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)