On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector General (OIG) determines have committed “information blocking” (as defined at 45 C.F.R. § 171.103).

As a reminder, the information blocking rules generally prohibit certain practices that are likely to interfere with the access, exchange, or use of electronic health information unless one or more of the eight specific exceptions are satisfied. This prohibition applies to health care providers, health information technology developers of certified health information technology, and health information exchanges/health information networks. Currently, there are no financial penalties for a health care provider’s failure to comply with the information blocking rules.

Under the Proposed Rule, if the OIG determines that a health care provider committed information blocking, it would refer the matter to the Centers for Medicare & Medicaid Services (CMS), and the health care provider would be subject to each of the following penalties (as applicable):

• Medicare Promoting Interoperability Program: An eligible hospital or critical access hospital (CAH) would not be a meaningful electronic health record (EHR) user in an applicable EHR reporting period. Such a designation would result in the eligible hospital losing 75% of the annual CMS market basket increase that is associated with qualifying as a meaningful EHR user, while the CAH would have its payment reduced to 100% of reasonable costs (versus 101% without an information blocking violation).
• Quality Payment Program: Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), an eligible clinician or group would not be a meaningful user of certified EHR technology in a performance period and would therefore receive a zero score in the Promoting Interoperability performance category of MIPS. The Promoting Interoperability score is usually approximately 25% of the total MIPS score.
• Medicare Shared Savings Program: A health care provider that is an accountable care organization (ACO), ACO participant, or ACO provider or supplier would be ineligible to participate in, and/or removed from, the Medicare Shared Savings Program for a period of at least one year.

The Proposed Rule also proposes the process that OIG will use to investigate information blocking and refer to CMS health care providers that have committed information blocking. OIG indicated that it would prioritize information blocking investigations of health care providers on practices that (i) resulted in, are causing, or have the potential to cause patient harm; (ii) significantly impacted a provider’s ability to care for patients; (iii) were of long duration; and (iv) caused financial loss to federal health care programs, or other government or private entities. Notably, OIG expressly indicates that the investigation priorities are not a regulatory proposal and are for informational purposes only.

The Proposed Rule is not yet finalized, and the comment period for the Proposed Rule closes at 5 p.m. on January 2, 2024. Anyone interested in submitting comments to HHS can find more information here.