HHS Postpones Implementation of the SUNSET Rule

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The US Department of Health and Human Services (HHS) postponed the implementation of a controversial Trump era rule that would have required the department to review thousands of its regulations while the rule undergoes judicial review. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) was first proposed in November 2020 and finalized on 19 January 2021, one day before President Joe Biden’s inauguration.

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In a Federal Register notice, HHS states that the effective date will be postponed to March 22, 2022, because the allegations of harm made by the plaintiffs in County of Santa Clara et al. v. HHS et al. are credible; a postponement will “permit HHS to review the SUNSET final rule in light of the claims raised in the litigation; and the balance of equities and the public interest warrant postponement of the effective date to preserve the status quo while the Court considers the challenge to the SUNSET final rule.” The rule, “Securing Updated and Necessary Statutory Evaluations Timely,” would have required agency regulations to be reviewed every ten years or otherwise expire.

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Although the SUNSET final rule affects more than 17,000 HHS regulations – which would automatically expire in 2026 without an HHS retrospective review process requiring a pace 20 times faster than HHS has ever conducted – the rule was rushed through in spite of public input on the proposed rule that was critical of the regulation.

In publishing the final rule, HHS conceded that roughly a quarter of the comments received on the Nov. 4, 2020, proposed rule during the public comment period requested that HHS withdraw the proposed rule. Further, at a November 23, 2020, public hearing on the proposed rule, all speakers “either expressed concerns about the proposed rule, opposed it, or requested that the Department withdraw it,” according to the final rule.

The final rule’s provisions stipulate that HHS regulations that have a “significant economic impact upon a substantial number of small entities” be reviewed every 10 years. The Department’s review shall consider the following factors, according to the final rule:

  • The continued need for the rulemaking, consideration of which shall include but not be limited to the extent to which the rulemaking defines terms or sets standards used in or otherwise applicable to other federal rules;
  • The nature of complaints or comments received concerning the rulemaking from the public;
  • The complexity of the rulemaking;
  • The extent to which the rulemaking overlaps, duplicates or conflicts with other federal rules, and, to the extent feasible, with State and local governmental rules; and
  • The degree to which technology, economic conditions, or other factors have changed in the area affected by the rulemaking since the rulemaking was promulgated or the last time the rulemaking was reviewed by the Department; and
  • Whether the rulemaking complies with applicable law.

There has been some talk of Congress overturning the rule, but that has yet to be seen.

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