HHS Issues Proposed Rule Governing its Regulatory Review of New and Existing Rules

On November 4, 2020, the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking requiring the agency 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 certain 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.

All HHS regulations will be subject to a two-step review: 1) assessing whether they have a significant economic impact on a substantial number of small entities, the standard set out under the RFA; and, if the rule qualifies for review under the RFA, 2) a more detailed review that will consider, as prescribed in the RFA, (i) the continued need for the rule, (ii) complaints about the rule, (iii) the rule’s complexity, (iv) the extent to which the rule duplicates or conflicts with other rules, and (v) whether technological, economic, and legal changes favor amending or rescinding the rule.