Trump Administration HHS Rule Challenged by Coalition of Non-Profits and California County

Six plaintiffs filed suit against the Department of Health and Human Services (HHS) on Tuesday over a rule the agency promulgated entirely within the prior administration’s “lame duck” period that the complainants describe as a “ticking timebomb set to go off in five years.…” The County of Santa Clara, the California Tribal Families Coalition, the National Association of Pediatric Nurse Practitioners, the American Lung Association, the Center for Science in the Public Interest, and the Natural Resources Defense Council’s complaint for declaratory and injunctive relief under the Administrative Procedure Act (APA) asks the Northern District of California to vacate and set the rule aside.

The 50-page filing explains that the HHS and its sub-agencies, like the Food and Drug Administration and the Centers for Medicare and Medicaid Services, administer a wide range of statutory programs that impact nearly every aspect of the nation’s healthcare system, which alone accounts for 20% of the United States’ economy, in addition to food and drug manufacturing, and social services systems. The programs reportedly operate pursuant to regulations that oversee health insurance, pharmaceuticals and vaccines, Medicare and Medicaid, and protections for children and the elderly, amongst many others, the complaint states.

The plaintiffs challenge the outgoing presidential administration’s “Sunset Rule,” which they claim masquerades as a Regulatory Flexibility Act (RFA) plan for periodically reviewing pre-existing regulations that impact small entities. In reality, the coalition asserts, the challenged Sunset Rule amends nearly all HHS regulations to include self-executing expiration dates. If effectuated, and absent HHS action otherwise, the Sunset Rule will cause approximately 17,200 regulations to “expire” in 2026, with additional regulations automatically terminating thereafter.

Reportedly, the only way to avoid the thousands of expirations is for HHS to conduct and finalize a rear-view review of each regulation, requiring a “resource-intensive and time-consuming effort on par with full notice-and-comment rulemaking, but at a pace 20 times faster than the Department has ever conducted retrospective review in the past—all without any guarantee that the Department will conduct such review.”

The plaintiffs argue that if it takes effect, the Sunset Rule threatens to derail federal programs amidst “incalculable costs and chaos.” They contend that the last-minute change was made without regard for required procedures, is contrary to law, and arbitrary and capricious in violation of the APA.

The plaintiffs are represented by the Democracy Forward Foundation, and the County of Santa Clara and the Center for Science in the Public Interest by their own counsel.