’s service coordinator or IEP team in person or by telephone with the participant or the participant’s parent, on the participant’s behalf relating to development of the IEP. The covered services include convening and conducting an IEP team to: Perform a multidisciplinary assessment of the participant; and Develop an initial IEP. Ongoing Service Coordination. Ongoing service coordination is provided by a participant's service coordinator. Definition. For purposes of this section, “unit of service” means: At least one contact per month by the service coordinator in person, by telephone, or by written progress notes or log with the participant or the participant's parent, on the participant's behalf relating to the child's ongoing service coordination; and The provision of all other necessary services covered under these regulations. As necessary, the Program shall include as covered services the following: Acting as a central point of contact relating to IEP services for a participant; Maintaining contact with: The child's direct service providers, as applicable, which may include, but not be limited to, the child's Maryland Medicaid Managed Care Program provider or the Rare and Expensive case management provider; and A participant and the participant's parent through home visits, office visits, written notes, school visits, telephone calls, and follow-up service as necessary; Implementing the IEP by referring the participant to direct service providers, assisting the participant in gaining access to services specified in the IEP, and providing linkage to agreed-upon direct service providers of services; Discussing with direct service providers the services needed and available for the participant, assessing the quality and quantity of services being provided, following up to identify any obstacles to a participant’s utilization of services, coordinating the service delivery, and performing ongoing monitoring to determine whether the services are being delivered in an integrated fashion as recommended in the IEP and meet the participant’s current needs; Providing a participant and the participant’s parent with information and direction that will assist them in successfully accessing and using the services recommended in the IEP; Informing a participant’s parent of the participant’s and the family’s rights and responsibilities in regard to specific programs and resources recommended in the IEP; Conducting, with a participant’s parent at a meeting or by other means acceptable to the parent and the service coordinator, a periodic review of the participant’s IEP every 6 months, or more frequently if warranted or the parent requests a review; and Reviewing at least annually at a meeting or by other means acceptable to the participant’s parent and others involved in the review process: The degree of a participant’s progress toward achieving the goals established in the IEP; and Whether the goals or recommended services need to be revised. Administrative, supervisory, and monitoring services associated with the ongoing service coordination, including coordinating with the child's primary care provider, are included as part of the service. IEP Review. Definition. “Unit of service” means: A completed initial 60-day, interim, or annual IEP review as evidenced by a signed revised IEP or, if a revised IEP was not done, IEP team records documenting a meeting in which there is participation by at least two different disciplines; and At least one contact by the service coordinator or IEP team in person, by telephone, or by written progress notes or log with the participant or the participant's parent, on the participant's behalf. The covered services include convening and conducting an IEP team to: Perform a multidisciplinary reassessment of the participant's status and service needs; and Review and revise, as necessary, the participant’s IEP. Autism Waiver Service Coordination is intended to: Assist a waiver participant in gaining access to the Autism Waiver services approved in the waiver participant's waiver plan of care; Assure coordination of the waiver participant's Autism Waiver services with other services received by the waiver participant; and Assure that the waiver participant's full range of needs are adequately met, so as to assure the individual's: Appropriate placement in the community; Health and safety; Quality of care; and Access to authorized, necessary services. Waiver Service Coordinator. A waiver service coordinator employed by a provider shall assist with meeting the provider’s responsibilities specified in this regulation and Regulation .04-2 of this chapter. Waiver Multidisciplinary Team. A waiver multidisciplinary team: Shall be convened by the local lead agency or local school system to: Assess or reassess a waiver applicant's or waiver participant's need and eligibility for Autism Waiver services; and Develop or review the waiver participant's waiver plan of care; and Shall include: The waiver participant's service coordinator; The waiver applicant's or waiver participant's parent or parents; A chairman who is the official representative of the local lead agency or local school system; and Other service providers and individuals, as appropriate. Waiver Plan of Care. A waiver participant's waiver plan of care is: Initially developed on admission to the Autism Waiver; Reviewed at least every 12 months; and Revised as necessary by a waiver multidisciplinary team convened by the waiver participant's service coordinator. A waiver participant’s waiver plan of care shall be submitted to MSDE before implementation. Any revisions or additions to a waiver participant’s waiver plan of care shall be submitted to MSDE before implementation. A waiver participant’s Autism Waiver service coordinator may make minor changes to the waiver participant’s waiver plan of care without reconvening the waiver multidisciplinary team, if the change is approved by the waiver participant’s parent or parents, and MSDE is notified. A waiver participant’s initial or revised waiver plan of care shall include the: Identification of Autism Waiver service or services to be delivered; Service start date; Service stop date; Approved amount of services to be delivered; and Provider or providers. Three types of Autism Waiver Service Coordination shall be provided, at times concurrently; Waiver initial assessment; Waiver ongoing service coordination; and Waiver reassessment. Waiver Initial Assessment. Definition. For the purposes of this section, “unit of service” means: A completed initial waiver plan of care, submitted to MSDE and signed by the service coordinator, the waiver participant or the parent or parents of a minor child, and all other members of the waiver multidisciplinary team; or The provision of all necessary services specified in §A(2) of this regulation. The covered services shall include: Convening, coordinating, and participating on the waiver multidisciplinary team to perform the initial assessment and develop the waiver participant's initial waiver plan of care; Assisting the waiver participant or the parent or parents of a minor child with scheduling and attending the appointments required for the waiver initial assessment; Referring the waiver participant to approved Autism Waiver providers specified in the waiver plan of care; Assisting the waiver participant with gaining access to the Autism Waiver services preauthorized in the waiver plan of care; Assisting waiver participants with the waiver enrollment process specified in COMAR 10.09.56; and Assisting with completion of forms and coordinating with the Department for determination of the waiver participant's Medicaid financial and technical eligibility in a timely fashion. Waiver Ongoing Autism Waiver Service Coordination. Definition. For the purposes of this section, a monthly “unit of service” means: At least one documented monthly contact by the waiver participant’s service coordinator in person, by telephone, via telehealth, or through written progress notes with the waiver participant or parent; A quarterly visit to the waiver participant’s residence, residential program, or day program conducted in person or via telehealth, including at least one in-person visit to the waiver participant’s residence every 12 months; and The provision of all other necessary services specified in §B(2) of this regulation. The covered services shall include, as necessary: Acting as a central point of contact relating to a waiver participant; Coordinating Autism Waiver Service Coordination with the Department and MSDE; Referring the waiver participant to the Autism Waiver providers specified in the waiver plan of care; Assisting the waiver participant with gaining access to the Autism Waiver services preauthorized in the waiver plan of care according to the type, level, amount, frequency, and duration; Assisting with coordination of the Autism Waiver service delivery; Providing the waiver participant and the parent or parents with information and direction to assist them with accessing and successfully utilizing the Autism Waiver services preauthorized in the waiver plan of care; Maintaining contact with the waiver participant’s waiver and other service providers and with the waiver participant or parent through documented in-person visits, telehealth contact, telephone calls, mailings, and follow-up services as necessary; Following up to identify any problems or obstacles to the waiver participant's appropriate receipt of the Autism Waiver services specified in the waiver plan of care; Assisting to resolve any conflicts or crises in delivery of the waiver participant's Autism Waiver services which jeopardize the waiver participant's community placement or the health and safety of the waiver participant or another individual; Making minor changes to the waiver participant’s waiver plan of care as necessary, without reconvening the waiver multidisciplinary team, if the change is approved by the waiver participant’s parent or parents and submitted to MSDE; Assuring that the necessary documentation is maintained in the waiver participant’s file, as specified in Regulation .03-1B(5) of this chapter; Providing MSDE with required information in the established time frame on waiver participants enrolled in the Autism Waiver; and Monitoring on an ongoing basis: The appropriateness of the type, amount, duration, and quality of the Autism Waiver services received by a waiver participant; Whether a waiver participant's Autism Waiver services are delivered in an integrated and coordinated fashion and adequately meet the waiver participant's current needs; and The impact of the Autism Waiver services on the waiver participant's health, safety, development, relationships with family members and other persons, home environment, educational program, quality of life, and life satisfaction. Waiver Reassessment. For the purposes of this section, “unit of service” means: A completed waiver plan of care review at least every 12 months, with revisions as necessary, which is submitted to MSDE and signed by the Autism Waiver service coordinator, the waiver participant or the parent or parents of a minor child, and all other members of the waiver multidisciplinary team; Assisting waiver participants with the waiver’s eligibility redetermination process, as specified in COMAR 10.09.56; Assisting families with making informed choices in selecting between a home and community-based waiver documented in the Autism Waiver Transitioning Youth Service Delivery Option Form or other documentation as required; Assisting the waiver participant or the parent or parents of a minor child with completion and submission of the application forms and accompanying documentation for the Medicaid financial and technical eligibility redetermination, in coordination with the Department, before the deadline established by the Department; Completing a risk assessment within 45 days of receiving notification of eligibility by the Department using the Autism Waiver Risk Assessment form; Completing a risk assessment if the participant’s status changes, to ensure the applicant can be safely maintained in a home and community-based setting utilizing Autism Waiver services; or Providing written notice to a MSDE representative of the participant’s ineligibility for the Autism Waiver. Service Coordination for Children with an IEP or enrolled in the Autism Waiver is advisory in nature except for Autism Waiver Service Coordination, covered under Regulations .03-1, .04-1, and .04-2 of this chapter. A restriction may not be placed on a qualified participant’s option to receive the services covered under this chapter except that Autism Waiver Service Coordination, as defined by Regulations .03-1, .04-1, and .04-2 of this chapter, is required for waiver eligible persons who choose to enroll in the Autism Waiver. The services covered under this chapter may not restrict or otherwise affect the: Participant's eligibility for Title XIX benefits or other available benefits or programs except as limited by §E of this regulation; Freedom of the participant's parent to select from all available services for which the participant is found to be eligible; Participant's parent's free choice among qualified providers of services covered under this chapter, as well as among service providers of other services for which the participant qualifies; or Provider's right to bill the Program for other covered Program services. Service Coordination for Children with an IEP or enrolled in the Autism Waiver may not be: Provided as an integral and inseparable part of another covered Program service; Provided as an administrative function necessary for the proper and efficient operation of the State's Medical Assistance plan; or Delivered as part of institutional discharge planning. Reimbursement may not be made for the services covered under this chapter if the participant is receiving a similar case management service under another Program authority. Reimbursement may not be made to providers that participate on, but do not convene, an IEP team or teams, for ongoing service coordination for residential students who reside in facilities that receive Medical Assistance reimbursement for residential services. Only waiver participants may receive Autism Waiver Service Coordination, covered under Regulations .04-1 and .04-2 of this chapter. Request for Payment. An approved provider shall submit requests for payment for the services covered under this chapter according to procedures established by the Program. The Program reserves the right to return to the provider, before payment, all requests not properly completed. A provider shall: Bill the Program for the appropriate fee or fees specified in §C of this regulation; Accept payment from the Program as payment in full for the services covered under this chapter and make no additional charge to the participant or any other party; and Submit a request for payment in the manner specified by the Program, that includes the: Date or dates of service, Participant's name and Medical Assistance number, Provider’s name, location, and Medicaid provider number; and Nature, unit or units, and procedure code or codes of covered services provided. Providers that convene or conduct an IEP team or teams in accordance with COMAR 13A.05.01 may bill the Program for all IEP-related services contained in this chapter. Providers that participate on, but do not convene or conduct, an IEP team or teams, may only bill for ongoing service coordination, only for day students. These providers may not bill for ongoing service coordination for the residential students who reside in facilities that receive Medical Assistance reimbursement for residential services. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. The Program shall make payment only to one qualified provider for covered services rendered on a particular date of service to a participant and according to the following fee schedule covered under this chapter: Initial IEP: no more than one unit of service may be reimbursed per participant ... $500; Ongoing IEP service coordination: no more than one unit of service per month may be reimbursed for a participant ... $150; IEP review: at most, three units of service may be reimbursed for a participant in a 12-month period ... $275; Waiver initial assessment: No more than one unit of service may be reimbursed per waiver participant ... $500; Waiver ongoing service coordination: No more than one unit of service per month may be reimbursed for a waiver participant ... $150; Waiver reassessment: At most, four units of service may be reimbursed for a waiver participant in a 12-month period ... $275. The Program may not make payment for ongoing service coordination when, for the same month, payment is made to the provider for furnishing to the participant: An initial IEP service; or An IEP review service. The Program may not make payment for more than one IEP review in the same month, unless a subsequent review is documented as an emergency. The Program may not make payment for an initial IEP and an IEP review in the same month, unless a review is documented as an emergency. If an IEP review takes more than one meeting to complete, the Program shall only make payment for the meeting during which the review was signed. A provider shall be paid the lesser of: The provider's usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate established under §C of this regulation Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are those set forth in COMAR 10.09.36.09. State regulations are interpreted in accordance with COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.10 adopted as an emergency provision effective June 17, 1993 (20:14 Md. R. 1165); adopted permanently effective September 27, 1993 (20:19 Md. R. 1472) Regulations .01—.06 amended as an emergency provision effective March 23, 1998 (25:8 Md. R. 595); amended permanently effective June 29, 1998 (25:13 Md. R. 993): Regulations .01—.06 amended effective July 1, 2001(28:12 Md. R. 1107) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); March 28, 2016 (43:6 Md. R. 407): November 13, 2023 (50:22 Md. R. 973) Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 407) Regulation .03 amended as an emergency provision effective July 1, 2002 (30:1 Md. R. 23); amended permanently effective March 3, 2003 (30:4 Md. R. 316) Regulation .03 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .03B amended effective October 14, 2013 (40:20 Md. R. 1652) Regulation .03B, C amended effective March 28, 2016 (43:6 Md. R. 407) Regulation .03-1 adopted effective November 13, 2023 (50:22 Md. R. 973) Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 407); November 13, 2023 (50:22 Md. R. 973) Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulations .04-1 and .04-2 adopted effective July 1, 2001(28:12 Md. R. 1107) Regulations .04-1 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .04-1D amended effective March 28, 2016 (43:6 Md. R. 407) Regulation .04-2 amended effective March 28, 2016 (43:6 Md. R. 407); November 13, 2023 (50:22 Md. R. 973) Regulation .04-2C amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 407) Regulation .06A, C amended effective November 13, 2023 (50:22 Md. R. 973) In this chapter, the following terms have the meanings indicated. Terms Defined. “Caregiver” means a willing and able individual who is trained in providing care to the participant. “Certified medication technician (CMT)” means an individual, regardless of title, who: Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing; Is certified by the Board under COMAR 10.39.04; and Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. “Certified nursing assistant (CNA)” means an individual, regardless of title, who: Is certified by the Maryland Board of Nursing under COMAR 10.39.05; and Routinely performs nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. “Delegated nursing services” has the meaning stated in COMAR 10.27.11. Employment. “Employment” means the condition of having paid work. “Employment” includes job training or classes required to obtain government licensure or certification to engage in an occupation or profession, and work to fulfill requirements to obtain Temporary Cash Assistance or other public benefits. “Department” has the meaning stated in COMAR 10.09.36.01. “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision of preventive health care under 42 CFR §441.50 et seq., including medical and dental services, in order to assess growth and development and to detect and treat health problems in Medical Assistance recipients under 21 years old. “Electronic visit verification (EVV)” has the meaning stated in COMAR 10.09.36.03-2. “Emergency medical condition” means a health condition manifested by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent lay individual possessing an average knowledge of health and medicine to result in: Placing health in jeopardy; Serious impairment to bodily functions; Serious dysfunction of any bodily organ or part; or Development or continuance of severe pain. “Emergency service” means a service or care rendered to a recipient exhibiting an emergency medical condition as defined in §B(3) of this regulation. “EPSDT screen” means the complete package of various health screening procedures, required by the State periodicity schedule, or a partial screen, that an EPSDT participant receives. “Home” means the place of residence, occupied by the recipient, other than a residence or facility where private duty nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment. “Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10. "Home health aide (HHA)” means an individual, regardless of title, who meets all the conditions of participation specified in: 42 CFR §484.36; and Health Occupations Article, Title 8, Annotated Code of Maryland. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Nurse” means a person who is licensed to practice as a registered nurse (RN) or licensed practical nurse (LPN) in the jurisdiction in which services are provided. “Nursing care plan” means a plan developed by a registered nurse that identifies the patient's diagnoses and needs, the goals to be achieved, and the interventions required to meet the patient's medical condition. “Participant” means a recipient who is eligible for and receiving services in accordance with the provisions of this chapter. “Plan of care” means an individualized care plan, written in collaboration with the participant or family, including the plan developed under COMAR 10.09.27 and 10.09.69, which outlines a plan of action to meet the goals or expected outcomes for the participant. “Preauthorization” means the approval required from the Department or its designee before services may be rendered. “Primary medical provider (PMP)” means the medical provider who functions as the principal medical provider to the participant including a physician, certified nurse midwife, or nurse practitioner. “Private duty nursing services” means skilled nursing services for recipients who require more individual and continuous care than is available under the home health program, and which are provided by a registered nurse or a licensed practical nurse, in a recipient's own home or another setting when normal life activities take the recipient outside his or her home. “Program” has the meaning stated in COMAR 10.09.36.01. “Progress note” means a signed and dated written notation by the home care nurse which: Summarizes facts about the care given and the participant's responses during a given period of time; Specifically addresses the established goals of treatment; Is consistent with the participant's plan of care; and Is written during the course of care. “Provider” has the meaning stated in COMAR 10.09.36.01. “Recipient” has the meaning stated in COMAR 10.09.36.01. “Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05. “School” means courses or classes for the acquisition of a General Education Diploma, high school diploma, associate's degree, or a first-time bachelor's degree. “Supervision” means authoritative, procedural guidance by a licensed registered nurse for the accomplishment of a function or activity, as well as the process of critical watching, directing, and evaluating another's performance. “Urgent service” means a service or care for a medical condition that is manifested by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent lay individual who possesses an average knowledge of health and medicine, to result in an emergency medical condition. “Witness” means the recipient or an individual who, on behalf of the recipient, is able to personally verify that the recipient received private duty nursing services. Nurses rendering or supervising the provision of private duty nursing services shall be licensed in accordance with licensing requirements specified in COMAR 10.09.36.02. An agency providing services pursuant to this chapter shall meet all applicable licensure and certification requirements of the jurisdiction in which the agency is providing services. Requirements for participation for nursing services are that a provider shall: Meet the general Medical Assistance provider requirements as specified in COMAR 10.09.36.03; Be licensed as a: Residential service agency under COMAR 10.07.05; or Home health agency under COMAR 10.07.10; Have on staff at least one registered nurse supervisor who: Provides and documents initial direction to the participant's caregivers and assigned nurse, CNA, or HHA regarding the provision of nursing services to the participant; Documents that each assigned nurse, CNA, or HHA providing home care services has the necessary skills to meet the participant's needs including knowledge of any medical equipment in use by the participant; Conducts and documents a monthly review of the progress notes to assure adequacy and quality of care; Makes supervisory visits in the participant's home or another site where the participant is receiving nursing services and regularly evaluates the assigned nurse’s performance of the nursing services in accordance with COMAR 10.27.09 and 10.27.10; Makes supervisory visits in the participant's home or another site where the participant is receiving CNA or HHA services and regularly evaluates their performance of the delegated nursing tasks in accordance with COMAR 10.27.11; Completes a note after each supervisory visit that becomes part of the participant's file; Provides and documents training to the participant's caregiver or caregivers and the individual or individuals providing backup to the caregiver or caregivers; and Develops an initial nursing care plan which is reevaluated 30 days after the initial assessment and modified as necessary to meet the participant's nursing needs; Ensure that each nurse, CNA, or HHA rendering services to a participant: Has a valid, nontemporary, nursing license or certification to provide nursing, CNA, or HHA services in the jurisdiction in which services are rendered; Has completed a skills checklist and demonstration of competency on an annual basis that was observed, documented, and verified by the signature of the RN supervisor or an RN designated by the supervisor; Demonstrates to the provider's nurse supervisor sufficient specialized training and experience to deliver the level of service required by each participant to whom the nurse, CNA, or HHA renders direct care; Demonstrates to the provider's nurse supervisor, on a continuing basis, the ability to carry out competently the services specified in a participant's care plan, subject to review by the Department or its designee; Participates in the multidisciplinary team process, if appropriate, including attending team meetings, for children receiving home and community-based services under COMAR 10.09.27, and renders services in accordance with the plan of care recommended by the team and approved by the Department or its designee, including any subsequent revisions to that plan; Is currently certified in cardiopulmonary resuscitation (CPR) at the time services are rendered; Provides care and services in accordance with generally accepted nursing practices; Knows how to contact the provider and the registered nurse supervisor; Provides care according to the provider's policies for the delivery of services to participants as described in §E of this regulation; Has not been convicted of, received a probation before judgment for, or entered a plea of nolo contendere to a felony of any crime involving moral turpitude or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; and If a CNA or HHA, has completed the training and been certified by the Maryland Board of Nursing as a CMT; Develop policies for the delivery of services to participants, including policies on the following: Skill assessments; Emergency procedures; Administration of drugs, including controlled substances; Clinical record maintenance; Job description and educational qualifications of all staff members; Clinical management; Infection control procedures; Disposal of biomedical waste; Maintenance of equipment; Supervision, including appropriate frequencies of direct supervision; Staffing and scheduling, including contingency plans for care of the participant in the absence of the caregiver, assigned nurse, CNA, or HHA; A quality assurance program; Procedures for resolution of complaints; and Coordination of care, when appropriate, including: Delineation of service responsibilities when other service providers are involved in a participant's care; Notification to participants of each service provider's responsibilities in these instances; and Development of a discharge plan when the participant, the participant's legal representative, or the provider terminates care; Conduct a reference check on each nurse, CNA, or HHA rendering care to a participant consisting of: A documented face-to-face interview between agency representatives and the nurse, CNA, or HHA; Documented efforts at verification of past employment history; and A criminal background check to include, when caring for a child, an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services, in accordance with Family Law Article, §5-561, Annotated Code of Maryland; Maintain a personnel folder at the agency's business office for each nurse, CNA, and HHA which shall include the following: Verification of current nursing license or certification; A copy of the current CPR certification; Documentation related to: The face-to-face interview; Verification that any nurse who serves a participant younger than 19 years old has past employment which shall include at least 1 year of clinical experience which includes pediatric direct patient care within the last 3 years; and Verification of the CNA or HHA’s past employment which shall include at least 1 year of clinical experience within the last 3 years; Written verification of a criminal background check; and Documentation of a completed skills checklist signed and dated by the registered nurse supervisor or the registered nurse supervisor designee and the assigned nurse, CNA, or HHA; Provide the participant or the participant's caregiver with the following written information: Name and phone number of the provider's contact person; and Name of each nurse, CNA, or HHA assigned by the provider to render services to the participant; Provide a mechanism for the timely investigation of written complaints such that: Disruption of service does not result from the filing of a complaint; Complete files are maintained on the source, category, and disposition of the complaint; A summary report of the complaint investigation is made available to the Department or the Department's designee; A summary report of the complaint investigation is made available for public inspection, upon request; and When a complaint investigation is not conducted, reasons are documented and forwarded with the complaint to the Department or the Department's designee; Provide back-up services when the assigned nurse, CNA, or HHA is unable to provide the services; Ensure a nurse, CNA, or HHA is not scheduled to work for more than a total of 60 hours per week or 16 consecutive hours and that the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department; Demonstrate on a continuing basis the capacity to provide services to participants in the amount and level required in the participant's care plan including the development of a contingency plan to assure coverage; Provide the participant or the participant's representative with: At least 14 days written notice of termination of services when it is the provider's decision to terminate and the medical condition remains unchanged; and A copy of a developed discharge plan if the participant, the participant's representative, or the provider elects to discontinue the provider's services to the participant; Ensure that each nurse, CNA, or HHA rendering services to a participant: Completes a progress note for each shift which becomes part of the participant's permanent record; Is providing services which follow the participant's care plan; and Is providing services ordered by the participant's primary medical provider before the start of care and renewed every 60 days as indicated by the participant’s primary medical provider’s signed and dated orders; Maintain sufficient documentation to demonstrate that the requirements of this chapter are met. The Program shall cover services rendered by a nurse, CNA, or HHA when the: Services are ordered by the participant's primary medical provider and renewed every 60 days after that; Services are directly related to the plan of care; Services are described in the nursing care plan and progress notes; Services are of a scope that is more individual and continuous than what is available under the home health program; Services are delivered in the recipient's home, or other setting when normal life activities take the recipient outside the home; Services include supervision of family caregivers in the home while family caregivers practice the skills necessary to provide care to the recipient in accordance with the established plan of care; Services are preauthorized in accordance with Regulation .06 of this chapter; Services are received by the participant as documented by the signature of the participant or the participant’s representative on the nursing provider’s official form; Services are determined medically necessary for a participant after the provider has completed an initial nursing assessment that reflects the participant’s need for an awake and alert caregiver; Participant has at least one caregiver willing and able to accept responsibility for the participant’s care when the nurse, CNA, or HHA is not available; Caregiver provides documentation of each of the following when applicable: The caregiver’s work schedule along with commuting times; The caregiver’s school attendance as defined in Regulation .02 of this chapter along with commuting times; and Emergency circumstances, as determined by the Department, including but not limited to the inability of the primary caregiver to provide care due to hospitalization or an acute debilitating illness for up to a 60-day period; and Services are provided only in the absence of the willing and able caregiver during sleeping hours and during the times documented in §A(11) of this regulation. The Program shall cover nursing services rendered by a registered nurse when: The complexity of the services or the condition of a participant requires the judgment, knowledge, and skills of a registered nurse in accordance with COMAR 10.27.09 and the services cannot be: Performed by a licensed practical nurse in accordance with COMAR 10.27.10; and Delegated to a CNA or HHA pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland and in accordance with COMAR 10.27.11; Sufficient documentation is maintained by the registered nurse including signed and dated progress notes which are reviewed by the registered nurse supervisor; Supervisory visits are conducted and documented by the registered nurse supervisor based on acceptable standards of practice; and Services are preauthorized by the Department. The Program shall cover nursing services rendered by a licensed practical nurse when: The complexity of the services or the condition of a participant requires the judgment, knowledge, and skills of a licensed practical nurse in accordance with COMAR 10.27.10 and the services: Do not require the knowledge and skills of a registered nurse in accordance with COMAR 10.27.09; and Cannot be delegated to a CNA or HHA pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11; Sufficient documentation is maintained by the licensed practical nurse including signed and dated progress notes which are reviewed by the registered nurse supervisor; Supervisory visits are conducted and documented by the registered nurse supervisor based on acceptable standards of practice; and Services are preauthorized by the Department. The Program shall cover delegated nursing services provided by a CNA or HHA who is also certified as a CMT when: The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of the CNA or HHA for at least 2 or more continuous hours; The services provided include but are not limited to: Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or Other nursing services properly delegated by a nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11; Sufficient documentation is maintained by the CNA or HHA including signed and dated progress notes which are reviewed by the nurse supervisor; and Supervisory visits are conducted and documented by a registered nurse supervisor in accordance with COMAR 10.27.09 and 10.27.11. The Program shall cover a provider's initial assessment of a participant's medical need for services when the assessment: Is 3 hours or less; Does not require preauthorization; Demonstrates: A comprehensive assessment of the recipient's health status; An assessment of the need for services; An assessment of the scope and duration of services to be provided; An assessment of the recipient's residence; and Consultation with the primary medical provider, and a multidisciplinary team if the participant is receiving services under COMAR 10.09.27, to confirm the need for services and to develop a plan of care; and Is conducted by a licensed registered nurse. If a need for services is confirmed during a participant's initial assessment, the registered nurse, in conjunction with the participant's primary medical provider, shall develop a care plan. When a participant also receives services under COMAR 10.09.27, the nurse or registered nurse supervisor shall participate as a member of the multi-disciplinary team and recommend a plan of care. The care plan shall be reviewed and updated to reflect the current service orders and shall include: Prognosis; Diagnoses; Treatment; Treatment goals; Services required, including specific nursing procedures; Frequency of visits (that is, hours of nursing care ordered for each day); Duration of treatment; Functional limitations; Permitted and prohibited activities; Diet; Medications; Mental status; A list of medical supplies related to each nursing procedure and how these are to be used in the participant's care: A list of durable medical equipment related to each nursing procedure and how the equipment is to be used in the participant's care; Safety measures to protect against injury; Emergency plan; Contingency plan for back-up coverage; Nurse's role in including the family in the provision of care; Plan to decrease services when the participant's condition improves or as the caregivers become better able to meet the participant's needs; and Other appropriate items. The Department may preauthorize on a short-term basis services for assessment purposes only, when medical information is insufficient to determine medical necessity; Services shall be decreased as the caregivers become better able to meet the participant's needs. The Program shall cover nursing services ordered by the participant's primary medical provider when the primary medical provider is an individual who is enrolled as a provider in the Program with an active status on the date of service. Under this chapter, the Program does not cover the following: Home health services that are covered under COMAR 10.09.04; Services rendered by a nurse, CNA, or HHA who is a member of the participant's immediate family or who ordinarily resides with the participant; Custodial services; Services not deemed medically necessary at the initial assessment or the most recent plan of care review; Services delivered by a nurse, CNA, or HHA who is not directly supervised by a registered nurse who documents all supervisory visits and activities; Services not preauthorized by the Department or the Department's designee, with the exception of the initial assessment; Services provided to a participant in a hospital, residential treatment center, or an intermediate care facility for individuals with intellectual disabilities or a residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment; Services not directly related to the plan of care; Services specified in the plan of care, when the plan of care has not been signed by the recipient or the recipient's legally authorized representative, the Department or the Department's designee, and the recipient's primary medical provider, when the services are covered under COMAR 10.09.27; Services described in the plan of care whenever a major change occurs in the recipient's medical condition or skilled nursing care needs; Services not ordered by the recipient's primary medical provider as a result of a partial or complete EPSDT screen; Services specified in Regulation .04 of this chapter which duplicate or supplant services rendered by the recipient's family caregivers or primary caregivers as well as other insurance, privilege, entitlement, or program services that the recipient receives or is eligible to receive; Services specified in Regulation .04 of this chapter to recipients eligible for any third-party liability coverage of those services; Services provided for the convenience or preference of the recipient or the primary caregiver rather than as required by the recipient's medical condition; Services which are not initially ordered before the start of care and renewed every 60 days by the participant's primary medical provider; Services provided by a nurse, CNA, or HHA who does not possess a valid, current, and nontemporary nursing license or certifications to provide services in the jurisdiction in which services are rendered; Services provided by a nurse, CNA, or HHA who does not have a current cardiopulmonary resuscitation (CPR) certification for the period during which the services are rendered; Direct payment for supervisory visits that do not meet acceptable standards of practice in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11; Services rendered to a participant by a nurse, CNA, or HHA in the assigned staff's home; Services not documented; and Respite services. The Program shall only cover one-to-one nursing when a participant's condition requires that level of service and shared services are not an option. Nursing services may only be provided to EPSDT eligible individuals under 21 years old. The Program does not cover nursing services ordered by an: Individual who is not enrolled as a provider in the Program with an active status on the date of service; and Entity, facility, or another provider that is not an individual. The Department or the Department's designee shall preauthorize nursing services, according to medical necessity, frequency, and duration, as a prerequisite to payment beyond the initial assessment. Preauthorization is issued when: Program procedures are met; Program limitations are met; The requirements specified in this chapter are met; and The Department or the Department's designee determines that the services are medically necessary. The provider shall request the Department or the Department's designee to authorize the initiation or continuance of nursing services before the initiation or continuation of services unless services are rendered to a participant in need of emergency or urgent medical services. The provider shall request the Department or the Department's designee to authorize emergency or urgent medical services rendered to a recipient not later than the close of business the next business day after the emergency or urgent service is rendered. If nursing services in excess of the initial authorized amount are necessary, then: The assigned nurse or registered nurse supervisor shall contact the primary medical provider for approval of additional hours; and The provider shall request the Department or the Department's designee to authorize the increase in services before the initiation of change for nonemergency and nonurgent changes and not later than the close of business the next business day after the emergency or urgent service is rendered. An existing preauthorization shall remain in effect when a recipient is discharged from a hospital admission of less than or equal to 72 consecutive hours and there is no substantive change in the recipient's plan of care requiring a change in the number of authorized units of nursing services. Since preauthorization does not guarantee Program eligibility, the provider is responsible for checking for Program eligibility on the date of service. Preauthorization is only valid for services initiated within the period authorized by the Department or the Department's designee. Preauthorization is only valid for services rendered over a fixed period of time, such as: The periods designated for recipients who are served under COMAR 10.09.27; For the designated time initially ordered by the recipient's primary care provider, up to 30 days; and For intervals of 60 days after that or as considered necessary by the Department or the Department's designee. Authorization shall be rescinded by the Department or the Department's designee when: The recipient is terminated from care; The participant is admitted to a residential treatment center, an intermediate care facility for individuals with intellectual disabilities, or a nursing facility; The recipient is discharged from a hospital admission of less than or equal to 72 consecutive hours resulting in a change in the recipient's plan of care; The recipient is admitted to a hospital for a period of more than 72 consecutive hours; or The Department or the Department's designee determines that the care is no longer medically necessary. Payment procedures are as set forth in COMAR 10.09.36.04 and .06. Payments. Payments shall be made directly to a qualified provider. To receive payment for services under Regulation .04 of this chapter, a provider and its workers shall use the electronic visit verification method and data management system approved by the Department to document time and submit claims in accordance with COMAR 10.09.36.03-2. Providers shall be paid the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate established according to the fee schedule published by the Department. Rates. Effective July 1, 2022, through December 31, 2023, rates for the services outlined in this regulation shall be as follows: $17.87 for 15 minutes of services provided by a registered nurse to one participant; $12.32 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence; $11.58 for 15 minutes of services provided by a licensed practical nurse to one participant; $7.99 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence; $6.12 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant; $4.22 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence; $5.08 for 15 minutes of services provided by a CNA or HHA to one participant; $3.50 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and A flat rate of $71.41 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA. Effective January 1, 2024 through June 30, 2024, rates for the services outlined in this regulation shall be as follows: $19.2951 for 15 minutes of services provided by a registered nurse to one participant; $13.3101 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence; $12.5061 for 15 minutes of services provided by a licensed practical nurse to one participant; $8.6266 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence; $6.6105 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant; $4.5611 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence; $5.4874 for 15 minutes of services provided by a CNA or HHA to one participant; $3.7848 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and A flat rate of $77.13 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA. Effective July 1, 2024, rates for the services outlined in this regulation shall be as follows: $19.8739 for 15 minutes of services provided by a registered nurse to one participant; $13.7094 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence; $12.8813 for 15 minutes of services provided by a licensed practical nurse to one participant; $8.8854 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence; $6.8088 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant; $4.6979 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence; $5.6520 for 15 minutes of services provided by a CNA or HHA to one participant; $3.8983 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and A flat rate of $79.44 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA. The Program’s rates as specified in this regulation shall adjust each year, subject to the limitations of the State budget. The nursing services provider shall identify the individual who ordered the nursing services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim. Recovery and reimbursement are those set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are those set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective May 5, 1993 (20:11 Md. R. 911); adopted permanently effective August 2, 1993 (20:15 Md. R. 1220) Regulations .01, .03—.07 amended as an emergency provision effective June 1, 1994 (21:13 Md. R. 1152); amended permanently effective September 26, 1994 (21:19 Md. R. 1635) Regulations .01 and .03—.06 amended as an emergency provision effective January 1, 1997 (23:26 Md. R. 1856); amended permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01B amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); August 27, 2007 (34:17 Md. R. 1507); March 10, 2008 (35:5 Md. R. 641); April 1, 2014 (41:6 Md. R. 379); August 21, 2023 (50:16 Md. R. 726) Regulation .02 amended effective January 31, 2005 (32:2 Md. R. 146) Regulation .03 amended effective January 31, 2005 (32:2 Md. R. 146); April 1, 2014 (41:6 Md. R. 379) Regulation .03C, H amended effective August 23, 1999 (26:17 Md. R. 1323) Regulation .03D, G amended effective March 10, 2008 (35:5 Md. R. 641) Regulation .04 amended effective March 10, 2008 (35:5 Md. R. 641); April 1, 2014 (41:6 Md. R. 379) Regulation .04A amended effective June 24, 2024 (51:12 Md. R. 619) Regulation .04A, C amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146) Regulation .04I adopted effective January 1, 2018 (44:26 Md. R. 1214) Regulation .05 amended effective April 1, 2014 (41:6 Md. R. 379); June 24, 2024 (51:12 Md. R. 619) Regulation .05A amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); March 10, 2008 (35:5 Md. R. 641) Regulation .05C repealed effective March 10, 2008 (35:5 Md. R. 641) Regulation .05E adopted effective January 1, 2018 (44:26 Md. R. 1214) Regulation .06 amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); April 1, 2014 (41:6 Md. R. 379) Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .07 amended effective July 3, 2006 (33:13 Md. R. 1064); October 31, 2011 (38:22 Md. R. 1345); April 1, 2014 (41:6 Md. R. 379); October 24, 2016 (43:21 Md. R. 1166); May 20, 2019 (46:10 Md. R. 486) Regulation .07B amended as an emergency provision effective January 1, 2000 (27:2 Md. R. 140); amended permanently effective May 1, 2000 (27:8 Md. R. 798) Regulation .07B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) Regulation .07B amended effective April 6, 2009 (36:7 Md. R. 524); August 21, 2023 (50:16 Md. R. 726) Regulation .07C amended effective November 14, 2022 (49:23 Md. R. 995); August 21, 2023 (50:16 Md. R. 726); May 11, 2026 (53:9 Md. R. 413) Regulation .07D amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1347); amended permanently effective September 24, 2007 (34:19 Md. R. 1650) Regulation .07D amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) Regulation .07D amended effective March 22, 2010 (37:6 Md. R. 477) Regulation .07E repealed effective March 10, 2008 (35:5 Md. R. 641) Regulation .07F adopted effective January 1, 2018 (44:26 Md. R. 1214) In this chapter, the following terms have the meanings indicated. Terms Defined. “Activities of daily living” means tasks or activities that include, but are not limited to: Bathing and completing personal hygiene routines; Dressing and changing clothes; Eating; Toileting, including: Bladder and bowel requirements; Routines associated with the achievement or maintenance of continence; and Incontinence care; Mobility, including: Transferring from a bed, chair, or other structure; Moving, turning, and positioning the body while in bed or in a wheelchair; and Moving about indoors or outdoors. “Area agency” has the meaning stated in Human Services Article, §10-101(b), Annotated Code of Maryland. “Assisted living services provider” means a provider licensed by the Department in accordance with COMAR 10.07.14. “Case management” means services which assist an applicant or a participant in gaining access to the waiver services covered under this chapter, as well as to other services under the Medical Assistance Program. “Case manager” means an individual performing case management services under a waiver program. Community Setting. “Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to: Seek employment and work in competitive integrated settings; Engage in community life; Control personal resources; and Receive services. “Community setting” does not mean: Hospitals; Nursing facilities; Institutions for mental diseases; Intermediate care facilities for individuals with intellectual disabilities; Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; Prisons; Residential treatment centers; or Any establishment that furnishes food, shelter, and some treatment or services to four or more persons unrelated to the proprietor. “Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department. “Family member” means an adult who: Lives with or provides care to the participant; and Is not paid to provide the care. “Home” means the participant's place of residence in a community setting. “Home and Community-Based Options Waiver” means the program implemented under this chapter in accordance with the document for this waiver and any amendments to it submitted by the Department and approved by the Secretary of Health and Human Services, which authorizes the waiver of certain specified statutory requirements limiting coverage for home and community-based services under the Maryland Medical Assistance Program. “Instrumental activities of daily living” means tasks or activities that include, but are not limited to: Preparing meals; Performing light chores that are incidental to the personal assistance services provided to the participant; Shopping for groceries; Nutritional planning; Traveling as needed; Managing finances and handling money; Using the telephone or other appropriate means of communication; Reading; and Planning and making decisions. “Maryland Department of Aging” has the meaning stated in Human Services Article, Title 10, Annotated Code of Maryland. “Medicaid” means the Medical Assistance Program. “Medical Assistance Program” means the Program administered by Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients. “Medical day care” means a program of medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living in accordance with COMAR 10.09.07. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventative, curative, ameliorative, palliative or rehabilitative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, the participant's family, or the provider. “Nursing facility” means a facility which is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10. “Participant” means an individual who: Has been determined to meet the qualifications for participation in the waiver as specified in Regulation .03 of this chapter; and Is enrolled with the Department to receive Medicaid services. “Person-centered” means that the plan reflects what is important to the individual, what is important for his or her health and welfare, and is developed with input from the individual and the individual's representative when applicable. “Plan of service” means the written, person-centered support plan developed by the applicant or participant with support from the case manager and the individual's representative, when applicable. “Principal” means a person who: Has a direct or indirect ownership or control interest of 5 percent or more in the provider; Is an officer, director, agent, or managing employee of the entity; or Was described in §B(20)(a) of this regulation, but is no longer so described because of a transfer of ownership or control interest to an immediate family member or a member of the household of the person who continues to maintain an interest described in §B(20)(a) of this regulation. “Program” means the Medical Assistance Program. “Provider” has the same meaning stated in COMAR 10.09.36. “Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter. “Recipient” means an individual who is certified by the Department as eligible for, and is receiving, Medical Assistance benefits. “Reportable event ” means an allegation of, or an actual occurrence of, an incident that may pose an immediate or serious risk, or has potential to adversely affect the physical or mental health, safety, or well-being of a waiver applicant or participant, or complaints regarding administrative service or quality of care issues. “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in or associated with an individual's place of residence. “State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements. “Telehealth” has the meaning stated in COMAR 10.09.49.02. “Waiver applicant” means an individual who is applying for participation in the waiver, to receive the services covered under this chapter. “Waiver” means the Home and Community-Based Options Waiver as implemented through this chapter. Assisted living services providers shall be licensed by the Department in accordance with COMAR 10.07.14. The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered: Physicians; Registered nurses; Licensed practical nurses; Occupational therapists; Physical therapists; Dietitians; Nutritionists; Social workers; and Psychologists. The following shall be appropriately licensed, certified, or approved by the Department to provide services under this chapter: Licensed home health agency under COMAR 10.09.04; Certified residential services agency under COMAR 10.07.05; Nursing facility under COMAR 10.07.02; and Medical day care center under COMAR 10.09.07. General Requirements. To be eligible for participation, an individual shall be determined by the Department to meet the conditions of §§B—E of this regulation. Eligibility for waiver services shall be reevaluated every 12 months or more frequently if needed due to a significant change in the participant’s condition, needs, or financial status. Technical Eligibility. To be eligible for services covered under this chapter, an applicant or participant shall be determined by the Department to meet the technical eligibility criteria if the individual: Has been determined by the Department to need a nursing facility level of care; Is at least 18 years old; Is not simultaneously enrolled for services covered under: Another Medicaid waiver program under the authority of §1915(c) of the Social Security Act; or The Program of All-Inclusive Care for the Elderly (PACE); Has an active plan of service that: Is based on: The assessment and recommended plan of care; and Consultation with the applicant or participant; Addresses the applicant’s or participant’s needs; Specifies the names of service providers; Is cost neutral, which is determined by adding annualized costs of services covered under this chapter and any other State Plan services which are not covered for nursing facility residents, and ensuring that the resulting amount is not more than 125 percent of the Program's average per capita-annualized-net payments for nursing facility services. Any assessed participant contributions will not be considered in determining cost neutrality; and Includes the signature of the participant, the individual’s representative if applicable, and the case manager listed within the plan of service; Is offered the choice between waiver services and nursing facility services; Chooses to receive waiver services; Resides in a home, as defined under Regulation .02B of this chapter; and Uses at least one waiver service within a 12-month period. Medical Assistance Eligibility. An individual is not eligible to receive waiver services during a penalty period imposed under COMAR 10.09.24.08-1 or 10.09.24.08-2 due to disposal of assets. All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to waiver applicants and participants, with the following exceptions: COMAR 10.09.24.04J(1)—(3); COMAR 10.09.24.06B(2)(a)(ii); COMAR 10.09.24.08G; COMAR 10.09.24.10C; COMAR 10.09.24.10D(4)—(6); COMAR 10.09.24.10-1C(3)(a); and COMAR 10.09.24.15A-2(2). Cost of Care. For a participant whose home is an assisted living facility, the Department shall reduce its monthly payment for assisted living services by the amount remaining after deducting from the individual's total nonexcluded monthly income the following amounts in the following order: A personal needs allowance, consisting of the amount established in accordance with COMAR 10.09.24.10D(2)(c) and the assisted living provider's charge, not exceeding $420 per month, for room and board; A spousal or family maintenance allowance, or both, if applicable, in accordance with COMAR 10.09.24.10-1C(3)(b) and (c); and Incurred medical expenses in accordance with COMAR 10.09.24.10D(2)(f)—(h). The Department shall determine the amount of available income to be paid by a participant towards the cost of assisted living services. The participant shall pay the amount of available income for the participant’s cost of care, and the assisted living provider’s monthly charge for room and board, directly to the assisted living services provider. Waiver Eligibility. Based on the criteria established in §§A—C of this regulation an applicant's eligibility for services under this chapter shall be established by the Department based on the following policies for the effective date of waiver eligibility: No retroactive eligibility; and Waiver eligibility may not begin before the latest of the following five dates: Waiver application date; Effective date of medical certification for the waiver's institutional level of care; Date that the applicant's written waiver plan of service is established, which shall include at least one waiver service and may be a provisional plan for not more than the first 60 days of waiver enrollment; Date that the applicant or representative signed a form designated by the Department to indicate the choice of waiver services as an alternative to institutionalization; and Date of the applicant's discharge from institutionalization in a long term care facility, if applicable. Annual Cap and Registry for Waiver Participation. The Department shall establish an annual cap, approved by the federal Centers for Medicare and Medicaid Services (CMS), for the number of unduplicated individuals who may receive the services covered under this chapter, based on available State and federal funding. Eligible individuals shall be enrolled in the waiver on a first-come, first-served basis until the annual cap on waiver participation is reached. Once the annual cap on waiver participation is reached: A registry list shall be established for individuals interested in applying for waiver services; Individuals on the registry shall have an opportunity to apply for the waiver in accordance with procedures established by the Department; and The Department and CMS may authorize increasing the waiver cap if the Department determines that sufficient Program funds are available to reimburse the services recommended in the individual's plan of service and the participant's other Program services for the remainder of the State fiscal year. Individuals in nursing facilities who are receiving Medicaid services for at least 30 days may apply directly for the waiver without being put on the registry list. Termination of Participation. A participant shall be terminated from participation in the waiver if the participant: No longer meets the eligibility requirements specified in §§B—E of this regulation; Voluntarily chooses, or the participant’s authorized representative chooses on the participant’s behalf, to disenroll from the waiver program; Moves to another state; Is an inpatient for 30 consecutive days or more in a hospital or nursing facility; or Dies. If an individual is terminated from the waiver, the same individual may re-enter the waiver during the same waiver year, or within 90 days of termination contingent on waiver capacity, provided that the individual meets all of the eligibility requirements of the waiver. To participate as a provider of a service covered under this chapter a provider shall: Meet all of the conditions for participation as a Maryland Medical Assistance Program provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; Verify the qualifications of all individuals who render services on the provider's behalf, and provide a copy of the current license or credentials upon request; Implement the reporting and follow-up of incidents and complaints in accordance with the Department's established reportable events policy; Agree to cooperate with required inspections, reviews, and audits by authorized governmental representatives; Agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter for only those services covered under this chapter which have been: Pre-approved in the participant's plan of service; Provided in a manner consistent with the participant's plan of service; and Identified in the provider agreement as within the scope of the provider's Medicaid participation; Agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years, in a manner approved by the Department; Agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and with consultation and agreement by the participant or a participant's representative when applicable; Submit a transition plan to the case manager and participant or participant's representative when applicable when suspending or terminating services; Verify Medicaid eligibility at the beginning of each month that services will be rendered; Not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; Notify the Department in writing at least 45 days in advance of any: Voluntary closure; Change of ownership; Change of location; Sale of the business; Change in the name under which the provider is doing business; or Change in provider tax identification number; Include in the notice to the Department regarding any change of status under §A(11) of this regulation, the method for informing waiver participants and representatives of its intent to close, change ownership, change location, or sell its business; Apply for a new license if applicable, whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of waiver services; Submit a Medicaid provider application to the Department if the new owner chooses to participate in the waiver program; Obtain a state and federal background check through the Criminal Justice Information System on all staff in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland; Render services in person, except as expressly authorized by the Department in the regulation governing that service type; and If rendering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services; Undergone the imposition of sanctions under COMAR 10.09.36.08; Been subject to disciplinary action, including actions by the licensing board, that indicate behavior which is potentially harmful to participants; Been cited by a State agency for deficiencies which affect participants health and safety; or Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to: Failure to meet contractual obligations; or Fraudulent billing practices. A provider who renders health-related services to participants shall agree to: Periodically indicate the condition of a participant in accordance with the procedures and forms designated by the Department; and Share and discuss the documented information at the request of the participant. A provider, its principals, or its staff may not have a history of behavior or convictions that could be harmful to participants, as evidenced through a State and federal background check conducted in accordance with §A(15) of this regulation. To participate in the program as a provider of assisted living services under this chapter a provider shall: Be licensed by the Department at the time that services are rendered, in accordance with COMAR 10.07.14, to provide assisted living services; Be or employ a manager who is qualified as: A licensed physician; A licensed registered nurse; A licensed practical nurse; or An individual with at least 3 years’ experience in direct patient care in a private home, certified home, or health-related facility; Employ an alternate assisted living manager who meets the requirements as specified in §A(2) of this regulation. Have at least one staff person per eight residents on duty at all times during daytime hours, and have a staff-to-resident ratio at night which is adequate to provide the required services and maintain the facility in a safe and orderly condition, with additional staffing if required by the Department depending on residents' functional levels; Participate in training on the waiver billing process and other waiver requirements, as specified by the Department; Have the appropriate insurance coverage to cover the provider and its employees and vehicles if the provider chooses to transport participants to medical, social, recreational, and other services; Cooperate with other service providers and quality assurance monitors by: Facilitating on-site visits of authorized quality assurance monitors to review compliance with waiver and regulatory requirements; Facilitating a case manager's on-site visits to the facility, which shall occur at least quarterly, to review the facility, regulatory compliance, service provision, and participants' status and needs; Communicating with a participant's case manager concerning the participant's status, needs, and service provision; Informing the case manager within 1 working day of any significant change in the participant's status and service needs; Facilitating, as necessary and appropriate, the delivery of authorized waiver and State Plan services in the plan of service; and Facilitating waiver participant's relocation to comparable housing, if necessary, including transfer of all personal belongings and financial arrangements; and Submit claims consistent with the provisions of Regulation .22 of this chapter. Bed Reservations. If bed reservations are offered to participants who are absent from an assisted living facility, the bed reservations policy shall: Be provided to all residents and, where appropriate, the resident's representative, at admission; Be fairly and consistently applied to all residents; Specify that the bed reservation service is not a Medicaid covered service; Clearly state that it is the resident's decision whether to reserve the bed; and Specify that the charges to participants for bed reservation days may not exceed the full Medicaid waiver per diem rate. An assisted living provider may limit waiver participation to a designated unit or units only if approved by Department and the facility resident agreement contains the following provisions: The facility's participation in the Program is limited to one or more designated units and, in order to access Medicaid waiver benefits, the resident shall reside in a designated unit; A resident of a designated unit has a right to apply for the waiver at any time and access waiver benefits without restrictions by the provider when the resident is found eligible by the Program; and A resident not in a designated unit who is otherwise eligible or seeking eligibility for the waiver shall be given first consideration and, with all other factors equal, first priority in admission to a vacant bed in a designated unit. To participate in the program as a provider of behavior consultation services under this chapter a provider shall: Be: A health services agency that: Employs a qualified individual or individuals to render behavior consultation services; and Assures supervision of the individual rendering behavior consultation services by a licensed mental health professional or by a bachelor's level nurse with 4 years of experience or with an appropriate graduate degree; or An individual who is: Qualified to render behavior consultation services; and Licensed to practice independently; Assure that the individual who renders behavior consultation services: Is a licensed: Registered nurse; Psychologist; or Clinical social worker; and Has: Direct experience working with adults with behavioral problems; and Demonstrated ability to perform assessments; and Assure response within 24 hours to a referral from a participant's case manager for behavior consultation services. To participate in the program as a provider of Senior Center Plus services under this chapter a provider shall: Be approved and monitored by the Maryland Department of Aging as a nutrition service provider; Meet all local and State requirements to operate as a nutrition site, which include but are not limited to inspection and approval of the facility by the local fire marshal, periodic fire drills, and inspection and approval by the local sanitarian to assure compliance with health department requirements for food service facilities; Assure that the facility provides an accessible environment, in compliance with the Americans with Disabilities Act (ADA), 28 CFR Part 36; Maintain adequate records on participants, including progress notes and outcomes; Provide at least one staff person per eight clients, with additional staffing if required by the Maryland Department of Aging depending on participants' functional levels; Employ as the center's manager or in another staff position an individual who: Is a licensed health professional or a licensed social worker; Has at least 3 years’ experience in direct patient care at an adult day care center, nursing facility, or health-related facility; and Participates in training specified and approved by the Maryland Department of Aging; Provide Senior Center Plus services to participants at least 4 hours a day, 1 or more days a week on a regularly scheduled basis, in an out-of-home, outpatient setting; Serve at least one nutritional meal per day that: Is prepared in a licensed food service establishment; Meets at least 1/3 of the daily recommended dietary allowance; and Does not constitute a full nutritional regimen of three meals per day; Serve snacks, as desired by the participants, when the day program exceeds 6 hours; and Have menus reviewed and approved quarterly by a registered dietitian for nutritional adequacy. To participate in the Program as a provider of family training under this chapter a provider shall: Be a self-employed trainer or an agency that employs qualified trainers in accordance with §§B—D of this regulation; Have demonstrated experience with the skill being taught; Be willing to meet at the participant's home to provide services; and Employ licensed registered nurses, occupational therapists, physical therapists, or social workers who are appropriately experienced and licensed to provide the needed training. To participate in the program as a provider of dietitian and nutritionist services under this chapter a provider shall be a: Dietitian or nutritionist who is licensed in accordance with COMAR 10.56.01 and Health Occupations Article, Title 5, Annotated Code of Maryland; or Professional group or agency which employs an individual who is licensed in accordance with §A of this regulation. To participate in the program as a provider of medical day care services under this chapter a provider shall: Meet the licensure requirements as provided in COMAR 10.12.04; and Meet the requirements of COMAR 10.09.07. To participate in the Program as a provider of respite care services under Regulation .18-1 of this chapter a provider shall be enrolled as a provider of: Assisted living services under this chapter; or Nursing facility services under COMAR 10.09.10. To participate in the program as a provider of case management services under this chapter a provider shall: Be an area agency or other entity designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act; and Agree to be monitored by the Department. The Program shall reimburse for the services specified in Regulations .13—.19 of this chapter when, pursuant to the requirements of this chapter, these services have been pre-approved by the Department in the participant’s plan of service, and billed in accordance with the payment procedures in Regulation .22 of this chapter. Assisted living services shall include the provision of: A structured, supportive environment in a home-like setting; Personal assistance and chore services including: Assisting the participant, as necessary, with performing activities of daily living and instrumental activities of daily living, including cuing the participant to perform these activities; Routine housekeeping, laundry, household care, and chore services needed to maintain the facility as a clean, sanitary, and safe environment; and Menu planning, food shopping, and meal preparation and serving; Basic personal hygiene supplies, including but not limited to: Soap; Bathroom tissue; Paper towels; Toothpaste; Toothbrush; and Shampoo; 24-hour supervision of participants to assure health and safety; Assistance with medication administration, in accordance with COMAR 10.27.11 and COMAR 10.07.14; Recreational and social activities of a nontherapeutic and nonhabilitative nature which are confined to the assisted living facility and are for the purpose of socialization; Reminding the participant of medical appointments; Assistance with transportation arrangements to needed services; Conferring with the participant's case manager about the participant's status and service needs, as necessary; Assisting the participant in accessing needed medical or mental health services in emergency situations; and Other services specified for assisted living programs in COMAR 10.07.14. The living environment and service provision shall reflect participants' individualized needs and preferences. Assisted living services reimbursed under this chapter may not include room and board. A provider may bill for the length of a home visit to a participant, upon completion of the services specified in §C of this regulation. Behavior consultation services may be preauthorized by a participant's plan of service when: A participant or the participant's representative request the service due to an identified behavioral issue; or The participant's behavior is: Potentially dangerous to the participant's or another person's health and functioning; or Placing the participant at risk of institutionalization due to health and safety concerns. Behavior consultation services include a: Home visit by an individual qualified to render services to: Evaluate a participant's behavior; Assess the situation; Determine the contributing factors; and Recommend interventions and treatments; and Written report with the results of the provider’s assessment and recommendations, which shall be reviewed verbally by the participant, the participant’s representative and family when applicable, and the participant’s case manager and caregivers, which may include an assisted living provider, to discuss: The report's findings and recommendations; and A course of action, including any related needed medical interventions. Behavior consultation services do not include: The time spent on related activities before or after the home visit; or The provider's time spent on any supervisory or consultative services provided to the renderer of services. The initial assessment provided in §C of this regulation to evaluate a participant's behavior, assess the situation, and determine the contributing factors shall be performed in person. The verbal review described in §C(2) of this regulation may be delivered via telehealth if recommendations do not require hands-on training or intervention. Except as provided in §§E and F of this regulation, behavior consultation services may be rendered via telehealth. A day of service is covered by the Program when the participant attends for at least 4 hours, not including transportation to and from the center. Senior Center Plus services include a program of structured group recreational activities, supervised care, assistance with activities of daily living and instrumental activities of daily living, and enhanced socialization provided in an out-of-home, outpatient setting. Social and recreational activities designed for elderly, disabled individuals, as well as one nutritious meal shall be available at the center. This program is designed to promote the participants' optimal functioning and to have a positive impact on the participants' orientation and cognitive ability. A provider may choose to provide transportation to and from the site of the Senior Center Plus services. These transportation services may: Not be included in the provider's daily rate negotiated with the Maryland Department of Aging; and Be reimbursed through some other funding source for transportation services. This service does not cover: Transportation; Direct health care; or A full regimen of three meals per day. The Program covers family training when the service is approved in the plan of service and rendered to a family member by a qualified provider, not including the time spent planning, preparing, setting up or following up after the training. The training and counseling services may not include services rendered: On a group basis or in a classroom setting; or To a family member of a participant residing in a licensed assisted living facility. The topics covered by the training and counseling services shall be: Targeted to the individualized needs of the family member receiving the training, as related to the participant's needs; Sensitive to the educational background, culture, and general environment of the participant or family member receiving the training; and Specified in the plan of service as necessary to: Ensure the participant's health and safety; and Prevent the participant's institutionalization. The training and counseling services may include: Instruction on treatment regimens and dementia; Use of equipment specified in the plan of service; Other issues; or Follow-up training as authorized. The initial assessment for training and counseling following a rehabilitative or hospital stay shall be performed in person. If family members are unable to participate fully in the service when delivered via telehealth, the provider shall perform the service in person. Except as provided in §§E and F of this regulation, family training services may be rendered via telehealth. Dietitian and nutritionist services shall include: The provision of nutrition care plan outcomes and approaches; Nutrition care planning, nutrition assessment, and dietetic instruction; and Services within the scope of practice of the nutritionist's or dietitian's license, as defined by: Health Occupations Article, Title V, Annotated Code of Maryland; and Regulations under COMAR 10.56 for the Board of Dietetic Practice. Dietitian and nutritionist services may not include services rendered: On a group basis or in a classroom setting; or To participants residing in a licensed assisted living facility. The services shall be: Covered if the participant's medical condition requires the judgment, knowledge, and skills of a licensed nutritionist or licensed dietitian; Targeted to the individualized needs of the participant, rather than being of general interest; Sensitive to the educational background, culture, religion, eating habits and preferences, and general environment of the participant; and Specified in the participant's plan of service as necessary to: Ensure the participant's health and safety; and Prevent the participant's institutionalization or hospitalization. The initial assessment and counseling following a rehabilitative or hospital stay shall be performed in person. If family members are unable to participate fully in the service when delivered via telehealth, the provider shall perform the service in person. Except as provided in §§D and E of this regulation, dietitian and nutrition services may be rendered via telehealth. A provider shall render medical day care services in accordance with COMAR 10.09.07. Respite care services shall: Be provided to participants who, due to physical or cognitive impairments, are unable to care for themselves; Be furnished on a short-term basis because of the absence or need for relief of an individual normally providing the care; Provide a period of rest and renewal, which contributes to maintaining the participant at home in the community; Be provided at planned intervals, in a time of crisis, or as needed; Include the participant's room and board; Include overnight care; and Including the following services: Supervising participants with cognitive impairments to ensure the individual’s health and safety; Assisting participants with functional impairments to perform activities of daily living or instrumental activities of daily living; and Delegated nursing functions, such as medication assistance or administration by appropriately trained, certified, and supervised staff. Case management services shall be targeted to address the individualized needs of the participant and be sensitive to the educational background, culture, and general environment of the participant. Case management services include time spent by a qualified provider conducting any of the following activities: Assisting with the initial or annual waiver eligibility process; Assisting with the application and supporting the individual in maintaining all public and private benefits, resources, and entitlements; Conducting an assessment of needs, and developing a person-centered plan of service, to include all services needed to live safely in the community; Assisting the participant with referrals, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to: Behavioral health; Educational services; Disposable medical supplies and durable medical equipment; Housing; Medical services; and Social services; Monitoring the provision of services to determine if services are received in accordance with the plan of services; Facilitating referrals to other programs if the individual is denied waiver services; and Using information technology systems developed by the Department. The Program shall reimburse for the services specified in Regulations .13—.19 of this chapter, if provided in accordance with the requirements of this chapter and if the service: Is recommended on the participant’s plan of service as necessary in order to: Prevent the applicant’s or participant’s admission to an institution; or Assure the health and safety of an applicant or participant in the community; Has been pre-approved by the Department in the participant’s plan of service; Is provided to an enrolled participant; Is medically necessary; Is provided by a Medicaid provider who meets the conditions for participation under this chapter; and Is cost-neutral for the Program, which is determined by adding annualized costs of services covered under this chapter and any other State Plan services which are not covered for nursing facility residents, and ensuring that the resulting amount is not more than: 125 percent of the Program's average per capita-annualized-net payments for nursing facility services for a waiver participant in accordance with the provisions of Regulation .03B(4)(d) of this chapter; and In the aggregate for all waiver participants, 100 percent of the Program’s average per capita-annualized-net payments for nursing facility services. Reimbursement may be made by the Program only when the requirements of this chapter are met. The Program may not reimburse the following combinations of services for a participant for the same date of service: Senior Center Plus and Medical Day Care under this chapter; Assisted living services under this chapter and personal assistance services under COMAR 10.09.20 or COMAR 10.09.84; Assisted living services and respite care under this chapter; or Respite care under this chapter and personal assistance services covered under COMAR 10.09.20 or COMAR 10.09.84. Reimbursement by the Program for respite care shall be limited to 14 days per occurrence. To receive payment as a provider of services covered under Regulations .13—.19 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department's billing manual. Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06. Payments. Payments shall be made directly to a qualified provider. A provider shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rates established in §D of this regulation. Rates. For dates of service beginning July 1, 2022, through June 30, 2024, fees per unit of service shall be as follows: Assisted Living Level II, No Medical Day Care: reimbursed at the maximum rate of $81.57 per day; Assisted Living Level III, No Medical Day Care: reimbursed at the maximum rate of $102.94 per day; Assisted Living Level II, Medical Day Care: reimbursed at the maximum rate of $61.21 per day; Assisted Living Level III, Medical Day Care: reimbursed at the maximum rate of $77.18 per day; Behavioral Consultation: reimbursed at the maximum rate of $89.22 per hour; Case Management — Administrative: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit; Case Management — Comprehensive: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit; Case Management — Ongoing: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit; Dietitian and Nutritionist Services: reimbursed at the maximum rate of $89.22 per hour; Family 1/1 Training: reimbursed at the maximum rate of $89.22 per hour; Medical Day Care Services: reimbursed at the maximum rate of $104.81 per day; and Senior Center Plus: reimbursed at the maximum rate of $64.90 per day. For dates of service beginning July 1, 2024, fees per unit of service shall be as follows: Assisted Living Level II, No Medical Day Care: reimbursed at the maximum rate of $90.74 per day; Assisted Living Level III, No Medical Day Care: reimbursed at the maximum rate of $114.51 per day; Assisted Living Level II, Medical Day Care: reimbursed at the maximum rate of $68.09 per day; Assisted Living Level III, Medical Day Care: reimbursed at the maximum rate of $85.86 per day; Behavioral Consultation: reimbursed at the maximum rate of $99.25 per hour; Case Management — Administrative: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; Case Management — Comprehensive: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; Case Management — Ongoing: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; Dietitian and Nutritionist Services: reimbursed at the maximum rate of $99.25 per hour; Family 1/1 Training: reimbursed at the maximum rate of $99.25 per hour; Medical Day Care Services: reimbursed at the maximum rate of $116.59 per day; and Senior Center Plus: reimbursed at the maximum rate of $72.19 per day. The Program’s rates for covered services under Regulations .13—.19 of this chapter shall be adjusted subject to the limitations of the State budget. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are those set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. This chapter shall be implemented January 6, 2014. Health-General Article, §§2-104(b), 15-103, 15-105, 15-132, and 15-141.2, Annotated Code of Maryland Effective date: Regulations .01—19 adopted as an emergency provision effective July 22, 1993 (20:16 Md. R. 1275); adopted permanently effective October 26, 1993 (20:21 Md. R. 1654) Chapter revised effective December 25, 2000 (27:25 Md. R. 2281) Chapter revised effective June 21, 2004 (31:12 Md. R. 912) Regulation .05A amended effective July 17, 2006 (33:14 Md. R. 1164) Regulation .33C amended effective June 20, 2005 (32:12 Md. R. 1046); July 17, 2006 (33:14 Md. R. 1164) Chapter revised effective April 9, 2007 (34:7 Md. R. 698) Regulation .03C amended effective September 20, 2010 (37:19 Md. R. 1284) Regulation .14 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective December 1, 2008 (35:24 Md. R. 2078) Regulation .14-1 adopted effective April 15, 2013 (40:7 Md. R. 610) Regulation .15 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078) Regulation .17 adopted as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); adopted permanently effective September 21, 2009 (36:19 Md. R. 1436) Regulation .30 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective December 1, 2008 (35:24 Md. R. 2078) Regulation .30-1 adopted effective April 15, 2013 (40:7 Md. R. 610) Regulation .32F, G amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078) Regulation .32H adopted as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); adopted permanently effective September 21, 2009 (36:19 Md. R. 1436) Regulation .33A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078) Regulation .33C amended effective April 6, 2009 (36:7 Md. R. 524); February 8, 2010 (37:3 Md. R. 176); October 31, 2011 (38:22 Md. R. 1346); April 15, 2013 (40:7 Md. R. 610) Regulation .33D adopted effective January 6, 2014 (40:26 Md. R. 2163) Regulations .01—.37 repealed and new Regulations .01—.27 adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .01 amended effective November 27, 2023 (50:23 Md. R. 1004) Regulation .04A amended effective November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413) Regulation .04D adopted effective May 11, 2026 (53:9 Md. R. 413) Regulation .10-1 adopted effective December 11, 2014 (41:24 Md. R. 1427) Regulation .13 amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .14 amended effective January 30, 2017 (44:2 Md. R. 84); November 27, 2023 (50:23 Md. R. 1004) Regulation .15A amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .16A amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .16E, F, G adopted effective November 27, 2023 (50:23 Md. R. 1004) Regulation .17 amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .17D, E, F adopted effective November 27, 2023 (50:23 Md. R. 1004) Regulation .18 amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .18-1 adopted effective December 11, 2014 (41:24 Md. R. 1427) Regulation .18-1 amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .19 amended effective January 30, 2017 (44:2 Md. R. 84) Regulation .21B amended effective December 11, 2014 (41:24 Md. R. 1427) Regulation .21C adopted effective December 11, 2014 (41:24 Md. R. 1427) Regulation .22A amended effective May 11, 2026 (53:9 Md. R. 413) Regulation .22C amended effective July 4, 2016 (43:13 Md. R. 712); November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413) Regulation .22D amended effective January 30, 2017 (44:2 Md. R. 84); May 20, 2019 (46:10 Md. R. 486); November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413) In this chapter, the following terms have the meanings indicated. Terms Defined. “Advanced duties” means medical acts that require training and certification beyond the basic physician assistant education program. “Board” means the State Board of Physicians. “Delegation agreement” means a document that is executed by a licensed physician and a physician assistant containing the requirements of Health Occupation Article, §15-302, Annotated Code of Maryland, and COMAR 10.32.03.05. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Dispense” means to dispense starter dosages or drug samples. “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Modification” means any change to the delegation agreement that governs the physician assistant’s performance of duties, including but not limited to practice location, scope of practice, change of supervising physician (primary or alternate), and prescriptive authority. “Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02. “Physician assistant” means an individual who is licensed to practice medicine with physician supervision. “Practice as a physician assistant” means the performance of medical acts that are: Delegated by a supervising physician to a physician assistant; Within the supervising physician’s scope of practice; and Appropriate to the physician assistant’s education, training, and experience. “Program” means the Maryland Medical Assistance Program. “Provider” means a licensed physician assistant who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. “Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. "Supervision” means the responsibility of the physician to exercise on-site supervision or to be able to provide immediate available direction for the physician assistants performing delegated medical acts, and includes: Oversight of the physician assistant and acceptance of direct responsibility for the patient services and care rendered by the physician assistant; Continuous availability to the physician assistant either in person, by telephone, by electronic means, or by some other form of telecommunication; and Designation of one or more alternate supervising physicians. