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)