By Daniel B. Vukmer, Esq.
Effective January 1, 1998, all diagnostic tests, with few exceptions, require some level of physician supervision. Supervisory requirements formerly applied to “diagnostic x-ray tests” and were not clearly defined. Under the new regulations, diagnostic tests payable under the physician fee schedule, including diagnostic x-ray, nuclear medicine procedures, MRI, CAT, ultrasound and cardiovascular procedures will require physician supervision. Exempted from the regulations are mammography procedures and certain tests performed by audiologists, psychologists and physical therapists. It is important to note that these requirements should not affect hospital-based physicians furnishing diagnostic tests to hospital inpatients or outpatients. The regulations define three levels of supervision: General, Direct and Personal.
“General Supervision” is defined to mean that the procedure is furnished under a physician’s “overall direction and control.” Although a physician is ultimately responsible for the nonphysician personnel and the equipment, he/she need not be present at the facility during the test. This level of supervision is required for:
• Plain films of the extremities, pelvis, vertebral column or skull.
• Plain films of the chest and abdomen that do not involve the use of contrast media.
• Electrocardiograms except when the code description requires otherwise.
• Electroencephalograms, polysomnography and sleep studies.
• MRI and CAT when not introducing contrast media.
The next level of supervision is “Direct Supervision” and is defined to mean that a physician must be present in the office suite and immediately available to furnish assistance. This does not require the physician to be present in the room during the procedure. This level applies to such procedures as:
• Any procedures where contrast materials are used.
• Nuclear medicine procedures.
• X-rays other than as listed under General Supervision procedures.
• Ultrasound procedures.
It is interesting to note that ultrasound procedures were not originally slated for the Direct Supervision requirement because there was no real issue of patient safety; thus, ultrasound procedures would have been performed under the “General Supervision” category as originally proposed by HHS. However, HHS later reasoned that ultrasound procedures are more “effective” when performed under Direct Supervision. The Medicare program considers the “effectiveness” of a treatment in determining whether it is “reasonable and necessary” under the Medicare program and, therefore, according to HHS, an increase in the supervision requirement would be required to make the procedure “reasonable and necessary.” Although the procedure-by-procedure application of this logic is somewhat specious, it is consistent with previous HCFA public statements that these rules “represent its judgment that diagnostic procedures are safe and effective only when they are furnished with appropriate physician supervision.”
Finally, the “Personal Supervision” level means that a physician must be in attendance in the room during the performance of the procedure. This level applies to:
• Cardiovascular stress tests.
• Cardiac catheterization.
• Radiological supervision and interpretation procedures.
Some physicians argued to HHS that this level of supervision for cardiovascular stress tests may be somewhat inconsistent with a 1990 joint task force statement set forth by the American College of Physicians, American College of Cardiology and the American Heart Association. The task force took the position that exercise testing for selected patients can be performed by nonphysicians so long as a supervising physician is in the immediate vicinity. The Personal Supervision requirement was justified by HHS on several grounds, including the fact that the age of Medicare patients is a factor in determining safety precautions and that medical expertise may be necessary for interpretations during the performance of a test.
Exceptions to Supervision Regulations
There are several exceptions to which these regulations will not apply. First, diagnostic tests furnished to hospital inpatients or outpatients will not be subject to these regulations where the outpatient tests are performed by or under the supervision of the hospital or where the inpatient tests are performed under arrangement with the hospital and billed by the hospital. Second, diagnostic tests personally performed by a physician or services billed as “incident to” physician services would not be subject to the requirements. Finally, the regulations will not apply to diagnostic tests performed by hospitals, the office of a patient’s attending or consulting physician, rural health clinics or federally qualified health centers.
Independent Diagnostic Testing Facilities
Providers currently billing Medicare as a free-standing MRI, mobile x-ray or other Independent Physiological Lab (IPL), should be prepared for another layer of supervisory requirements. Effective July 1, 1998, IPLs will become Independent Diagnostic Testing Facilities (IDTFs) which not only subjects the tests to the supervisory requirements but also mandates certain qualifications for supervising physicians.
For all levels of physician supervision, the physician must “evidence proficiency in the performance and interpretation of each type of diagnostic procedure performed by the IDTF.” The proficiency may be documented by certification in specific medical specialties or subspecialties or by criteria established by the carrier for the service area in which the IDTF is located. Nonphysician personnel such as lab technicians must demonstrate basic qualifications and be licensed or certified by the state or a national credentialing body. If the IDTF operates across state boundaries, then it must maintain documentation that its personnel are licensed and certified in each of the states.
The impact of these regulations on mobile diagnostic units is unclear. Certainly, the units will be required to identify a physician who will have overall responsibility for the workings of the unit and the training and certification of staff. In addition, should the IDTF perform procedures requiring Direct or Personal supervision, then mobile IDTFs will need to enlist the services of a “traveling physician.” HHS has specifically rejected the idea of having an “on-line” tele-radiologist who could direct a response team at the IDTF site, and commented that “a physician cannot appropriately provide direct or personal supervision of diagnostic tests through telemedicine.”
Identifying IDTFs subject to these regulations will require some interpretation of the regulations. IDTFs are defined as a “fixed location, a mobile entity, or an individual nonphysician practitioner.” An IDTF is independent of a physician’s office or hospital; however, these rules apply when an IDTF furnishes diagnostic procedures in a physician’s office. According to HHS comments on the new regulations, an IDTF “is distinct from a physician’s office or hospital and does not directly use the test results to treat a patient. The IDTF’s sole purpose is to furnish a test.” Neither the new regulations nor the previous IPL regulations specifically define the term “independent” for purposes of identifying whether a facility qualifies as an IDTF; however, the current regulations for Independent Clinical Laboratories, by way of analogy, look to the “independence” of the facility and should be useful in determining whether an entity qualifies as an IDTF.
Clinical laboratory regulations allow for payment of diagnostic laboratory services if the laboratory is an approved “Independent Clinical Laboratory.” For purposes of those regulations, independent laboratories include facilities providing services to hospital patients that are operated by or under the supervision of a hospital if the hospital does not meet at least the definition of an emergency hospital. If the hospital is an emergency hospital, then the facility will not be “independent.” An out-of-hospital laboratory is ordinarily presumed to be independent unless there is written evidence establishing that it is operated by or under the supervision of a hospital which meets at least the definition of an emergency hospital, or of the organized medical staff of such a hospital.
The physician supervision regulations will place additional duties on diagnostic laboratories and the physicians responsible for the tests. As applied to Independent Diagnostic Testing Facilities, these regulations will require the presence of a physician during certain tests, even in mobile facilities. In addition, the IDTF supervising physicians must meet the educational qualifications set forth above, thus requiring not only physician presence, but the presence of physicians who are specialized in the interpretation of such test results.
Daniel B. Vukmer, Esq., is with the law firm of Houston Harbaugh, P.C. in Pittsburgh.