CMS Rulemaking

CMS regulations establish or modify the way CMS administers its programs. CMS' regulations may impact providers or suppliers of services or the individuals enrolled or entitled to benefits under CMS programs. Regulations that CMS plans to publish within the upcoming year can be found on OMB’s Unified Agenda web site (see link below).

CMS publishes its regulations in the daily national "Federal Register". The "Federal Register" is available online and at many public libraries and colleges. To view published regulations and notices, refer to the Federal Register link below.

Proposed Regulations

A "proposed rule" or proposed regulation announces CMS' intent to issue a new regulation or modify an existing regulation. A proposed regulation also solicits public comments during a comment period. It sets forth proposed amendments to the Code of Federal Regulations (CFR), but does not amend the CFR.

By law, anyone can participate in the rulemaking process by commenting in writing on the regulations CMS proposes. CMS encourages public input and carefully considers these comments before it develops a final regulation. CMS generally receives public comments on its proposed regulations.

The "comment period" specifies how long CMS will accept public comments. Usually, the record – or docket – stays open for comments at least 60 days for regulations, though some comment periods may differ. (Weekends and holidays are counted in determining the closing date of a comment period.)

For information on submitting comments on a regulation for which CMS is accepting comments, please visit the eRulemaking Page at the link below.

Alternatively, you may refer to the instructions cited in the regulation.

Here are some other suggestions for ensuring your comment(s) have the greatest possible impact:

• Refer to the regulation title and the CMS number, listed at the beginning of the regulation (for example, Programs of All-Inclusive Care for the Elderly (PACE) Update (CMS-4168-P).
• Clearly indicate if you are for, or against, the proposed regulation or some part of it and why. CMS regulatory decisions are based largely on law, clinical and scientific evidence, and program experience. CMS reviewers look for reasoning, logic, and good science in the comments they evaluate.
• Include a copy of articles or other references that support your comments. Only relevant material should be submitted.
• If an article or reference is in a foreign language, it must be accompanied by an English translation verified to be accurate. A copy of the original publication should accompany translations.
• To protect privacy when submitting medical information, remove names or other information that would identify patients.

Comments Received

CMS logs in all public comments received timely and places them in the official rulemaking record. All comments are public information that may be reviewed by anyone online.

Final Regulations

After considering public comments that it receives by the close of the comment period, CMS may develop and publish a final regulation. If the final regulation has a significant impact on a significant number of entities or its impact results in $100 million or more, the final regulation is generally effective 60 days after the publication date. At the time CMS forwards the rule for publication, it also forwards the regulation to the Government Accountability Office (GAO) and both houses of the Congress for review.

A final regulation that does not meet the "significant impact" criteria, is generally effective 30 days after publication. If CMS finds good cause to waive the delay in the effective date of a final regulation because the delay is unnecessary, impractical, or contrary to the public's interest, or the statute permits waiving the delay, the final regulation is effective upon publication.