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. A physician assistant applying for provider status shall: Be licensed to practice as a physician assistant in Maryland or in the state or jurisdiction in which the service is provided; Be in compliance with requirements set forth in COMAR 10.32.03; If practicing in Maryland, have a delegation agreement with a supervising physician that outlines the physician assistant’s duties within the medical practice or facility which has been filed with and approved by the Board of Physicians; and If practicing in Maryland, have a delegation agreement with a supervising physician that documents the specialized training, education, and experience of the physician assistant for performing advanced duties. A physician having a written agreement to supervise a physician assistant shall: Be licensed to practice medicine in the state in which the physician assistant is providing services; Delegate only medical acts that are within the scope of the practice of the physician and are suitable to be performed by the physician assistant, taking into account the physician assistant’s education, training, and level of competence; Accept Program reimbursement as payment in full for services provided; Establish and review drug and other medical guidelines with the physician assistant; Participate with the physician assistant in reviewing and discussing medical diagnoses and the therapeutic and corrective measures employed in the practice setting; Be available for consultation in person, by telephone, electronic means, or by some other form of telecommunication; and Designate an alternate supervising physician if the physician identified in the delegation agreement temporarily becomes unavailable. For hospitals, correctional facilities, detention centers, or public health facilities, the primary supervising physician shall keep an ongoing list of all approved alternate supervising physicians within the alternate supervising physicians’ scopes of practice, with each alternate supervising physician’s signature and date. A physician assistant shall: Meet all general provider requirements set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. A physician assistant shall: Have a written and executed delegation agreement with a licensed physician approved by the Board, or as required by the state in which services are provided; and If the primary supervising physician delegates the prescribing of controlled dangerous substances to a physician assistant, if required by applicable law, the physician assistant shall: Obtain a Maryland Controlled Dangerous Substance (MCDS) license from the Maryland Division of Drug Control; and After obtaining an MCDS license: Register with the Drug Enforcement Administration (DEA); and Obtain a license from the DEA. To participate as a provider, the physician assistant shall submit to the Program a copy of the provider's: Current approved delegation agreement; and Current license to practice in the state in which services are provided. Modification of Delegation Agreement. If the provider's approved written delegation agreement with the physician is modified or terminated by either party, the physician assistant and supervising physician shall notify the Program within 5 days in writing. If the delegation agreement is modified, the physician assistant and the supervising physician shall submit to the Program a copy of the modified or new written agreement. If the duties of the physician assistant are limited, reduced, or result in other changes of employment that might be grounds for disciplinary actions under Health Occupations Article, §15-314, Annotated Code of Maryland, the supervising physician, hospital, alternative health care system, or employer shall notify the Program immediately or within 5 days in writing. A physician assistant may practice in Maryland: Only in accordance with the delegation agreement approved by the Board; or If out-of-State, only in accordance with the scope of practice allowed by the licensing authority in the state in which services are provided. The Program covers medically necessary services rendered to participants in accordance with: The functions allowed under: The Physician Assistant’s Practice Act; COMAR 10.32.03; and The physician assistant’s written delegation agreement with a physician; or If out-of-State, those functions authorized in the state in which the services are provided. The services in §A of this regulation shall be described in the participant's medical record in sufficient detail to support the invoice submitted for those services. The Program does not cover the following under these regulations: Services not encompassed by the physician assistant’s written delegation agreement with the physician, if required by the state in which services are provided; Services not medically necessary; Services prohibited by the Board; Services prohibited in the state in which services are provided; Physician assistant services included as part of the cost of an inpatient facility, hospital outpatient department, or freestanding clinic; Visits by or to the physician assistant solely for the purpose of the following: Prescription, drug, or food supplement pickup; Recording of an electrocardiogram; Ascertaining the patient's weight; Interpretation of laboratory tests or panels; or Prescribing or administering oral medications; Drugs and supplies which are acquired by the licensed and certified physician assistant at no cost; Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take appropriate oral medications are documented in the patient's medical record; More than one visit per day per participant unless adequately documented as an emergency situation; Services paid under the free-standing dialysis program described in COMAR 10.09.22; Physician assistant billings for those laboratory or X-ray services performed by another facility, which shall bill the Program directly; Immunizations required for travel outside the continental United States; Acupuncture; Hypnosis; Travel expenses; Prescriptions and injections for central nervous system stimulants and anoretic agents when used for weight control; Investigational or experimental drugs and procedures; Services denied by Medicare as not medically justified; and Services for which the patient specifically requests to see a physician. The provider shall submit the request for payment in the format designated by the Department. The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by any properly completed forms required by the Department. The provider shall charge the Program the provider's customary charge to the general public for similar services and charge the provider's acquisition cost for injectable drugs or dispensed medical supplies. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §D of this regulation; and The provider's reimbursement is not limited to the provider's customary charge. The Department shall reimburse the physician assistant for covered services at the lesser of: The provider's customary charge unless the service is free to individuals not covered by Medicaid; or The maximum rates according to COMAR 10.09.02.07E. Payments on Medicare claims are authorized, if: Services are covered by the Program; The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make supplemental payments on Medicare claims subject to the following provisions: Deductible insurance shall be paid in full; and Coinsurance shall be paid at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; and Providing a copy of a participant's medical record when requested by another licensed provider on behalf of the participant. The Program may not make direct payment to participants. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Physician assistants who are employed by or under contract to any physician, clinic, or hospital may not bill for any service for which reimbursement is sought by the physician, clinic, or hospital. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. State regulations shall be interpreted in conformity with COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: May 11, 2015 (42:9 Md. R. 647) Regulation .03A amended effective July 10, 2023 (50:13 Md. R. 512) Regulation .06 amended effective September 26, 2016 (43:19 Md. R. 1072) Regulation .06G amended effective July 10, 2023 (50:13 Md. R. 512) In this chapter, the following terms have the meanings indicated. Terms Defined. Active Treatment. “Active treatment” means, according to 42 CFR §483.440(a), a continuous active treatment program which includes aggressive, consistent implementation of a program of specialized and generic training, treatment, health services, and related services that is directed toward the: Acquisition of the behaviors necessary for the individual to function with as much self-determination and independence as possible; or Prevention or deceleration of regression or loss of current optimal functional status. “Active treatment” does not mean, according to 42 CFR §483.440(a), services to maintain generally independent individuals who are able to function with little supervision or in the absence of a continuous active treatment program. “Applicant” means an individual who is applying as a participant in the Autism Waiver. “Autism” has the meaning stated in §C of this regulation. “Autism Waiver” means the Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder. “Certified special educator” means a professional who holds an appropriate certificate as defined by COMAR 13A.12.01.02. “Department” means the Maryland Department of Health, or its authorized agents acting on behalf of the Department. “Developmentally disabled” means a condition, as specified in 42 CFR §435.1010 for persons with related conditions, resulting in a severe, chronic disability which meets all of the following conditions: Is attributable to: Cerebral palsy or epilepsy; or A condition such as autism, except for mental illness, which is found to be closely related to intellectual disability because the condition results in impairment of general intellectual functioning or adaptive behavior similar to that of intellectually disabled individuals, and requires treatment or services similar to those required for intellectually disabled individuals; Is manifested before the individual is 22 years old; Is likely to continue indefinitely; and Results in substantial functional limitations in three or more of the following areas of major life activities: Self-care; Understanding and use of language; Learning; Mobility; Self-direction; Capacity for independent living; or Other areas of major life activities. “Early intervention services” means services that: Are designed to meet the developmental needs of infants and toddlers with disabilities; Are provided under public supervision and in conformity with an individualized family service plan; and Meet applicable State and federal standards. “Eligible person” means an individual who meets the qualifications, as specified in Regulation .02 of this chapter, for participation in the Autism Waiver. “Family” means adults who: Live with or provide care to the participant; and Are not paid to provide the care. “HIPAA” means the Health Insurance Portability and Accountability Act of 1996 developed to improve portability of health insurance coverage, reduce healthcare fraud and abuse, and protect individual privacy of personal health records. “Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder” means the program implemented under this chapter in accordance with the document, and any amendments to it, submitted by the Department to, and approved by, the Secretary of the U. S. Department of Health and Human Services, which authorizes the waiver, pursuant to §1915(c) of Title XIX of the Social Security Act, of certain specified statutory requirements limiting coverage for home and community-based services under the Medical Assistance Program. “ICF-ID level of care” means an assessment that an individual needs the level of services provided in an intermediate care facility for the intellectually disabled and persons with related conditions (ICF-ID), including active treatment. “Individualized education program (IEP)” means a written statement for a student with a disability that is developed, reviewed, and revised in accordance with 20 U.S.C. §1414 and COMAR 10.09.52. “Individualized family service plan (IFSP)” means a written, individualized plan for early intervention and other services for an infant or toddler, in accordance with COMAR 10.09.40, 10.09.50, and 13A.13.01. “Intermediate care facility for individuals with intellectual disabilities (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that: Is primarily for the diagnosis, treatment, or rehabilitation of individuals with intellectual disabilities or persons with related conditions; and Provides, in a protected residential setting, ongoing evaluation, planning, 24-hour supervision, coordination, and integration of health or rehabilitative services to help each individual function at the individual's greatest ability. “Local lead agency” means the agency designated by the local governing authority in each jurisdiction to administer the interagency system of early intervention services under the direction of the State Department of Education. “Local school system” means the public local education agency in each jurisdiction. “Medicaid” means the Medical Assistance Program. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01B. “Multidisciplinary team” means the IEP team or IFSP participants, consistent with the Individuals with Disabilities Education Act (IDEA), which is convened for a participant. Parent. “Parent” means the adult representative of a minor applicant or participant. “Parent” includes: A natural or adoptive parent; A legal guardian; A person acting in the place of a parent, such as a grandparent or stepparent, with whom the participant lives, including those relatives or stepparents who are foster parents; An individual appointed as the parent surrogate in accordance with Education Article, §8-412, Annotated Code of Maryland, for matters within the scope of the Individuals with Disabilities Education Act (IDEA); and Any other person who is legally responsible for the participant's welfare. “Participant” means an eligible person who is enrolled in the Autism Waiver. “Positive behavior intervention” means a range of intervention strategies that are designed to prevent problem behaviors while teaching socially appropriate alternative behaviors. “Program” means the Medical Assistance Program, as stated in COMAR 10.09.36.01B. “Provider” means an individual, association, partnership, corporation, or unincorporated group that: Is approved as meeting the conditions for waiver participation specified in this chapter; and Has enrolled with the Program to provide one or more of the waiver services covered under this chapter. “Provider agreement” means a contract between the Program and a provider. “Qualified diagnostician” means an individual whose license or certification permits diagnosis of Autism Spectrum Disorder. “Recipient” means an individual who is certified by the Department as eligible to receive Program benefits. “Reportable event policy” means a process developed to protect the health and safety of waiver participants in the community by identifying, documenting, and resolving complaints and incidents. “Retainer payment” means payment made to providers of residential habilitation services while the participant is hospitalized or absent from the residential habilitation program. “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food which are provided in or associated with an individual's place of residence. “Service coordinator” means the individual who provides case management services for Autism Waiver participants in accordance with COMAR 10.09.52. “Special educator” means a professional who holds an appropriate certificate as defined by COMAR 13A.12.01.02. “State Department of Education (MSDE)” means the agency responsible for ensuring that all children with disabilities residing in the State are identified, assessed, and provided with a free, appropriate public education consistent with State and federal laws. “State fiscal year” means the 12-month period of July 1 through June 30 over which the State budgets its spending. “State Plan” means the plan for the Medical Assistance Program as submitted by the Department and approved by the Secretary of the U.S. Department of Health and Human Services according to Title XIX of the Social Security Act, as modified or amended. “Waiver plan of care” means the written, individualized treatment plan developed for a participant, which identifies the waiver services covered under this chapter. Autism. “Autism” means autism spectrum disorder, which is diagnosed when an individual has a total of six or more of the following items under §C(1)(a), (b), and (c) of this regulation, with at least two from §C(1)(a) and one each from §C(1)(b) and (c): Qualitative impairment in social interaction, as manifested by at least two of the following: Marked impairment in the use of multiple nonverbal behaviors such as eye-to-eye gaze, facial expression, body postures, and gestures to regulate social interaction; Failure to develop peer relationships appropriate to developmental level; A lack of spontaneous seeking to share enjoyment, interests, or achievements with other people (for example, by a lack of showing, bringing, or pointing out objects of interest); Lack of social or emotional reciprocity; Qualitative impairments in communication as manifested by at least one of the following: Delay in, or total lack of, the development of spoken language, not accompanied by an attempt to compensate through alternative modes of communication such as gesture or mime; In individuals with adequate speech, marked impairment in the ability to initiate or sustain a conversation with others; Stereotyped and repetitive use of language or idiosyncratic language; Lack of varied, spontaneous make-believe play or social imitative play appropriate to developmental level; Restricted repetitive and stereotyped patterns of behavior, interests, and activities, as manifested by at least one of the following: Encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal either in intensity or focus; Apparently compulsive adherence to specific, nonfunctional routines or rituals; Stereotyped and repetitive motor mannerisms (for example, hand or finger flapping or twisting, or complex whole body movements); Persistent preoccupation with parts or objects. “Autism” includes: Delays or abnormal functioning in at least one of the following areas, with onset before age 3 years: Social interaction; Language as used in social communication; or Symbolic or imaginative play; An individual's behavior that is not better accounted for by Rett's Disorder or Childhood Disintegrative Disorder; Pervasive Developmental Disorder Not Otherwise Specified (including Atypical Autism, Rett's Disorder, and Asperger's Disorder). Medical Eligibility for the Autism Waiver. To be medically eligible for the services covered under the chapter, an applicant shall be certified by the licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee to need ICF-IID level of care using the standardized process for determination of eligibility for level of care in an ICF-IID. Every 12 months, or more frequently if determined necessary by the service coordinator or multidisciplinary team due to a significant change in the participant’s condition or needs, a participant’s medical need for ICF-IID level of care shall be reevaluated by the licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee, as part of the multidisciplinary team process and using the form for determination of eligibility for level of care in an ICF-IID. The form certifying ICF-IID level of care shall be signed by the: Chairman of the multidisciplinary team, who is the official representative of the local school system or local lead agency; and Team's licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee. Technical Eligibility for the Autism Waiver. An applicant or participant shall be determined by the multidisciplinary team to meet the waiver’s technical eligibility-criteria if the individual: Is between 1 year old and the end of the school year in which the individual turns 21 years old; Is determined to be developmentally disabled and is diagnosed with autism spectrum disorder, every 3 years or more often as requested by MSDE, by a qualified diagnostician using an evaluation methodology considered sufficient by the multidisciplinary team; Uses at least one waiver service monthly, not including family consultation, unless otherwise authorized by the State Department of Education; Has an IFSP or IEP; If the child has an IEP, receives 15 hours or more per week of special education and related services and requires a more intensive therapeutic program than other students or is currently participating in an approved Home and Hospital Program pursuant to the procedures of COMAR 13A.03.05 and 13A.05.01; Is identified through the public education or early intervention service system as being potentially qualified for and needing Autism Waiver services; Can be safely maintained in the community with the assistance of Autism Waiver services; Chooses, or the parent or parents of a minor child chooses on the child’s behalf, to receive Autism Waiver services as an alternative to services in an (ICF-IID), and documents that choice on the consent form for Autism Waiver services; and Is not enrolled in: Home Care for Disabled Children under a Model Waiver, in accordance with COMAR 10.09.27; Community Based Services for Developmentally Disabled Individuals Pursuant to a 1915(c) Waiver, in accordance with COMAR 10.09.26; or Any other Medicaid waiver program under §1915(c) of Title XIX of the Social Security Act. Medical Assistance Eligibility. Categorically Needy. A recipient is eligible for Autism Waiver services if the recipient is eligible for Medicaid in the community according to the categorically needy regulations in COMAR 10.09.24 or 10.09.11. Optionally Categorically Needy. An individual is eligible for Autism Waiver services as optionally categorically needy in accordance with 42 CFR §435.217 if the individual's countable income does not exceed 300 percent of the applicable payment rate for Supplemental Security Income (SSI), and the individual's countable resources do not exceed the SSI resource standard for one. For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one. For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income regulations in COMAR 10.09.24 which are applicable to aged, blind, or disabled individuals who are institutionalized, with the exceptions specified in §C(4) of this regulation. For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource regulations set forth in COMAR 10.09.24.08 and .10 which are applicable to aged, blind, or disabled persons who are institutionalized, with the exceptions specified in §C(4) of this regulation. An individual is not eligible to receive Autism Waiver services if a disposal of assets or establishment of a trust results in a penalty under COMAR 10.09.24.08-1 or .08-2, until the penalty period expires. All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to Autism Waiver applicants and participants, with the following exceptions: COMAR 10.09.24.04J(1), (2), and (3); COMAR 10.09.24.04K; COMAR 10.09.24.06B(2)(a)(ii); COMAR 10.09.24.08G(1); COMAR 10.09.24.08H; COMAR 10.09.24.09; COMAR 10.09.24.10; and COMAR 10.09.24.10-1. Post Eligibility Determination of Available Income. The participant's or parents' income may not be applied toward the costs of the participant's: Autism Waiver services; or Room and board in a residential habilitation facility. Autism Waiver Eligibility. If an applicant is verified by the multidisciplinary team and the State Department of Education: To meet all of the criteria specified in §§A—C of this regulation, the participant’s service coordinator, the representative of the local school system or local lead agency, the representative of the State Department of Education, and the Program shall certify Autism Waiver eligibility and the Program shall establish the effective date for enrollment; or Not to meet all of the criteria specified in §§A—C of this regulation: The service coordinator, the representative of the local school system or local lead agency, and the representative of the State Department of Education shall certify the Autism Waiver eligibility determination; and The applicant, or the parent or parents of a minor child, shall be informed in writing by the Department for ineligibility, and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 10.09.24.13, and 42 CFR Part 431, Subpart E. Every 12 months, or more often if there is a significant change in the participant's condition or needs: The multidisciplinary team and the State Department of Education shall verify whether the participant remains eligible for the Autism Waiver by meeting all of the criteria specified in §§A—C of this regulation; The service coordinator, the representative of the local school system or local lead agency, and the representative of the State Department of Education shall certify the redetermination of Autism Waiver eligibility; and If the multidisciplinary team and the State Department of Education verify that the participant no longer meets all of the eligibility criteria specified in §§A—C of this regulation, the: Participant's eligibility shall be terminated, as of the effective date established by the multidisciplinary team and the State Department of Education, and Participant, or the parent or parents of a minor child, shall be informed in writing of the determination, the reason or reasons for ineligibility, and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 10.09.24.13, and 42 CFR Part 431, Subpart E. Multidisciplinary Team. A multidisciplinary team shall be convened by the local school system or local lead agency in accordance with COMAR 10.09.52 to: Assess or reassess an applicant's or participant's need and eligibility for Autism Waiver services; Review the applicant's or participant's IEP or IFSP, as necessary; and Develop or review, and revise as necessary, the applicant's or participant's Autism Waiver plan of care. The multidisciplinary team shall include: The applicant's or participant's service coordinator who shall attend at least one statewide Autism Waiver training session per year; The applicant's or participant's parent or parents; A chairman who is the official representative of the local school system or local lead agency; Other appropriate professionals representing the local school system or local lead agency, as necessary and consistent with the Individuals with Disabilities Education Act (IDEA); and Other service providers and individuals, as appropriate. Risk Assessment. Upon initial review, or if the participant's status changes, the service coordinator shall conduct a risk assessment to ensure the applicant can be safely maintained in a home and community-based setting utilizing Autism Waiver services. A risk assessment shall be conducted by the service coordinator using the Autism Waiver Risk Assessment form. A participant’s Autism Waiver plan of care or plan of care addendum: Identifies the specific Autism Waiver services to be provided to the participant, as covered under this chapter; Specifies for each identified Autism Waiver service the: Description of the specific service to be provided; Service start date; Estimated duration; Approved frequency and units of services to be delivered; and Provider; and Identifies medical conditions that require a written, signed emergency protocol. To provide Autism Waiver services, the provider: Shall be approved in accordance with the requirements specified in this chapter; Shall have a provider agreement in effect, signed with the Program; Shall meet all the conditions for participation specified in COMAR 10.09.36, except as otherwise specified in this chapter; Shall assure that professional employees who render or delegate services under this chapter have the appropriate experience and health-related license or professional certification to meet the participant's needs, including equivalency review by an accredited agency for credentials obtained outside of the United States, before rendering services to any Autism Waiver participant; Shall assure that direct care workers who render services under this chapter: Meet the minimum age requirement, set forth by service, before rendering services to any Autism Waiver participant; Receive adequate and appropriate training, within 60 days of employment and annually thereafter, pertaining to care for children with autism spectrum disorder including: Training concerning abuse, neglect, and exploitation; Positive behavioral interventions and restraints rendered by a MSDE approved trainer; Reportable event policy; and HIPAA; Work under the ongoing supervision of a qualified professional employee of the provider who has annual training in: Abuse, neglect, exploitation; Positive behavioral interventions and appropriate use of restraints rendered by a MSDE-approved trainer; Reportable event policy; and HIPAA; Are approved by the provider as qualified to meet the participant's needs; Are approved by the participant's parents; and Have volunteer or employment experience working with children with autism spectrum disorder or other developmental disabilities as a service provider or as a family member for a minimum of 100 hours, that may include: Internships; Post high school educational experience with developmental disabilities; Shadowing experienced staff; Employment with a developmental disabilities agency; or Fulfilling the community service requirement through volunteering with a child with autism or another developmental disability; Shall be required to have a professional on-call at all times, and employ or contract with certain professionals for consultation as needed when providing: Residential habilitation services; Intensive individual support services; and Therapeutic integration services; Shall employ on-call professionals and professional consultants: Who are: Board-certified behavior analysts; Certified school psychologists; Certified special educators; Individuals with a masters or doctorate degree in special education or a related field and 5 years experience in providing training or consultation in autism spectrum disorder or other developmental disabilities; Licensed certified social workers; Licensed professional counselors; Nurse psychotherapists; Physicians; Psychologists; Occupational therapists; Physical therapists; Registered nurses; or Speech therapists; and Who have: Experience providing services to children with autism spectrum disorder or other developmental disabilities; A background in behavior management techniques; and Knowledge of the specific children being served by the provider. Shall verify the licenses, credentials, and references of all individuals who render or delegate services on the provider's behalf under this chapter, and have a copy of the licenses, credentials, and at least three written references available for inspection; Shall maintain current, written, and signed contracts with all contractors providing waiver services on behalf of the provider that include: The scope of services to be performed; The requirement to comply with all applicable Medicaid regulations; The requirement to complete and maintain written documentation of service delivery, individualized for each participant on each day that the participant receives services; A clause that no monies shall be sought from the waiver participant or the participant's family if the contract is breached by either the provider or contractor; and A current copy of a provider license or certification and insurance as required in this chapter; With the exception of environmental accessibility adaptation providers, shall submit to a preemployment criminal background investigation; With the exception of respite care and environmental accessibility adaptations providers, shall submit separate, written treatment plans to service coordinators within 30 calendar days of the initiation of services in accordance with State guidelines for each individual service and at least once in each 12-month period thereafter, or more frequently if the treatment plan changes; If an agency, shall require supervisory and direct care employees of provider agencies to: Submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services, in accordance with Family Law Article, §5-561, Annotated Code of Maryland; Request the Department of Public Safety and Correctional Services to send the child care criminal history report to the Department’s Division of Community Long Term Care; and Not have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or crime involving moral turpitude or theft, or have other criminal history that indicated behavior that is potentially harmful to participants; If an agency, shall: Pay for the criminal background check; Request clearance from the Department for all applicants prior to an offer of employment; and Submit monthly Criminal Justice Information System's update reports to the Maryland State Department of Education; If self-employed, shall: Submit an application for a criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services; Request the Department of Public Safety and Correctional Services to send the child care criminal history report to the Department’s Division of Community Long Term Care; Pay for the criminal background check; Not have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or crime involving moral turpitude or theft, or have other criminal history that indicated behavior that is potentially harmful to participants; and Submit monthly Criminal Justice Information System’s update reports to the State Department of Education. Shall have the option to request the Department to waive the provisions of §§L(3) and N(4) of this regulation if the applicant demonstrates that: The conviction, probation before judgment, or plea of nolo contendere for a felony or any crime involving moral turpitude or theft was entered more than 10 years before the date of the provider’s or prospective employee’s application; and The criminal history does not indicate behavior that is potentially harmful to participants; Shall have adequate liability insurance; Shall provide services in accordance with the requirements of the Autism Waiver plan of care, this chapter, the Autism Waiver, and all relevant federal, State, and local laws and regulations; Shall agree to submit claims for payment by the Program for only those services covered under this chapter which have been identified and documented in a participant's Autism Waiver plan of care; Shall agree to maintain and have available to the Department or the State Department of Education personnel records and written documentation describing waiver services rendered, including dates and hours of services provided to participants, for a period of 6 years, in a manner approved by the Department or its designee; Shall agree not to suspend, increase, or reduce services for a participant without a waiver plan of care or plan of care addendum from the service coordinator for that participant; Unless a risk to health and safety exists, shall agree not to terminate services for a participant without providing: 30 days written notice to the participant, parent or guardian, and service coordinator; and Assistance in the discharge planning process; Is not eligible to participate in the waiver if the provider or any of its principals were previously program providers, or if its principals were principals in program providers, that have overpayments that remain due and owing to the Department; Is not eligible if the provider or its principals within the past 24 months have: Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services; Been suspended or removed from participating as a Medicaid provider; Undergone the imposition of sanctions under COMAR 10.09.36.08; Been subject to disciplinary action including actions by providers or any of its principal's licensing board; Been cited by a State agency for deficiencies which affect a participant's health and safety; or Experienced a termination of a reimbursement agreement with or been barred from work or participation by a public or private agency due to: Failure to meet contractual obligations; or Fraudulent billing practices; Shall maintain written quarterly records documenting face-to-face supervision of direct care employees and direct observation of the participant that includes: Date and location of supervision; Review, feedback, and oversight of the implementation of treatment plan goals; Review, feedback, and oversight of the implementation of positive behavior intervention; Review, feedback, and oversight of the scope of activities during service; Review, feedback, and oversight of data collection; Date and name of supervisor, name of employee, and name of the participant; and Signature of supervisor; Shall agree to keep all records available for inspection or audit by the Department or the Department's designee at any reasonable time during business hours; Shall implement and follow the Reportable Event policy in accordance with the Department's established policy by: Reporting incidents and complaints to the participant's service coordinator within 24 hours; Submitting a written report within 7 calendar days on a form designated by the Department; and Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subject to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.06.04; May not: Render direct services to the provider's own child; or Render supervision to the direct care worker of the provider's own child; With the exception of environmental accessibility adaptations providers and residential habilitation providers, shall submit to the service coordinator monthly service tracking forms for each participant served within 20 calendar days of the end of each month; With the exception of environmental accessibility adaptations providers, shall attend at least one Autism Waiver training conducted by the State each year and shall participate in: One training annually regarding the prevention, identification, and reporting of abuse, neglect, and exploitation; One training annually regarding positive behavioral intervention and restraints; and All statewide Autism Waiver trainings during any year in which the provider is under recommendation for disenrollment from the waiver or has had Medicaid payments suspended; Shall satisfactorily complete all aspects of the Autism Waiver provider applications process; Shall notify the Program within 15 days of occurrence of any change to contact information; Shall maintain communications with the program by maintaining a working telephone and answering machine, facsimile machine, and e-mail account; Shall have status as a Maryland Medicaid Autism Waiver provider, including the Medicaid provider number, terminated if no services have been provided for 24 consecutive months; Shall, when transportation is provided: Implement the provider’s transportation policy; Identify the driver in daily contact notes or a transportation log; Document the start and stop times transportation is provided for each day that a participant is transported; Maintain a copy of the current automobile liability coverage and documentation of payment for the vehicle transporting a participant; and Maintain a current copy of the valid State driver’s license and driving record for staff transporting a waiver participant; and Shall comply with all administrative policies, procedures, transmittals, and guidelines issued by the Department or its designee. To provide the services covered under Regulation .11 of this chapter, the provider agency shall: Provide services in a facility that meets the following requirements: Complies with regulations governing residential programs licensed under the: Developmental Disabilities Administration including COMAR 10.22.02 and 10.22.08; or Governor's Office for Children including COMAR 14.31.06; Has eight or fewer beds, unless approved by the State Department of Education to have up to 16 beds due to special needs of children; Has no more than two individuals in a bedroom; Provides opportunities for participants to have personal items in the participant's bedroom that reflect the participant's personal tastes; Provides for input and participation of the participant into eating times, menus, and meal preparation, as appropriate for specific health conditions and in accordance with treatment standards; Provides opportunities for participants to participate in community activities; and Is located and integrated into a residential community. Have at least 3 years of experience in providing habilitation services to children who have autism spectrum disorder or other developmental disabilities; Employ a full-time program director, to assure adequate coordination and supervision of the covered services, who has either: A valid Maryland certificate as a special education supervisor, principal, or special educator, and at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or At least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment; Provide round-the-clock staffing which: Includes at all times at least one direct care staff person on site for every three children, with more staffing as necessary based on participants' needs; and Unless the provider designates that it does not provide residential habilitation on weekends, is for 365 days a year, Have on call 24 hours a day a designated supervisor for the direct care workers, who: Has at least a bachelor's degree in a human services field plus 3 years of experience in the area of autism spectrum disorder or other developmental disabilities, or an associate degree in human services plus 5 years of experience with persons with autism or other developmental disabilities; or Meets the professional guidelines for a qualified intellectual disabilities professional or qualified developmental disabilities professional; Demonstrate the necessary staff capacity to provide intensive residential habilitation services when needed by participants; Employ or contract with certain professionals who meet provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter for consultation; Have at least one professional on call 24 hours a day, 7 days a week for crisis intervention who meets provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter; Demonstrate the capability and capacity of providing Autism Waiver residential habilitation services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: Abuse, neglect, and exploitation; Positive behavior interventions and restraints; Implementation of treatment plans; Transportation of participants; Maintenance of required documentation; Training and supervision of staff; Quality assurance; Emergency back-up plans; and HIPAA; Assure the provision of services in the least restrictive environment in the community that is appropriate to participants' needs; Provide documented evidence of integration of the residential habilitation program with other community-based services received by Autism Waiver participants; Document arrangements for the provision of medical services needed by participants, including helping them to get to medical appointments and to obtain services in an emergency; For initial approval and as a condition of occupancy of any facility used by the program, submit written documentation from responsible approval or licensing authorities verifying that the facility is in compliance with applicable health, fire safety, and zoning regulations; For continued approval, maintain written documentation of compliance with applicable health, fire safety, and zoning regulations as a condition of occupancy of any facility used by the program; Assure that the participant's needs are met for shelter, food, clothing, and furnishings; Maintain daily contact logs completed on the same day the service is provided and reflective of the individual plan’s goals and community-based activities from Regulation .11F of this chapter; and Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the residential habilitation individual plan. To provide the service covered under Regulation .15 of this chapter, the provider shall: Have at least 3 years of experience in providing habilitation services to children with autism; Employ a full-time program director, to assure adequate coordination and supervision of the covered services, who shall either: Hold a valid Maryland certificate as a special education supervisor, principal, or special educator, and have at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or Have at least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment; Employ direct care workers who meet provider qualifications in accordance with Regulation .04E of this chapter; Employ or contract with certain professionals for consultation as needed who meet provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter; Assure supervision of direct care workers by a: Licensed psychologist; Certified school psychologist; Certified special educator; Licensed certified social worker; Licensed professional counselor; Board Certified Behavioral Analyst; or Individual with a masters or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities; Have at least one professional on call at all times for crisis intervention who meets provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter; Demonstrate the capability and capacity of providing intensive individual support services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: Abuse, neglect, and exploitation; Positive behavior interventions and restraints; Implementation of treatment plans: Emergency backup plans; Transportation of participants; Maintenance of required documentation; Training and supervision of staff; Quality assurance; and HIPAA; Assure the provision of services in the least restrictive environment in the community that is appropriate to a participant's needs; Provide documented evidence of integration of the covered services with other community-based services received by Autism Waiver participants; Document arrangements to obtain medical services for participants in an emergency; Provide the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service, and at least annually thereafter, or more frequently if the treatment plan changes; Document goals related to transportation and the participant’s needs on the treatment plan when transportation will be provided; Maintain daily contact logs completed on the same day the service is provided and reflective of treatment plan goals and activities; and Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the intensive individual support services treatment plan. To provide one or more of the services covered under Regulation .14 of this chapter, the provider shall: Have at least 3 years of experience in providing habilitation services to children with autism spectrum disorder or other developmental disabilities; Employ a full-time program director to assure adequate coordination and supervision of the covered services, who shall: Hold a valid Maryland certificate as a special education supervisor, principal, or special educator, and have at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or Have at least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment; Employ direct care workers who meet provider qualifications in accordance with Regulation .04E of this chapter; Have on site at least one direct care worker for every three participants on the waiver, with more staffing as necessary based on participants’ needs; Designate an on-site supervisor for the direct care workers who is: A licensed psychologist; A certified school psychologist; A certified special educator; A licensed certified social worker; A licensed professional counselor; A board-certified behavioral analyst; A licensed or certified as a music, art, drama, dance, or recreation therapist; or An individual with a master's or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities; Employ or contract with certain professionals for consultation in accordance with Regulation .04G(1) and (2) of this chapter; Have at least one professional on call at all times for crisis intervention in accordance with Regulation .04G(1) and (2) of this chapter; Demonstrate the capability and capacity of providing therapeutic integration services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: Abuse, neglect, and exploitation; Positive behavior interventions and restraints; Implementation of treatment plans; Emergency backup plans; Transportation of participants; Maintenance of required documentation; Training and supervision of staff; Quality assurance; and HIPAA; Provide documented evidence of services in the least restrictive environment in the community that is appropriate to a participant's needs; Provide documented evidence of integration of the covered services with other community-based services received by participants; Document arrangements to obtain medical services for participants in an emergency; For initial approval and as a condition of occupancy of any facility used by the program: Submit written documentation from responsible agency or licensing authorities verifying that the facility is in compliance with applicable health, fire safety, and zoning regulations; and Allow an on-site review by the MSDE; For continued approval, maintain written documentation of compliance with applicable health, fire safety, and zoning regulations as a condition of occupancy of any facility used by the program; Provide the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service and at least annually or more frequently if the treatment plan changes; Maintain daily contact logs completed on the same day the service is provided and reflective of individual plan goals and activities; and Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the therapeutic integration treatment plan. To provide one or more of the services covered under Regulation .14-1 of this chapter, the provider shall: Meet all the conditions of Regulation .06-1 of this chapter; and Have an on-site direct care worker for every participant receiving one-to-one intervention for intensive therapeutic integration. The respite care provider shall have adequate liability insurance and be appropriately bonded. A professional who provides respite care services or supervises a direct care worker rendering the services shall be: Certified in accordance with COMAR 13A.12.01 as a psychologist or special educator; or Licensed as a psychologist, social worker, registered nurse, professional counselor, or occupational therapist; or A qualified developmental disabilities professional in accordance with COMAR 10.09.26.01B(28); Certified nationally by the Behavior Analyst Certification Board as a Board Certified Behavior Analyst; or An individual with a master's degree or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities. An agency that provides respite care services shall employ direct care workers who meet qualifications in accordance with Regulation .04E of this chapter. A respite care provider shall demonstrate the capability and capacity of providing respite care services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: Abuse, neglect, and exploitation; Positive behavior interventions and restraints; Emergency backup plans; Transportation of participants; Maintenance of required documentation; Training and supervision of staff; Quality assurance; and HIPAA. Documentation of Service. Maintain daily contact logs completed on the same day the service is provided and reflective of interventions; and Make documentation of services available for review by the State, when requested. To provide the services covered under Regulation .17 of this chapter, a consultant shall be: Certified in accordance with COMAR 13A.12.01 as a psychologist, special educator, or speech therapist; Licensed as a psychologist, certified social worker, nurse psychotherapist, speech therapist, professional counselor, marriage and family therapist, or occupational therapist; Nationally certified as a Board Certified Behavior Analyst; or An individual with a master's or doctorate degree from an accredited university in special education or a related field and have at least 5 years experience providing training or consulting in the area of autism spectrum disorder; and The provider shall have training and at least 2 years of experience, which: Is relevant to the family’s needs; Is related to behavior intervention or how to keep the child safe in the home environment; and Was involved with providing services to children with autism spectrum disorder as a service provider or as a family member. The provider shall develop a plan with goals and interventions and submit the plan to the participant’s service coordinator within 30 calendar days of initiation of service delivery, and at least annually thereafter, or more frequently if the instructional plan changes. The provider shall demonstrate the capability and capacity of providing family consultation services by submitting documentation of experience and a written implementation plan. The provider shall maintain family contact logs completed on the same day the service is provided that are reflective of the family plan, goals and activities. The provider shall maintain and make available for review by the State, documentation of the 6-month review and update the status relative to each goal in the family plan. To provide the services covered under Regulation .18 of this chapter, the provider shall: Be the store, vendor, contractor, or builder from which the adaptation is purchased; Be able to install the adaptation, if necessary; Be able to service or maintain the adaptation, as necessary; and If construction is involved: Have the appropriate State license as a contractor or builder; and Be appropriately and adequately bonded. To provide the services covered under Regulation .19 of this chapter, the provider shall: Be an individual with a bachelor’s degree; and Have 3 years of full-time experience serving adults with autism disabilities. Adult life planning service providers shall work with the participants and the participants families to develop a treatment plan incorporating the principles of self-determination, person-centered planning, decision making, and planning for adulthood. The provider shall submit the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service delivery, and at least annually thereafter, or more frequently if the plan changes. At the completion of each year of adult life planning services, the provider shall provide a report of documented evidence of progress towards self-determination, community integration, and coordination with adult services. The provider shall maintain Adult Life Planning contact logs completed on the same day the service is provided and reflective of the Adult Life Planning treatment plan goals and activities. The Program under this regulation does not cover the following: Any Medicaid State Plan services which are provided by medical professionals employed by or under contract with the residential habilitation provider; Room and board; Direct or indirect payments to the participant's immediate family; Routine care and supervision which a family is expected to provide; Activities or supervision reimbursed by a source other than Medicaid; and The facility's maintenance, upkeep, and improvement. The residential habilitation program shall: Provide community-based, intensive residential placements for participants who cannot live at home at the present time because they require highly supervised and supportive environments; Provide a home-like, safe, 24-hour, therapeutic living environment of treatment, intervention, training, supportive care, and oversight; Be designed to assist Autism Waiver participants in acquiring, retaining, and improving the self-help, socialization, and adaptive skills necessary to reside successfully in home and community-based settings; Work closely with the participant's service coordinator to provide transition services for each participant in placement to allow, as appropriate, for the: Participant's eventual return to the family (natural, adoptive, or surrogate); or Participant to acquire the skills and resources for group or independent living; and Coordinate with the participant's educational, health, and medical service providers. A participant's placement in residential habilitation services shall be: Preauthorized by the multidisciplinary team; and Reviewed by the multidisciplinary team at least annually. Residential habilitation services shall be received in facilities located in the State which are: Licensed group homes; Licensed alternative living units; or Community-based residential facilities approved by the State Department of Education for special education services. Intensity Levels. Residential habilitation services are provided and reimbursed at a regular or intensive level for a participant. To be approved by the multidisciplinary team for the intensive level of residential habilitation services, the participant must need: Awake overnight staffing; and At minimum, 4 hours of one-on-one staffing. Services. A residential habilitation program shall provide all of the services listed in §F(2)—(12) of this regulation, as necessary for the participant. Habilitation. The residential rehabilitation program shall provide training to assist a participant to acquire, retain, or improve skills in a wide variety of areas that directly affect the ability to reside as independently as possible. Behavior Shaping and Management. The residential rehabilitation program shall train, supervise, and assist the participant, which may include psychiatric or psychological interventions, in appropriate communication and expression of emotions and desires, compliance, assertiveness, acquisition of socially appropriate behaviors, and reduction of inappropriate behaviors. Daily Living Skills. The residential rehabilitation program shall train or assist the participant in dressing, personal hygiene, self-administration of medications, proper use of appliances and adaptive or assistive devices, home safety, first aid, and emergency procedures. Self-Direction. The residential rehabilitation program shall train the participant in identifying and responding to dangerous or threatening situations, making decisions and choices affecting the participant's life, and initiating changes in living arrangements or life activities. Functional Living Skills Training. The residential rehabilitation program shall train the participant in self-reliance, money management, and money handling and purchases. Socialization. The residential rehabilitation program shall train, supervise, or assist the participant to facilitate the participant's involvement in general community activities and establishment of relationships with peers, which may: Not include participation in activities which are solely diversional or recreational in nature; and Include: Assisting the participant with learning and practicing skills of cooperation and participation; Assisting the participant to identify and participate in activities of interest; and Providing specific training activities necessary to assist the participant to participate in activities of interest on an ongoing basis. Mobility. The residential rehabilitation program shall train, supervise, and assist the participant to: Enhance movement within the participant's living, working, or education environment; Master the use of adaptive aids and equipment; and Access and use public transportation, independent travel, or other movement within the community. Transportation. The residential rehabilitation program shall provide transportation for the participant to recreation, leisure activities, or skills training. Crisis Intervention and Planning. The residential rehabilitation program shall include: Planning for crises in the participant's residential habilitation placement; and Making the necessary behavioral or environmental interventions to stabilize and preserve the participant's residential habilitation placement, or resolve an intensive behavioral episode. Medication Management, Monitoring, and Training. The residential rehabilitation program shall provide, as needed and appropriate, medication management, monitoring, and training in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11. Transition Services. The residential rehabilitation program shall provide training and experiential learning activities for a participant in a residential habilitation placement, which: Assist with developing discharge planning goals for the participant; Assist the participant in making the transition to home, the next planned placement, or independent living; Are responsive to the participant's individualized developmental and behavioral needs; and Promote self-reliance and age-appropriate behavior. A supervisor who has been trained in accordance with Regulation .04E(3) of this chapter shall: Train and provide ongoing supervision to the direct care worker rendering residential habilitation services; Supervise the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervene to reduce the likelihood of reoccurrence; Plan and regularly review the participant’s therapeutic activities and behavior plan; Meet regularly with the participant and family and observe the participant in the residential habilitation setting; and Develop and identify on the individualized treatment plan, the goals, interventions, and tasks that the residential habilitation direct care worker is implementing. A unit of service for residential habilitation shall be on a per diem basis. Therapeutic integration services under this regulation: Are provided at a nonresidential setting separate from the home or facility where the participant lives; Focus on expressive therapies and therapeutic recreational activities; Include as important components the development of socialization skills, enhancement of self-esteem, and behavior management; Are especially needed for participants who have problems with socialization, isolation, hyperactivity, impulse control, and behavioral or other related disorders; Are not solely educational or recreational in nature, but have a therapeutic habilitative orientation, as evidenced in written progress notes; Shall be culturally competent and congruent with the participant's cultural norms; May include individual or group counseling; Shall assure coordination with the participant's other service providers, service coordinator, and multidisciplinary team; Shall be guided by the participant's individualized treatment plan; Shall be based on an individualized written plan that identifies goals of the specific therapeutic activities provided; Shall provide: General therapeutic and therapeutic recreational services; Behavioral management; Planning for crises with the participant during a session; Socialization groups; and One or more of art, music, dance, or activity therapies, as appropriate for participants; Shall have a supervisor who has been trained in accordance with Regulation .04E(3) of this chapter that: Trains and provides ongoing supervision to the direct care worker rendering therapeutic integration services; Supervises the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervenes to reduce the likelihood of reoccurrence; Plans and regularly reviews the participant’s therapeutic activities and behavior plan; Meets regularly with the participant and family and observes the participant in the community setting; and Develops and identifies, on the individualized treatment plan, the goals, interventions, and tasks that the therapeutic integration direct care worker is implementing; Shall, when transportation is provided: Have individualized goals for transportation for the participant on the participant’s treatment plan; and Document the start and stop times transportation is provided for each day that a participant is transported; For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the community setting. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the community setting. Intensive therapeutic integration services under this regulation: Are provided at a nonresidential setting separate from the home or facility where the participant lives; Shall have an on-site direct care worker for every participant receiving one-to-one interventions for intensive therapeutic integration; Shall include expressive therapies and therapeutic recreational activities; Shall include the development of socialization skills, enhancement of self-esteem, and behavior management; Are for participants who require one-to-one interventions and also have problems with socialization, isolation, hyperactivity, impulse control, and behavioral or other related disorders; Are not solely educational or recreational in nature, but have a therapeutic habilitative orientation, as evidenced in written progress notes; Shall be culturally competent and congruent with the participant’s cultural norms; Shall assure coordination with the participant’s other service providers, service coordinator, and multidisciplinary team; Shall be based on the participant’s individualized written treatment plan that identifies goals of the specific therapeutic activities provided; Shall provide: General therapeutic and therapeutic recreational services; Behavioral management; Planning for crises with the participant during a session; Socialization groups; and One or more of art, music, dance, or activity therapies, as appropriate for participants; Shall have a supervisor who has been trained in accordance with Regulation .04E(3) of this chapter that: Trains and provides ongoing supervision to the direct care worker rendering therapeutic integration services; Supervises the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervenes to reduce the likelihood of reoccurrence; Plans and regularly reviews the participant’s therapeutic activities and behavior plan; Meets regularly with the participant and family and observes the participant in the community setting; Develops intervention on an individualized basis and identifies the interventions on an individualized treatment plan; and Identifies, in the treatment plan, the goals and tasks that the intensive therapeutic integration direct care worker is implementing; and Shall, when transportation is provided: Have individualized goals for transportation for the participant on the participant’s treatment plan; and Document the start and stop times transportation is provided for each day that a participant is transported. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the community setting. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the community setting. Intensive individual support services: Are intensive, one-on-one interventions with the participant provided by a direct care worker; May be received by the participant on a long-term basis; Are authorized in the participant's Autism Waiver plan of care if the participant's behavior without this intervention would require a more restrictive residential or treatment setting; May be provided in the participant's home or another setting except a residential or youth camp facility; May be provided by more than one direct care worker necessitating ongoing coordination between the direct care workers; Are goal-oriented and task-oriented, with interventions developed on an individualized basis based on the participant's individualized treatment plan; Use the home and community environment as a learning experience and opportunity to illustrate and model alternative ways for the participant to behave; Assist the participant in achieving successful home and community living through structured support, reinforcement, modeling, and behavior management, as evidenced in written progress notes; Shall, when transportation is provided: Have individualized goals for transportation for the participant on the participant's plan; and Document the start and stop times transportation is provided for each day that a participant is transported; Are intended to: Prevent or defuse crises; Promote developmental and social skills growth; Provide the participant with behavior management skills; Give the participant a sense of security and safety; Assist the participant with maintaining self-sufficiency and impulse control; Improve the participant's positive self-expression and interpersonal communication; Improve the participant's ability to function and cooperate in the home and community; Reverse negative behaviors and attitudes; and Foster stabilization; and Include: One-on-one support, assistance, oversight, and intervention; Time-structuring activities; Immediate behavioral reinforcements; Time-out strategies; and Crisis intervention techniques. Direct care workers and supervisors rendering intensive individual support services shall collaborate with the participant's family, providers of other waiver services, and other professionals working with the participant in the home or other community settings, including the schools. A professional who meets the provider qualifications of Regulation .04G(1)(a)—(f) of this chapter shall: Train and provide ongoing supervision to the direct care worker rendering intensive individual support services; Supervise the direct care worker when crisis intervention services are rendered, to evaluate the nature of the crisis and intervene as necessary to reduce the likelihood of reoccurrence; Plan and regularly review the participant's therapeutic activities and behavior plans; Meet regularly with the participant and family and observe the participant in the home setting; Develop intervention on an individualized basis and identify the interventions on an individualized treatment plan; and Identify in the treatment plan goals and tasks that the intensive individual support services direct care worker is implementing. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. Respite care: Shall consist of one-on-one interventions with the participant; Shall be rendered by a qualified: Professional who meets the qualifications in Regulation .07B of this chapter; or Direct care worker who is supervised by a qualified professional; Shall include assistance with activities of daily living provided to participants who are unable to care for themselves; Shall be furnished on a short-term basis because of the absence of or need for relief of the participant's family that normally provides the care; Shall be provided in the participant's home or place of residence, or community setting, not including a residential habilitation facility; May be provided in a youth camp certified by the Maryland Department of Health under COMAR 10.16.06; and May be provided in a site licensed to accommodate individuals for respite care by the Developmental Disabilities Administration. Respite care may not: Be available for participants receiving residential habilitation services; Include the direct care worker's or the participant's room and board; or Be rendered by a participant's parent. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. Family consultation shall be provided as specified in the family consultation plan, and: Shall be based on family-oriented goals to benefit the participant; Shall be provided to one family at a time; May not include advocacy regarding a participant's IEP; and May not include training and supervision of direct care workers. A participant's family: Shall be trained by a qualified licensed or certified professional to provide intensive one-on-one interventions with the participant; May be instructed in the treatment regimens, behavior intervention and modeling, skills training, and use of equipment specified in the participant's Autism Waiver plan of care; Shall be provided with training updates as necessary to maintain the participant safely at home; and Shall be present to receive family consultation services. Services. A participant’s family shall receive in-person, individualized consultation when providing the habilitation services listed in §C(2)—(8) of this regulation, as necessary for the participant. Habilitation. The participant’s family shall receive consultation to assist the participant to acquire, retain, or improve skills in a wide variety of areas that directly affect the participant’s development and ability to reside as independently as possible, including communication skills. Self-Direction. The participant’s family shall receive consultation to assist the participant in: Identifying and responding to dangerous or threatening situations; Making decisions and choices affecting the participant's life; and Initiating changes in living arrangements or life activities, as appropriate. Behavior Shaping and Management. The participant’s family shall receive consultation to assist the participant with appropriate expression of emotions and desires, compliance, assertiveness, acquisition of socially appropriate behaviors, and the reduction of inappropriate behaviors. Daily Living Skills. The participant’s family shall receive consultation to assist the participant, as appropriate, in: Dressing; Eating; Personal hygiene; Self-administration of medications; Proper use of appliances and adaptive or assistive devices; Home safety; First aid; and Emergency procedures. Socialization. The participant’s family shall receive consultation which facilitates the participant’s involvement in family and community activities and establishing relationships with siblings and peers, which may include: Assisting the participant to identify activities of interest; Arranging for participation in those activities; and Identifying specific interventions necessary to assist the participant’s involvement in those activities on an ongoing basis. Mobility. The participant’s family shall receive consultation to assist the participant with: Enhancing movement within the participant's living arrangement; Mastering the use of adaptive aids and equipment; and Accessing and using public transportation, independent travel, or other movement within the community. Money Management. The participant’s family shall receive consultation to assist the participant with: Handling personal finances; Making purchases; and Meeting personal financial obligations. Family consultation does not include activities that are not covered under §C of this regulation. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. Environmental accessibility adaptations are those physical adaptations to the participant's home, which are reasonable and medically necessary to: Prevent the participant's institutionalization; Assure: The participant's health, welfare, and safety; and A safe, therapeutic environment; Prevent the participant's self-injurious behavior; and Enable the participant to function with greater independence in the home. Environmental accessibility adaptations include: Alarms or locks on doors, windows, or fences; Protective padding on walls or floors; Plexiglass on windows; Outside gates and fences; Brackets for appliances; Raised electrical switches and sockets; Safety screen doors; and Individual tracking devices. The environmental accessibility adaptations shall be preauthorized in the participant's plan of care and by the State Department of Education. All construction shall: Be provided in accordance with applicable State or local building codes; and Pass the required inspections. Window locks may only be used if there is no other way to prevent a participant's rapid movement into a potentially dangerous situation. With the added safety precautions, it shall be assured that the house has enough exits, so there are not fire or safety concerns. Several rooms may be secured, but not the whole house. As appropriate, the adaptations shall be approved by the fire department or fire marshal as meeting the fire safety requirements. This service is not covered for facilities where residential habilitation services are delivered. Excluded are those adaptations or improvements to the home, such as carpeting, roof repair, and central air conditioning, which: Are of general utility; Are not of direct medical or remedial benefit to the participant; or Add to the home's total square footage. Adult life planning services shall be provided as specified in the adult life planning treatment plan. Adult life planning services shall: Result in the participant's transition from Autism Waiver services to comparable, necessary adult life services; Be based on the participant's need for services and support after disenrollment from the Autism Waiver; and Be provided only to participants age 14 years old or older. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. The Department shall reimburse for services under this chapter when the services are: Provided to a participant who meets the qualifications for eligibility specified in Regulation .02 of this chapter; Preauthorized in the participant's plan of care by the State Department of Education and the multidisciplinary team, as being reasonable and medically necessary to prevent institutionalization; Provided by an approved provider which meets the conditions for participation of this chapter; and Rendered pursuant to: The relevant definition of covered services in this chapter; All other requirements specified in this chapter; and The Autism Waiver proposal and any amendments to it approved by the Secretary of the U.S. Department of Health and Human Services. Reimbursement may be made by the Program only when all of the requirements of this chapter are met. Residential habilitation services may not be reimbursed for the same date of service as intensive individual support services, therapeutic integration services, intensive therapeutic integration services, or respite care. Therapeutic integration services, intensive therapeutic integration services, and intensive individual support services under this chapter and school health-related services under COMAR 10.09.50 may not be reimbursed for the same period of the same day. Therapeutic integration and intensive therapeutic integration services may not be rendered during the same week to a participant. Therapeutic integration and intensive therapeutic integration services may include transportation time when at least 2 units of service have been provided on-site, and the maximum units of service billed may not exceed 12 units. For dates of service before July 1, 2023, 24 units; or For dates of service on or after July 1, 2023, 12 units. Environmental accessibility adaptations may be reimbursed only if preauthorized by the State Department of Education. If an environmental accessibility adaptation is anticipated to cost over $500, at least two bids or prices shall be obtained, based on which the State Department of Education may approve the purchase. The Program may reimburse for a participant not more than: For dates of service before July 1, 2023: 1 unit per date of service for residential habilitation services at either the regular or intensive level; 40 units of therapeutic integration services per week; 30 units of intensive therapeutic integration services per week; 12 units or fewer than 2 units of therapeutic integration or intensive therapeutic integration services for a date of service; 50 units of intensive individual support services per week; 48 units of respite care for a date of service; 672 units of respite care per State fiscal year; 12 units of family consultation for a date of service; 80 units of family consultation per State fiscal year; A total of $2,000 for environmental accessibility adaptations over a 36-month period; 16 units of intensive individual support services per day; 30 units of adult life planning services per State fiscal year, for participants 16 years old or older; A lifetime maximum of 90 units of adult life planning services per participant, for participants 16 years old or older; and 15 units of retainer payment per calendar year at either the regular or intensive level when the participant is absent from the residential habilitation program for the purposes of family visitation, hospitalization, or other overnight stays; or For dates of service on or after July 1, 2023: 1 unit per date of service for residential habilitation services at either the regular or the intensive level; 80 units of therapeutic integration services per week; 60 units of intensive therapeutic integration services per week; 24 units or fewer than 2 units of therapeutic integration or intensive therapeutic integration services for a date of service; 160 units of intensive individual support services per week; 96 units of respite care for a date of service; 1344 units of respite care per State fiscal year; 24 units of family consultation for a date of service; 160 units of family consultation per State fiscal year; A total of $2,104 for environmental accessibility adaptations over a 36-month period; 32 units of intensive individual support services per day; 80 units of adult life planning services per State fiscal year, for participants 14 years old or older; 16 units of adult life planning services per date of service, for participants 14 years old or older; and 15 units of retainer payment per calendar year at either the regular or intensive level when the participant is absent from the residential habilitation program for the purposes of family visitation, hospitalization, or other overnight stays. Respite services may not be reimbursed for the same period of the same day as: Residential habilitation; Intensive individual support services; Family consultation; Therapeutic integration; Intensive therapeutic integration; or Adult life planning services. The Program does not reimburse transportation costs such as gas, maintenance, or other vehicle operating expenses. Adult life planning services under this chapter and school health-related services under COMAR 10.09.50 may not be reimbursed for the same period of the day. The Program does not reimburse for any autism waiver services for a participant whose residential placement in a 24-hour, 365-day residential program is funded with non-Medicaid federal, State, or local government funds. Request for Payment. An approved provider shall submit requests for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36.04 or otherwise established by the Program. The provider shall: Bill the Program in accordance with the payment methodology specified in §§D and E of this regulation; Accept payment from the Program as payment in full for the services covered under this chapter and make no additional charge to the participant or any other party for these services; and Submit a request for payment in a manner approved by the Program, which includes the: Date or dates of service; Participant's name and Medicaid number; Provider's name, location, and Program identification number; Type, procedure code or codes, and unit or units of covered services provided; and Amount of reimbursement requested. Documentation Required. Payments by the Program or its designee may be withheld if the provider fails to submit requested evidence of services provided, staff qualifications, corrective action plans, or other types of documentation related to ensuring the health and safety of a participant. Payments shall be released upon receipt and approval by the Program or its designee of the requested documentation. An appeal by the provider under COMAR 10.01.03 does not stay the withholding of payments. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Payments. Payments shall be made only to a qualified provider for services covered under this chapter which are rendered to a participant. Providers shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate established according to the fee schedule published by the Department. Rates. The Department shall publish a fee schedule for services covered under this chapter that shall be publicly available and updated at least annually or upon any changes made by the Department. Subject to the limitations of the State budget, the Program’s rates as specified in this regulation shall increase by 4 percent each year through Fiscal Year 2026. Effective July 1, 2022, the Program shall pay according to the following fee-for-service schedule: Residential habilitation services and retainer payments reimbursed at one of the following all-inclusive, maximum rates for a participant: $283.69 per unit for the regular level of service; or $567.45 per unit for the intensive level of service. Therapeutic integration services reimbursed at the maximum rate of $17.19 per unit. Intensive therapeutic integration services reimbursed at the maximum rate of $21.49 per unit. Intensive individual support services reimbursed at the maximum rate of $21.49 per unit. Respite care reimbursed at the maximum rate of $16.80 per unit. Family consultation reimbursed at the maximum rates of $70.55 per unit. Adult life planning services reimbursed at the maximum rate of $70.55 per unit. Environmental accessibility adaptations reimbursed at the maximum rate of $2,104 per 36-month period amount billed by the provider, which shall be the lesser of the: Amount authorized by the State Department of Education; or Actual cost of the job. Effective July 1, 2023, the Program shall pay according to the following fee-for-service schedule: Residential habilitation services and retainer payments reimbursed at one of the following all-inclusive, maximum rates for a participant: $283.69 per unit for the regular level of service; or $567.45 per unit for the intensive level of service. Therapeutic integration services reimbursed at the maximum rate of $8.5950 per unit. Intensive therapeutic integration services reimbursed at the maximum rate of $10.7450 per unit. Intensive individual support services reimbursed at the maximum rate of $10.7450 per unit. Respite care reimbursed at the maximum rate of $8.4000 per unit. Family consultation reimbursed at the maximum rate of $35.2750 per unit. Adult life planning services reimbursed at the maximum rate of $35.2750 per unit. Environmental accessibility adaptions reimbursed at the maximum rate of $2,104 per 36-month period amount billed by the provider, which shall be the lesser of the: Amount authorized by the State Department of Education; or Actual cost of the job. Recovery and reimbursement are set forth in COMAR 10.09.36.07 and include, but are not limited to: Providing waiver services without a valid required license or appropriate credentials as required; Employing staff or consultants that do not meet conditions for participation in accordance with Regulation .04 of this chapter to provide services to waiver participants; Lacking adequate documentation of services that were billed to the Program; Submitting claims for services not authorized in the participant's plan of care; and Providing services that are not in accordance with the requirements of this chapter and other applicable regulations and law. Cause for suspension or removal and imposition of sanctions is set forth in COMAR 10.09.36.08. In addition to the sanctions specified at COMAR 10.09.36.08, the Department may limit: The number of participants served by the provider; and The number and type of services provided. Appeal procedures for providers are those set forth in COMAR 10.09.36.09. Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-130, Annotated Code of Maryland Effective date: July 1, 2001 (28:12 Md. R. 1108) Regulation .01C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Regulation .02A, B amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .02B amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Regulation .04 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .04D amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Regulation .05A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .06 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .07C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Regulation .07C amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .08A amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Regulation .08A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .10F, G, H amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .11C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Regulation .12 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .13 repealed as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); repealed permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .14 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .15A, C amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .16A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .21E amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Regulation .21F amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) Regulation .22C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) Chapter revised effective August 13, 2007 (34:16 Md. R. 1432) Regulation .22D amended effective February 8, 2010 (37:3 Md. R. 176) Chapter revised effective April 19, 2010 (37:8 Md. R. 615) Regulation .01B amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449); May 18, 2020 (47:10 Md. R. 516) Regulation .02 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .02A amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .02A, B amended effective April 16, 2012 (39:7 Md. R. 492); May 18, 2020 (47:10 Md. R. 516) Regulation .03B amended effective May 18, 2020 (47:10 Md. R. 516) Regulation .04 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449); September 16, 2024 (51:18 Md. R.809) Regulation .05 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .05E amended effective October 14, 2013 (40:20 Md. R. 1652) Regulation .05Q amended effective April 16, 2012 (39:7 Md. R. 492) Regulation .06 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .06E, M amended effective April 16, 2012 (39:7 Md. R. 492) Regulation .06-1 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .06-1P amended effective April 16, 2012 (39:7 Md. R. 492) Regulation .06-2 adopted effective April 11, 2016 (43:7 Md. R. 449) Regulation .07 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449) Regulation .08 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449) Regulation .10A amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .11E amended effective April 11, 2016 (43:7 Md. R. 449); May 18, 2020 (47:10 Md. R. 516) Regulation .11G, H adopted effective April 11, 2016 (43:7 Md. R. 449) Regulation .14 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .14B amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .14C amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .14G amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .14-1 adopted effective April 11, 2016 (43:7 Md. R. 449) Regulation .14-1B amended effective September 16, 2024 (51:18 Md. R.809) Regulation .14-1C adopted effective September 16, 2024 (51:18 Md. R. 809) Regulation .15 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .15D amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .15E adopted effective September 16, 2024 (51:18 Md. R. 809) Regulation .16C adopted effective April 11, 2016 (43:7 Md. R. 449) Regulation .16C amended effective September 16, 2024 (51:18 Md. R.809) Regulation .16D adopted effective September 16, 2024 (51:18 Md. R. 809) Regulation .17 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .17E amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .17F adopted effective September 16, 2024 (51:18 Md. R. 809) Regulation .19 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .19B, C amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .19D adopted effective September 16, 2024 (51:18 Md. R. 809) Regulation .21 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .21E, H amended effective May 18, 2020 (47:10 Md. R. 516); September 16, 2024 (51:18 Md. R. 809) Regulation .21J adopted effective April 16, 2012 (39:7 Md. R. 492) Regulation .22A, E amended effective November 27, 2023 (50:23 Md. R. 1004) Regulation .22D amended effective October 31, 2011 (38:22 Md. R. 1346); April 11, 2016 (43:7 Md. R. 449) Regulation .22D, E amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .22E amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .24 amended effective April 16, 2012 (39:7 Md. R. 492) In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicant” means an entity which submits an application to become a partially capitated provider. “Capitation payment” means the sum of money paid by the Program on behalf of an enrollee on a regular periodic per capita basis for capitated services. “Capitated services” means a service provided by a PCP or one of its subcontractors for which the Department has agreed to pay a capitation payment to the PCP. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Enrollee” means a recipient who has entered into an agreement to receive certain Medical Assistance services from or through a PCP. