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)