HHS finalizes rule on reassessing regulations

Jan. 11, 2021

The Department of Health and Human Services (HHS) finalized a 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.

Under the 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 has said.

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are exempt, including regulations that are jointly issued with other agencies, regulations that legally cannot be rescinded, and regulations issued with respect to a military or foreign affairs function or addressed solely to internal management or personnel matters (two categories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).

The American Hospital Association (AHA) opposed the rule, noting that HHS has approximately 18,000 regulations that “encompass a massive range of topics and affect a huge number of providers, beneficiaries and citizens.” The AHA said the rule does not provide adequate mechanisms for public input during the review process.

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