CMS has announced updates to the process for making Medicare national coverage determinations (NCDs) to provide clarity and transparency with regard to modifications made to the coverage process since the Medicare Modernization Act. Among other things, the notice addresses: the procedures for requesting an NCD or reconsideration of an existing NCD; public participation in the NCD process; informal contacts prior to requesting an NCD; what constitutes a complete, formal request for an NCD or formal request for reconsideration of an existing NCD; external requests for NCDs; CMS internally-generated review of NCDs; and time frames. CMS had previously addressed these topics in a 2003 Federal Register notice and in subsequent subregulatory guidance documents.

Most notably, the notice outlines a new, expedited administrative process to remove certain NCDs that CMS determines to be no longer needed, thereby enabling local Medicare contractors to determine Medicare coverage. In explaining the impetus for its proposal, CMS notes that “[w]e are aware that clinical science and technology evolve and that items and services that were once considered state-of the-art or cutting edge may be replaced by more beneficial technologies or clinical paradigms.” CMS therefore intends to periodically review the inventory of NCDs that have not been reviewed for more than 10 years to evaluate whether there is a continued need for national policies. CMS believes that local contractor discretion is more appropriate in these cases because “the future utilization for items and services within these policies will be limited.” Under the new, streamlined process, rather than use the formal NCD reconsideration process (which generally takes 9 to 12 months), CMS will periodically publish on its website a list of NCDs proposed for removal along with the agency’s rationale. CMS will solicit public comment for 30 calendar days, and then either: (1) follow the proposal to remove the NCD; (2) retain the policy as an NCD; or (3) formally reconsider the NCD and post a tracking sheet to that effect on the CMS coverage website. The final list will be effective upon posting it to the website.

CMS states that the notice does not alter or amend its regulations that establish rules related to the administrative review of NCDs. CMS also states that it continues to “pursue our efforts to work with various sectors of the scientific and medical community to develop and publish on our website documents that describe our approach when analyzing scientific and clinical evidence to develop an NCD.”

The notice is effective on August 7, 2013.