Changes to CMS’ Process for Opening, Deciding or Reconsidering National Coverage Determinations

On August 7, 2013, the Centers for Medicare and Medicaid Services (“CMS”) published a Notice in the Federal Register that CMS is updating the process for opening, deciding or reconsidering national coverage determinations (“NCDs”) from prior guidance from September 26, 2013.   

§1862(l) of the Social Security Act (“the Act”) defines an NCD as a determination by the Secretary of the Department of Health and Human Services (“HHS”) “with respect to whether or not a particular item or service is covered nationally under [Title XVIII-Medicare].” 

NCDs are the general rules to ensure that similar claims for similar items or services are covered similarly, under Medicare Part A or Part B.   In addition, §1862(l) of the Act also establishes the timeframe for the NCD process and opportunity for public comment.

The Notice details the process for: (1) informal contacts and inquiries made prior to requesting an NCD, which are encouraged but not required by CMS; (2) formal requests for an NCD or reconsideration of an NCD, including the elements required for a request to be considered complete; (3) requests for NCDs from external parties, such as Medicare beneficiaries, manufacturers, physicians, or physician professional associations; (4) CMS reviews of NCDs that are initiated internally by CMS; and (5) an expedited process to remove NCDs under certain circumstances to ensure CMS’ policies and processes remain effective and efficient.  

The Notice also reiterates: (1) the internal and external process for requesting an NCD or NCD reconsideration; (2) a tracking system that provides public notice of CMS’ acceptance of a complete, formal request and subsequent actions; (3) the process for public comment prior to CMS’ issuance of a decision memorandum; and (4) how CMS uses public comments to inform the NCD final decision.

For additional information on NCD’s please contact Meghan Linvill McNab at