July 10, 2008
By: Julie E. Kass
The Proposed Physician Fee Schedule for 2009 issued in the July 7, 2008 Federal Register (73 Fed. Reg. 38,502) contains a surprising provision that would require all physicians and non-physician practitioners who furnish diagnostic testing services (except diagnostic mammography services) to enroll as independent diagnostic testing facilities (IDTFs) and meet almost all of the IDTF standards. [See http://edocket.access.gpo.gov/2008/pdf/E8-14949.pdf.] This would apply even if physicians are providing the services only to their own patients and not to the general public. Notably, these standards would increase requirements for physicians providing diagnostic imaging in their offices and limit their ability to share or block lease diagnostic equipment with other physicians and health care entities.
CMS makes clear that it received comments to the 2008 fee schedule IDTF proposed rules that raised concerns regarding the ability of physicians or physician groups who provide testing in their offices to circumvent the IDTF standards by enrolling and billing through their group practices, even when they are treating the general public. Although CMS proposed these new rules under the guise of improving quality, CMS cites to no data or anecdotal evidence that the quality of testing in physician offices is substandard. CMS does comment that physicians who provide diagnostic testing in their offices are not currently required to provide qualified non-physician personnel to conduct the testing. Accordingly, CMS proposes that physicians and non-physician practitioners who furnish diagnostic testing services, except diagnostic mammography services, enroll as IDTFs.
In enrolling as an IDTF physician practices would need to meet all of the current IDTF enrollment standards, such as physician supervision by a physician able to perform and interpret the tests performed and performance of tests by technicians who meet specified qualifications. Physician IDTFs would not be required to meet the IDTF supplier standards that would otherwise necessitate additional comprehensive liability coverage, a formal clinical complaint process, posting IDTF standards, posting visible signs of business hours and separately enrolling each practice location. One outcome of this rule is that physicians would no longer be able to block lease or share diagnostic equipment with other physicians or health care entities. CMS is specifically soliciting comments on:
- whether to create additional exceptions to the IDTF enrollment standards for physicians,
- whether physicians should be able to provide testing without the benefit of qualified nonphysician personnel,
- whether to limit this enrollment requirement to only certain diagnostic tests that are more costly and utilize more expensive equipment, and
- whether the policy should apply to tests beyond imaging, such as electrocardiograms and other diagnostic tests frequently furnished by primary care physicians.
Based on CMS' recognition that these changes would take time to implement, it has proposed an effective date of September 30, 2009. For newly enrolling suppliers, the effective date of this rule would be January 1, 2009.
While CMS did not make any changes to the in-office ancillary services exception under the Stark portion of the fee schedule, the proposed IDTF enrollment standards for physician and non-physician practitioners would have a similar chilling effect on providing certain shared or block leased expensive diagnostic testing equipment , such as MRIs and CT scanners in physician offices.