MASSACHUSETTS - MEDICAL STANDARDS GOVERNING SCREENING AND DIAGNOSTIC MEDICAL TESTING OFFICES

January 1, 2008

Massachusetts state laws and regulations that affect your medical practice

1. What is an Independent Diagnostic Testing Facility (IDTF)?

A Medicare-certified diagnostic imaging center, freestanding MRI center, portable X-ray provider, sleep center, or mammography van, in a fixed location or mobile entity, that is physically and financially independent of a hospital or physician's office, and performs diagnostic tests. These tests must be performed by a physician or by licensed, certified non-physician personnel under appropriate physician supervision and comply with applicable laws.

130 MA ADC 431.402

(a) The following diagnostic testing facilities are eligible to participate in MassHealth as IDTF providers:

(1) Diagnostic imaging centers: centers that perform a variety of tests, including ultrasounds, positron emission tomography (PET) scans and other imaging studies;

(2) Freestanding MRI centers: independent MRI Centers that perform MRI or magnetic resonance angiography (MRA) services in accordance with standards developed by the American College of Radiology (ACR);

(3) Portable X rays: all suppliers of portable x-ray services who are in compliance with and are certified under the Medicare program;

(4) Sleep centers: clinics that perform diagnostic tests to determine the existence and type of sleep disorders; and

(5) Mammography vans: mobile facilities that provide radiological tests for breast cancer.

(b) To be eligible to participate as a MassHealth provider, an IDTF must:

(1) Be located and doing business in the Commonwealth of Massachusetts;

(2) Operate under a clinic license issued by the Massachusetts Department of Public Health;

(3) When required, obtain a determination of need, issued by the Massachusetts Department of Public Health;

(4) Participate in the Medicare program as an independent diagnostic testing facility; and

(5) Have all radiology equipment used to provide services inspected and certified by the Massachusetts Department of Public Health.

130 MA ADC 431.404

3. What are the requirements for sleep centers enrolled as IDTFs?

Sleep centers enrolled as IDTFs may bill for at-home pulse oximetry services. The MassHealth agency will pay only for pulse oximetry tests and polysomnography used to determine sleep disorders. For sleep testing to be performed in an IDTF, the supervising physician must be certified by boards in psychiatry and neurology, internal medicine with pulmonary specialty, or in sleep medicine. IDTF technologists must be certified in electroneurodiagnostic testing or registered in polysomnography.

130 MA ADC 431.412

4. What are the record-keeping requirements for IDTFs?

(a) The IDTF is responsible for assuring the medical necessity of the tests and maintaining test results in the member's health record.

(b) IDTFs must maintain a medical-record system promoting quality and confidential member care in accordance with Massachusetts Department of Public Health regulations. The system must collect and retain data in a comprehensive and efficient manner and permit the prompt retrieval of information. Accurate and complete medical records must be maintained for each member receiving testing services from the IDTF. The data maintained in the member's medical record must also be sufficient to justify any further diagnostic procedures. The medical record must be clear and legible, and readily accessible to health-care practitioners and the MassHealth agency. The medical record must be maintained by the IDTF for at least six years.

( c ) The medical record must contain, at a minimum, the following information:

(1) The member's name, address, telephone number, date of birth, and MassHealth identification number;

(2) The date of service;

(3) The name, title and signature of the referring clinician;

(4) A written order for the tests to be performed;

(5) The name, title, and signature of the person performing the service;

(6) The name of the supervising physician;

(7) The pertinent findings on examination; and

(8) Tests performed and results.

130 MA ADC 431.415

5. What is the definition of "medically necessary" services?

The MassHealth agency will not pay a provider for services that are not medically necessary and may impose sanctions on a provider for providing or prescribing a service or for admitting a member to an inpatient facility where such service or admission is not medically necessary.

(a) A service is "medically necessary" if:

(1) It is reasonably calculated to prevent, diagnose, prevent the worsening of, alleviate, correct, or cure conditions in the member that endanger life, cause suffering or pain, cause physical deformity or malfunction, threaten to cause or to aggravate a handicap, or result in illness or infirmity; and

(2) There is no other medical service or site of service, comparable in effect, available, and suitable for the member requesting the service, that is more conservative or less costly to the MassHealth agency. Services that are less costly to the MassHealth agency include, but are not limited to, health care reasonably known by the provider, or identified by the MassHealth agency pursuant to a prior authorization request, to be available to the member.

(b) Medically necessary services must be of a quality that meets professionally recognized standards of health care, and must be substantiated by records including evidence of such medical necessity and quality. A provider must make those records, including medical records, available to the MassHealth agency upon request.

( c ) A provider's opinion or clinical determination that a service is not medically necessary does not constitute an action by the MassHealth agency.

130 MA ADC 450.204

6. What diagnostic tests are not covered by MassHealth?

The MassHealth agency does not pay for the following services:

(a) Diagnostic tests associated with male or female infertility;

(b) Tests performed for experimental or investigational purposes, or that are themselves experimental or investigational; and

( c ) Tests performed for forensic purposes including but not limited to tests performed to establish paternity and post-mortem examinations.

130 MA ADC 431.414

7. What are the general requirements for radiologists?

Each clinic which provides diagnostic radiology shall retain, at least on a consulting basis, a board certified or board qualified radiologist to meet the needs of the clinic. The radiologist shall be responsible for the proper performance of the radiological services.

105 MA ADC 140.361

8. What are the requirements for radiologic technologists?

Diagnostic radiology procedures which are not performed or directly supervised at all times by a board certified or board qualified radiologist shall be performed only by licensed radiologic technologists.

105 MA ADC 140.362

9. What are the requirements for diagnostic radiology facilities?

Each clinic providing diagnostic radiology services shall provide the following, in adequate and suitable form for the services provided:

(1) X-ray equipment appropriate to the diagnostic services offered by the clinic;

(2) At least one radiographic room of adequate size for the equipment provided;

(3) Space for preparation of barium mixtures, if applicable; and

(4) Adequate storage space for files of x-ray films.

105 MA ADC 140.363

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.