As the 21st Century Cures Act begins to be enforced, interoperability plays an important role in ensuring access to electronic health information.
What is information blocking?
Information blocking occurs when an “Information Blocking Actor,” which may be a health care provider or provider organization, health information network (HIN), health information exchange (HIE), or certified developer of health information technology, intentionally delays or prevents the sharing of electronic health information (EHI). Health plans may also be considered “Actors” under certain circumstances as per a FAQ published by the Office of the National Coordinator of Health Information Technology (the “ONC”).
Who is subject to the 21st Century Cures Act?
For purposes of the ONC’s Cures Act Final Rule, in 45 CFR part 171, the term "actor" includes health care providers, health IT developers of certified health IT, and health information networks (HIN) or health information exchanges (HIE), as defined in 45 CFR 171.102. Although health plans and other payers are not specifically identified within any of these definitions, they also are not specifically excluded.
To the extent an individual or entity that is a payer also meets the 45 CFR 171.102 definition of "health care provider," "health IT developer of certified health IT" or "health information network or health information exchange," that individual or entity would be considered an "actor" for purposes of information blocking. In addition, the HIN/HIE definition is a functional definition and should be reviewed for potential applicability to a health plan’s activities.
The Health and Human Services (HHS) of the Office of the Inspector General (OIG) has finalized penalties of up to $1,000,000 per instance of information blocking by HINs, HIEs, and certified developers of health information technology. However, civil monetary penalties for provider organizations that engage in information blocking have not been defined, creating an “enforcement gap.” This has led to challenges with obtaining EHI for legitimate health care purposes from some provider organizations.
In April of 2022, the Secretary of the Department of Health and Human Services (HHS), Xavier Becerra, stated that the HHS was receiving “hundreds of complaints” related to information blocking, and that closing the provider enforcement gap by imposing civil monetary penalties is a “top HHS priority.” Once enforcement of information blocking by providers is finalized it could have a significant downstream impact on access to medical records for patients, providers, payers, and other stakeholders.