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Partially capitated provider (PCP)” means a public or private legal entity which is organized for the purpose of providing or arranging for the provision of medical and health-related services which meets the conditions for participation in Regulations .02 and .03 of this chapter for enrollment and which is eligible to enter into a contract with the Department to receive a capitated payment for a limited number of services. “Program” means the Maryland Medical Assistance Program as defined in COMAR 10.09.36.01. “Provider” means a partially capitated provider. “Provider agreement” means the agreement between the Department and the partially capitated provider which specifies the terms of the relationship between the Department and the provider, and includes the amount of the capitation payment and the specific services to be provided for the capitation payment. “Recipient” has the meaning stated in COMAR 10.09.36.01. An applicant shall demonstrate to the satisfaction of the Department that it has the managerial, financial, clinical, and administrative capability to carry out the duties required by these regulations. An applicant shall submit the following documents to the Department along with a completed application form: A narrative of the applicant's overall plan for providing and arranging for the provision of high quality services to enrollees efficiently, effectively, and economically; A description of the organization and staff responsible for delivering health care and a copy of the applicant's organizational documents; An annualized pro forma budget and financial plan for the operation of the organization or, at the Department's option, of the appropriate unit within the organization responsible for the operation for delivery of services pursuant to this regulation for the first 3 years of its anticipated operations which demonstrates its financial viability based on reasonable assumptions; An annualized cash flow chart; A statement of policy and procedures for accounting, methods of reimbursing subcontractors, and payment of emergency and out-of-area claims; Balance sheets; Any other financial information the Program requires; Full and complete information at all times as to the identity of each person or corporation with an ownership or control interest in the PCP and of any subcontractor in which the applicant has a 5 percent or more ownership interest; A detailed description of the applicant's quality assurance plan which demonstrates compliance with Regulation .07 of this chapter; A description of a system for the receipt and prompt adjudication of complaints and grievances by enrollees which complies with Regulation .12 of this chapter; A description of the process by which data about services provided will be collected; Copies of all of the applicant's contracts with subcontractors; A description of the boundaries of the geographic area or area the applicant wishes to serve; and A copy of the applicant's marketing plan. If the applicant will be at risk for services it will not directly provide, the applicant shall identify and document a source of funds which will comprise the reserve account required by Regulation .10 of this chapter. A PCP shall meet the general conditions for participation as set forth in COMAR 10.09.36.03. In addition, the PCP shall: Ensure that all of its employees, subcontractors, and employees of its subcontractors are appropriately licensed in the jurisdiction in which they are practicing; Enter into and maintain contractual arrangements necessary to meet the medical and health needs of enrollees for which it is receiving a capitation payment, except for emergency treatment and out-of-area referrals; Accept all Medical Assistance recipients who qualify for the PCP's services who select the PCP and who reside in the PCP's designated geographic area; Allow each enrollee to choose his or her health professionals within the PCP to the extent possible and appropriate; Comply with the requirements of Regulations .05 — .12 of this chapter; Monitor the quality of the services its subcontractors render to its enrollees; Be accessible 24 hours a day to enrollees unless the Program waives this requirement in the provider agreement; Agree to provide services to enrollees as promptly as appropriate; Have a marketing plan which has been approved by the Department and conduct marketing activities in accordance with that plan; and Meet all other applicable requirements of federal and State law. In accordance with 42 CFR §434.26(b)(4), an applicant who does not come within one of the exceptions specified in 24 CFR §434.26(b) shall request from the Department a waiver of 42 CFR §434.26(a), which provides that Medicaid recipients and Medicare beneficiaries may constitute not more than 75 percent of the enrollees of a health maintenance organization or prepaid capitation plan. The Department shall pursue a waiver for good cause. Providers may be capitated for one of the following packages of services subject to the approval of the Department: Inpatient hospital services, as long as the applicant, if regulated by the Health Services Cost Review Commission, has received permission from that agency to receive capitation payments; Mental health services, including but not limited to, psychiatric inpatient treatment and community mental health outpatient services; Not more than two of the following services or groups of services: Outpatient hospital services, Physician services, Laboratory and X-ray services, Nursing facility services, EPSDT, and family planning services, and Home health services; Any service covered by the Program other than a service specified in §A or C of this regulation; Inpatient hospital services as listed in §A of this regulation, plus one or more of the services included in §D of this regulation; or Not more than two of the services listed in §C of this regulation, plus one or more of the services included in §D of this regulation. The Department shall determine the boundaries of the geographic area that a PCP may serve. The Department shall limit enrollment in a PCP to recipients who live in that area. The PCP is responsible for the enrollment of recipients who have chosen to enroll in the PCP. The PCP shall enter into an enrollment contract with a recipient on the form approved by the Department. The PCP shall enroll eligible recipients in the order in which the eligible recipients apply and may not discriminate on the basis of health status in its enrollment, re-enrollment, or disenrollment procedures. Termination of enrollment may be initiated by the enrollee, the enrollee's parent, guardian, or legal representative, by the PCP, or by the Department. The Department shall approve all terminations of enrollment. The PCP shall specify in its provider agreement the methods by which the PCP will assure the Department that its marketing plans, procedures, and materials are accurate and do not mislead, confuse, or defraud the Department or recipients. The Department shall preapprove all marketing plans, procedures, and materials. A PCP shall maintain an internal quality assurance system based on written policies, standards, and procedures that is in accordance with accepted medical practices and professional standards and that includes, at a minimum, the following: A comprehensive quality assurance plan which: Addresses both the quality of clinical care and nonclinical aspects of service such as accessibility, coordination, and continuity of care, Provides for review by physicians and other health professionals of the process followed in the provision of health services, Provides feedback to health professionals and PCP staff regarding performance and patient results, Objectively and systematically monitors and evaluates the quality and appropriateness of care to enrollees through quality of care studies and related activities, and Provides for continuous performance of the activities, including tracking of issues over time; A comprehensive utilization management program monitored by the PCP's governing body; and A credentialing process for determining whether physicians and other health professionals who are under contract to the PCP are licensed and qualified to perform their services. The PCP shall have an effective procedure for reporting to the Department the following information: The cost of operations; Patterns of utilization; The health status of enrollees; Information demonstrating that the PCP has a fiscally sound operation; and Complaints and grievances made by enrollees. The PCP shall collect and submit to the Department service specific encounter data by service type in the format and at the frequency designated by the Department. The PCP shall maintain adequate records to document that the services were delivered. The PCP shall prepare and submit to the Department quarterly financial and quality assurance reports as specified by the Department. Subject to the requirements of 42 CFR 431F (1994), the PCP and its subcontractors may not release or disclose any information concerning an enrollee except with the written permission of the: Department; Enrollee; or Enrollee's attorney, legal representative, or guardian. The PCP shall include in its provider agreement a clause that the PCP will hold harmless both the Department and its enrollees from any liability for payment for the legal obligations of the PCP. The PCP shall give the Department access to the PCP's financial records at reasonable intervals in order to monitor the PCP's financial solvency. The PCP shall file annual audited financial statements with the Department. A PCP in operation for less than 1 year shall file an interim statement. The provider agreement shall provide for the continuation of benefits to all enrollees for the duration of the contract period for which payment has been made. The PCP shall have a financially sound operation as demonstrated by: A positive net worth; and Sufficient cash and adequate liquidity, as determined by the Department, to meet the PCP's obligations as they become due. The PCP shall provide full and complete information as to the identity of each person or corporation with an ownership or control interest in the PCP and of any subcontractor in which the PCP has a 5 percent or more ownership interest. PCPs that are at risk for services that the PCPs do not directly provide shall deposit an amount equal to the portion of 2 months' capitation payments relating to the services in a reserve account in trust. The agreement establishing the reserve account, which is subject to the Department's approval, may provide that the Department is the sole beneficiary of the trust, and that the trust funds may be disbursed only at the request of the Department to prevent or postpone the PCP's insolvency. Minimum Insurance Coverage. The PCP shall provide written evidence to the Department on an annual basis that it has sufficient insurance issued by an insurer authorized by the Maryland Insurance Administrator to engage in the insurance business to protect its financial viability and its ability to carry out its contractual obligations. The coverage shall include at a minimum: Malpractice coverage for all professional and related employees of the provider as well as for the organization itself; Bonding of all employees and officers who have any responsibility for the accounting and financial management activities of the provider; and Workers' compensation, fire, theft, casualty, and other coverage as required by State and local laws. PCPs which are governmental units or are funded by the Behavioral Health Administration or the Developmental Disabilities Administration of the Department and subject to the oversight of one of these agencies are exempt from the requirements of this regulation. The PCP shall ensure that the following provisions are contained in all subcontracts: A description of the services to be provided by the subcontractor; A description of other activities to be performed by the subcontractor; Providing for release to the PCP of any information necessary for the PCP to perform any of its obligations under its contract with the Department, including but not limited to compliance with the reporting and quality assurance requirements of this chapter; That the facilities and records of the subcontractor shall be open to inspection by the PCP and the Department and that medical records or copies of medical records will be transferred to the PCP upon request upon termination of the subcontractor; That a termination of the subcontract may not be effective without 30 days prior written notice to the Department; That the subcontractor shall look solely to the PCP for compensation for services provided to recipients; The subcontractor shall cooperate with the PCP in implementing the PCP's quality assurance program; and Such other provisions as the Department may reasonably require, taking into consideration the nature of the services to be provided and the requirements of this contract. The Department shall preapprove subcontracts. A subcontract may not alter or negate the PCP's legal responsibility to the Department under the PCP's provider agreement and this chapter. The PCP shall have an internal grievance procedure which has been preapproved by the Department. The PCP shall provide a copy of its internal grievance procedures to all enrollees. The internal grievance procedure may: Provide for the prompt resolution of any complaints of enrollees or their representatives; Assure the participation of individuals with the authority to require corrective action; and Require that a written record be made of all grievances and complaints by enrollees, and the responses taken by the PCP. The PCP shall submit monthly reports to the Department that summarize any grievances and complaints, the actions taken by the PCP in response to the complaints and grievances, and the PCP's plans to address the problems raised in the complaints and grievances. The Department shall pay a PCP a per capita capitation payment for capitated services. The Department shall calculate the capitation payment as a percentage of the cost to the Program of providing the same services on a fee-for-service basis to an actuarially equivalent non-enrolled group. Recovery and reimbursement under this chapter are as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions under this chapter are as set forth in COMAR 10.09.36.08. Appeal procedures under this chapter are as set forth in COMAR 10.09.36.09. Interpretation of this regulation is subject to COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date Regulations .01 — .17 adopted as an emergency provision effective June 14, 1995 (22:14 Md. R. 1051); adopted permanently effective October 23, 1995 (22:21 Md. R. 1616) Regulation .10I amended effective March 30, 2026 (53:6 Md. R. 291) This chapter governs the coverage of services for the Medical Assistance Family Planning Program. Eligibility shall be established according to COMAR 10.09.37. In this chapter, the following terms have the meanings indicated. Terms Defined. “Advanced practice nurse” means an individual who meets the requirements in COMAR 10.09.01. “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. “Early and Periodic Screening, Diagnostic and Treatment (EPSDT)” means the provision to individuals younger than 21 years old, of preventative health care under 42CFR §441.50 et seq. as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services. “Family planning” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health. “Free-standing clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home, and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. “Hospital” means an institution that is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the service is provided. “Local health department (LHD)” means the Baltimore City Health Department and its subgrantees, or a county health department and its subgrantees. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Participant” means an individual who is certified as eligible for the Family Planning Program as described in COMAR 10.09.37. “Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland, or similar establishment or institution which is legally authorized to dispense legend drugs to the public in the state in which the establishment or institution is located. “Physician” means an individual licensed to practice medicine in the state in which the physician's practice is located. “Physician assistant” means an individual who meets the requirements in COMAR 10.09.55. “Physician office and other point-of-care laboratory” means a medical laboratory at a site or facility operated as a part of, or in association with, the medical practice of licensed medical practitioners permitted to perform clinical laboratory procedures, community health center, emergency treatment center, health maintenance organization, or county or local health department, where clinical laboratory procedures are performed for patients seen by the practitioner or a practitioner employed or otherwise engaged by one of these entities. “Program” means the Maryland Medical Assistance, Family Planning Program. “Provider” means a health care provider who: Meets the licensure requirements set forth in Regulation .03 of this chapter; Meets the conditions for participation set forth in Regulation .04 of this chapter; and Provides the services described in Regulation .05 of this chapter. An advanced practice nurse shall be licensed to practice as described in COMAR 10.09.01. A doctor of medicine or osteopath shall be licensed and legally authorized to practice medicine in the state in which the service is delivered as described in COMAR 10.09.02. A physician assistant must be licensed to practice as described in COMAR 10.09.55. Medical laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located: In Maryland or out-of-State with representation or specimen pick-up in Maryland, comply with the requirements of Health-General Article, §§17-202, 17-212, and 17-214.1, Annotated Code of Maryland, and COMAR 10.10.01; or Out-of-State without representation or specimen pick-up in Maryland, comply with other applicable standards established by the state and locality in which the services are provided. A pharmacy may not qualify as a provider without first having obtained a permit from the: Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or Appropriate agency in the state in which the pharmacy is located. Physician office and other point-of-care laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located: In Maryland, comply with the requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or Out-of-State, comply with other applicable standards established by the state and locality in which the services are provided. Providers shall be enrolled as Medical Assistance Program providers and shall meet the requirements for participation in the Maryland Medical Assistance Program as set forth in COMAR 10.09.36.03, as well as the requirements for participation as set forth in the COMAR chapter defining the provider and covered service being rendered. Services covered in Regulation .05A—C of this chapter shall be provided by: A physician; An advance practice nurse; or A physician assistant. Providers shall accommodate the cultural and ethnic diversity of the populations to be served. The following services are covered under this chapter: Office medical visits for the primary purpose of providing age and sex appropriate family planning services, which include: Focused history, physical exam, and laboratory testing necessary to evaluate and manage the participant’s choice of chemical, mechanical, or other method to prevent conception; Basic education regarding human sexuality and reproduction; Advice and counseling regarding all family planning methods, including natural family planning measures and sterilization procedures, the availability and effectiveness of methods, procedures involved in each, and untoward effects and potential complications of each method; and Referral mechanism and documented referral for all patients demonstrating illness, disease, or pregnancy; Specimen collection by venipuncture or capillary puncture when performed by either the medical practitioner or the laboratory; Pregnancy test if indicated by physical examination or history, or both, when performed by either the medical practitioner or the laboratory; The following laboratory tests: Hemoglobin or hematocrit, or both; Urinalysis for albumin sugar; Urine culture and sensitivity studies; Appropriate laboratory tests to screen for sexually transmitted infections; Smear wet mount and KOH with interpretation; Rubella titer of females without documentation of prior rubella immunization; and Pap smear; Pharmaceutical supplies and devices: To prevent conception through chemical, mechanical, or other methods, which are covered by the Maryland Medical Assistance Program under COMAR 10.09.03.04; and To treat sexually transmitted infections when diagnosed during the course of an office visit, as outlined in §A of this regulation, which are covered under COMAR 10.09.03.04 except treatment for: Human immunodeficiency virus; and Hepatitis. Permanent sterilization only when performed according to criteria in 42 CFR Part 441, Subpart F, Sterilizations, as amended, and when the appropriate forms are: Properly completed; and Available in the medical record for review; Human papillomavirus vaccine; and Abortions performed in accordance with Health-General Article, §15-103, Annotated Code of Maryland. The following services are not covered: Services not medically necessary; Transportation services; EPSDT services; Services delivered in an in-patient hospital setting or ambulatory surgical center other than: Permanent sterilizations; and A hysterosalpingogram following the Essure procedure; Infertility services, including reversal of sterilization; and Any service not listed in Regulation .05 of this chapter. Limitations for advanced practice nurse services covered under this chapter are those set forth in COMAR 10.09.01.05. Limitations for physician services covered under this chapter are those set forth in COMAR 10.09.02.05. Limitations for free-standing clinic services covered under this chapter are those set forth in COMAR 10.09.08.07. Limitations for pharmacy services covered under this chapter are those set forth in COMAR 10.09.03.05. Limitations for medical laboratory services covered under this chapter are those set forth in COMAR 10.09.09.05. Limitations for acute hospital services covered under this chapter are those set forth in COMAR 10.09.92.05. Limitations for physician assistant services covered under this chapter are those set forth in COMAR 10.09.55.05. Limitations for ambulatory surgery centers covered under this chapter are those set forth in COMAR 10.09.42.05. Payment procedures are those set forth in COMAR 10.09.36.04. Billing time limitations are those set forth in COMAR 10.09.36.06. Payment procedures for advanced practice nurses are those set forth in COMAR 10.09.01.06. Payment procedures for physician services in the office or home are those set forth in COMAR 10.09.02.07. Payment procedures for clinic services delivered in federally qualified health centers are those set forth in COMAR 10.09.08.05. Payment procedures for clinic services delivered in local health departments, family planning clinics, and other free-standing clinics are those set forth in COMAR 10.09.02.07. Payment procedures for pharmacy services are those set forth in COMAR 10.09.03.07. Payment procedures for medical laboratory services are those set forth in COMAR 10.09.09.07. Payment procedures for acute hospital services are those set forth in COMAR 10.09.92.07. Payment procedures for physician assistant services are those set forth in COMAR 10.09.55.06. Payment procedures for ambulatory surgery centers are those set forth in COMAR 10.09.42.06. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. The requirements related to appeal procedures under COMAR 10.09.36 and 10.09.37 apply to this chapter. The requirements relating to fraud and abuse under COMAR 10.09.24.14 shall apply to this chapter. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.12 adopted as an emergency provision effective October 19, 1994 (21:23 Md. R. 1930); adopted permanently effective April 10, 1995 (22:7 Md. R. 536) Regulation .01B, C amended as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); amended permanently effective October 13, 2003 (30:20 Md. R. 1448) Regulation .01B, C amended effective January 12, 2009 (36:1 Md. R. 21) Regulation .01 repealed and new Regulation .01 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .01B amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .02B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .02B amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .02B amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .04D adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .05A, D, E amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .05F amended effective January 12, 2009 (36:1 Md. R. 21); March 31, 2025 (52:6 Md. R. 267) Regulation .05F amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .05G amended effective March 31, 2025 (52:6 Md. R. 267) Regulation .05H adopted effective March 31, 2025 (52:6 Md. R. 267) Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507); March 31, 2025 (52:6 Md. R. 267) Regulation .06A amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .07 amended effective June 11, 2012 (39:11 Md. R. 686); December 31, 2018 (45:26 Md. R. 1243) Regulation .10 repealed and new Regulation .10 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686) In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrative services organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System. “Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department. “Definitive drug test” means a drug screening test that includes: The ability to identify individual drugs and distinguish between structural isomers, but not necessarily stereoisomers, using gas chromatography or mass spectrometry and liquid chromatography or mass spectrometry; Qualitative or quantitative results; All source types for specimen selection; and Specimen validity testing, per day, 1—22 or more drug classes including metabolites, if performed. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. “Hospital” means an institution which: Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and Is licensed under COMAR 10.07.01 or is licensed by the state in which the service is provided. “Individualized education program (IEP)” has the meaning stated in COMAR 10.09.50.01. “Individualized Family Service Plan (IFSP)” has the meaning stated in COMAR 10.09.50.01. “Local school system (LSS)” means a local public school district. “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Participant” means an individual who is certified as eligible for, and is receiving, medical assistance benefits. “Presumptive drug test” means a drug screening test that includes: Any number of drug classes; Any number of devices; The use of direct optical observation, instrument assisted direct optical observation or instrumented chemistry analyzers; and Sample validation. “Program” has the meaning stated in COMAR 10.09.36.01. “Provider” means an organization or an individual practitioner furnishing the services covered under this chapter which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number. “Public Behavioral Health System” means the system that provides medically necessary behavioral health services, including mental health and substance use disorder services, for Medical Assistance participants and certain other uninsured individuals. “Specialty mental health services” means services for which a participant’s diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter. To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02. To participate in the Program, a provider shall: Meet the conditions for provider participation in the Medical Assistance Program as set forth in COMAR 10.09.36.03; Meet the conditions for licensure and practice as set forth in COMAR 10.63.01, 10.63.02, and 10.63.06; Have clearly defined and written patient care policies; and Maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, meets the following requirements: Includes the date of service with service start and end times; Includes the participant’s primary behavioral health complaint or reason for the visit; Includes a brief description of the service provided, including progress notes; Includes an official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate title; Is made available to the following as requested: The Department; The ASO; The Core Service Agency; The Office of Inspector General; and The Office of the Attorney General Medicaid Fraud Control Unit; and Is consistent with the medical records confidentiality and disclosure requirements of: Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and Relevant federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164. Individual Practitioner Providers. To participate in the Program as an individual practitioner of specialty mental health services, the provider shall: Be licensed and legally authorized to practice independently by the appropriate Board to practice in the state in which the service is rendered; and Demonstrate, by training and experience, the competency to provide mental health services as one of the following: A licensed certified social worker-clinical; A nurse psychotherapist (APRN-PMH); A pediatric nurse practitioner with a PMHS; A nurse practitioner-psychiatric (CRNP-PMH); A physician who demonstrates the competency to provide specialty mental health services; A licensed certified counselor which includes: A licensed clinical professional counselor; A licensed clinical marriage and family therapist; A licensed clinical counselor-alcohol and drug; or A licensed clinical professional art therapist; A psychiatrist certified by the American Board of Psychiatry and Neurology or possessing the minimum educational and training requirements to take the Board of Psychiatry and Neurology examination for certification in psychiatry; or A psychologist. Community Mental Health Program Providers. To participate in the Program as a community-based mental health program provider, the provider shall be approved under COMAR 10.63.01, 10.63.02, and 10.63.06 and possess licensure by the Behavioral Health Administration as: A psychiatric rehabilitation program serving adults in compliance with COMAR 10.63.03.09; A psychiatric rehabilitation program serving minors in compliance with COMAR 10.63.03.10; A mobile treatment program, which shall: Comply with COMAR 10.63.03.04; Consist of a multidisciplinary team including, at a minimum: A program director that is a mental health professional; A psychiatrist or psychiatric nurse practitioner (CRNP-PMH); A licensed registered nurse; At least one licensed social worker or licensed graduate social worker; and; At least one mental health professional who may include the staff identified in §B(3)(b)(iii) and (iv) of this regulation; and Maintain sufficient staffing to fulfill the following service requirements including: Initial and continuing psychiatric evaluation, diagnosis, and individual treatment planning; Medication services; Independent living skills assessment and training; Health promotion and training; Interactive therapies; Crisis intervention services; and Support, linkage, and advocacy; or An outpatient mental health clinic in compliance with: COMAR 10.63.03.05; and Staffing requirements as described in COMAR 10.63.03.05 and including: A program director who is a licensed mental health professional or has a master’s degree in a related field and is employed by the OMHC and is on-site at the organization for at least 20 hours per week; A medical director as described in COMAR 10.63.03.05 and is serving the organization for at least 20 hours per week; A multidisciplinary licensed mental health professional staff as described in COMAR 10.63.03.05, including representatives of two different mental health professions, each of whom shall be on-site 50 percent of the OMHC’s regularly scheduled hours; Graduate level students and interns, who may deliver services under supervision of a licensed mental health professional and when a licensed mental health professional co-signs all documentation of contact with participants. Federally Qualified Health Centers. To participate in the Program as a Federally Qualified Health Center, the provider shall be in compliance with COMAR 10.09.08. Other Licensed or Approved Mental Health Providers. To participate in the Program as a specialty mental health provider not defined in §§A—C of this regulation, a provider shall be approved pursuant to COMAR as a: Targeted case management provider in compliance with: If serving children, COMAR 10.09.90; and If serving adults, COMAR 10.09.45; Residential treatment center in compliance with COMAR 10.07.04 and 10.09.29; Hospital in compliance with COMAR 10.09.92—10.09.95; Non-hospital-based mental health psychiatric day treatment provider in compliance with: COMAR 10.63.03.08; Staffing requirements described in 10.63.03.08 and including: A multidisciplinary team employed at least on a part-time basis; and A program director; Service requirements as described in 10.63.03.08 and including: An individual treatment plan developed by the multi-disciplinary team within 4 working days of admission; Psychopharmacological treatment; Occupational therapy; Activity therapy; and Other necessary medical, psychological, and social services; and COMAR 10.05.01.11 for requirements of the physical environment; 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families Waiver provider in compliance with COMAR 10.09.89; Therapeutic behavioral service provider in compliance with COMAR 10.09.34; Medical laboratory in compliance with COMAR 10.09.09; or Local school systems in compliance with COMAR 10.09.50 as a provider of school-based health-related services. A participant is eligible for specialty mental health services if: The individual meets the Department’s medical necessity criteria; and The service is appropriate to the specific provider type or community-based mental health provider listed in Regulation .04 of this chapter. Individuals are eligible for Psychiatric Rehabilitation Programs for adults if the individual: Has been referred for psychiatric rehabilitation program services by a licensed mental health professional who: Is enrolled as a provider in the Program with an active status on the date of service; Facilitates an informed choice of psychiatric rehabilitation program providers; and Currently provides inpatient, residential treatment center, or outpatient mental health services to the individual; Has a diagnosis listed in COMAR 10.67.08.02N; and Is in need of program services in order to improve or restore independent living and social skills necessary to support the individual’s recovery, ability to make informed decisions and choices, and participation in community life. Individuals are eligible for Psychiatric Rehabilitation Programs for minors if the individual: Has been referred for psychiatric rehabilitation program services by a licensed mental health professional who: Is enrolled as a provider in the Program with an active status on the date of service; Facilitates an informed choice of psychiatric rehabilitation program providers; and Currently provides inpatient, residential treatment center, or outpatient mental health services to the minor; Is currently in, and remains in, active mental health treatment; Has the appropriate consent to participate in psychiatric rehabilitation program services; Has a diagnosis listed in COMAR 10.67.08.02N and severe functional impairments in at least one life domain; With psychiatric rehabilitation program services, is expected to have reduced symptoms of their mental illness or functional behavioral impairment as a result of their mental illness based on the clinical evaluation and ongoing treatment plan; and Is at risk of requiring a higher level of care, or is returning from a higher level of care. Individuals are eligible for Mobile Treatment Services if it is assessed that the individual will benefit from mobile treatment services and the individual is: Experiencing homelessness; Unable or unwilling to use, on a continuing basis, community-based mental health services that are prescribed for the individual; or In an institution or inpatient facility and would be able to reside in a community setting if the individual received MTS and other appropriate support services. The ASO shall reimburse the following specialty mental health services rendered to participants when authorized by the ASO: Medically necessary specialty mental health services delivered by providers listed in Regulation .04 of this chapter, for which the primary diagnosis is listed in COMAR 10.67.08.02M or N; Telehealth services as defined in COMAR 10.09.49 when rendered in accordance with limitations in Regulation .07 of this chapter; and Presumptive drug tests and definitive drug tests, when ordered by a specialty mental health provider, with a behavioral health primary diagnosis listed in COMAR 10.67.08.02M or N on the claim. Specialty mental health services billed by local school systems are covered under the following conditions: The services are not furnished as part of an individualized education program or individualized family service plan) as defined in COMAR 10.09.50.01; and The services are rendered by a school psychologist or school social worker that meets the qualifications described in COMAR 10.09.50.02. The Program does not cover the following: Services not delivered in compliance with the COMAR references listed in Regulations .04 and .05 of this chapter; Services not medically necessary; Investigational or experimental drugs and procedures; Specialty mental health services for participants in an institution for mental disease as defined in 42 CFR §435.1009 unless the service is delivered through the §1115 HealthChoice Demonstration Waiver; Specialty mental health visits solely for the purpose of: Prescribing medication; Administering medication; Drug or supply pick-up; Collecting laboratory specimens; Interpreting laboratory tests or panels; or Administering injections, unless the following are documented in the participant’s medical record: Medical necessity; and The participant’s inability to take appropriate oral medications; Separate reimbursement to an employee of a program for services that have been provided by and reimbursed directly to a program; Vocational counseling, vocational training at a classroom or job site, and academic or remedial educational services; Services provided to or for the primary benefit of individuals other than the participant; Outpatient Mental Health Clinic services delivered to a participant with a primary diagnosis of substance use disorder, unless the claim reflects a secondary diagnosis of mental health; An on-site psychiatric rehabilitation program visit by a participant on the same day that the participant receives medical day care services under COMAR 10.09.07; Psychiatric rehabilitation program services rendered via telehealth when: They are rendered as a group service; or The total services rendered via telehealth comprise more than 50 percent of a participant’s services rendered; Non-emergency services not authorized by the ASO; Mental health services delivered by a primary care provider and reimbursed through Medicaid Fee for Service or the Maryland Medicaid Managed Care Program; Services delivered by Federally Qualified Health Centers other than those billed using the T-code or H-code, which may include the following, delivered by two separate but appropriately licensed providers: One T-code for mental health services per day; and One H-code for substance use disorder services per day; Supported employment services provided by a community-based psychiatric rehabilitation program, except in cases of clinic coordination; Residential crisis services; Respite care services, other than those provided through the 1915(i) Intensive Behavioral Health Services program described in COMAR 10.09.89; Services provided to participants in a hospital inpatient setting, with the exception of services delivered by: Physicians; and Nurse Practitioners; Housing services; Services rendered but not appropriately documented; Services reimbursed by the ASO not included in this chapter; Mobile Treatment or ACT Services without a minimum of four in-person services provided per month; Services rendered by community based specialty mental health programs with an immediate family member of an employee of the program serving on the governing body, board of directors, or advisory committee, whichever applies; and Psychiatric rehabilitation services referred by: An individual who is not enrolled as a provider in the Program with an active status on the date of service; and An entity, facility, or another provider that is not an individual. The ASO shall establish a process, through a utilization review system, for authorization of specialty mental health services. The ASO shall authorize services that are: Medically necessary; Of a type, frequency, and duration that are consistent with expected results and cost-effective; and Delivered in a manner consistent with this chapter. Preauthorization is not required before a provider renders services in an emergency department. Except as provided in Regulation .08C of this chapter, no payment shall be rendered for services that have not been authorized. Payment procedures shall be followed as specified in COMAR 10.09.36.04. A provider shall deliver and document services in accordance with Department regulations in order to receive reimbursement. Unless the care is free to other patients, a provider shall bill the Program its usual and customary charge to the general public. The Department shall authorize supplemental payment on Medicare claims only if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that the services are medically necessary; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make payment on Medicare claims subject to the following provisions: Deductible and coinsurance shall be paid in full for services designated as mental health services by Medicare; and The Program shall reimburse services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of this chapter. A provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail or telehealth, unless the services are provided in compliance with COMAR 10.09.49; or Services not authorized consistent with Regulation .08 of this chapter. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. The Department shall reimburse providers according to the fee schedule in COMAR 10.21.25. Psychiatric rehabilitation programs shall identify the mental health professional who referred the individual to psychiatric rehabilitation services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Appeal procedures for providers are as set forth in COMAR 10.09.36.09. Appeal procedures for applicants and participants are as set forth in COMAR 10.01.03 and 10.01.04. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 2-105(b), 15-102.8, 15-103, 15-105, and 15-105.2, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective February 3, 1995 (22:4 Md. R. 232); adopted permanently effective June 5, 1995 (22:11 Md. R. 821) Regulations .01 and .03—.07 amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1291); emergency status expired December 31, 1997; amended permanently effective February 9, 1998 (25:3 Md. R. 144) Regulation .04 amended effective February 12, 1996 (23:3 Md. R. 168) Regulation .05 amended effective February 12, 1996 (23:3 Md. R. 168); August 10, 1998 (25:16 Md. R. 1274) Regulation .07K—M amended effective August 10, 1998 (25:16 Md. R. 1274) Regulations .01—.11 under, Rehabilitation and Other Mental Health Services, repealed and new Regulations .01—.14 under, Specialty Mental Health Services, adopted effective December 22, 2014 (41:25 Md. R. 1479) Regulation .01B amended effective October 26, 2015 (42:21 Md. R. 1300); October 10, 2016 (43:20 Md. R. 1110); May 12, 2025 (52:9 Md. R. 405) Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .03 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420) Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420); December 31, 2018 (45:26 Md. R. 1243); May 12, 2025 (52:9 Md. R. 405) Regulation .04B amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .04B, D amended effective October 10, 2016 (43:20 Md. R. 1110) Regulation .05 repealed and new Regulation .05 adopted effective October 26, 2015 (42:21 Md. R. 1300) Regulation .05 amended effective April 23, 2018 (45:8 Md. R. 420) Regulation .05B, C amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1300); May 12, 2025 (52:9 Md. R. 405) Regulation .06C amended effective October 10, 2016 (43:20 Md. R. 1110) Regulation .07 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420) Regulation .07D, K, N amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .07V amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .08 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .09 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .09F amended effective May 12, 2025 (52:9 Md. R. 405) Regulation .09I adopted effective April 23, 2018 (45:8 Md. R. 420) Regulation .12 amended effective October 26, 2015 (42:21 Md. R. 1300) Regulation .13 amended effective October 26, 2015 (42:21 Md. R. 1300) In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrator” means the third party that contracts with the Department to administer the Program. “Annual household income” has the meaning stated in Regulation .02B of this chapter. “Department” means the Maryland Department of Health. “Eligible individual” means an individual who meets the criteria set forth in Regulation .02A of this chapter: “Enrollee” means an individual enrolled in the Senior Prescription Drug Assistance Program. “Household member” means: An eligible individual; The spouse of an eligible individual if the spouse resides in the same residence as the eligible individual; and An individual who: Is related to an eligible individual by blood, marriage, or adoption; Resides in the same residence as the eligible individual; and Is dependent on the eligible individual or the spouse of the eligible individual for at least one-half of the individual's support. “Prescription drug plan sponsor” means a nongovernmental entity that is certified by the Centers for Medicare and Medicaid Services as meeting the requirements of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 for offering in the State: A Medicare Part D prescription drug plan; or A Medicare Advantage Plan that provides prescription drug benefits. “Program” means the Senior Prescription Drug Assistance Program established under Health-General Article, Title 15, Subtitle 10, Annotated Code of Maryland. “Program Fund” means the Fund established under Insurance Article, §15-1004, Annotated Code of Maryland. “Reasonable administrative expenses” means administrative expenses including, but not limited to, marketing, advertising, mailing, printing, and fully allocated costs for administration of the Program. Support and Maintenance Furnished in-Kind. “Support and maintenance furnished in-kind” means any food or shelter that is: Given to an eligible individual or the spouse of an eligible individual without cost; or Received by an eligible individual or the spouse of an eligible individual because another person has paid the cost. “Support and maintenance in-kind” includes the provision of room, rent, garbage collection services, mortgage payments, real property tax payments, and heating fuel, gas, electricity, water, and sewage payments. To be eligible for enrollment in the Program, an individual shall: Be a resident of Maryland; Be a Medicare beneficiary enrolled in the Medicare Part D Voluntary Prescription Drug Benefit Program or a Medicare Advantage Plan that provides Part D coverage; Have an annual household income, as described in §B of this regulation, at or below 300 percent of the Federal Poverty Guidelines that apply to the individual based on the number of household members of the individual; Not be enrolled in a health benefit plan, other than a Medicare Part D prescription drug plan or a Medicare Advantage Plan, that provides prescription drug benefits at the time the individual applies for enrollment in the Program; and Not be eligible for a full federal low-income subsidy under 42 CFR §423.772. Consideration of Annual Household Income. Annual household income to be considered in determining financial eligibility is both earned and unearned income of the applicant and spouse who reside in the same residence, projected for a 12-month period beginning with the month in which the person submits the application for enrollment in the Program. Earned income includes: Wages, commissions, fees, profit from self-employment, salaries, and tips; The value of nonmonetary compensation received for services rendered; and Profit from rent received from a roomer, tenant, or boarder. Unearned income includes: Payment from unemployment insurance, the Family Investment Program, the Supplemental Security Income Program, Veteran's and Workers' Compensations, private insurance, Black Lung Program, Railroad Retirement, Social Security, pensions, annuities, and other regular benefits received; Except as provided in §B(4) of this regulation, support from absent relatives, support from legally responsible relatives, and income which is received on a regular basis from relatives and friends who are not legally responsible; Parental income received by a child as support from his natural or adoptive parents or putative father; and Income from assets received as either interest, dividends, or other income from savings accounts, certificates, stocks, bonds, insurance policies, mortgages, and from real property that is not included as earned income. Unearned income does not include support and maintenance furnished in-kind. An eligible individual may apply for enrollment in the Program by submitting a completed application to the Administrator. Maximum Capacity of Program. The Administrator may not enroll additional individuals at a time when the Program's total enrollment reaches the level authorized by the Department. The Program shall maintain a waiting list of individuals who meet the eligibility requirements for the Program but who are not served by the Program because of funding limitations. If, after the Program reaches its maximum capacity as established by the Department, the number of individuals enrolled decreases, the Administrator may recommence enrolling eligible individuals in the Program as specified in this regulation, until the Program's enrollment again reaches the authorized maximum. The Department may direct the Administrator to limit enrollment based on the amount of money remaining in the Program Fund. Disenrollment. The Administrator may, after first providing reasonable notice to the enrollee, disenroll from the Program an enrollee for any of the causes specified in §E(2) of this regulation. An enrollee may be disenrolled from the Program if the enrollee: Ceases to meet the eligibility criteria set forth in §A of this regulation; or Is enrolled in: A Medicare Part D prescription drug plan that does not charge a premium; or A Medicare Advantage Plan that does not charge a premium for prescription drug coverage. The Department shall develop and implement an outreach program targeted at eligible individuals. The Department shall publicize the existence and eligibility requirements of the Program through the following entities: The Department of Aging; Local health departments; Continuing care retirement communities; Places of worship; Civic organizations; Community pharmacies; and Any other entity that the Department determines is appropriate. The Department of Aging, through its Senior Health Insurance Program, shall: Assist eligible individuals in applying for coverage under the Program; and Provide notice of the Program and its eligibility requirements to potentially eligible individuals who seek health insurance counseling services through the Department of Aging. The Department shall ensure that the entities used to publicize the existence of the Program under §B of this regulation, have sufficient Program applications and enrollment materials for distribution. Mail-In Application. The Department shall develop a mail-in application for the Program. The Administrator shall make available mail-in applications to eligible individuals. Any outreach performed by the Department on behalf of the Program shall be funded through the Program Fund. Administrator Contract. The Administrator and the Department shall execute an Administrator contract specifying the terms under which the Administrator shall operate the Program, including but not limited to an agreement by the Administrator to: Provide the prescription drug benefit subsidies described in Regulation .06 of this chapter; Submit a detailed quarterly financial accounting of the Program, including the identification of all revenue and cost items to the Department; Develop and implement a marketing plan designed to notify eligible individuals throughout the State of the existence and eligibility criteria for the Program; and Collect and submit to the Department, data regarding the costs for program enrollees. Program Operation. The Administrator shall operate the Program in a manner consistent with: The terms of this chapter; The Administrator contract governing operation of the Program that is executed between the Department and the Administrator; and All applicable federal and State law. Prescription Drug Benefit Subsidies. The Administrator shall pay to prescription drug plan sponsors the subsidy payments that the Program has agreed to make on behalf of member enrollees of the prescription drug plan sponsors. The Administrator shall develop a Program description booklet. The Program description booklet is subject to approval by the Department. The Program description booklet shall describe the essential features of the Program including: Eligibility requirements; A listing of available prescription drug plans and details of the prescription drug plans; Termination provisions; Appeal procedures; Other Program guidelines; and All other terms, conditions, and limitations of the Program. The Program shall: Provide a prescription drug benefit subsidy, as determined by the Department, that may pay all or some of the deductibles, coinsurance payments, premiums, and copayments under the federal Medicare Part D Pharmaceutical Assistance Program for enrollees of the Program; and Provide the subsidy to the maximum number of individuals eligible for enrollment in the Program, subject to the money available in the Program Fund. The Program may annually provide an additional subsidy, up to the full amount of the Medicare Part D Prescription Drug Plan premium, for individuals who qualify for a partial federal low-income subsidy. The Department shall determine annually: The number of individuals to be enrolled in the Program; The amount of subsidy to be provided under §A of this regulation; and The amount of any additional subsidy provided under §B of this regulation. The Department may enter into contracts with prescription drug plan sponsors who have been approved by the Centers for Medicare and Medicaid Services to offer Medicare Part D plans in the State. A prescription drug plan sponsor that enters into a contract with the Department shall agree to perform its obligations in a manner that complies with: Medicare Part D and any federal regulations adopted to implement Medicare Part D; The Program; The terms and conditions of the contract; and Guidance from the Centers for Medicare and Medicaid Services. A contract entered into with the Department shall include provisions that require the prescription drug plan sponsor to: Coordinate with the Program in identifying member enrollees; Accept the premium subsidy on behalf of member enrollees; Apply the premium subsidy to the member enrollee's total premium costs; Separately bill member enrollees for any premium owed in excess of the premium subsidy paid by the Program; Account for the subsidies received from the Program; Communicate in writing with member enrollees, including notifying member enrollees of their enrollment status; Share enrollment data and information with the Department; Report data and enrollment information as required by the Department; Reconcile Program and member payments with enrollment data; and Transmit information to appropriate third-parties, including the Administrator and the Centers for Medicare and Medicaid Services. The Program Fund shall include: Interest and investment income attributable to the Program Fund; and Money deposited to the account by a nonprofit health service plan in accordance with §C of this regulation. On or before April 1, 2003 and quarterly thereafter, the nonprofit health service plan required to subsidize the Program under Insurance Article, §14-106(d), Annotated Code of Maryland, shall deposit to the Program Fund the amount that is necessary to operate and administer the Program for the following quarter. The amount deposited by the nonprofit health service plan under §C of this regulation: Shall be determined by the Department based on enrollment, expenditures, and revenue for the previous year; and May not exceed the amounts specified in Insurance Article, §14-106(e), Annotated Code of Maryland. The Department shall provide funds to the Administrator, in accordance with the contract with the Administrator, for the cost of the State subsidy and administrative expenses incurred on behalf of the Program. The Administrator shall: Permit inspection of its papers, books, and records pertaining to its operation of the Program by the Department or its designee; and Cooperate with any inspections and audits performed on the Administrator or the Program by the Department or its designee. Health-General Article, §15-1005(b)(1), Annotated Code of Maryland Effective date: Chapter recodified from 31.17.04 Senior Prescription Drug Assistance Program, to 10.09.60 Senior Prescription Drug Program effective July 1, 2016 Regulation .01B amended effective February 13, 2017 (44:3 Md. R. 188) Regulation .02D amended effective February 13, 2017 (44:3 Md. R. 188) Regulation .03 amended effective February 13, 2017 (44:3 Md. R. 188) Regulation .04A, B amended effective February 13, 2017 (44:3 Md. R. 188) Regulation .05B amended effective February 13, 2017 (44:3 Md. R. 188) Regulation .06 amended effective February 13, 2017 (44:3 Md. R. 188) Regulation .07 amended effective February 13, 2017 (44:3 Md. R. 188) Regulation .08 amended effective February 13, 2017 (44:3 Md. R. 188) In this chapter, the following terms have the meanings indicated. Terms Defined. “Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with the waiver, this chapter, and COMAR 10.09.30, assesses waiver applicants and participants. “Authorized representative” means a spouse, legal guardian, parent, individual with power of attorney, or other individual designated in writing to the Department, authorized concerning the applicant's or recipient's eligibility under this chapter, to: Act on an applicant's or recipient's behalf; and Assist with the application or redetermination process and in other communication with the Department. "Centers for Medicare and Medicaid Services (CMS)" means the federal agency responsible for administering Medicare, Medicaid, and several other health related programs. “Department” means the Maryland Department of Health. “Eligibility” means an individual's qualification for participation in the Medical Day Care Services Waiver, in accordance with the requirements of this chapter. “Eligible” means that an individual is determined to meet the requirements of this chapter for eligibility as a Medical Day Care Services Waiver participant. “Medicaid” means the Maryland Medical Assistance Program administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients. “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults, who, because of their degree of impairment, need health maintenance and restorative services supportive to their community living. “Medical Day Care Services Waiver” means the program implemented under this chapter in accordance with the CMS-approved application for this waiver and any amendments to it submitted by the Department and approved by CMS. “Multidisciplinary team” means the group consisting of members of the medical day care center’s professional staff, the participant, the participant’s authorized representative, healthcare professionals, and waiver case managers, as appropriate, that establishes and updates the participant’s service plan and plan of care. “Nursing facility” means a facility that is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10. “Participant” means an individual who: Meets the qualifications for participation in the waiver as specified in Regulations .02 through .04 of this chapter; and Is enrolled by the Department to receive waiver services. “Plan of care” means a written plan established by the multidisciplinary team in accordance with COMAR 10.12.04.22 and based on: A medical order; and An assessment of the participant’s health status and special care requirements. “Primary care provider” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant. “Program” means the Maryland Medical Assistance Program. “Provider” means a facility licensed under COMAR 10.12.04 furnishing medical day care services through an appropriate agreement with the Department, and identified as a Program provider by the issuance of an individual account number. “Recipient” means a person who is certified by the Department as eligible for, and is receiving, Medical Assistance benefits. “Service plan” means an approved document which specifies the type, amount, frequency, and duration of all waiver and other Medicaid services required to safely support the waiver participant in the community. “State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements. “Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. “Waiver” means the Medical Day Care Services Waiver as implemented through this chapter. “Waiver applicant” means an individual who is applying for participation in the waiver to receive the services covered under this chapter. “Waiver year” means the State fiscal year from July 1 through June 30. Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as a: Recipient of Supplemental Security Income (SSI); Member of a low income family with children, as described in §1931 of the Social Security Act; or Recipient eligible in another mandatory or optional categorically needy coverage group covered in the community under the State Plan. Medically Needy. An individual is eligible for waiver services as medically needy if the individual is receiving Medical Assistance as an aged, blind, or disabled medically needy individual in accordance with COMAR 10.09.24.03D and .09. An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires. Medical Eligibility. To be eligible for the services covered under COMAR 10.09.07, a waiver applicant or participant shall be certified by the Department or its designee as needing nursing facility services, pursuant to COMAR 10.09.10. The initial assessment for enrollment to the Program shall be conducted by AERS and submitted to the Department or its designee for certification. For the purpose of enrollment, the assessment of the applicant’s need for nursing facility services is valid for 1 year. The Department or its designee shall annually certify as medically eligible only those financially eligible participants who require nursing facility services as defined under COMAR 10.09.10. The annual continued stay assessment shall be conducted by the medical day care provider's nursing staff or, at the discretion of the Department, by the Department's designee, with an assessment instrument approved by the Department and submitted to the Department or its designee for certification. Technical Eligibility. An individual shall be determined by the Department or its designee to be eligible for waiver services if the individual: Is 16 years old or older; Is not enrolled simultaneously in both the Medical Day Care Services Waiver, and: Another Medicaid home and community-based services waiver under §1915(c) of the Social Security Act; Programs of All-Inclusive Care for the Elderly (PACE); or A Medicaid capitated program that includes nursing facility or community-based long term care services; Has a service plan that: Recommends medical day care services at least one time per week based on a medical order; Is based on an initial or continued stay assessment approved by the Department or its designee; Is developed and signed by: The participant or authorized representative; and Appropriate members of the multidisciplinary team; Is revised as necessary due to a significant change in the participant’s condition or service needs; Is reviewed at least annually by the participant or authorized representative and the multidisciplinary team to: Determine the appropriateness and adequacy of the services; and Ensure that the services furnished are consistent with the nature and severity of the participant's condition and with the plan of care; Is determined by the Department or its designee as appropriate for home and community-based care; Is informed of feasible alternatives to nursing facility services that are available under the waiver; Is offered the choice between waiver and nursing facility services; and Chooses, or the individual's authorized representative chooses on the individual's behalf, to receive waiver services. Based on the criteria established in Regulations .02 and .03 of this chapter, an applicant's eligibility for services under this chapter shall be established by the Department, and waiver eligibility may not begin before the latest of the following five dates: Waiver application date; Effective date of medical certification for the waiver's institutional level of care; Date that the applicant's written waiver service plan is established; Date that the applicant or representative signed a form designated by the Department to indicate the choice of waiver services as an alternative to institutionalization; or Date of the applicant's discharge from institutionalization in a long term care facility, if applicable. The Department or its designee shall reevaluate a participant's eligibility for waiver services annually. A participant shall be terminated from participation in the waiver as of the effective date of ineligibility as determined by the Department if the participant: No longer meets the eligibility requirements specified in Regulations .02 and .03 of this chapter; Voluntarily chooses, or the participant's authorized representative chooses on the participant's behalf, to disenroll from the waiver; Moves to another state; Is an inpatient for 30 consecutive days or more in a chronic hospital or nursing facility; Does not receive waiver services for 90 consecutive days; or Dies. Reenrollment in the Waiver. If an individual is terminated from the waiver, the same individual may reenroll in the waiver during the same waiver year, if the individual meets all of the eligibility requirements of the waiver. For each State fiscal year beginning on July 1, the Department shall establish a cap, approved by CMS, for the number of unduplicated individuals who may receive the services covered under this chapter, based on available State and federal funding. The annual cap for waiver participation may be revised, based on the Department's updated estimates of participants' Program expenditures for the State fiscal year, as compared with the available funding. Eligible individuals shall be enrolled in the waiver program on a first-come, first-served basis until the annual cap on waiver participation is reached. Once the annual cap on waiver participation is reached: A registry shall be established for individuals interested in applying for waiver services; and Individuals on the registry shall have an opportunity to apply for the waiver as openings become available. Conditions for provider participation are those set forth in COMAR 10.09.07. Providers shall maintain a service plan for each participant that includes: Name, address, and telephone number of the participant; Medical Assistance number of the participant; Name and telephone number of the participant’s primary care provider and of any managed care organization with which the participant is enrolled; Dated signatures of the participant or authorized representative, and each of the other individuals participating on the multidisciplinary team; A statement that the participant or authorized representative shall have access to the individual's medical day care services plan of care; A statement that enrollment is voluntary, but that the participant or the participant's caregiver shall notify the medical day care center when the participant is unable to attend; Authorization and frequency of attendance of medical day care services; Names of provider or providers that render waiver or State Plan services; and Approval by the Department or its designee. Covered services are those set forth in COMAR 10.09.07. Limitations are those set forth in COMAR 10.09.07. Payment procedures are those set forth in COMAR 10.09.07. Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04. Cause for suspension or removal and imposition of sanctions for providers shall be in accordance with COMAR 10.09.36. If the Department determines that a provider has failed to accurately assess the rehabilitative, cognitive, behavioral, and functional abilities and deficits, or medical service needs of an applicant or consumer, and to accurately convey such an assessment to the Department for purposes of obtaining an authorization to provide medical day care services, the Department shall: Suspend all eligibility decisions based upon assessments submitted by the provider until such time as the provider's assessment is validated by an independent assessment conducted by the Department's utilization control agent or the Department's designee; and Conduct remedial training of provider staff in accurately assessing rehabilitative, cognitive, behavioral, and functional abilities and deficits, or medical service needs, and in accurately conveying such assessments to the Department or its designee for purposes of establishing medical eligibility for medical day care service. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-111, Annotated Code of Maryland Effective date: Regulations .01—.12 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective October 6, 2008 (35:20 Md. R. 1775) Regulation .01B amended effective February 15, 2016 (43:3 Md. R. 273); May 20, 2019 (46:10 Md. R. 485) Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 485) Regulation .03B amended effective February 15, 2016 (43:3 Md. R. 273) Regulation .06B amended effective May 20, 2019 (46:10 Md. R. 485) This chapter governs the determination of eligibility for the separate Children’s Health Insurance Program (separate CHIP) and the CHIP Health Services Initiative with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014. Eligibility for the separate CHIP Program may be established for a targeted low-income child from conception to birth when the birthing parent would qualify for Medicaid but for their immigration status, when the family income is equal to or less than 250 percent of the federal poverty level. Eligibility for the CHIP Health Services Initiative for the birthing parent of a targeted low-income child may be established beginning on the first day of the month following the end of the pregnancy and ending on the last day of the fourth month after the pregnancy ends if the targeted low-income child applied for the separate CHIP Program on or before the day prior to their birth and was subsequently found eligible for the separate CHIP Program. In this chapter, the following terms have the meanings indicated. Terms Defined. “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). Applicant. “Applicant” means an individual whose written application for the separate CHIP Program has been submitted to the local health department or the local department of social services but has not received final action. “Applicant” includes an individual whose application is submitted through a representative. “Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an insurance affordability program to the Department or its designee. “Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. “Authorized representative” has the meaning stated in COMAR 10.01.04.12. “Birthing parent” means the individual who gives birth to the targeted low-income child who is enrolled in the separate CHIP Program on the day prior to their birth. “CHIP Health Services Initiative” means services offered to improve the health of low-income children pursuant to §2105(a)(1)(D)(ii) of the Social Security Act. “Department” means the Maryland Department of Health. “Determination” means a decision regarding an applicant’s eligibility for the separate CHIP Program. “Eligibility worker” means an employee of the local health department, or the local department of social services, responsible for determining the eligibility of applicants and participants. “Family members” means those individuals living with the applicant whose income is counted as household income under Regulation .07B of this chapter. “Federal poverty level” means the nonfarm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981. “Inpatient services” means services received by a participant while in a medical institution, birthing center, or clinic for which Medical Assistance is provided. “Institution for mental diseases” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed under COMAR 10.07.04. “Insurance affordability program” means a program that is one of the following: Maryland Medicaid; The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; The separate CHIP Program; An optional state basic health program established under §1331 of the Affordable Care Act; A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under 26 U.S.C. §36B of the Internal Revenue Code; or A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under 42 U.S.C. §1402 of the Affordable Care Act. “Living together” means sharing a common household. “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. “Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI-based insurance affordability programs, including, by delegation, certain eligibility in the program. “Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.09.24.02. “Period under consideration” has the meaning stated in COMAR 10.09.24.02. “Postpartum period” means the period of time beginning on the first day of the month following the end of the pregnancy and ending on the last day of the fourth month after the pregnancy ends. “Public institution” has the meaning stated in COMAR 10.09.24.02. “Qualified alien” has the meaning defined in 8 U.S.C. §1641. “Participant” means an individual who is certified as eligible for the Maryland Children’s Health Program. “Redetermination” has the meaning stated in COMAR 10.09.24.02. “Separate CHIP Program” means the program for targeted low-income children established under Title XXI of the Social Security Act. “Spouse” has the meaning stated in COMAR 10.09.24.02. “Targeted low-income child” means an individual who qualifies for the Maryland Children’s Health Program from conception to birth when the birthing parent is not eligible for Medicaid as a citizen or qualified alien, when the family income is equal to or less than 250 percent of the federal poverty level. “Title XIX” means the title of the Social Security Act, 42 U.S.C. §1396 et seq., which governs establishment of a medical assistance program for low-income individuals. “Title XXI” means the title of the Social Security Act through which funding is provided, in part, for the separate CHIP Program. Eligibility for the separate CHIP Program may be established for a targeted low-income child from conception to birth when the: Birthing parent is not a citizen or qualified alien; and Family income is equal to or less than 250 percent of the federal poverty level. Eligibility for the CHIP Health Services Initiative may be established for a birthing parent for postpartum coverage if a targeted low-income child applied for the separate CHIP Program on or before the day prior to their birth and was subsequently found eligible for the separate CHIP Program. The Department or its designee shall determine eligibility for a targeted low-income child and a birthing parent. The Department or its designee shall give oral, written, or electronic information about the separate CHIP Program and CHIP Health Services Initiative such as: Requirements for eligibility; Available services; An individual’s rights and responsibilities; Information in plain English, supported by translation services; and Information accessible to disabled individuals requesting an application. An individual requesting health coverage from an insurance affordability program shall be given an opportunity to apply. The Department or its designee shall make the application available to the individual without delay by telephone, by mail, in person, or by internet or other available electronic means, and in a manner accessible to disabled individuals requesting an application. A resident temporarily absent from the State but intending to return may apply for health coverage from an insurance affordability program by telephone, by mail, in person, or by internet or other available electronic means to the Department or its designee in any jurisdiction. The individual shall: Demonstrate continued residency in the State; and Meet all nonfinancial and financial requirements to be determined eligible. Application Filing and Signature Requirements. An individual who wishes to apply for health coverage under an insurance affordability program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant’s choice. For the purpose of establishing eligibility of a child applicant who is neither pregnant nor postpartum, a parent or stepparent living with the child shall complete and sign the written, telephonic, or electronic application. If the child does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application. The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee. An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application, but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §I of this regulation. Period Under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established under §G of this regulation. For a targeted low-income child, the period under consideration is from conception to birth, and for retroactive eligibility, the 1, 2, or 3 months immediately preceding the month of application for the separate CHIP Program if those months are prior to the birth. For the birthing parent, the period under consideration is the postpartum period and contingent on the application of the targeted low-income child on or before the last day of the fourth month after the pregnancy ends. Processing applications time limitations shall operate in accordance with the requirements of COMAR 10.09.24.04. Required Information. All information needed to determine eligibility for the separate CHIP Program and CHIP Health Services Initiative shall be reported. When there is evidence of inconsistency between information attested by the applicant and data reported by the State and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. Third-Party Liability. A participant shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for the participant’s medical expenses. A participant shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. In accident situations, a participant shall notify the Department or its designee of the: Time, date, and location of the accident; Name and address of the participant’s attorney; Names and addresses of all parties and witnesses to the accident; and Police report number if an investigation is made. The Department or its designee shall: Maintain a written or electronic record including documentation of any required elements of eligibility; and Restrict disclosure of information concerning a participant to purposes directly connected with the administration of the Medical Assistance Program, including: Establishing eligibility; Determining the extent of coverage under Medical Assistance; Providing services for participants; and Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Medical Assistance Program. An applicant or participant shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic, or electronic application. Individuals qualifying for coverage under this section are not required to provide a Social Security number or meet satisfactory immigration status. Residency. To be eligible for benefits under this chapter, an individual shall be a resident of Maryland, in accordance with the requirements of COMAR 10.09.24.05-3. Age. To be eligible for benefits under this chapter, a birthing parent shall apply for coverage before the last day of the fourth month after the pregnancy ends, regardless of the birthing parent’s age. Inmate of a Public Institution. To receive benefits under this chapter, a targeted low-income child or birthing parent may not be an inmate of a public institution, as specified in COMAR 10.09.24.05-5B. Institution for Mental Diseases. To be eligible for benefits under this chapter, a targeted low-income child or birthing parent may not be a patient in an institution for mental diseases, unless such individuals are eligible in accordance with COMAR 10.09.24.05-5C. No Private Health Insurance. In order to be eligible for benefits under Title XXI of the Social Security Act, a targeted low-income child or birthing parent whose income is equal to 133 percent but less than 250 percent of the Federal Poverty Level may not be covered by an employer-sponsored health benefit plan. Required Information. An applicant shall report to the Department all information needed to determine eligibility for the separate CHIP Program and CHIP Health Services Initiative. When there is evidence of inconsistency between information attested by the applicant and data reported by the State and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. The applicant shall report the income of any family member, except for the income of a member that does not file a federal tax return and is not claimed as a federal tax dependent. Determining Countable Household Income. In determining an applicant’s financial eligibility for the separate CHIP Program, the applicant’s current household income is considered. For the targeted low-income child applicant, household income shall consist of the income of the child applicant and the following family members when living with the child applicant: The child applicant’s parents; and At the option of the child applicant’s parents, any of the child applicant’s siblings. When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application. Treatment of Income. Countable gross income for the separate CHIP Program shall be the household income calculated according to MAGI. MAGI income limits shall be: Converted from traditional income limits to account for elimination of income disregards; and Increased by 5 percentage points of the federal poverty level for the following circumstances: When an individual’s income exceeds the Medicaid income standard; and The income standard is the highest income standard under which the individual can be determined eligible. Household Composition. For purposes of determining the income standard applicable to an applicant or participant, the following rules apply: An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made; For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: Spouse; and Natural, adopted, or step children; In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals: Natural, adopted, or step parents; and Natural, adopted, or step siblings; In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made; and For a child applicant, the household size shall consist of the child and the following individuals: Natural, adopted, or step parents; and Natural, adopted, or step siblings. No resources or assets test may be applied to an applicant or participant who is subject to a MAGI-based income test. An applicant is financially eligible for the separate CHIP Program or the CHIP Health Services Initiative if, for the period under consideration, the applicant’s countable household income as determined under Regulation .07 of this chapter does not exceed 250 percent of the federal poverty level for a family size equal to the size of the family of the applicant. For a targeted low-income child, certification for the separate CHIP Program begins: On the first day of the month of application, no earlier than conception, and continues until the last day of the month in which the pregnancy ends; or For retroactive coverage, if medical expenses were incurred during the earlier months: 3 months before the month of application but no earlier than conception; and Continues until the last day of the month in which the pregnancy ends. For the birthing parent of a targeted low-income child, certification for the CHIP Health Services Initiative begins: On the first day of the month following the end of the pregnancy, and continues until the last day of the fourth month after the pregnancy ends; For retroactive coverage, if medical expenses were incurred during the earlier months: 3 months before the month of application, if those months are not prior to the last day of the month in which the pregnancy ends; and Continues until the last day of the month in which the pregnancy ends. A targeted low-income child certified for the separate CHIP Program is entitled to all health benefits through the Maryland Medicaid Managed Care Program. A birthing parent certified for the CHIP Health Services Initiative is entitled to all health benefits through the Maryland Medicaid Managed Care Program. Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant’s legal rights and obligations and give the applicant written or electronic notification of the following: For eligible individuals: The basis and effective date for eligibility; Instructions for reporting changes that may affect the participants’ eligibility; and The right to request a hearing; or For ineligible individuals: A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; Information regarding application for MAGI Exempt coverage groups; and The right to request a hearing. Participant Responsibility. After an individual has been determined to be eligible for the separate CHIP Program and is enrolled in the separate CHIP Program, the participant or the participant’s representative shall: Within 10 days of the occurrence, notify the Department if there is a change in the participant’s, the participant’s parent’s, or the participant’s guardian’s: Income; Employment; Address; or Health insurance coverage status; Limit use of the Medical Assistance card to the individual whose name appears on the card; and When written or electronic notice of cancellation is received, discontinue use of the Medical Assistance card on the first day of ineligibility and return the card to the Department. Failure to comply with §B(1) of this regulation may result in: The termination of assistance; or Referral to the Department for fraud investigation, or for criminal or civil prosecution. A participant shall cooperate with the Department’s quality control and audit review process, including verification of all information pertinent to the determination of eligibility. If the participant refuses to cooperate, the participant’s coverage shall be terminated subject to timely and adequate notice under COMAR 10.01.04.03. Unscheduled Redetermination. The Department or its designee shall: Promptly make an unscheduled redetermination of a child participant’s eligibility when changes in circumstances or relevant facts are: Reported by someone on the participant’s behalf; or Brought to the attention of the Department or its designee from other responsible sources; Notify the participant that redetermination is required to establish continuing eligibility; and Notify the participant of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. Eligibility Decisions. Participants who are determined: Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or Ineligible because of a change in circumstances or failure to establish eligibility following a change in circumstance shall be sent notice in accordance with §A(2) of this regulation. A participant whose eligibility has been canceled may reapply at any time after the cancellation of eligibility and a new period under consideration shall be established. Scheduled Redetermination. Except for children eligible as newborns of eligible individuals the Department or its designee shall make a scheduled redetermination of a child participant’s eligibility at least every 12 months. The requirements relating to hearings under COMAR 10.01.04 apply to this chapter. The requirements relating to fraud and abuse under COMAR 10.09.24.14 apply to this chapter. The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, except for COMAR 10.09.24.15A(1) and (2), apply to this chapter. State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation. Estates and Trusts Article, §14.5-1002; Health-General Article, §§2-104(b), 2-105(b), 15-103, 15-105, 15-121, and 15-401—15-407; Annotated Code of Maryland Effective date: November 13, 2023 (50:22 Md. R. 974) In this chapter, the following terms have the meanings indicated. Terms Defined. “Certified violence prevention professional” means a prevention professional who meets the requirements of Regulation .02 of this chapter. “Community violence” means intentional acts of interpersonal violence committed in public areas by individuals who are not family members or intimate partners of the victim. “Community violence prevention services” means evidence-based, trauma-informed, supportive, and nonpsychotherapeutic services provided by a certified violence prevention professional, within or outside a clinical setting, for the purpose of promoting improved health outcomes and positive behavioral change, preventing injury recidivism, and reducing the likelihood that an individual who is the victim of community violence will commit or promote violence. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq. “Interpersonal violence” means the intentional use of physical force or power against another individual by an individual or a small group of individuals. “Provider” means the entity who through appropriate agreement with the Department has been identified as a Program provider by the issuance of an individual account number. An individual rendering services under this chapter shall complete an accredited training and certification program for certified violence prevention professionals, approved by the Department. An accredited training and certification program for certified violence prevention professionals shall: Consist of at least 35 hours of initial training, addressing the following topics: The profound effects of trauma and violence and the basics of trauma-informed care; Community violence prevention strategies, including conflict mediation and retaliation prevention related to community violence; Case management and advocacy practices; and Patient privacy and the federal Health Insurance Portability and Accountability Act of 1996; and Require at least 6 hours of continuing education every 2 years. General requirements for participation in the Program are that a provider shall: Meet all conditions for participation as set forth in COMAR 10.09.36.03; and If rendering services via telehealth, comply with COMAR 10.09.49 and any sub regulatory guidance issued by the Department. Specific requirements for participation in the Program as a community violence prevention service provider are that a provider shall: Maintain documentation that an individual rendering community violence prevention services under this chapter meets the certification requirements as provided in Regulation .02 of this chapter and maintain documentation of certification; Maintain an affiliation with at least one trauma Primary Adult Resource Center (PARC), level I, or level II licensed short-term general hospital or children’s hospital in Maryland through which the provider entity is authorized to provide community violence prevention services to beneficiaries in the hospital; and Ensure that the certified violence prevention professional is providing community violence prevention services in compliance with any applicable standard of care, rule, regulation, and State or federal law. Effective July 1, 2023, the Department shall reimburse for community violence prevention services as described in §B of this regulation when these services: Are medically necessary; and Rendered to a participant who: Has been exposed to community violence or has a personal history of injury resulting from community violence; Is at an elevated risk of violent injury or retaliation resulting from another act of community violence, as determined by a certified or licensed health care provider or social services provider; and Has been referred by a certified or licensed health care provider to a certified violence prevention professional to receive community violence prevention services. Community violence prevention services shall include one or more of the following interventions: Mentorship; Conflict mediation; Crisis intervention; Referrals to certified or licensed health care professionals or social services providers; Patient education; and Screening services. The Program shall cover a maximum of 100 30-minute units of services in a rolling 12-month period. Under this chapter, the Program does not cover services: Following an episode of intimate partner violence or domestic violence; Delivered by a provider that is not affiliated with a trauma PARC, level I, or level II licensed short-term general hospital or children’s hospital in Maryland; and Provided in excess of 100 30-minute units of services in a rolling 12-month period. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. The provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §G of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. The Program will reimburse a provider for covered services: The lesser of the provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or In accordance with §G of this regulation. The provider may not bill the Program or the participant for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; or Providing a copy of a program participant’s medical record when requested by another provider on behalf of the participant. Payments for services rendered to a Program participant shall be made directly to a qualified provider or program. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Reimbursement. Payments shall be made in 30-minute units of service. Effective July 1, 2023, rates for the services outlined in this chapter shall be reimbursed at $32.76 per unit. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: November 13, 2023 (50:22 Md. R. 974) In this chapter, the following terms have the meanings indicated. Terms Defined. “Behavioral health care manager” means a nurse, clinical social worker, or psychologist working under the oversight and direction of the physician or other primary care provider with formal education or specialized training to provide coordination and intervention in behavioral health. “Collaborative Care Model” means the Psychiatric Collaborative Care Model, a patient-centered, evidence-based approach for integrating physical and behavioral health services in primary care settings that includes: Care coordination and management; Regular, systematic monitoring and treatment using a validated clinical rating scale; Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and Regular, systematic consultation for patients who do not show clinical improvement. “Federally qualified health center (FQHC)" means an entity as defined by Health-General Article, §24-1301, Annotated Code of Maryland, and §1905(l)(2)(B) of the Social Security Act. “Participant” means an individual who: Has been determined to meet the qualifications for services under the Collaborative Care Model as specified in Regulation .04 of this chapter; and Is enrolled with the Department to receive Medicaid services. “Primary care provider (PCP)” means a physician, or other provider type as defined in COMAR 10.67.05.05, who is the primary coordinator of care for the enrollee, and whose responsibility is to provide accessible, continuous, comprehensive, and coordinated health services covering the full range of benefits required by the Maryland Medical Assistance Program. “Program” means the Maryland Medical Assistance Program. “Psychiatric consultant” means a licensed psychiatrist, psychiatric nurse practitioner, addiction medicine specialist, or any other behavioral health medicine specialist as allowed under federal regulations governing the model who is trained in psychiatry and qualified to prescribe medication. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. A provider may not knowingly employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Program participants. The Program covers the following medically necessary services rendered to participants under the Collaborative Care Model: Care coordination and management; Regular, systematic monitoring and treatment using a validated clinical rating scale; Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and Regular, systematic consultation for patients who do not show clinical improvement. Eligibility for services under the Collaborative Care Model is limited to participants with a behavioral health diagnosis that is clinically appropriate for the primary care setting for which there is a validated tool to monitor symptoms and quantify outcomes. Under this chapter, the Program does not cover the following: Services not specified in Regulation .03 of this chapter; Services not medically necessary; Services prohibited by the Maryland Nurse Practice Act or by the State Board of Nursing; Advanced practice nursing services included as part of the cost of: An inpatient facility; A hospital outpatient department; or A freestanding clinic; Visits by or to the provider solely for the purpose of the following: Prescription, drug, or food supplement pick-up; Recording of an electrocardiogram; Ascertaining the patient’s weight; Interpretation of laboratory tests or panels; or Prescribing or administering medication; Drugs and supplies which are acquired by the provider at no cost; Services paid under the free-standing dialysis program as described in COMAR 10.09.22; Prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control; Acupuncture; Hypnosis; Travel expenses; Investigational or experimental drugs and procedures; Services denied by Medicare as not medically justified; Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service; Laboratory or X-ray services performed by another facility, which shall be billed to the Program directly by the facility; and For certified nurse midwives, a separate visit charge on date of delivery. The provider shall submit the request for payment of services rendered according to procedures established by the Program and in the form designated by the Program. The Program reserves the right to return to the provider, before payment, all claims not properly signed, completed, and accompanied by properly completed forms required by the Program. Unless the service is free to the general public, the provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §G of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. The Program will pay for covered services, the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The Program’s fee schedule. The provider may not bill the Program or the participant for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; Professional services rendered via telehealth when services are indicated as an exclusion; or Providing a copy of a participant’s medical record when requested by another provider on behalf of the participant. Reimbursement. Providers may bill one 60-minute or 70-minute code per month, and two additional 30-minute codes per month, unless otherwise excepted in §G(2)or (3) of this regulation. FQHCs may bill once per month, using a separate FQHC code. If the primary care team determines that the participant’s condition requires more or less frequent visits than described above, the care manager may order an alternate schedule. The Maryland Medical Assistance Program's procedures for payment are contained in COMAR 10.09.02.07D. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Health-General Article, §15–141.1, Annotated Code of Maryland Effective date: August 5, 2024 (51:15 Md. R. 707) Effective date: Regulations .01—.23 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) Regulations .01—.23 adopted effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulations .02C, .04C, .08, .11, .15, .17A, .18, .20B, and .22C amended and Regulation .11-1 adopted as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144); November 1, 1999 (26:22 Md. R. 1692); February 18, 2002 (29:3 Md. R.220) Regulation .02 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .02G amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .02G and H amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .03P amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .03T adopted effective February 18, 2002 (29:3 Md. R.220) Regulation .03 repealed and new Regulation .03 adopted effective December 23, 2002 (29:25 Md. R. 1981) Regulation .04C amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .05 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .05 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .05K amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .08 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .10B amended effective February 18, 2002 (29:3 Md. R.220) Regulation .11 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .11 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .11 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. 