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)