The American College of Radiology provides the following only as general information. Readers should not construe this educational resource to provide specific legal advice on their individual practice matters. This information is subject to change depending on future rules and/or clarifications.
The 21st Century Cures Act Section 4004 expanded the authority of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to investigate and penalize information blocking practices. The provision is relevant to three types of actors —providers, developers of certified health information technology, and health information networks/exchanges. Information blocking by a provider necessitates that the provider knows the practice is unreasonable and likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI).
The EHI definition will be limited on a temporary basis to the data elements represented by the U.S. Core Data for Interoperability (USCDI) , including imaging narrative data. After this initial period, the EHI definition will expand to include virtually all electronic protected health information (ePHI) that is part of the Health Insurance Portability and Accountability Act (HIPAA)-designated record set, with certain limitations.
Providers that engage in practices implicating the provision can be reported to HHS and investigated on a case-by-case basis. If a given practice is found to be in violation, the provider will then be subject to disincentives under existing HHS authorities. Provider-specific disincentives have yet to be defined by HHS agencies, and regulatory implementation is currently incomplete.
HHS defined eight exceptions —i.e., activities that would otherwise implicate the provision, but are exempt from penalization because they are deemed reasonable and necessary. Practices that meet the conditions of at least one exception have additional assurance they will not be penalized.
Providers that engage in practices that implicate the provision, but do not meet the conditions of an exception, will not be automatically penalized. HHS will evaluate such practices to determine, based on circumstances and the provider’s knowledge of the unreasonableness of the practice, whether information blocking has occurred.
HHS delayed the applicability date of the information blocking provision until April 5, 2021. Likewise, the EHI definition expansion from the USCDI to ePHI was delayed until Oct. 6, 2022.
However, HHS has yet to finalize enforcement rules, including identifying disincentives for providers. There could be a gap between April 5, 2021 and the future enforcement timeframe. HHS has not yet clarified if providers and other actors will be retrospectively investigated and penalized for any information blocking practices that occur in that gap.
When enacted in 2016, Congress intended the information blocking provision to discourage anticompetitive, anti-exchange behaviors not already addressed by existing anti-kickback/self-referral rules. If well-implemented and appropriately enforced, the information blocking provision should help broadly advance data-sharing and interoperability, including in many ways that help radiology providers connect with referring providers.
It is necessary that radiology providers comply by appropriately responding to requests for legally permissible access, exchange, or use of EHI. It is generally advisable for actors to be educated about the provision through their legal/compliance teams. As the provision is broadly applicable across all of medicine, several institutions already have implemented compliance programs, and approaches can vary from facility to facility depending on circumstances and localized interpretations of the rules.
It is generally recommended that actors access first-party information from relevant HHS agencies, as there are varying and inconsistent interpretations, which has exacerbated confusion about the information blocking provision.
- HHS information blocking resources – This website provides guidance documents, answers to frequently asked questions, and other links. This is a good starting place to learn about the information blocking provision.
- HHS ONC final rule on exceptions (May 1, 2020) – This final rule covers many topics related to the HHS Office of the National Coordinator for Health IT’s purview with respect to the 21st Century Cures Act. This includes, but is not limited to, areas of relevance to ONC in the information blocking provision, particularly defining the eight exceptions. It does not address enforcement considerations, disincentives/penalties, and other information blocking topics that are in the purview of other HHS agencies.
- HHS ONC interim final rule on timeline extensions (Nov. 4, 2020) – This interim final rule extended the compliance timeframes related to ONC’s May 1, 2020 rule, including with respect to key information blocking timelines like the applicability and EHI definition expansion dates.
- 21st Century Cures Act – The “Cures Act” was a legislative package in 2016 that addressed numerous healthcare policy topics, including establishing the information blocking provision (Sec. 4004).