0936-AA09 202110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0936 Office of the Inspector General OIG 0900 Department of Health and Human Services HHS Amendments to Civil Monetary Penalty Law Regarding Grants, Contracts, and Information Blocking

The final regulation modifies 42 CFR 1003 and 1005 by addressing three issues.  First, the 21st Century Cures Act (Cures Act) provision that authorizes the Department of Health and Human Services (HHS) to impose civil monetary penalties, assessments, and exclusions upon individuals and entities that engage in fraud and other misconduct related to HHS grants, contracts, and other agreements.  Second, the Cures Act information blocking provisions that authorize the Office of Inspector General to investigate claims of information blocking and provide HHS the authority to impose CMPs for information blocking.  Third, the Bipartisan Budget Act of 2018 increases in penalty amounts in the Civil Monetary Penalties Law.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 42 CFR 1003 42 CFR 1005 21st Century Cures Act Pub. L. 114-255 secs. 4004 and 5003 Bipartisan Budget Act of 2018 (BBA 2018), Pub. L. 115-123. sec. 50412 Yes

The 21st Century Cures Act (Cures Act) set forth new authorities which need to be added to HHS’s existing civil monetary penalty authorities. This final rule seeks to add the new authorities to the existing civil monetary penalty regulations and to set forth the procedural and appeal rights for individuals and entities. The Bipartisan Budget Act of 2018 (BBA) amended the Civil Monetary Penalties Law (CMPL) to increase the amounts of certain civil monetary penalties which requires amending the existing regulations for conformity. The final rule seeks to ensure alignment between the increased civil monetary penalties in the statute and the civil monetary penalties set forth in the OIG’s rules.

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The legal authority for this regulatory action is found in: (1) section 1128A(a)-(b) of the Social Security Act, the Civil Monetary Penalties Law (42 U.S.C. 1320a-7a), which provides for civil monetary penalty amounts; (2) section 1128A(o)-(s) of the Social Security Act, which provides for civil monetary penalties for fraud and other misconduct related to grants, contracts, and other agreements; and (3) section 3022(b) of the Public Health Service Act (42 U.S.C. 300jj-52), which provides for investigation and enforcement of information blocking.

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The regulations incorporate the statutory changes to HHS' authority found in the Cures Act and the BBA. The alternative would be to rely solely on the statutory authority and not align the regulations accordingly. However, we concluded that the public benefit of providing clarity by placing the new civil monetary penalties and updated civil monetary penalty amounts within the existing regulatory framework outweighed any burdens of additional regulations promulgated.

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We believe that there are no significant costs associated with these proposed revisions that would impose any mandates on State, local, or Tribal governments or the private sector. The regulation will provide a disincentive for bottlenecks to the flow of health data that exist, in part, because parties are reticent to share data across the healthcare system or prefer not to do so. The final rule will help foster interoperability, thus improving care coordination, access to quality healthcare, and patients’ access to their healthcare data.

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We believe the risks of this regulatory action are minimal because we are relying upon statutory authorities and placing the regulation within our existing regulatory framework.

]]> NPRM 04/24/2020 85 FR 22979 NPRM Comment Period End 06/23/2020 Final Action 03/00/2022 No No None No No No No Chris Hinkle Senior Advisor 0936 Office of the Inspector General OIG 202 891-6062 christina.hinkle@oig.hhs.gov 330 Independence Avenue SW, Washington DC 20201