1838) Regulation .11 amended effective February 18, 2002 (29:3 Md. R.220); December 23, 2002 (29:25 Md. R. 1981) Regulation .11-1 and .11-2 adopted February 9, 1998 (25:3 Md. R. 144) Regulation .11-1 and .11-2E amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulations .11-1 and .11-2 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1838) Regulation .15 amended effective February 9, 1998 (25:3 Md. R. 144); December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R.220) Regulation .15B amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .15D, E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .16 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .17A amended effective February 9, 1998 (25:3 Md. R. 144); December 23, 2002 (29:25 Md. R. 1981) Regulation .17B amended effective February 18, 2002 (29:3 Md. R.220) Regulation .18 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .18-1 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993) Regulation .18-1 amended effective December 25, 2000 (27:25 Md. R.2281) Regulation .18-1C adopted effective November 1, 1999 (26:22 Md. R. 1692) Regulation .19 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); emergency status extended at 26:1 Md. R. 17, 26:6 Md. R. 480, and 26:8 Md. R. 614; emergency status expired May 1, 1999 Regulation .19 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999 Regulation .19 amended effective November 1, 1999 (26:22 Md. R. 1692) Regulation .19 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulation .19 amended effective December 25, 2000 (27:25 Md. R.2281) Regulation .19 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .19A amended as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931 and 29:4 Md. R. 413 Regulation .19B amended effective December 24, 2001 (28:25 Md. R. 2190) Regulation .19B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .19D amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulations .19-1—.19-3 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulations .19-1—.19-4 adopted effective December 25, 2000 (27:25 Md. R. 2281) Regulations .19-1 and .19-2 repealed and new Regulation .19-1 adopted effective December 24, 2001 (28:25 Md. R. 2190) Regulation .19-1 repealed as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); repealed permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulations .19-3 and .19-4 amended and recodified to be new Regulations .19-2 and .19-3 effective December 24, 2001 (28:25 Md. R. 2190) Regulation .19-3 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .19-3 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .19-4 adopted effective December 23, 2002 (29:25 Md. R. 1981) Regulations .19-5 and.19-6 adopted as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931; emergency status extended at 29:4 Md. R. 413 Regulation .20 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .20 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .20A amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .21 amended effective December 25, 2000 (27:25 Md. R. 2281); December 24, 2001 (28:25 Md. R. 2190); July 7, 2003 (30:13 Md. R. 854) Regulation .22 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999 Regulation .22 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulation .22 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; adopted permanently effective June 25, 2001 (28:12 Md. R. 1109) Regulation .22 amended effective December 24, 2001 (28:25 Md. R. 2190) Regulation .22A amended and F—J adopted effective November 1, 1999 (26:22 Md. R. 1692) Regulation .22C amended effective February 9, 1998 (25:3 Md. R. 144) Regulations .24 and .25 adopted as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .24 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulation .24 amended effective December 25, 2000 (27:25 Md. R.2281); December 23, 2002 (29:25 Md. R. 1981) Regulation .24-1 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 31, 2000 Regulation .26 adopted effective February 18, 2002 (29:3 Md. R. 220) Regulation .27 adopted effective February 18, 2002 (29:3 Md. R. 220) Chapter revised effective February 2, 2004 (31:2 Md. R. 82) Regulation .01 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .02G amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .02G, J, X amended effective November 7, 2016 (43:22 Md. R. 1221) Regulation .02K amended effective December 24, 2012 (39:25 Md. R. 1613) Regulation .02O, S amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .02V amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02Z adopted effective November 5, 2007 (34:22 Md. R. 1977) Regulation .02CC amended effective October 5, 2009 (36:20 Md. R. 1528); March 14, 2016 (43:5 Md. R. 385) Regulation .02DD adopted effective February 6, 2012 (39:2 Md. R. 141) Regulation .02EE adopted effective December 24, 2012 (39:25 Md. R. 1613) Regulation .02K, L amended effective October 28, 2013 (40:21 Md. R. 1775) Regulation .02FF adopted effective October 28, 2013 (40:21 Md. R. 1775) Regulation .03 amended effective February 12, 2018 (45:3 Md. R. 156) Regulation .03A, B amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .03B amended effective December 19, 2005 (32:25 Md. R. 1941); April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180) Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 27, 2010 (37:26 Md. R. 1787); February 6, 2012 (39:2 Md. R. 141); December 24, 2012 (39:25 Md. R. 1613); December 12, 2013 (40:24 Md. R. 2017); August 29, 2016 (43:17 Md. R. 955); November 7, 2016 (43:22 Md. R. 1221); December 31, 2018 (45:26 Md. R. 1245) Regulation .04B amended effective April 10, 2006 (33:7 Md. R. 668); February 16, 2015 (42:3 Md. R. 316) Regulation .04C amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205) Regulation .05I amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .05G amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .05K amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .06C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .08C, E amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .08I amended effective December 24, 2012 (39:25 Md. R. 1613) Regulation .08K amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .08M repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .10C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .10D amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .10E amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .10F amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .11 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .11E amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .11F amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .11G amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .11-1 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .11-2 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .12B amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .12D repealed effective December 31, 2018 (45:26 Md. R. 1244) Regulation .13F amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .14 amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .14A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .15 amended effective February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244) Regulation .15B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .15C amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .15D amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .15E amended effective December 19, 2005 (32:25 Md. R. 1941); April 19, 2010 (37:8 Md. R. 615) Regulation .15F amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .15L adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .16 repealed effective November 5, 2007 (34:22 Md. R. 1977) Regulation .17 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .17A amended effective November 6, 2006 (33:22 Md. R. 1732); June 30, 2008 (35:13 Md. R. 1180); February 6, 2012 (39:2 Md. R. 141) Regulation .17B amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); February 1, 2016 (42:23 Md. R. 1434) Regulation .18H amended effective November 5, 2007 (34:22 Md. R. 1977) Regulation .18I, J adopted effective February 6, 2012 (39:2 Md. R. 141) Regulation .19 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634) Regulation .19 amended as an emergency provision effective April 1, 2005 (32:9 Md. R. 847); amended permanently effective July 18, 2005 (32:14 Md. R. 1276) Regulation .19 amended effective April 15, 2013 (40:7 Md. R. 611) Regulation .19A, B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); amended permanently effective June 16, 2008 (35:12 Md. R. 1120) Regulation .19A amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .19B amended effective December 20, 2004 (31:25 Md. R.1790); December 19, 2005 (32:25 Md. R. 1941); April 10, 2006 (33:7 Md. R. 669) Regulation .19B amended as an emergency provision effective July 1, 2006 (33:20 Md. R. 1610); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) Regulation .19B amended as an emergency provision effective January 1, 2007 (34:4 Md. R. 396); amended permanently effective April 9, 2007 (34:7 Md. R. 699) Regulation .19B amended as an emergency provision effective September 14, 2007 (34:21 Md. R. 1911); amended permanently effective November 19, 2007 (34:23 Md. R. 2027) Regulation .19B amended effective January 12, 2009 (36:1 Md. R. 21); July 27, 2009 (36:15 Md. R. 1166); January 25, 2010 (37:2 Md. R. 67); June 14, 2010 (37:12 Md. R. 800); December 27, 2010 (37:26 Md. R. 1788); April 4, 2011 (37:8 Md. R. 431); April 30, 2012 (39:8 Md. R. 534); December 10, 2012 (39:24 Md. R. 1577); July 7, 2014 (41:13 Md. R. 752); February 16, 2015 (42:3 Md. R. 316); October 26, 2015 (42:21 Md. R. 1301); May 9, 2016 (43:9 Md. R. 530); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319); August 26, 2019 (46:17 Md. R. 726) Regulation .19D amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 446); amended permanently effective May 24, 2004 (31:10 Md. R. 795) Regulation .19D amended effective June 14, 2010 (37:12 Md. R. 800); October 26, 2015 (42:21 Md. R. 1301); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319) Regulation .19-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .19-3 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .19-3 amended effective June 19, 2006 (33:12 Md. R. 997); April 9, 2007 (34:7 Md. R. 698); June 14, 2010 (37:12 Md. R. 800); April 30, 2012 (39:8 Md. R. 534) Regulation .19-3 repealed effective October 28, 2013 (40:21 Md. R. 1775) Regulation .19-3 adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .19-3A, B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .19-3A, B amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .19-3B amended effective December 24, 2012 (39:25 Md. R. 1613); February 3, 2014 (41:2 Md. R. 91) Regulation .19-3C amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .19-3C, D amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .19-5 adopted effective December 19, 2005 (32:25 Md. R. 1941) Regulation .19-5 repealed and new Regulation .19-5 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .19-5F amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .19-5G amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .19-5H amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) Regulation .20 amended effective August 8, 2011 (38:16 Md. R. 945); February 26, 2018 (45:4 Md. R. 205) Regulation .20A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .20A amended effective April 10, 2006 (33:7 Md. R. 668); November 5, 2007 (34:22 Md. R. 1977); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316) Regulation .20A, B amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .20A, D amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .20B, C amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .20C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .20E adopted effective August 29, 2016 (43:17 Md. R. 955) Regulation .21 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .21 amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .21B amended effective June 19, 2006 (33:12 Md. R. 997); April 19, 2010 (37:8 Md. R. 615) Regulation .22 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .22C, D amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .23 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .23C amended effective November 7, 2016 (43:22 Md. R. 1221) Regulation .23D amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .23D amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .24 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .24 repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .25B amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .28 adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .28 amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .28 repealed effective February 26, 2018 (45:4 Md. R. 205) Chapter transferred to COMAR 10.67.04 effective November 1, 2019 (46:22 Md. R. 977) In this chapter, the following terms have the meanings indicated. Terms Defined. “Assistance in Community Integration Services (ACIS)” means the ACIS program, a health related social needs benefit for qualified individuals, which is implemented in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services. “Compliance activities” means tasks undertaken to ensure that ACIS is delivered in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services. “Continuum of Care Program” means the regional or local planning body that coordinates housing and services funding for families and individuals experiencing homelessness. “Homelessness” has the meaning stated in 24 CFR §578.3. “Lead entity” means a local health department or local governmental agency, which: Has been awarded participant spaces in the ACIS program; Is an enrolled provider with the Maryland Medical Assistance Program; Is responsible for leadership, coordination, oversight, and monitoring of ACIS; Shall serve as the organizing hub and contact point for ACIS with all collaborators, including the participant’s MCO; and Shall facilitate the financial arrangement and payments with designated subcontractors. “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Participant” has the meaning stated in COMAR 10.09.36.01. “Program” means the Maryland Medical Assistance Program. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. A lead entity shall: Have been awarded participant spaces for ACIS by the Program; and Be a member of its local Continuum of Care Program. Eligibility for ACIS services under this chapter is limited to individuals who meet the following health and housing criteria: The individual is a participant that uses Maryland Medical Assistance; The individual meets at least one of the following health criteria: Repeated emergency department visits; Repeated hospital admissions in the past year; or Two or more chronic conditions as defined in §1945(h)(2) of the Social Security Act; and The individual meets at least one of the following housing criteria: Is homeless, chronically homeless, or at risk of homelessness as defined in 24 CFR §578.3; or Is at risk of institutional placement. The Program shall cover the following ACIS services: Compliance activities; and Housing and tenancy-based case management services when three or more services, as specified in §B of this regulation, are delivered per month per participant. Housing and tenancy-based case management services include the following: Community integration assessments to identify the participant’s: Housing preferences; Needs for support to maintain community integration; Budgeting needs; Needs for assistance applying for social services; and Needs for support regarding understanding and meeting obligations of tenancy; The development of a person-centered community integration plan with enumerated measurable goals inclusive of review and modification of the plan when necessary; Participation in meetings related to: Housing support; Crisis management; and Person-centered planning; Assistance in connecting individuals with social services defined in the integration plan such as: Housing required to meet the participant’s medical care needs; Independent living services; Counseling services; Employment support services; Services required to meet the participant’s medical needs; Transportation for services; and Entitlement programs; Assistance in communication with property managers or landlord for accommodation needs; and Connecting the participant to training and resource support related to being housed and household management. Under this chapter, the Program does not cover the following: Services provided to or for the primary benefit of individuals other than the participant; Services rendered but not appropriately documented; and Room and board. Providers may not bill for monthly ACIS case-management services if less than three housing and tenancy-based case management services were rendered to the participant for the month. Providers may not bill for compliance activities more than once per participant per calendar year. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Payments for services rendered to a participant shall be made directly to the qualified lead entity. Effective January 1, 2025, rates for the services outlined in this chapter shall be as follows: $725 per member per month for ACIS housing and tenancy-based case management; and $100 per member per year for compliance activities. Recovery and reimbursement regulations are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08 Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: May 12, 2025 (52:9 Md. R. 405) Effective date: Regulations .01—.30 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .01 amended effective December 27, 2010 (37:26 Md. R. 1787); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .01A amended effective November 6, 2006 (33:22 Md. R. 1732); February 27, 2017 (44:4 Md. R. 253) Regulation .01B amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .01C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .01C amended effective August 16, 2004 (31:16 Md. R. 1255) Regulations .01D, .04, .06, .07B, .10, .13, .21A, and .28 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .01D amended effective December 19, 2005 (32:25 Md. R. 1941); October 5, 2009 (36:20 Md. R. 1528) Regulation .01G adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .02 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .03A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .03A amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .04 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .04A, C amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .04A, D amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .04C amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .04D amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .04G, H adopted effective February 6, 2012 (39:2 Md. R. 141) Regulation .05 amended effective February 18, 2002 (29:3 Md. R. 220) Regulation .05A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .06 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); amended permanently effective December 25, 2000 (27:25 Md. R. 2281) Regulation .06 repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .06A amended effective February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) Regulations .07, .09, .10, and .27 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .06 adopted effective February 16, 2015 (42:3 Md. R. 316) Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .07B amended effective December 24, 2012 (39:25 Md. R. 1613); February 27, 2017 (44:4 Md. R. 253) Regulation .07F adopted effective February 9, 1998 (25:3 Md. R. 144) Regulation .07F amended effective April 10, 2006 (33:73 Md. R. 668) Regulation .07G adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .07H adopted as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .07I adopted effective October 26, 2015 (42:21 Md. R. 1301) Regulation .08 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .09 amended effective February 9, 1998 (25:3 Md. R. 144); November 6, 2006 (33:22 Md. R. 1732) Regulation .10 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .10 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .10A amended effective February 2, 2004 (31:2 Md. R. 82); November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .10C amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 445); amended permanently effective April 12, 2004 (31:7 Md. R. 584) Regulation .10C repealed effective June 30, 2008 (35:13 Md. R. 1180) Regulation .11 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .11B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .11B amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .12 amended effective February 18, 2002 (29:3 Md. R. 220) Regulation .12 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .12 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .12 amended effective November 6, 2006 (33:22 Md. R. 1732); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 27, 2017 (44:4 Md. R. 253) Regulation .13A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .13D adopted effective February 2, 2004 (31:2 Md. R. 82) Regulation .14A, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .14C amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .15 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .15 amended effective November 6, 2006 (33:22 Md. R. 1732); November 7, 2016 (43:22 Md. R. 1221) Regulation .16 amended effective December 23, 2002 (29:25 Md. R. 1981); November 6, 2006 (33:22 Md. R. 1732) Regulation .17 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .18 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .19 amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); February 26, 2018 (45:4 Md. R. 205); October 22, 2018 (45:21 Md. R. 973) Regulation .20A amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144); February 18, 2002 (29:3 Md. R. 220); April 10, 2006 (33:7 Md. R. 668); December 24, 2012 (39:25 Md. R. 1613); April 28, 2014 (41:8 Md. R. 471); February 27, 2017 (44:4 Md. R. 252); October 22, 2018 (45:21 Md. R. 973) Regulation .21A amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) Regulation .21D amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .22 amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) Regulation .23 amended effective February 18, 2002 (29:3 Md. R. 220); November 6, 2006 (33:22 Md. R. 1732) Regulation .24 amended effective October 28, 2013 (40:21 Md. R. 1775); August 26, 2019 (46:17 Md. R. 726) Regulation .24A, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .24C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .25 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .26 amended effective November 6, 2006 (33:22 Md. R. 1732); February 16, 2015 (42:3 Md. R. 316) Regulation .26-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .26-2 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .26-3 adopted effective August 29, 2016 (43:17 Md. R. 955) Regulation .26-4 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .26-5 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .27 amended effective December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775) Regulation .27A amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); October 22, 2018 (45:21 Md. R. 973) Regulation .27B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .27B amended as an emergency provision effective March 9, 1998 (25:7 Md. R. 525); amended permanently effective June 15, 1998 (25:12 Md. R. 947) Regulation .27B amended effective November 1, 1999 (26:22 Md. R. 1692); December 25, 2000 (27:25 Md. R. 2281); December 23, 2002 (29:25 Md. R. 1981); February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) Regulation .27B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .27B amended effective April 10, 2006 (33:73 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) Regulation .28 amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316); April 10, 2017 (44:7 Md. R. 355) Regulation .28D amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .28G amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) Regulation .28H repealed effective December 23, 2002 (29:25 Md. R. 1981) Regulation .28H adopted effective November 6, 2006 (33:22 Md. R. 1732) Regulation .28H amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .28I adopted effective April 9, 2007 (34:7 Md. R. 698) Regulation .28I, J amended effective October 28, 2013 (40:21 Md. R. 1775) Regulation .28K adopted effective October 28, 2013 (40:21 Md. R. 1775) Regulation .29E—G adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .30 repealed effective December 31, 2018 (45:26 Md. R. 1244) Regulation .31 adopted effective April 28, 2014 (41:8 Md. R. 471) Chapter transferred to COMAR 10.67.06 effective November 1, 2019 (46:22 Md. R. 977) Effective date: February 26, 2018 (45:4 Md. R. 205) Regulation .01L amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .01N adopted effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred to COMAR 10.67.07 effective November 1, 2019 (46:22 Md. R. 977) The purpose of the Rare and Expensive Case Management (REM) program is to provide case management services and subspecialty care for Maryland Medicaid Managed Care Program eligible individuals with rare and expensive conditions. The program is designed to provide Maryland Medicaid Managed Care Program eligible individuals diagnosed with qualifying rare and expensive conditions the following benefits when the individual elects to participate in the program: Case management services; and REM optional services. In this chapter, the following terms have the meanings indicated. Terms Defined. “Activities of daily living” means tasks or activities that include but are not limited to bathing, feeding, toileting, dressing, and ambulation. “Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed. “Caregiver” means a willing and able individual who is trained in providing care to the participant. “Case management” means assessing, planning, coordinating, and monitoring the delivery of medically necessary health-related services. “Case management provider” means the Department's designee, or a subcontractor of the designee, which provides case management to participants assigned to it by the Department. “Case manager” means, an individual who is: A social worker with active and nationally recognized certification in case management or an RN; Employed by the Department's designee; and Assigned by the Department's designee to manage the care of some or all of the participants. “Cause” means a significant change in medical condition such that it is no longer medically efficacious for the individual to remain in the MCO as determined by the Department. “Certified medication technician (CMT)” means an individual who: Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing; Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. “Certified nursing assistant (CNA)” means an individual who: Is certified by the Maryland Board of Nursing under COMAR 10.39.05; and Routinely performs nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. “Certified nursing assistant certified as a CMT (CNA-CMT)” means an individual who: Is certified by the Maryland Board of Nursing under COMAR 10.39.05 and 10.39.04; Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing; and Routinely performs nursing tasks including medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. “Chiropractor” means an individual who is licensed by the Maryland State Board of Chiropractic Examiners to practice chiropractic in Maryland. “Delegated nursing services” means nursing services provided to a participant by a CNA, CNA-CMT, HHA, or HHA-CMT under the supervision of an RN in accordance with COMAR 10.27.11. “Dental service provider” means an individual who is licensed and legally authorized to practice dentistry in the state in which the service is provided. “Department” means the Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. “Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Maryland State Board of Dietetic Practice to practice dietetics in Maryland. “Early and periodic screening, diagnosis, and treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects, physical and mental illnesses, and conditions discovered by EPSDT screening services. “EPSDT-certified provider” means a physician, physician assistant or nurse practitioner who is certified by the Department's EPSDT program to provide well-child services according to the Department's periodicity schedule and program standards to enrollees younger than 21 years old. “EPSDT periodicity schedule” means the list approved by the Department of required or recommended preventive health care services for children and adolescents. “EPSDT services” means: Screening services provided by an EPSDT-certified provider that are required or recommended on the EPSDT periodicity schedule; and Health care services performed to diagnose, treat, or refer problems or conditions discovered during the comprehensive well-child service. “Evaluation” means a determination of the health status of a patient in a patient's home or any other appropriate setting by a licensed professional for the purpose of designing an individual plan of care, which incorporates the modalities of treatment that will promote optimal functional ability and recuperation. “Family member” means an adult who: Lives with or provides care to the participant; and Is not paid to provide the care under the REM program. “HealthChoice” means Maryland Medicaid's Statewide mandatory managed care program as defined in COMAR 10.67.04. “Home” means the place of residence, occupied by the participant, other than a residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment. “Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10. “Home health aide (HHA)” means an individual who meets all the conditions of participation specified in: 42 CFR §484.36; and Health Occupations Article, Title 8, Annotated Code of Maryland. “Home health aide certified as a CMT (HHA-CMT)” means an individual who: Meets all the conditions of participation specified in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland; and Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing. “Hospital” means an institution licensed by and providing services in accordance with Health-General Article, §19-301, Annotated Code of Maryland. “Individualized education program (IEP)” means a written description of special education and related services developed by an IEP team to be implemented to meet the individual needs of a child. “Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family developed by an IFSP team. “Interdisciplinary team" means the group comprised of the case manager and relevant service providers to develop the case management plan under the overall direction and coordination of the case manager, in consultation with the participant and, when applicable, the participant's family. “Intermediate care facility for individuals with intellectual disabilities or individuals with related conditions (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that provides health-related services or health rehabilitative services for individuals with intellectual disabilities or related conditions. “Licensed practical nurse (LPN)” means an individual licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for categorically eligible and medically needy individuals. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, the participant's family, or the provider. “Medicare” means the federal program that provides benefits to the aged and disabled under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Nurse” means an individual who is licensed to practice as a registered nurse (RN) or a licensed practical nurse (LPN) in the jurisdiction in which services are provided. “Nurse practitioner” means an individual who is licensed and certified to practice as a nurse practitioner in the jurisdiction in which services are provided. “Nursing facility” has the meaning stated in COMAR 10.09.10.01B. “Nutritional counseling” means the assessment of the participant's nutritional status and education about improving their nutritional status provided by a licensed dietitian-nutritionist. “Nutritional supplements” means enteral feeding which is medically indicated as either the sole source of nutrition or a supplement that enhances the physical well-being of the participant. “Occupational therapist” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice occupational therapy in Maryland. “Participant” means an eligible individual who is enrolled in the Program. “Physician” means an individual who is licensed or otherwise legally authorized to practice in the jurisdiction in which the services are rendered. “Physician assistant” means an individual who is licensed to practice medicine with physician supervision as stated in the Health Occupations Article, §§15-301(d) and (e) and 15-302, Annotated Code of Maryland. “Plan of care” means the document which governs a participant's care management which includes the: Case management assessment report; Interdisciplinary plan of care; and Case management plan. “Preauthorization” means the approval required from the Department or its designee before specific services may be rendered. “Primary care provider (PCP)” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medicaid Managed Care Program, as specified in COMAR 10.67.06. “Private duty nursing” means skilled nursing services for participants, who require more individual and continuous care than is available under the home health program, which are provided by a registered nurse (RN) or a licensed practical nurse (LPN), in a participant's home or another setting when normal life activities take the participant outside his or her home. “Program”, unless the context indicates otherwise, has the meaning stated in COMAR 10.09.36.01B. “Progress note” means a signed and dated written notation by the RN, LPN, CNA, CNA-CMT, HHA, or HHA-CMT, which: Summarizes facts about the care given and the participant's response during a given period of time; Specifically addresses the established goals of treatment; Is consistent with the participant's plan of care; and Is written during the course of care. “Provider” means an individual, agency, or facility, which is enrolled in the Program through an agreement with the Department, and has been identified as a Program provider by the issuance of a provider number. “Rare and expensive case management (REM)” means a Maryland Medical Assistance program that provides case management services and optional services to eligible individuals with specific rare and expensive conditions. “Rare and expensive condition” means a medical diagnosis or condition identified in Regulation .16 of this chapter. “Registered nurse (RN)” means an individual licensed to practice registered nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. “REM optional services” means the services listed in Regulations .10 and .11 of this chapter, which meet the general requirements under Regulation .09 of this chapter. “Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05. “Residential treatment center” means any institution which falls within the jurisdiction of Health-General Article, §19-308, Annotated Code of Maryland, and is licensed as required by COMAR 10.07.04 or other applicable standards established by the state in which the service is provided. “School” means courses or classes for the acquisition of a General Education Diploma, a high school diploma, an associate degree, or a first-time bachelor’s degree. “Social worker” means an individual who is licensed by the Maryland State Board of Social Work Examiners to practice social work in Maryland. “Speech-language pathologist” means an individual who is licensed by the Maryland Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice speech-language pathology in Maryland. An individual is eligible to participate in the REM program if the individual: Is eligible for Maryland Medicaid Managed Care as specified in COMAR 10.67.02.01; Has one or more of the diagnoses specified in Regulation .17 of this chapter; and Elects to participate in the REM program. The Department shall render a determination of an individual's eligibility within 5 business days on receipt of: A completed REM application; Any requested documentation verifying an individual meets the criteria set forth in §A of this regulation; and Verbal or written confirmation an individual elects to participate. Anyone may refer an individual into the REM program including, but not limited to a: Family member; Physician; Discharge planner; Hospital; Clinic; Social worker; and Managed care organization (MCO). The Department shall enroll an individual determined eligible in the REM program when: All pertinent documentation regarding needed medical services is received, reviewed, and approved; Confirmation of the individual's election to participate in the program is received; and The individual is being discharged from an institution or transitioning from an MCO and service coordination is complete. When an MCO participant is referred to the REM program for enrollment, the MCO shall: Provide confirmation of the qualifying diagnosis to the Department; and Continue to provide the MCO participant's care until the Department confirms the diagnosis and enrolls the MCO participant into REM. An individual shall be enrolled in or auto-assigned into an MCO as specified in COMAR 10.67.02, not later than 60 days from the date the individual becomes ineligible for REM, as a result of changes in the diagnosis or age group criteria specified in Regulation .17 of this chapter, except when the individual was allowed to remain in REM in accordance with §I of this regulation. A REM participant may elect to disenroll from REM and enroll in an MCO by notifying the Department of that decision except when the individual was allowed to remain in REM in accordance with §I of this regulation. Election to Remain in MCO. An individual who becomes eligible for REM while enrolled in an MCO may elect to remain in an MCO by notifying the Department of that decision. When a REM-eligible individual elects to remain in an MCO, the Department, in consultation with the MCO and the REM-eligible individual, may determine whether the MCO can appropriately meet the individual's medical needs within the parameters of the program benefit package as described in COMAR 10.67.06. If the MCO determines it cannot appropriately meet the individual's medical needs, the MCO shall submit to the Department written justification for its decision. If the Department determines the MCO can meet the individual's medical needs, the Department shall notify the MCO of its decision in writing. If the Department determines that the MCO cannot appropriately meet the individual's needs, the Department shall issue a written determination to the individual and the MCO which includes: The reason for the determination; and An explanation of the individual's right to appeal the determination according to the procedures set forth in COMAR 10.01.04. If the Department determines that the MCO can appropriately meet the individual's medical needs, the individual's election becomes effective and cannot be revoked without cause for a period of 1 year from the effective date. The Department shall allow an individual who, immediately before enrollment in REM, was receiving medical services from a specialty clinic or other setting to continue to receive services in that setting on enrollment in the REM program when the provider is willing to participate as a Medical Assistance fee-for-service provider. An individual eligible for REM who has elected to enroll in an MCO or to remain enrolled in an MCO may not receive REM services under the REM program. The Department shall disenroll from the REM program a participant who no longer meets the conditions specified in Regulation .03 of this chapter unless: The participant does not meet the condition under Regulation .03A(1) of this chapter because the participant becomes eligible for Medicare; and At the time the participant became eligible for Medicare the participant was approved for and was receiving private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services under the REM program. An individual disenrolled from REM by the Department who maintains HealthChoice eligibility is subject to the MCO enrollment provisions specified in COMAR 10.67.02 except when the individual was allowed to remain in REM in accordance with §I of this regulation. Department-Initiated Disenrollment. The Department shall disenroll from REM an enrollee: Who has been continuously institutionalized for a period of more than 90 successive days in a long-term care facility, subject to the long-term care facility obtaining the Department’s determination that the enrollee’s institutionalization has been medically necessary; Who has been, or is expected to be, continuously institutionalized for more than 30 successive days in an institution for mental disease (IMD); Upon admission to an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID); Who loses Medicaid eligibility or who changes to an assistance category not eligible for MCO enrollment, subject to COMAR 10.67.02; Who has died; or Who is an inmate of a public institution, including a State-operated institution or facility. Effective Date of Disenrollment. An enrollee’s disenrollment shall take effect: Immediately when the enrollee dies; From the first day of the month following the month in which the enrollee lost Medicaid eligibility; On the first day of the month following the month in which the Department receives the required notification, when the enrollee permanently relocates outside of the State; or From the first day of the month following the month in which the Department verifies an enrollee is an inmate. A REM participant is eligible for the following: Fee-for-service Medical Assistance benefits available to a Medical Assistance participant not enrolled in an MCO; Services described in Regulations .10 and .11 of this chapter when determined medically necessary by the Department; A case management assessment performed by a REM case manager who shall: Gather all relevant information needed to determine the participant’s condition and needs including the participant’s medical records; Consult with the participant's current service providers; and Evaluate the relevant information and complete a needs analysis including medical, psychosocial, environmental, and functional assessments; and Case management services performed by a REM case manager who shall: When necessary, assist the REM participant, offering the participant a choice, if possible, in selecting and obtaining a PCP, who may be a specialist to the participant’s condition, giving preference to any pre-established relationships between the participant and the participant’s PCP; Develop a plan of care in consultation with the participant, the participant's family members as authorized by the participant when possible, the PCP, and other providers rendering care that: Includes the participant's health status and needs for medical, health-related, housing, and social services including, but not limited to: All pertinent diagnoses including the REM qualifying diagnosis; Type, frequency, and duration of services; Treatment goals for each type of service; Medical equipment and supplies; Medication; Social support structure; Current service providers; Assigned level of care; Nutritional status; Education or vocational information; Current living arrangement; and Emergency plan, if appropriate; and Is developed in consultation with the interdisciplinary team; Implement the plan of care and assist the participant in gaining access to medically necessary services by linking the participant to those services; Monitor service delivery, perform record reviews, and maintain contacts with the participant, services providers, and family members to evaluate the participant's condition and progress and to determine whether revision is needed in the plan of care or in services' delivery; As necessary, initiate and implement modifications to the plan of care and communicate these changes to the participant, parents or caregivers, and pertinent health care providers; Monitor a participant's receipt of EPSDT services as specified in COMAR 10.67.06; and Assist the participant with the coordination of school health-related services such as the IEP or the IFSP as described in COMAR 10.09.50. A case manager providing case management under this chapter shall be: An RN; or A social worker. The following professionals providing services under this chapter to REM participants shall be licensed, certified, or otherwise legally authorized to practice in the jurisdiction in which the services are rendered: Physicians; Physician Assistants; Nurse Practitioners; RNs and LPNs; Chiropractors; Dentists; Dietitian-Nutritionists; Occupational therapists; Social workers; Speech-language pathologists; and CNAs, HHAs, CNA-CMTs, and HHA-CMTs. A provider rendering services pursuant to this chapter shall meet all applicable licensure and certification requirements of the jurisdiction in which the provider is providing services. A provider rendering services to REM participants, pursuant to this chapter, may not have current sanctions or current disciplinary actions imposed by: The jurisdictional licensing or certification authority; The Medicare Program; The Program; or Other federally funded healthcare programs. A provider rendering services pursuant to this chapter shall: Meet the applicable conditions for participation set forth in COMAR 10.09.36; Meet the provider qualification requirements specified in Regulation .06 of this chapter for its provider type; Meet the specific conditions for provider participation set forth in this chapter; Provide services in accordance with the applicable requirements of this chapter and all other relevant State and local laws and regulations; Verify the qualifications of all subcontracted or employed professionals and individuals engaged by the provider agency to render services covered under this chapter and provide a copy of their current licensure and credentials on request to the Department; Provide services to REM program participants in a manner consistent with the REM participant’s plan of care; and When the Department determines it is necessary, participate in the interdisciplinary team meetings for the purpose of: Developing and implementing a participant's treatment plan or plan of care with the Department; or Accessing a specific service. Case Management Providers. To participate in the Program, a case management provider shall meet the conditions set forth in Regulations .06 and .07 of this chapter. Chiropractic Service Providers. To participate in the Program, the chiropractic service provider shall: Meet the: Conditions set forth in Regulation .07 of this chapter; and Requirements for chiropractic providers specified in COMAR 10.43.04; Develop a goal-directed treatment plan that is based on an evaluation conducted during the initial assessment, which requires: A review or evaluation of the treatment plan 30 days after the initial assessment; and A review and update of the treatment plan every 90 days; and Render services in accordance with orders written by a physician, physician assistant, or nurse practitioner. Dental Service Providers. To participate in the Program, the dental service provider shall meet the: Conditions set forth in Regulation .07 of this chapter; and Requirements for dental providers specified in COMAR 10.09.05. Nutritional Supplement Providers. To participate as a provider of nutritional supplements, a provider shall meet the: Conditions of participation as set forth in Regulation .07 of this chapter; and Criteria of the conditions for participation for pharmacy providers set forth in COMAR 10.09.03. Shift Private Duty Nursing/CNA/CNA-CMT/HHA/HHA-CMT Providers. To participate as a provider agency for shift private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services, a provider shall: Meet the conditions set forth in Regulation .07 of this chapter; Meet all requirements of conditions for participation set forth in COMAR 10.09.53.03; Participate in interdisciplinary team meetings, when requested by the Department or its designee; Develop a goal-directed written nursing care plan that is based on an evaluation conducted during the initial assessment, which requires: A review or evaluation of the nursing care plan 30 days after the initial assessment; and A review and update of the nursing care plan every 90 days; Ensure timesheets are signed by the individual rendering services; Ensure a nurse's, CNA’s, CNA-CMT’s, HHA’s, or HHA-CMT’s shift to be not more than a total of 60 hours per week or 16 consecutive hours and that the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department; Obtain the participant's signature or the signature of the participant's witness on the provider's official forms to verify receipt of service; and Be licensed as a: Residential service agency in accordance with COMAR 10.07.05; or Home health agency in accordance with COMAR 10.07.10 which meets the conditions of participation specified by the Medicare program in 42 CFR §484.36. Occupational Therapy Providers. To participate in the Program as a provider of occupational therapy services, a provider shall: Meet the conditions set forth in Regulation .07 of this chapter; Be a self-employed occupational therapist licensed according to COMAR 10.46.01; Be an agency or clinic which employs occupational therapists or be a Program provider of home health services under COMAR 10.09.04; and Develop a goal-directed written treatment plan that is based on an evaluation conducted during the initial assessment which requires: A review or evaluation of the treatment plan 30 days after the initial assessment; and A review and update of the treatment plan every 90 days. Speech-Language Pathology Providers. To participate in the Program, a speech-language pathology provider shall: Meet the conditions set forth in Regulation .07 of this chapter; Be a self-employed speech-language pathologist according to COMAR 10.41.03 or be a Program provider of home health services under COMAR 10.09.04; Be an agency or clinic that employs speech-language pathologists; and Develop a goal-directed written treatment plan that is based on an initial assessment, which requires: A review or evaluation of the treatment plan 30 days after the initial assessment; and A review and update of the treatment plan every 90 days. For participants in the REM program, the Program covers and shall reimburse for services specified in Regulations .10 and .11 of this chapter when these services are: Medically necessary; Prescribed by a: Physician; Physician assistant; or Nurse practitioner; Preauthorized, when required, by the Department; Rendered in accordance with accepted health professional standards; Rendered in accordance with the treatment plan or physician's, physician assistant’s, or nurse practitioner’s order, or both; and Delivered by an enrolled Medical Assistance provider. Chiropractic services are covered for REM participants when: Services are provided to a REM participant who is 21 years old or older; Services are provided by a physician or chiropractor; The qualifying REM diagnosis or related illness shows deterioration or worsening symptoms and other traditional treatments have been ineffective; The treatment enhances or restores the participant's level of functioning; or Symptoms resulting from the REM diagnosis or related illness impairs a participant's activities of daily living. Dental services are covered when services are: Provided to a REM participant who is 21 years old or older; and Rendered as specified in COMAR 10.09.05. Nutritional counseling services are covered when services are provided: To a REM participant who is 21 years old or older; and By a dietitian-nutritionist. Nutritional supplements are covered when the services: Include nutritional supplements or enteral feeding when medically necessary other than those administered by tube; and Are as described in COMAR 10.09.03. The Department shall cover a physician's, physician assistant’s, or nurse practitioner’s participation at interdisciplinary team meetings when the case manager, in conjunction with the team or specific team members, convenes the team meeting for the purpose of developing or reviewing the REM participant's plan of care to ensure continuity of care or access to a specific service. Occupational therapy services are covered when services are provided: To a REM participant who is 21 years old or older; By an occupational therapist; and In accordance with COMAR 10.46.01 and 10.46.02. Speech-language pathology services include only those services that are provided: To a REM participant who is 21 years old or older; By a speech-language pathologist; and In accordance with COMAR 10.41.02 and 10.41.03. The Program shall cover shift nursing services provided by an RN or LPN when: The services are more individualized and continuous than what is available under the home health program; The services are delivered to the participant in the participant's home, in school, or in other normal life activity setting or settings which occur outside the participant's home; Services are provided to a REM participant who is 21 years old or older; Services are determined medically necessary for a participant after the provider has completed an initial nursing assessment that reflects the participant’s need for an awake and alert caregiver; The participant has at least one caregiver willing and able to accept responsibility for the participant’s care when the nurse, CNA, or HHA is not available; The caregiver provides documentation of each of the following when applicable: The caregiver’s work schedule along with commuting times; The caregiver’s school attendance as defined in Regulation .02 of this chapter along with commuting times; and Emergency circumstances, as determined by the Department, including but not limited to the inability of the primary caregiver to provide care due to hospitalization or an acute debilitating illness for up to a 60-day period; Services are provided only in the absence of the willing and able caregiver during the sleeping hours and during the times documented in §A(6) of this regulation; Services are rendered in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland; Sufficient documentation concerning the services provided is maintained by the RN or LPN including: Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and Signed and dated progress notes which are reviewed monthly by the RN supervisor; The nurse's shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the nurse is off 8 or more hours before starting another shift unless otherwise authorized by the Department; Services are rendered by an RN or an LPN who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; and Monthly supervisory visits of an RN or an LPN are: Conducted and documented by an RN supervisor; and Based on acceptable standards of practice. The Program shall cover service`s provided by a CNA or CNA-CMT when: The CNA or CNA-CMT is certified by the Maryland Board of Nursing and meets all the requirements to render services pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; The CNA-CMT has completed the training and has been certified by the Maryland Board of Nursing as a CMT; Services are of a scope that is more individual and continuous than what is available under the home health program; The services provided include but are not limited to: Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or Other health care services properly delegated by an RN or an LPN pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; Services are rendered by a CNA or CNA-CMT who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; The CNAs or CNA-CMTs shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the CNA or CNA-CMT has 8 hours or more off before starting another shift unless otherwise authorized by the Department; Sufficient documentation concerning the services provided is maintained by the CNA or CNA-CMT including: Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and Signed and dated progress notes which are reviewed every 2 weeks by the RN supervisor; Supervisory visits are conducted and documented every 2 weeks by an RN; The services are included in the REM participant's plan of care developed by the case manager; and Services are preauthorized by the Department. The Program shall cover services provided by a HHA or HHA-CMT when: Services are provided by an unlicensed individual who meets all the conditions of participation specified by the Medicare program in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland; The HHA-CMT has completed the training and has been certified by the Maryland Board of Nursing as a CMT; Services are more individualized and continuous than what is available under the home health program; The services provided include but are not limited to: Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or Other health care services properly delegated by an RN or LPN pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; Services are rendered by a HHA or HHA-CMT who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; The HHAs or HHA-CMTs shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the HHA or HHA-CMT has 8 hours or more off before starting another shift unless otherwise authorized by the Department; Sufficient documentation is maintained by the HHA or HHA-CMT including: Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and Signed and dated progress notes which are reviewed every 2 weeks by the RN supervisor; Supervisory visits are conducted and documented every 2 weeks by an RN; The services are included in the REM participant's plan of care developed by the case manager; and Services are preauthorized by the Department. The Department shall pay for services specified in this chapter delivered to a REM participant only if the services have been ordered by the participant's physician or nurse practitioner, and preauthorized, when necessary, by the Department or its designee. For REM participants, the Department may not pay for the following comparable case management services: HIV targeted case management as described in COMAR 10.09.32, except for HIV Diagnostic Evaluation Services as described in COMAR 10.09.32.03C and .04A; and Model Waiver case management as described in COMAR 10.09.27. The REM program does not cover the following: Shift private duty nursing, CNA or CNA-CMT, or HHA or HHA-CMT services rendered by a nurse, CNA, HHA, CNA-CMT, or HHA-CMT who is a member of the participant's immediate family or who ordinarily resides with the participant; Services which are not medically necessary; Services not supervised by an RN when delivered by the following: An RN or an LPN; A CNA; An HHA; A CNA-CMT; or An HHA-CMT. REM optional services not preauthorized as required by the Department or its designee; REM optional services not prescribed by the participant's physician, physician assistant, or nurse practitioner; Services specified in this chapter which duplicate or supplant services rendered by the participant's family caregivers or primary caregivers as well as other insurance, privilege, entitlement, or Program services that the participant receives or is eligible to receive; Services provided for the convenience or preference of the participant or the primary caregiver rather than required by the participant's medical condition; Speech, language, or occupational therapy services rendered in a classroom setting; Shift private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services ordered by a physician assistant; Custodial services; Services provided to a participant in a: Hospital; Residential treatment center; Intermediate care facility for individuals with intellectual disabilities; or Residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment; Services not directly related to the participant’s plan of care; Services described in the plan of care whenever a major change occurs in the participant's medical condition or skilled nursing care needs that indicates such services are no longer necessary; Services which are not initially ordered before the start of care and renewed every 60 days by the participant’s primary medical provider; Services provided by a nurse, CNA, or HHA who does not possess a valid, current, and nontemporary nursing license or certifications to provide services in the jurisdiction in which nursing services are rendered; Services provided by a nurse, CNA, or HHA who does not have a current cardiopulmonary resuscitation (CPR) certification for the period during which the services are rendered; Direct payment for supervisory visits that do not meet acceptable standards of practice in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11; Services rendered to a participant by a nurse, CNA, or HHA in the assigned staff’s home; Services not documented; and Respite services. The Program shall only cover one-to-one nursing when a participant’s condition requires that level of service and shared services are not an option. The Program shall only cover nursing services ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service. Except for initial assessments unless otherwise specified, preauthorization by the Department or its designee is required for all services under Regulations .10 and .11 of this chapter. The Department or its designee shall issue preauthorization when the Department: Determines that services are medically necessary; and Authorizes the services before the initiation or continuance of the requested service. Authorization of services shall be rescinded by the Department or its designee when: The participant is admitted to a hospital, residential treatment center, nursing facility, or ICF/IID; The participant is no longer REM eligible; The Department determines the care is no longer medically necessary; or The participant dies. A provider shall submit a request for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36. The Department shall pay for covered services at the lower of: The lowest price, including negotiated contract prices, that is offered to any other purchaser for the same or similar service during the same time period, after extending to the Program all rebates, coupons, and negotiated discounts; The actual charge billed by the provider; or Any fee schedule developed for reimbursement of the same service provided under Medical Assistance. For dates of service from January 1, 2021, through June 30, 2022, the Department shall pay $445.86 for a case management assessment, as described in Regulation .05C of this chapter. For dates of service from January 1, 2021, through June 30, 2022, the Department shall make payments monthly for case management services at one of the rates specified below: Level of Care 1: $329.22; Level of Care 2: $196.22; or Level of Care 3: $103.56. Effective July 1, 2022, the Department shall pay $463.69 for a case management assessment, as described in Regulation .05C of this chapter. Effective July 1, 2022, the Department shall make payments monthly for case management services at one of the rates specified below: Level of Care 1: $342.39; Level of Care 2: $204.07; or Level of Care 3: $107.70. The rates found in §§E and G of this regulation are the monthly rates paid by the Department for a participant receiving case management as follows: Level of Care 1 is intensive level of case management, assessment, and coordination of services for a participant who: Is acutely ill; Has an unstable clinical condition; Has an exacerbated chronic illness; or Has a newly diagnosed condition; Level of Care 2 is case management to a participant who has a history of exacerbations of medical issues requiring services on an ongoing basis to attain stable service or treatment plans; and Level of Care 3 is case management that is required on an ongoing basis to monitor a participant’s stability and treatment plans. Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36. Cause for suspension or removal and imposition of sanctions is set forth in COMAR 10.09.36. ICD10 ICD 10 Description Age Limit B20 Human immunodeficiency virus (HIV) disease 0—20 C96.0 Multifocal and multisystemic Langerhans-cell histiocytosis 0—64 C96.5 Multifocal and unisystemic Langerhans-cell histiocytosis 0—64 C96.6 Unifocal Langerhans-cell histiocytosis 0—64 D61.01 Constitutional (pure) red blood cell aplasia 0—20 D61.09 Other constitutional aplastic anemia 0—20 D66 Hereditary factor VIII deficiency 0—64 D67 Hereditary factor IX deficiency 0—64 D68.00 Von Willebrand disease, unspecified 0—64 D68.01 Von Willebrand disease, type 1 0—64 D68.020 Von Willebrand disease, type 2A 0—64 D68.021 Von Willebrand disease, type 2B 0—64 D68.022 Von Willebrand disease, type 2M 0—64 D68.023 Von Willebrand disease, type 2N 0—64 D68.029 Von Willebrand disease, type 2, unspecified 0—64 D68.03 Von Willebrand disease, type 3 0—64 D68.04 Acquired von Willebrand disease 0—64 D68.09 Other von Willebrand disease 0—64 D68.1 Hereditary factor XI deficiency 0—64 D68.2 Hereditary deficiency of other clotting factors 0—64 E70.0 Classical phenylketonuria 0—20 E70.1 Other hyperphenylalaninemias 0—20 E70.20 Disorder of tyrosine metabolism, unspecified 0—20 E70.21 Tyrosinemia 0—20 E70.29 Other disorders of tyrosine metabolism 0—20 E70.30 Albinism, unspecified 0—20 E70.40 Disorders of histidine metabolism, unspecified 0—20 E70.41 Histidinemia 0—20 E70.49 Other disorders of histidine metabolism 0—20 E70.5 Disorders of tryptophan metabolism 0—20 E70.81 Aromatic L-amino acid decarboxylase deficiency 0—20 E70.89 Other disorders of amino-acid metabolism 0—20 E71.110 Isovaleric acidemia 0—20 E71.111 3-methylglutaconic aciduria 0—20 E71.118 Other branched-chain organic acidurias 0—20 E71.120 Methylmalonic acidemia 0—20 E71.121 Propionic acidemia 0—20 E71.128 Other disorders of propionate metabolism 0—20 E71.19 Other disorders of branched-chain amino-acid metabolism 0—20 E71.2 Disorder of branched-chain amino-acid metabolism, unspecified 0—20 E71.310 Long chain/very long chain acyl CoA dehydrogenase deficiency 0—64 E71.311 Medium chain acyl CoA dehydrogenase deficiency 0—64 E71.312 Short chain acyl CoA dehydrogenase deficiency 0—64 E71.313 Glutaric aciduria type II 0—64 E71.314 Muscle carnitine palmitoyltransferase deficiency 0—64 E71.318 Other disorders of fatty-acid oxidation 0—64 E71.32 Disorders of ketone metabolism 0—64 E71.39 Other disorders of fatty-acid metabolism 0—64 E71.41 Primary carnitine deficiency 0—64 E71.42 Carnitine deficiency due to inborn errors of metabolism 0—64 E71.50 Peroxisomal disorder, unspecified 0—64 E71.510 Zellweger syndrome 0—64 E71.511 Neonatal adrenoleukodystrophy 0—64 E71.518 Other disorders of peroxisome biogenesis 0—64 E71.520 Childhood cerebral X-linked adrenoleukodystrophy 0—64 E71.521 Adolescent X-linked adrenoleukodystrophy 0—64 E71.522 Adrenomyeloneuropathy 0—64 E71.528 Other X-linked adrenoleukodystrophy 0—64 E71.529 X-linked adrenoleukodystrophy, unspecified type 0—64 E71.53 Other group 2 peroxisomal disorders 0—64 E71.540 Rhizomelic chondrodysplasia punctata 0—64 E71.541 Zellweger-like syndrome 0—64 E71.542 Other group 3 peroxisomal disorders 0—64 E71.548 Other peroxisomal disorders 0—64 E72.01 Cystinuria 0—20 E72.02 Hartnup’s disease 0—20 E72.03 Lowe’s syndrome 0—20 E72.04 Cystinosis 0—20 E72.09 Other disorders of amino-acid transport 0—20 E72.11 Homocystinuria 0—20 E72.12 Methylenetetrahydrofolate reductase deficiency 0—20 E72.19 Other disorders of sulfur-bearing amino-acid metabolism 0—20 E72.20 Disorder of urea cycle metabolism, unspecified 0—20 E72.21 Argininemia 0—20 E72.22 Arginosuccinic aciduria 0—20 E72.23 Citrullinemia 0—20 E72.29 Other disorders of urea cycle metabolism 0—20 E72.3 Disorders of lysine and hydroxylysine metabolism 0—20 E72.4 Disorders of ornithine metabolism 0—20 E72.51 Non-ketotic hyperglycinemia 0—20 E72.52 Trimethylaminuria 0—20 E72.53 Primary hyperoxaluria 0—20 E72.59 Other disorders of glycine metabolism 0—20 E72.81 Disorders of gamma aminobutyric acid metabolism 0—20 E72.89 Other specified disorders of amino-acid metabolism 0—20 E74.00 Glycogen storage disease, unspecified 0—20 E74.01 von Gierke disease 0—20 E74.02 Pompe disease 0—20 E74.03 Cori disease 0—20 E74.04 McArdle disease 0—20 E74.09 Other glycogen storage disease 0—20 E74.12 Hereditary fructose intolerance 0—20 E74.19 Other disorders of fructose metabolism 0—20 E74.21 Galactosemia 0—20 E74.29 Other disorders of galactose metabolism 0—20 E74.4 Disorders of pyruvate metabolism and gluconeogenesis 0—20 E75.00 GM2 gangliosidosis, unspecified 0—20 E75.01 Sandhoff disease 0—20 E75.02 Tay-Sachs disease 0—20 E75.09 Other GM2 gangliosidosis 0—20 E75.10 Unspecified gangliosidosis 0—20 E75.11 Mucolipidosis IV 0—20 E75.19 Other gangliosidosis 0—20 E75.21 Fabry (-Anderson) disease 0—20 E75.22 Gaucher disease 0—20 E75.23 Krabbe disease 0—20 E75.242 Niemann-Pick disease type C 0—20 E75.243 Niemann-Pick disease type D 0—20 E75.244 Niemann-Pick disease type A/B 0—20 E75.25 Metachromatic leukodystrophy 0—20 E75.26 Sulfatase deficiency 0—20 E75.29 Other sphingolipidosis 0—20 E75.3 Sphingolipidosis, unspecified 0—20 E75.4 Neuronal ceroid lipofuscinosis 0—20 E75.5 Other lipid storage disorders 0—20 E76.01 Hurler’s syndrome 0—64 E76.02 Hurler-Scheie syndrome 0—64 E76.03 Scheie’s syndrome 0—64 E76.1 Mucopolysaccharidosis, type II 0—64 E76.210 Morquio A mucopolysaccharidoses 0—64 E76.211 Morquio B mucopolysaccharidoses 0—64 E76.219 Morquio mucopolysaccharidoses, unspecified 0—64 E76.22 Sanfilippo mucopolysaccharidoses 0—64 E76.29 Other mucopolysaccharidoses 0—64 E76.3 Mucopolysaccharidosis, unspecified 0—64 E76.8 Other disorders of glucosaminoglycan metabolism 0—64 E77.0 Defects in post-translational mod of lysosomal enzymes 0—20 E77.1 Defects in glycoprotein degradation 0—20 E77.8 Other disorders of glycoprotein metabolism 0—20 E79.1 Lesch-Nyhan syndrome 0—64 E79.2 Myoadenylate deaminase deficiency 0—64 E79.8 Other disorders of purine and pyrimidine metabolism 0—64 E79.9 Disorder of purine and pyrimidine metabolism, unspecified 0—64 E80.3 Defects of catalase and peroxidase 0—64 E84.0 Cystic fibrosis with pulmonary manifestations 0—64 E84.11 Meconium ileus in cystic fibrosis 0—64 E84.19 Cystic fibrosis with other intestinal manifestations 0—64 E84.8 Cystic fibrosis with other manifestations 0—64 E84.9 Cystic fibrosis, unspecified 0—64 E88.40 Mitochondrial metabolism disorder, unspecified 0—64 E88.41 MELAS syndrome 0—64 E88.42 MERRF syndrome 0—64 E88.49 Other mitochondrial metabolism disorders 0—64 E88.89 Other specified metabolic disorders 0—64 F84.2 Rett’s syndrome 0—20 G11.0 Congenital nonprogressive ataxia 0—20 G11.10 Early-onset cerebellar ataxia, unspecified 0—20 G11.11 Friedreich ataxia 0—20 G11.19 Other early-onset cerebellar ataxia 0—20 G11.2 Late-onset cerebellar ataxia 0—20 G11.3 Cerebellar ataxia with defective DNA repair 0—20 G11.4 Hereditary spastic paraplegia 0—20 G11.8 Other hereditary ataxias 0—20 G11.9 Hereditary ataxia, unspecified 0—20 G12.0 Infantile spinal muscular atrophy, type I (Werdnig-Hoffman) 0—20 G12.1 Other inherited spinal muscular atrophy 0—20 G12.21 Amyotrophic lateral sclerosis 0—20 G12.22 Progressive bulbar palsy 0—20 G12.29 Other motor neuron disease 0—20 G12.8 Other spinal muscular atrophies and related syndromes 0—20 G12.9 Spinal muscular atrophy, unspecified 0—20 G24.1 Genetic torsion dystonia 0—64 G24.8 Other dystonia 0—64 G25.3 Myoclonus 0—5 G25.9 Extrapyramidal and movement disorder, unspecified 0—20 G31.81 Alpers disease 0—20 G31.82 Leigh’s disease 0—20 G31.9 Degenerative disease of nervous system, unspecified 0—20 G32.81 Cerebellar ataxia in diseases classified elsewhere 0—20 G37.0 Diffuse sclerosis of central nervous system 0—64 G37.5 Concentric sclerosis (Balo) of central nervous system 0—64 G71.00 Muscular dystrophy, unspecified 0—64 G71.01 Duchenne or Becker muscular dystrophy 0—64 G71.02 Facioscapulohumeral muscular dystrophy 0—64 G71.031 Autosomal dominant limb girdle muscular dystrophy 0—64 G71.032 Autosomal recessive limb girdle muscular dystrophy due to calpain-3 dysfunction 0—64 G71.033 Limb girdle muscular dystrophy due to dysferlin dysfunction 0—64 G71.0340 Limb girdle muscular dystrophy due to sarcoglycan dysfunction, unspecified 0—64 G71.0341 Limb girdle muscular dystrophy due to alpha sarcoglycan dysfunction 0—64 G71.0342 Limb girdle muscular dystrophy due to beta sarcoglycan dysfunction 0—64 G71.0349 Limb girdle muscular dystrophy due to other sarcoglycan dysfunction 0—64 G71.035 Limb girdle muscular dystrophy due to anoctamin-5 dysfunction 0—64 G71.038 Other limb girdle muscular dystrophy 0—64 G71.039 Limb girdle muscular dystrophy, unspecified 0—64 G71.09 Other specified muscular dystrophies 0—64 G71.11 Myotonic muscular dystrophy 0—64 G71.20 Congenital myopathy, unspecified 0—64 G71.21 Nemaline myopathy 0—64 G71.220 Centronuclear myopathy 0—64 G71.228 Other centronuclear myopathy 0—64 G71.29 Other congenial myopathy 0—64 G80.0 Spastic quadriplegic cerebral palsy 0—64 G80.1 Spastic diplegic cerebral palsy 0—20 G80.3 Athetoid cerebral palsy 0—64 G82.50 Quadriplegia, unspecified 0—64 G82.51 Quadriplegia, C1-C4 complete 0—64 G82.52 Quadriplegia, C1-C4 incomplete 0—64 G82.53 Quadriplegia, C5-C7 complete 0—64 G82.54 Quadriplegia, C5-C7 incomplete 0—64 G91.0 Communicating hydrocephalus 0—20 G91.1 Obstructive hydrocephalus 0—20 I67.5 Moyamoya disease 0—64 K91.2 Postsurgical malabsorption, not elsewhere classified 0—20 N03.A Chronic nephritic syndrome with C3 glomerulonephritis 0—20 N03.1 Chronic nephritic syndrome with focal and segmental glomerular lesions 0—20 N03.2 Chronic nephritic syndrome w diffuse membranous glomrlneph 0—20 N03.3 Chronic neph syndrome w diffuse mesangial prolif glomrlneph 0—20 N03.4 Chronic neph syndrome w diffuse endocaplry prolif glomrlneph 0—20 N03.5 Chronic nephritic syndrome w diffuse mesangiocap glomrlneph 0—20 N03.6 Chronic nephritic syndrome with dense deposit disease 0—20 N03.7 Chronic nephritic syndrome w diffuse crescentic glomrlneph 0—20 N03.8 Chronic nephritic syndrome with other morphologic changes 0—20 N03.9 Chronic nephritic syndrome with unspecified morphologic changes 0—20 N08 Glomerular disorders in diseases classified elsewhere 0—20 N18.1 Chronic kidney disease, stage 1 0—20 N18.2 Chronic kidney disease, stage 2 (mild) 0—20 N18.30 Chronic kidney disease, stage 3, unspecified 0—20 N18.31 Chronic kidney disease, stage 3a 0—20 N18.32 Chronic kidney disease, stage 3b 0—20 N18.4 Chronic kidney disease, stage 4 (severe) 0—20 N18.5 Chronic kidney disease, stage 5 0—20 N18.6 End stage renal disease 0—20 N18.9 Chronic kidney disease, unspecified 0—20 Q01.9 Encephalocele, unspecified 0—20 Q02 Microcephaly 0—20 Q03.0 Malformations of aqueduct of Sylvius 0—20 Q03.1 Atresia of foramina of Magendie and Luschka 0—20 Q03.8 Other congenital hydrocephalus 0—20 Q03.9 Congenital hydrocephalus, unspecified 0—20 Q04.3 Other reduction deformities of brain 0—20 Q04.5 Megalencephaly 0—20 Q04.6 Congenital cerebral cysts 0—20 Q04.8 Other specified congenital malformations of brain 0—20 Q05.0 Cervical spina bifida with hydrocephalus 0—64 Q05.1 Thoracic spina bifida with hydrocephalus 0—64 Q05.2 Lumbar spina bifida with hydrocephalus 0—64 Q05.3 Sacral spina bifida with hydrocephalus 0—64 Q05.4 Unspecified spina bifida with hydrocephalus 0—64 Q05.5 Cervical spina bifida without hydrocephalus 0—64 Q05.6 Thoracic spina bifida without hydrocephalus 0—64 Q05.7 Lumbar spina bifida without hydrocephalus 0—64 Q05.8 Sacral spina bifida without hydrocephalus 0—64 Q05.9 Spina bifida, unspecified 0—64 Q06.0 Amyelia 0—64 Q06.1 Hypoplasia and dysplasia of spinal cord 0—64 Q06.2 Diastematomyelia 0—64 Q06.3 Other congenital cauda equina malformations 0—64 Q06.4 Hydromyelia 0—64 Q06.8 Other specified congenital malformations of spinal cord 0—64 Q07.01 Arnold-Chiari syndrome with spina bifida 0—64 Q07.02 Arnold-Chiari syndrome with hydrocephalus 0—64 Q07.03 Arnold-Chiari syndrome with spina bifida and hydrocephalus 0—64 Q30.1 Agenesis and underdevelopment of nose, cleft or absent nose only 0—5 Q30.2 Fissured, notched and cleft nose, cleft or absent nose only 0—5 Q31.0 Web of larynx 0—20 Q31.8 Other congenital malformations of larynx, atresia or agenesis of larynx only 0—20 Q32.1 Other congenital malformations of trachea, atresia or agenesis of trachea only 0—20 Q32.4 Other congenital malformations of bronchus, atresia or agenesis of bronchus only 0—20 Q33.0 Congenital cystic lung 0—20 Q33.2 Sequestration of lung 0—20 Q33.3 Agenesis of lung 0—20 Q33.6 Congenital hypoplasia and dysplasia of lung 0—20 Q35.1 Cleft hard palate 0—20 Q35.3 Cleft soft palate 0—20 Q35.5 Cleft hard palate with cleft soft palate 0—20 Q35.9 Cleft palate, unspecified 0—20 Q37.0 Cleft hard palate with bilateral cleft lip 0—20 Q37.1 Cleft hard palate with unilateral cleft lip 0—20 Q37.2 Cleft soft palate with bilateral cleft lip 0—20 Q37.3 Cleft soft palate with unilateral cleft lip 0—20 Q37.4 Cleft hard and soft palate with bilateral cleft lip 0—20 Q37.5 Cleft hard and soft palate with unilateral cleft lip 0—20 Q37.8 Unspecified cleft palate with bilateral cleft lip 0—20 Q37.9 Unspecified cleft palate with unilateral cleft lip 0—20 Q39.0 Atresia of esophagus without fistula 0—3 Q39.1 Atresia of esophagus with tracheo-esophageal fistula 0—3 Q39.2 Congenital tracheo-esophageal fistula without atresia 0—3 Q39.3 Congenital stenosis and stricture of esophagus 0—3 Q39.4 Esophageal web 0—3 Q42.0 Congenital absence, atresia and stenosis of rectum with fistula 0—5 Q42.1 Congen absence, atresia and stenosis of rectum without fistula 0—5 Q42.2 Congenital absence, atresia and stenosis of anus with fistula 0—5 Q42.3 Congenital absence, atresia and stenosis of anus without fistula 0—5 Q42.8 Congenital absence, atresia and stenosis of other parts of large intestine 0—5 Q42.9 Congenital absence, atresia and stenosis of large intestine, part unspecified 0—5 Q43.1 Hirschsprung’s disease 0—15 Q44.2 Atresia of bile ducts 0—20 Q44.3 Congenital stenosis and stricture of bile ducts 0—20 Q44.6 Cystic disease of liver 0—20 Q45.0 Agenesis, aplasia and hypoplasia of pancreas 0—5 Q45.1 Annular pancreas 0—5 Q45.3 Other congenital malformations of pancreas and pancreatic duct 0—5 Q45.8 Other specified congenital malformations of digestive system 0—10 Q60.1 Renal agenesis, bilateral 0—20 Q60.4 Renal hypoplasia, bilateral 0—20 Q60.6 Potter’s syndrome, with bilateral renal agenesis only 0—20 Q61.02 Congenital multiple renal cysts, bilateral only 0—20 Q61.19 Other polycystic kidney, infantile type, bilateral only 0—20 Q61.2 Polycystic kidney, adult type, bilateral only 0—20 Q61.3 Polycystic kidney, unspecified, bilateral only 0—20 Q61.4 Renal dysplasia, bilateral only 0—20 Q61.5 Medullary cystic kidney, bilateral only 0—20 Q61.9 Cystic kidney disease, unspecified, bilateral only 0—20 Q64.10 Exstrophy of urinary bladder, unspecified 0—20 Q64.12 Cloacal extrophy of urinary bladder 0—20 Q64.19 Other exstrophy of urinary bladder 0—20 Q75.0 Craniosynostosis 0—20 Q75.1 Craniofacial dysostosis 0—20 Q75.2 Hypertelorism 0—20 Q75.4 Mandibulofacial dysostosis 0—20 Q75.5 Oculomandibular dysostosis 0—20 Q75.8 Other congenital malformations of skull and face bones 0—20 Q77.4 Achondroplasia 0—1 Q77.6 Chondroectodermal dysplasia 0—1 Q77.8 Other osteochondrodysplasia with defects of growth of tubular bones and spine 0—1 Q78.0 Osteogenesis imperfecta 0—20 Q78.1 Polyostotic fibrous dysplasia 0—1 Q78.2 Osteopetrosis 0—1 Q78.3 Progressive diaphyseal dysplasia 0—1 Q78.4 Enchondromatosis 0—1 Q78.6 Multiple congenital exostoses 0—1 Q78.8 Other specified osteochondrodysplasias 0—1 Q78.9 Osteochondrodysplasia, unspecified 0—1 Q79.0 Congenital diaphragmatic hernia 0—1 Q79.1 Other congenital malformations of diaphragm 0—1 Q79.2 Exomphalos 0—1 Q79.3 Gastroschisis 0—1 Q79.4 Prune belly syndrome 0—1 Q79.59 Other congenital malformations of abdominal wall 0—1 Q89.7 Multiple congenital malformations, not elsewhere classified 0—10 R75 Inconclusive laboratory evidence of HIV 0—12 months Z21 Asymptomatic human immunodeficiency virus infection status 0—20 Z99.11 Dependence on respirator (ventilator) status 1—64 Z99.2 Dependence on renal dialysis 21—64 Appeal procedures are as set forth in COMAR 10.01.04 and 10.09.36. Health-General Article, §§2-104(b), 15-103(b)(4)(i), and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.17 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) Regulations .01—.17 adopted effective March 10, 1997 (24:5 Md. R. 408) Regulations .01, .02, .05, .06, .08—.11, and .13 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .01 amended effective February 9, 1998 (25:3 Md. R. 144) Regulations .01, .02, and .14 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261) Regulations .01, .02, .09, .10, and .14 amended effective January 1, 1999 (25:26 Md. R. 1925) Regulation .01O amended effective October 16, 2000 (27:20 Md. R. 1839) Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .02 repealed as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; repealed permanently effective June 25, 2001 (28:12 Md. R. 1109) Regulation .03 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109) Regulation .04 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109) Regulation .05 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .05 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109) Regulation .06B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .09B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .10B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .11B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .13B amended effective February 9, 1998 (25:3 Md. R. 144) Regulations .01—.17 repealed and new Regulations .01—.17 adopted effective February 2, 2004 (31:2 Md. R. 84) Regulation .02B amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .04 amended effective December 24, 2012 (39:25 Md. R. 1613) Regulation .05B, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .05C, D amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .07G amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .09 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .12B amended effective November 5, 2007 (34:22 Md. R. 1977) Regulation .12C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .13B, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .13C amended effective October 14, 2013 (40:20 Md. R. 1652) Regulation .14E, F, G adopted effective October 5, 2009 (36:20 Md. R. 1528) Regulation .14E amended effective April 4, 2011 (38:7 Md. R. 431) Regulation .17 amended effective November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613) Regulation .17 repealed and new Regulation .17 adopted effective October 26, 2015 (42:21 Md. R. 1301) Chapter revised effective July 2, 2018 (45:13 Md. R. 665) Regulation .02B amended effective June 24, 2024 (51:12 Md. R. 619) Regulation .04F amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .04K, L adopted effective November 23, 2023 (50:23 Md. R. 1005) Regulation .11A amended effective June 24, 2024 (51:12 Md. R. 619) Regulation .12 amended effective June 24, 2024 (51:12 Md. R. 619) Regulation .14 amended effective November 14, 2022 (49:23 Md. R. 996); November 23, 2023 (50:23 Md. R. 1005) Regulation .14D, E amended effective May 20, 2019 (46:10 Md. R. 486); November 18, 2019 (46:23 Md. R. 1065) Regulation .17 amended effective May 20, 2019 (46:10 Md. R. 486); November 14, 2022 (49:23 Md. R. 996); November 23, 2023 (50:23 Md. R. 1005) Effective date: Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .02C, D amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .05B amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .06B amended effective October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471) Regulation .06C amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) Regulation .07 amended as an emergency provision effective June 15, 2001 (28:13 Md. R. 1214); amended permanently effective September 17, 2001 (28:18 Md. R. 1621) Regulation .07C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .07H amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .08A amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .10 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) Regulation .10A, C amended effective October 5, 2009 (36:20 Md. R. 1528); October 28, 2013 (40:21 Md. R. 1775) Regulation .10C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .10C amended effective December 25, 2000 (27:25 Md. R. 2281); November 6, 2006 (33:22 Md. R. 1732) Regulation .11 repealed effective October 5, 2009 (36:20 Md. R. 1528) Regulations .01—.10 under, Maryland Medicaid Managed Care Program: Specialty Mental Health System, repealed and new Regulations .01—.03 under, Maryland Medicaid Managed Care Program: Non-Capitated Covered Services, adopted effective December 22, 2014 (41:25 Md. R. 1479) Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319) Regulation .02L amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .02M amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .02N adopted effective February 27, 2017 (44:4 Md. R. 253) Regulation .03 amended effective October 22, 2018 (45:21 Md. R. 973) Regulation .03K amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .03N, O amended effective August 28, 2017 (44:17 Md. R. 834) Regulation .03P adopted effective August 28, 2017 (44:17 Md. R. 834) Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834) Chapter transferred to COMAR 10.67.08 effective November 1, 2019 (46:22 Md. R. 977) Effective date: Regulations .01—.03 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); December 31, 2018 (45:26 Md. R. 1244) Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244) Regulation .02A, B amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .02B, C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .02C amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .02C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .02C amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .02-1 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .03 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); December 31, 2018 (45:26 Md. R. 1244) Regulation .03-1 adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .03-2 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .04 adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .04 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .04B amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .05 adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .05 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .05A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .05A, B amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .05F, G adopted effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred to COMAR 10.67.09 effective November 1, 2019 (46:22 Md. R. 977) Effective date: Regulations .01—.06 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) Regulations .01—.06 adopted effective March 10, 1997 (24:5 Md. R. 408) Regulations .01, .02, and .03 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .01 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .01C adopted effective February 26, 2018 (45:4 Md. R. 205) Regulation .02A, E amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .02F amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .04 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .04A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .05 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .05B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .05B amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .05C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .06B amended effective February 26, 2018 (45:4 Md. R. 205) Regulations .01—.06 repealed effective December 31, 2018 (45:26 Md. R. 1244) Effective date: Regulations .01 and .02 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01A amended effective June 30, 2008 (35:13 Md. R. 1180); December 31, 2018 (45:26 Md. R. 1244) Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .01B amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .01C repealed effective December 31, 2018 (45:26 Md. R. 1244) Regulation .01-1 adopted as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); adopted permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .02 repealed and new Regulation .02 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .03 adopted effective February 18, 2002 (29:3 Md. R. 220) Regulation .03C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Chapter transferred to COMAR 10.67.10 effective November 1, 2019 (46:22 Md. R. 977) Effective date: Regulations .01—.07 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993) Regulation .03 amended effective December 25, 2000 (27:25 Md. R. 2281) Regulation .08 repealed effective November 1, 1999 (26:22 Md. R. 1692) Chapter revised effective December 24, 2001 (28:25 Md. R. 2190) Regulation .02B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Chapter transferred to COMAR 10.67.11 effective November 1, 2019 (46:22 Md. R. 977) Effective date: February 2, 2004 (31:2 Md. R. 82) Regulation .02A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) Regulations .01—.04 repealed and new Regulations .01—.05 adopted effective October 26, 2015 (42:21 Md. R. 1301) Regulation .02B amended effective August 29, 2016 (43:17 Md. R. 955) Regulation .05B amended effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred to COMAR 10.67.12 effective November 1, 2019 (46:22 Md. R. 977) The following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Early and periodic screening, diagnosis and treatment (EPSDT)” means the provision of preventive health care, including medical and dental services under 42 CFR §441.50 et seq., in order to assess growth and development and to detect and treat health problems in Medical Assistance eligible individuals younger than 21 years old. “Federally qualified health center (FQHC)” means an entity that has entered into an agreement with the Centers for Medicare and Medicaid Services (CMS) to meet Medicare requirements under 42 CFR §405.2464 and in accordance with 42 CFR §405.2401(b). “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice, dental practice, or both; The most cost efficient that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, family, or provider. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Participant” means an individual who is certified as eligible for, and who is receiving, Medical Assistance benefits. “Primary care provider (PCP)” means a practitioner who is the primary coordinator of care for the participant, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medical Assistance Program. “Primary health services” means a basic level of health care, including diagnostic, treatment, consultative, referral, and preventive health services, generally rendered by: General practitioners; Family practitioners; Internists; Obstetricians; Gynecologists; Pediatricians; Physician assistants; and Nurse practitioners. “Program” means the Maryland Medical Assistance Program. “Provider” means a school-based health center which has been approved by the Department. “School-based health center (SBHC)” means a health center that: Is located on school grounds; Provides on-site primary and preventive health care, referrals, and follow-up services; Could provide on-site dental care or behavioral health care, referrals, and follow-up services; and Has been approved by the Maryland Department of Health. “Specialty behavioral health” means services specified in COMAR 10.09.59.06 and 10.09.80.05. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. A physician, nurse practitioner, or physician assistant providing services in an SBHC shall be licensed and legally authorized to practice in the state in which the service is provided. A dentist or dental hygienist providing services in an SBHC shall be licensed and legally authorized to practice in the state in which the service is provided. General requirements for participation in the Program are that a provider shall: Meet the conditions for participation as set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. To participate as a Maryland Medicaid SBHC, a provider shall: Be approved by the Maryland Department of Health as an SBHC; Meet conditions for participation as a: Free-standing clinic as set forth in COMAR 10.09.08.03B; Physician as set forth in COMAR 10.09.02.03; or Nurse practitioner as set forth in COMAR 10.09.01.03. Provide somatic health care services through health professionals who: Are trained and experienced in community health and providing health care services to school-aged children; Have knowledge of health promotion and illness prevention strategies for children and adolescents; and Are EPSDT certified; Ensure staff is assigned responsibilities consistent with the staff's education and experience and within the staff's scope of practice; Designate an individual to be responsible for overall management of the SBHC; Whenever comprehensive primary health services are being delivered, maintain a staffing pattern that includes at least one of the following on-site: A physician; A nurse practitioner; or A physician assistant; Maintain policies and procedures that ensure confidentiality of services and records which are practiced consistently, in accordance with Health-General Article, §4-301, Annotated Code of Maryland; Maintain data collection and storage capabilities adequate to maintain medical records and standard demographic data; Require any physician assistant employed by the provider to have a delegation agreement with the supervising physician in accordance with COMAR 10.09.55.02 and .03; and Transmit a health visit report: To the student's MCO and PCP within 3 business days of the health visit, as designated by the Department, for inclusion in the student-participant's medical record; and If follow-up care with the PCP within 1 week of the health visit is required and the health visit report is mailed, to the student's MCO and PCP by telephone, email, or fax on the day of the SBHC visit. Specific requirements for participation in the Program as a dentist or dental hygienist in an SBHC are that a provider shall meet the conditions for participation as set forth in COMAR 10.09.05.03AE. An SBHC, designated by the Department as meeting the criteria specified in Regulation .03 of this chapter, is eligible for reimbursement by the Program for the following services: Comprehensive well-child care, including the administration of vaccines in accordance with the Maryland Healthy Kids Preventive Health Schedule, when: Performed by EPSDT certified providers; and Rendered according to EPSDT standards set forth in COMAR 10.09.23.03; Follow-up of positive or abnormal EPSDT screening components without approval of the PCP, except when referral for specialty care is indicated; Comprehensive preventive and primary health services; Family planning services as described in COMAR 10.09.58.05; Covered dental services in accordance with COMAR 10.09.05; Specialty behavioral health services in accordance with COMAR 10.09.59 and 10.09.80; and Routine sports physicals. The Program does not cover the following: Services not specified in Regulation .04 of this chapter; Services not medically necessary; Investigational and experimental drugs and procedures; Basic school health services as defined in COMAR 13A.05.05.05.15; Nursing or other health services provided as part of a participant's individualized educational program (IEP) as defined in COMAR 10.09.50.01B or individualized family service plan (IFSP) as defined in COMAR 10.09.50.01B; Skilled nursing services provided to enable a participant to be safely maintained in the school setting such as: Nasogastric tube feedings; Catheterization; Oral, nasotracheal, or tracheal suctioning; and Nebulizer treatments; School health services which are required in all school settings such as: Hearing and vision screening unless completed as part of an EPSDT well-child check-up; Routine assessment of minor injuries; First aid; Administration of medications including supervision of self-administered medications; General health promotion counseling; and Review of health records; Vaccines supplied by Vaccines for Children (VFC); Visits for the sole purpose of: Administering medication; Checking blood pressure; Measuring weight; Interpreting lab results; or Group or individual health education; and Services provided outside of the physical location of the approved SBHC, unless services are rendered via telehealth in accordance with COMAR 10.09.49 and any subregulatory guidance issued by the Department. The provider shall charge the Program the provider’s customary charge to the general public for similar services and charge the provider’s acquisition cost for injectable drugs or dispensed medical supplies. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §B of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. Local health department clinics, general clinics, physicians, and nurse practitioners shall be paid the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The maximum rates according to COMAR 10.09.02.07. The Department shall reimburse an SBHC, sponsored by an LHD or general clinic, for dental services in accordance with COMAR 10.09.05.07. The Department shall reimburse an SBHC, sponsored by an LHD, general clinic, nurse practitioner, or physician, for specialty behavioral health services in accordance with COMAR 10.21.25 and 10.09.80.08. The Department shall reimburse an SBHC, sponsored by an FQHC, for services in accordance with COMAR 10.09.08.08. The provider shall submit a completed request for payment in the format designated by the Department or HealthChoice MCO, including required documentation. The dental provider shall submit a request for payment in the format designated by the Department and in accordance with COMAR 10.09.05.07. The Program reserves the right to return to the provider, before payment, all invoices not properly completed. Unless the service is free to individuals not covered by Medicaid, a provider shall bill the Program the provider’s customary charge to the general public for similar services. The Department shall authorize payment on Medicare cross-over claims only if: The provider accepts Medicare assignments; Medicare makes a direct payment to the provider; Medicare determines the services are medically necessary; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: A deductible shall be paid in full; Coinsurance shall be paid at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; Services not covered by Medicare, but considered medically necessary by the Program, shall be paid according to the limitations of this chapter; and Coinsurance shall be paid in full to FQHC providers. An SBHC providing self–referred services as described in COMAR 10.67.06.28 to an MCO participant shall: Verify eligibility and MCO assignment through EVS on the day of service; Submit claims within 180 days of performing the service; Submit claims using the CMS 1500 for paper processing and the HIPAA compliant 837P for electronic processing; and Bill third party insurers before billing the MCO with the exception of well-child care and immunizations. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; More than one visit to complete an EPSDT screen; and Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. The Program may not make direct payment to participants. The Program may not make a separate direct payment to any individual employed by or under contract to any SBHC for services provided in an SBHC. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09. State regulations shall be interpreted in conformity with COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: April 10, 2017 (44:7 Md. R. 355) Regulation .01B amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .03A, B amended effective June 14, 2021 (48:12 Md. R. 473); November 13, 2023 (50:22 Md. R. 973) Regulation .04EF amended effective June 9, 2025 (52:11 Md. R. 533) Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973) Regulation .05H—K amended effective June 9, 2025 (52:11 Md. R. 533) Regulation .06 amended effective June 14, 2021 (48:12 Md. R. 473) In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Free-standing clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. “Free-standing urgent care center” means a location, distinct from a hospital emergency room, a physician's office, or a free-standing clinic, whose purpose is to diagnose and treat illness or injury for unscheduled, ambulatory patients seeking immediate medical attention. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, U.S.C. §1395 et seq. “Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits. “Patient” means a participant awaiting or undergoing health care or treatment. “Physician” means an individual legally licensed to practice medicine in the state in which the physician's practice is located. “Program” means the Maryland Medical Assistance Program. “Provider” means a free-standing urgent care center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a Medical Assistance provider number. “Urgent care” means the delivery of ambulatory care, such as for acute illnesses or minor traumas, in a facility dedicated to the delivery of unscheduled, walk-in care outside of a hospital emergency department, a free-standing clinic, or a physician's office. License requirements under this chapter are found in COMAR 10.09.36.02. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland. Urgent care services may be performed only by health care practitioners who are licensed to perform these procedures within the state in which the center is located. