The 2008 Medicare Physician Fee Schedule also includes revised performance standards for Independent Diagnostic Testing Facilities (IDTFs). The revisions are promulgated via 42 CFR § 410.33. The link below is the text of the regulations with the new provisions "boxed" for easy identification. Following is a description of these new IDTF performance standards beginning January 1, 2008:
1. Supervising Physician. Supervising physicians may supervise no more than three IDTF sites, which restriction applies equally to both fixed sites and mobile units. Please note the comments state that a mobile IDTF may visit multiple locations and it still be considered as one mobile unit. The number of places a mobile IDTF visits does not alter its status as a single unit, and up to three fixed base or mobile units may be under the general supervision of one physician.
A physician supervisor of diagnostic tests is governed by 42 CFR § 410.32 (b). General supervision is defined as requiring overall direction and control, but not in physician presence during the performance of a procedure. Presence in the office suite, as in direct supervision for incident to purposes, is obviously not required if three sites may be supervised simultaneously.
2. Notice of Changes. The regulations establish two classes of changes for reporting purposes. Changes in ownership, location, general supervision, and adverse legal actions must be reported to the Medicare Contractor within thirty (30) days of the change. All other changes must be reported within ninety (90) days.
3. Physical Location. IDTFs must maintain a physical facility on an appropriate site. Post office boxes, commercial mail boxes, hotels and motels are specifically excluded as appropriate physical sites. The physical facility must include space for the equipment appropriate to the services, facilities for hand washing and patient privacy accommodation, and the storage of business and medical records. The comments clarify that the hand washing and patient privacy accommodations do not apply to facilities that do not involve actual patient visits, and that medical and business records storage can be accomplished via electronic access.
4. Comprehensive Liability Insurance. All IDTFs must have a comprehensive liability insurance policy of at least $300,000 per location, which policy must be obtained from a non-relative owned company, and the IDTF must notify CMS of any policy changes or cancellations.
5. Patient Complaints. The IDTF must insure that patient complaints are answered and documented and that the documentation of the complaint is maintained at the IDTF site, or the home office site for mobile units. The contents of the complaint record are listed in the regulations.
6. Shared Facilities. With the exception of hospital based and mobile IDTFs, a fixed based IDTF may not share a practice location with another Medicare enrolled organization, or lease its operations or its locations to another Medicare enrolled provider, or share diagnostic equipment used in the initial diagnostic tests.
a. The comments state the intent of Regulations to prohibit group practices from leasing its facilities on a block-time basis to IDTFs and then referring its patients to that facility, noting an alarming prolifer action of allegedly abusive leasing arrangements. However, the comments also specifically authorize shared common spaces (e.g. hallways, parking lots and common are as) but preclude shared suites on locations, prohibiting the use of the same suite number in a certain office building.
b. The shared office space restrictions do not apply to mobile IDTFs, or prohibit IDTFs from being located within hospitals.
c. The sharing limitations do not apply to the sharing of staff.
d. The space-sharing prohibition incorporates a one-year transition allowance, becoming effective on January 1, 2009.
e. The comments also authorize an IDTF to lease space from a hospital and purchase back-office suites (e.g. transcription, building, collection, recordkeeping and computer access) based upon a flat fee on cost plus contract. This comment does not mention physician practices, but those activities are not prohibited by the revised performance standards.
7. Effective Date. The effective date for an IDTF Medicare billing process is defined as the later of the filing date of the Medicare enrollment application or the date the IDTF first start furnishing services at the new practice location. The filing date is considered to be the filing date of the enrollment application from which the IDTF obtains approval, so that would exclude incomplete or rejected applications. Their retroactivity is, therefore, limited to a situation where the IDTF is both in service and has filed an application, meaning that the retroactivity period is the period limited to the waiting period for approval of the application (assuming the application is approved).