On July 3, 2023, the long-awaited final rule from the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) titled “Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General’s Civil Money Penalty Rules” (the “OIG Final Rule”) was published in the Federal Register.1 The OIG Final Rule establishes civil monetary penalties (“CMPs”) of up to $1 million per information blocking violation pursuant to Section 4004 of the 21st Century Cures Act (the “Cures Act”).2 Penalties may be imposed on developers of certified health information technology (“health IT”) (including entities that offer certified health IT), health information exchanges (“HIEs”), and health information networks (“HINs”) beginning on September 1, 2023. The OIG Final Rule concludes the rulemaking process that OIG began with a proposed rule published in the Federal Register on April 24, 2020 (the “OIG Proposed Rule”) but does not establish information blocking penalties for health care providers, who will be subject “appropriate disincentives” to be established in future HHS rulemaking.
The OIG Final Rule provides helpful information to the industry regarding information blocking enforcement priorities, factors that will be considered in determining CMP amounts, and how OIG will coordinate with other agencies—such as the Office of the National Coordinator for Health IT (“ONC”), HHS Office for Civil Rights (“OCR”), Federal Trade...
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