Stage 2 Meaningful Use Final Rule Sent to OMB

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Posted By: Roberta Mullin July 24, 2012

CMS NPRM on Stage 2 Meaningful Use Moves Closer to Final Rule

Back in early March, two Notices of Proposed Rulemaking were published in the Federal Register. One was issued by ONC and the other by CMS. The CMS rule is the “Meaningful Use rule”. It deals with the new requirements that CMS is proposing for stage 2 meaningful use and what participants in the EHR Incentive Programs would have to meet to demonstrate meaningful use in the program. The companion ONC rule discusses the certification capabilities and standards and tests that Certified EHR Technology (CEHRT) would actually have to do. The two rules overlap some but they are different. The rules were under public comment for 60 days which ended in early May. Since then the ONC and CMS have been reviewing the submitted public comment and crafting the Final Rules for release and publication.

Before the rules can be released and published in the Federal Register, they must be reviewed by the Office of Management and Budget (OMB). Last week the CMS rule was sent to the OMB for review. This will be the final step before release and publication in the Federal Register.

To review the CMS NPRM see our post summary of Stage 2 meaningful use which looks at the 5 major provisions proposed.

Regulation and Information Clearance Process

The Paperwork Reduction Act requires Federal agencies to take specific steps before requiring or requesting information from the public. These steps include (1) seeking public comment on proposed information collections and (2) submitting proposed collections for review and approval by OMB. Within OMB, the Office of Information and Regulatory Affairs (OIRA) carries out the information collection review.

The following process is used to obtain OMB approval for an information collection.

  1. The agency develops an information collection that it wishes to implement.
  2. The agency publishes a Federal Register notice about the proposed information collection and provides the public with 60 days to provide comment on the proposed collection.
  3. The agency considers the public’s comments and makes changes as appropriate to address concerns raised by the public.
  4. The agency submits the ICR to OMB for review and publishes a second Federal Register notice announcing the start of OMB’s review. The second notice provides the public with an additional 30 days to provide comments.
  5. After reviewing the ICR and considering public comments, OIRA concludes its review by approving the collection or taking one of the other actions noted above.

The period for OIRA review is limited by Executive Order 12866 to 90 days. There is no minimum period for review. Under the Executive Order, the review period may be extended indefinitely by the head of the rulemaking agency; alternatively, the OMB Director may extend the review period on a one-time basis for no more than 30 days.

For more information on the process see the Reginfo.gov. In the coming weeks we will be discussing both Final Rules with leaders from CMS, ONC and other on MU Live! so stay tuned.