Medicare Coverage Determination Process

Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). National coverage determinations (NCDs) are made through an evidence-based process, with opportunities for public participation. In some cases, CMS' own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). In the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on a local coverage determination (LCD).

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 amended several portions of the NCD development process with an effective date of January 1, 2004.

On and after January 1, 2004, the following changes to the NCD process will be effective:

• For NCD requests not requiring an external technology assessment (TA) or Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) review, the decision on the request shall be made not later than 6 months after the date the completed request is received; (§731(a)(2)(A))
• For those NCD requests requiring either an external TA and/or MEDCAC review, and in which a clinical trial is not requested, the decision on the request shall be made not later than 9 months after the date the completed request is received; (§731(a)(2)(B))
• Not later than the end of the 6 or 9 month period described above, the proposed decision shall be made available on the CMS website (or other appropriate means) for public comment. This comment period shall last 30 days, and comments will be reviewed and a final decision issued not later than 60 days after the conclusion of the comment period. A summary of the public comments received and responses to the comments will continue to be included in the final NCD. (§731(a)(3)(A))
• An Annual Report shall be issued listing the national coverage determinations made in the previous year and explaining how to get more information on those determinations. (§953(b))