HHS Issues Final Rule Delaying the Securing Updated and Necessary Statutory Evaluations Timely

The Department of Health and Human Services (HHS) issued a final rule delaying the requirements of the rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule). The rule requires health regulations to expire if they aren't reviewed every ten years. The final rule also corrects errors in the SUNSET final rule.

The rule is effective March 22, 2022.

(Updated March 22, 2021)

 

The Department of Health and Human Services (HHS) issued a final rule requiring it to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which requires regular review of significant regulations. If a given regulation is subject to the RFA, HHS must review the regulation every ten years to determine whether the regulation is still needed and whether it is having appropriate impacts. Regulations will expire if HHS does not assess and, if required, review them in a timely manner.

Under the final rule, any regulation issued by HHS, with certain exceptions, will cease to be effective ten years after it is issued, unless HHS performs a plenary assessment of the regulation and a more detailed review of those regulations that have a significant economic impact upon a substantial number of small entities.

All HHS regulations, with certain exceptions will be subject to a two-step review:

  • Assessing whether they have a significant economic impact on a substantial number of small entities, the standard set out under the RFA; and, if it qualifies for review under the RFA,
  • A more detailed review that will consider, as prescribed in the RFA, (i) the continued need for the rule, (ii) complaints about it, (iii) the rule’s complexity, (iv) the extent to which it duplicates or conflicts with other rules, and (v) whether technological, economic, and legal changes favor amending or rescinding the rule.

Rules issued by an HHS component that are more than ten years old need to be reviewed within five calendar years of the effective date of this final rule, making the effective date of considerable substantive significance because it starts the clock for reviews.  By providing five calendar years from the effective date, rather than two as proposed, private entities have over five years to become accustomed to, and participate in, the review process.

The final rule is effective March 22, 2021.

News Release

(Posted January 19, 2021)