HHS Withdraws the ‘Ill-Considered’ Trump-Era SUNSET Rule

The Biden administration is withdrawing a controversial Trump-era rule that would have sunset thousands of health regulations. 

At the end of the Trump administration, the Health and Human Services Department proposed and then issued a final rule that would have required the elimination of thousands of rules after 10 years unless certain conditions were met. That was one of many of its last-minute or “midnight regulations,” as is customary by outgoing administrations, amid the unprecedented presidential transition. This particular rule attracted much scrutiny and criticism.

“In essence, implementation of the [‘Securing Updated and Necessary Statutory Evaluations Timely’ (SUNSET)] final rule would likely have led to a sharply diminished ability of the department to provide federal leadership in public health and human services,” stated a document published in the Federal Register on May 27. “The department believes that implementation of the SUNSET final rule fundamentally conflicts with our policies and ability to achieve our statutory missions.              

Additionally, the “significant repercussions were not adequately considered in issuing the SUNSET final rule in part because the process to promulgate the rule was extremely unusual, if not unprecedented,” HHS stated.  

The final rule – issued the day before Biden’s inauguration – was set to take effect on March 22, 2021, but after a lawsuit was filed seeking to overturn it, HHS delayed the effective date twice. 

Biden’s HHS reviewed the SUNSET final rule “in light of the allegations in the lawsuit, the many substantive comments submitted on the SUNSET proposed rule, and the different policy views held by the Biden-Harris administration as compared to the previous administration which issued the SUNSET final rule,” according to the May 27 document. Now the rule will be withdrawn as of July 26. 

During the 60-day comment period on the proposal to withdraw the SUNSET rule, HHS received about 80 public comments, most of which were in support of the withdrawal, according to HHS. Withdrawal of the rule will save the department about $70 million (in 2020 dollars) over the next 10 years, according to the department’s primary estimate. 

Then-HHS Secretary Alex Azar argued when the rule was introduced in November 2020 that it would carry out the requirements of the Regulatory Flexibility Act enacted in 1980 as presidents have said for decades that agencies should review their regulations retrospectively. 

“With HHS regulatory responsibilities as wide-ranging as food safety, drug approval, adoption and childcare, and healthcare financing, it’s essential that we know—and inform the American people—whether we’re executing on these responsibilities in a way that maximizes benefits, minimizes costs, and keeps up with the times,” he added. 

Biden’s HHS said the department “is committed to effective and appropriate retrospective review of its regulations and looks forward to exploring ways to improve its processes through means other than binding regulations.” 

The coalition that sued over the rule were pleased with the Biden’s administration decision. The plaintiffs included the County of Santa Clara in California, the California Tribal Families Coalition, the National Association of Pediatric Nurse Practitioners, the American Lung Association, the Center for Science in the Public Interest, and the Natural Resources Defense Council. Counsel included lawyers from Democracy Forward, a legal nonprofit.  

“The ‘Sunset Rule’ was an ill-considered and sweeping effort to deregulate healthcare and food safety, ax thousands of important public health protections, and tie the Department of Health and Human Services’ hands at the worst possible time – all without going through any of the legal requirements,” said the coalition’s statement. “This is a victory not only for our nation’s public health and healthcare sector but also for the millions of Americans, including more than 36 million children, who would have been hurt by the resulting regulatory chaos, uncertainty, and elimination of key protections.” 

This final rule was one of a few that Democratic lawmakers attempted to rollback using the Congressional Review Act. While they were successful on a few, the HHS rule was not one of them.