EHR Certification and Standards Final Rule Sent to OMB

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Posted By: Roberta Mullin August 2, 2012

ONC NPRM Moves Closer to Final Rule

A little over a week ago we reported the CMS NPRM for Stage 2 Meaningful Use had been sent to the OMB. The two Notices of Proposed Rulemaking one from ONC and the other from CMS were published in the Federal Register back in March and together they proposed how they envisioned Stage 2 of meaningfully using certified EHR technology. While the CMS rule focuses on demonstration of meaningful use, the ONC rule outlines the certification capabilities and standards along with tests that Certified EHR Technology (CEHRT) would be required 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 reviewed the submitted public comments and crafted the Final Rules for release and publication.

[Related Article: ONC NPRM Stage 2 Certification Rule]

Before the rules can be released and published in the Federal Register, they must be reviewed by the Office of Management and Budget (OMB). Yesterday, ONC submitted their NPRM for review. This will be the final step before release and publication in the Federal Register. To keep track of what is currently under review by the OMB, visit the Reginfo.gov Dashboard. There you can sort and filter by Department and Agencies.

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.

And stay tuned, MU Live! will be back in August with industry leaders discussing both Final Rules. Check out some of our scheduled guests.