April 2007 | Vol. 25, No. 4

Medicare IDTF Regulations Update

Since December of last year there have been several changes to the Medicare guidelines for operation of Independent Diagnostic Testing Facilities (IDTF). These changes have created some confusion in our membership, which I will try to address here.

An IDTF was defined by Medicare in 1999 as a facility providing diagnostic medical services operationally and financially independent of a hospital or physician office. These facilities have been required by federal regulation to comply with a number of requirements to enroll in and be allowed to bill Medicare under the Physician Fee Schedule.

Revised IDTF regulations were published December 1, 2006 in the Federal Register “final rule” under Title 42 (Public Health) Section 410.33.  This was the product of a system-wide review from 2003-04 by the Office of Inspector General, in response to increased utilization rates at IDTFs. Fourteen specific standards of IDTF compliance are enumerated in this new rule.

On January 26 of this year, CMS published IDTF-related changes to its “Program Integrity Manual” (Pub. 100-08) which is essentially an interpretation by CMS of how the federal regulations will be enforced. This was published in the form of a “change request” entitled Implementation of New Compliance Standards for Independent Diagnostic Testing Facilities (IDTFs), and was to be effective on February 26, 2007. The interpretations listed in this PIM update were found by many in the industry to be even more strict that those in the Final Rule changes.

After a great deal of input from industry representatives, CMS released another bulletin about a week prior to the posted effective date of February 26th. This bulletin stated simply:

NOTE: The CR 5449, dated January 26, 2007 is rescinded and will not be replaced at this time. Please discard all materials related to CR 5449. We apologize for any inconvenience this may have caused.
This notice rescinded the changes only in the CMS Program Integrity Manual, but it remains important to understand the CMS Final Rule standards from December (42 CFR 410.33(g)) are unchanged and still in effect. Anyone owning or operating an IDTF is strongly encouraged to read this document to ensure the new compliance standards are being met. A summary of the regulations from CMS may be downloaded here:
http://www.cms.hhs.gov/MedicareProviderSupEnroll/
downloads/Independentdiagnostictestingfacility.pdf

David Parlato
Chair, SVU Advocacy Committee