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)