AAFP Calls on HHS to Halt Proposed SUNSET Rule

“The AAFP is concerned about the impact that this proposed rule could have on agencies’ ability to respond to the worsening COVID-19 pandemic and administer the health care coverage, payment and public health programs that family physicians and their patients depend on,” said the Dec. 2 letter to HHS Secretary Alex Azar.

The letter was in response to a proposed rule, Securing Updated and Necessary Statutory Evaluations Timely, published Nov. 4 in the Federal Register with an unusually abbreviated 30-day public-comment window applicable to most parts. It was signed by Board Chair Gary LeRoy, M.D., of Dayton, Ohio.

In a first, SUNSET would essentially affix expiration dates to federal regulations, compelling HHS and its agencies — including the CDC, the FDA and CMS — to review most of their rules within 10 years of enactment or else let them lapse. If finalized, it would require that some 2,500 existing regulations be assessed in the two years immediately following.

It would be a mammoth undertaking almost certain to leave numerous rules unreviewed and therefore in jeopardy. HHS anticipates it would have to spend as much as 78,000 hours on the initial push, despite the rule containing no funding mechanism.

A Nov. 5 MedPage Today article summarized SUNSET in stark terms: “In other words, any older rules that HHS fails to review during the two-year window would simply vanish from the Code of Federal Regulations.” The article also included reactions from several policy experts who expressed reservations about its broadness, intent and legality.

“You can’t get rid of regulations willy-nilly if the legislation driving them is still around,” Gail Wilensky, Ph.D., who worked at HHS and in the White House under President George H.W. Bush, told MedPage Today.

The Academy’s letter made a similar point, reminding HHS that the Regulatory Flexibility Act — which the agency cites as the mandate for its proposed rule — “does not provide for the sunsetting of regulations that are not reviewed.”

For that disconnect among other reasons, SUNSET has drawn widespread criticism, with various analyses concluding that it’s designed to hinder the next administration and would be time-consuming and costly to implement without yielding regulatory improvements.

The Academy objected to the new administrative burdens and harmful lack of clarity likely to emerge from a finalized SUNSET rule.

“While the AAFP supports efforts to reduce the regulatory burdens on physicians and recognizes the potential value of retrospective review, we believe this rule will increase regulatory complexity and lead to disruptions for a myriad of health care stakeholders,” the letter warned.

“In addition to causing disruption and uncertainty, the AAFP is concerned that this rule will interfere with agencies’ ability to perform their essential functions and promulgate important new regulations. Many of these functions are of even greater importance now, as our nation faces a growing COVID-19 case load and must undertake the process of reviewing and distributing new vaccines and therapeutics. If this proposed rule were implemented as proposed, we believe that the agencies administering health programs would be overburdened and the patients, physicians and other stakeholders they serve will be negatively impacted.”

The letter concluded by again urging HHS to rescind SUNSET.

“We instead recommend that HHS prioritize mitigating the impact of the pandemic and ensuring high-quality, affordable health care for all Americans,” the Academy wrote.