On Wednesday November 4, 2020, the U.S. Department of Health and Human Services (“HHS” or the “Department”) set forth a Proposed Rule that would set expiration dates for the regulations set forth by HHS, unless the Department periodically assesses the regulations to determine if they are subject to the Regulatory Flexibility Act (“RFA”). The proposed rule has been referred to by HHS Chief of Staff, Brian Harrison, as “the boldest and most significant regulatory reform effort ever undertaken by HHS.” Mr. Harrison explained that the proposed rule “would sunset burdensome regulations unless their necessity is publicly demonstrated to the American people.”

The RFA, which was signed into law in 1980, contains a provision requiring federal agencies to establish and publish their plans for “periodic review of rules which have or will have a significant impact upon a substantial number of small entities.” The purpose of this review is for regulatory agencies to determine whether the rules they have previously set forth should continue without change or whether they should be amended or rescinded. In conducting such reviews, the RFA provides that agencies should consider the following factors:

  • the continued need for the rule;
  • the nature of the comments or complaints received concerning the rule from the public;
  • the complexity of the rule;
  • the extent to which the rule overlaps, duplicates, or conflicts with other Federal Rules, and to the extent feasible, with the rules set forth by state and local governments; and
  • the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed the area affected by the rule.

Although the RFA has been in place for four decades, federal agencies have not been known to prioritize largescale periodic review, perhaps due to the fact that there is no real consequence for failing to do so. The proposed rule set forth by HHS does, however, incentivize the federal agency to conduct the retrospective review required under the RFA by providing that regulations not reviewed within ten years of being issued or undergoing review will automatically expire. Conducting the retrospective assessment in order to secure a rule’s survival is certainly less administratively onerous than having to re-promulgate an expired rule. However, if finalized, this rule would result in an immense amount of work for an agency with such wide-reaching responsibilities as HHS. The Department is responsible for food safety, drug approval, adoption and childcare, and healthcare financing and has roughly 18,000 regulations, with roughly 12,400 of them being more than ten years old. If finalized, the proposed rule provides that the vast majority of these rules would need to be assessed within two years.

As with everything else you have probably read in the past week, whether this proposed rule is ever formally adopted may very well depend on the results of the 2020 national election. The proposed rule is subject to a 60-day comment period after which there will be a public hearing. Depending on the public comments, HHS could try to finalize the final rule after conclusion of the public comment period. However, should Joe Biden be named the 46th president of the United States, his new administration would be able to withdraw the proposed rule if the administration feels so inclined, unless HHS under the Trump Administration manages to act with record speed and finalize the proposed rule prior to January 20, 2021.