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with the requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.09.09.02 and 10.10.01.02, as applicable; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. The general requirements for participation in the Program are that a provider shall: Meet all the conditions for participation as set forth in COMAR 10.09.36; and If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. The specific requirements for participation in the Program as a free-standing urgent care center include the following: Have clearly defined, written, patient care policies; Define the center's hours of operation and clearly communicate those hours of operation to the public and other relevant organizations; Ensure that patients seeking urgent care are seen without prior appointments; During the hours of operation, have: A supervising physician, available for consultation either in-person or via telehealth; and At least one qualified physician, certified nurse practitioner, or physician assistant present; Maintain adequate documentation of each participant visit as part of the individual’s medical record, which, at a minimum, shall include: Date of service; Participant’s reason for visit; A brief description of service provided; and A legible signature and printed or typed name of the professional providing care, with the appropriate title; Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01; and Have laboratory testing and radiology services available to meet the needs of the patients receiving urgent care. The Program covers the following medically necessary services rendered to participants in a free-standing urgent care center: Acute illnesses with a sudden onset; Minor trauma; Diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative services, when clearly related to the participant’s individual needs; Urgent care services, when the services are performed by a physician or one of the following acting within the scope of their practice: A licensed physician assistant; A licensed registered nurse; or A certified nurse practitioner; and Laboratory services as governed by Regulation .02 of this chapter. The Program does not cover the following: Services not medically necessary; Investigational and experimental drugs and procedures; Services denied by Medicare as not medically necessary; Services rendered via telehealth that do not comply with the telehealth requirements established in COMAR 10.09.49 and any other subregulatory guidance issued by the Department; Laboratory or x-ray services performed by another facility; Immunizations, except for: Tetanus; and Rabies; Visits only to accomplish one or more of the following: Collection of specimens for laboratory procedures; Interpretation of laboratory tests or panels; Ascertaining the patient's weight; and Measurement of blood pressure; Well child visits; and Sports physicals Payment for free-standing urgent care centers is as follows: Urgent care centers are reimbursed a facility fee, which is determined by the Program; In addition to the facility fee, the Program shall reimburse for services rendered by the physician, nurse practitioner, or physician assistant during the visit at the free-standing urgent care center; and If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with the provisions of this regulation; and The provider's reimbursement is not limited to the provider's customary charge. Reimbursement by the Program for facility services, which are included in the facility fee, includes: Nursing, technician, and related services; Use of the center; Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances, and any equipment directly related to the treatment of the illness or injury; and Administrative costs. The Department shall pay for covered services at the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The Department's fee for: Professional services in accordance with COMAR 10.09.02.07D; and Laboratory services in accordance with COMAR 10.09.09.07D. The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. The Program reserves the right to return to the provider, before payment, all invoices that are not properly completed. The Program shall authorize payment on Medicare claims only if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; Medicare has determined that the services are medically necessary; Services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make supplemental payment on Medicare claims subject to the limitations of the State budget and the following provisions: Deductible insurance shall be paid in full; Beginning with August 1, 2010 dates of service, coinsurance shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but considered medically necessary by the Program, will be paid according to the limitations of Regulation .04 of this chapter. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; or Professional services rendered by mail or telephone. The Program may not make a direct payment to a participant. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. If the participant has insurance, or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. Causes for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: April 21, 2008 (35:8 Md. R. 805) Regulation .01B amended effective July 10. 2023 (50:13 Md. R. 512) Regulation .03 amended effective July 10. 2023 (50:13 Md. R. 512) Regulation .04 amended effective July 10. 2023 (50:13 Md. R. 512) Regulation .04D amended effective April 24, 2017 (44:8 Md. R. 404) Regulation .05D amended effective July 10. 2023 (50:13 Md. R. 512) Regulation .05F amended effective March 31, 2025 (52:6 Md. R. 267) Regulation .06A amended effective April 24, 2017 (44:8 Md. R. 404) Regulation .06A, C, H amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .06C amended effective June 14, 2021 (48:12 Md. R. 473) Regulation .06G amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .06I amended effective July 10. 2023 (50:13 Md. R. 512) Regulation .07A amended effective July 10. 2023 (50:13 Md. R. 512) Regulation .09 amended effective January 24, 2011 (38:2 Md. R. 84) Regulation .10 amended effective July 10. 2023 (50:13 Md. R. 512) The following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq. “Evidence-based home visiting model” means a voluntary early childhood strategy program that includes focused, individualized, and culturally competent services for expectant parents, young children, and their families designed to enhance parenting and promote the growth and development of young children. “Home” means the program participant’s place of service in a community setting defined by the evidence-based home visiting models. “Home visiting program” means the organization or entity accredited by an evidence-based home visiting model to provide home visiting services under that model. “Home visiting services” means services provided during the prenatal and postpartum periods in the program participant’s home by the home visiting program, including but not limited to: Pregnancy education; Child development education; Diet and nutritional education; Stress management; Sexually transmitted diseases (STD) prevention education; Tobacco use screening and cessation education; Alcohol and other substance misuse screening and counseling; Depression screening; Postpartum depression education; Domestic and intimate partner violence screening and education; Breastfeeding support and education; Guidance and education with regard to well woman visits to obtain recommended preventive services; Maternal-infant safety assessment and education; Counseling regarding postpartum recovery, family planning, and needs of a newborn; Assistance for the family in establishing a primary source of care and a primary care provider; Parenting skills, parent-child relationship building, and confidence building; Child developmental screening at major developmental milestones from birth to two years old; Facilitation of access to community or other resources that can improve birth-related outcomes such as: Transportation; Housing; Alcohol, tobacco, and drug cessation; and WIC, SNAP, and intimate partner violence resources; Monitoring for high blood pressure or other complications of pregnancy; and Medical assessment of the postpartum mother and infant. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Postpartum period” means the period that begins immediately after childbirth up to a period of time following childbirth as defined by the evidence-based home visiting model. “Prenatal period” means the developmental period between conception and birth. “Program” means the Maryland Medical Assistance Program. “Program participant” means one of the following individuals enrolled in the evidence-based home visiting model: Birthing parent; Infant; Child up to the age permitted under the evidence-based home visiting model; or Other individuals, as recognized under the evidence-based home visiting model. “Provider” means a qualified individual licensed or certified to deliver home visiting services as a part of an evidence-based home visiting model. The home visiting program provider shall have an active accreditation status from one of the following evidence-based home visiting models: Healthy Families America (HFA); or Nurse Family Partnership (NFP). General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03; and Specific requirements for participation in the home visiting program are that the provider shall provide proof of accreditation by one of the following evidence-based home visiting models: Healthy Families America (HFA); or Nurse Family Partnership (NFP). The Program covers home visiting services rendered in the program participant’s home when the services: Are rendered during the birthing parent’s prenatal period and postpartum periods; and If not rendered in person, comply with the telehealth requirements established in COMAR 10.09.49 and any subregulatory guidance issued by the Department. The Program does not cover: Expenses including: Administrative overhead; Lactation consulting services; and Program start-up costs for evidence-based model accreditation, initial training, or consultation; or Services that are not medically necessary. The provider shall submit the request for payment in the format designated by the Department. The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program. The provider shall charge the Program the provider’s customary charge to the general public for similar services. The Program will reimburse a provider for covered services: The lesser of the provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or In accordance with §I of this regulation. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §I of this regulation; and The provider’s reimbursement is not limited to the provider’s customary charge. The provider may not bill the Program or the participant for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail; or Providing a copy of a program participant’s medical record when requested by another provider on behalf of the participant. Payments for services rendered to a Program participant shall be made directly to a qualified provider. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Effective January 1, 2022, the Program shall reimburse a flat rate of $188 per home visit. Recovery and reimbursement regulations are set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09 Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: January 13, 2022 (49:1 Md. R. 13) This chapter establishes requirements for qualified State and local corrections facilities to make presumptive eligibility determinations effective July 1, 2017. In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicant” means an individual who has applied for presumptive eligibility at a participating qualified correctional facility. “Application” means the presumptive eligibility application. “Correctional facility” has the meaning stated in Correctional Services Article, §1-101, Annotated Code of Maryland, and includes: Correctional facilities under the direction of the Department of Public Safety and Correctional Services; and Local correctional facilities within the State’s 24 local jurisdictions. “Department” means the Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Determination” means a decision regarding an applicant’s presumptive eligibility. “Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2). “Former foster care” means an individual who: Is younger than 26 years old; Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance: On attaining age 18 and leaving out-of-home placement; or On attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B. “Incarcerated inmate” means an individual who resides in a public institution involuntarily as a result of being accused or found guilty of a criminal offense, including the duration of time in which the individual is involuntarily residing in the public institution in a preadjudication or pretrial status. “Income” means property or a service received by an individual in cash or in-kind that can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq. “Memorandum of understanding” means the agreement by which the correctional facility has contracted with the Department and been deemed a qualified entity eligible to make presumptive eligibility decisions. “Presumptive eligibility” means temporary eligibility for Medical Assistance as determined by an eligibility worker at a participating qualified correctional facility in accordance with this chapter. A correctional facility based in Maryland is eligible to participate as a presumptive eligibility entity. The eligibility worker shall: Using the Department’s eligibility verification system, verify the individual is not actively enrolled in the Maryland Medical Assistance Program; and Complete the full Medical Assistance application process; Unless the individual is enrolled in the Maryland Medical Assistance Program, the eligibility worker shall: Fill out the presumptive eligibility application based on information supplied by the applicant; Make a presumptive eligibility determination based on the following information: Residency; Citizenship; Family size and composition; and Gross family income; Sign the application; and Inform the applicant in writing of the presumptive eligibility determination, which includes an explanation of the presumptive eligibility coverage span. In order to ensure the applicant has temporary Medical Assistance coverage, the eligibility worker shall submit the presumptive eligibility application to the Department on the date the application is completed. After the application has been submitted, the correctional facility shall: Keep all written and signed presumptive eligibility applications on file for 6 years; and Make the file available to the Department on request. On finding that a qualified correctional facility has failed to meet the requirements of §§A—E of this regulation, the facility shall take reasonable corrective action measures, as determined by the Department, to address the noncompliance. An individual shall apply for presumptive eligibility through a participating correctional facility. An individual who applies for presumptive eligibility shall attest to: The citizenship requirements in COMAR 10.09.24.05; The residency requirements in COMAR 10.09.24.05-3; The individual’s pregnancy status; The individual’s family size; and The individual’s household’s gross monthly income. If an incarcerated inmate in a Maryland-based correctional facility is determined to be eligible for one of the following coverage groups, the individual may qualify for presumptive eligibility for correctional facilities: Parents and other caretaker relatives whose household income is equal to or less than 133 percent of the federal poverty level; Pregnant women whose income is equal to or less than 250 percent of the federal poverty level; Childless adults 19 years old or older and younger than 65 years old whose household income is equal to or less than 133 percent of the federal poverty level; and Former foster care individuals who are younger than 26 years old. Presumptive eligibility may not be granted to an individual who: Is currently enrolled in the Maryland Medical Assistance Program or Medicare; With the exception of pregnant women, had a prior presumptive eligibility period during the last 12 months; Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or Does not meet the citizenship requirements stated in COMAR 10.09.24.05. Presumptive eligibility begins on the day the presumptive eligibility worker determines the individual is presumptively eligible. Presumptive eligibility ends on the earlier of: The day the individual is determined eligible for Medical Assistance; or The last day of the month following the month in which the correctional facility determined presumptive eligibility, if an individual: Is found ineligible for Medical Assistance; or Failed to apply for Medical Assistance. A non-pregnant individual may be determined presumptively eligible once per a 12-month period. A pregnant individual may be determined presumptively eligible once per pregnancy. An individual or an organization does not have appeal rights for presumptive eligibility determinations. Health-General Article, §15-103(b), Annotated Code of Maryland Effective date: December 18, 2017 (44:25 Md. R. 1180) Regulation .02B amended effective December 30, 2019 (46:26 Md. R. 1164); March 30, 2026 (53:6 Md. R. 291) Regulation .03 amended effective December 30, 2019 (46:26 Md. R. 1164) In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrative Service Organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System. “Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department. “Community-based substance use disorder program” means a program that provides services in community settings not regulated by the Health Services Cost Review Commission. “DATA 2000 waived provider” means a provider who has received a waiver under the Drug Addiction and Treatment Act of 2000 which expands the clinical context of medication assisted opioid dependency treatment and permits qualified physicians, nurse practitioners, and physician assistants to dispense or prescribe certain narcotic medications that have a lower risk of abuse, like buprenorphine, in settings other than an opioid treatment program. “DEA” means the Drug Enforcement Administration of the U.S. Department of Justice. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. “Discharge plan” means a written description of specific goals and objectives to assist the participant upon leaving treatment. “Documentation” means the written medical record. “Individualized treatment plan” means a written plan of action that is developed and periodically updated and revised to address a participant’s specific service needs. “License” means the approval issued to a program by the BHA or its designee that permits a behavioral health provider to operate in Maryland. “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Medication management” means a visit with a physician, nurse practitioner, or physician assistant for the purpose of evaluation, prescribing, and providing medications for substance use disorder symptom reduction, withdrawal management, or medication assisted treatment. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Peer recovery support services” means a set of nonclinical activities provided by individuals in recovery from behavioral health concerns, including substance use or addictive disorders or mental health concerns, who use their personal, lived experiences and training to support other individuals with substance use or addictive disorders. “Program” has the meaning stated in COMAR 10.09.36.01. “Progress note” means an objective documentation of the participant’s progress in relation to specific treatment goals and objectives. “Recovery support services” means community-based services provided to people and their families during the initiation, on-going, and post-acute stages of their recovery from substance abuse. “Substance use disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances. “Substance use disorder services” means the services for which a participant’s diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter. “Telehealth” has the meaning stated in COMAR 10.09.49.02. “Treatment plan” means a written plan that addresses the individual’s biopsychosocial needs through goals and objectives and is updated as needed according to the treatment modality. To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02 and 10.63.01.03. A provider shall be in compliance with COMAR 10.09.36.03 and 10.63.01.05. A provider of community-based substance use disorder services shall include: Community-based substance use disorder providers that: Are licensed by the Department as community-based substance use disorder providers pursuant to the requirements listed in Regulation .05 of this chapter; Maintain verification of licenses and credentials of all professionals employed by or under contract with the provider in their respective personnel files; and Require any physician assistant employed by the provider to have a delegation agreement with the supervising physician in accordance with COMAR 10.09.55.02 and .03; Federally qualified health centers in compliance with COMAR 10.09.08; or Opioid treatment programs that: Are licensed by the Department’s Behavioral Health Administration; Are approved by the U.S. Drug Enforcement Administration; and Comply with 42 CFR Part 8. A provider of substance use disorder services shall maintain adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, includes: The date of service with start and end times; Documents all services received by the participant; The participant’s primary reason for the substance use disorder visit; A description of the service provided; Progress notes; and An official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate degree or title. The providers shall make the documentation required under Regulation .05C available, as requested to carry out required activities, to: The Department; The ASO; The Core Service Agency; The Local Addictions Authority; The Local Behavioral Health Authority; The Office of Inspector General of the Department; and The Office of the Attorney General Medicaid Fraud Control Unit. A provider shall comply with all federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164. If delivering services via telehealth, a provider shall comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. A participant may self-refer or be referred to substance use disorder treatment by a: Provider; Family member; Caregiver; or Local health authority. An individual is eligible for substance use disorder services if: The individual meets the Department’s medical necessity criteria; and The service is appropriate to the specific provider type or community-based substance use disorder providers listed in Regulation .05 of this chapter. Comprehensive substance use disorder assessment at a minimum shall: Be delivered through: A BHA licensed substance use disorder treatment provider; or An opioid treatment program; Be completed before providing the community based behavioral health services listed in §§BI of this regulation; Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and Include: An assessment of the following areas: Drug and alcohol use; and Substance use disorder treatment history; Referrals for physical and mental health services; and Recommendation for the appropriate level of substance use disorder treatment. Peer recovery support services shall: Be included as part of a written individualized treatment plan that includes specific individualized goals; Be delivered through a BHA licensed: Outpatient substance use disorder treatment provider in compliance with COMAR 10.63.03.06, 10.63.03.03 or 10.63.03.07; or Opioid treatment program in compliance with COMAR 10.63.03.19; Be provided by staff who, at a minimum: Maintains active certification by BHA or its designee; Self-identifies as an individual with life experience of being diagnosed with behavioral health concerns, including substance use disorders, addictive disorders, or mental health concerns; Completes ongoing training as approved by BHA or its designee; and Receives supervision by: A registered peer supervisor approved by BHA or its designee; or An individual practitioner as defined in COMAR 10.09.59.04A(2) or a certified alcohol and drug counselor who is approved to supervise by the relevant board and who must be an approved registered peer supervisor on or after September 1, 2023; and Be provided directly to the participant either in-person or via telehealth. Level 1 group and individual substance use disorder counseling shall: Comply with COMAR 10.63.03.06; Be delivered through: A BHA licensed substance use disorder treatment provider; or An opioid treatment program; Include services for participants who require less than 9 hours weekly for adults and 6 hours weekly for adolescents; Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall: Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and Include: Participant treatment plan goals; Referrals to ancillary services, if needed; and Referral to recovery support services, if needed; and Include family members, if necessary, as long as the participant is also present in a Level 1 group counseling session. Level 2.1 Intensive Outpatient services shall: Comply with COMAR 10.63.03.03; Be delivered through a BHA licensed substance use disorder treatment provider only; Include services for participants who require outpatient treatment for 9 or more hours weekly for an adult and 6 or more hours weekly for an adolescent; Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall: Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and Include: Participant treatment plan goals; and Specific interventions that reflect the amounts, frequencies and intensities appropriate to the objective of the treatment plan; and Include a discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services. Level 2.5 partial hospitalization services shall: Comply with COMAR 10.63.03.07; Be delivered through a BHA licensed substance use disorder treatment provider; Include services for participants who require a minimum of 20 hours weekly of structured outpatient treatment delivered in the following ways: Half day sessions with a minimum of 2 hours per day of services; or Full day sessions with a minimum of 6 hours per day of services; Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall: Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and Include: Participant treatment plan goals; and Specific interventions that reflect the amounts, frequencies and intensities appropriate to the objective of the treatment plan; and Include a discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services. Ambulatory withdrawal management service shall: Comply with COMAR 10.63.03.18; Be delivered through a BHA licensed substance use disorder treatment provider; Include the following services as medically necessary: Administration and monitoring of medication, including administration and monitoring of psychotropic medication by qualified staff, as necessary; and Managing withdrawal symptoms; and Include a participant progress note added to the participant-s record after each session. Buprenorphine and other medication assisted treatment delivered by a BHA licensed substance use disorder treatment provider that employs a practitioner who holds a DEA registration with Schedule III authority in compliance with 21 U.S.C. §823 shall include the following: Services delivered by a DEA registered practitioner with Schedule III authority, including: Pharmacological interventions, including the use of FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants; At a minimum, medical services required to be provided by the Program that: Ensure that participants receive a dose adequate to alleviate withdrawal symptoms; Employ dose increases and behavior therapy before mandatory detoxification for participants continuing to use drugs; Establish participant dosing based on an individual need; Provide flexible dosage tapering and withdrawal management with dosage reductions at the participant’s request; Ordering and administering non-narcotic drugs; and Services provided by alcohol and drug counselors and other staff as appropriate, including: Substance use disorder and related counseling as recommended in the individualized treatment plan; and Point of care presumptive drug testing that shall be: Presumptive in nature and performed at the point of care; and Capable of being read by direct optical observation only. For dates of service before January 1, 2023, BHA licensed substance use disorder treatment providers rendering buprenorphine and other medication assisted treatment are required to comply with requirements for DATA 2000 waived providers. Opioid maintenance therapy services delivered through the use of methadone or buprenorphine by opioid treatment programs shall comply with 10.63.03.19 and include: An individualized treatment plan that shall be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; The following services: Pharmacological interventions, including the use of FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants; Point of care presumptive drug testing; Definitive drug testing when completed by a laboratory; Substance use disorder and related counseling as recommended in the individualized treatment plan; Periodic medication management; Medical services, including, but not limited to, those required to be provided by the Program that ensure that participants receive a dose adequate to alleviate withdrawal symptoms; and Ordering and administering non-narcotic drugs; A discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services; and Guest dosing arrangements with other opioid treatment programs, as medically necessary. Medication assisted treatment induction service delivered by opioid treatment programs shall include the following services, as medically necessary: Pharmacological interventions, including the use of one of the following FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants: Buprenorphine; or Methadone; Medical services, including, but not limited to, those required to be provided by the Program that ensure that participants receive a dose adequate to alleviate withdrawal symptoms; and Ordering and administering non-narcotic drugs. The Program under this chapter does not cover the following: Community-based substance use disorder services not specified in Regulation .05 of this chapter; Community-based substance use disorder services not approved by a licensed physician or other licensed practitioner of the healing arts, within the scope of his or her practice under State law; Services not identified by the Department as medically necessary or listed in Regulation .05 of this chapter; Investigational and experimental drugs and procedures; Substance use disorder visits solely for the purpose of: Prescribing medication; Administering medication; Drug or supply pick-up; Collecting laboratory specimens; Interpreting laboratory tests or panels; or Administering injections, unless the following are documented in the participant’s medical record: Medical necessity; and The participant’s inability to take appropriate oral medications; Services that are provided in a hospital inpatient or outpatient setting or in an intermediate care facility for behavioral health; Services beyond the provider’s scope of practice; Services that are separately billed but included as part of another service; Buprenorphine induction and buprenorphine maintenance therapy services that are: Delivered by a participant’s primary care provider which are the responsibility of the Managed Care Organization as specified in COMAR 10.67.08; or Delivered without a primary diagnosis of substance use disorder; Presumptive and definitive drug testing when billed by: An opioid treatment program; An intensive outpatient program; or A partial hospitalization program provider; ( Peer recovery support services that are not provided either in-person or via telehealth; and Services not authorized consistent with this chapter. Providers may not be reimbursed by the Program for: More than one comprehensive substance use disorder assessment for a participant per provider per 12-month period unless there is a break in treatment over 30 calendar days; More than one Level 1 group counseling session per day per participant; More than six Level 1 individual counseling units as measured in 15 minute increments per day per participant; More than four sessions of Level 2.1 Intensive Outpatient treatment per week; Level 1 group or individual counseling during the same week as a Level 2.1 Intensive Outpatient treatment or Level 2.5 Partial Hospitalization service unless the participant has been discharged from or admitted to a new level of care; Overlapping episodes of Level 2.1 Intensive Outpatient treatment and Level 2.5 Partial Hospitalization; Level 1 group or individual counseling during the same week as Level 1 group or individual counseling offered by another provider; Psychiatric day treatment service as described in COMAR [10.09.02.01] 10.63.03.08 or an intensive outpatient mental health service on the same day as a Level 2.1 Intensive Outpatient program or Level 2.5 Partial Hospitalization program Buprenorphine maintenance therapy delivered by an opioid treatment program or a BHA licensed substance use disorder treatment provider during the same week as Methadone Maintenance Therapy; Ambulatory withdrawal management during the same week as an opioid maintenance therapy, medication assisted treatment induction, or buprenorphine maintenance service; Medication management billed by an opioid treatment program or a BHA licensed substance use disorder treatment provider during the same days as medication assisted treatment induction; Community-based substance use disorder services on the same day that a participant received similar services as a hospital inpatient or outpatient; Services delivered by federally qualified health centers other than those billed using T-codes that may include the following delivered by two separate appropriately licensed providers: One T-code for mental health services per day with associated mental health procedure code; and One T-code for substance use disorder services with associated H-code per day; Services rendered but not appropriately documented to the level of service; Services rendered by mail; Completion of forms or reports; Broken or missed appointments; Travel to and from site of service; and Transportation costs. In order to bill for an individual in Level 2.1 Intensive Outpatient treatment, the per diem session shall include a minimum of 2 hours. A maximum of 4 per diems may be billed per week. In order to bill for an individual in Level 2.5 Partial Hospitalization, the per diem rate for a half day session shall include a minimum of 2 hours. In order to bill for an individual in Level 2.5 Partial Hospitalization, the per diem rate for a full day session shall include a minimum of 6 hours. The Department shall pay participating opioid treatment programs, per participant, per week provided the participant received ongoing opioid treatment medications and at least one face-to-face documented treatment service in the month for which the Program is billed. In order for an opioid treatment program to bill for medication assisted treatment induction, the provider shall bill this service only in the first week of treatment per participant or in the first week of treatment after a break from treatment of at least 6 months. In order for an opioid treatment program to bill for buprenorphine maintenance therapy, the provider shall bill this service per participant per week. In order to bill for ambulatory withdrawal management, providers may bill up to 5 per diems during the detoxification episode if determined medically necessary by the Department. Peer recovery support services may not be used to supplant the minimum billing requirements for: Level 2.1 Intensive Outpatient treatment as described in §C of this regulation; Level 2.5 Partial Hospitalization half day session as described in §D of this regulation; Level 2.5 Partial Hospitalization full day session as described in §E of this regulation; and Opioid treatment program services as described in §F of this regulation. All drug screening lab claims submitted to the ASO by providers other than opioid treatment programs shall list the applicable substance use disorder diagnosis. For services outlined in Regulation .05 of this chapter, the community-based substance use disorder program shall notify the ASO and obtain authorization to provide substance use disorder services from the ASO. The ASO agent shall authorize services that are: Medically necessary; and Of a type, frequency, and duration that are consistent with expected results and cost-effectiveness. No payment shall be rendered for services that have not been authorized by the Department or its designee. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. Unless the care is free to other patients, a provider shall bill the Program their usual and customary charge to the general public. For dates of service July 1, 2023 through December 31, 2023, rates for the services outlined in this chapter shall be as follows: For services outlined in this regulation, as delivered through a BHA licensed substance use disorder treatment provider: Comprehensive substance use disorder assessment — $198.35; Level 1 group substance use disorder counseling — $54.49 per session; Level 1 individual substance use disorder counseling — $27.93 per 15-minute increment with a maximum of six 15-minute increments per day; Level 2.1 Intensive Outpatient treatment — $174.60 per diem; Level 2.5 Partial Hospitalization half day session — $181.58 per diem; Level 2.5 Partial Hospitalization full day session — $293.31 per diem; Ambulatory Withdrawal Management —$97.78 per diem; Individual peer support services — $16.87 per 15-minute increment; Group peer support services — $4.69 per 15-minute increment; Point of care presumptive drug test read with direct optical observation only — $10.02 per test; Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test; Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. For services outlined in this regulation as delivered through an opioid treatment program: Comprehensive substance use disorder assessment — $198.35; Level 1 group substance use disorder counseling — $54.49 per session; Level 1 individual substance use disorder counseling — $27.93 per 15-minute increment with a maximum of six 15-minute increments per day; Opioid Maintenance Therapy — $86.27 per participant per week; Medication Assisted Treatment Induction — $279.36 per participant per week; Buprenorphine Maintenance Therapy — $76.69 per participant per week; Individual peer support services — $16.87 per 15-minute increment; Group peer support services — $4.69 per 15-minute increment; and Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. For dates of service January 1, 2024, through June 30, 2024, rates for the services outlined in this chapter shall be as follows: For services outlined in this chapter, as delivered through a BHA licensed substance use disorder treatment provider: Comprehensive substance use disorder assessment — $214.22; Level 1 group substance use disorder counseling — $58.85 per session; Level 1 individual substance use disorder counseling — $30.16 per 15-minute increment with a maximum of six 15-minute increments per day; Level 2.1 Intensive Outpatient treatment — $188.57 per diem; Level 2.5 Partial Hospitalization half day session — $196.11 per diem; Level 2.5 Partial Hospitalization full day session — $316.77 per diem; Ambulatory Withdrawal Management —$105.60 per diem; Individual peer support services — $18.22 per 15-minute increment; Group peer support services — $5.07 per 15-minute increment; Point of care presumptive drug test read with direct optical observation only — $10.02 per test; Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test; Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. For services outlined in this chapter as delivered through an opioid treatment program: Comprehensive substance use disorder assessment — $214.22; Level 1 group substance use disorder counseling — $58.85 per session; Level 1 individual substance use disorder counseling — $30.16 per 15-minute increment with a maximum of six 15-minute increments per day; Opioid Maintenance Therapy — $93.17 per participant per week; Medication Assisted Treatment Induction — $301.71 per participant per week; Buprenorphine Maintenance Therapy — $82.83 per participant per week; Individual peer support services — $18.22 per 15-minute increment; Group peer support services — $5.07 per 15-minute increment; and Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. Effective July 1, 2024, rates for the services outlined in this chapter shall be as follows: For services outlined in this chapter, as delivered through a BHA licensed substance use disorder treatment provider: Comprehensive substance use disorder assessment — $220.65; Level 1 group substance use disorder counseling — $60.62 per session; Level 1 individual substance use disorder counseling — $31.06 per 15-minute increment with a maximum of six 15-minute increments per day; Level 2.1 Intensive Outpatient treatment — $194.23 per diem; Level 2.5 Partial Hospitalization half day session — $201.99 per diem; Level 2.5 Partial Hospitalization full day session — $326.27 per diem; Ambulatory Withdrawal Management —$108.77 per diem; Individual peer support services — $18.77 per 15-minute increment; Group peer support services — $5.22 per 15-minute increment; Point of care presumptive drug test read with direct optical observation only — $10.02 per test; Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test; Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. For services outlined in this chapter as delivered through an opioid treatment program: Comprehensive substance use disorder assessment — $220.65; Level 1 group substance use disorder counseling — $60.62 per session; Level 1 individual substance use disorder counseling — $31.06 per 15-minute increment with a maximum of six 15-minute increments per day; Opioid Maintenance Therapy — $95.97 per participant per week; Medication Assisted Treatment Induction — $310.76 per participant per week; Buprenorphine Maintenance Therapy — $85.31 per participant per week; Individual peer support services — $18.77 per 15-minute increment; Group peer support services — $5.22 per 15-minute increment; and Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. The Program shall make no direct payment to participants. The Department shall authorize supplemental payment on Medicare claims only if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that the services are medically necessary; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make payment on Medicare claims subject to the following provisions: Deductible and coinsurance shall be paid in full for services designated as mental health services by Medicare; and The Program shall reimburse services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of this chapter. Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. The Department shall give to the provider reasonable written notice of the Department’s intention to impose sanctions. In the notice, the Department shall: Establish the: Effective date of the proposed action; and Reasons for the proposed action; and Advise the provider of the right to appeal. Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09. This chapter shall be interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 7.5-204, 7.5-205(d), 7.5-402, 8-204(c)(1),15-103(a)(1), and 15-105(b), Annotated Code of Maryland Effective date: Regulations .01—.09 adopted as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); adopted permanently effective May 31, 2010 (37:11 Md. R. 765) Chapter revised effective December 22, 2014 (41:25 Md. R. 1480) Regulation .01B amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); August 5, 2024 (51:15 Md. R. 708) Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1302); September 25, 2017 (44:19 Md. R. 897) Regulation .03 amended effective October 26, 2015 (42:21 Md. R. 1302); November 14, 2022 (49:23 Md. R. 996) Regulation .03A, B amended effective September 25, 2017 (44:19 Md. R. 897) Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1302) Regulation .05 amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); September 25, 2017 (44:19 Md. R. 897); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); August 5, 2024 (51:15 Md. R. 708) Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); May 15, 2023 (50:9 Md. R. 379) Regulation .06A, B amended effective November 14, 2022 (49:23 Md. R. 996) Regulation .07C amended effective October 26, 2015 (42:21 Md. R. 1302) Regulation .08 amended effective October 26, 2015 (42:21 Md. R. 1302); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); November 24, 2025 (52:23 Md. R. 1139) Regulation .08D amended effective October 24, 2016 (43:21 Md. R. 1166); April 10, 2017 (44:7 Md. R. 356); January 1, 2018 (44:26 Md. R. 1215); December 30, 2019 (46:26 Md. R. 1164) Regulation .08D – F amended August 5, 2024 (51:15 Md. R. 708) The purpose of the Increased Community Services (ICS) Program is to enable certain nursing facility residents to access home and community-based services by allowing those nursing facility residents to contribute to the cost of care through a monthly assessment and thus enabling those individuals to live at home with ICS and other Medicaid services instead of in a nursing facility. In this chapter, the following terms have the meanings indicated. Terms Defined. “Activities of daily living” means bathing, eating, toileting, dressing, and mobility including transfer. “Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with this chapter and COMAR 10.09.30, evaluates ICS applicants and participants. “Agency-employed attendant” means an attendant who is employed by, or under contract with, an attendant care provider agency. “Applicant” means an individual who has submitted to the Department an application for the ICS Program. “Assessment fee” means the fee the participant is required to pay as a condition of eligibility for the ICS Program and Medical Assistance benefits. “Assistance” means that another individual: Physically performs an activity for the participant; Physically helps the participant to perform an activity; Is present while the participant performs an activity because the participant's safety or health may be jeopardized if the activity is not monitored or performed due to the participant's physical or mental status; or Cues or encourages the participant to perform the activity. “Assisted living services provider” means a provider licensed by the Department in accordance with COMAR 10.07.14 and enrolled in the Maryland Medical Assistance Program to provide the services covered under Regulation .37 of this chapter. “Attendant” means an individual who provides a participant with attendant care services. “Attendant care provider agency” means an agency that is enrolled in the Maryland Medical Assistance Program to provide the services covered under Regulation .30 of this chapter. “Attendant Care Services” means assistance with activities of daily living, instrumental activities of daily living, and performance of delegated nursing functions. “Case management agency” means an agency enrolled by the Maryland Medical Assistance Program to provide case management services to ICS applicants and participants. “Case management services” means services that assist an applicant or a participant to gain access to ICS services, Medicaid State Plan services, and other community services. “Delegated nursing functions” means services, other than assistance with activities of daily living and instrumental activities of daily living, provided to a participant by: An enrolled attendant under the supervision of an enrolled licensed registered nurse in accordance with COMAR 10.27.11; or A nurse practitioner in accordance with COMAR 10.27.07. “Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department. “Determination” means a decision by the Department regarding an applicant's or participant's eligibility for the ICS Program. “Fiscal intermediary” means an agency that is under contract with the Department to provide fiscal intermediary services. “Fiscal intermediary services” means certain employer-related payroll functions, such as State and federal tax withholding and Social Security withholding, performed on behalf of participants who elect to use the participant-employed model of attendant care services. Home. “Home” means the place where the participant resides. “Home” does not include a hospital, nursing facility, or other institution that is regulated under: COMAR 10.22.03 for licensed community-based residential facilities for individuals with intellectual or developmental disabilities; or COMAR 10.21.22 for residential rehabilitation programs for individuals with serious or chronic mental illness. "Increased Community Services (ICS) Program” means the Medicaid home and community-based services program implemented under this chapter in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services. “Instrumental activities of daily living” means tasks or activities that include: Preparing a light meal; Performing light chores; Shopping for groceries; Traveling beyond a walking distance; Managing finances and handling money; Using the telephone; and Planning and making decisions. “Maryland Medical Assistance Program” means the Program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for low income and medically indigent persons. “Medicaid” means the Maryland Medical Assistance Program. “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically disabled adults who, because of the degree of impairment, need health maintenance and restorative services that support their community living. “Medical day care center” means a facility operated for the purpose of providing medical day care services in an ambulatory care setting to medically disabled adults who do not require 24-hour inpatient care, but because of the degree of impairment, are not capable of full-time independent living. “Medically necessary” means the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Nurse” means an individual who is currently licensed to practice nursing in the State. “Nurse monitor” means a registered nurse who provides nursing supervision of attendants in accordance with COMAR 10.27.11 and this chapter. “Nursing facility” means an institution which is licensed by the Department under COMAR 10.07.02. “Nursing facility services” means services provided to individuals who do not require hospital care, but who, because of a mental or physical condition, require skilled nursing care and related services, rehabilitative services, or, on a regular basis, health-related care and services above the level of room and board. “Nursing supervision” means a nurse monitor's supervision of an attendant in accordance with COMAR 10.27.11 and this chapter. “Participant” means an individual who meets the qualifications for participation in the ICS program as specified in Regulation .03 of this chapter and is enrolled with the Department to receive ICS services. “Participant-employed attendant” means an attendant who does not work for an attendant care provider agency and who may be chosen, trained, supervised, and fired by the participant. “Participant-employed model” means the delivery of attendant care services when: An ICS participant chooses the attendant who will render services; The attendant is an enrolled Medicaid provider; and The participant utilizes services of a fiscal intermediary. “Plan of care” means the recommended or revised recommended service plan developed by AERS after an evaluation of an applicant or participant. “Plan of service” means the written plan that: Is developed jointly by the applicant or participant and the case manager; Is based upon: The AERS evaluation; The AERS plan of care; and The case manager's face-to-face interview with the applicant or participant; Addresses the applicant's or participant's needs and desires; and Specifies the type, amount, frequency, costs, and duration of all ICS and other Medicaid services required to safely support the participant in the community. “Provider” means an entity which is enrolled in the Maryland Medical Assistance Program to provide one or more of the services covered under Regulations .22 — .37 of this chapter. “Quality plan” means the plan developed by the Department to address quality assurance and oversight for the ICS program. “Registered nurse” means an individual licensed to practice as a registered nurse under Health Occupations Article, Title 8, Annotated Code of Maryland. “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in, or associated with, an individual’s place of residence. “State Plan” means the document approved by the Centers for Medicare and Medicaid Services describing the nature and scope of the Maryland Medical Assistance Program in accordance with federal requirements at §1902(a) of Title XIX of the Social Security Act. General Requirements. To be eligible for participation in the ICS Program, an applicant or participant shall be determined by the Department to meet the conditions of §§B — E of this regulation. A participant's eligibility for ICS services shall be reevaluated by the Department every 12 months or more frequently if needed due to a significant change in the participant's condition, needs, or financial status. The Department shall have 45 days from the date of a complete application to make an eligibility determination. Technical Eligibility. To be eligible for the services covered under this chapter, an applicant or participant shall be determined by the Department to meet the technical eligibility criteria for ICS services if the individual: Had been living in a nursing facility at the time of application and for at least the last 6 months before the date of application and meets all eligibility requirements before transitioning into the community; Had been eligible for Medicaid for at least 30 consecutive days immediately before being enrolled in the ICS Program; Is not otherwise eligible for services covered under: The authority of §1915(c) of Title XIX of the Social Security Act; or The Programs of All-Inclusive Care for the Elderly under COMAR 10.09.44; Is at least 18 years old; Has a plan of service that: Includes Medical Assistance and ICS services necessary to safely serve the participant in the community; and Is determined by the Department to cost less than the cost to Medicaid if the individual were to remain in the institution; Is offered the choice between ICS and nursing facility services; Chooses, or the individual’s authorized representative chooses on the individual’s behalf, to receive ICS services; Is being discharged from a nursing facility into ICS services in the community and would be institutionalized in a nursing facility if not for the ICS services; Resides in a home, as defined under Regulation .02B of this chapter; and Uses at least one ICS service within a 12-month period. Medical Eligibility. An applicant shall be determined by the Department’s utilization control agent to need nursing facility services covered under COMAR 10.09.10. Every 12 months, or more frequently if determined necessary by the Department due to a significant change in the participant's condition or needs, AERS shall revaluate the participant to verify the continued need for nursing facility services. Financial Eligibility. An ICS participant shall: Without regard to any assets of a spouse, meet the resource limit for Long-Term Care Medical Assistance set forth in COMAR 10.09.24.08M; Receive income, after all available disregards and exclusions set forth in COMAR 10.09.24.07L and 10.09.24.07J, without regard to any income of a spouse, that exceeds 300 percent of the current monthly Supplemental Security Income payment rate, known as the Federal Benefit Rate (FBR); Pay to the Department an assessment fee equal to the amount by which income, after all available disregards and exclusions set forth in COMAR 10.09.24.07L and 10.09.24.07J, exceeds 300 percent of the FBR, as follows: The initial assessment shall be paid to the Department not later than 15 days from the date of the assessment invoice sent by the Department to the participant, unless the exception in §D(4) of this regulation applies; Subsequent assessments shall be paid on or before the last day of the month on which the assessment invoice is sent to the participant by the Department; and If a participant receives a past due notice, the participant has 15 days from the date of the notice to remit payment; and Be allowed an exception to the initial monthly assessment if discharged from the nursing facility on a date other than the first of the month, in which case the participant shall be required to pay the first assessment before the first day of the first full month of ICS participation. Medical Assistance Eligibility. An individual is not eligible to receive ICS services during a penalty period under COMAR 10.09.24.08-1 or 10.09.24.08-2 due to disposal of assets or establishment of a trust. All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to ICS applicants and participants, with the following exceptions: COMAR 10.09.24.06B(2)(a)(ii); COMAR 10.09.24.08G(1); COMAR 10.09.24.08H; COMAR 10.09.24.10B(2) — (3); COMAR 10.09.24.10C; COMAR 10.09.24.10D(2)(a), (b), and (h); COMAR 10.09.24.10D(3) — (6); COMAR 10.09.24.10-1B(1); COMAR 10.09.24.10-1B(4); COMAR 10.09.24.10-1B(7); COMAR 10.09.24.10-1C(3)(a); and COMAR 10.09.24.15A-2(2). Cost of Care. For a participant whose home is an assisted living facility, the Department shall reduce its monthly payment for assisted living services by the amount remaining after deducting from the individual's total nonexcluded monthly income the following amounts in the following order: A personal needs allowance, consisting of the amount established in accordance with COMAR 10.09.24.10D(2)(c) and the assisted living provider's monthly charge to the participant for room and board; and Incurred medical expenses in accordance with COMAR 10.09.24.10D(2)(f) and (g). The Department shall determine the amount of available income to be paid by a participant towards the cost of assisted living services. The participant shall pay the assisted living services provider directly for the participant’s cost of care and room and board. Participant Cap and Registry for ICS Participation. The Department shall establish a cap, approved by the federal Centers for Medicare and Medicaid Services (CMS), on the number of participants who may receive the services covered under this chapter at any one time, based on available State and federal funding. Eligible individuals shall be enrolled in the ICS Program on a first-come, first-served basis until the participant cap is reached. Once the CMS-approved participant cap is reached, a registry of applicants shall be established by the Department on a first-come, first-served basis. Termination of Participation. A participant shall be terminated from participation in the ICS Program if the participant: No longer meets the eligibility requirements specified in §§B — E of this regulation; Voluntarily chooses, or the participant's legal representative chooses on the participant's behalf, to disenroll from the ICS Program; Moves to another state; Is an inpatient for 30 consecutive days or more in a hospital or nursing facility; or Dies. Re-Entering the ICS Program. If a participant is terminated from the ICS Program, the same individual may re-enter the ICS Program, provided: That the individual meets all of the requirements §§B — E of this regulation; and There is available capacity. If an individual cannot find a community residence before his or her application expires, the individual may reapply to the ICS Program as long as the individual continues to meet all other eligibility requirements. To participate as a provider of a service covered under Regulations .22 — .37 of this chapter, a provider shall: Meet all of the conditions for participation as a Maryland Medical Assistance Program provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; Meet the licensure and certification requirements specified in this chapter, if applicable; Meet the applicable conditions for provider participation in this chapter; Apply in accordance with the conditions of participation under Regulations .05 — .20 of this chapter, by completing the application forms designated by the Maryland Medical Assistance Program; Have a signed provider agreement in effect with the Maryland Medical Assistance Program; Verify the qualifications of all individuals who render ICS services on the provider's behalf, and provide a copy of the current license or credentials of these individuals upon request; Provide services in accordance with: A participant's plan of service; The provider agreement; The ICS Program; and All relevant federal, State, and local laws and regulations; Agree to inform the case manager within 24 hours, and within 7 calendar days file a written report on a form designated by the Department, in the case of any threat to the health, safety, or welfare of the participant such as: Potential eviction; Suspected abuse or neglect; or Significant interruption of service; Immediately notify the Adult Protective Services office at the local department of social services and law enforcement if the provider believes that the participant has been subjected to abuse, neglect, self-neglect, or exploitation in the community, in accordance with COMAR 07.06.14.04; Agree to cooperate with required inspections, reviews, and audits by authorized governmental representatives; Agree to provide services, and to subsequently bill the Department in accordance with the payment procedures specified at Regulation .40 of this chapter for only covered services which have been: Preapproved in the participant's plan of service; Provided in a manner consistent with the participant's plan of service; and Authorized in the provider agreement as within the scope of the provider's Medicaid participation; Agree to maintain and have available written documentation of ICS services, including dates and hours of services provided to participants for a period of 6 years, in a manner approved by the Department; Agree not to suspend, terminate, increase, or reduce services for a participant without authorization from the participant’s case manager; and Agree to comply with the requirements in the Department's quality plan for the ICS Program. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: Been subject to sanctions under COMAR 10.09.36.08; Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services; Been subject to a disciplinary action by a licensing board; Been cited by a State agency for deficiencies which affect recipients' health and safety; or Been terminated under a reimbursement agreement with or been barred from work or participation by a public or private agency due to: Failure to meet contractual obligations; or Fraudulent billing practices. A provider who renders health-related services to participants, including attendants, participant trainers, occupational therapists, speech and language therapists, physical therapists, nutritionists, dietitians, medical day care centers, and registered nurses, shall agree to: Periodically indicate the condition of a participant in accordance with the procedures and forms designated by the Department; and Share and discuss the documented information at the request of the participant. To participate in the ICS Program as a provider of participant training under Regulation .22 of this chapter, a provider shall: Be a self-employed trainer or an agency that employs qualified trainers in accordance with §§B and C of this regulation; Demonstrate experience in the skill being taught; and Be willing to meet at the participant's home to provide services. To participate in the ICS Program as a provider of family training services under Regulation .23 of this chapter, a provider shall: Be: One of the following self-employed professionals: Registered nurse or nurse practitioner licensed according to COMAR 10.27.01 and 10.27.07; Occupational therapist licensed according to COMAR 10.46.01; Speech-language pathologist licensed according to COMAR 10.41.03; or Physical therapist licensed according to COMAR 10.38.01; or An agency which employs or contracts with a licensed professional specified in §A(1) of this regulation who will render the service; and Demonstrate experience in the skill being taught. To participate in the ICS Program as a provider of case management services under Regulation .24 of this chapter, a provider shall: Be enrolled as a case management provider in accordance with COMAR 10.09.55.15-3; Accept all referrals from the Department, or other designated agency; and Be monitored by the Department. To participate in the ICS Program as a provider of transition services under Regulation .25 of this chapter, a provider shall be the case management provider in accordance with Regulation .07 of this chapter and shall: Assist individuals to transition from a nursing facility to a community-based residence; and Arrange and coordinate the services necessary to facilitate the transition. To participate in the ICS Program as a provider of environmental assessments under Regulation .26 of this chapter, a provider shall: Be a licensed occupational therapist, or an agency or professional group employing a licensed occupational therapist; Receive a referral from the participant's case manager, based on services preauthorized in the plan of service; and Document the provider's findings and recommendations on a form approved by the Maryland Medical Assistance Program. To participate in the ICS Program as a provider of environmental accessibility adaptations under Regulation .27 of this chapter, a provider shall: Be the store, vendor, or contractor, from which the adaptation is purchased; Provide or arrange for any required installation, servicing, or training; and Provide services according to a written schedule indicating an estimated start date and completion date. If construction is involved, the provider shall also meet the following requirements: Be properly licensed by the State as a contractor or builder; Be properly bonded; Obtain all necessary State and local permits; Ensure that the work passes the required inspections; and Perform all work in accordance with State and local building codes. To participate in the ICS Program as a provider of personal emergency response systems under Regulation .28 of this chapter, a provider shall: Be the store, vendor, organization, or company which sells, rents, installs, services, or runs the device or service; Provide or arrange for any installation, servicing, training, or monitoring required for the device or system; and Assure that any response center is: Responsible for monitoring or responding to a notification of an emergency by the system; and Adequately staffed 24 hours a day, 7 days a week by properly trained staff. To participate in the ICS Program as a provider of assistive technology services under Regulation .29 of this chapter, a provider shall: Be one of the following entities: The store, vendor, organization, or company which sells or rents the equipment or system; or A Maryland Medical Assistance Program provider of disposable medical supplies and durable medical equipment under COMAR 10.09.12; Provide or arrange for any installation, servicing, training, or monitoring required for the proper operation of the equipment or system; and Provide services in accordance with written estimated start and completion dates. To participate in the ICS Program as a provider of attendant care services under Regulation .30 of this chapter, unless otherwise exempted under §F of this regulation, an attendant shall: Be a participant-employed or agency-employed attendant; Be at least 18 years old; Be legally eligible for employment rendering attendant care services in the State; Be able to communicate, read, write, and follow directions in English; Be currently certified from a nationally recognized organization in the following areas: Cardiopulmonary resuscitation; and Basic first aid; Receive instruction and training on the attendant care services required in the participant's plan of service from the nurse monitor before rendering services; Be supervised by a nurse monitor in accordance with the requirements of Regulation .31 of this chapter; Accept instruction and training from: The participant; The nurse monitor; The case manager; A treating physician; Other involved professionals; or A Department representative; Submit to a pre-employment criminal background investigation for which the individual shall: Submit an application for a criminal history record check to the Criminal Justice Information System Office, Department of Public Safety and Correctional Services; Direct the Department of Public Safety and Correctional Services to send the criminal history report to the Department; and Pay for the criminal history record check and report; and Agree to submit written documentation of services rendered to each participant to the case manager on a form designated by the Department. To participate in the ICS Program as a provider of attendant care services under Regulation .30 of this chapter, unless otherwise exempted under §F of this regulation, an attendant may not: Be a spouse; Be a parent of a dependent child; Be an individual who has full and unrestricted powers of guardianship; Render services to any participant before being evaluated by a nurse monitor as able to: Understand and carry out the attendant care services specified in the participant's plan of service; and Perform the required duties; Unless meeting the conditions of §C of this regulation, have been convicted of, received a probation before judgment for, or entered a plea of nolo contendere to, a felony or any crime involving moral turpitude, drugs, or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; or Be listed on the Maryland Geriatric Nursing Assistants Registry or any other registry with a determination of abuse, misappropriation of property, or neglect. If requested by the provider applicant, the Department may waive the provisions of §B(5) of this regulation if the applicant demonstrates that: The conviction, probation before judgment, or a plea of nolo contendere to a felony or any crime involving moral turpitude, drugs, or theft was entered more than 10 years before the date of the provider application; and The criminal history does not indicate behavior that is potentially harmful to participants. If required to perform any delegated nursing functions as defined in Regulation .02B of this chapter, an attendant who meets the requirements of §§A and B of this regulation, shall also: Be certified as: A nursing assistant in accordance with COMAR 10.39.01; or If required to administer medications: Certified medicine aide in accordance with COMAR 10.39.03; or Medication technician in accordance with COMAR 10.39.04; Be supervised by a nurse monitor; and Comply with the requirements of the Maryland Board of Nursing as set forth in COMAR 10.27.11. To participate in the ICS Program as an agency provider of attendant care services, a provider agency shall: Be one of the following: A public or private agency that has been approved by the Department of Human Services, in accordance with COMAR 07.06.14; A Medicaid provider of: Home health services under COMAR 10.09.04; or Personal care services under COMAR 10.09.20.03B; or A residential services agency certified in accordance with COMAR 10.07.05; Employ or contract with attendants, who meet the requirements in §§A — C of this regulation, in sufficient numbers to ensure that a qualified attendant is available to provide the attendant care services ordered in the plan of service; Supervise each attendant who is employed by or under contract with the attendant care provider agency; Employ or contract with licensed registered nurses to act as nurse monitors and provide nursing supervision, in accordance with Regulations .14 and .31 of this chapter; Be available to give instructions to attendants and to answer questions during a normal working day, including having a nurse monitor available to respond to medical or health-related issues that are within the scope of the nurse's license; Keep accurate records on each participant receiving attendant care services from the agency, which contain: The plan of service; Identification of each attendant providing services to the participant; Dates and times when attendants worked; Tasks the attendants performed; Nurse monitors' instructions to the attendants; and Progress notes and observations on the attendant and the participant; Keep records and submit reports as required by the Department; Maintain 24-hour availability by beeper for emergencies; and Submit written documentation of services rendered to each participant as required by the Maryland Medical Assistance Program and on a form designated by the Department. Exemptions. Subject to approval by the Department, participant-employed attendants may be exempted from the qualifications described at §A(2), (4), and (5) of this regulation at the request of the participant. Providers that have been exempted from any qualification may only serve the participant or participants who have requested the exemption. The Department may: Grant exemptions; and Revoke exemptions for cause. To participate in the ICS Program as a provider of nursing supervision of attendants under Regulation .31 of this chapter, a provider shall be: A self-employed registered nurse or nurse practitioner licensed according to COMAR 10.27.01 and 10.27.07; or An agency or clinic which employs registered nurses or nurse practitioners licensed according to COMAR 10.27.01 and 10.27.07. The registered nurse or nurse practitioner who renders nursing supervision services shall: Be an individual who is: Self-employed; or Employed by or under contract with an agency as specified in §A(2) of this regulation; Meet the requirements of the Maryland Board of Nursing regarding nursing services and delegation of nursing functions in accordance with COMAR 10.27.11; Be willing to delegate nursing tasks to unlicensed, certified individuals according to COMAR 10.27.11; and Maintain detailed, written documentation of services rendered to participants including progress notes and service outcomes, as specified by the Department. A provider shall ensure that a nurse monitor is available to provide the nursing supervision services specified in Regulation .31 of this chapter. To participate in the ICS Program as a provider of home-delivered meals under Regulation .32 of this chapter, a provider shall: Be approved and monitored by the Department; and Use a cooking facility or food preparation site that: Has a food service license issued by the local health department, in accordance with COMAR 10.15.03, or an appropriate license from the state in which the site is located; and Is approved for each licensing renewal based on inspections performed by State sanitarians in accordance with COMAR 10.15.03, or by the licensing authority in the state in which the site is located. To participate in the ICS Program as a provider of dietitian and nutritionist services under Regulation .33 of this chapter, a provider shall be a: Dietitian or nutritionist who is licensed in accordance with COMAR 10.56.01 and Health Occupations Article, Title 5, Annotated Code of Maryland; or Professional group or agency which employs an individual who is licensed in accordance with §A of this regulation. To participate in the ICS Program as a provider of behavior consultation services, as specified in Regulation .34 of this chapter, a provider shall: Be: A health services agency that: Employs a qualified individual or individuals to render behavior consultation services; and Assures supervision of, or consultation to, the individual rendering behavior consultation services by a licensed mental health professional or by a bachelor's level nurse with 4 years of experience in psychogeriatrics or with an appropriate graduate degree; or An individual who is: Qualified to render behavior consultation services; and Licensed to practice independently; Assure that the individual who renders behavior consultation services: Is a licensed Registered nurse; Psychologist; or Clinical social worker; and Has: Experience in psychogeriatrics; Direct experience working with elderly individuals with dementia or behavioral problems; and Demonstrated ability to perform assessments; and Assure response within 24 hours to a referral from a participant's case manager for behavior consultation services. To participate in the ICS Program as a provider of medical day care services under Regulation .35 of this chapter, a provider shall: Be licensed according to COMAR 10.12.04; and Meet the requirements of COMAR 10.09.07. To participate in the ICS Program as a provider of Senior Center Plus services, as specified in Regulation .36 of this chapter, a provider shall: Be approved and monitored by the Maryland Department of Aging as a nutrition service provider; Meet all local and State requirements to operate as a nutrition site, which include but are not limited to inspection and approval of the facility by the local fire marshal, periodic fire drills, and inspection and approval by the local sanitarian to assure compliance with health department requirements for food service facilities; Assure that the facility is accessible to individuals with disabilities; Maintain adequate records on participants, including progress notes and outcomes; Provide at least one staff person per eight clients, with additional staffing if required by the Maryland Department of Aging depending on participants' functional levels; Employ as the center's manager or in another staff position an individual who: Is a licensed health professional or a licensed social worker; Has at least 3 years’ experience in direct patient care at an adult day care center, nursing facility, or health-related facility; Is literate and able to communicate in English; and Participates in training specified and approved by the Maryland Department of Aging; Provide Senior Center Plus services, as specified in Regulation .36 of this chapter, to participants at least 4 hours a day, 1 or more days a week on a regularly scheduled basis, in an out-of-home, outpatient setting; Serve at least one nutritional meal per day that: Is prepared in a licensed food service establishment; Meets at least one-third of the daily recommended dietary allowance; and Does not constitute a full nutritional regimen of three meals per day; Serve snacks, as desired by the participants, when the day program exceeds 6 hours; and Have menus reviewed and approved quarterly by a registered dietitian for nutritional adequacy. To participate in the ICS Program as an assisted living services provider, a provider shall: Be licensed by the Department at the time that services are rendered, in accordance with COMAR 10.07.14, to provide assisted living services: At the Level 2 moderate level of care or Level 3 high level of care; and For the level of care needed by each participant residing in the facility, including any needed resident-specific waiver in accordance with COMAR 10.07.14.09; Meet the requirements of COMAR 10.07.14 for Assisted Living Programs; Be or employ a manager who is literate, able to communicate in English, and qualified as: A licensed physician; A licensed registered nurse; A licensed practical nurse; or An individual with at least 3 years’ experience in direct patient care in a private home, certified home, or health-related facility; Employ an alternate assisted living manager who meets the requirements as specified in §A(3) of this regulation; Have at least one staff person per eight residents on duty at all times during daytime hours, and a staff-to-resident ratio at night sufficient to provide the required services and maintain the facility in a safe and orderly condition, and such additional staffing as required by the Department or the Maryland Department of Aging depending on residents' functional levels; Participate in training on the ICS Program billing process and other ICS Program requirements, as specified by the Department and the Maryland Department of Aging; Have appropriate insurance coverage for the provider and its employees and vehicles if the provider transports participants to medical, social, recreational, and other services; Cooperate with other service providers and quality assurance monitors by: Facilitating on-site visits of authorized quality assurance monitors to review compliance with ICS and regulatory requirements; Facilitating a case manager's on-site visits to the facility, which shall occur at least quarterly, to review the facility, regulatory compliance, service provision, and participants' status and needs; Communicating with a participant's case manager concerning the participant's status, needs, and service provision; Informing the case manager within 1 working day of any significant change in the participant's status and service needs; Facilitating, as necessary and appropriate, the delivery of authorized ICS and State Plan services in the plan of service; and Facilitating the ICS participant's relocation to comparable housing, if necessary, including transfer of all personal belongings and financial arrangements; and Submit claims consistent with the provisions of Regulation .40 of this chapter. Bed Reservations. If bed reservations are offered to participants who are absent from an assisted living facility, the bed reservations policy shall: Be provided to all residents and, where appropriate, the resident's representative, at admission; Be fairly and consistently applied to all residents; Specify that the bed reservation service is not a Medicaid covered service; Clearly state that it is the resident's decision whether to reserve the bed; and Specify that the participant's payments for bed reservation days may not exceed the full Medicaid per diem rate for Level II or Level III assisted living services, as applicable. Designated Units. An assisted living provider may limit Medicaid participation to designated units only if approved by the Maryland Department of Aging and the facility resident agreement contains the following provision: The facility's participation in the Maryland Medical Assistance Program is limited to one or more designated units and, in order to access Medicaid benefits, the resident shall reside in a designated unit. The Maryland Medical Assistance Program shall reimburse for the services specified in Regulations .22 — .37 of this chapter when, pursuant to the requirements of this chapter, these services have been preapproved by the Department in the participant's plan of service and documented as: Necessary to prevent institutionalization in a nursing facility; and Cost-neutral to the ICS Program, in accordance with Regulation .38E of this chapter. Definition. “Unit of service” means an hour of service rendered one-on-one by a qualified provider to a participant, not including the time spent by the provider: Planning, preparing, or setting up the training; Following up after the training; or Traveling to and from the training. Participant training includes instruction and skill building in such areas as how to recruit, select, train, direct, supervise, and fire participant-employed attendants, money management, budgeting, independent living, meal planning, and other areas specified in the participant's plan of service. The topics covered by participant training shall: Be specified in the participant's plan of service as necessary to safely maintain the participant at home; Be targeted to the individualized needs of the participant; and Be sensitive of the educational background, culture, and general environment of the participant. Participant training shall include updates as necessary to maintain or improve skills, if these updates are in the plan of service. Definitions. “Family member” means an individual who: Lives with or provides assistance to the participant; and Is not paid to provide the care. “Unit of service” means an hour of service rendered by a qualified provider to one or more family members at the same time in the participant's home or the provider's office, regardless of the number of family members trained at one time, not including the time spent by the provider: Planning, preparing, or setting up the training; Following up after the training; or Traveling to and from the training. Family training includes instruction about treatment regimens and the use of equipment specified in the plan of service. The topics covered by family training shall be: Specified in the participant's plan of service as necessary to safely maintain the participant at home; Targeted to address the individualized needs of the participant; and Sensitive of the educational background, culture, and general environment of the family member. Family training shall include updates in the plan of service as necessary to continue to safely maintain the individual at home. Definition. “Unit of service” means a 15-minute increment of service rendered by a qualified provider to a participant or the participant's representative. Case management services shall be targeted to address the individualized needs of the participant and be sensitive to the educational background, culture, and general environment of the participant. Case management services include time spent by a qualified provider conducting any of the following activities: Assisting with an initial or annual ICS Program eligibility process; Assisting with an application and maintaining all public and private benefits, resources, and entitlements; Conducting an assessment of needs, and developing a person-centered plan of services, to include all services needed to live safely in the community; Assisting with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the individual's needs including, but not limited to: Community integration; Medical services; Social services; Educational services; Behavioral health; Legal services; and Housing; Contacting ICS Program providers and Medicaid State Plan providers not less than monthly and documenting that services were received in the amount, type, frequency, and duration described in the plan of services; Ensuring timely receipt of all other services and documenting follow-up; Facilitating referral to other programs if the individual is denied ICS Program services; and Using information technology systems developed by the Department. Definition. “Unit of service” means a one-time service that is: Not otherwise available under the ICS Program; Approved in the plan of service; and Rendered to a participant by a qualified provider to assist the participant in transitioning from a nursing facility or assisted living facility to independent living. Transition services may include some or all of the following: Security deposits; Essential furnishings and moving expenses; Deposits or fees for utility services; and Other health and safety assurances including pest eradication. Transition services may not include recreational items such as televisions, cable TV access, or DVD players. Definition. “Unit of service” means the completion of: An on-site environmental assessment of the participant’s home; and A form approved by the Maryland Medical Assistance Program. An environmental assessment may not be provided before the effective date of the participant's eligibility for ICS Program services. The service may be recommended by a multidisciplinary team in the plan of service for a participant when the service is considered necessary to: Ensure the health and safety of a participant with special environmental needs; and Obtain additional professional advice from an occupational therapist about the: Physical structure of a participant's home or residence; and Functional or mental limitations or disabilities of a participant as they relate to the environment. Included in the environmental assessment, as necessary and appropriate, may be: An evaluation of the presence and likely progression of a disability or a chronic illness or condition in a participant; Environmental factors in the facility or home; The participant's ability to perform activities of daily living; The participant's strength, range of motion, and endurance; The participant's need for assistive devices and equipment; and The participant's, family's, or service provider's knowledge of health, safety, and stress reduction factors. Based on an inspection of the home and interviews with the participant, family, or service provider, the provider shall complete a form, to be reviewed by the case manager, which details the provider's findings and recommendations as to a participant's need for ICS Program services. Definition. “Unit of service” means one or more physical adaptations to a participant's home or place of residence which is completed as one job by a qualified provider and which constitute a single accessibility adaptation. If the owner of the home is the participant, environmental accessibility adaptations may be made only if approved by the participant, in the participant's plan of service. If the owner is not the participant, environmental accessibility adaptations may be made only if approved by the owner of the home, who agrees that the participant will be allowed to remain in the residence for at least 1 year, and if approved by the participant, in the participant’s plan of service. Environmental accessibility adaptations shall include those physical adaptations or modifications to the participant's home which are required to make it accessible to the participant because of the: Physical structure of the residence; or Participant's specific functional needs. Environmental accessibility adaptations may include but are not limited to: Visual fire alarms; Telecommunication type machines (TTYs); Ramps; Grab bars or handrails; Stair glides; Widening of doorways; Modification of bathroom or kitchen facilities to make them physically accessible; Specialized electrical and plumbing systems to accommodate the medical equipment and supplies which are necessary for the participant's welfare; Locks, buzzers, or other devices on doorways to prevent or stop wandering; and Home modifications to help a participant identify the physical environment. To be reimbursed, all services shall: Be provided in accordance with applicable State and local building codes; and Pass required inspections. Definition. “Unit of service” means any of the following: Purchase and installation; Maintenance or repair; or Monthly cost of a covered system or rented device or equipment. A personal emergency response system is an electronic device or system which enables a participant to secure help in an emergency and may include: A device connected to the participant's telephone or other device and programmed to signal, upon activation of a help button, a response center with properly trained staff on duty 24 hours a day, 7 days a week; A portable help button to allow for the participant's mobility; and A motion detector when necessary for the participant's health, safety, and welfare. Definition. “Unit of service” means a device or appliance that is purchased as one item, including: Any required training in the use of the device; and An assessment for the use of the device, if the assessment is: Performed directly by the provider; and Routinely included as part of the provider's cost for the item. Assistive technology includes nonexperimental technology or adaptive equipment, excluding service animals, which enables a participant to live in the community and to participate in community activities. Assistive technology may include: Environmental control units for participants' homes to allow spontaneous or programmed control of household appliances and other home devices; Personal computers, software, and computer accessories which enable participants to function more independently; Maintenance and repair of the covered assistive technology devices and equipment; Augmentative communication and communication-enhancement devices; Aids for daily living and self-help aids used in activities such as eating, bathing, cooking, dressing, toileting, and home maintenance; and Equipment needed to adapt the participant's or family's automotive vehicle for personal transportation such as: Adaptive driving aids; Hand controls; and Wheelchair lifts, and other lifts used for personal transportation. To be covered under this chapter, each item of assistive technology shall meet applicable standards of manufacture, design, usage, and installation. Definition. “Unit of service” means an hour of service that is in the plan of service and rendered to a participant by a qualified provider in the participant's home or in a community setting. Except as provided in §C of this regulation, the ICS Program covers the following attendant care services: Assistance with activities of daily living; Delegated nursing functions, such as assistance with the participant's administration of medications or other remedies, when ordered by a physician, if this assistance is: Specified in the participant's plan of service; and Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing; Assistance with protecting a participant from harm or neglect; Assistance with instrumental activities of daily living, provided as incidental to the services covered under §B(1) — (3) of this regulation; and Accompanying the participant outside of the home during the participant's community activities. Attendant care services may not include: Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant; The cost of food or meals; Housekeeping services, other than those incidental services covered under §B(4) of this regulation; Expenses related to room and board for either the participant or the attendant; Expenses incurred while escorting a participant to obtain medical diagnosis or treatment; or Skilled medical services performed by individuals with a professional medical license or certification. Definition. “Unit of service” means an hour of service rendered by a nurse monitor to a participant in the participant's home or another community-based setting. Nursing supervision services include the following: Development of the participant's plan for attendant care: After consultation with the participant, family members, participant's personal physician, case manager, and other providers; and In conformance with the participant's: AERS evaluation; AERS plan of care; and Plan of service; Providing health-related information and training to the attendant concerning topics related to the care, or progress, of the participant, including: The performance of the services in the participant's plan for attendant care; and Information that should be brought to the attention of the attendant care provider agency, the nurse monitor, personal physician, or case manager; Ensuring that each attendant to be supervised by the provider meets the requirements in Regulation .13A, B, and D of this chapter; Nursing supervision of the participant's medical condition and the care rendered by an attendant, including any delegated nursing functions performed by an attendant, in accordance with COMAR 10.27.11 and the schedule specified in §B(5) of this regulation, by reviewing the: Participant's plan of service and specific plan for attendant care; Interactions between the participant and the attendant; Attendant's performance and ability to render the required services; and Participant's medical condition and need for attendant care services or for referral to other services; Providing the necessary type and frequency of nursing supervision required in accordance with COMAR 10.27.11, with the exception of COMAR 10.27.11.04C, including visits to a participant's home or other service delivery site for observation at least every: 45 days if the attendant administers medications to the participant; 3 months if the attendant assists the participant with self-administration of medications; 4 months if the attendant does not administer medications or assist the participant with medication self-administration; or At a greater frequency established by the nurse monitor due to the participant's medical condition or clinical status; Rendering a professional evaluation, in accordance with Regulation .13B(3) of this chapter, of a attendant's ability to carry out the participant's specific plan for attendant care; and Documenting an action plan to address health and safety or medical concerns, including missed nursing supervision visits, and providing a copy of the plan to the case management agency within 5 business days. The services covered under this regulation may not include nursing services other than those services described in this regulation. Definition. “Unit of service” means one meal delivered to the participant's home, including the cost of the food, food preparation, and delivery. The meal shall be intended for consumption at home. This service may not constitute the participant's full nutritional regimen of three meals per day. Each meal shall: Be nutritionally adequate for the participant's age based on the Recommended Dietary Allowance (RDA) or Dietary Reference Intake (DRI), as established by the Food and Nutrition Board of the National Research Council; and Meet either of the following: At least one-third of the RDA or DRI; or Therapeutic or restrictive diet requirements ordered by the participant's physician, dietitian, or nutritionist, including any ordered nutritional supplements. The ICS Program's coverage under this regulation may not: Result, when combined with home-delivered meals received under Title III of the Older Americans Act, in public funding for the participant's full daily nutritional regimen of three meals; or Supplant payment for home-delivered meals under Title III. Definition. “Unit of service” means an hour of service rendered one-on-one by a qualified provider for a participant in the participant's home or the provider's office. Dietitian and nutritionist services shall include: The provision of a nutrition care plan as part of the ICS Program multidisciplinary team process; Nutrition care planning, nutrition assessment, and dietetic instruction; and Services within the scope of practice of the nutritionist's or dietitian's license, as defined by: Health Occupations Article, Title 5, Annotated Code of Maryland; and Regulations under COMAR 10.56 for the Board of Dietetic Practice. Dietitian and nutritionist services may not include services rendered on a group basis or in a classroom setting. The services shall be: Covered if the participant's medical condition requires the judgment, knowledge, and skills of a licensed nutritionist or licensed dietitian; Targeted to the individualized needs of the participant, rather than being of general interest; Sensitive to the educational background, culture, religion, eating habits, preferences, and general environment of the participant; and Specified in the participant's plan of service as necessary to: Ensure the participant's health and safety; and Prevent the participant's institutionalization or hospitalization. Definition. “Unit of service” means an hour of service rendered by a qualified individual during a home visit to a participant, not including: The time spent on related activities before or after the home visit; or The time spent on supervisory or consultative services to the provider. A provider may bill for the length of a home visit to a participant, upon completion of the services specified in §D of this regulation. Behavior consultation services may be preauthorized by a participant's plan of care as necessary and appropriate when: A participant's behavior is: Disruptive; Potentially dangerous to the participant's or another person's health and functioning; or Placing the participant at risk of institutionalization due to health and safety concerns; and Advice is needed as to how to manage the disruptive behavior of a participant. Behavior consultation services include a: Home visit by an individual qualified to render services to: Evaluate a participant's acute behavior change; Assess the situation; Determine the contributing factors; and Recommend interventions and treatments; Written report prepared for review by the case manager and the assisted living services provider or the participant's family, which assesses the situation and makes recommendations; and Verbal review of the report with the case manager and the assisted living services provider or the participant's family to discuss: The report's findings and recommendations; and A course of action, including any related needed medical interventions. Definition. “Unit of service” means a day of service rendered by a qualified provider to a participant in accordance with COMAR 10.09.07. The ICS Program reimburses for a day of care which includes the following services: Health care services supervised by the director, medical director, or health director, which emphasize primary prevention, early diagnosis and treatment, rehabilitation and continuity of care, including the following: Participation in the development of the individual participant's plan of care; Participation in the determination of the participant's medical, psychosocial, and functional status; Consultation with the participant's personal physician; and Consultation with staff regarding a participant's condition and health care needs; Nursing services performed by a registered nurse or by a licensed practical nurse under the supervision of a registered nurse which include: The evaluation of the needs of the participants for nursing care; The supervision of any nursing staff; Preventive and maintenance services; Observation and monitoring of participant's condition; Rehabilitative services; The teaching and training activities in appropriate self-care techniques; The supervision of medication normally self-administered; The provision of health education; Discharge planning; and Nursing services that may be delegated to other staff in accordance with COMAR 10.27.11; Physical therapy services, performed by or under supervision of a licensed physical therapist, that: Are of a diagnostic, rehabilitative, therapeutic, or maintenance nature, and are provided based on the assessment by the physician that the: Participant will improve significantly in a reasonable and generally predictable period of time; or Services are necessary for the establishment of a safe and effective maintenance program required in connection with a specific disease state; Are directly related to the physician's written plan of care which specifies: Part or parts to be treated; Type of modalities or treatments to be rendered; Expected results of physical therapy treatments; and Frequency and duration of treatment; The complexity of the services, or the condition of a participant, require the judgment, knowledge, and skills of a licensed physical therapist; and The services are considered to be an effective treatment according to accepted standards of medical practice; Occupational therapy services, performed by an occupational therapist, that meet the following conditions: The treatment requires the special skills of an occupational therapist; The services are directly related to the physician's written plan of care which specifies the: Treatment to be rendered; Frequency and duration of the treatment; and Expected results; The treatment is provided with the expectation that there will be a significant practical improvement in a participant's level of functioning within a reasonable period of time; and The services fall within one or more of the following categories: Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests; Selection and teaching of task-oriented therapeutic activities designed to restore physical function; Teaching of compensatory techniques to improve the level of independence in the activities of daily living; Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance according to COMAR 10.09.12; and Improvement of mobility skills; Personal care services which include assistance with activities of daily living; Nutrition services which include the following: Meals and snacks as specified under COMAR 10.12.04.19; Therapeutic diets as specified under COMAR 10.12.04.19; and Dietary counseling and education; Social work services performed by a licensed, certified social worker, or licensed social work associate which include: Screening and interviewing, or assisting designated staff with screening and interviewing prospective participants to determine the general appropriateness of the individual for the full assessment process for medical day care services; Ongoing services to include: Identifying the emotional and social needs of participants during the rendering of medical day care services; Maintaining linkages with community support resources for the participant including relatives, friends, and other care providers; Counseling to improve the participant's response to the plan of care, chronic condition, and prospects for recovery or stabilization, but does not include diagnosing or treating mental disorders; Counseling a participant and a participant's family in the availability and utilization of public and private community services, referral to, and coordination of these services; Assisting participants in obtaining health care services that are not available through the medical day care center, such as vision care, podiatry, or medical equipment; Counseling participants to assist with acclimation to the medical day care center's services and to promote active involvement in their plan of care; Coordinating and implementing group and family counseling in conjunction with plan of care goals; Writing notes in the participant's records that reflect the social work activities performed; and Participating in the multidisciplinary team meetings; and Discharge planning and referral services including: Written procedures for discharge, referral, and follow-up; A discharge summary with post discharge goals; Recommendations for continuing care; and Referral to appropriate community service agencies and health care providers to facilitate the participant's return to more independent living; Activity programs in accordance with COMAR 10.12.04.14C; and Transportation services that: Are provided or arranged for a participant by the medical day care staff; Maximize the following types of transportation services: Walking, for a person who lives within walking distance of the medical day care center and who is sufficiently mobile; Family-supplied transportation provided by friends, neighbors, or volunteers; and Public transportation services; Are procured by the provider after options described in §B(9)(b) of this regulation have been exhausted; Are the responsibility of the provider to: Arrange contractual agreements with transportation providers to meet the transportation needs of the participants; and Group participants, where possible, in the same taxi, van or specially equipped vehicles, to minimize the cost of transportation; Are provided in accordance with a primary transportation plan and a back-up plan; Are documented, indicating the type of transportation used by each participant; Are scheduled to ensure that a participant's one-way transit time does not exceed 1 hour as specified under COMAR 10.12.04.27; and Are included in the day of care for: Trips and outings which are part of the activities program; and A participant's medical appointment escorted by center staff. The day care service shall be: Authorized in the participant's plan of service; Medically necessary; Adequately described in progress notes in the participant's medical record, signed and dated by the individual providing care; and Provided to participants documented to be present at the medical day care center a minimum of 4 hours a day. Definition. “Unit of service” means a day of attendance by a participant for at least 4 hours, not including transportation to and from the center. Senior Center Plus services include a program of structured group recreational activities, supervised care, assistance with activities of daily living and instrumental activities of daily living, and socialization provided in an out-of-home, outpatient setting. Social and recreational activities designed for elderly and disabled individuals, and one nutritious meal shall be provided by the center. This program is designed to promote the participants' optimal functioning and to improve their orientation and cognitive ability. A provider may choose to provide transportation to and from the site of the Senior Center Plus services. These transportation services: May not be included in the provider's daily rate negotiated with the Maryland Department of Aging; and Shall be reimbursed through some other funding source for transportation services. Senior Center Plus does not cover: Transportation; Direct health care; or A full regimen of three meals per day. Definition. “Unit of service” means a day of service and does not include days that the participant was not residing in the provider's assisted living facility, meaning that the participant: Had not yet moved into the facility; Had moved out of the facility; Was an inpatient at a hospital, nursing facility, or other medical institution for one or more nights; or Was absent from the provider's facility for more than 7 nights during a calendar month at the participant's choice for personal reasons, such as to visit family or take a vacation. Assisted living services shall include the provision of: A structured, supportive environment in a home-like setting; Personal care and chore services including: Assisting the participant, as necessary, with performing activities of daily living and instrumental activities of daily living, including cuing the participant to perform these activities; Routine housekeeping, laundry, household care, and chore services needed to maintain the facility as a clean, sanitary, and safe environment; and Menu planning, food shopping, and meal preparation and serving; Basic personal hygiene supplies, including but not limited to: Soap; Bathroom tissue; Paper towels; Toothpaste; Toothbrush; and Shampoo; 24-hour supervision of participants to assure health and safety; Assistance with medication administration, in accordance with COMAR 10.27.11 and COMAR 10.07.14; Recreational and social activities; Reminding the participant of medical appointments; Assistance with transportation arrangements to Program and other needed services; Conferring with the participant's case manager about the participant's status and service needs; Assisting the participant in accessing needed medical or mental health services in emergency situations; and Other services specified for assisted living programs in COMAR 10.07.14. Assisted living services shall reflect the participants' individualized needs and preferences. Assisted living services reimbursed under this chapter may not include room and board. The Maryland Medical Assistance Program shall reimburse for the services specified in Regulations .22 — .37 of this chapter, if the service: Is recommended in the applicant’s or participant's plan of service as necessary in order to: Prevent admission to a nursing facility; Safely deinstitutionalize the individual from a nursing facility into the community; or Assure the participant’s health and safety in the community; Has been preapproved by the Department in the participant's plan of service; Is provided to an enrolled participant who meets the qualifications for eligibility specified in Regulation .03 of this chapter; Is appropriate, relative to other community-based services; Is cost-neutral for the ICS Program after receipt of the monthly assessment fee and by calculating, on an annualized basis, the cost of services covered under this chapter and other State Plan services that are not covered for nursing facility residents; and Is provided by a Medicaid provider of ICS Program services who meets the appropriate conditions for participation under this chapter. Reimbursement may be made by the Maryland Medical Assistance Program only if the requirements of this chapter are met. The total reimbursement by the Maryland Medical Assistance Program for environmental accessibility adaptations and assistive technology combined is limited to the amount specified at Regulation .40C(4)(f)(ii) or (h)(ii) of this chapter during the participant’s annual plan of service period, with exceptions allowed at the Department's discretion in the following circumstances: The amount exceeds the limit, but will allow the individual to return home from a nursing facility or avoid immediate placement in a nursing facility, and does not exceed the participant's cost neutrality under Regulation .38E of this chapter; or Expenditures in excess of the annual limit will reduce the participant's ongoing Medicaid cost of care significantly without exceeding the participant's cost neutrality. Reimbursement for services or equipment estimated to cost more than the amount specified in Regulation .40C(4)(g)(ii) of this chapter shall be preapproved by the Department based on at least two cost estimates obtained from prospective vendors. Reimbursement by the Maryland Medical Assistance Program for environmental accessibility adaptations covered under Regulation .27 of this chapter is limited to modifying two residences of the participant every 3 consecutive years. Excluded from coverage under Regulation .27 of this chapter are adaptations or improvements to the home which: Are of general utility, such as carpeting, roof repair, and central air conditioning; Are not of direct medical or remedial benefit to the participant; or Add to the home's total square footage. Reimbursement by the Maryland Medical Assistance Program for personal emergency response systems covered under Regulation .28 of this chapter may only be allowed for participants who: Are alone for significant parts of the day; Have no regular caregiver for extended parts of the day; and Would otherwise require extensive routine supervision to ensure the participant's health and safety. The Maryland Medical Assistance Program may not reimburse for attendant care services provided under this chapter if: On the same date of service, a participant also received personal care services under COMAR 10.09.20; or Rendered for more than 23 hours for a participant on the same date of service. Reimbursement for the following services shall be limited to 8 hours per service per date of service: Family training; Participant training; or Nursing supervision. The total amount of reimbursement by the Maryland Medical Assistance Program for transition services is limited to a one-time expense of $3,000 per participant, with exceptions allowed at the Department's discretion. Request for Payment. An approved provider shall: Submit a request for payment for the services covered under this chapter according to procedures set forth in COMAR 10.09.36.04; and Include the following information on the request: Date or dates of service; Participant's name and Medical Assistance number; Provider's name, location, and identification number; Nature, procedure code or codes, and unit or units of the covered services provided; and Amount of reimbursement requested. The provider shall submit a request for payment in a manner approved by the Maryland Medical Assistance Program. Participant-employed attendants shall submit a request for payment to a designated fiscal intermediary who shall: Submit bills to the Department; Withhold appropriate taxes; and Remit reimbursement to the provider for services rendered. A request for payment shall include all units of service rendered, as defined in Regulations .22 — .37 of this chapter, during a given time period for a participant. Except as specified in §A(3) of this regulation, the provider shall bill the Department, or its authorized agent, in accordance with the payment methodology specified in Regulation .41 of this chapter for services approved by the Department. Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06. Payments. Payments for services rendered to a participant shall be made: Directly to a qualified provider; or To a designated fiscal intermediary for distribution to participant-employed attendants. A provider shall be paid the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate established in Regulation .41 of this chapter. Payment by the Department for the services covered under this chapter: Shall be considered as payment in full; and May not supplement or be supplemented by payment from other sources, such as the participant, family, a public program, or private agency. The ICS Program’s rates as specified in Regulation .41A — C, E, I — M, O, and P of this chapter shall increase on July 1 of each year beginning July 1, 2012, subject to the limitations of the State budget, by the lesser of: 2.5 percent; or The change from March to March in the medical care component of the Consumer Price Index for all urban consumers (CPI-U) for the Washington-Baltimore area. To receive payment as a provider of services covered under Regulations .23, .24, and .33—.37 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department's billing manual. Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06. Payments. Payments shall be made directly to a qualified provider. A provider shall be paid the lesser of: The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rates established in §D of this regulation. Rates. For dates of service beginning July 1, 2024, fees per unit of service shall be as follows: Assisted Living Level II, No Medical Day Care—reimbursed at the maximum rate of $90.74 per day; Assisted Living Level III, No Medical Day Care—reimbursed at the maximum rate of $114.51 per day; Assisted Living Level II, Medical Day Care—reimbursed at the maximum rate of $68.09 per day; Assisted Living Level III, Medical Day Care—reimbursed at the maximum rate of $85.86 per day; Behavioral Consultation—reimbursed at the maximum rate of $99.25 per hour; Case Management—Administrative—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; Case Management—Comprehensive—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; Case Management—Ongoing—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; Dietitian and Nutritionist Services—reimbursed at the maximum rate of $99.25 per hour; Family 1/1 Training—reimbursed at the maximum rate of $99.25 per hour; Medical Day Care Services—reimbursed at the maximum rate of $116.59 per day; and Senior Center Plus—reimbursed at the maximum rate of $72.19 per day. The ICS Program’s rates for covered services under Regulations .23, .24, and .33—.37 of this chapter shall be adjusted subject to the limitations of the State budget. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures for providers are those set forth in COMAR 10.09.36.09. Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: June 11, 2012 (39:11 Md. R. 687) Regulation .40C amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .41 amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .41 repealed effective December 11, 2025 (52:23 Md. R. 1198) Regulation .41 adopted effective December 11, 2025 (52:23 Md. R. 1198) In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Healthcare Common Procedure Coding System (HCPCS)” means a set of health care procedure codes based on the American Medical Association's Current Procedural Terminology (CPT). “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Medicare-certified facility” means a facility which is certified for Medicare by the regional office of the Centers for Medicare and Medicaid Services (CMS). “Provider-based outpatient oncology facility” means an outpatient facility that is: Owned by a hospital; Located off-site from the hospital; and Not regulated by the Health Services Cost Review Commission (HSCRC). “Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. In order to participate in the Program, the provider shall: Meet all requirements as set forth in COMAR 10.09.36.02; and Ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed and if located: In Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or Out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. To participate in the Program, a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. Specific requirements for participation with the Department as a provider-based outpatient oncology facility require that the provider shall: Be a Medicare-certified facility; Have clearly defined, written patient care policies; and Maintain adequate documentation of each recipient visit as part of the plan of care, which at a minimum, shall include: Date of service; A description of the service provided; and A legible signature and printed or typed name of the professional providing care, with the appropriate title. The Program covers the following services when medically necessary: Radiation therapy; Chemotherapy; IV Infusion; Blood transfusions; Medical supplies; Drugs; and Bone marrow biopsies. The following services are not covered: Any service or treatment that is not medically necessary; Experimental or investigational services; Services that are specifically included as part of another service; and Professional fees provided by physicians billed separately from the facility’s charges. General policies for payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. Specific Payment Procedures for a Provider-Based Outpatient Oncology Facility. The provider shall submit a request for payment on the form designated by the Department for dates of service on or after July 1, 2012. Except for drugs which shall be billed to the Program using the National Drug Code (NDC) and appropriate the HCPCS, the Department shall reimburse the facility at an amount that is equal to 80 percent of the Medicare rate of reimbursement. The Department shall authorize payment on Medicare claims if: The provider accepts Medicare; Medicare makes direct payment to the provider; and Medicare has determined the services are medically necessary. The provider may not bill the Program or the recipient for: Completion of forms or reports; Broken or missed appointments; or Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. The Program makes no direct payments to recipients. The billing time limitations are set forth in COMAR 10.09.36. If the recipient has insurance, or if any other person is obligated either legally or contractually to pay for or to reimburse for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Department. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the claim. If payment is made by both the Program and by the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. General policies governing cause for suspension or removal and imposing sanctions that are applicable to all providers are set forth in COMAR 10.09.36.08. General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104, 15-103, and 15-105, Annotated Code of Maryland Effective date: September 17, 2012 (39:18 Md. R. 1196) Regulation .06B amended effective July 4, 2016 (43:13 Md. R. 712) In this chapter, the following terms have the meanings indicated. Terms Defined. “Claim” means a demand for payment, whether or not the right is reduced to judgment, liquidated, unliquidated, fixed, contingent, matured, unmatured, disputed, undisputed, legal, equitable, secured or unsecured. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or certified to provide health care services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. “Recipient” means: An individual who is certified as eligible for, and is receiving, Program benefits; An individual who was certified as eligible for and received Program benefits; or The successor in interest of a person identified in §B(6)(a) or (b) of this regulation. “Third party” means any individual, entity or program that is or may be liable to pay all or part of the expenditures for Program benefits. The Department may not pay medical claims that are payable by a third party. The Department is assigned any and all rights to payments by any third party that result from medical care received by the recipient, together with the rights of any other individuals eligible for Program benefits for whom the recipient can make assignment. This assignment shall be effective to the extent of the amount of medical assistance actually paid by the Program. If a recipient has a cause of action against a third party, including a claim under Insurance Article, §19-509 or 19-510, Annotated Code of Maryland, the Department shall be subrogated to that cause of action to the extent of any payments made by the Department on behalf of the recipient that result from the occurrence that gave rise to the cause of action. The Department’s subrogation claim shall be limited to that portion of the claim that represents compensation for the medical expenses paid by the Program until the date of an award, settlement or judgment. Judicial Allocation of Medical Expenses from an Award or Settlement. A recipient may not agree, in settlement of the recipient’s cause of action, to an allocation of medical expenses less than the amounts set forth in §F of this regulation, without prior approval of the Department. If an action decided by the court does not determine the allocation of medical expenses in such action, the allocation shall be determined in accordance with §F of this regulation. Provided that the Department is provided at least 10 days advance written notice of any hearing at which the allocation of medical expenses shall be heard, the Department shall defer to the court’s determination of the allocation of medical expenses. The Department’s Recovery in Subrogation Claims. Except as provided in §§F(2) — (4) of this regulation, in satisfaction of the Department’s subrogation claim, the Department shall recover the lesser of: The full amount of past medical costs paid by the Program; or 50 percent of the judgment, award or settlement less attorney fees, litigation costs, and other deductions required by law. For the benefit of the recipient, the Department’s recovery in subrogation claims as provided in §F(1) of this regulation shall be reduced by one-third, for the amount of the attorney’s fees incurred by the recipient in bringing the case, unless the Department files a petition to intervene in a case in which it has a subrogation interest, is independently represented by counsel and has been provided the notice required by §E(3) of this regulation. The Department shall provide the recipient written notice under COMAR 10.01.04.03 of the amount of the subrogation claim it proposes to recover as provided in §§F(1)—(2) of this regulation and of the recipient’s right to request a fair hearing to present evidence of a different allocation of medical expenses. If the recipient files a request for a hearing, the recipient shall bear the burden of proof and the hearing shall be governed by COMAR 10.01.04. Unless the recipient files a timely request for a hearing within 30 days of receipt of the written notice, the Department shall recover the amount of the subrogation claim set forth in the written notice to the recipient. If the amount of money actually collected by the recipient is less than the amount of the judgment or award because available insurance coverage is less than the amount of the judgment or award, the Department’s recovery as calculated in §F(1) of this regulation shall be proportionally reduced by the same percentage as is the amount actually collected compared to the amount of the judgment or award. Unless ordered by a court, the Department may not be required to join, intervene, or otherwise become a party to the cause of action against a third party to maintain the Department’s subrogation right under §C of this regulation. An action brought under this regulation is not exclusive and is independent of and in addition to any right, remedy, or cause of action available to the State, the Department, other State agencies, or a Program recipient or other individual. The Department may enter into contracts for the collection of medical expenses already paid by the Program from potential third parties. The Department may pay, from the funds recovered by the contractor, amounts owed to the federal government as the Department’s share of the Program paid claim, and the costs of collecting the funds. The Department may assign the Department’s rights of subrogation to a managed care organization and shall provide notice of the assignment to the recipient or the recipient’s attorney. The Department may compromise or settle and release the Department’s subrogation claim if, in the Department’s judgment, collection of the claim will cause substantial hardship to the: Recipient; or Surviving dependents of a deceased recipient in a wrongful death action. A recipient shall cooperate with and assist the Department in identifying and providing information concerning third parties who may be liable to pay for care and services received by the recipient under the Program. A recipient is required to assist and cooperate fully with the Department in the Department’s efforts to secure the Department’s rights in Regulation .02 of this chapter, including but not limited to: Notifying the Program’s Division of Recoveries and Financial Services in writing within 10 days of filing suit or commencing an action against a third party; Notifying the Program’s Division of Recoveries and Financial Services in writing before negotiating or entering a settlement with a third party; Subject to Regulation .05 of this chapter, paying to the Program within 30 days all funds received from a third party to the extent necessary to satisfy the subrogation rights of the Department; Disclosing information regarding health insurance or other third party resources when applying for Program benefits; Notifying providers of health and casualty coverage and other third party resources when requesting medical care; Notifying the Program of any health insurance obtained after becoming eligible for Medicaid; Notifying the Program’s Division of Recoveries and Financial Services of any casualty or liability insurance that may cover medical treatment received due to an injury; and Executing and delivering to the Program such documents as reasonably requested by the Program to pursue the Department’s subrogation claim. As a condition of medical assistance eligibility, a person who applies for Program benefits shall, at the time of application: Assign to the Department the applicant's rights of payment for care and services from a third party to the extent the Department has paid for care and services; Cooperate with and assist the Department in identifying and providing information concerning third parties who may be liable to pay for care and services received by the recipient under the Program; and Agree to apply for all other available third party resources that may be used to: Provide or pay for the cost of care or services received by the recipient; or Finance reimbursement to the State for the cost of care or services received by the recipient. Nothing in this regulation shall require a recipient to file a civil or other action for the purpose of reimbursing the State for the cost of care or services. If a recipient fails or refuses to commence a civil or other action to enforce the legal liability of a third party, the Department may commence an independent action, after notice to the recipient, to recover all medical costs to which the Department is entitled. In any such action by the Department, the recipient in interest may be joined as a party. Failure of the applicant or recipient to cooperate with the Program to secure the Department’s rights to subrogation and assignment may result in the denial or termination of the recipient’s Program eligibility. Recipients terminated under this regulation shall be notified in writing of the proposed Program action and afforded the opportunity for a fair hearing under COMAR 10.01.04. An attorney representing a recipient in a cause of action that gives rise to the Department’s right of subrogation under Regulation .02 of this chapter shall notify the Program’s Division of Recoveries and Financial Services in writing before: Filing a claim; Commencing an action; or Negotiating a settlement. The notice required under §A of this regulation shall include submission of the following information: The recipient's name, Social Security Number, date of birth, last known address, and telephone number; The name of any person against whom the recipient is making a claim; The identification of each potentially liable third party, including that party's name, last known address, and telephone number; The name of any insurer of any person against whom the recipient is making a claim, if known; The date of the injury or illness giving rise to the claim; A short statement identifying the nature of the recipient’s claim or the terms of any settlement, judgment or award; Copies of the pleadings and other papers related to the action or claim; and A valid release of the confidentiality of the recipient’s medical records from the date of the injury until the date of the notice. In any action or claim by a recipient to recover damages for an injury or illness that has resulted in the Department providing or paying for Program benefits, an attorney who represents a recipient shall give the Program’s Division of Recoveries and Financial Services written notice: Not later than 30 calendar days after any judgment or award in such action or claim; or Before the resolution of the cause of action or claim. In addition to the notices required in §§A and C of this regulation, an attorney required to give notice under §A or C of this regulation shall give the Program’s Division of Recoveries and Financial Services additional written notice not later than 30 calendar days after judgment, award, or settlement of the action or claim stating the amount and terms of any judgment, award, or settlement of the action or claim. Upon receiving the notice required pursuant to §A of this regulation, the Department shall, within 3 business days, acknowledge in writing its claim to the recipient or the attorney of the recipient and to the third party. The Department shall provide the amount of the claim and an itemized list of charges within 15 business days pursuant to Regulation .06 of this chapter. Nothing herein shall prevent the Department from thereafter updating the amount of the claim and itemized list of charges within a reasonable time after the recipient’s provider notifies the Department of additional charges. Upon receiving the notice required pursuant to §A of this regulation, the Department shall, within 3 business days, advise the recipient or the attorney of the recipient and the third party, in writing, whether the recipient is: A Medicaid recipient; A member of a Medicaid Managed Care Organization (MCO); or Not a Medicaid recipient. Under Regulation .06 of this chapter, the Department shall provide the amount of the claim and an itemized list of charges within 15 business days of receipt of the notice required under §A of this regulation. Nothing in this regulation shall prevent the Department from updating the amount of the claim and itemized list of charges within a reasonable time after the recipient’s provider notifies the Department of additional charges. Except as provided in §§B—E of this regulation, a third party shall have no further liability if it settles or compromises a dispute in good faith and without knowledge that the individual is a recipient of Program benefits. A recipient, or the recipient’s attorney, guardian, or personal representative, who receives money as a result of a judgment, award, or settlement of an action or claim in which the Department has a subrogation claim shall: Deduct applicable attorney fees and litigation costs from the total judgment, award, or settlement; Subject to §C of this regulation, hold and forward to the Department the remainder of the judgment, award, or settlement for the benefit of the Department to the extent required for the Department’s subrogation claim. A recipient shall first repay the Department for costs of past Program services provided to the recipient related to that action or claim before placing any money received from a judgment, award, or settlement into any special needs trust, pooled trust, or pooled trust sub-account, or otherwise distributing the recovered funds to or for the benefit of the recipient. If the recipient and the Department disagree about the amount of the Department’s subrogation right under Regulation .02 of this chapter, the recipient may place the undisputed portion of the judgment, award or settlement into any special needs trust, pooled trust, or pooled trust sub-account, or otherwise distribute the undisputed portion to or for the benefit of the recipient, and the disputed portion of the judgment, award or settlement into an escrow account pending resolution of the disagreement. The Department may only discharge a claim under Regulation .06 of this chapter if the discharge complies with federal law. Liability to the Department. Except as otherwise provided in §E(3) of this regulation, a person who, after written notice of the Department’s subrogation claim under Regulation .04F of this chapter, disposes of money as a result of a judgment, award, or settlement of an action or claim in violation of §B or C of this regulation, without the written approval of the Department, shall be liable to the Department for any amount that, because of the disposition, is not recoverable by the Department. Except as otherwise provided in §E(3) of this regulation, any person who fails to comply with the notice requirements of Regulation .04 of this chapter is liable to the Department for: The total amount of the Department’s claim created pursuant to Regulation .06 of this chapter; and Any attorney’s fees and litigation expenses incurred by the Department in enforcing the Department’s subrogation rights. A person is not liable to the Department under §E(1) or (2) of this regulation if a court determines that there was good cause for: Disposing of the money in violation of §B or C of this regulation; or Failing to comply with the notice requirements of Regulation .04 of this chapter. In a case where the Department is subrogated to the rights of the recipient, the Department has a claim to the proceeds of the recovery from the persons liable, whether the proceeds of the recovery are by way of judgment, settlement, or otherwise and shall, to the extent permitted by federal law, be satisfied in full. The claim is in the amount of all Program benefits paid minus any deductions required by law. The claim is effective when: Filed with a court of competent jurisdiction in the State; and Notice of filing of the claim is served by the Department upon the third party, personally or by registered, certified, or insured mail, return receipt requested. If any provision of this chapter related to subrogation, assignment, or lien conflicts with federal law concerning the Program or receipt of federal funds to finance the Program, the provision does not apply to the extent of the conflict. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-120—15-121.3, Annotated Code of Maryland Effective date: June 24, 2013 (40:12 Md. R. 1042) The purpose of Community First Choice is to provide certain home and community-based services and supports, as an alternative to institutional placements, to individuals who have been determined to require an institutional level of care. In this chapter, the following terms have the meanings indicated. Terms Defined. “Activities of daily living (ADLs)” means tasks or activities that include, but are not limited to: Bathing and completing personal hygiene routines; Dressing and changing clothes; Eating; Mobility, including: Transferring from a bed, chair, or other structure; Moving, turning, and positioning the body while in bed or in a wheelchair; and Moving about indoors or outdoors; and Toileting, including: Bladder and bowel requirements; Routines associated with the achievement or maintenance of continence; and Incontinence care. “Applicant” means an individual who is applying to receive services under this chapter. “Assistance” means that another individual: Physically performs the activity for the participant; Physically helps the participant to perform the activity; Monitors the participant’s performance of the activity in order to ensure health and safety; or Cues or encourages the participant to perform the activity. “Case management services” means services which assist an applicant or a participant in gaining access to waiver and other covered Medicaid services. “Case manager” means a person performing case management services under a waiver program and acting in the role of the supports planner. “Certified medication technician (CMT)” means an individual, regardless of title, who: Completes a course in medication administration approved by the Maryland Board of Nursing; Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. “Certified nursing assistant (CNA)” means an individual, regardless of title, who: Is certified by the Maryland Board of Nursing under COMAR 10.39.01; and Routinely performs delegated nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. “Community First Choice” means the Medicaid home and community-based services program implemented under this chapter in accordance with the application and any amendments to it submitted by the Department and approved by the Secretary of Health and Human Services, which authorizes the provision of certain home and community-based services under the Maryland Medical Assistance Program. Community Setting. “Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to: Seek employment and work in competitive integrated settings; Engage in community life; Control personal resources; and Receive services. “Community setting” does not mean: Hospitals; Nursing facilities; Institutions for mental diseases; Intermediate care facilities for individuals with intellectual disabilities; or Other institutions. “Conflicts of interest” means real or seeming incompatibility between one’s private interests and one’s public or fiduciary duties. “Delegated nursing functions” means nursing services provided to a participant by an enrolled personal assistance worker under the supervision of a: Registered nurse in accordance with COMAR 10.27.11; or Nurse practitioner in accordance with COMAR 10.27.07. “Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department. Home. “Home” means the participant’s place of residence in a community setting. “Home” does not mean: An assisted living program as defined in COMAR 10.07.14; A residential rehabilitation program licensed as a therapeutic group home under COMAR 10.21.07; An alternative living unit, group home, or individual family care home as defined in COMAR 10.22.01; Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; or Any other provider-owned or controlled residence. “Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. “Instrumental activities of daily living” means tasks or activities that include, but are not limited to: Preparing meals; Performing light chores that are incidental to the personal assistance services provided to the participant; Shopping for groceries; Nutritional planning; Traveling as needed; Managing finances and handling money; Using the telephone or other appropriate means of communication; Reading; and Planning and making decisions. “Medicaid” means the Program, administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy participants. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, ameliorative, palliative, or rehabilitative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, the participant’s family, the provider, or the worker. “Nurse” means an individual who is currently licensed to practice nursing in the State under COMAR 10.27.01. “Nurse monitor” means a registered nurse who completes nursing assessments on participants and evaluates the delivery of care. “Nursing facility” means a facility which is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10. “Participant” means an individual who: Has been determined to meet the qualifications for participation in Community First Choice as specified in Regulation .04 of this chapter; and Is enrolled with the Department to receive Medicaid services. “Personal assistance provider agency” means a public or private agency that: Employs or contracts with personal assistance workers; and Has been enrolled by the Program as a provider of personal assistance services. Personal Assistance Services. “Personal assistance services” means assistance specific to the functional needs of a participant with a chronic illness, medical condition, or disability. “Personal assistance services” includes: Assistance with activities of daily living and instrumental activities of daily living; and The performance of delegated nursing function. “Plan of service” means the written support plan that: Reflects what is important to the individual and what is important for his or her welfare; and Is developed with support from the supports planner with input from the individual and, when applicable, the individual’s representative. “Preauthorized” means approved by the Department or its designee before services can be rendered. “Program” means the Maryland Medicaid Program. “Provider” has the same meaning as defined in COMAR 10.09.36. “Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter. “Quality plan” means the plan developed by the Department to address quality assurance and oversight. “Recommended plan of care” means the recommended service plan developed by a nurse after a face-to-face evaluation of an applicant or participant. “Representative” means: The person authorized by the individual to serve as a representative in connection with the provision of Community First Choice services and supports; The individual who signs the plan of service on the participant’s behalf; Any individual who makes decisions on behalf of the participant related to the participant’s plan of service; A legal guardian of the individual for the participant; or The parent or foster parent of a dependent minor child. “Supports planner” means an individual who coordinates services, including: Supporting development of a plan of service; Interacting with third parties on behalf of, or in conjunction with, the applicant or participant; and Ensuring an accurate plan of service is provided to the Department. “Telephonic timekeeping system” means a system developed by the Department for workers to time stamp the start and finish of services provided to a participant. “Worker” means an individual who is employed by or contracts with a personal assistance provider agency to provide personal assistance services. The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered: Physicians; Registered nurses; Licensed practical nurses; Certified medication technicians; Certified nursing assistants; Occupational therapists; Physical therapists; Speech pathologists; Nutritionists; and Dietitians. To participate in the Program, a participant shall: Be determined by the Department to need the level of care provided in a hospital, nursing facility, an intermediate care facility for individuals with intellectual disabilities, an institution providing psychiatric services for individuals younger than 21 years old, or an institution for mental diseases for individuals 65 years old or older; Be eligible for Medicaid under an eligibility group defined in COMAR 10.09.24, except for Regulations .03C, .03-1—.03-3, and .05-2; and Reside at home. To be eligible for participation, a participant shall have an active plan of service. The plan of service shall: Be based on: The evaluation and recommended plan of care; and Consultation with the applicant or participant; Address the applicant’s or participant’s health and safety needs; Specify the items and services needed to safely support the participant in the community, including: A plan for receiving personal assistance services in case of an emergency; and Specific requests for items or services that substitute for human assistance; Specify the provider agency providing personal assistance services; and Include the signature of the: Participant or, when applicable, the individual’s representative; Supports planner; and Personal assistance provider agency listed within the plan of service. A participant’s eligibility for services shall be re-evaluated by the Department every 12 months, or more frequently if needed due to a significant change in the participant’s condition or needs. Participant eligibility shall be terminated if the participant: No longer meets the required level of care; No longer resides at home; Is without services for 30 consecutive calendar days; Voluntarily chooses, or the participant’s legal representative chooses on the participant’s behalf, to disenroll from the Program; Moves to another state; Is an inpatient for 30 consecutive days or more in an institutional setting, including but not limited to a chronic hospital or nursing facility; or Dies. To participate as a provider of a service covered under this chapter, a provider: Shall meet all of the conditions for participation as a Medicaid provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; Shall obtain written verification of the qualifications of all individuals who render services on the provider’s behalf and provide a copy of the current license or credentials on request; Shall implement the reporting and follow-up of incidents and complaints in accordance with the Department’s established policy by: Reporting incidents and complaints within 24 hours of knowledge of the event; Submitting a written report within 7 calendar days on a form designated by the Department; and Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subjected to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.02.16; Shall agree to cooperate with required inspections, reviews, and audits by authorized governmental agents; Shall agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter, for only those services covered under this chapter which have been: Preauthorized in the participant’s plan of service; Provided in a manner consistent with the participant’s plan of service; and Identified in the provider agreement as within the scope of the provider’s Medicaid participation; Shall agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years from the date of service, in a manner approved by the Department; Shall agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and only after consultation and input from the participant or, when applicable, the participant’s representative; Shall submit a transition plan to the case manager or supports planner and participant or, when applicable, the participant’s representative when suspending or terminating services; Shall verify Medicaid eligibility at the beginning of each month that services will be rendered; May not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; and Shall be free from conflicts of interest. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: Had a license or certificate suspended or revoked as a health care provider, health care facility, or direct care services worker; Been suspended or removed from participating as a Medicaid provider under COMAR 10.09.20; Undergone the imposition of sanctions under COMAR 10.09.36.08; Been subject to disciplinary action, including actions by the licensing board or any provider or principal of any provider agency; Been cited by a State agency for deficiencies which affect participants’ health and safety; or Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to: Failure to meet contractual obligations; or Fraudulent billing practices. A provider who renders health-related services to participants shall agree to: Periodically provide information about a participant in accordance with the procedures and forms designated by the Department; and Share and discuss the documented information at the request of the participant. Personal assistance service providers shall: Be licensed as a Residential Service Agency under COMAR 10.07.05 to provide Level Two or Level Three home care services; Employ a registered nurse who shall: Assess each new participant who requires personal assistance services; Participate in developing the worker instructions and in assigning appropriate personnel; Delegate nursing tasks, as appropriate, to a CNA or a CMT in accordance with COMAR 10.27.11; and Participate in instructing the workers who will provide the assistance, when indicated; Employ workers who will accept instruction on the personal assistance services required in the participant’s plan of service from the following: The participant or, when applicable, the participant’s representative; The nurse monitor; A treating physician or nurse practitioner; or An individual from the Department; Allow participants to have a significant role in the delivery of their specific care including: Directing the services and supports identified in their plan of service; and Exercising as much control as desired to select, train, schedule, determine duties, and dismiss the personal assistance worker in their home; Notify the Department in writing at least 45 days in advance of any: Voluntary closure; Change of ownership; Change of location; Sale of the business; Change in the name under which the provider is doing business; or Change in provider tax identification number; Include in the notice to the Department the method for informing participants and representatives of its intent to close, change ownership, change location, or sell its business; Include in the notice to the Department, and inform participants and representatives, of the transition plan developed by the agency to ensure continuity of services to participants; If applicable, apply for a new license whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of services; Submit a Medicaid provider application to the Department if the new owner chooses to participate in the Program; At least monthly, collect and maintain the participant’s signature, or that of the participant’s representative when applicable, verifying services rendered; and Conduct a criminal history records check on all direct service workers including nurses, in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland. A worker who performs delegated nursing services in accordance with COMAR 10.27.11 shall: If required to administer medications in accordance with the plan of service, be a certified medications technician; and If performing other delegated nursing functions, also be a certified nursing assistant. A personal assistance provider agency may not assign the participant’s representative to provide services to that participant. To participate in the Program as a supports planning provider under Regulation .15 of this chapter, a provider shall: Agree to be monitored by the Department; and Be: Identified by the Department through a solicitation process; or The area agency on aging that is enrolled to provide case management services under COMAR 10.09.54. To participate in the Program as a provider of consumer training under Regulation .16 of this chapter, a provider shall: Be a self-employed trainer or an agency that employs qualified trainers in accordance with §B of this regulation; Have demonstrated experience with the skill being taught; and Be willing to meet at the participant’s home to provide services. To participate in the Program as a provider of personal emergency response systems under Regulation .17 of this chapter, a provider shall: Be the store, vendor, organization, or company which sells, rents, installs, services, or operates the device or service; Provide or arrange for any installation, maintenance, training, or monitoring required for the device or system; Ensure that any response center is: Responsible for monitoring and responding to a notification of an emergency by the system; and Adequately staffed 24 hours a day, 7 days a week by properly trained staff; and Submit reports to the Department regarding activation and participant use no less than monthly or at a greater frequency as requested by the Department. To participate in the program as a provider of items or services that substitute for human assistance, the provider shall: Be approved and monitored by the Department; Provide or arrange for any installation, maintenance, training, or monitoring required for the proper operation of the device or system, if applicable; and Receive a referral from the participant, participant’s case manager, or supports planner, based on services preauthorized in the plan of service. To participate in the Program as a provider of home-delivered meals, the provider shall: Use a cooking facility or food preparation site that has a food service license issued by the local health department, in accordance with COMAR 10.15.03, or an appropriate license from the state in which the site is located; and Be approved for each licensing renewal based on inspections performed by State sanitarians in accordance with COMAR 10.15.03, or by the licensing authority in the state in which the site is located. To participate in the Program as a provider of assistive devices, equipment, or technology services, the provider shall be one of the following entities: A Program provider of disposable medical supplies and durable medical equipment under COMAR 10.09.12; or The store, vendor, organization, or company which sells or rents the equipment or system, subject to Department approval. To participate as a provider of accessibility adaptations a provider shall: Have a current license with the Maryland Home Improvement Commission; and Be approved by the Department. To participate in the Program as a provider of environmental assessments under Regulation .19 of this chapter, the provider shall: Be a licensed occupational therapist, or an agency or professional group employing a licensed occupational therapist; Receive a referral from the participant’s supports planner, based on services preauthorized in the plan of service; and Document the provider’s findings and recommendations on a form approved by the Program. To participate in the Program as a nurse monitoring provider under Regulation .20 of this chapter, a provider shall: Be designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act; Employ or contract with registered nurses who hold a current professional license to practice in Maryland; Agree to accept all referrals from the Department; and Agree to be monitored by the Department. The Program shall reimburse for the services specified in Regulations .14—.21 of this chapter, when, pursuant to the requirements of this chapter, these services have been preauthorized by the Department in the participant’s plan of service, billed in accordance with the payment procedures in Regulation .24 of this chapter, and documented as necessary to prevent institutionalization. The Program covers personal assistance services that are approved in the plan of service and rendered to a participant by a qualified provider in the participant’s home or a community setting. The Program covers the following services when provided by a personal assistance provider: Assistance with activities of daily living; Delegated nursing functions if this assistance is: Specified in the participant’s plan of service; and Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing; Assistance with tasks requiring judgment to protect a participant from harm or neglect; Assistance with or completion of instrumental activities of daily living, provided in conjunction with the services covered under §B(1)—(3) of this regulation; and Assistance with the participant’s self-administration of medications, or administration of medications or other remedies, when ordered by a physician. Personal assistance services may not include: Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant; The cost of food or meals prepared in or delivered to the home or otherwise received in the community; or Housekeeping services, other than those incidental to services covered under §B of this regulation. Supports planning services shall: Address the individualized needs of the participant; Be sensitive to the educational background, culture, and general environment of the participant; Support the participant to self-direct services and exercise as much control as desired to select, train, supervise, schedule, determine duties, and dismiss the personal assistance worker; and Ensure freedom of choice among any willing provider for all services. Supports planning services include the following activities: Assisting the participant in developing a plan of service in consultation with the applicant or participant and any individual requested by the participant; Assisting the participant with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to: Behavioral health; Educational services; Disposable medical supplies and durable medical equipment; Housing; Medical services; and Social services; Monitoring the provision of services to determine if services are received in accordance with the plan of service; Using information technology systems developed by the Department; Coordinating with the fiscal intermediary to assist in managing budgeted resources; Providing guidance and support to help individuals self-direct their services; and Administering funds for transition services. Consumer training includes instruction and skill building in such areas including, but not limited to, acquisition, maintenance, and enhancement of skills necessary for the participant to accomplish ADLs and IADLs. The topics covered by consumer training shall be: Targeted to the individualized needs of the participant receiving the training; and Sensitive of the educational background, culture, and general environment of the participant receiving the training. Consumer training does not include time spent by the provider: Planning, preparing, or setting up the training; or Following up after the training. The Program covers the following related to a device, system, or piece of equipment described under §B of this regulation: Purchase and installation; Monthly cost of a covered system or rented device or equipment, including monitoring, maintenance, and repair. A personal emergency response system is an electronic device or system which enables a participant to secure help in an emergency and may include but is not limited to: A device connected to the participant’s telephone or other device and programmed to signal, upon activation of a help button, a response center with properly trained staff on duty 24 hours a day, 7 days a week; A portable help button to allow for the participant’s mobility; and A motion detector when necessary for the participant’s safety. The program covers items or services that increase a participant’s independence or substitute for human assistance, to the extent that expenditures would otherwise be made for the human assistance. Each item or service shall: Be preauthorized in the participant’s plan of service as necessary to: Prevent the participant’s institutionalization; and Ensure the participant’s health, safety, and independence; Specifically relate to ADLs or IADLs within the approved plan of service; Comply with policies and procedure guidance defined by the Department; Meet necessary standards of manufacture, design, usage, and installation, if applicable; Be provided in accordance with applicable State and local building codes and pass required inspections, if applicable; and Not be prescribed primarily to provide comfort or convenience. Each item or service shall be confirmed by the Program as not covered for the participant by: Medicaid under the State Plan as durable medical equipment or pharmacy services under COMAR 10.09.03, 10.09.12, or 10.09.67; Medicare; or Any other third-party payer. The Program covers home-delivered meals provided during meal periods that personal assistance services are not provided. Home-delivered meals shall be: Delivered to the participant’s home; Intended for consumption at home; Nutritionally adequate for the participant’s age based on the Recommended Dietary Allowance (RDA) or Dietary Reference Intake (DRI), as established by the Food and Nutrition Board of the National Research Council and demonstrated by having the menus certified in writing by a physician, dietitian, or nutritionist; and At least one-third of the RDA, DRI, or therapeutic diet requirements ordered by the participant’s physician, dietitian, or nutritionist, including any ordered nutritional supplements. Technology that substitutes for human assistance includes: Environmental controls for the home or automobile; Personal computers, software, or accessories; Augmentative communication devices; Maintenance or repair of technology devices; Self-help aids that assist with activities of daily living or instrumental activities of daily living; and Assessments and training in the use of assistive technology. The Program covers an on-site environmental assessment and adaptations of a home or residence where the participant lives or will live as a participant. An environmental assessment or adaptation may not be provided before the effective date of the participant’s enrollment in services. The environmental assessment may be recommended by a multidisciplinary team in the plan of service for a participant when an environmental assessment is considered necessary to: Ensure the health and safety of a participant with special environmental needs; and Obtain additional professional advice from an occupational therapist about the: Physical structure of a participant’s home or residence; and Functional or mental limitations or disabilities of a participant as they relate to the environment. Included in the environmental assessment, as necessary, may be: An evaluation of the presence and likely progression of a disability or a chronic illness or condition in a participant; Environmental factors in the facility or home; The participant’s ability to perform activities of daily living; The participant’s strength, range of motion, and endurance; and The participant’s need for assistive devices and equipment. Based on an inspection of the home and interviews with the participant and any individual requested by the participant, the provider shall complete a form, to be reviewed by the supports planner, which details the provider’s findings and recommendations, especially relating to a participant’s need for services. The program covers the following services when provided by a nurse monitor: Being available to give instruction and to answer questions; Complying with the Department’s reportable events policy; and Maintaining an up-to-date client profile in an electronic database designated by the Department. The Program covers nurse monitoring services according to the following schedule: Contact with the participant for the purpose of reviewing participant status at a minimum of every 6 months with at least one in-person home or workplace visit every 12 months; and Additional nurse monitoring services at a frequency established in conjunction with the participant or, when applicable, the participant’s representative, based on the participant’s medical condition or clinical status. Home and Workplace Visits. The nurse monitoring provider shall use the home or workplace visit for the following purposes: To assess the participant’s condition; To assess the quality of personal assistance services; and To determine the need for discharge from personal assistance services or referral to other services. The nurse monitor shall assess the quality of personal assistance services by: Reviewing documentation related to the provision of personal assistance services; and Observing the performance of the worker, as appropriate. Definition. “Transition service” means a service that is: Not otherwise available under the Program; Approved in the plan of service; and Rendered to assist the participant in transitioning from an institution or a provider-owned residence to a home or community-based residence. Transition services may include all or some of the following: Security deposits; Essential furnishings and moving expenses; Set-up fees or deposits for utility services; and Other health and safety assurances. Transition services may not include recreational items including, but not limited to: Televisions; Cable television access; or Gaming systems. The Program shall reimburse for the services specified in Regulations .14—.21 of this chapter, if provided in accordance with the requirements of this chapter and if the service: Is recommended on the participant’s plan of service as necessary in order to: Prevent the applicant’s or participant’s admission to an institution; Safely transition the applicant or participant from an institution, such as a nursing facility, into the community; or Assure the health and safety of an applicant or participant in the community; Has been preauthorized by the Department in the participant’s plan of service; Is provided to an enrolled participant; Is medically necessary; and Is provided by a Medicaid provider who meets the conditions for participation under this chapter. Reimbursement for Personal Emergency Response System is limited to participants who: Live alone; or Have no regular caregiver for extended parts of the day and would otherwise require extensive routine supervision to ensure the participant’s health and safety. The Department shall establish a budget for personal assistance services and home-delivered meals that may be included in the participant’s plan of service, based on each participant’s assessed need. The Program does not cover the following services: Service primarily for the purpose of housekeeping unrelated to the participant’s activities of daily living, such as: Cleaning of the floor and furniture in areas not occupied by the participant; Laundry other than that incidental to services for the participant; and Shopping for groceries or household items unless in the company of the participant; Services provided by providers not approved for participation by the Department; Expenses incurred while escorting participants: To obtain medical diagnosis or treatment; To or from the participant’s workplace; or For participation in social or community activities; Expenses related to room and board for either the participant or the worker; Transition services more than 60 days post transition; Personal assistance services provided outside the State for more than 30 days per calendar year; Environmental adaptations to the home which: Are of general maintenance, such as carpeting, roof repair, and central air conditioning; Are not of direct medical or remedial benefit to the participant; Add to the home’s total square footage; or Modify the exterior of the home, other than the provision of ramps, lifts, sidewalks necessary to utilize a ramp or lift, and railings; or Experimental technology or equipment. Payment for supports planning and nurse monitoring services shall be limited to direct services to the participant and may not be made for: Administrative overhead; Travel; Internal quality monitoring activities; Staff supervision, training, or consultation; or Services rendered by an individual supports planner or nurse monitor in excess of 7 hours per day unless preauthorized by the Department in writing. Payment for environmental adaptations and technology that substitutes for human assistance is limited to a combined reimbursement of up to $15,000 over a 3-year period per participant. For technology items or services above $1,000, multiple quotes from providers are required. Request for Payment — Personal Assistance. To receive payment as a personal assistance provider agency under Regulation .14 of this chapter, a provider and its workers shall use the telephonic timekeeping system approved by the Department to: Document time; and Submit claims. Request for Payment — All Other Covered Services. To receive payment as a provider of services covered under Regulations .15—.21 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department’s billing manual. Billing time limitations are set forth in COMAR 10.09.36.06. Payments. Payments for services rendered to a participant shall be made directly to a qualified provider. A provider shall be paid the lesser of: The provider’s usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The rate established according to the fee schedule published by the Department. Effective May 1, 2017, for personal assistance services up to 12 hours per day, payment will be made in 15-minute units of service. For individuals who are determined to need more than 12 hours of personal assistance per day, a daily rate for the service will be paid. Rates. The Department shall publish a fee schedule for services covered under this chapter which shall be publicly available and updated at least annually or upon any changes made by the Department. Effective July 1, 2018, the Program’s rates for covered services under Regulations .14—.16, .18D, .19, and .20 of this chapter shall increase on July 1 of each year by 3 percent, subject to the limitations of the State budget. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. Appeal procedures shall be as set forth in: COMAR 10.09.36.09; and COMAR 10.01.03. Appeal procedures for applicants and participants are those set forth in: COMAR 10.09.24.13; and COMAR 10.01.04. Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: March 17, 2014 (41:5 Md. R. 343) Regulation .01 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .02B amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449); February 12, 2018 (45:3 Md. R. 156) Regulation .03 amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449) Regulation .04 amended effective June 8, 2015 (42:11 Md. R. 724) Regulation .04A, B amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .05A amended effective February 12, 2018 (45:3 Md. R. 156) Regulation .05A, B amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .05A, C amended effective June 8, 2015 (42:11 Md. R. 724) Regulation .06 amended effective June 8, 2015 (42:11 Md. R. 724); November 9, 2015 (42:22 Md. R. 1377); April 11, 2016 (43:7 Md. R. 449) Regulation .06A amended effective February 12, 2018 (45:3 Md. R. 156) Regulation .07 amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449); February 12, 2018 (45:3 Md. R. 156) Regulation .10D adopted effective February 12, 2018 (45:3 Md. R. 156) Regulation .13 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .14A amended effective January 30, 2017 (44:2 Md. R. 85) Regulation .15 amended effective January 30, 2017 (44:2 Md. R. 85) Regulation .15B amended effective February 12, 2018 (45:3 Md. R. 156) Regulation .15B, C amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449) Regulation .16 amended effective January 30, 2017 (44:2 Md. R. 85) Regulation .17A amended effective January 30, 2017 (44:2 Md. R. 85) Regulation .18 amended effective February 12, 2018 (45:3 Md. R. 156) Regulation .18E adopted effective January 30, 2017 (44:2 Md. R. 85) Regulation .19 amended effective February 12, 2018 (45:3 Md. R. 156) Regulation .19A amended effective January 30, 2017 (44:2 Md. R. 85) Regulation .20 amended effective April 11, 2016 (43:7 Md. R. 449); January 30, 2017 (44:2 Md. R. 85) Regulation .20B amended effective June 8, 2015 (42:11 Md. R. 724) Regulation .22B amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .23 amended effective April 11, 2016 (43:7 Md. R. 449) Regulation .23B amended effective January 30, 2017 (44:2 Md. R. 85) Regulation .23C amended effective June 8, 2015 (42:11 Md. R. 724); February 12, 2018 (45:3 Md. R. 156) Regulation .23E, F adopted effective February 12, 2018 (45:3 Md. R. 156) Regulation .23D adopted effective November 9, 2015 (42:22 Md. R. 1377) Regulation .24 amended effective April 11, 2016 (43:7 Md. R. 449); January 30, 2017 (44:2 Md. R. 85); February 12, 2018 (45:3 Md. R. 156) Regulation .24A, E amended effective June 8, 2015 (42:11 Md. R. 724) Regulation .24F amended effective May 20, 2019 (46:10 Md. R. 486) Regulation .27 amended effective June 8, 2015 (42:11 Md. R. 724) The following terms have the meanings indicated. Terms Defined. “Certified nurse midwife (CNM)” means a registered nurse who is certified by the American College of Nurse-Midwives, and is licensed in the state in which the service is provided. “Commission for the Accreditation of Birth Centers (CABC)” means the independent authority that accredits developing and existing birth centers in the United States of America, according to established national standards. “Department” means the Maryland Department of Health. “Free-standing Birth Center” means a free-standing facility not associated with a hospital that provides physician or certified nurse midwifery services. "Medical Assistance Program” means the program, financed by federal, state, and local funds, for the comprehensive medical care for persons of all ages within certain income limits. “Medically necessary” means the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Newborn” means an infant who is not more than 48 hours old. “Participant” means an individual who is eligible for Program benefits. “Physician” means an individual legally licensed to practice medicine by the Board or in the state in which the physician's practice is located. “Program” means the Maryland Medical Assistance Program. “Provider” means a free-standing birth center. A free-standing birth center shall be certified by the Commission for the Accreditation of Birth Centers, and: Be licensed to operate in Maryland pursuant to Health General Article 19, Subtitle 3b, Annotated Code of Maryland and in accordance with the requirements as set forth in COMAR 10.05.02; or If located out-of-State, comply with the regulations of the jurisdiction in which the free-standing birth center is located. The free-standing birth center shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. A CNM providing services in a free-standing birth center shall meet the license requirements in accordance with COMAR 10.09.21.02B. A physician providing services in a free-standing birth center shall meet the requirements in accordance with COMAR 10.09.02.02B. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. Specific requirements for participation in the Program as a free-standing birth center require that the provider: Verify the licenses and credentials of all clinical professionals employed by or under contract with the free-standing birth center as set forth in COMAR 10.05.02.04. Maintain adequate documentation of each participant’s delivery service and newborn care as set forth in COMAR 10.05.02.11. Comply with safety requirements as set forth in COMAR 10.05.02.09 and COMAR 10.05.02.10. The Program covers the facility-related services provided by the free-standing birth center for the care of the delivering mother and newborn, and covers the cost of; Support staff; The use of the free-standing birth center; and Supplies, linens, and equipment. The Program does not cover laboratory or x-ray services performed by another facility. The facility performing these services shall bill the Program directly. Professional services are to be billed separately from the free-standing birth center facility fee. The Program will reimburse free-standing birth centers for: A facility fee of $2,000 for the care of the delivering mother and delivery of the newborn, if the delivery takes place at the facility; and A facility fee of $500 for the care of the newborn. If the mother is transferred to a hospital prior to delivering the newborn, the Department will reimburse as follows: If the mother was at the birth center for less than 2 hours, before the delivery of the newborn, the reimbursement will be at 25 percent of the Medicaid rate; If the mother was at the birth center for 2 to 5 hours, before the delivery of the newborn, the reimbursement will be at 50 percent of the Medicaid rate; If the mother was at the birth center for 5 to 8 hours, before to the delivery of the newborn, the reimbursement will be at 70 percent of the Medicaid rate; and If the mother was at the birth center for more than 8 hours, before the delivery of the newborn, the reimbursement will be at the full Medicaid rate. The Program shall pay for covered services at the lower of the: Provider's customary charge to the general public; or The Program’s fee. The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. The Program reserves the right to return to the provider, before payment, all invoices that are not properly completed. The Program may not make a direct payment to a recipient. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. If the recipient has insurance or if any other person is obligated either legally or contractually to pay for or to reimburse for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Department. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the claim. If payment is made by both the Program and by the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less. The provider shall reimburse the Department for any overpayment. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08 Appeal procedures are as set forth in COMAR 10.09.36.09. General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: May 1, 2014 (41:8 Md. R. 471) Effective date: April 28, 2014 (41:8 Md. R. 471) Regulation .08B amended effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred to COMAR 10.67.13 effective November 1, 2019 (46:22 Md. R. 977) In this chapter, the following terms have the meanings indicated. Terms Defined. “CMS” means Centers for Medicare and Medicaid Services. “Department” means Maryland Department of Health. "Independent Diagnostic Testing Facility (IDTF)” means a fixed location or mobile entity independent of a hospital or physician’s office where diagnostic services are performed by licensed certified non-physician personnel under appropriate physician supervision. “Major medical equipment” means: All cardiac catheterization equipment necessary to perform heart catheterization; A computerized tomography (CT) scanner; A lithotriptor; Radiation therapy equipment, including a linear accelerator; and A Magnetic Resonance Imager (MRI). “Mammography” means the radiographic examination of the soft tissues of the breast. “Medically necessary” means medically necessary as defined in COMAR 10.09.36.01. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “NPI” means National Provider Identifier. “Program" means the Maryland Medical Assistance Program. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. A facility or mobile unit that is operating radiological equipment shall be licensed or certified and registered by the Department of the Environment in accordance with COMAR 26.12.01 through COMAR 26.12.03. A facility that performs mammography services shall be certified by the Food and Drug Administration (FDA). A facility operating major medical equipment shall meet all the general licensing requirements for a facility as provided in COMAR 10.05.03.02. The driver of the Mobile IDTF unit: Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; and May not have: Violations related to the operation of a motor vehicle in the last 3 years; and Any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. Requirements for participation in the Program as an IDTF provider/mobile IDTF provider require that the provider: Be approved by Medicare to furnish diagnostic services in an IDTF; Meets the licensure requirements in accordance with Regulation .02 of this chapter; and Meets performance standards in accordance with 42 CFR §410.33(g). Specific Requirements for Participation in the Program as a Mobile IDTF Provider. The mobile IDTF shall have electronic technology that enables the same day exchange of patient records with the treating physician’s office. An IDTF mobile unit shall: Maintain physician’s order & diagnostic test records for each patient; Observe all patient rights; Obtain written, informed consent from a parent or legal guardian before providing services to a minor; Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating: Equipment; Flammability; Construction; Infection control; Sanitation procedures; and Zoning; Comply with the statutes and regulations of the Maryland Department of the Environment for all radiographic and imaging equipment; Obtain all applicable county and city licenses or permits necessary to operate the mobile IDTF; Provide access to a ramp or a lift if services are provided to disabled individuals; Have ready access to an adequate supply of potable water, including hot water; Have immediate access to toilet facilities; Have an appropriately covered noncorrosive metal container for refuse and waste materials; Have a carbon monoxide detection device or system installed and in proper working condition; Have written procedures for medical emergencies; and Have appropriate equipment to treat medical emergencies. The owner or owners of a mobile unit shall submit a business plan to the Department for the mobile unit that includes: The mission of the mobile unit; Verification of ownership of the mobile unit; A list of the technical staff that will render services in the mobile unit; and The targeted population. The Program covers medically necessary radiology services rendered to a recipient in an IDTF when the services are: Rendered in a CMS certified IDTF or an IDTF Mobile Unit; Provided according to the laws and regulations of the state and locality in which they are rendered; Rendered by a physician or supervised technician; Ordered in writing by the treating physician or non-physician practitioner, in accordance with State law, who is enrolled as a provider in the Program with an active status on the date of service; and Adequately documented in the recipient’s medical record. Radiology services include the following: Diagnostic X-rays; Computerized Tomography (CT) procedures; Magnetic Resonance Imaging (MRI); Magnetic Resonance Angiography (MRA); Nuclear medicine imaging and radionuclide used in the procedures; Diagnostic mammography and certain mammography screening; Ultrasound (US procedures); Position Emission Tomography (PET); Radiation oncology; and Bone mass measurements. Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Nuclear Medicine Imaging to include Position Emission Tomography (PET) are covered only when billed by providers who are accredited by one of the following: The American College of Radiology; The Intersocietal Accreditation Commission; or The Joint Commission on Accreditation of Health Organizations (JCAHO). The Program does not cover the following: Services for which the IDTF provider cannot supply a properly completed order identifying the authorized ordering practitioner by National Provider Identifier (NPI); IDTF services ordered by an: Individual who is not enrolled as a provider in the Program with an active status on the date of service; and Entity, facility, or another provider that is not an individual. Services not adequately documented in the recipient’s medical record; Services not medically necessary; Procedures that are the provider as investigational or experimental in nature; Services which are specifically included as an integral part of another service; Consultations; Office Visits; Injections; Surgeries; and Therapeutic services. General policies for payment that are applicable to all providers are set forth in COMAR 10.09.36.04. IDTF providers shall identify the individual who ordered the diagnostic services by either: Recording the National Provider Identifier (NPI) number for the individual provider on the claim; or Recording the name and NPI of the authorized ordering provider on the invoice and attaching to the invoice a copy of the properly completed order that identifies the authorized ordering provider. The Department shall reimburse the IDTF providers for covered services at the lesser of: The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or The Department’s fee schedule. The Department’s fee-schedule is contained in COMAR 10.09.02.07D. Payments on Medicare cross-over claims are authorized if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; Medicare has determined that the services are medically necessary; Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: Coinsurance shall be paid at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate. The Program may not make a direct payment to a recipient. Billing time limitations are those set forth in COMAR 10.09.36.06. The provider may not bill the Program or recipient for: Completion of forms and reports; Broken or missed appointments; Services rendered by mail or telephone; and Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. General policies governing recovery and reimbursement procedures that are applicable to all providers are set forth in COMAR 10.09.36.07. General policies governing the cause for suspension and removal and imposition of sanctions procedures that are applicable to all providers are set forth in COMAR 10.09.36.08. General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: April 28, 2014 (41:8 Md. R. 472) Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .07B amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .07C, I amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D amended effective February 27, 2017 (44:4 Md. R. 252) In this chapter, the following terms have the meanings indicated. Terms Defined. “CMS” means Centers for Medicare and Medicaid Services. “Department” means the Maryland Department of Health. “Mammography” means the radiographic examination of the soft tissues of the breast. “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means medically necessary as defined in COMAR 10.09.36.01. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “NPI” means National Provider Identifier. “Program” means the Medical Assistance Program. “Portable X-ray provider” means an entity that moves its portable X-ray equipment that is separate from and unattached to the vehicle to a fixed location (e.g. a physician’s office or nursing home). “Provider” means: An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Program recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number; An agent, employee, or related party of a person identified in §B(10)(a) of this regulation; or An individual or any other person with an ownership interest in a person identified in §B(10)(a) of this regulation. “Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. Providers of Medical Assistance Program services shall, to the extent required by law, be licensed and legally authorized to practice or deliver services in the state in which the service is provided. The provider and the equipment personnel shall be licensed or registered in accordance with applicable federal, State and local laws in accordance with 42 CFR §486.100. The portable X-ray provider shall be certified and registered by the Department of Environment in accordance with COMAR 26.12.01—.03 A portable X-ray provider that performs mammography services shall be certified by the Food and Drug Administration (FDA). The driver that transports portable X-ray equipment: Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; May not have violations related to the operation of a motor vehicle in the last 3 years; and May not have any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. The provider shall also: Be certified by CMS to furnish portable X-ray services; Meet the licensure requirements as provided in Regulation .02 of this chapter; Meet performance standards in accordance with 42 CFR §410.33(g); Ensure that portable X-ray services are rendered under the supervision of a qualified physician in accordance with 42 CFR §486.102; Ensure that portable X-ray services are rendered by a qualified technician in accordance with 42 CFR §486.104; Ensure that portable X-ray services performed for Medical Assistance recipients are ordered by a doctor of medicine or a doctor of osteopathy and records are properly preserved in accordance with 42 CFR §486.106; Ensure that inspections of all X-ray equipment and shielding are made by qualified individuals at intervals not greater than 24 months in accordance with 42 CFR §486.110; and Identify the ordering practitioner who authorized the diagnostic services by either: Recording the National Provider Identifier (NPI) number for the individual practitioner on the claim; or Recording the name and NPI of the authorized ordering practitioner on the invoice and attaching to the invoice a copy of the properly completed order that identifies the authorized ordering practitioner. The Program covers medically necessary services rendered to recipients, when the services are: Provided according to the laws and regulations of the State and locality in which they are rendered in accordance with 42 CFR §486.100; Rendered by a physician who meets the qualification standards in accordance with 42 CFR §486.102 or qualified non-physician (technician) who meets the qualification standards in accordance to 42 CFR §486.104; and Ordered in writing by the treating physician or nurse practitioner who is enrolled as a provider in the Program with an active status on the date of service in accordance with State law. Portable X-ray services include the following: Skeletal films involving extremities, pelvis, vertebral column, and skull; Chest films which do not involve the use of contrast media; Abdominal films which do not involve the use of contrast media; Diagnostic mammograms, if approved by the FDA; Transportation of portable X-ray equipment to a patient’s home or a long term care facility (LTCF); and Electrocardiograms (EKGs/ECGs). The Program does not cover the following: Services for which the portable X-ray provider cannot provide a properly completed order identifying the authorized ordering physician or practitioner by National Provider Identifier (NPI); Services not adequately documented in the recipient’s medical record; Services not medically necessary; Procedures that are known by the provider as investigational or experimental in nature; Services which are specifically included as an integral part of another service; Consultations; Office visits; Injections; Surgeries; and Therapeutic services. X-ray services ordered by an: Individual who is not enrolled as a provider in the Program with an active status on the date of service; and Entity, facility, or another provider that is not an individual. General policies for payment that are applicable to all providers are set forth in COMAR 10.09.36.04. The Department shall allow a single transportation payment for each trip the portable X-ray provider makes to a particular location. The Department shall reimburse for covered services at the lesser of: The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or The Department’s fee schedule. The Department’s fee-schedule is contained in COMAR 10.09.02.07D. Payments on Medicare cross-over claims are authorized if : The provider accepts Medicare assignment; Medicare makes direct payment to the provider; Medicare has determined that the services are medically necessary; The services are covered by the program; and The initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make supplemental payment on Medicare claims subject to the following provisions: Coinsurance shall be paid at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate. The Program may not make a direct payment to a recipient. Billing time limitations are those set forth in COMAR 10.09.36.06. The provider may not bill the Program or recipient for: Completion of forms and reports; Broken or missed appointments; Services rendered by mail or telephone; and Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. The portable X-ray provider shall identify the individual who ordered the portable X-ray services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim. General policies governing recovery and reimbursement procedures that are applicable to all providers are set forth in COMAR 10.09.36.07 General policies governing the cause for suspension and removal and imposition of sanctions procedures that are applicable to all providers are set forth in COMAR 10.09.36.08. General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: April 28, 2014 (41:8 Md. R. 472) Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1214) Regulation .05K adopted effective January 1, 2018 (44:26 Md. R. 1214) Regulation .07C, I amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .07D amended effective February 27, 2017 (44:4 Md. R. 252) Regulation .07J adopted effective January 1, 2018 (44:26 Md. R. 1214) The purpose of this chapter is to implement a home and community-based services benefit for children and youth with serious emotional disturbances (SED) and their families, authorized under a 1915(i) Medicaid State Plan Amendment. Eligible participants are served by care coordination organizations through a care coordination service delivery model that utilizes child and family teams to create and implement individualized plans of care that are driven by the strengths and needs of the participants and their families. In this chapter, the following terms have the meanings indicated. Terms Defined. “1915(c)” means a federal waiver that allows states to provide home- and community-based care to individuals who would otherwise be institutionalized. “1915(i)” means the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program described in this chapter. “Administrative services organization (ASO)” has the meaning stated in COMAR 10.67.01.01. “Behavioral Health Administration (BHA)” means the Department’s administration, as defined by Health General Article Title XX, Annotated Code of Maryland, or its designee. “Care coordinator” means an individual employed through the care coordination organization that is responsible for providing case management services to 1915(i) participants and families as described in COMAR 10.09.90. “Caregiver” means an individual with responsibility for 24-hour care and supervision of a minor. “Care coordination organization (CCO)” means an entity with a minimum of 3 years of experience providing care coordination services that is approved by the Department to provide case management services to 1915(i) participants and their families, pursuant to COMAR 10.09.90. “Child and family team (CFT)” means a team of individuals selected by the participant and family to work with them to design and implement the plan of care. “Core service agency (CSA)” has the meaning stated in COMAR 10.21.17. “Crisis plan” means a document that is developed by a CFT to address actions that need to be taken in the event that an individual is experiencing a behavioral health crisis, which is included as part of the plan of care. “Department” means the Maryland Department of Health (MDH) or its designee. “Department of Human Services (DHS)” has the meaning stated in Human Services Article, Title 2, Annotated Code of Maryland. “Department of Public Safety and Correctional Services (DPSCS)” has the meaning stated in Correctional Services Article, Title 2, Annotated Code of Maryland. “Diagnostic Criteria (DC) 0-5” means a system for diagnosing mental health and developmental disorders in infants and toddlers. “Expressive and experiential behavioral services” means the use of art, dance, music, equine, horticulture, or drama to accomplish individualized goals as part of the plan of care. “Family” means: One or more parents and children related by blood, marriage, or adoption, and residing in the same household; or A parent substitute or substitutes, including informal and formal kinship caregivers as set forth in Health-General Article, §20-105, Annotated Code of Maryland, and Education Article, §7-101, Annotated Code of Maryland, or legal guardians, who have responsibility for the 24 hour care and supervision of a child. “Family peer support” means a service as described in Regulation .09 of this chapter. “Family peer support partner” means an individual providing family peer-to-peer support services. “Family support organization (FSO)” means an approved entity under Regulation .09D of this chapter. “Institution for mental disease (IMD)” has the meaning stated in COMAR 10.67.01.01B. “Local departments of social services (DSS)” has the meaning stated in Human Services Article, Title 3, Annotated Code of Maryland. “Maryland Children’s Health Program (MCHP)” has the meaning stated in COMAR 10.09.43. “Medical Assistance Program” has the meaning stated in COMAR 10.67.02. “Mental health professional” has the meaning stated in COMAR 10.21.17.02. “Natural support” means a family member, friend, or community member, or organization selected by the participant or family, or both, to participate on the CFT. “Participant” means an individual who meets the qualifications, as specified in Regulation .03 of this chapter, for benefit eligibility. “Plan of care (POC)” means a written document that is: Developed by the CFT that describes the services to be provided to the participant; and Approved by the Department in accordance with 42 CFR §441.301. