November 1, 2021, 1:05 p.m. News Staff — In a win for the Academy’s advocacy, HHS on Oct. 29 proposed to withdraw a controversial rule mandating that thousands of existing health care-related regulations be reviewed or rescinded. The AAFP had objected to the rule’s administrative burdens and harmful lack of clarity.
The rule, Securing Updated and Necessary Statutory Evaluations Timely, requires expiration dates for federal regulations, a new mandate 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. It would affect some 2,500 existing regulations over its first two years. Despite the rule’s lack of a designated funding mechanism, HHS estimated 78,000 hours of labor would be required to complete the reviews — a figure the proposed withdrawal now suggests was an underestimation.
SUNSET was announced Nov. 4, 2020, and given an unusually abbreviated 30-day public comment window, during which the Academy (among numerous other stakeholders) called on HHS to withdraw the 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 Academy cautioned in a Dec. 2, 2020, letter to (then) HHS Secretary Alex Azar.
The rule was finalized on Jan. 19, 2021, the last day of the previous administration. HHS has acknowledged that nearly all of the roughly 500 written responses it received during SUNSET’s comment period opposed the rule. Analyses suggested it would be time-consuming and costly without yielding regulatory improvements.
Days ahead of the rule’s scheduled March 22 effective date, HHS said it would delay implementation until 2022 — a reprieve that in itself answered one of the Academy’s warnings.
“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,” the December 2020 letter said. “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.”
This week’s proposed withdrawal of the rule is expected to become final in early 2022.