WASHINGTON — It finally happened: the SUNSET rule has really ridden off into the — well, you know.
The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule, first proposed in November 2020 and finalized the day before President Trump left office, 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’s 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.
Last March, the Biden administration delayed the rule’s implementation for 1 year, until March 2022, so it could be reviewed; HHS noted that a lawsuit had been filed seeking to overturn the rule. A review was therefore needed because the suit’s allegations of harm were “credible,” HHS said in a Federal Register notice. On March 3, the administration again delayed the rule’s implementation — this time until September 22 — 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.”
While this has been going on, the Biden administration has also been proceeding along another avenue — trying to get the rule withdrawn completely.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.” It is the latter process — a complete withdrawal — that the agency has now finished, posting a final rule on Friday in the Federal Register formalizing the SUNSET rule’s withdrawal. HHS estimated a cost savings for withdrawing the SUNSET rule of $69.9 million in 2020 dollars, annualized over 10 years, using a 3% discount rate.
In the final withdrawal rule, HHS catalogued its flaws in the previous rulemaking. “First, the department should have engaged in a more thorough consideration of the comments, and should have given greater weight to the potential harms to stakeholders and the public health,” the agency wrote. “We have found that there were several procedural shortcuts taken in issuing the SUNSET final rule which may have impeded full consideration of the commenters’ significant objections to the proposal, as well as the care and meticulousness devoted to the final product.”
For example, “the SUNSET final rule was issued on a timeline of less than 3 months, which is unusually expedited for a rule of this significance, particularly given the potential impacts not just on small businesses but also the general public, larger businesses, tribes, states, non-governmental organizations, and other regulated entities and stakeholders across a wide range of industrial sectors,” the notice said.
“The SUNSET rule was also remarkably expansive in scope, requiring review and possibly regulatory or deregulatory activity across a variety of distinct substantive statutes within the jurisdiction of several operating divisions (e.g., CMS, FDA, CDC, Substance Abuse and Mental Health Services Administration, the Office for Civil Rights, and the Administration for Children and Families). However, it appears that the comments were not adequately considered … and, contrary to policy, the department did not consult with tribal governments.”
“Second, the department should have more thoroughly examined the factual basis of the SUNSET final rule before issuing it,” the agency continued. “We have now concluded that the rule rested on a flawed understanding of the resources required for implementing the SUNSET final rule,” and likely would have caused HHS regulations to expire and force HHS “to make resource allocation decisions which could have impeded the department’s ability to carry out other key priorities.”
HHS also determined, the SUNSET rule “is contrary to several policy goals of the current administration” — for example, “the current administration’s policy is to equip executive departments and agencies with flexibility to use available tools such as robust regulatory action to confront the urgent challenges facing the nation, including the COVID-19 pandemic, economic recovery, racial justice, and climate change.”
Authors noted: “numerous commenters expressed concern about the anticipated impacts on various populations, including children, the elderly, the disabled, those living in poverty, and communities marginalized by racism and prejudice, who could lose eligibility for programs and services if the regulations underpinning the eligibility requirements were to expire.”
The Medical Group Management Association (MGMA), a lobbying group for physician practices, was happy to see the rule disappear. “After 15 months of waiting, MGMA is relieved to see that the Biden administration finally withdrew the SUNSET rule,” Claire Ernst, JD, MGMA’s director of government affairs, said in a statement. “This rule, which was originally finalized right before the last administration left office, could have led to major disruptions and unintended consequences for medical groups and the patients they treat.” (Disclosure: Anders Gilberg, MGMA’s senior vice president for government affairs, is a member of MedPage Today’s editorial board.)
The rule may be gone, but the concept behind it is still floating around in Republican circles. Sen. Rick Scott (R-Fla.) has proposed that all federal legislation sunset within 5 years. “If a law is worth keeping, Congress can pass it again,” Scott said in a policy booklet he published entitled “An 11-Point Plan to Rescue America.” The plan has garnered intense opposition, with the Michigan Democratic Party noting that “the plan would raise taxes on tens of millions of Americans and … [require] Congress to re-authorize every federal law, including those governing Medicare, Medicaid, and Social Security. This could create an opening for Republicans to ultimately kill those programs, if they so desire.”