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual or entity that has enrolled with the Program to provide one or more benefit services covered under this chapter. “Public mental health system” means the system for the delivery of mental health treatment and supports to eligible individuals as described in COMAR 10.67.08. “Residential treatment center” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food provided in or associated with an individual’s place of residence. “Respite care” has the meaning stated in COMAR 10.21.27. “Serious emotional disturbance (SED)” has the meaning stated in COMAR 10.21.17. “Service area” means, during the phase-in of the 1915(i), the geographic area in Maryland where the 1915(i) is available. “State Plan” means the Plan described in §1902(a) of Title XIX of the Social Security Act. “Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. For an applicant to be eligible for 1915(i) services, the applicant shall meet all of the criteria in §§B—H of this regulation. The applicant shall be younger than 18 years old at the time of enrollment. The applicant shall reside in a home- and community-based setting that is: Located in the 1915(i) service area; and Not any of the following excluded settings: Therapeutic Group Home (TGH) licensed by the Behavioral Health Administration (BHA) under COMAR 10.21.07; Psychiatric Respite Care facility located on the grounds of an institution for mental disease (IMD) for the purpose of placement; Residential program for adults with serious mental illness licensed under COMAR 10.63; or Group residential facility licensed under COMAR 10.63. Consent. For individuals younger than 16 years old, the family or medical guardian of the participant shall give consent for the individual to participate in the 1915(i); For individuals 16 years old or older, the individual shall give consent to participate in the 1915(i). The applicant shall: Have a face-to-face psychosocial assessment completed or updated within 30 days of submission of the enrollment to the ASO that: Assigns a Diagnostic and Statistical Manual (DSM) behavioral health diagnosis or Diagnostic Criteria (DC) 0-5 diagnosis; Determines the applicant to be amenable to active clinical treatment; and Is conducted by a provider not associated with the CCO by which the participant may eventually be served; and Meet the Department’s written medical necessity criteria. The accessibility or intensity of currently available community supports and services are inadequate to meet the applicant’s needs due to the severity of the impairment without the provision of one or more of the services contained in the 1915(i) benefit. The applicant may not be served in a Health Home as defined in COMAR 10.09.33 while enrolled in the 1915(i). Medical Assistance Eligibility. Categorically Needy. An applicant is eligible for 1915(i) services if the applicant is eligible for Medicaid or Maryland Children’s Health Program (MCHP) in accordance with COMAR 10.09.11 or 10.09.24 and has a family income that does not exceed 300 percent of the Federal Poverty Line (FPL). Optional Categorically Needy. An applicant is eligible for the 1915(i) benefit as optionally categorically needy in accordance with §1902(a)(10)(A)(ii)(XXII) if the individual is receiving services through an existing 1915(c) HCBS waiver program. The Department may assist applicants in the benefit application process by: Informing the applicant and family verbally and in writing about services available in the 1915(i); Assisting the applicant and family to complete the eligibility determination for Medical Assistance for the 1915(i), if necessary; and Once Medical Assistance eligibility is determined, ensuring that the assessments and documentation required for a medical necessity determination are obtained and provided to the Department. Based on the criteria established in §§A—H of this regulation: An applicant’s eligibility for services under this regulation shall be established by the Department; There is no retroactive eligibility; and Benefit eligibility may not begin before: Verification of the applicant’s Medical Assistance eligibility for the 1915(i); and Completion of the independent evaluation by the Department that the applicant meets all criteria established in §§A—H of this regulation. If the applicant is determined to meet the needs-based eligibility criteria as established in §§A—H of this regulation, the Department shall: Obtain written consent from the family or medical guardian to participate in the 1915(i); and Ensure that the participant is referred immediately upon enrollment determination to a CCO. The Department shall re-evaluate a participant’s: Needs-based eligibility for 1915(i) services as specified in §§A—G of this regulation every 12 months, or more frequently due to a significant change in the participant’s condition or needs, in accordance with the Department’s medical necessity criteria; and Medical Assistance eligibility for 1915(i) services in accordance with the Department’s redetermination policy for all Medical Assistance enrollees. A participant shall be disenrolled from the 1915(i), as of the date established by the Department, if the participant: No longer meets all of the criteria for 1915(i) eligibility specified in §§A—H of Regulation .03 of this chapter; Voluntarily chooses to disenroll from the benefit, if the participant is 18 years old, or the participant’s family or medical guardian chooses to do so on behalf of a participant who is younger than 18 years old or in the custody of the State, or both; Is hospitalized for longer than 30 days; Moves out of the service area and cannot reasonably access services and supports; Is admitted to and placed in an RTC for longer than 60 days; Is admitted to and placed in a Therapeutic Group Home (TGH) licensed by BHA under COMAR 10.21.07 or an adult residential program approved under COMAR 10.21.22; Is placed in a Psychiatric Respite Care program, a non-medical group residential facility located on the grounds of an IMD primarily for the purpose of placement; Loses eligibility for Maryland Medical Assistance; Turns 22 years old; Is detained, committed to a juvenile justice or correctional facility, or incarcerated for longer than 60 days; Does not meet medical re-certification criteria; Does not participate in a Child and Family Team (CFT) meeting within 90 days; Is no longer actively engaged in ongoing behavioral health treatment with a licensed mental health professional; or Is placed in a group residential facility licensed under COMAR 14.31.05—.07. A participant who is not receiving 1915(i) services continuously after reaching age 18 is ineligible to enroll in the program at a later date. The 1915(i) shall provide community-based treatment to children with SED or co-occurring diagnosis through the care coordination model. Enrollment in 1915(i) services qualifies and requires the participant to receive case management services through a CCO, pursuant to COMAR 10.09.90. Each participant shall have an individualized POC that is managed by the CCO, pursuant to COMAR 10.09.90: In partnership with the CFT, the CCO shall: Reevaluate the POC at least every 45 days with re-administration of BHA-approved assessments as appropriate, and more frequently in response to a crisis; Determine the family vision, which will guide the planning process; Identify strengths of the entire team; Determine the needs that the team will work on; Determine outcome statements for meeting identified needs; Determine the specific services and supports required in order to achieve the goals identified in the POC; Create a mission statement that the team generates and commits to following; Identify the individuals responsible for each of the strategies in the POC; Review and update the crisis plan; and Meet at least every 45 days or more frequently as clinically indicated to: Coordinate the implementation of the POC; and Re-evaluate and update the POC as necessary. Benefit participants shall have access to specialty behavioral health services through the Department’s public behavioral health system. Participants shall also be enrolled in the Medical Assistance Program’s managed care program, known as HealthChoice, in accordance with eligibility requirements set forth in COMAR 10.67.02. The Department shall grant approval to providers to be eligible to receive Medicaid funds for 1915(i) services if the provider meets the requirements set forth in this chapter. Application. To provide 1915(i) services, a provider applicant shall: Submit an application to the Department on the form approved by the Department, with all questions answered and all required documents attached; and Attest that the provider applicant is in compliance with the general provider requirements and specific 1915(i) service requirements set forth in this chapter and in COMAR 10.09.36. Application Modification. A provider that proposes to change its 1915(i) service sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department. If the Department approves the application modification, the existing provider approval shall extend to the additional site, as applicable. Approval. The Department may grant approval to an applicant provider if the Department determines that the provider: Has no deficiencies that constitute a threat to the health, safety, or welfare of the individuals served; and Attests that it complies with the requirements set forth in this chapter. If the provider is granted approval under §D(1) of this regulation, to continue to be approved, the provider shall maintain documentation of compliance with the requirements set forth in this chapter. Sale or Transfer of Approval. The Department’s approval of a 1915(i) service provider is valid only for the provider to which the Department grants approval. A provider may not sell, assign, or transfer approval to another provider. Denial of Approval. If the Department proposes to deny approval to an applicant under the provisions of this chapter, the Department shall give written notice of the proposed denial to the: Provider applicant; Care coordination organization (CCO); and Administrative service organization (ASO). In the notice under §A(1) of this regulation, the Department shall include: The date on which the Department proposes to deny approval; The facts that warrant the proposed denial of approval; Citation of the regulation or regulations upon which the proposed denial is based; Notification that before the denial of approval, the provider may request a hearing under the provisions of COMAR 10.21.16; and When feasible, notification of a case resolution conference. Disciplinary Action. The Department may propose to take any of the following disciplinary actions against a provider: Revocation of approval; Suspension of approval; Probation with conditions; or Banning new admissions. The Department may propose to take one of the actions outlined in §B(1) of this regulation if the provider: Is out of compliance with the requirements of this chapter; Fails to maintain financial viability; or Obtains or attempts to obtain approval or payment by fraud, misrepresentation, or the submission of false information to the Department. Except under §C of this regulation, the Department shall send written notice of the proposed action not less than 45 calendar days in advance of the proposed action taken under this regulation to the: Provider; CCO; ASO; and Applicable CSA. In the notice under §B(3) of this regulation, the Department shall include: The date on which the Department proposes to take action and, when feasible, the date of a case resolution conference; The facts that warrant the proposed action; Citation of the regulation or regulations upon which the proposed action is based; and Notification that, before the action, the provider has the right to request a hearing under the provisions of COMAR 10.21.16. If, after notice and opportunity to be heard, the Department takes disciplinary action, the provider shall, within 10 working days: Notify individuals or the guardians of individuals receiving services of the action; and If the program ceases operations: Notify individuals or the guardians of individuals receiving services of the suspension; and Cooperate with the CCO, child and family team, and the Department in accessing appropriate alternate services for individuals served by the provider. Emergency Suspension of Approval. Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a provider, the Department may order the immediate suspension of the approval of the provider and the cessation of operation. If the Department takes the action under §C(1) of this regulation, the Department shall promptly give written notice of the proposed emergency suspension to the: Provider; CCO; ASO; and, Applicable CSA. In the notice under §C(2) of this regulation, the Department shall include: The proposed effective date of the emergency suspension; When feasible, the date of a pre-deprivation hearing and a case resolution conference before the Department’s final action; The findings under §C(1) of this regulation and the reasons that support the findings; and Notification that: Following the emergency suspension, the provider may request a hearing under the provisions of COMAR 10.21.16; and The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department. If the Department suspends approval, the provider shall immediately: Notify individuals or the guardians of individuals receiving services of the suspension; Cooperate with the CCO, child and family team, and the Department in accessing appropriate alternate services for individuals in the program; and Cease operations of the program. A provider of 1915(i) services shall: Provide the documentation required by the Department for initial approval and provider recertification, or as requested by the Department; Be approved by the Department as meeting the requirements of being able to provide the services set forth in this chapter; Have a provider agreement in effect, to include adherence to quality assurance, auditing, and monitoring policies and procedures; Receive training and certification as required and approved by the Department and determined to be appropriate for the level and scope of services provided; Meet all the conditions for participation in COMAR 10.09.36 except as otherwise specified in this chapter; Maintain general liability insurance, and provide proof of this insurance: At the time of initial application to be a provider of 1915(i) services; At recertification; and Upon request by the Department; Make available to the Department and federal funding agents all records for inspection and copying, including but not limited to: Personnel files for each individual employed, regardless of method of compensation; Financial records; Treatment records; and Service records; Comply with the following prohibitions against utilization of staff: Unless waived by the Department in accordance with §D of this regulation, prohibit from working with the participant or the participant’s family any staff, volunteers, students, or any individual who is: Convicted of, received probation before judgment, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft; or Has an indicated finding of child abuse or neglect; and Maintain administrative and medical records documenting the date, time, duration, and substantive notes associated with the services delivered, which shall be signed by the provider and indicated by the participant’s plan of care. Required Criminal Background Checks. The provider shall, at the provider’s own expense and for all staff, volunteers, students, and any individual providing services to participants and their families in the 1915(i): Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland; Request that DPSCS send the report to: The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or To the Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency; and Review the results of the background checks; Store background checks in a secure manner consistent with State and federal law; and Maintain written documentation in the individual’s personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation. Required Check for Abuse or Neglect. For each individual providing services to participants and the participant’s families in the 1915(i), the provider shall: Before employing any individual, submit a notarized Consent for Release of Information/Background Clearance Request form to the Department of Human Services (DHS) or a local department of social services (DSS) in the jurisdiction in which the individual lives, pursuant to COMAR 07.02.07.19; and Request that DHS or the local DSS send the report to: The director of the agency if the request is from a provider agency concerning staff, volunteers, or students who will work with the participant or family; or To the Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency. To provide 1915(i) services, an individual may not: Be the participant’s family member; Have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or any crime involving moral turpitude or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; or Be cited on any professional licensing or certification boards or any other registries with a determination of abuse, misappropriation of property, financial exploitation, or neglect. Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant’s family if the provider submits a request to the Department together with the following documentation that: For criminal background checks: The conviction, the probation before judgment, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application; The criminal history does not indicate behavior that is potentially harmful to participants; and Includes a statement from the individual as to the reasons the prohibition should be waived; and For abuse and neglect findings: The indicated finding occurred more than 7 years before the date of the clearance request; The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant’s family; and Includes a statement from the individual as to the reasons the prohibition should be waived. The Program covers the services listed in this chapter when the services are: Determined by the Department to be medically necessary; Preauthorized by Department; and Delivered in accordance with the participant’s POC. Family peer support services: May be provided without the presence of the participant; Are delivered by a family peer support partner employed by a family support organization (FSO); May include, but are not limited to: Explaining the role and function of the FSO to newly enrolled families and creating linkages to other peers and supports in the community; Working with the participant and family to identify and articulate concerns, needs, and vision for the future of the participant; Ensuring family and participant opinions and perspectives are incorporated into the CFT process and POC: Through communication with the care coordinator and team members; and By attending CFT meetings with the family to support family decision-making and choice of options; Listening to the family express needs and concerns and offering suggestions for engagement in the treatment process; Helping the family identify and engage its own natural support system and facilitating the family attending peer support groups and other FSO activities throughout the POC process; Working with the family: To organize and prepare for meetings in order to maximize participation in meetings; By informing the family about options and possible outcomes in selecting services and supports to assist with informed decision-making; and By supporting the family in meetings at school and other locations in the community and during court hearings; Empowering the family to make choices to achieve desired outcomes for the participant as well as the entire family; and Helping the family to acquire the skills and knowledge needed to attain greater self-sufficiency and maximum autonomy and assisting the family to develop the skills and confidence to independently identify, seek out and access resources that will assist in: Managing and mitigating the participant's behavioral health condition or conditions; Preventing the development of secondary or other chronic conditions; Promoting optimal physical and behavioral health; and Addressing and encouraging activities related to health and wellness. Are provided by a family support organization (FSO) that: Is designated as a private, nonprofit entity designated under §501(c)(3) of the Internal Revenue Service Code, and submits copies of the certificate of incorporation and Internal Revenue Service designation; Has a board of directors comprised of more than 50 percent of individuals who are: Caregivers with a current or previous primary daily responsibility for raising a child or youth with behavioral health challenges, Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; or Both §D(2)(a) and (b) of this regulation. Submits a list of board members with identification of those who are caregivers meeting the criteria in §D(2)(b) of this regulation; Establishes hiring practices that give preference to: Current or previous caregivers of a child or youth with behavioral health challenges; Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; or Both §D(4)(a) and (b) of this regulation; Submits a copy of the organization's personnel policy that sets forth the preferred employment criteria stated in §D(4) of this regulation; Employs a staff that is comprised of at least 75 percent of individuals who are: Current or previous caregivers of a child or youth with behavioral health challenges; or Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; Submits a list of staff and positions held with identification of those who fit the experienced caregiver and consumer criteria stated in §D(6) of this regulation; and Submits a certificate of eligibility that includes: Attestation of compliance with §D(1)—(6) of this regulation; and The organization’s mission statement that establishes the purpose of the organization as providing support and education to youth with emotional, behavioral, or mental health challenges and their caregivers; and Shall be provided by family peer support partners who: Are employed by an FSO; Are 18 years old or older; Receive supervision from an individual who: Is 21 years old or older; and Has at least 3 years of experience providing family peer-to-peer support or working with children with serious behavioral health challenges and their families; Have current or prior experience as a caregiver of a child with behavioral health challenges or be an individual who has experience with State or local services and systems as a consumer who has or had behavioral health challenges; and Receive training and certification as approved by the Department. Respite services: Include a set of specific short-term services documented in the POC that include: A schedule of the participant's activities during respite; Medication monitoring, if needed; The frequency, duration, and intensity of staff support; Respite locations; and The aftercare plan or recommendations; Include community-based respite services, which are provided in the participant's home or other community-based setting; Include out-of-home respite services, which provide a temporary overnight living arrangement outside of the participant’s home; and Are provided by organizations that shall: Meet the requirements of COMAR 10.63.03.15; Employ respite care specialists who are: 21 years old or older and have a high school diploma or high school equivalency; or At least 18 years old and enrolled in, or in possession of at least an associate degree from, an accredited college or university in a human services field, and are limited to providing services to participants under 13 years of age; Ensure that community-based respite services are provided in the participant's home or other community-based setting; and Ensure that out-of-home respite services are: Provided in a community-based temporary overnight living arrangement outside the participant's home; and Where applicable, delivered in accordance with COMAR 14.31.05—14.31.07. Expressive and experiential behavioral services: May be provided to an individual or group; Provide sensory modalities to participants to assist in achieving POC objectives; and Include: Art behavioral services; Dance behavioral services; Equine-assisted behavioral services; Horticultural behavioral services; Music behavioral services; or Drama behavioral services. Qualification to Provide Expressive and Experiential Behavioral Services. To provide expressive and experiential behavioral services, an individual shall have: A bachelor's or master's degree from an accredited college or university; and Current registration in the applicable association as outlined in §E(5) of this regulation; Association Registration. Art Behavioral Services. To provide art behavioral services, an individual shall be currently registered as a registered art therapist by: The Art Therapy Credentials Board in the American Art Therapy Association; or A comparable association with equivalent requirements. For Dance Behavioral Services. To provide dance behavioral services, an individual shall be currently registered as a dance therapist registered, or an academy of dance therapists registered in: The American Dance Therapy Association; or A comparable association with equivalent requirements. For Equine-Assisted Behavioral Services. To provide equine-assisted behavioral services, an individual shall be currently certified by: The Equine Assisted Growth and Learning Association (EAGALA) to provide services under the EAGALA model; Professional Association of Therapeutic Horsemanship International (PATHI); or A comparable association with certification requirements at least equivalent to EAGALA or PATHI. For Horticultural Behavioral Services. To provide horticultural behavioral services, an individual shall be currently registered as a horticultural therapist registered in: The American Horticultural Therapy Association; or A comparable association with equivalent requirements. For Music Behavioral Services. To provide music behavioral services, an individual shall be currently registered as a music therapist-board certified by: The Certification Board for Music Therapists, Inc; or A comparable association with equivalent requirements. For Drama Behavioral Services. To provide psychodrama/drama behavioral services, an individual shall be currently registered as a registered drama therapist or a board certified trainer in: The National Association for Drama Therapy; or A comparable association with equivalent requirements. Intensive In-Home Services (IIHS): Are strengths-based interventions with the child and his or her identified family that includes a series of components, such as: Functional assessments and treatment planning; Individualized interventions; Crisis response and intervention; or Transition support; May be provided to the child alone, to other family members, or to the child and family members together; Are intended to support a child to remain in his or her home and reduce hospitalizations and out-of-home placements or changes of living arrangements through focused intervention in the home and community; and May be used in situations such as the start of a child's enrollment in the 1915(i), upon discharge from a hospital or residential treatment center, or to prevent or stabilize after a crisis situation. Types of IIHS Providers. The Department may approve two types of IIHS providers: Evidence-Based Practice (EBP)-IIHS providers, to include providers of EBPs as determined by the Department; and Promising Practice IIHS providers (non-EBP), to include providers of the In-Home Intervention Program for Children (IHIP-C) and other promising practices, as determined by the Department. An EBP-IIHS provider shall have a certificate or letter from the national or intermediate surveyor or developer of the particular evidence-based practice to demonstrate that the EBP-IIHS provider meets all requirements for Department-approved EBP-IIHS, to include participating in all fidelity monitoring activities. A Non-EBP IIHS provider shall: Be a Department-approved IHIP-C provider or have a certificate or letter from a national or intermediate purveyor or developer of another promising practice; and Meet the requirements of §E of this regulation. All non-EBP IIHS providers not approved by the Department as IHIP-C providers shall: Ensure that there are Clinical Supervisors and staff who are responsible for creating, implementing, and managing the treatment plan with the child and family and the CFT; Provide crisis response services for the participants on the IIHS provider's caseload and ensure that on-call and crisis intervention services are: Provided by a licensed mental health professional trained in the intervention; Available 24-hours per day, 7 days per week, during the hours the provider is not open to the individual enrolled in the treatment; and In compliance with staffing, supervision, training, data collection, and fidelity monitoring requirements set forth by the purveyor, developer, or MDH and approved by the Department; Employ Clinical Supervisors who: Have a current license under the Health Occupations Article, Annotated Code of Maryland, as a: Licensed certified social worker-clinical (LCSW-C); Licensed clinical professional counselor (LCPC); Psychologist; Psychiatrist; Nurse psychotherapist; or Advanced practice registered nurse/psychiatric mental health (APRN-PMH); and Have at least 3 years of experience in providing mental health treatment to children and families; Employ mental health professionals who: Have a current license under the Health Occupations Article, Annotated Code of Maryland, as a: Licensed certified social worker (LCSW); LCSW-C; LCPC; Psychologist; Psychiatrist; Nurse psychotherapist; or APRN-PMH. Are supervised by a clinical lead supervisor; See the child in-person at least once per 7 days while receiving IIHS services; Employ in-home stabilizers who: Support the implementation of the treatment plan, but are not responsible for creating it or modifying it; Are at least 21 years old; Have at least a high school diploma or equivalency; and Have completed relevant, comprehensive, appropriate training before providing services, as outlined by the purveyor, developer, or the Department and approved by the Department; Provide a minimum of one face-to-face contact with the participant per week of service; Ensure a minimum of 50 percent of the mental health professionals' contacts with the participant or family, or both, is face-to-face; and Ensure that a minimum of 50 percent of the mental health professionals' time is spent working outside the agency's office and in the participant's home or community, as documented in case notes. Reimbursement shall be made by the Program only when all of the requirements of this chapter are met. The Program may not reimburse for: Services that are: Provided by a member of the recipient’s immediate family or an individual who resides in the recipient’s home; Not preauthorized by the Department; Not medically necessary; Beyond the provider’s scope of practice; Not appropriately documented; Part of another service paid for by the State; or Provided without a valid required license or appropriate credentials as specified in this chapter; Completion of forms or reports; Broken or missed appointments; Time spent in travel by the provider to and from site of service, except when with the participant or the participant’s family; or Costs of travel by the provider to and from the site of service. The Program may not reimburse more than the following: 1 session per day for out-of-home respite; 6 hours per day of community-based respite; 24 overnight units of respite annually; 2 types per day of expressive and experiential behavioral services; or 1 MCRS assessment for the development of the initial crisis plan. Intensive in-home services may not be reimbursed for the same day of service or on the same day of service as: Partial hospitalization/day treatment; Mobile crisis response services; or Other family therapies. Out-of-home respite and community-based respite services may not be reimbursed for the same day of service or on the same day of service as: Residential rehabilitation; Therapeutic behavioral services; or Any other public mental health system respite services. Out-of-home respite and community-based respite services do not include on-going day care or before or after school programs. Out-of-home respite and community based respite services may not be delivered to youth residing in Treatment Foster Care. No more than 25 percent of the family support organization’s claims in a 30-day period for family peer support may be telephonic for a participant or the participant’s family. Request for Payment. An approved provider shall submit requests for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36.04. The provider shall: Bill the ASO in accordance with the payment methodology specified in this chapter; Accept payment from the ASO as payment in full for the covered services rendered, and make no additional charge to the participant or any other party for these services; and Submit a request for payment in a manner approved by the Program, which includes a certification of the: Date or dates of service; Participant's name and Medicaid number; Provider's name, location, and provider identification number; Type, procedure code or codes, and unit or units of covered services provided; and Amount of reimbursement requested. Documentation Required. Payments by the Program or its designee may be withheld or recovered if the provider fails to submit: Requested evidence of services provided; Staff qualifications; Corrective action plans; or Any other types of documentation related to ensuring the health and safety of a participant. Payments shall be released upon receipt and approval by the Program or its designee of the requested documentation. An appeal by the provider under COMAR 10.01.03 does not stay the withholding of payments. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Payments. Payments shall be made only for services rendered by a 1915(i) provider approved by the Department and enrolled as a Medicaid provider. Services will only be paid when delivered in accordance with the POC that has been authorized by the Department. The Program shall pay according to the fee-for-service schedule for each of the covered services, as set forth in this regulation. Family peer support services as described in Regulation .09 of this chapter shall be reimbursed at the following rates: For dates of service from July 1, 2022 through June 30, 2023: $21.65 per 15-minute unit for face-to-face services; or $10.82 per 15-minute unit for telephonic or other non-face-to-face activities. Effective July 1, 2023: $22.30 per 15-minute unit for face-to-face services; or $11.84 per 15-minute unit for telephonic or other non-face-to-face activities. Respite services as described in Regulation .10 of this chapter shall be reimbursed at the following rates: July 1, 2022 through June 30, 2023: $34.12 per 1-hour unit of service for community-based respite services; or $270.46 per unit of out-of-home respite care. Effective July 1, 2023: $35.14 per 1-hour unit of service for community-based respite services; or $278.57 per unit of out-of-home respite care. Expressive and experiential behavioral services as described in Regulation .11 of this chapter, when provided by a licensed mental health professional, shall be reimbursed at the following rates: For dates of service from July 1, 2022 through June 30, 2023 For individual therapy: $92.77 per 45—50-minute session; or $121.55 per 75—80-minute session; and For group therapy: $36.87 per 45—60-minute session; or $47.95 per prolonged (75—90-minute) session. Effective July 1, 2023: For individual therapy: $95.55 per 45—50-minute session; or $125.20 per 75—80-minute session; and For group therapy: $37.98 per 45—60-minute session; or $49.39 per prolonged (75—90-minute) session. Expressive and experiential behavioral services as described in Regulation .11 of this chapter, when provided by a non-licensed mental health professional, shall be reimbursed at the following rates: For dates of service from July 1, 2022 through June 30, 2023: For individual therapy: $84.33 per 45-minute session; or $109.64 per 75—80-minute session; and For group therapy: $32.78 per 45—60-minute session; or $42.59 per prolonged (75—90-minute) session. Effective July 1, 2023: For individual therapy: $86.86 per 45-minute session; or $112.93 per 75—80-minute session; and For group therapy: $33.76 per 45—60-minute session; or $43.87 per prolonged (75—90-minute) session. Intensive in-home services as described in Regulation .12 of this chapter shall be reimbursed at the following rates: For dates of service from July 1, 2022 through June 30, 2023: $337.54 per week of service for EBP-IIHS providers; or $267.78 per week of service for non-EBP IIHS providers. Effective July 1, 2023: $347.67 per week of service for EBP-IIHS providers; or $275.81 per week of service for non-EBP IIHS providers. Recovery and reimbursement are set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08 and 10.21.10. Appeal procedures for providers are those set forth in COMAR 10.09.36.09. Appeal procedures for applicants and participants are those set forth in COMAR 10.01.04, 10.09.24.13, and 10.09.70. Health-General Article, §2-104(b), Annotated Code of Maryland Effective date: October 1, 2014 (41:19 Md. R. 1077) Regulation .15B amended effective July 4, 2016 (43:13 Md. R. 712) Regulation .10F amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) Regulation .11E amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) Regulation .12C amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) Regulation .13D amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) Regulation .14F amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) Chapter revised effective August 26, 2019 (46:17 Md. R. 726) Regulation .02B amended effective June 14, 2021 (48:12 Md. R. 473) Regulation .03C, E, H amended effective June 14, 2021 (48:12 Md. R. 473) Regulation .04A amended effective June 14, 2021 (48:12 Md. R. 473) Regulation .09D, E amended effective November 13, 2023 (50:22 Md. R. 974) Regulation .09F amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) Regulation .09F repealed effective November 13, 2023 (50:22 Md. R. 974) Regulation .10C, D amended effective November 13, 2023 (50:22 Md. R. 974) Regulation .10E amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) Regulation .10E repealed effective November 13, 2023 (50:22 Md. R. 974) Regulation .11C amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) Regulation .11C repealed effective November 13, 2023 (50:22 Md. R. 974) Regulation .12F amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) Regulation .12F repealed effective November 13, 2023 (50:22 Md. R. 974) Regulation .14 amended effective September 16, 2024 (51:18 Md. R. 809) Regulation .14E—I adopted effective November 13, 2023 (50:22 Md. R. 974) This chapter applies to providers organized to deliver mental health case management services for children and youth. The purpose of mental health case management care coordination is to assist participants in gaining access to needed medical, mental health, social, educational, and other services. In this chapter, the following terms have the meanings indicated. Terms Defined. “1915(i)” means the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program defined in COMAR 10.09.89. “Care coordination” means services which assist participants in gaining access to a full range of behavioral health services and, as necessary, any medical, social, financial assistance, counseling, educational, housing, and other support services. “Care coordination organization (CCO)” means an entity with a minimum of 3 years of experience providing care coordination services that: Are approved by the Department under this chapter; and Meet the requirements of COMAR 10.09.89 to provide care coordination to participants in the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program. “Care coordinator” means an individual employed through the care coordination organization who is responsible for providing care management services to benefit participants and families, including, but not limited to: Coordination of child and family team meetings; and Completion of the initial and revised plan of care. “Child and family team (CFT)” means the group of individuals, including both formal and informal supports and inclusive of the youth and the youth’s family, responsible for the creation and implementation of the plan of care. “Co-occurring disorder” means a diagnosis based on the current Diagnostic and Statistical Manual published by the American Psychiatric Association where the participant is indicated as having both a mental illness and substance use disorder. “Core service agency” has the meaning stated in COMAR 10.21.17. “Department” has the meaning stated in COMAR 10.09.36.01 and refers to the Department or its designee. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Mental Health Case Management: Care Coordination for Children and Youth” has the same meaning as “care coordination” as defined in this regulation. “Mental health professional” has the meaning stated in COMAR 10.21.17.02. “Mental health services” means those services described in COMAR 10.09.70. “Minor” means a child or adolescent younger than 16 years old. “Natural supports” means any individual who plays a positive, but nonprofessional, role in someone’s plan of care. “Participant” means an individual who meets the qualifications for participation in care coordination that are specified in Regulation .03 of this chapter. “Plan of care (POC)” means the individualized plan for supports and services prepared according to the requirements outlined in this chapter for a specific participant in care coordination, including a POC developed for 1915(i) participants pursuant to COMAR 10.09.89. “Program” has the meaning stated in COMAR 10.09.36.01. “Provider” means the care coordination provider. “Recipient” has the meaning stated in COMAR 10.09.36.01. “Residential treatment center (RTC)” has the meaning stated in COMAR 10.07.04. “Serious emotional disturbance (SED)” has the meaning stated in COMAR 10.21.17.02. “Young adult” means an individual who is 18 years old or older but not older than 21 years old. A participant shall be eligible for care coordination services if the recipient: Is in a federal eligibility category for Maryland Medical Assistance according to COMAR 10.09.24, which governs the determination of eligibility for the Maryland Medical Assistance Program; and Meets the criteria of either §B(1) or (2) of this regulation. The participant: Shall: Meet the diagnostic requirements of being either: An individual younger than 18 years old with a serious emotional disturbance or co-occurring disorder; or A young adult with a serious emotional disturbance or co-occurring disorder enrolled in care coordination services continuously under this chapter since reaching age 18; and Require community treatment and support in order to prevent or address: Inpatient psychiatric or substance use treatment; Treatment in a RTC or residential substance use treatment facility; An out-of-home placement; Emergency room utilization due to multiple behavioral health stressors; Homelessness or housing instability, or otherwise lacking in permanent, safe housing; or Arrest or incarceration due to multiple behavioral health stressors; or Shall: Meet the requirements of §B(1)(a); and Need care coordination services to facilitate community treatment following: Release from a detention center or correctional facility; or Discharge to the community from RTC placement or inpatient psychiatric unit. A participant that disenrolls after reaching 18 years of age and wishes to re-enroll in care coordination services at a later date shall do so pursuant to COMAR 10.09.45 if more than 120 calendar days has passed since disenrollment. In addition to meeting the eligibility criteria outlined under Regulation .03 of this chapter, participants shall be classified according to the levels of intensity listed in Regulation .05, 06, or .07 of this chapter, based on the severity of the participant’s behavioral health or co-occurring disorder, along with assessed strengths and needs. The Department or its designee shall review participant levels of care to confirm these are appropriate to the participants’ needs. Participants may not remain at Level III for longer than 6 consecutive months unless approved by the Department or its designee. The participant as described in Regulation .03A of this chapter shall meet at least two of the following conditions: The participant is not linked to behavioral health, health insurance, or medical services; The participant lacks basic supports for education, income, shelter, or food; The participant is transitioning from one level of intensity to another level of intensity of services; The participant needs care coordination services to obtain and maintain community-based treatment and services; The participant: Is currently enrolled in Level II or Level III Care Coordination services under this chapter; and Has stabilized to the point that Level I is most appropriate. The participant as described in Regulation .03A of this chapter shall meet three or more of the following conditions: The participant is not linked to behavioral health services, health insurance, or medical services; The participant lacks basic supports for education, income, food, or transportation; The participant is homeless or at-risk for homelessness; The participant is transitioning from one level of intensity to another level of intensity including transitions out of the following levels of service: Inpatient psychiatric or substance use services; RTC; or 1915(i) services under COMAR 10.09.89; Due to multiple behavioral health stressors within the past 12 months, the participant has a history of: Psychiatric hospitalizations; or Repeated visits or admissions to: Emergency room psychiatric units; Crisis beds; or Inpatient psychiatric units; The participant needs care coordination services to obtain and maintain community-based treatment and services; The participant: Is currently enrolled in Level III Care Coordination services under this chapter; and Has stabilized to the point that Level II is most appropriate; The participant: Is currently enrolled in Level I Care Coordination services under this chapter; and Has experienced one of the following adverse childhood experiences during the preceding 6 months: Emotional, physical, or sexual abuse; Emotional or physical neglect; or Significant family disruption or stressors. The participant shall meet at least one of the following conditions: The participant has been enrolled in the 1915(i) program for 6 months or less; The participant is currently enrolled in Level I or Level II Care Coordination services under this chapter and has experienced one of the following adverse childhood experiences during the preceding 6 months: Emotional, physical, or sexual abuse; Serious emotional or physical neglect; or Significant family disruption or stressors; The participant meets the following conditions: The participant has a behavioral health disorder amenable to active clinical treatment, diagnosed through a face-to-face psychosocial assessment by a licensed mental health professional; There is clinical evidence the minor has a SED and continues to meet the service intensity needs and medical necessity criteria for the duration of their enrollment; A comprehensive psychosocial assessment performed by a licensed mental health professional finds that the participant exhibits a significant impairment in functioning, representing potential serious harm to self or others, across settings, including the home, school, or community; The psychosocial assessment supports the completion of the Early Childhood Service Intensity Instrument (ECSII) for youth ages 0—5 or the Child and Adolescent Service Intensity Instrument (CASII) for youth ages 6—21, by which the participant receives a score of: 3 on the ECSII; or 3 or higher on the CASII; Youth with a score of 3, 4, or 5 on the CASII also shall meet the conditions outlined in §B of this regulation; and Youth with a score of 3 or 4 on the ECSII also shall meet the conditions outlined in §C of this regulation. Youth with a score of 3, 4, or 5 on the CASII shall meet one of the following criteria to be eligible based on their impaired functioning and service intensity level: Transitioning from a residential treatment center; or Living in the community, be 6 through 21 years old, and have: Any combinations of 2 or more inpatient psychiatric hospitalizations or emergency room visits in the past 12 months; or Been in an RTC within the past 90 calendar days. Youth who are younger than 6 years old who have a score of a 3 or 4 on the ECSII shall either: Be referred directly from one of the following: Inpatient or day hospital unit; Primary care physician (PCP); Outpatient psychiatric facility; Early Childhood Mental Health (ECMH) Consultation program in daycare; Head Start program; Judy Hoyer Center; or Home visiting program; or If living in the community, meet one or more of the following criteria in the past 12 months: Had one or more psychiatric inpatient or day hospitalizations; Had one or more ER visits; Exhibit severe aggression; Display dangerous behavior; Been suspended from school or childcare setting; Display emotional or behavioral disturbance prohibiting their care by anyone other than their primary caregiver; Be at risk for out-of-home placement or placement disruption; Have severe temper tantrums that place the child or family members at risk of harm; Have trauma exposures and other adverse life events; or Be at risk of family-related risk factors, including safety, parent-child relational conflict, and poor health and developmental outcomes. Selection of CCOs. The local core service agencies shall select child and youth CCOs through a competitive procurement process, at least once every 5 years. Regional CCOs may be procured at the mutual agreement of local core service agencies so long as the local core service agencies demonstrate that there is sufficient provider capacity to serve the children and youth in a particular region. The CCO shall: Be approved by the Department as a CCO; Commit to coordination with all agencies involved in the participant’s POC; and Work with the State and local child- and family-serving agencies to develop a network of clinical and natural supports in the community to address strengths and needs identified in each POC. Required Criminal Background Checks. The provider shall, at the provider’s own expense and for all staff, volunteers, students, and individuals providing care coordination services to participants and their families: Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland; Request that DPSCS send the report to: The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or The Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency; Review the results of the background checks; Store background checks in a secure manner consistent with State and federal law; and Maintain written documentation in the individual’s personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation. Prohibitions Against Utilization of Staff. Unless waived by the Department in accordance with §E of this regulation, the provider shall prohibit from working with the participant or the participant’s family any staff, volunteers, students, or individuals who: Are convicted of, received probation before judgment for, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft or have any other criminal history that indicates behavior which is potentially harmful to a participant; Are cited on any professional licensing or certification boards or any other registries with a determination of abuse, misappropriation of property, financial exploitation, or neglect; or Have an indicated finding of child abuse or neglect. Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant’s family if the provider submits a request to the Department together with the following documentation that: For criminal background checks: The conviction of, the probation before judgment for, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application; The criminal history does not indicate behavior that is potentially harmful to participants; and Includes a statement from the individual as to the reasons the prohibition should be waived; and For abuse and neglect findings: The indicated finding occurred more than 7 years before the date of the clearance request; The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant’s family; and Includes a statement from the individual as to the reasons the prohibition should be waived. The CCO shall provide all three levels of care coordination to ensure continuity of care for participants. General Requirements. To be eligible to be approved as a care coordination organization, an entity shall meet all of the: Conditions for participation as set forth in COMAR 10.09.36.03; and Medical Assistance provisions listed in COMAR designated for their provider type. Specific Requirements. A CCO: May not place restrictions on the qualified recipient’s right to elect to or decline to: Receive care coordination as authorized by the Department; and Choose a care coordinator, as approved by the Department, and other care providers; Shall employ appropriately qualified individuals as care coordinators, and care coordinator supervisors with relevant work experience, including experience with the populations of focus, including but not limited to: Youth younger than 18 years old with a serious emotional disturbance or co-occurring disorder; and Young adults with a serious emotional disturbance or co-occurring disorder; Shall assign care coordinators to the participant and family; Shall schedule a face-to-face meeting with the participant and family within 72 hours of notification of the participant’s enrollment in Care Coordination services; Shall convene the first CFT meeting within 30 calendar days of notification of enrollment to begin developing the POC; Shall collect information gathered during the application process including results from the physical examination, psychosocial and psychiatric screening, assessments, evaluations, and information from the CFT, participant, and family, and the identified supports to be incorporated as a part of POC development process; For 1915(i) participants: Shall arrange for the participant and family to meet with peer support partners within 30 calendar days of notification of enrollment to allow the participant and family the opportunity to determine the role of peer support in the development and implementation of the POC; and Shall arrange for the participant and family to meet with the intensive in-home service (IIHS) to develop the initial crisis plan within 1 week of enrollment in the 1915(i); Shall assure that: A participant’s initial assessment is completed within 10 calendar days after the participant has been authorized by Department and determined eligible for, and has elected to receive, care coordination services; and An initial POC is completed within 15 calendar days after completion of the initial assessment; Shall maintain an electronic health record for each participant which includes all of the following: An initial referral and intake form with identifying information, including, but not limited to, the individual’s name and Medicaid identification number; A written agreement for services signed by the participant or the participant’s legally authorized representative and by the participant’s care coordinator; An assessment as specified in Regulation .07of this chapter; and A POC as specified in Regulation .07D—E of this chapter; Shall have formal written policies and procedures, approved by the Department, or the Department’s designee, which specifically address the provision of care coordination to participants in accordance with the requirements of this chapter; Shall be available to participants and, as appropriate, their families or, if the participant is a minor, the minor’s parent or guardian, for 24 hours a day, 7 calendar days a week, in order to refer: Participants to needed services and supports; and In the case of a behavioral health emergency, participants to behavioral health treatment and evaluation services in order to divert the participant’s admission to a higher level of care; Shall document in the participant’s care coordination records if the participant declines care coordination services or if a service is terminated because it was not working; May not provide other services to participants unless the Department approves how conflict of interest standards would be safely addressed. Shall be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs that are applicable to participants; Shall maintain information on current resources for behavioral health, medical, social, financial assistance, vocational, educational, housing, and other support services including informal community resources; Shall safeguard the confidentiality of the participant’s records in accordance with State and federal laws and regulations governing confidentiality; Shall comply with the Department’s fiscal and program reporting requirements and submit reports to the Department in the manner specified by the Department; Shall provide services in a manner consistent with the best interest of recipients and may not restrict an individual’s access to other services; Shall assure the amount, duration, and scope of the care coordination activities are documented in a participant’s POC, which includes care coordination activities before discharge and after discharge when transitioning from an institution, to facilitate a successful transition into the community; and Shall commit to coordinating with all agencies involved in the participant’s POC. CCOs are required to maintain the following positions: Care coordinator supervisor who: Is a mental health professional with a minimum of a Master’s degree and who is licensed and legally authorized to practice under Health Occupations Article, Annotated Code of Maryland, and who is licensed under Maryland Practice Boards in the profession of: Social work; Professional Counseling; Psychology; Nursing; or Medicine; Has a minimum of 1 year of experience in behavioral health working as a supervisor; Has a minimum of 1 year of experience working with children and youth with mental health or co-occurring disorders; Provides clinical consultation and training to care coordinators regarding mental health or co-occurring disorders; Provides supervision of the POCs, and consultation to the CFT meetings, as needed; Is employed or contracted at a ratio of one supervisor to no more than eight care coordinators; and Meets training and certification requirements for care coordinator supervisors, as set by the Department; and Care coordinator who: Has at least a: Bachelor’s degree and has met the Department’s training requirements for care coordinators, or High school diploma or equivalency and is 21 years old or older and was a participant in, or is a direct caregiver, or was a direct caregiver of an individual who received services from the public and child- and family-serving system and meets the training and certification requirements for care coordinators as set forth by the Department; Is employed by the CCO to provide care coordination services to participants; and Provides management of the POC and facilitation of the CFT meetings. The Department shall reimburse for the care coordination services in this regulation when these services have been documented, pursuant to the requirements of this chapter, as necessary. Care coordination services shall be coordinated with, and may not duplicate activities provided as part of, institutional services and discharge planning activities. Care coordination may include contacts that are directly related to identifying the needs and supports for helping the participant to access services. The CCO shall engage in participant advocacy, including: Empowering the participant and, if the participant is a minor, the minor’s parent or guardian to secure needed services; Taking any necessary actions to secure services on the participant’s behalf; and Encouraging and facilitating the participant’s decision making and choices leading to accomplishment of the participant’s goals or, if the participant is a minor, encouraging the parent or guardian to carry out these decisions. Comprehensive Participant Assessment and Periodic Participant Reassessment. Providers shall use a child and youth assessment tool approved by the Department to perform participant assessments and reassessments. Initial assessment or reassessment involves the participant’s stated needs and review of information concerning the participant’s mental health, social, familial, educational, cultural, medical, developmental, legal, vocational, and economic status to assist in the formulation of a POC. The initial assessment or reassessment of the participant’s needs and progress shall be facilitated by the care coordinator and monitored by the CFT, which includes the participant, family members, and friends of the participant, as appropriate, or, if the participant is a minor, the minor’s parent or guardian, and community service providers, such as mental health providers, medical providers, social workers, and educators, as appropriate. Coordination and Facilitation of the CFT. The care coordinator shall: Identify a location for the CFT meetings that is suitable to the participant’s needs; Convene the CFT at least every 6 months, or more frequently, as clinically necessary; and For 1915(i) participants, convene as per the timeline and functions pursuant to COMAR 10.09.89. After an initial assessment, each participant shall be reassessed at a minimum of every 6 months. Development and Periodic Revision of the POC. After the initial assessment is completed, a POC shall be developed based on the information obtained through the comprehensive screening and assessment tools approved by the Department. The CCO shall finalize the POC within 30 calendar days of notification of enrollment and submit it to the Department or its designee. Development of and updates to the POC shall be youth- and family-directed and managed through CFT meetings. The POC shall meet the requirements of Regulation .12 of this chapter. The POC development process shall include: The CFT meeting, which includes the participant, and if the participant is a minor, the minor’s parent or guardian, providers, family members, and other interested persons, as appropriate, for the purpose of establishing, revising, and reviewing the POC; The development of the written, individualized POC based on the participant’s strengths, needs, and progress toward outcome measures; Transitional care planning that involves contact with the participant or, if the participant is a minor, the minor’s parent or guardian, or the staff of a referring agency, or a service provider who is responsible to plan for continuity of care from inpatient level of care or an out-of-home placement to another type of community service; and Discharge planning from care coordination, when appropriate and when the family is closer to its identified vision, when family needs have been met, and when outcome measures for care coordination have been achieved. After the POC is developed, the CCO shall update the POC as often as clinically indicated based on the strengths and needs of the participant but not less than: For Level I participants, every 6 months; For Level II participants, every 3 months; For Level III participants, every 45 calendar days; and For all participants, within 7 calendar days following a crisis event. The POC shall contain, at minimum: A description of the participant’s strengths and needs; The diagnosis or diagnoses established as evidence of the participant’s eligibility for services under this chapter; The goals of care coordination services to address the behavioral health, medical, social, educational, and other services needed by the participant, with expected target completion dates; A crisis plan including the proposed strategies and interventions for preventing and responding to crises and the youth and family’s definitions of what constitutes a crisis; Designation of the care coordinator with primary responsibility for implementation of the POC; Signatures of the care coordinator and other CFT members, if appropriate; Signatures of the participant and family indicating that the participant and family have: Participated in the development of the POC; and Had choice in the selection of services, providers, and interventions when possible, in the care coordination process of building the POC; and For 1915(i) participants, specified for each recommended service, the following information as appropriate or as required by the Department: Description of the service; Service start date; Estimated duration; Frequency and units of service as measured in 15 minute increments to be delivered; The specific need or goal that the service is related to; and The provider name and contact information. If not included in the POC, an ongoing record of contacts made on the participant’s behalf, which includes all of the following, shall be included in the participant’s chart: Date, start and end time, and subject of contact; Individual contacted; Electronic or scanned signature of care coordinator making the contact; Nature, content, and unit or units of service provided; Place of service; Whether strategies and tasks specified in the POC have been achieved; The timeline for obtaining needed services; The timeline for reevaluation of the plan; The need for and occurrences of coordination with child- and family-serving agencies and providers; The names and contact information for the participant’s primary care provider, dentist, and other health care providers; The medications that the participant is currently taking and the dosage and frequency of the medications; and Monthly summary notes, which reflect progress made towards the identified needs and outcome measures. The CCO shall: Coordinate and facilitate the CFT, with CFT meetings convened at least every 45 calendar days or more frequently as clinically indicated; Record and keep notes at every CFT meeting that include the CFT members who were present, a summary of the discussion, any changes to the POC, and action items for follow up, and share them with the CFT members, including those who were not in attendance; Update the POC to include change in progress, services, or other areas within 5 calendar days of the CFT meeting; and Ensure that the care coordinator: Facilitates CFT meetings; Facilitates access to the services and supports in the POC; and At the first meeting: Administers the appropriate assessments, as designated by the Department; Works with the participant and family to develop an initial crisis plan that includes response to immediate service needs; and For 1915(i) participants, provides an overview of the care coordination process. The care coordinator shall ensure that the participant or, if the participant is a minor, the minor’s parent or guardian has applied for, has access to, and is receiving the necessary services available to meet the participant’s needs, such as mental health services, resource procurement, transportation, or crisis intervention. The care coordinator shall take the necessary action as defined by the Department when the services identified under Regulation .13 of this chapter have not occurred. The linkage process shall include: Community and natural support development by contacting, with the participant’s consent, members of the participant’s support network, including CFT members, for example, family, friends, and neighbors, as appropriate, or, if the participant is a minor, the minor’s parent or guardian, to mobilize assistance for the participant; Crisis intervention by referral of the participant or, if the participant is a minor, the minor’s parent or guardian, to services on an emergency basis when immediate intervention is necessary; Arranging for the participant’s transportation to and from services; Outreach in an attempt to locate service providers which can meet the participant’s needs, or, if the participant is a minor, the minor’s parent or guardian’s needs; Reviewing the POC with the participant and the participant’s CFT, as appropriate, or, if the participant is a minor, with the minor’s parent or guardian, so as to enable and facilitate their participation in the plan’s implementation; and Provision of health and wellness education, information, and linkages to high-quality health care services, preventive and health promotion resources, and chronic disease management services with an emphasis on resources available in the family’s community and peer group. A CCO shall monitor, as per standards set forth by the Department, the activities and contacts that are considered necessary to ensure the POC is implemented and adequately addresses the participant’s needs, and include: The participant or, if the participant is a minor, the minor’s parent or guardian; and With proper consent: Family members and friends, if appropriate; Other individuals or agency representatives identified and approved as CFT members by the participant or, if the participant is a minor, the minor’s parent or guardian; and Other service providers, if any. The CCO shall: Follow up any service referral within 7 calendar days to determine whether the participant, or, if the participant is a minor, the minor’s parent or guardian, made contact with the service provider that the participant was referred to; and Monitor service provision on an ongoing basis, to ensure that the agreed-upon services are provided, are adequate in quantity and quality, and meet the participant’s needs and stated goals, or, if the participant is a minor, the parent’s or guardian’s stated needs and goals for the participant. The CCO shall, in accordance with the decisions and recommendations of the CFT, revise the POC to reflect the participant’s changing needs. Care coordination services are facilitative in nature. A restriction may not be placed on a qualified recipient’s option to receive mental health case management services. Care coordination services do not restrict or otherwise affect: Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation; The freedom of a participant or, if the participant is a minor, the minor’s parent or guardian to select from all available services for which the participant is found to be eligible; or A participant’s free choice among qualified providers or, if the participant is a minor, the minor’s parent or guardian’s free choice among qualified providers. The CCO may not bill the Program for: The direct delivery of an underlying medical, educational, social, or other service to which a participant has been referred; Activities integral to the administration of foster care programs; Activities not consistent with the definition of case management services under Section 6052 of the federal Deficit Reduction Act of 2005 (P.L. 109—171); Activities for which third parties are liable to pay; Activities delivered as part of institutional discharge planning; or A 15-minute unit of service for telephonic contact, unless the provider has delivered at least 8 minutes of service. Reimbursement may not be made for care coordination services if the participant is receiving a comparable care coordination service under another Program authority. A participant’s care coordinator may not be the participant’s family member or a direct service provider for the participant. Units of services for all levels of care coordination shall be 15 minutes of contact, which may include face-to-face and, with the exception of §G(4) of this regulation, non-face-to-face contacts with the participant, or, if the participant is a minor, with the minor’s parent or guardian, and indirect collateral contacts on behalf of the participant with other community providers, as per the following: For participants in Level I — General Coordination, allows a maximum of 12 units of service per month, with a minimum of two units of face-to-face contact; For participants in Level II — Moderate Care Coordination, allows a maximum of 30 units of service per month, with a minimum of four units of face-to-face contact; For participants in Level III — Intensive Care Coordination, allows a maximum of 60 units of service per month, with a minimum of six units of face-to-face contact; and For Level I and Level II, four additional units of service above and beyond the monthly maximum may be billed during the first month of service to the participant and every 6 months thereafter to allow for comprehensive assessment and reassessment of the participant, which shall be performed as a face-to-face service. All covered services under this chapter shall be preauthorized and comply with the requirements of COMAR 10.09.70.07 and COMAR 10.09.89 for services delivered to 1915(i) participants. The Program shall reimburse the provider according to the requirements in this chapter and COMAR 10.09.89 for services delivered to 1915(i) participants, and the fees established under COMAR 10.21.25. Request for Payment. A provider shall submit requests for payment of mental health case management services according to procedures established by the Department. A provider shall bill the Program for the appropriate fee under COMAR 10.21.25. The Program may not make direct payment to recipients. Minutes of service and units per participant are to be totaled by day and by service. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. Payment shall be made: Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; and According to the requirements of this chapter and COMAR 10.09.89 for 1915(i) participants, and the fees established in COMAR 10.21.25. Service Provision. Units of services for all levels of care coordination shall be 15 minutes of contact, which may include: Face-to-face and non-face-to-face contacts with the participant or, if the participant is a minor, with the minor’s parent or guardian; and Indirect collateral contacts on behalf of the participant with other community providers. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are those set forth in COMAR 10.09.36.09. State regulations are interpreted as those set forth in COMAR 10.09.36.10. Health-General Article, §2-104(b), Annotated Code of Maryland Effective date: October 1, 2014 (41:19 Md. R. 1078) Regulation .02B amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .03B amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .07 amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .07C amended effective November 14, 2022 (49:23 Md. R. 996) Regulation .09B amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .12A amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .13D amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .16D amended effective April 13, 2015 (42:7 Md. R. 568) This chapter establishes requirements for the determination of presumptive eligibility by qualified hospitals effective October 1, 2014. In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicant” means an individual who has applied for presumptive eligibility at a participating hospital. “Application” means the presumptive eligibility application. “Authorized representative” has the same meaning as set forth in COMAR 10.01.04.01. “Department” means the Maryland Department of Health which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Determination” means a decision regarding an applicant’s presumptive eligibility. “Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2). “Former foster care” means an individual who: Is younger than 26 years old; Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance: On attaining age 18 and leaving out-of-home placement; or On attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B. “Hospital” means an institution which: Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. “Income” means property or a service received by an individual in cash or in-kind, which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. “Incarcerated inmate in a public institution” has the meaning stated in COMAR 10.09.24.05-5B. “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq. “Presumptive eligibility” means temporary eligibility for Medical Assistance as determined by participating hospitals in accordance with these regulations. A hospital eligible to make presumptive eligibility decisions shall: Participate as a Maryland Medical Assistance Program provider in good standing; and Sign an agreement prepared by the Department. The agreement required under §A of this regulation shall require that the hospital: Comply with Departmental policies and procedures supplied by the Department at the time of application and training; Meet accuracy and timeliness standards established by the Department; Submit a list to the Department of hospital employees who will attend presumptive eligibility training developed by the Department; Prohibit employees who have not attended required trainings and passed a post-training test to make presumptive eligibility decisions; and Report all requested information on a form designated by the Department. Before assisting an applicant in filing a presumptive eligibility application, the hospital employee shall: Check the Department’s eligibility verification system to make sure the individual is not actively enrolled in the Maryland Medical Assistance Program; Provide information concerning the full Medical Assistance application process to the individual applying for presumptive eligibility and assist or refer the applicant to an individual who can assist the applicant in completing a full Medical Assistance application; Determine that the applicant has not: Had a prior presumptive eligibility period within the last 12 months for the individual other than pregnant women; or Had a prior presumptive eligibility period during the current pregnancy for a pregnant woman. The hospital employee shall fill out the presumptive eligibility application based on information supplied by the applicant. The hospital employee shall make a presumptive eligibility decision and sign the presumptive eligibility application based on the following information obtained pursuant to COMAR 10.09.91.05: Residency; Citizenship; Family size and composition; and Gross family income. The hospital employee shall inform the individual in writing of the hospital’s presumptive eligibility decision which includes an explanation of the presumptive eligibility period. The hospital shall submit the presumptive eligibility application to the Department on the date of application completion to allow the individual to have temporary Medical Assistance coverage. The hospital shall: Keep all written and signed presumptive eligibility applications on file for 6 years; and Make the file available to the Department upon request. A hospital qualified to make presumptive eligibility decisions shall: Make presumptive eligibility determinations in accordance with established Departmental policies and procedures; and Disqualify individual hospital employees who do not follow established Departmental regulations, policies and procedures. Upon a finding that a qualified hospital has failed to meet the requirements of §A of this regulation, the Department shall provide the hospital with additional training or take other reasonable corrective action measures to address the noncompliance. If the remedial measures taken pursuant to §B of this regulation fail to provide a satisfactory resolution, the Department shall disqualify the hospital from making presumptive eligibility determinations. An individual, the individual’s guardian, or a representative of the individual with personal knowledge shall apply for presumptive eligibility through a participating hospital. An individual, the individual’s guardian, or a representative of the individual with personal knowledge who applies for presumptive eligibility shall attest to: The citizenship requirements in COMAR 10.09.24.05; The residency requirements in COMAR 10.09.24.05-3; The individual’s pregnancy status; The individual’s family size; and The individual’s household’s gross monthly income. Presumptive eligibility may be established for the following eligibility groups: Parents and other caretaker relatives whose household income is equal to or less than 133 percent of the federal poverty level; Pregnant women whose income is equal to or less than 250 percent of the federal poverty level; Adults without dependent children who are older than 19 years old and younger than 65 years old, whose household income is equal to or less than 133 percent of the federal poverty level; Children who are younger than 19 years old who are under 300 percent of the federal poverty level; or Former foster care individuals who are younger than 26 years old. An individual may not apply for presumptive eligibility in Maryland if the individual: Is currently enrolled in the Maryland Medical Assistance Program or Medicare; Is an incarcerated inmate in a public institution as defined in COMAR 10.09.24.05-5B; Had a prior presumptive eligibility period during the last 12 months with the exception of pregnant women; Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or Does not meet the citizenship requirements stated in COMAR 10.09.24.05. Presumptive eligibility begins on the day the hospital determines that the individual is presumptively eligible. Presumptive eligibility ends on the earlier of: The day in which the individual is determined eligible for Medical Assistance; or The last day of the month following the month in which the hospital determined presumptive eligibility, if: An individual is found ineligible for Medical Assistance; or An individual failed to apply for Medical Assistance. A non-pregnant individual may be determined presumptively eligible once per a 12-month period. A pregnant individual may be determined presumptively eligible once per pregnancy. An individual or an organization does not have appeal rights for presumptive eligibility determinations. Health-General Article, §§2-104(b), 2-105(b), and 15-103, Annotated Code of Maryland Effective date: December 22, 2014 (41:25 Md. R. 1485) In this chapter, the following terms have the meanings indicated. Terms Defined. “Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care. “Acute level of care” means care in which a patient is treated: For a brief but severe episode of illness, for conditions that are the result of disease or trauma; and During recovery from surgery. “Acute rehabilitation hospital” means an institution devoted to therapy that is designed to facilitate the process of recovery from illness or injury for patients with various neurological, muscular-skeletal, orthopedic, and other medical conditions following stabilization of acute medical issues. “Administrative day” means a day of medical services delivered to a participant who no longer requires an acute level of care. “Administrative services organization (ASO)” means an organization with which the Department contracts to assist in the management and operation of the Maryland Public Behavioral Health System. “Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight. “Ancillary services” means diagnostic and therapeutic services, including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board. “Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided in an acute hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives during an inpatient hospitalization. “Date of service” means: For inpatient hospitalizations, the date of admission into an acute hospital up to, but not including, the date of discharge; For outpatient services, the date services are rendered in the outpatient department of the hospital; For emergency services, the date or dates the services are rendered in the emergency department of an acute hospital; or For observation services, the date or dates the services are rendered in an acute hospital. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Designee” means any entity designated to act on behalf of the Department. “Diagnosis-related group” means a participant classification system adopted by the U.S. Department of Health and Human Services, in which each hospital discharge case is assigned a category based on the primary diagnosis, secondary diagnoses (if any), procedures performed, age, sex, and discharge status of the participant. “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. “Emergency department” means the area in a hospital that is designed, staffed, and equipped to provide prompt treatment to individuals requiring immediate medical care for acute illness, trauma, and other medical conditions. “Emergency services” means any health care service provided to evaluate and treat any medical condition where immediate, unscheduled medical care is required. “Emergent condition” means a disease, illness, or injury characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson, who possesses an average knowledge of health and medicine, to result in: Placing the participant’s health or, with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy; Serious impairment of bodily functions; or Serious dysfunction of any bodily organ or part. “Freestanding medical facility” means a facility: In which medical and health services are provided; That is physically separate from a hospital or hospital grounds; and That is an administrative part of a hospital or related institution. “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, family, or provider. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Nonqualified alien” means a foreign-born resident who: Is not a naturalized U.S. citizen; and Is eligible for federal Medical Assistance coverage of only emergency medical services, as specified under COMAR 10.09.24.05-2A. “Observation services” means the medically necessary services used to assess the participant’s outpatient condition to determine the need for possible admission to an inpatient acute care setting. “Organ” means a part of an organism that is typically self-contained and has a specific vital function, such as a heart or liver. “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. “Outpatient services” means nonemergency services provided to the participant on the hospital campus that do not require hospital admission. “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. “Patient” means an individual awaiting or undergoing health care or treatment. “Preauthorization” means the approval required from the Department or its designee before a service can be rendered by the provider and reimbursed. “Preoperative day” means an inpatient day in an acute hospital before: Surgery for a participant who is being admitted for surgery; or A surgical procedure when the participant was admitted for a nonsurgical procedure but the need for surgery arose during that stay. “Program” means the Maryland Medical Assistance Program. “Prospective payment system” means a predetermined amount of reimbursement per day for inpatient hospital services. “Provider” means an acute hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number. “Retrospective review” means the process of determining medical necessity of an inpatient admission after the participant has been discharged from the hospital. “Specialty behavioral health” means services as defined in COMAR 10.09.70.02D and F. In order to participate in the Program, a provider shall: Be licensed as a hospital by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and Obtain other licenses, as set forth in COMAR 10.07.01. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of: Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and COMAR 10.10.01; or If located out-of-State, comply with: All applicable standards established by the state or locality in which the service is provided; and The requirements of COMAR 10.09.09.02. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. To participate in the Program as an acute hospital services provider, the provider shall: Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the Department of Health and Human Services; Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services; Accept payment by the Program as payment in full for the covered service; Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes: Date of service; The participant’s chief medical complaint or reason for visit; A description of the services provided, including: Progress notes; Imaging studies; Laboratory results; Medication administration records; and Discharge summary; and A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title; and If the hospital provider is the only hospital within the county, participate with each participating HealthChoice Managed Care Organization in the county. If an out-of-State or District of Columbia hospital, the hospital shall: Unless a waiver has been granted by the Secretary of Health and Human Services, have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XVII of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act; and Comply with applicable regulations of this chapter and COMAR 10.09.36. The Program covers the services listed in §B of this regulation according to the conditions and requirements indicated. The Program covers the following hospital services: Medically necessary emergency services as defined in COMAR 10.09.36.01, including triage, related ancillary services, and when necessary, observation stays of a participant who presents to a hospital emergency department; Medically necessary services performed in an outpatient department of a hospital; Medically necessary services performed at a freestanding medical facility; Medically necessary inpatient hospital services meeting the following criteria: Inpatient days, including preoperative days, determined to be medically necessary by the Department or its designee; Admissions from an emergency department resulting in a medically necessary inpatient stay; and Elective admissions that the Department or its designee determines to be medically necessary; Inpatient stays determined to be medically necessary due to an emergent condition by the Department or its designee for a nonqualified alien; Administrative days, which may include select ancillary services, determined to be necessary by the Department or its designee; and Medically necessary services performed in an acute rehabilitation hospital when the participant meets the following criteria at the time of admission: Requires active and ongoing therapeutic intervention of multiple therapy disciplines, one of which shall be physical or occupational therapy; Requires and can reasonably be expected to actively participate in, and benefit from, the therapy, which generally consists of: At least 3 hours of therapy a day, at least 5 days a week; or In well-documented cases, at least 15 hours of intensive rehabilitation therapy within a 7 day consecutive period; Is sufficiently stable to be able to actively participate in the therapy program; and Requires supervision by a licensed physician, who has specialized training and experience in inpatient rehabilitation, which includes: Conducting face-to-face visits with the patient at least 3 days a week to assess the patient both medically and functionally; and Modifying the course of treatment as needed to maximize the participant's capacity to benefit from the rehabilitation process. The coverage of ancillary services during administrative days as described under §B(6) of this regulation applies to special pediatric hospitals under COMAR 10.09.94. The Program does not cover: Hospital services, procedures, drugs, or hospital admissions that are investigational or experimental; Hospital services denied by Medicare as not medically necessary; Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant's inability to take appropriate oral medications is documented in the participant's medical record; Elective inpatient admissions without preauthorization; Elective inpatient admissions from the emergency department for dialysis services that are the result of problems occurring with placement in a freestanding dialysis facility; Outpatient visits for one or more of the following: Prescription drug or food supplement pick up; Collection of specimens for laboratory procedures; Recording of an electrocardiogram; Ascertaining the participant's weight; and Administration of vaccines; Interpretation of laboratory tests or panels; Autopsies; Weight control medications; Care provided to a well newborn beyond the: Length of the mother's stay for a normal obstetrical or uncomplicated caesarean section delivery; or First 4 days of the newborn's life when the mother remains in the hospital due to other circumstances; Telephones, televisions, or personal comfort items or services; Duplicate care or services; Elective admissions to hospitals outside of Maryland, except the District of Columbia, unless the Department or its designee determines that comparable services are not available in Maryland; Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner; Inpatient days provided in excess of the days approved by the Department or its designee; Hospital laboratory tests which are coverable under COMAR 10.09.09, unless the specimen is obtained in the hospital for a participant receiving inpatient, outpatient, emergency department, or observation services; Hospital services provided outside of the United States; and Ancillary services that are part of an observation stay beyond the initial 24 hours. Elective Inpatient Preauthorization Reviews. The hospital shall only request preauthorization for inpatient stays when such services: Cannot be provided on an outpatient basis; or Can only be provided in a facility that is licensed as an acute hospital. The hospital shall obtain preauthorization for elective inpatient admissions from the Department or its designee, before the participant is admitted, by providing the following information including, but not limited to: Participant’s medical history and physical; and Sufficient clinical information or documentation that supports the medical necessity of the acute inpatient admission. Concurrent Reviews. As long as the participant remains hospitalized, the Department or its designee shall perform concurrent reviews based on the participant’s diagnosis and medical condition. For emergency inpatient admissions that exceed more than 24 hours, the concurrent review process shall be initiated by the hospital within the first 48 hours of the admission, or by the next business day. For elective inpatient admissions, the hospital shall initiate the concurrent review process before the termination of days previously certified by the Department or its designee. The hospital shall forward sufficient clinical documentation to the Department or its designee that supports the need for continuing acute care. Documentation submitted shall include, but is not limited to: Current medical health status; Treatment received to date; and A proposed treatment plan for the continued stay. Retrospective Reviews. The hospital shall request that the Department or its designee perform a retrospective review of an inpatient admission after the participant is discharged, to determine the medical necessity of the admission and stay. The hospital shall provide the following to the Department or its designee when requesting a retrospective review following discharge from an acute hospital. Documentation submitted shall include, but is not limited to: The participant’s complete medical record; The principal, secondary, and tertiary diagnoses; and All surgical procedure codes. Reviews for Nonqualified Aliens. The Department or its designee reviews the admission and discharge summary of an emergency inpatient admission for a nonqualified alien to determine whether the inpatient hospital stay meets the emergent condition criteria as defined in COMAR 10.09.24.05-2A. Reviews for Behavioral Health. The hospital shall contact the behavioral health ASO to request an authorization for all inpatient admissions that are described in COMAR 10.09.70.02D and F. Reimbursement Principles for Acute Hospitals Located in Maryland. The Department will make no direct reimbursement to any State-operated hospital. The Department will claim federal fund recoveries from the U.S. Department of Health and Human Services for services to participants in State-operated hospitals. Except for administrative days, acute hospitals shall be reimbursed at the rate set for the Program by the HSCRC pursuant to COMAR 10.37.10 or allowed under COMAR 10.37.03. If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse providers: According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or On the basis of charges if less than reasonable cost. The Department may not reimburse for the services of a hospital’s salaried or contractual clinical staff as a separate line item. Charges for these services should be included in the room and board rate or the appropriate ancillary service only, when HSCRC has included these salaries in the hospital’s costs. The Program shall reimburse room and board charges from the day of admission up to, but not including, the date of discharge from the hospital. The provider shall submit a request for payment according to procedures established by the Department. The Program reserves the right to return to the provider any invoice that is not properly completed. Payments on Medicare claims are authorized if: The provider accepts Medicare assignment; Medicare makes a direct payment to the provider; Medicare determined that services are medically necessary; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. The Department shall make a supplemental payment on Medicare claims as follows: Deductible and co-insurance shall be paid in accordance with the limits of this regulation; and Hospitals shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case the deductible and co-insurance shall be paid in full. The provider shall not bill the Department or participant for: Completion of forms and reports; Broken or missed appointments; Services rendered by mail, telephone, or otherwise not in person, with the exception of telehealth services in accordance with COMAR 10.09.49; and Providing a copy of a participant’s medical record, when requested by another licensed provider on behalf of the participant. Billing time limitations are set forth in COMAR 10.09.36.06. Freestanding medical facilities are reimbursed by the Department at the rate set for the freestanding facility by HSCRC. Reimbursement Principles for Out-of-State Hospitals. For hospitals outside of Maryland, excluding the District of Columbia, claims reflecting dates of service on or after October 1, 2009, shall be reimbursed at a rate that is 100 percent of the amount reimbursable by the host state’s Title XIX agency or the amount of the hospital’s actual charges in total, whichever is less. Out-of-State providers are responsible for reimbursing the Department or its designee for overpayments, in accordance with COMAR 10.09.36.07. Reimbursement Principles for Administrative Days. The hospital shall be paid for administrative days that are requested at the time of retrospective review and that are authorized by the Department or its designee after review of the: Clinical documentation; Discharge plan indicating that the hospital was seeking placement for the participant on the administrative days requested; and Documentation that was submitted to the Department on the authorized form that shows placement activity occurred on each day claimed as an administrative day. To be paid for administrative days, for participants who are not ventilator dependent, the reimbursement amount shall be an estimated Statewide average of the Program nursing home payment rate as determined by the Department. A hospital is not eligible for administrative day reimbursement if the days have already been billed as acute days. Reimbursement Principles for Freestanding Acute Rehabilitation Hospitals. For freestanding acute rehabilitation hospitals not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse these hospitals using a prospective payment system. Inpatient Services Rate Calculation. A hospital in the District of Columbia shall: Bill its usual and customary charges; and Be reimbursed for covered services the lesser of its percentage of charges as calculated in §A(2) of this regulation or its charges. The percentage of charges in §A(1) of this regulation is the product of the following: The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; The lesser of 100 percent or the cost-to-charge projection percentage which is: The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §A(2)(a) of this regulation, to the midpoint of the prospective payment period; The percentage of the hospital’s costs which are efficiently and economically incurred as adjusted to reflect labor market differences between District of Columbia hospitals and Maryland hospitals; and The uncompensated care factor which is equal to: For pediatric hospitals with average lengths of stay less than 18 days, one plus two and a half times the quotient of the hospital’s uncompensated care divided by gross revenue; or For all other hospitals, one plus the quotient of the hospital’s uncompensated care divided by gross revenue. Effective for dates of service starting July 1, 2012, and forward, the rate calculated for FY 2012 in accordance with §A(2) of this regulation shall be increased by 9 percent. A hospital in the District of Columbia shall be reimbursed for administrative days in accordance with Regulation .07C of this chapter. Efficiently and economically incurred District of Columbia hospitals’ costs are those costs which are: Less than or equal to the adjusted costs for the same all-participant, refined-diagnosis-related groups in Maryland hospitals; For hospitals with average lengths of stay of 18 days or more: Less than or equal to the adjusted cost for the same diagnosis-related groups in Maryland hospitals; and Categorized into the following two age groups: younger than 18 years old, and 18 years old or older; Exclusive of: Maryland case charges greater than $500,000; and District of Columbia hospital case charges greater than $500,000 times the ratio of the average charge of the District of Columbia hospital case divided by the average charge of the Maryland hospital case; and Derived from hospital costs as specified in this subsection. Maryland hospital costs are the hospitals’ charges reduced by the hospital-specific ratio of operating costs to gross charges as determined by the Program or designee. There may not be a year-end cost settlement. Outpatient Services. A hospital located in the District of Columbia shall: Bill its usual and customary charges; and Be reimbursed for covered services the lesser of its percentage of charges as calculated in §B(2) of this regulation or its charges. The percentage of charges in §B(1) of this regulation is the product of: The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; and The lesser of 100 percent or the cost-to-charge projection percentage which is: The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §B(2)(a) of this regulation, to the midpoint of the prospective payment period. Effective for dates of service starting July 1, 2012, and forward, the rates calculated for FY 2012 in accordance with §B(2) of this regulation shall be increased by 9 percent. The analysis shall be performed by the Program or its designee. There may not be a year-end cost settlement. Outpatient reimbursement rates are implemented in conjunction with, and are applicable to, the same dates of service as inpatient rates. Submitting Cost Reports. