A controversial rule that threatened to invalidate thousands of existing health regulations, including protections for residents of senior living communities and other older adults, officially was withdrawn last week.
The U.S. Department of Health and Human Services published a final rule on Friday in the Federal Register withdrawing the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule. The withdrawal will be effective July 26.
“The SUNSET final rule, if implemented, would have significantly altered the operations of HHS with considerable negative repercussions for a diverse array of stakeholders,” the final rule reads. “We now conclude that these 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 estimates that withdrawing the rule will save the agency $70 million over 10 years.
If implemented, the rule “would have devastating consequences on the care, treatment and lives of residents in both nursing homes and assisted living residences,” leaders with the nonprofit National Consumer Voice for Quality Long-Term Care wrote in comments submitted in December 2020. The rule, the group said, would have adversely affected HHS’ ability to administer programs and ensure compliance with rules such as those governing the Long-Term Care Ombudsman Program and regulations such as those related to federal nursing home requirements of participation.
Some healthcare and consumer advocacy groups called the SUNSET rule a “ticking time bomb” and said it would create “incalculable costs and chaos,” according to a lawsuit filed last spring.
The SUNSET rule would have required HHS to review all 18,000 existing agency regulations before they automatically expired beginning in 2026. Among the affected agencies would have been the Centers for Medicare & Medicaid Services; the Administration for Community Living, which includes the Administration on Aging; the Health Resources and Services Administration, which administers COVID-19 relief; the Centers for Disease Control and Prevention; the Food and Drug Administration; and the National Institutes of Health. In addition to protections for the elderly and children, affected regulations would have included those governing Medicare and Medicaid, health insurance, pharmaceuticals and vaccines, mental health treatment, public health emergency prevention and preparedness, and food safety.
HHS’ withdrawal notice stated that the rule, introduced under the Trump administration, “lacked a public health or welfare rationale” for expediting rulemaking, that the expiration provision was unsound” and “unlawful,” and that the rule could “undermine the department’s ability to fulfill its public health and human services missions, promote national priorities and confront the challenges facing the nation.”
The SUNSET rule was proposed the day after the November 2020 federal election and finalized the day before President Joe Biden’s inauguration in January 2021.
Last fall, HHS sent a revised version of the proposed rule to the House House Office of Management and Budget. In March, the agency issued a notice delaying the effective date of the rule to Sept. 22.
