HHS issues proposed rule to automatically review regulations

Nov. 5, 2020

The Department of Health and Human Services (HHS) issued a proposed rule that would require the department 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, according to a press release from the department.

Under the proposed 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, HHS said.

That is, all HHS regulations, with certain exceptions (detailed below) 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 it qualifies for review under the RFA, 2) a more detailed review that will consider, as prescribed in the RFA, the continued need for the rule, complaints about it, the rule’s complexity, the extent to which it duplicates or conflicts with other rules, and whether technological, economic, and legal changes favor amending or rescinding the rule.

Certain regulations are exempt, including regulations that are jointly issued with other agencies, regulations that legally cannot be rescinded, and regulations issued with respect to a military or foreign affairs function or addressed solely to internal management or personnel matters (two categories exempt from standard rulemaking requirements under the Administrative Procedure Act).

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