0955-AA05 202310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0955 Office of the National Coordinator for Health Information Technology ONC 0900 Department of Health and Human Services HHS Establishment of Disincentives for Health Care Providers Who Have Committed Information Blocking

The rulemaking implements certain provisions of the 21st Century Cures Act (Cures Act) to establish appropriate disincentives for health care providers determined by the HHS Inspector General to have committed information blocking. Consistent with the Cures Act, the rulemaking establishes a first set of disincentives using HHS authorities under applicable Federal law, including authorities delegated to the Centers for Medicare & Medicaid Services.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 45 CFR 171 42 CFR 414 42 CFR 425 42 CFR 495 42 U.S.C. 300jj–52 42 U.S.C. 1302 42 U.S.C. 1306 42 U.S.C. 1395hh 42 U.S.C. 1395jjj 42 U.S.C. 1395rr(1) 5 U.S.C. 552.2 Yes

The rulemaking would implement a provision of the Cures Act which requires the HHS Office of the Inspector General (OIG) to refer health care providers that OIG determines to have committed information blocking to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking. Release of the proposed rule is needed to implement this critical component of the Cures Act and ensure effective enforcement of information blocking rules.

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The provisions would be implemented under the authority of the Public Health Service Act, as amended by the Cures Act.

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ONC will consider different available authorities under which appropriate disincentives could be established deter information blocking and still minimize regulatory burden for health care providers.

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The costs of this proposed rule would be minimal. Investigated parties may incur some costs in response to an OIG investigation or the application of a disincentive by an HHS agency, however, this would depend on the frequency of prohibited conduct. The expected benefits of the regulation are deterring information and its negative impacts on many important aspects of health care, including effective health information exchange, patient access, duplicative testing and costs, and the availability and quality of care.

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We anticipate that health care providers will express concern with the potential complexity of the approach (i.e., the application of a range of disincentives based on available authorities) as compared to a range of civil monetary penalties or fines. ONC will continue to consider additional potential risks, identify them for stakeholders, and seek comment from stakeholders during the comment period for the proposed rule.

]]> NPRM 11/01/2023 88 FR 74947 NPRM Comment Period End 01/02/2024 No No None No No No No Alex Baker Federal Policy Branch Chief 0955 Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology ASTP/ONC 202 690-7151 alexander.baker@hhs.gov 330 C Street SW, 7th Fl, Washington DC 20201