CMS Withdraws Heightened Restrictions For Independent Diagnostic Testing Facilities

By way of follow-up to our February 13, 2007 Client Alert, on February 21, 2007, the Centers for Medicare and Medicaid Services ("CMS") abruptly withdrew Transmittal 187, CR 5449, "Implementation of New Compliance Standards for Independent Diagnostic Testing Facilities" ("IDTFs"), just a week before its scheduled implementation date of February 26, 2007.
United States Food, Drugs, Healthcare, Life Sciences
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By way of follow-up to our February 13, 2007 Client Alert, on February 21, 2007, the Centers for Medicare and Medicaid Services ("CMS") abruptly withdrew Transmittal 187, CR 5449, "Implementation of New Compliance Standards for Independent Diagnostic Testing Facilities" ("IDTFs"), just a week before its scheduled implementation date of February 26, 2007. Transmittal 187 included a number of policy changes that were not included in the 2007 Medicare Physician Fee Schedule final rule. Most notably, these additional compliance standards included an expansion on the physical facility requirement, providing that IDTFs "may not share space with another active Medicare supplier" and they "may not share equipment with any other IDTF or supplier." This and the other proposed changes contained in Transmittal 187 could have had a significant impact on the operation and control of diagnostic imaging centers and other types of IDTFs. As of the publication of this alert, CMS has not indicated when it will issue new guidance to carriers and contractors on the implementation of any new IDTF standards. However, in a recent teleconference, a representative from the Program Integrity Division of CMS indicated that the policy changes likely will be reissued in a new form in the near future. Health care attorneys have speculated that Transmittal 187 was withdrawn due to questions regarding CMS’ legal authority to issue the proposed changes without a public notice and comment period, and that we likely will see similar changes proposed pursuant to corrected administrative process. We will make every effort to communicate any further guidance or clarification released by CMS to our clients as soon as it is made available.

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