The U.S. Department of Health and Human Services (HHS) has turned out the lights on a “sunset” rule requiring extensive federal review of thousands of regulations, which the Texas Medical Association and others in organized medicine believed would needlessly divert HHS’ attention from the COVID-19 pandemic.
HHS finalized its withdrawal of the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule in the Federal Register on May 27. The final version of the rule would have required the agency to review certain regulations within five years of the rule’s adoption, and then again within 10 years after that. Any rule not reviewed by HHS within those timeframes would have automatically expired. The agency estimated 18,000 regulations would have required an assessment in the first 10 years after the rule became effective.
The first version of SUNSET was proposed in 2020 in the final months of the Trump administration, with an initial automatic review-or-expire timeframe of two years after the rule went into effect. TMA objected to that proposal in a letter to HHS in December 2020, with then-TMA President Diana L. Fite, MD, writing that it “would significantly interfere with HHS’ ability to focus on responding to the ongoing public health emergency by diverting scarce resources to the review of regulations.”
“TMA sees no compelling reason to conduct this automatic review at this time, especially when HHS resources should be devoted to helping physicians, hospitals, communities, and states more effectively respond to and stamp out [coronavirus],” she wrote. “Instead, we implore HHS to focus its full attention and resources on combatting the COVID-19 pandemic.”
HHS issued the final version on Jan. 19, 2021, one day before the beginning of the Biden administration. A lawsuit against the department over SUNSET prompted HHS to push out the effective date, and in October 2021, the agency issued a proposal to withdraw the rule.
The American Medical Association also objected to SUNSET. Following its withdrawal, AMA said the rule would undermine HHS’ focus on COVID and would “create unnecessary regulatory uncertainty.”
“The prospect of a rule slipping through this process and simply expiring would have serious implications for insurance markets, hospitals, physicians and patients, among other affected parties,” AMA said in a National Advocacy Update.
AMA also said the SUNSET regulation “appears to violate the Administrative Procedure Act, which requires that in order for a rule to be duly promulgated, it must go through notice and comment rulemaking and, therefore, if HHS had wanted to sunset each of the 18,000 regulations subject to this rule, then the department must issue a proposed rule and provide the public adequate notice and opportunity to comment. The AMA greatly appreciates HHS’ consideration of these concerns and withdrawal of this flawed rule.”