Section 1862(l)(3) of the Social Security Act establishes an opportunity for the public to submit comments on proposed national coverage determinations. CMS encourages public comments and the submission of additional medical, technical, and scientific evidence, and must respond to these comments in our final determination as required by law. Public participation increases the quality of agency decision making.
CMS often receives a wide variety of comments in response to a pending national coverage determination. This material may include recommendations from medical societies, published articles, or clinical trials, as well as results of individual practitioners or narratives of patient experiences. The agency recognizes that many types of evidence have value, and considers clinical experience in making our determinations. The appropriate weight to be accorded to particular types of evidence may vary depending on a variety of factors. For example, public comments citing published, methodologically strong clinical evidence that assesses the relative magnitude of an intervention or technology's benefits and risk of harm to Medicare beneficiaries or is generizable to the Medicare population often give CMS instructive and valuable information. Other public comments may include evidence which has not gone through similar methodological rigor such as the results of individual practitioners or evidence that is not generizable to the Medicare population and thus contain information that may be less instructive in making a national coverage determination.
CMS uses public comments to inform its proposed and final decisions, and responds in detail to all public comments received on a proposed decision when issuing a final decision memorandum.
In general, CMS does not need individually identifiable health information to inform its proposed or final decisions. Any public comment received with individually identifiable health information will be edited prior to posting.
“Individually identifiable health information” is information, including demographic data, that relates to:
- the individual's (or any relative of the individual) past, present, or future physical or mental health or condition,
- the provision of health care to the individual, or
- the past, present, or future payment for the provision of health care to the individual,
and that identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual [45 C.F.R. § 160.103]. Individually identifiable health information includes many common identifiers (e.g., address, birth date, Social Security Number).
Members of the public are encouraged to use the comments process to seek clarification of posted information, to provide additional information that may be useful in the decision making process, and to provide informed opinions on the subject under consideration. Researchers, physicians, and other others members of the health care community may have important insights that they wish to share, and professional societies may wish to impart their groups' positions. Public comments that cite the published clinical evidence are most helpful. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. Public comments that are part of letter writing campaigns by groups or individuals who espouse a single point of view through identical or nearly identically worded emails or documents are not useful. Multiple iterations such as these will be considered as a single comment.
Public comment periods are typically 30 days in length and will close at midnight (Eastern) on the 30th day. When a document is open for public comment, the word COMMENT will appear in an orange box on that page. Please submit your comments using that button.
NOTE: In accordance with HHS guidelines, CMS will only post materials that are 508 compliant. Comments submitted electronically through this website (using the orange comment button) are automatically entered into 508 compliant format. We are requesting that submitters that send comments outside of that electronic process ensure that the comments are 508 compliant.
Section 508 is an amendment to the Rehabilitation Act of 1973 which requires that Federal websites be accessible to people with disabilities. Web accessibility means that people with disabilities can perceive, understand, navigate, and interact with the Web.
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