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Medicare Coverage ~ Coverage Guidance Documents
Request for Public Input
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires that the Secretary make available to the public the factors that are considered in making National Coverage Determinations (NCD) of whether an item or service is reasonable and necessary. To do this, CMS is currently developing a process for producing guidance documents similar to that used by the US Food and Drug Administration. These guidance documents will give the public-particularly individuals or organizations that might request an NCD-detailed information on the NCD process and related evaluation and decision-making factors.
While awaiting completion of this process, we invite public comment on possible topics for the guidance documents. The range of topics include the NCD process, criteria for determining reasonable and necessary, issues that are referred for a Technology Assessment or to the Medicare Coverage Advisory Committee, and evidence required in sector-specific areas. We will consider all of these suggestions; however, CMS may not issue guidance documents on all suggestions received. We will also have an additional request for topics following publication of the guidance document process. Comments may be submitted via the public comments function available at www.cms.hhs.gov/coverage/8h.asp#comment.
