On August 7, 2013, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register1 a notice that updated the processes that CMS uses for opening, deciding or reconsidering National Coverage Determinations (NCDs) for items and services under the Medicare program. The notice supersedes the 2003 Federal Register notice2 that had been utilized for almost ten years in which CMS announced the procedures for considering NCD requests and issuing NCDs. The 2013 notice does not alter or amend the regulations governing the administrative appeals of NCDs, however.

In a major departure from past practice, CMS also established an expedited administrative process for removing certain older NCDs, thereby enabling local Medicare contractors to independently determine coverage for items and services addressed by NCDs rescinded under the new process. Manufacturers and other advocates of older technologies should be prepared for CMS to actively reassess its previous coverage determinations and take steps to ensure that those decisions are based on clinical evidence that is scientifically sound. This increased scrutiny of coverage decisions by CMS may also present manufacturers with opportunities to introduce CMS to newer products that are innovations of the older technologies under review.