October 01, 2020

Cures Act Sec. 4004 Information Blocking Implementation Likely Delayed

What you need to know…

  • The enforcement timeframe for the 21st Century Cures Act “information blocking” prohibition (Section 4004) defined in ONC’s May 1, 2020 final rule will likely be delayed.
  • The start of enforcement is contingent on completion of an OIG rulemaking that is still ongoing.
  • A new ONC rule currently in the review pipeline appears likely to extend it even further due to COVID-19.
  • Regardless of any enforcement delays or extensions, we encourage the community to explore available information and promote appropriate data sharing.

The United States Department of Health and Human Services’ efforts to implement “information blocking” prohibitions from Section 4004 of the 21st Century Cures Act of 2016 began with publication of a final rule by the Office of the National Coordinator for Health Information Technology (ONC) on May 1, 2020. This final rule was released for early public access in mid-March 2020 and summarized in the American College of Radiology® (ACR®) Advocacy in ActionMarch 14, 2020 .

ONC’s rule indicated that earliest possible enforcement could begin six months after publication, in November 2020, but that enforcement was contingent on completion of a related rulemaking within the Office of Inspector General (OIG) to promulgate civil monetary penalties for non-provider-actors. It was generally viewed as optimistic that OIG’s rulemaking could be completed within six months, and an eventual delay was anticipated.

As of this writing, the OIG final rule has yet to be published or submitted for White House Office of Management and Budget (OMB) regulatory review, and the November 2020 start is now nearly infeasible. Moreover, other HHS agencies (e.g., CMS, etc.) have yet to implement new disincentives specifically for provider-actors found in violation of the Cures information blocking provision. Therefore, HHS implementation of Cures Sec. 4004 continues to be incomplete and facing a likely delay.

On Sept. 17, 2020, ONC submitted an Interim Final Rule (IFR) for OMB review titled, Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency. Based on the title, this IFR appears to indicate that a further extension may be imminent due to the ongoing pandemic. ONC’s COVID-19 IFR is currently inaccessible to the public and will likely be published within the next few months.

In the meantime, the ACR Government Relation staff continue to communicate with HHS and other stakeholders while waiting for the future rules to be published. Read the ACR summary of the ONC final rule, check out the draft ACR overview slide deck and learn more in the ACR article on the publication date and timeframe contingency. ACR members with questions about the information blocking provision should contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at mpeters@acr.org.