What are the new Medicare rules governing independent diagnostic testing facilities?
Effective Jan. 1, 2007, as part of the 2007 Physician Fee Schedule, independent diagnostic testing facilities (IDTFs) are subject to heightened standards under 42 C.F.R. § 410.33(g). For example, each supervising physician is limited to supervising a maximum of three IDTFs and is responsible for their overall operation and administration. An IDTF operating across state boundaries must maintain documentation that its physicians and technicians are licensed/ certified in each of the states in which it operates. An IDTF must meet certain standards, including having a physical facility on an appropriate site; having a comprehensive liability insurance policy of at least $300,000 per location; agreeing not to directly solicit patients; and posting the standards for review by patients and the public.
However, the new Medicare compliance standards set forth in Change Request 5449, scheduled to go into effect on Feb. 26, 2007, have been rescinded. The following is an overview of those standards, which may or may not reappear in the future. Importantly, the IDTF's date of application would have determined its effective billing date. For those applications received on or after the scheduled effective date, the billing date would have been the date the application was approved by the contractor, which could have been months later.
There were 14 standards that an IDTF had to certify that it met on its enrollment application. The standards were in addition to, not in lieu of, other federal and state statutory and regulatory requirements. The key standards included the following:
First, an IDTF could not share space with another active Medicare supplier (physician-owners were exempt from this requirement), nor could the IDTF share equipment with any other IDTF or supplier.
Second, an IDTF could not directly solicit patients. The IDTF could only accept patients referred by a physician or nonphysician practitioner who ordered testing.
Third, the IDTF was required to permit the Centers for Medicare and Medicaid Services (CMS) to conduct unannounced, on-site inspections to confirm compliance with the standards.
Interpreting Physicians and Supervising Physicians
The IDTF applicant was required to list all physicians for whose diagnostic test interpretations the IDTF would bill. The IDTF had to have one or more supervising physicians responsible for direct and ongoing oversight of the quality of testing performed, the proper operation and calibration of equipment used in the testing, and the qualifications of nonphysician IDTF personnel. Each supervising physician would have had to complete and sign an attestation statement.
All technicians were required to meet the standards of state licensure or certification at the time the IDTF enrolled. If a specific license or certification was required for nonphysician personnel, the IDTF could not contract with an individual or other entity to provide the licensed services.
Desk and Site Reviews
All new IDTF applicants had to receive a desk review and a site review prior to enrollment and issuance of a billing number.
There were three broad implications to the new rules. First, the rules could have restricted the ability of an IDTF to enter into part-time leasing arrangements with physician groups or others, as the IDTF could not share space with another active Medicare supplier (unless it was with a physician-owner), and could not share equipment with another IDTF or supplier. Second, the rules could have limited the type of permissible relationships between an IDTF and technicians, since the IDTF had to ensure that technicians were licensed or certified at the time the IDTF enrolled, and could not contract with an individual or entity for those services for which a specific license was required. Third, the rules would have restricted the ability of a new provider to perform tests and submit bills for them to Medicare until the IDTF was fully enrolled, which could have taken months.
For specific questions regarding this topic, please seek legal counsel.
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