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FEATURE


Systems, which has resulted in CMS publishing a proposed rule every July. All proposed rules, or Notices of Proposed Rulemaking, published in the Federal Register must contain a statement of the time, place and nature of public rulemaking proceedings, a reference to the legal authority under which the rule is proposed, and either the terms or substance of the proposed rule or a description of the subjects and issues involved. The notices must also specify a period of time during which public comments will be accepted on the proposed rule. Anyone may comment on a proposed


rule. When ASC rules are being consid- ered, ASCA is usually involved in at least this part of the rulemaking process. Once the proposed rule is published, ASCA works with its members, key experts in the ASC community, related stakehold- ers and others to develop comments that it submits to the appropriate federal agency. ASCA also notifies its members through the association’s “Government Affairs Update” when relevant pro- posed rules go up for comments. The time period for accepting com-


ments may vary. Agencies may use shorter comment periods, like 30 days, for simple regulations, and comment periods of 180 days or longer for com- plex regulations. The public may request that an agency allow more time to sub- mit comments. CMS extended the com- ment period on the recent MACRA RFI in response to such requests. Addition- ally, agencies can be required to hold public hearings, Webcasts or interac- tive Internet sessions where individu- als and organizations can make state- ments and submit data. Agencies may choose to, but are not required to, reopen a closed com- ment period to enable the public to continue to comment. They may also open a second comment period that invites comments that respond to prior comments. Agencies may also issue additional proposed rules or decide to


Generally, a final rule is effective 30 days after publication in the Federal Register, but significant rules do not go into effect until 60 days after publication.”


—Steven Selde, ASCA


terminate the rulemaking process if novel issues are raised in the comment period. These steps are taken so that the public has a clear idea of what the regulation entails and ample opportu- nity to provide comments.


The Final Rule Once an agency finishes collecting public comments on a proposed rule, it considers those comments, decides whether or not to make any changes in the proposed rule and issues a final rule. That rule, like the proposed rule, is published in the Federal Register. Agencies are not required to include every issue and idea raised during the comment period in the final rule. Generally, a final rule is effective


30 days after publication in the Fed- eral Register, but significant rules do not go into effect until 60 days after publication. Final rules are subject to review issuing agency and other


from the


branches of the federal government. Agencies may choose to revise a final rule after taking into account new data


Steven Selde is ASCA’s assistant regulatory counsel. Write him at sselde@ ascassociation.org.


ASC FOCUS FEBRUARY 2016 15


and developments in the issue area, rec- ommendations from congressional or federal committees and petitions from the public. Under the Congressional Review Act, newly released final rules also must be submitted to Congress and the Government Accountability Office for review. CMS’ final rule on the Elec- tronic Health Record (EHR) Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017, released last October, was heav- ily criticized by members of Congress, with many noting that the final rule may be reviewed and modified through the Congressional Review Act. Lawsuits filed by individuals


and organizations that are adversely affected by a final rule can result in a court decision to vacate, or set aside, a final rule. Following a judicial deci- sion of this kind, the regulations are sent back to the agency that issued them for correction.


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