Physician labs come of age, with some caveats
Physician labs come of age, with some caveats
Changes go into effect in July
If your practice owns a laboratory housed in a separate facility, expect some changes in the way you do business with the Health Care Financing Administration (HCFA). The first is a welcome change that will open up more business opportunities, while the second physician supervisory requirements may take a bit more juggling.
Tucked inside the final rule issued late last October to implement its new relative value-based practice expense formula, HCFA attached a new regulation intended to eliminate independent physiological laboratories in favor of a new regulatory classification dubbed independent diagnostic testing facilities (IDTFs).
The bottom line: Independent physician laboratories must convert to IDTF status by July 1 to be reimbursed by HCFA. You do not have to wait until July to switch. In fact, HCFA prefers you do it now by by writing your Part B Medicare carrier. Once a lab elects IDTF status, it is no longer subject to local medical review policies that currently preclude independent physician labs from performing procedures that hospitals or other entities are able to perform.
"Given the restrictive nature of many existing carrier policies, this component of the final rule is likely to be welcomed by many independent physician labs," notes Bill Sarraille, a health care lawyer with the Washington, DC, legal firm of Arent Fox Kinter Plotkin & Kahn.
Supervisory requirements a must
But before you start celebrating, be prepared. The new rule also subjects these new IDTFs to a wide variety of restrictions not required of physician offices and hospitals, says Sarraille. Specifically, IDTFs must have one or more supervisory physicians. The supervisory physicians are required to demonstrate "proficiency in the performance and interpretation of each type of diagnostic procedure performed by the IDTF," according to HCFA.
"Although this language might be interpreted to require supervising physicians to be board-certified in the appropriate specialty and certified as a technologist, the preamble to the final rule appears to suggest that board certification in a given specialty or subspecialties will be sufficient," argues Sarraille. Another possibility is that independent physician labs will simply need to meet criteria established by the commercial carriers the lab does business with.
Under the original regulatory proposal, the supervisory physician would not have been permitted to order any tests from the IDTF. Based on comments submitted by Arent Fox and others, however, HCFA changed this proposal in its final rule. As a result, the revised rule permits a supervising physician to order tests from the IDTF where the supervising physician is also the beneficiary’s attending physician.
Under the final rule, the laboratory’s technologists are required to be licensed or certified by the state in which they practice. If the state does not provide those services, the technologists must be certified by the appropriate national credentialing body.
The final rule also requires that all orders placed with the IDTF must be in writing. This rule does not affect orders in a hospital or a physician office setting. "HCFA rejected comments that suggested that this requirement would be difficult to implement," notes Sarraille.
For the most part, diagnostic tests performed in a physician’s office or an IDTF must be performed with some level of physician supervision. Diagnostic tests performed in a hospital are not subject to the physician supervision requirement.
Four specific diagnostic tests are excluded from the physician supervision rule:
• diagnostic mammography procedures;
• diagnostic tests personally performed by a "qualified audiologist";
• diagnostic psychological testing personally performed by a "qualified psychologist" under Section 2070.2 of the Medicare Carriers Manual;
• electrophysical procedures performed by a physical therapist qualified as an electrophysiologic specialist.
When it comes to other diagnostic tests, it’s helpful to think of the physician supervision requirements for physician-owned labs in terms of levels. There are three types of requirements, depending on the type of tests ordered: general supervision, direct supervision, and personal supervision.
• Level one: General supervision. Some diagnostic tests require only "general supervision," which means the test is performed subject to a physician’s overall direction or control, vs. an actual physical presence during the test.
Tests subject to the "general supervision" requirement include:
plain films (X-rays) involving the extremities, pelvis, vertebral column, or skull;
plain films of the chest or abdomen that do not involve the use of contrast media;
electrocardiograms (except when the code description specifies physician supervision, such as with a cardiovascular stress test);
electroencephalograms, polysomnography, and sleep studies.
"Although not assigned to the general supervision level in the original regulatory proposal, HCFA’s final rule permits CTs and MRIs not involving any contrast media to be performed subject only to general physician supervision," according to Sarraille.
• Level two: Direct supervision. Other tests, however, must be performed under "direct" supervision, meaning that a physician must be "present in the office suite" during the procedure.
Direct supervision is required for MRIs (with contrast), computerized axial tomography (with contrast), other procedures involving contrast materials, nuclear medicine procedures, and all X- rays not listed in the examples given of "general supervision" procedures.
• Level three: Personal supervision. This level of supervision, which means the physician must be present in the room with the patient at the time of testing, is required for cardiovascular stress tests, cardiac catherization, and radiological supervision and interpretation procedures. The preamble specifically lists pulmonary stress testing under CPT 94620 as a procedure requiring personal supervision.
When the original proposal was made, there was some concern that the term "cardiovascular stress testing" would be interpreted broadly to require personal supervision even where the stress involved was minimal, including, for instance, where simple provocative maneuvers are used.
Although it appears that the final rule does not require personal supervision in such cases, the regulation does impose the direct supervision requirement for these services, Sarraille points out.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.