OMB Reviewing Final Rules to Update Meaningful Use and HIT Certification Criteria

In this month’s post, we take a look at an article posted on Radiology and HIT Blog on September 11, 2015 which discusses the next round of final rules which are currently under review.

Earlier this month, the HHS Office of the National Coordinator for HIT (ONC) and Centers for Medicare and Medicaid Services (CMS) submitted final rules to update the EHR Incentive Program participation and technology certification requirements for White House Office of Management and Budget (OMB) regulatory review. OMB regulatory review is one of the final closed steps prior to public release, and the process typically takes 30 to 90 days.

There are two CMS final rules (2015-2017 and Stage 3) and one ONC final rule (2015 Edition HIT certification criteria) under review. We should expect at least the main final rule on meaningful use (MU) modifications for 2015-2017 to be published before October to enable 90-day reporting periods to commence on October 1. The Stage 3 final rule also includes “modifications for 2015-2017” in the title, which could mean pieces of the MU fix are divided between some sort of expedited “modifications” final rule and a lengthier “Stage 3” final rule to be published later. However, it is equally possible that all three CMS and ONC final rules will be published simultaneously given that all three were submitted for OMB review on the same September 3 date.


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ONC 2015 Edition Certification Criteria Proposed Rule

In this month’s post, we take a look at the ONC 2015 Edition Proposed Rule.

The 2015 Edition Proposed Rule introduces the beginning of the Office of National Coordinator for Health Information Technology’s (ONC’s) more frequent approach to health information technology certification regulations. Under this approach, ONC intends to update certification criteria editions every 12 to 18 months in order to provide smaller, more incremental regulatory changes and policy proposals. This approach gives stakeholders greater and earlier visibility into our regulatory direction before compliance is required, provides more time for public input on policy proposals under consideration for future rulemakings, and enables our certification processes to more quickly adopt newer industry standards that can enhance interoperability.

The 2015 Edition EHR certification criteria proposed in this rule would be voluntary. No EHR technology developer who has certified its EHR technology to the 2014 Edition would need to recertify to the 2015 Edition in order for its customers to participate in the EHR Incentive Program. Furthermore, eligible professionals, eligible hospitals, and critical access hospitals that participate in the EHR Incentive Programs would not need to “upgrade” to EHR technology certified to 2015 Edition in order to have EHR technology that meets the Certified EHR Technology (CEHRT) definition. Instead, the 2015 Edition EHR certification criteria would accomplish three policy objectives:

  • Enable a more efficient and effective response to stakeholder feedback
  • Incorporate ”bug fixes” to improve on 2014 Edition EHR certification criteria in ways designed to make our rules clearer and easier to implement
  • Reference newer standards and implementation specifications that reflect our commitment to promoting innovation and enhancing interoperability

The proposed rule was published in the Federal Register on February 26, 2014. ONC will accept comments on the proposed rule through April 28, 2014 via A voluntary public comment template offers a simple and organized way to submit comments on the proposed certification criteria and associated standards and implementation specifications, and respond to specific questions posed in the preamble of the proposed rule. The final rule is expected to be issued in summer 2014.

Proposed Rule (Federal Register):

Public Comment Template:

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