HHS withdraws Trump-era SUNSET rule
The lawsuit against the rule compared its self-executing expiration dates for regulations to a ticking time bomb.
Photo: Alex Wong/Getty Images
The Department of Health and Human Services has withdrawn a Trump-era rule that mandated the sunset of any rule more than 10 years old unless it was reviewed within five years.
Under the Biden Administration, HHS delayed implementation of the Securing Updated and Necessary Statutory Evaluations Timely, or SUNSET rule that was originally scheduled to take effect on March 22. Due to a lawsuit filed on March 9, 2021, which sought to overturn the SUNSET final rule, HHS extended the rule's effective date until September 22.
After conducting a review of the SUNSET final rule, including the oral and written comments on its proposal, and the allegations in a lawsuit brought against it, HHS published a notice of proposed rulemaking to withdraw or repeal the SUNSET final rule.
On Thursday, HHS announced it was withdrawing the SUNSET final rule as of July 26.
WHY THIS MATTERS
After HHS released the rule in January 2021, provider and other groups came forward to protest its implementation.
In comments submitted to HHS, the American Hospital Association voiced concerns that the rule did not provide an adequate mechanism for obtaining public input on the substance of the regulations being reviewed. There could be serious consequences of inadvertently removing rules, with negative impacts on beneficiaries, consumers and the public in general, the AHA said.
"HHS states that the risk of a regulation inadvertently expiring is outweighed by the benefit of institutionalizing retrospective review," the AHA said. "We strongly disagree."
The Association of American Medical Colleges submitted comments urging withdrawal of the entire proposed rule prior to it being finalized.
In March 2021, several groups including the County of Santa Clara, the California Tribal Families Coalition, National Association of Pediatric Nurse Practitioners, and others sued HHS to vacate the rule.
Under the rule, the vast majority of the Department's existing regulations would expire automatically in 2026, with the remainder set to expire over the following five years, the lawsuit said. The only way under the rule to prevent expiration is for HHS to conduct and finalize retrospective review of each regulation. The lawsuit estimated the number of regulations to be about 18,000.
This would be "a resource-intensive and time-consuming effort on par with full notice-and-comment rulemaking, but at a pace 20 times faster than the Department has ever conducted retrospective review in the past – all without any guarantee that the Department will conduct such review," the lawsuit said. "In other words, the outgoing administration planted a ticking time bomb set to go off in five years unless HHS, beginning right now, devotes an enormous amount of resources to an unprecedented and infeasible task."
The Sunset rule would amend regulations that significantly affect the tribal member plaintiffs and other Indian tribes, including regulations governed by the Indian Self-Determination and Education Assistance Act, the lawsuit said.
"The automatic expiration of these regulations and the uncertainty regarding their continued existence will impose significant costs on the CTFC (California Tribal Families Coalition), its members, and other tribes," the lawsuit said. "The process created by the Sunset Rule will also impose millions of dollars in costs on tribes simply to participate in the review of regulations affecting tribes."
THE LARGER TREND
HHS first published the final rule on January 19, 2021, under the lame-duck period of the Trump Administration.
The Sunset Rule amended nearly all HHS regulations to add self-executing expiration dates.
Twitter: @SusanJMorse
Email the writer: SMorse@himss.org
