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Medicare Coverage ~ Process

Changes to the National Coverage Determination Process

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 amended several portions of the National Coverage Determination (NCD) development process with an effective date of January 1, 2004. However, due to time constraints, it is not possible to develop a formal document explaining the changes and revised process by that date. Accordingly, effective for NCDs undertaken on or after January 1, 2004, this Note serves as an alert outlining the changes being made to the NCD process as a result of the legislation.

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 Coverage Advisory Committee (MCAC) review, the decision on the request shall be made not later than 6 months after the date the completed request is received;
• For those NCD requests requiring either an external TA and/or MCAC 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;
• Not later than the end of the 6 or 9 month period described above, a draft of 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.

These and other modifications as required by the legislation will be further defined in a subsequent guidance document.