In early March, the Biden administration again delayed the implementation date of the Trump administration’s so-called SUNSET rule. The rule is now delayed until September 22.
“While HHS does not concede that plaintiffs would establish irreparable harm in litigation, HHS agrees that it is appropriate to postpone the effective date of the SUNSET final rule to preserve the status quo and to ensure that HHS has time to evaluate the rule before it takes effect to avoid the possibility of confusion among the regulated community,” the agency said.
SUNSET Rule
The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule was proposed in November 2020 and finalized the day before President Trump left office. It requires that any regulation issued by HHS, with certain exceptions, will cease to be effective 10 years after it is issued, unless HHS assesses the regulation and decides it is still useful and is not unduly burdensome. The department also gave itself 5 years to review all regulations on the books that were already more than 10 years old.
Several healthcare groups including the American Lung Association sued to halt the rule in March 2021. The groups argued in court that the rule was a “ticking timebomb” that would drain HHS resources and was approved in violation of federal law.
However, in March of 2021, the Biden administration delayed the rule’s implementation for one year, until March 2022, so it could be reviewed. “On March 9, 2021, a lawsuit was filed seeking to overturn the SUNSET final rule,” HHS said in a Federal Register notice. “HHS finds that the interests of justice require that the SUNSET final rule’s effective date be postponed pending judicial review” because a court could reasonably find merit in the plaintiffs’ claims and because the suit’s allegations of harm are “credible,” the agency said.
At the same time, the Biden administration has also been trying to get the rule withdrawn completely. In October 2021, HHS issued a proposed regulation to “withdraw or repeal the SUNSET final rule in its entirety.”
“The SUNSET final rule, if implemented, would significantly alter the operations of HHS with considerable repercussions for a diverse array of stakeholders,” HHS wrote. “The rule is expansive in scope and impact, faced considerable opposition from stakeholders (and very little support), and lacked a public health or welfare rationale for expediting rulemaking.”
That withdrawal process is still continuing, HHS said in early March’s Federal Register announcement. “The comment period on the Withdrawal [proposed rule] closed on December 28, 2021, and HHS received approximately 80 comments. HHS is actively engaged in considering the comments and developing a final rule.”