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REGS : 10.09.87 Free-Standing Independent Diagnostic Testing Facilities (MEDICAL CARE PROGRAMS)


 Content Editor

Maryland Register
Issue Date:  February 7, 2014
Volume 41 • Issue 3 • Page 216—218
Title 10
10.09.87 Free-Standing Independent Diagnostic Testing Facilities
Authority: Health-General Article, § 2-104(b), 15-103, and 15-105, Annotated Code of Maryland
Notice of Proposed Action
The Secretary of Health and Mental Hygiene proposes to adopt new Regulations .01—.10 under a new chapter, COMAR 10.09.87 Free-standing Independent Diagnostic Testing Facilities.
Statement of Purpose
The purpose of this action is to implement policies and procedures for free-standing independent diagnostic testing facilities.
Comparison to Federal Standards
There is a corresponding federal standard to this proposed action, but the proposed action is not more restrictive or stringent.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele A. Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 W. Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499; TTY:800-735-2258, or email to, or fax to 410-767-6483. Comments will be accepted through March 10, 2014. A public hearing has not been scheduled.
.01 Definitions.
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) “CMS” means Centers for Medicare and Medicaid Services.
(2) “Department” means The Department of Health and Mental Hygiene.
(3) “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.
 (4) “Major medical equipment” means:
(a) All cardiac catheterization equipment necessary to perform heart catheterization;
(b) A computerized tomography (CT) scanner;
(c) A lithotriptor;
(d) Radiation therapy equipment, including a linear accelerator; and
(e) A Magnetic Resonance Imager (MRI).
(5)”Mammography” means the radiographic examination of the soft tissues of the breast.
(6) “Medically necessary” means medically necessary as defined in COMAR
(7) “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.
(8) “NPI” means National Provider Identifier.
(9) “Program” means the Maryland Medical Assistance Program.
.02 License Requirements.
A. The provider shall meet all license requirements as set forth in COMAR
B. 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.
C. A facility that performs mammography services shall be certified by the Food and Drug Administration (FDA).
D. A facility operating major medical equipment shall meet all the general licensing requirements for a facility as provided in COMAR
E. The driver of the Mobile IDTF unit:
(1) Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; and
(2) May not have:
(a) Violations related to the operation of a motor vehicle in the last 3 years; and
(b) Any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years.
.03 Conditions for Participation.
A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR
B. Requirements for participation in the Program as an IDTF provider/mobile IDTF provider require that the provider:
(1) Be approved by Medicare to furnish diagnostic services in an IDTF;
(2) Meets the licensure requirements in accordance with Regulation .02 of this chapter; and
(3) Meets performance standards in accordance with 42 CFR §410.33(g).
C. Specific Requirements for Participation in the Program as a Mobile IDTF Provider.
(1) The mobile IDTF shall have electronic technology that enables the same day exchange of patient records with the treating physician’s office.
(2) An IDTF mobile unit shall:
(a) Maintain physician’s order & diagnostic test records for each patient;
(b) Observe all patient rights;
(c) Obtain written, informed consent from a parent or legal guardian before providing services to a minor;
(d) Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating:
(i) Equipment;
(ii) Flammability;
(iii) Construction;
(iv) Infection control;
(v) Sanitation procedures; and
(vi) Zoning;
(e) Comply with the statutes and regulations of the Maryland Department of the Environment for all radiographic and imaging equipment;
(f) Obtain all applicable county and city licenses or permits necessary to operate the mobile IDTF;
(g) Provide access to a ramp or a lift if services are provided to disabled individuals;
(h) Have ready access to an adequate supply of potable water, including hot water;
(i) Have immediate access to toilet facilities;
(j) Have an appropriately covered noncorrosive metal container for refuse and waste materials;
(k) Have a carbon monoxide detection device or system installed and in proper working condition;
(l) Have written procedures for medical emergencies; and
(m) Have appropriate equipment to treat medical emergencies.
(3) The owner or owners of a mobile unit shall submit a business plan to the Department for the mobile unit that includes:
(a) The mission of the mobile unit;
(b) Verification of ownership of the mobile unit;
(c) A list of the technical staff that will render services in the mobile unit; and
(d) The targeted population.
.04 Covered Services.
A. The Program covers medically necessary radiology services rendered to a recipient in an IDTF when the services are:
(1) Rendered in a CMS certified IDTF or an IDTF Mobile Unit;
(2) Provided according to the laws and regulations of the state and locality in which they are rendered;
(3) Rendered by a physician or supervised technician;
(4) Ordered in writing by the treating physician or non-physician practitioner in accordance with state law; and
(5) Adequately documented in the recipient’s medical record.
B. Radiology services include the following:
(1) Diagnostic X-rays;
(2) Computerized Tomography (CT) procedures;
(3) Magnetic Resonance Imaging (MRI);
(4) Magnetic Resonance Angiography (MRA);
(5) Nuclear medicine imaging and radionuclide used in the procedures;
(6) Diagnostic mammography and certain mammography screening;
(7) Ultrasound (US procedures);
(8) Position Emission Tomography (PET);
(9) Radiation oncology; and
(10) Bone mass measurements.
C. 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:
(1) The American College of Radiology;
(2) The Intersocietal Accreditation Commission; or
(3) The Joint Commission on Accreditation of Health Organizations (JCAHO).
.05 Limitations.
The Program does not cover the following:
A. Services for which the IDTF provider cannot supply a properly completed order identifying by name, the authorized ordering practitioner;
B. Services not adequately documented in the recipient’s medical record;
C. Services not medically necessary;
D. Procedures that are the provider as investigational or experimental in nature;
E. Services which are specifically included as an integral part of another service;
F. Consultations;
G. Office Visits;
H. Injections;
I. Surgeries; and
J. Therapeutic services.
.06 Preauthorization Requirements. Reserved.
.07 Payment Procedures.
A. General policies for payment that are applicable to all providers are set forth in COMAR
B. IDTF providers shall identify the ordering who authorized the diagnostic services by either:
(1) Recording the National Provider Identifier (NPI) number for the individual provider on the claim; or
(2) 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.
C. The Department shall reimburse the IDTF providers for covered services at the lower of:
(1) The provider’s usual and customary charge; or
(2)The Department’s fee schedule.
D. The Department’s fee-schedule is contained in the Maryland Medical Assistance Program Physicians’ Services Provider Fee Manual which is incorporated by reference in COMAR
E. Payments on Medicare cross-over claims are authorized if:
(1) The provider accepts Medicare assignment;
(2) Medicare makes direct payment to the provider;
(3) Medicare has determined that the services are medically necessary;
(4) Initial billing is made directly to Medicare according to Medicare guidelines.
F. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions:
(1) Coinsurance shall be paid at the lesser of:
(a) 100 percent of the coinsurance amount; or
(b) The balance remaining after the Medicare payment is subtracted from the Medicaid rate.
G. The Program may not make a direct payment to a recipient.
H. Billing time limitations are those set forth in COMAR
I. The provider may not bill the Program or recipient for:
(1) Completion of forms and reports;
(2) Broken or missed appointments;
(3) Services which are provided at no charge to the general public;
(4) Services rendered by mail or telephone; and
(5) Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient.
.08 Recovery and Reimbursement.
General policies governing recovery and reimbursement procedures that are applicable to all providers are set forth in COMAR
.09 Cause for Suspension or Removal and Imposition of Sanctions.
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 Appeal Procedures.
General policies governing appeal procedures that are applicable to all providers are set forth in COMAR
Secretary of Health and Mental Hygiene