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. When reports are not received within 5 months and an extension has not been granted: For hospitals reimbursed in accordance with this regulation, the Program shall reduce the inpatient percentage of payment for that hospital by 5 percentage points, starting the calendar month after the calendar month in which the report is due, which will remain in effect until the report has been submitted, and there will be no refund; or For hospitals reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and Refund withholdings at cost settlement. If a provider discontinues participation in the Program, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Program shall grant an extension for submission of cost reports: Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §C(2) of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .12 of this chapter. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. For purposes of §C(1)—(6) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. When a report is received after imposing a reduction as specified in §C(2)(a) of this regulation, the rate of reimbursement calculated using the latest cost report information shall be implemented starting with the 1st day of the 4th full calendar month after the month in which the report was received by the Program. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and Refund withholdings at cost settlement. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Program shall grant an extension for submission of cost reports: Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .12 of this chapter. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. Retrospective Cost Reimbursement for Freestanding Acute Rehabilitation Hospitals. An acute rehabilitation hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed according to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413, or on the basis of charges if less than reasonable cost. In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, or groups of costs, or costs of specific groups of participants. When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments, thus resulting in a reduction of allowable costs. Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found in 42 CFR §413, adjusted for Medicaid allowable costs. Allowable costs specific to the Program shall be limited to a base year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year. Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year shall be: For an existing provider, the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved; or For a new provider, the 12-month period immediately before the provider was initially subject to target rate increases. Initial Interim Rates. In order to establish an initial interim rate, the provider shall submit to the Department or its designee, before the beginning of the first billing period, the following: A detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate; A current, projected, and prior year’s charge rate schedule; Finalized prior year’s Medicare cost reports and the most current submission; A detailed revenue schedule; and Audited financial statements. The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment on a charge basis exceed the allowable cost for these services. Initial Interim Rates for Newly Established Services or Providers. The provider shall submit to the Department or its designee, a detailed cost build-up, consistent with Medicare principles and cost finding that supports the requested rate that follows. The Department will compare the rate with a compatible facility and determine a reasonable rate that does not exceed the projected charges. Revision of Interim Rates. The provider may request an interim rate revision if the actual and projected costs exceed the interim rate by 10 percent. The provider shall furnish the Department or its designee with appropriate documentation showing the reason for the increase and other necessary comparisons. The Department will lower the provider’s interim rate to closely approximate the final allowable reasonable cost based on the results of the prior year’s review. The provider may request no more than one interim rate revision during the provider’s fiscal year. Cost Settlement. The provider shall submit to the Department or its designee: A Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement; A copy of its Maryland Medical Assistance log; Cost reports that are sufficient in detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers; and A finalized Medicare cost report for the cost reporting year. Final Program costs shall be Maryland Medical Assistance specific. Tentative cost settlements may not be performed on a routine basis. However, the Program reserves the right to calculate tentative settlements in limited cases, when appropriate, as determined by the Department. The Department will base final settlement on the results of the finalized Medicare cost reports. The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under §A(10)—(13) of this regulation. Within 60 days after the provider receives the notification described in §B of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal. The provider may request review of the settlement under §A(10)—(13) of this regulation by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee. The Appeal Board shall be composed of the following: A representative of the hospital industry who is: Knowledgeable in Medicare and Medicaid reimbursement principles; and Appointed by the Secretary of the Department; An individual who: Is employed by the State; Is knowledgeable in Medicare and Medicaid reimbursement principles; Did not participate in the verification of costs; and Is appointed by the Secretary of the Department; and A third member selected by the first two members of the Appeal Board. When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member. If the provider elects not to appeal to the Appeal Board: The provider shall pay the amount due within 60 days after the notification described in §B of this regulation; The provider may request a longer payment schedule within 60 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule; and The Department shall establish a longer payment schedule if, in the Department’s judgment based on sufficient documentation submitted by the provider, failure to grant a longer payment schedule would: Result in financial hardship to the provider; or Have an adverse effect on the quality of participant care furnished by the facility. If the provider elects to appeal to the Appeal Board, the following provisions apply: Within 30 days after a provider’s filing of an appeal of the Department or its designee’s determination that the provider owes money to the Program, the Department or its designee shall: Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and Notify the provider of that amount; In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed; Subject to the provisions of §H(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G(3) of this regulation. Appeal Board Findings. After the Department receives the findings of the Appeal Board, the Department shall: Determine the amount that is due either to the Program or to the provider; and Notify the provider of that amount. The portion of the amount in controversy that is paid is subject to an award of interest that is: Calculated from the date the appeal was filed through the date of payment; and Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. Interest paid to a provider under §I(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs. If the provider accepted the determination made under §I(1) of this regulation, within 60 days after the provider receives the notification under §I(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any. Subject to §I(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any. If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G(3) of this regulation. After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§G—I of this regulation, and in addition to the sanctions provided in Regulation .12 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the decision of the Appeal Board as the final decision for judicial review under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland. If the provider or the Department appeals the final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §I(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination. The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. If refund of a payment as specified in §A of this regulation is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland Effective date: April 10, 2017 (44:7 Md. R. 354) Regulation .04B amended effective June 24, 2024 (51:12 Md. R. 619) Regulation .05P, Q amended effective June 24, 2024 (51:12 Md. R. 619) Regulation .05 R adopted effective June 24, 2024 (51:12 Md. R. 619) Regulation .07A amended effective November 18, 2019 (46:23 Md. R. 1065) In this chapter, the following terms have the meanings indicated. Terms Defined. “Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care. “Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care that the provider is licensed to deliver. “Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where individuals stay at least overnight. “Ancillary services” means diagnostic and therapeutic services including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board. “Appropriate facility” means: A facility located within a 25-mile radius of the participant’s residence; or If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance. “Brain injury” means an injury or insult to the brain that occurs after birth and is not related to congenital or degenerative disease, which results in cognitive, physical, behavioral, or emotional disability that is documented in the medical record. “Brain injury community integration program” means a program located on the campus of a licensed chronic hospital and approved by the Department to treat individuals with primary diagnoses of brain injury resulting in functional limitations and disability, who need services designed to transition to home or a community-based program of services and supports. Chronic Hospital. “Chronic hospital” means an institution licensed by the Maryland Department of Health in accordance with COMAR 10.07.01.03B, which provides services to patients with complex medical needs who do not require hospitalization in an acute hospital, but whose treatment needs exceed the capabilities of a nursing facility. “Chronic hospital” does not mean a: Long-term care hospital, as defined at 42 CFR §412.23(e); or Long-term care facility, as defined at 42 CFR §483.5(a). “Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided by a chronic hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives, performed during an inpatient hospitalization. “Date of service” means: For inpatient hospitalizations, the date of admission into a chronic hospital up to, but not including, the date of discharge; or For outpatient services, the date services are rendered in the outpatient department of the hospital. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Designee” means any entity designated to act on behalf of the Department. “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Interdisciplinary team” means a physician-led multidisciplinary clinical team consisting of, at a minimum: The participant or an individual of the participant’s choice; A physician; A registered nurse; A social worker; The participant’s case manager; and Any other clinical professional indicated by an individual’s specific needs, including but not limited to: A psychologist; A behavioral analyst; A dietitian or nutritionist; and Licensed therapists in other disciplines. “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, family, or provider. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Neuro-behavioral” means the discipline within medical rehabilitation that focuses on behavioral impairments seen in association with brain injury resulting from trauma, hypoxia, or ischemia. “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. “Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission. “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. “Program” means the Maryland Medical Assistance Program. “Provider” means a chronic hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number. In order to participate in the Program, a provider shall: Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital; and Obtain any other licenses required by COMAR 10.07.01. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of: Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and COMAR 10.10.01; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02. The provider shall obtain accreditation by the Commission on Accreditation of Rehabilitation Facilities if it provides neuro-behavioral rehabilitation or brain injury services. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. To participate in the Program as a chronic hospital services provider, the provider shall: Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the U.S. Department of Health and Human Services; 24 hours per day, 7 days per week, meet the following staffing requirements: On-call or on-site physician services; On-site registered nurses; On-site respiratory therapist services; and On-site advanced cardiac life support services; Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services; Accept payment by the Program as payment in full for the covered service; Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; and Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes: Date of service; The participant’s chief medical complaint or reason for admission; A description of the services provided, including: Progress notes; Imaging studies; Laboratory results; Medication administration records; and Discharge summary; and A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title. To participate in the Program as a provider operating a brain injury community integration program, the provider shall be: Accredited by the Commission on Accreditation of Rehabilitation Facilities; and Approved by the Department to provide the Program. Staff Requirements. In addition to the requirements in Regulation .03 of this chapter, a brain injury community integration program shall meet staffing requirements, as approved by the Program, necessary to provide the neuro-behavioral management programming set forth in Regulation .05D of this chapter. At least annually, in a form specified by the Program, a provider operating a brain injury community integration program shall report on the individuals admitted to and participating in the program, including: Length of stay; Discharge setting; and Any other data specified by the Program. Chronic hospitals shall provide the following services: Complex respiratory care services; Complex wound care services; Services for participants with multiple co-morbidities, including but not limited to services necessary to care for: Ventilator-assisted individuals who have been ventilator dependent for less than 6 months and who need further medical stabilization or are candidates for weaning from ventilator assistance; Tracheostomy participants who require suctioning more frequently than every 2 hours or are candidates for decannulation; More than two extensive stage IV decubiti which require daily intensive treatment that is not available in a nursing facility; or Extensive post-operative or post-traumatic care with multiple drains or extensive dressing change or therapies beyond the capabilities of a nursing facility; For participants admitted for medically necessary rehabilitation services, physical therapy, occupational therapy, or speech therapy, directed by an interdisciplinary team; and Ancillary services. Treatment Plan. Within 24 hours of a participant’s admission, a physician shall perform a documented face-to-face evaluation of the participant and begin developing an individualized treatment plan designed to meet the participant’s assessed needs. By the 7th day of a participant’s admission, an interdisciplinary team shall establish a written, individualized treatment plan for the participant, which shall include, at a minimum: Diagnoses; Treatment goals; Frequency of interventions for each type of service ordered; Duration of treatment of each type of service ordered; and Prognosis. The physician-led interdisciplinary team shall update the individualized treatment plan weekly until discharge. The Program covers outpatient hospital services provided by a chronic hospital when the services are: Medically necessary; and Provided to individuals who are eligible for Medical Assistance and who are not current inpatients at the chronic hospital, except when payment for certain outpatient services provided to a participant on the date of inpatient admission or within 3 calendar days before the date of an inpatient admission are bundled, in accordance with 42 CFR §412.2(c)(5). The program covers the following brain injury community integration program services: Neuro-behavioral management programming, which includes, but is not limited to: Assessment of maladaptive behaviors using valid and reliable behavioral measurement tools; Pharmacologic intervention provided to manage maladaptive behaviors related to brain injury; Neuro-behavioral programming created, implemented, overseen, and revised as needed; Incorporation of neuro-behavioral programming into therapy and care for participants in the community integration program; and Referral to a neuro-psychiatrist, as needed, if a neuro-psychiatrist is not a member of the facility staff; Cognitive skills adaptation and compensation programming, including: Specific programming dedicated to cognitive skills adaptation and compensation; and Incorporation of cognitive compensatory strategies into community integration program participant’s interdisciplinary team treatment; Community re-entry programming, including specific programming dedicated to social or pragmatic skills, leisure skills, and life skills; and According to the participant’s needs: The services of a psychiatrist or psychiatric nurse; Services and supports related to substance use disorders and other addictions; Speech therapy, which includes but is not limited to: Cognitive skills; Communication skills; Swallowing ability; and Linguistic programming that assists the patient to connect the meaning of words to their context; Occupational therapy, which includes but is not limited to: Instrumental activities of daily living; and Community re-entry activities; Physical therapy, which includes but is not limited to: Ambulation; and Motor planning and coordination; Dietary services, which includes but is not limited to nutritional needs assessment and monitoring; and Case management, which includes but is not limited to: Treatment planning; and Discharge planning. The Program covers administrative days approved by the Department or its designee according to the conditions set forth in Regulation .08C of this chapter. The Program does not cover: Services for individuals who are not eligible for Medicaid; Services for individuals who are not medically eligible for chronic hospital services; Services identified by the Department or its designee as not medically necessary; Hospital services, procedures, drugs, or hospital admissions that are investigational or experimental; Duplicated care or services; Interpretation of laboratory tests or panels; Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner involved in the participant’s care; or Telephones, televisions, or personal comfort items or services. General Requirements. An admission to a chronic hospital is medically necessary for a participant whose: Medical condition is not stabilized subsequent to a course of treatment at an acute hospital, or whose deteriorating medical condition resulted in a readmission to an acute hospital from a nursing facility or community setting; and Service and care needs require active and continuing medical treatment at an intensity and frequency not provided in a nursing facility, as defined in COMAR 10.09.10.01B, such as: 24-hour availability of a physician, physician assistant, or nurse practitioner, and associated nursing staff; and Active and continuing medical treatment by a physician at least three times per week as documented in the medical record, physician orders, and physician progress notes. An admission to a chronic hospital is medically necessary for a participant who: Requires rehabilitation services of a lesser intensity or frequency than the acute inpatient rehabilitation services provided in a special rehabilitation hospital; and May have comorbidities or a level of medical complexity that preclude admission to a special rehabilitation hospital. A participant who may not be able to fully participate in a chronic hospital rehabilitation program may be admitted for a brief trial period of inpatient care after review by the Department or its designee and approval by the Program. If no progress on rehabilitative goals occurs, the participant shall be discharged to a lower level of care. Medical Criteria for Brain Injury Community Integration Programs. In order to be preauthorized by the Program for services in a brain injury community integration program, a participant: Shall have a primary diagnosis of brain injury; Shall be at low risk of potential medical instability; May not require acute inpatient physical rehabilitation services; Shall require an intensive neuro-behavioral or neuro-cognitive rehabilitation program at a chronic level of care as described in §A of this regulation in order to: Address pervasive and persisting maladaptive behaviors, or behavioral health risk factors, that preclude a safe discharge to the community or to a less restrictive setting; and Relearn basic living and adaptive skills; Shall have potential for achievement of specific functional outcomes with the potential of improving functional ability so that discharge to a less restrictive setting is a reasonable goal; Shall need rehabilitative programming, which may include: Recreation therapy; Speech language pathology; Occupational therapy; Physical therapy; and Neuro-psychology; Shall require at least two contacts daily within the rehabilitative programming that address the neuro-behavioral or neuro-cognitive needs of the participant; Shall require active and continued clinical treatment by a physician who is experienced in neuro-rehabilitation and in psychopharmacology for a minimum of three contacts per week; Shall require a structured and integrated environment of care that provides on-going behavioral programming designed to reduce maladaptive behaviors that are reinforced by clinical support and administrative staff; Shall make progress toward the achievement of specified functional outcomes; and Shall have the ability to participate in the required number of therapy sessions. Admission and Prior Approval. For participants and individuals who have applied for Medical Assistance, the provider shall request a determination from the Department or its designee at the time of admission, or at the time of application for Medical Assistance, that the individual meets the medical eligibility criteria set forth in Regulation .07A of this chapter. For a participant to be preauthorized for services in a brain injury community integration program, a provider that meets the requirements of Regulation .04 of this chapter shall request a determination from the Department or its designee that the participant meets the criteria set forth in Regulation .07B of this chapter. If the provider obtains the determination set forth in §A(1) or (2) of this regulation after admission, the eligibility determination shall be effective on the date that the determination was requested. Concurrent Review. On a monthly basis, the provider shall notify the Department or its designee of all persons who have: Received an initial determination of medical eligibility for chronic hospital services; Been determined to continue to meet medical eligibility criteria for chronic hospital services; Been discharged; or Been determined to no longer be medically eligible. Concurrent review shall be conducted every 14 days as long as the participant remains hospitalized to ensure the medical necessity of the participant’s inpatient stay. The Department or its designee may conduct on-site reviews. Administrative Days. To be paid for administrative days, the provider shall document, in a form designated by the Department, information which satisfies the conditions listed below: The participant who was initially eligible has been determined to no longer require chronic hospital services, and the provider has: Received a determination from the Department or its designee that the participant requires the level of service provided by a nursing facility but an appropriate facility is not available; Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; and Submitted documentation to the Department or its designee that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; or The participant is no longer medically eligible to receive chronic hospital services but cannot be moved, and the following conditions are met: The medical reason the participant cannot be moved is documented by the attending physician in the participant’s medical record; The attending physician reevaluates the medical cause of the participant’s inability to be moved at least once every 7 days; and The provider documents the active treatments used to resolve the medical cause of the participant’s inability to be moved; To receive reimbursement for administrative days, the provider shall document that it has met the conditions of §C(1) of this regulation, at least every 14 days. Documentation shall be submitted to the Department or its designee no later than 3 business days following the end of the 14-day period. Reimbursement of Maryland Chronic Hospitals. In-State chronic hospitals shall be reimbursed according to: Rates approved by the HSCRC pursuant to COMAR 10.37.03; or The administrative day rate as follows: For a participant who is not ventilator-dependent, payment for approved administrative days shall be the estimated Statewide average Medicaid nursing facility payment rate as determined by the Department; and For a participant who is ventilator-dependent, payment for approved administrative days shall be the estimated average Medicaid nursing facility payment rate for ventilator-dependent residents as determined by the Department. State-operated chronic hospitals shall be reimbursed according to Regulation .10 of this chapter. The Department shall make no direct reimbursement to any State-operated chronic hospital. Reimbursement of Out-of-State Hospitals. The Department shall reimburse an out-of-State hospital that provides a level of service equivalent to that provided at a chronic hospital only if: The proposed admission is first reviewed by the Department or its designee and the out-of-State placement is determined medically necessary according to Regulation .07A of this chapter; The hospital possesses the same certifications and accreditations as the Program requires for a comparable level of services and specific program in a Maryland chronic hospital; and The hospital meets one of the following conditions: The hospital proposes to provide a service or specific treatment that the participant cannot obtain in a Maryland chronic hospital; or The hospital is located geographically closer to the established residence of the participant than a Maryland chronic hospital. The Department shall reimburse an out-of-State hospital at the lesser of: The average rate established by the HSCRC for an equivalent cost center for a Maryland chronic hospital; or The rate charged by the out-of-State hospital pursuant to 42 CFR Part 412, Subpart O. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and Refund withholdings at cost settlement. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Program shall grant an extension for submission of cost reports: Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .14 of this chapter. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found at 42 CFR §413, adjusted for Program allowable costs. Allowable costs specific to the Program shall be limited to a base year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year. Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year for an existing provider shall be the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved. The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment exceed the allowable cost for these services. Revision of Interim Rates. The provider may request an interim rate revision should the actual and projected cost exceed the interim rate by 10 percent. The provider shall furnish the Department or its designee with appropriate schedules showing the reason for the increase and any other information supporting the request. The Department will lower the provider’s interim rate to closely approximate the final allowable reasonable cost based on the results of the prior year’s review. The provider may request not more than two interim rate revisions during the accounting year. Cost Settlement. The provider shall submit to the Department or its designee a Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement. The provider shall also submit a copy of its Maryland Medical Assistance log. The submitted cost report shall be in sufficient detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers. Tentative cost settlements may not be performed on a routine basis. However, the Program reserves the right to calculate tentative settlements in limited cases, when appropriate, as determined by the Department. The provider shall furnish the Department or its designee with a finalized Medicare cost report for the cost reporting year. The Department will base final settlement on the results of the finalized Medicare cost reports. The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under Regulation .11 of this chapter. Within 60 days after the provider receives the notification described in §A of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal. The provider may request review of the settlement under Regulation .11 of this chapter by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee. The Appeal Board shall be composed of the following: A representative of the hospital industry who is: Knowledgeable in Medicare and Medicaid reimbursement principles; and Appointed by the Secretary of the Department; A person who: Is employed by the State; Is knowledgeable in Medicare and Medicaid reimbursement principles; Did not participate in the verification of costs; and Is appointed by the Secretary of the Department; and A third member selected by the first two members of the Appeal Board. When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member. If the provider elects not to appeal to the Appeal Board: The provider shall pay the amount due within 60 days after the notification described in §A of this regulation; If the provider requests a longer payment schedule within 60 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule; and The Department shall establish a longer payment schedule if, in the Department’s judgment based on sufficient documentation submitted by the provider, failure to grant a longer payment schedule would: Result in financial hardship to the provider; or Have an adverse effect on the quality of participant care furnished by the facility. If the provider elects to appeal to the Appeal Board, the following provisions apply: Within 30 days after a provider appeals a determination by the Department or its designee that the provider owes money to the Program, the Department or its designee shall: Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and Notify the provider of that amount; In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed; Subject to the provisions of §G(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation. Appeal Board Findings. After the Department receives the findings of the Appeal Board, the Department shall: Determine the amount that is due either to the Program or to the provider; and Notify the provider of that amount. The portion of the amount in controversy that is paid is subject to an award of interest that is: Calculated from the date the appeal was filed through the date of payment; and Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. Interest paid to a provider under §H(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs. If the provider accepted the determination made under §H(1) of this regulation, within 60 days after the provider receives the notification under §H(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any. Subject to §H(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any. If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation. After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§F—H of this regulation, and in addition to the sanctions provided in Regulation .14 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the decision of the Appeal Board as the final decision for judicial review under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland. If the provider or the Department appeals the final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §H(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination. The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. If refund of a payment as specified in §A of this regulation, is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland Effective date: April 10, 2017 (44:7 Md. R. 354) Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .05A amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .07A amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .08A, B amended effective May 20, 2019 (46:10 Md. R. 487) In this chapter, the following terms have the meanings indicated. Terms Defined. “Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care. “Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care that the provider is licensed to deliver. “Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight. “Ancillary services” means diagnostic and therapeutic services including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board. “Appropriate facility” means: A facility located within a 25-mile radius of the participant’s residence; or If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance. “Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided by a special pediatric hospital, which allows for close monitoring of the participant’s progress, treatment goals, and objectives, performed during an inpatient hospitalization. “Date of service” means: For inpatient hospitalizations, the date of admission into a special pediatric hospital up to, but not including, the date of discharge; or For outpatient services, the date services are rendered in the outpatient department of the hospital. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Designee” means any entity designated to act on behalf of the Department. “Diagnosis-related group” means a participant classification system adopted by the U.S. Department of Health and Human Services, in which each hospital discharge case is assigned a category based on the primary diagnosis, secondary diagnoses, if any, procedures performed, and age, sex, and discharge status of the participant. “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Level of care” means an assessment that an individual needs the level of services provided in a special psychiatric hospital. “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, family, or provider. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. “Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission. “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. “Plan of treatment” means a written plan developed by a participant’s consulting physician and other appropriate clinicians, which is provided to the Department on request and includes: Diagnosis; Treatment goals; Specific procedures planned for the participant, including surgeries; Duration of treatment of each type of service ordered; Expected length of stay; and Any other appropriate information, including caregiver education and discharge plan. “Program” means the Maryland Medical Assistance Program. “Prospective payment system” means a predetermined amount of reimbursement per day for inpatient hospital services. “Provider” means a special pediatric hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number. Special Pediatric Hospital. “Special pediatric hospital” means a facility licensed by the Office of Health Care Quality as a special hospital that provides nonacute medical, rehabilitation, therapy, and palliative services to children and adolescents younger than 22 years old. “Special pediatric hospital” includes an out-of-State or District of Columbia hospital identified by the Program as: A facility that provides nonacute medical, rehabilitation, therapy, and palliative services to children and adolescents younger than 22 years old; and A facility that provides nonacute medical, rehabilitation, and therapy services to individuals ages 2 through 22 with co-occurring medical and behavioral conditions. In order to participate in the Program, a provider shall: Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital; and Obtain other licenses, as set forth in COMAR 10.07.01. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of: Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and COMAR 10.10.01; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36. To participate in the Program as a special pediatric hospital services provider, the provider shall: Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the U.S. Department of Health and Human Services; Directly provide, or make available through contractual arrangements or transfer agreements, medically necessary covered services; Accept payment by the Program as payment in full for the covered services; Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; and Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes: Date of service; The participant’s chief medical complaint or reason for admission or outpatient visit; A description of the services provided, including: Progress notes; Imaging studies; Laboratory results; Medication administration records; and Discharge summary; and A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title. If an out-of-State or District of Columbia hospital, the hospital shall: Have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XIX of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act unless a waiver has been granted by the Secretary of Health and Human Services; and Allow HealthChoice managed care organizations to pay no more and no less than the reimbursement rates established in Regulation .07 of this chapter unless the parties mutually agree to an alternative arrangement in a contract either on or after July 1, 2011. The Program covers the following inpatient services at special pediatric hospitals: A hospital admission determined to be medically necessary for a participant who is stable enough for transfer to a post-acute setting and requires medical or rehabilitative services that: Cannot be provided at a lower level of care; and Meets the medical eligibility criteria under Regulation .06 of this chapter; Administrative days for the length of time certified by the Department or its designee; Inpatient admissions for intensive occupational therapy, physical therapy, or speech therapy on a regimen which is less than 3 hours per day, 5 days per week, when these services are provided in a unit that is accredited by the Commission on Accreditation of Rehabilitation Facilities to provide rehabilitation services; and Ancillary services. The Program covers the following outpatient hospital services: Medically necessary services for the provision of diagnostic, curative, palliative, or rehabilitative treatment; and For a participant younger than 21 years old, physical therapy, occupational therapy, speech therapy, and audiology services if: The therapy provider develops a written plan of treatment in collaboration with the participant’s primary care physician and the participant or the parent or guardian of the participant; The service is provided according to the plan of treatment; and The services provider sends an update of the plan of treatment to the participant’s primary care physician every 90 days. The Program does not cover: Investigational or experimental hospital services, procedures, or drugs; Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant’s inability to take appropriate oral medications is documented in the participant’s medical record; Outpatient visits intended to accomplish one or more of the following: Prescription drug or food supplement pick-up; Collection of specimens for laboratory procedures; Recording of an electrocardiogram; or Ascertaining the participant’s weight; Interpretation of laboratory tests or panels; Autopsies; Immunizations required for travel outside the continental United States; Leaves of absence beyond the period of the census check of the same day; Day care; Psychological evaluations and treatments except when: Ordered by a physician, and the medical necessity is documented in the participant’s medical record; or Performed as mental health service, as part of the plan of treatment; Duplicated care or services; Elective admissions to hospitals outside of Maryland and the District of Columbia unless the Department or its designee determines that comparable services are not available in Maryland, except under certain conditions where child participants are in foster care, or are for other reasons placed outside the State and are covered under certain criteria, as determined by the Department or its designee; Inpatient and outpatient diagnostic services not specifically ordered by the attending physician or other responsible practitioner; Inpatient days or services provided in excess of the days approved by the Department or its designee; Hospital laboratory tests which are coverable under COMAR 10.09.09.04, if the specimen is not obtained in the hospital; Hospital services provided outside of the United States; The completion of forms and reports; Broken or missed appointments; Professional services rendered by mail or telephone; or Telephones, televisions, or personal comfort items or services. The Department or its designee shall conduct utilization review to determine that special pediatric hospital admissions and outpatient services are authorized only when medically necessary. Review Procedure. For all admissions, the special pediatric hospital shall provide: The elements of a participant’s medical record specified by the Department or its designee for preadmission review, and request to certify the participant’s admission; and Sufficient clinical information or documentation to the Department or its designee that supports the need for admission to a special pediatric hospital including, but not limited to: Current medical health status; Treatment received to date; Proposed treatment plan for requested admission; and Expected length of stay. Admission for inpatient services may be authorized only when these services cannot be provided: On an outpatient basis; or In a facility that is licensed to provide a more appropriate level of care to the participant. Concurrent review shall be conducted as long as the participant remains hospitalized, based on the participant’s diagnosis and condition, to ensure the medical necessity of the participant’s inpatient stay, at the following intervals: After an initially authorized 14-day stay, or at the end of the expected length of stay identified at admission, whichever comes first; and Every 14 days following the initial concurrent review, in a form and including clinical documentation as specified by the Department or its designee. The Department or its designee may conduct on-site reviews after an initially authorized period of 30 days, and every 30 days thereafter until discharge. An elective inpatient hospital admission requires preadmission authorization by the Department or its designee. Administrative Days. To be paid for administrative days, the provider shall document, in a form designated by the Department, information which satisfies the conditions listed below: The participant has been determined to no longer require special pediatric hospital services, and the provider has: Received a determination from the Department or its designee that the participant requires the level of service provided in a lower-acuity facility, but an appropriate facility is not available; Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; and Submitted documentation to the Department or its designee that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; or The participant is no longer medically eligible to receive special pediatric hospital services but cannot be moved, and the following conditions are met: The medical reason the participant cannot be moved is documented by the attending physician in the participant’s medical record; The attending physician reevaluates the medical cause of the participant’s inability to be moved at least once every 7 days; and The provider documents the active treatments used to resolve the medical cause of the participant’s inability to be moved; To receive reimbursement for administrative days, the provider shall document that it has met the conditions of §C(1) of this regulation, at least every 14 days. Documentation shall be submitted to the Department or its designee no later than 3 business days following the end of the 14-day period. HSCRC Reimbursement Principles. Except for hospitals reimbursed under the provisions of §B of this regulation and except for administrative days, hospitals located in Maryland that participate in the Program shall charge and be reimbursed according to rates approved by the HSCRC pursuant to COMAR 10.37.03. If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse a provider: According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or On the basis of charges if less than reasonable cost. The Department may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item. Annual Market Basket Reimbursement Principles. Except as specified in §B(2)—(5) of this regulation, a special pediatric hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed according to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413, or on the basis of charges if less than reasonable cost. In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, or groups of costs, or costs of specific groups of participants. When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments, thus resulting in a reduction of allowable costs. For days of service on or after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse these hospitals using a prospective payment system consisting of per diem rates based on service categories audited and adjusted in the provider’s fiscal year 2004 cost report. The base per diem rates shall be: Annually adjusted by the factor indicated in the Centers for Medicare and Medicaid Services Annual Market Basket Update Factor for the Long Term Care Hospital Prospective Payment System; and Determined by allocating Medicaid inpatient costs into service categories as follows: Rehabilitation categories — $1,486.58; Feeding categories — $2,213.98; Severe behavior categories — $2,544.66; and Other categories — $1,126.69. For new services established after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Program shall pay at an initial rate that is set as an interim rate at the Medicaid weighted average rate of all existing inpatient per diem rates. After the first full year, actual cost data shall be used to prospectively set the new service rate. For days of service on or after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse hospital based outpatient services on a prospective basis that shall be adjusted annually by the difference between the: Medicaid weighted average charge increase; and Centers for Medicare and Medicaid Services Outpatient Prospective Payment System Market Basket Update Factor. For outpatient services in §B(4) of this regulation, the revenue shall be maintained at the fiscal year 2011 level beginning July 1, 2011. Out-of-State Hospitals Reimbursement Principles. An out-of-State hospital, except a hospital located in the District of Columbia, shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency. The hospital shall be reimbursed for administrative days in accordance with Regulation .09E of this chapter. For outpatient services, an out-of-State hospital, except a hospital located in the District of Columbia, shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency. Inpatient Services Base Rate Calculation. A hospital in the District of Columbia shall: Bill its usual and customary charges; and Be reimbursed for covered services the lesser of its percentage of charges as calculated in §A(2) of this regulation or its charges. The percentage of charges in §A(1) of this regulation is the product of the following: The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; The lesser of 100 percent or the cost-to-charge projection percentage which is: The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §A(2)(a) of this regulation, to the midpoint of the prospective payment period; The percentage of the hospital’s costs which are efficiently and economically incurred as determined in accordance with §A(6) of this regulation; and The uncompensated care factor, which is equal to one plus the quotient of the hospital’s uncompensated care divided by gross revenue. Effective for dates of service starting July 1, 2012, and forward, the rate calculated for FY 2012 in accordance with §A(2) of this regulation shall be increased by 9 percent. A hospital in the District of Columbia shall be reimbursed for administrative days in accordance with Regulation .08C of this chapter. Efficiently and economically incurred District of Columbia hospitals’ costs are costs which are: Less than or equal to the adjusted costs for the same all participant refined-diagnosis related groups in Maryland hospitals; For hospitals with average lengths of stay of 18 days or more: Less than or equal to the adjusted cost for the same diagnosis-related groups in Maryland hospitals; and Categorized into the following two age groups: younger than 18 years old, and 18 years old or older; Exclusive of: Maryland case charges greater than $500,000; and District of Columbia hospital case charges greater than $500,000 times the ratio of the average charge of the District of Columbia hospital case divided by the average charge of the Maryland hospital case; and Derived from hospital costs as specified in this subsection. Maryland hospital costs are the hospitals’ charges reduced by the hospital specific ratio of operating costs to gross charges as determined by the Program or designee. There may not be a year-end cost settlement. For hospitals located in the District of Columbia that are not acute children’s hospitals, the reimbursement amount described in §A(1) of this regulation will be reduced by 2 percent. Outpatient Services. A hospital located in the District of Columbia shall: Bill its usual and customary charges; and Be reimbursed for covered services the lesser of its percentage of charges as calculated in §B(2) of this regulation or its charges. The percentage of charges in §B(1) of this regulation is the product of: The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; and The lesser of 100 percent or the cost-to-charge projection percentage which is: The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §B(2)(a) of this regulation, to the midpoint of the prospective payment period. Effective for dates of service starting July 1, 2012, and forward, the rates calculated for FY 2012 in accordance with §B(2) of this regulation shall be increased by 9 percent. The analysis shall be performed by the Program or its designee. There may not be a year-end cost settlement. Outpatient reimbursement rates are implemented in conjunction with, and are applicable to, the same dates of service as inpatient rates. Cost Reporting. A special pediatric hospital provider reimbursed according to this regulation shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. When reports are not received within 5 months and an extension has not been granted: For hospitals reimbursed in accordance with Regulation .08 of this chapter, the Program shall reduce the inpatient percentage of payment for that hospital by 5 percentage points, starting the calendar month after the calendar month in which the report is due, which will remain in effect until the report has been submitted, and there will be no refund; or For a hospital reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and Refund withholdings at cost settlement. If a provider discontinues participation in the Program, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Program may grant an extension for submission of cost reports: Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year, and the provider has not received an extension, the Department may impose, in addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §C(2) of this regulation, one or more sanctions as provided for in Regulation .11 of this chapter. When a report is not submitted by the last day of the sixth month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. For purposes of §C(1) — (6) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. When a report is received after imposing a reduction as specified in §C(2)(a) of this regulation, the rate of reimbursement calculated using this cost report information shall be implemented starting the 1st day of the 4th full calendar month after the month in which the report was received by the Program. The Program shall pay room and board charges for the day of admission, and may not pay room and board charges for the day of discharge from the hospital. The provider shall submit a request for payment according to procedures designated by the Department. Payments of Medicare Claims. Payment of Medicare claims is authorized if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; Medicare determined that services were medically necessary; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. Payment of a deductible and co-insurance related to Medicare claims shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case deductible and co-insurance shall be paid in full. Out-of-State Hospital Reimbursement. The Program shall reimburse hospitals outside of Maryland, excluding the District of Columbia, at a rate that is 100 percent of the amount reimbursable by the host state’s Title XIX agency or the amount of the hospital’s actual charges in total, whichever is less. Out-of-State providers are responsible for reimbursing the Department for overpayments, in accordance with Regulation .10 of this chapter. Payment for Administrative Days. The provider shall document, on forms designated by the Department, information that satisfies the conditions stated in Regulation .06C of this chapter. The provider shall: Receive determination from the Department or its designee that the participant no longer requires the level of care that the special pediatric hospital is licensed to provide; Receive determination from the Department or its designee that the participant requires services at a lower level of acuity, and a bed in an appropriate facility is not available; and Notify the Department or its designee of discharge planning before the termination of the need for inpatient hospitalization at the level the facility is licensed to provide, and obtained a level of care determination from the agent. During the period of administrative days, the Department or its designee shall review the documentation in increments of not more than 14 days. For participants who are not ventilator-dependent, payment for approved administrative days shall be the lesser of: An estimated Statewide average Medicaid nursing home payment rate as determined by the Department; or If the hospital has a unit which is a skilled nursing facility, the allowable costs in effect under Medicare or extended services provided to participants of the unit. The Department will make no direct payment to the participant. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. Noncompliance with the Program’s requirements as determined by the Department or its designee shall result in nonpayment of the claim. Payment on claims to a hospital located in the District of Columbia shall be reduced by a quarterly claims processing fee of 6 percent. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. If refund of a payment as specified in §A of this regulation is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. General policies governing the interpretive regulations that are applicable to providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland Effective date: April 10, 2017 (44:7 Md. R. 354) In this chapter, the following terms have the meanings indicated. Terms Defined. “Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care which the provider is licensed to deliver and is awaiting placement in a nursing home or residential care facility. “Admission” means the formal acceptance by a specialty psychiatric hospital of a patient who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight. “Ancillary services” means diagnostic and therapeutic services, provided exclusive of room and board, including but not limited to: Radiology; Laboratory tests; Pharmacy services; and Physical therapy services. “Appropriate facility” means: A facility located within a 25-mile radius of the participant’s residence; or If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance. “Concurrent review” means a periodic reauthorization of continued eligibility for the level of services provided by a special psychiatric hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives during an inpatient hospitalization. “Date of service” means: For inpatient hospitalizations, the date of admission into a special psychiatric hospital up to, but not including, the date of discharge; For outpatient services, the date services are rendered in the outpatient department of the special psychiatric hospital; and For observation services, the date or dates the services are rendered in a special psychiatric hospital, which are ordered by a medical staff practitioner to determine the need for inpatient admission. “Department” means the State Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Designee” means any entity designated to act on behalf of the Department. “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. “Emergent condition” means a disease, illness, or injury characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson, who possesses an average knowledge of health and medicine, to result in: Placing the participant’s health or, with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy; Serious impairment of bodily functions; or Serious dysfunction of any bodily organ or part. “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Level of care” means an assessment that an individual needs the level of services provided in a special psychiatric hospital. “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. “Medicaid” means the Maryland Medical Assistance Program. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the participant, family, or provider. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Mental health services” means those services described in COMAR 10.09.59.06 rendered to treat the diagnoses set forth in COMAR 10.09.70.02. “Nonqualified alien” means a foreign-born resident who: Is not a naturalized U.S. citizen; and Is eligible for federal Medical Assistance coverage of only emergency medical services, as specified under COMAR 10.09.24.05-2A. “Observation services” means the medically necessary diagnostic services used to assess the participant’s outpatient condition to determine the need for possible admission to an inpatient special psychiatric care setting. “Organ” means a part of an organism that is typically self-contained and has a specific vital function, such as a heart or liver. “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. “Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission. “Partial hospitalization” means outpatient, intensive, nonresidential psychiatric treatment, which is an alternative to inpatient acute general hospitalization, for any part of a 24-hour day for a minimum of 4 consecutive hours per day. “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. “Patient” means an individual awaiting or undergoing health care or treatment. “Plan of treatment” means a written plan, developed to address the referred problem or problems, which includes: Diagnosis; Treatment goals; Frequency of visits for each type of service ordered; Duration of treatment of each type of service ordered; Prognosis; and Other appropriate items. “Preauthorization” means the approval required from the Department or its designee before a service can be rendered by the provider and reimbursed. “Program” means the Maryland Medical Assistance Program. “Provider” means a special psychiatric hospital which through agreement with the Department has been identified as a Program provider by the issuance of a provider number. “Retrospective review” means the process of determining medical necessity of an inpatient admission after the participant has been discharged from the hospital. “Special psychiatric hospital” means an institution that: Provides short-term services for psychiatric illnesses in a hospital setting with facilities, medical staff, and all necessary personnel to provide diagnosis, care, and treatment; Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. In order to participate in the Program, a provider shall: Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a specialty psychiatric hospital; and Obtain other licenses, as set forth in COMAR 10.07.01. A provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of: Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and COMAR 10.10.01; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. To participate in the Program as a special psychiatric hospital services provider, the provider shall: Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the Department of Health and Human Services; Meet the following staffing requirements 24 hours per day, 7 days per week: On-call or on-site physician services including psychiatric physicians; On-site registered nurses; On-site advanced cardiac life support services; If licensed to provide inpatient psychiatric services for individuals younger than 21 years old: Meet the requirements for participation as defined in 42 CFR §440.160; and Provide acute psychiatric services as defined in 42 CFR Part 441, Subpart D; Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services; Accept payment by the Program as payment in full for the covered service; Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; Maintain documentation of each contact with the participant as part of the medical record, which, at a minimum, includes: Date of service; A plan of treatment as defined in Regulation .01B of this chapter; The participant’s chief medical complaint or reason for visit; A description of the services provided, including: Progress notes; Imaging studies; Laboratory results; Medication administration records; and Discharge summary; and A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title; Submit to the Department or its designee within 5 months of the close of the hospital’s fiscal year, as required by the Department, a hospital cost report for outpatient services which are subject to cost settlement in accordance with Regulation .11 of this chapter; If an out-of-State or District of Columbia hospital, the special psychiatric hospital shall: Unless a waiver has been granted by the Secretary of Health and Human Services, have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XVII of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act; and Comply with applicable regulations of this chapter and COMAR 10.09.36. The Program covers the following inpatient special psychiatric hospital services: Medically necessary services for the number of days, per admission, including days certified by the Department or its designee; Medically necessary mental health services authorized in accordance with COMAR 10.09.59.08 and as set forth in Regulation .05B(4) of this chapter; Medically necessary services when these services are: Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment; and Described in the participant’s medical record in sufficient detail to support the invoices submitted for services. Administrative days for the length of time certified by the Department or its designee; Leaves of absence for therapeutic reasons or extenuating circumstances up to 12 hours per day, if the participant returns the same day, before the census check; and Observation services. The Program covers partial hospitalization when the hospital has: Written approval from the Office of Licensing and Certification Programs to be a provider of partial hospitalization in accordance with COMAR 10.21.02; A certificate of need from the Maryland Health Resources Planning Commission, if required, to be a provider of partial hospitalization; and Obtained preauthorization in accordance with COMAR 10.09.59.08. There are limitations placed on the coverage of some special psychiatric hospital inpatient and outpatient services. The Program does not cover: Special psychiatric hospital services, procedures, drugs or admissions that are investigational or experimental; Services identified by the Department or its designee as not medically necessary; Elective inpatient admissions without preauthorization; Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant’s inability to take appropriate oral medications is documented in the participant’s medical record; Inpatient mental health services for an individual between 21 and 64 in a special psychiatric hospital of more than 16 beds that primarily engages in providing mental health services for an individual who is not waiver-eligible, as defined in COMAR 10.67.01.01, except: When receiving mental health services in the special psychiatric hospital immediately before the participant reached 21 years old, in which case the services may be continued until the earlier of the following: The date the participant no longer requires the services; or The date the participant reaches 22 years old; Effective July 1, 2019, services of up to 15 days per month, when: The participant has co-occurring substance use and mental health diagnoses; and The provider is located in-State or, effective January 1, 2022, the provider is located in a contiguous state or the District of Columbia; or Effective January 1, 2022, services up to 60 days, when: The participant has a primary mental health diagnosis; and The provider is located in-State, a contiguous state, or the District of Columbia; Outpatient visits for one or more of the following: Prescription drug or food supplement pick up; Collection of specimens for laboratory procedures; Recording of an electrocardiogram; Ascertaining the participant’s weight; and Administration of vaccines; Leaves of absence beyond the period of the census check of the same day; Psychological evaluations and treatments except when: Ordered by a physician, and the medical necessity is documented in the participant’s medical record; or Performed as mental health services as part of an approved treatment plan; Telephones, televisions, or personal comfort items or services; Duplicated care or service as indicated by more than one charge for the same stay or more than one room accommodation for the same time, for example, a charge for an inpatient day and observation room charge; Administrative days for participants pending discharge to home or nonmedical institutions; Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner; Inpatient days provided in excess of the days approved by the Department or its designee; Hospital laboratory tests which are coverable under COMAR 10.09.09, unless the specimen is obtained in the hospital; Admissions to special psychiatric hospitals, unless the participant is diagnosed with any one of the specialty mental health codes listed in COMAR 10.09.70.02 or unless the Department or its designee grants a special exception based on the complexity of the situation at admission; or Elective admissions to hospitals outside of Maryland, except the District of Columbia, unless the Department or its designee determines that comparable services are not available in Maryland. Elective Inpatient Preauthorization Reviews. The special psychiatric hospital shall only request preauthorization for inpatient stays when such services: Cannot be provided on an outpatient basis; or Can only be provided in a facility that is licensed as a special psychiatric hospital. The special psychiatric hospital shall obtain preauthorization for elective inpatient admissions from the Department or its designee, before the participant is admitted, by providing the following information including, but not limited to: Participant’s medical history and physical; and Sufficient clinical information or documentation that supports the medical necessity of the inpatient admission. Concurrent Review Process. The concurrent review process shall be initiated by the hospital. If the participant remains hospitalized, additional days shall be certified by the Department or its designee before the termination of the previously certified days. The special psychiatric hospital shall forward sufficient clinical information or documentation to the Department or its designee that supports the need for continuing care. Information submitted shall include: Current health status; Treatment received to date; Proposed treatment plan for continued stay; and Discharge planning. Retrospective Reviews. The special psychiatric hospital shall request that the Department or its designee perform a retrospective review of an inpatient admission after the participant is discharged, to determine the medical necessity of the admission. The special psychiatric hospital shall provide the following to the Department or its designee when requesting a retrospective review following discharge from a special psychiatric hospital. Documentation submitted shall include, but is not limited to: The participant’s complete medical record; The principal, secondary, and tertiary diagnoses; and All relevant procedure codes. Reviews for Nonqualified Aliens. The Department or its designee reviews the admission and discharge summary of an emergency inpatient admission for a nonqualified alien to determine whether the inpatient special psychiatric hospital stay meets the emergent condition criteria as defined in COMAR 10.09.24.05-2A. Reimbursement Principles. The Department will make no direct reimbursement to any State-operated hospital. The Department will claim federal fund recoveries from the U.S. Department of Health and Human Services for services to participants in State-operated hospitals. The Department shall compare the current rates with the projected upper payment limit for inpatient days of service on or after July 1, 2012, in freestanding private psychiatric hospitals in Maryland whose rates for commercial providers are set by the HSCRC. If the rates do not exceed the projected upper payment limit calculated by the Department, the Department shall reimburse these hospitals using a rate of 94 percent of the current rates for services set by the HSCRC for each hospital’s commercial providers in the fiscal year the prospective payments are made. If the rates do exceed the projected upper payment limit calculated by the Department, the per diem payments to each such hospital shall be decreased by the same proportion that the projected upper payment limit is exceeded. If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse providers: According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or On the basis of charges if less than reasonable cost. The Department may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item. When HSCRC has included these salaries in the hospital’s costs, charges for these services shall be included in the room and board rate or the appropriate ancillary service only. Payment advances other than those made in accordance with HSCRC regulations may not be made routinely. Inpatient and outpatient services in District of Columbia special psychiatric and outpatient services in in-State special psychiatric hospitals are cost-settled on an annual basis according to §B of this regulation. Effective October 1, 2018, an out-of-State special psychiatric hospital shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency. An out-of-State provider shall submit proof of host state rates on an annual basis. Retrospective Cost Reimbursement. Except as specified in §A of this regulation, a special psychiatric hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed: According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or On the basis of charges, if less than reasonable cost. In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, groups of costs, or costs of specific groups of participants. When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments thus resulting in a reduction of allowable costs. Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found at 42 CFR §413, adjusted for Medicaid allowable costs. Allowable costs specific to the Program shall be limited to a base-year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year. Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year shall be: For an existing provider, the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved; and For a new provider, or all of these, the 12-month period immediately before the provider was initially subjected to target rate increases. Initial Interim Rates. In order to establish an initial interim rate, the provider shall submit to the Department or its designee, before the beginning of the first billing period, at least 90 days before the beginning of billing for services, the following: A detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate; A current, projected, and prior year’s charge rate schedule; Finalized prior year’s Medicare cost reports and the most current submission; A detailed revenue schedule; and Audited financial statements. The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment on a charge basis exceed the allowable cost for these services. Initial Interim Rates for Newly Established Services or Providers. The provider shall submit to the Department or its designee, a detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate that follows Medicare principles and cost finding. The Department will compare the rate with a compatible facility and determine a reasonable rate that does not exceed the projected charges. Revision of Interim Rates. The provider may request an interim rate revision should the actual and projected cost exceed the interim rate by 10 percent. The provider shall furnish the Department or its designee with appropriate schedules showing the reason for the increase and other any other information that supports the rate increase. The Department will lower the provider’s interim rate to approximate the final allowable reasonable cost based on the results of the prior year’s review. The provider may request not more than two interim rate revisions during the accounting year. Cost Settlement. The provider shall submit to the Department or its designee: A Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement; A copy of the provider’s Program log; and A finalized Medicare cost report for the cost reporting year. The final Program cost report shall be sufficiently detailed to support a separate cost finding for Maryland Medical Assistance unique cost centers. The provider shall also submit a copy of its Maryland Medical Assistance log. The submitted cost report shall be in sufficient detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers. Tentative cost settlements may not be performed on a routine basis. However, the Program may, when it determines appropriate, calculate tentative settlements. The provider shall furnish the Department or its designee with a finalized Medicare cost report for the cost reporting year. The Department will base final settlement on the results of the finalized Medicare cost reports. The Program shall reimburse room and board charges for the day of admission, but may not reimburse room and board charges for the day of discharge from the hospital. The provider shall submit request for payment according to procedures established by the Department. Payments on Medicare claims are authorized if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; Medicare determined the services were medically necessary; The services are covered by the Program; and Initial billing is made directly to Medicare according to Medicare guidelines. Payment on Medicare claims is subject to the following provisions: Deductible and co-insurance, according to the limits of §E of this regulation, shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case deductible and co-insurance shall be paid in full; or Services not covered by Medicare, but by the Program, if medically justified according to §E of this regulation. Administrative Days. To be paid for administrative days, the special psychiatric hospital shall document, on forms designated by the Department, information demonstrating that the participant who was initially eligible has been determined to no longer require special psychiatric hospital services and the provider has: Received a determination from the Department or its designee that the participant requires the level of service provided in a lower-acuity facility, but an appropriate facility is not available; Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; Maintained documentation in the participant’s medical record that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; and Notified the local agency responsible for development of the discharge treatment and education plan of the potential placement, if the participant is at risk of a residential treatment center placement on admission; If the participant requires the level of care provided by a residential treatment center and a bed in a residential treatment center is not available, in order to be paid for administrative days, the special psychiatric hospital shall document that it timely notified local coordinating councils and any other local agency, as appropriate, of the necessity to continue inpatient psychiatric service at a residential treatment center before the termination of the need for inpatient psychiatric hospitalization; If the participant is at an inappropriate level of care but cannot be moved, in order to be paid for administrative days, the special psychiatric hospital shall: Provide the attending physician’s declaration that, because of physical or emotional problems, the participant is unable to be moved; Document in the participant’s medical record the attending physician’s reasons why the participant cannot be moved; and Document the attending physician’s reevaluation of the participant’s inability to be moved in the participant’s record at least every 14 days in special psychiatric hospital. Payment for approved administrative days for a special psychiatric hospital seeking placement of a participant to a residential treatment center shall be the average residential treatment center rate issued pursuant to COMAR 10.09.29.13B. The Department may not reimburse a special psychiatric hospital for administrative days if: The special psychiatric hospital bills the Program for days of care for which the hospital is licensed to provide; or The Program or the Program’s designee determines the participant no longer requires the level of care for the days requested. The Department may not make direct payment to the participant. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. Noncompliance with the Program’s requirements as determined by the Department or its designee shall result in nonpayment of the claim. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. If refund of a payment as specified in §A of this regulation, is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and Refund withholdings at cost settlement. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Program shall grant an extension for submission of cost reports: Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or Concurrent with any extension granted to the special psychiatric hospital by Medicare, but not to exceed 60 days from the due date of cost reports. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .09 of this chapter. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under Regulation .07 of this chapter. Within 60 days after the provider receives the notification described in §A of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal. The provider may request review of the settlement under Regulation .07 of this chapter by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee. The Appeal Board shall be composed of the following: A representative of the hospital industry who is: Knowledgeable in Medicare and Medicaid reimbursement principles; and Appointed by the Secretary of the Department; An individual who: Is employed by the State; Is knowledgeable in Medicare and Medicaid reimbursement principles; Did not participate in the verification of costs; and Is appointed by the Secretary of the Department; and A third member selected by the first two members of the Appeal Board. When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member. If the provider elects not to appeal to the Appeal Board, the provider shall: Pay the amount due within 60 days after the notification described in §A of this regulation; or Request a longer payment schedule within 60 days after the provider receives notification of the amount due to the Program. After consultation with the provider, the Department may establish a longer payment schedule if it determines, based on sufficient documentation submitted by the provider, that failure to grant a longer payment schedule would: Result in financial hardship to the provider; or Have an adverse effect on the quality of participant care furnished by the facility. If the provider elects to appeal to the Appeal Board, the following provisions apply: Within 30 days after the filing of an appeal by a provider that the Department or its designee determined owes money to the Program, the Department or its designee shall: Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and Notify the provider of that amount; In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed; Subject to the provisions of §H(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G of this regulation. Appeal Board Findings. After the Department receives the findings of the Appeal Board, the Department shall: Determine the amount that is due either to the Program or to the provider; and Notify the provider of that amount. The portion of the amount in controversy that is paid is subject to an award of interest that is: Calculated from the date the appeal was filed through the date of payment; and Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. Interest paid to a provider under §I(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs. If the provider accepted the determination made under §I(1) of this regulation, within 60 days after the provider receives the notification under §I(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any. Subject to §I(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any. If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G of this regulation. After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§F—I of this regulation, and in addition to the sanctions provided in Regulation .09 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the Appeal Board’s decision as the final agency decision under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland. If the provider or the Department appeals a final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §I(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination. The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding. General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland Effective date: April 10, 2017 (44:7 Md. R. 354) Regulation .05B amended effective September 9, 2019 (46:18 Md. R. 774); May 1, 2023 (50:8 Md. R. 338) Regulation .07A amended effective December 31, 2018 (45:26 Md. R. 1245) This chapter applies to remote patient monitoring services reimbursed by the Maryland Medical Assistance Program effective January 1, 2018. The purpose of providing medically necessary services via remote patient monitoring is to assist participants in managing and controlling their chronic conditions in order to reduce readmissions and emergency department visits and to improve quality of care The target populations are high-risk Maryland Medical Assistance Program participants with a chronic disease capable of monitoring via remote patient monitoring. In this chapter, the following terms have the meanings indicated. Terms Defined. “Certified nurse midwife” means an individual who meets the licensure and conditions of participation for certified nurse midwives set forth in COMAR 10.09.01. “Certified nurse practitioner” means an individual who meets the licensure and conditions of participation for certified nurse practitioners set forth in COMAR 10.09.01. “Department” means the Maryland Department of Health, which is the single State agency designated to administer the “Episode” means the span of treatment during which remote patient monitoring services are rendered to eligible participants. “Home” means the place of residence occupied by the participant, other than a hospital, nursing facility, or other medical or psychiatric institution. “Home health agency" means a public or private agency or organization that meets the licensure requirements and conditions of participation of COMAR 10.09.04. “Maryland Medical Assistance Program” means the program of comprehensive medical, behavioral, and other health-related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. “Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02. “Physician assistant” means an individual who meets the licensure requirements and conditions of participation set forth in COMAR 10.09.55. “Program” means the Maryland Medical Assistance Program. “Provider” means an individual or an organization who: Meets the requirements of Regulations .03 and .04 of this chapter; and Through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of a unique provider number. “Remote patient monitoring” means the use of synchronous or asynchronous digital technologies that collect or monitor medical, patient-reported, and other forms of health care data for Program participants at an originating site and electronically transmit that data to a distant site provider to enable the distant site provider to assess, diagnose, consult, treat, educate, provide care management, suggest self-management, or make recommendations regarding the Program participant’s health care. The provider shall: Meet all license requirements as set forth in COMAR 10.09.36.02; and Be licensed in the state in which the participant resides. A home health agency shall be: Licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland; Part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland; or Legally authorized to provide home health services in the jurisdiction in which the service is provided. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided. A certified nurse practitioner shall: Hold a current license to practice registered nursing in Maryland, and be certified as a nurse practitioner by the Nursing Board; or Meet the nurse practitioner regulatory requirements of the state in which the services are provided. A physician assistant applying for provider status shall: Be licensed to practice as a physician assistant in Maryland or in the state or jurisdiction in which the service is provided; Be in compliance with requirements set forth in COMAR 10.32.03; If practicing in Maryland, have a delegation agreement with a supervising physician that outlines the physician assistant’s duties within the medical practice or facility which has been filed with and approved by the Board of Physicians; and If practicing in Maryland, have a delegation agreement with a supervising physician that documents the specialized training, education, and experience of the physician assistant for performing advanced duties. To provide remote patient monitoring, the provider shall: Be enrolled with an active status as a Maryland Medical Assistance Program provider on the date the service is rendered; Be a: Physician; Physician assistant; Certified nurse practitioner; or Home health agency when remote patient monitoring services are prescribed by a physician; and Meet the requirements for participation in the Medical Assistance Program as set forth in COMAR 10.09.36.03. Medical Record Documentation. A remote patient monitoring provider shall: Maintain documentation using either electronic or paper medical records; Retain remote patient monitoring records according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland; Submit the preauthorization on a form developed by the Department; and Include the participant’s consent to participate in remote patient monitoring. Remote patient monitoring is not a substitute for delivery of care. Provider shall see patients in person periodically for follow-up care. A participant is eligible to receive remote patient monitoring services if: The participant is enrolled in the Maryland Medical Assistance Program on the date the service is rendered; The participant consents to remote patient monitoring services and has the capability to utilize the monitoring tools and take actions to improve self-management of the chronic disease; The participant has the internet connections necessary to host the equipment in the home; The participant is at risk for avoidable hospital utilization due to a poorly controlled chronic disease capable of being monitored via remote patient monitoring; and The provision of remote patient monitoring may reduce the risk of preventable hospital utilization and promote improvement in control of the chronic condition Remote patient monitoring services include: Installation; Education for the participant in the use of the equipment; and Daily monitoring of vital signs and other medical statistics. The remote patient monitoring provider shall establish an intervention process to address abnormal data measurements in an effort to prevent avoidable hospital utilization. Physician, nurse practitioner, and physician assistant providers who establish remote patient monitoring programs shall be responsible for: Establishing criteria for reporting abnormal measurements; Informing the participant of abnormal results; and Monitoring results and improvements in patient’s ability to self-manage chronic conditions. Medical interventions by a physician, nurse practitioner, or physician assistant based on abnormal results shall be reimbursed according to COMAR 10.09.02.07. A home health agency shall: Have an order by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner who has examined the patient and with whom the patient has an established, documented and ongoing relationship; Report abnormal measurements to the participant and to the ordering provider; and Send the ordering provider a weekly summary of monitoring results, including improvement in patient’s ability to self-manage chronic conditions. Remote patient monitoring services are only covered for participants who meet the eligibility criteria specified in Regulation .05 of this chapter. The Program does not cover: Remote patient monitoring equipment; Upgrades to remote patient monitoring equipment; The internet connections necessary to transmit the results of remote patient monitoring services to the provider’s offices; or More than: 2 months of remote patient monitoring services per episode; and Two episodes per year per participant. Home health agencies may only be reimbursed for remote patient monitoring when the service is ordered by a physician. The Department may preauthorize services when the provider submits to the Department adequate documentation demonstrating the: Participant’s condition meets the criteria listed in Regulation .05 of this chapter; and Participant has not already been preauthorized for two episodes during the past rolling calendar year. After providing the services outlined in Regulation .06 of this chapter, the remote patient monitoring provider shall submit the request for payment using the format designated by the Department. Home health agencies shall: Bill on a UB04; and Be paid a monthly rate. Physicians, nurse practitioners, and physician assistants who provide remote patient monitoring shall: Bill using a CMS 1500 or an 837P; and Be paid a monthly rate. Professionals following up on abnormal results from remote patient monitoring shall be paid the lesser of: Provider’s customary charge unless the service is free to individuals not covered by Medicaid; or The Department’s professional fee schedule as found in COMAR 10.09.02.07. Recovery and reimbursement shall be in accordance with COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions shall be in accordance with COMAR 10.09.36.08. Providers filing appeals from administrative decisions made in connection with these regulations shall do so in accordance with COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §15-103(b), Annotated Code of Maryland Effective date: January 1, 2018 (44:26 Md. R. 1215) Regulation .01C amended effective July 24, 2023 (50:14 Md. R. 593) Regulation .02B amended effective July 24, 2023 (50:14 Md. R. 593) Regulation .05 amended effective July 24, 2023 (50:14 Md. R. 593) Regulation .06E amended effective July 24, 2023 (50:14 Md. R. 593)