Recent court rulings imperil public health and patient protections

Many federal rules that safeguard public health and shield patients from industry abuses face uncertain futures as a result of conservative-driven court opinions that undercut the authority of regulators.

A series of rulings has expanded the power of judges to second-guess the decisions of federal scientists and other government experts, potentially eroding the power of agencies such as the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), and the Environmental Protection Agency (EPA).

In light of this new legal landscape, journalists may want to consider asking lawmakers, regulators and regulated entities about the potential impact of court challenges when reporting on both new and existing regulations.

Here’s what experts have to say about two recent opinions: one has been decided and one is still working its way through the courts.

Loss of Chevron deference will have a wide-ranging impact

Many health care regulations are endangered by the Supreme Court’s stunning decision to overturn the Chevron doctrine. This decades-old legal precedent required judges to defer to an expert agency’s reasonable interpretation of an unclear statute.

Although the cases at hand pertained to the fishing industry, legal experts say the opinion invites a surge of litigation against agency regulations related to public health and health care. In a separate opinion, the Supreme Court expanded the time frame to sue federal agencies, opening up more potential challenges to federal rules.

Federal agencies can be expected to be more cautious and detailed in their rulemaking to fend off industry challenges, former deputy CMS administrator Cindy Mann, J.D., noted at a recent KFF Health Wonk Shop.

The decision will also make it harder for Congress to write legislation, said Dean Rosen, a former chief health care advisor to former Senate Majority Leader Bill Frist. Lawmakers often leave laws intentionally vague for political and pragmatic reasons, he added.

Speakers at the KFF forum expressed concern that the new legal environment will impede the government’s ability to act nimbly amid industry changes and public health emergencies.

The law firm Baker Donelson listed potential hotbeds for lawsuits against the federal government:

Medicare reimbursement.
Medicare and Medicaid coverage.
Medicare and Medicaid administration.
The nondiscrimination requirement of the Affordable Care Act (ACA).
FDA oversight of food, drugs and medical devices.
Social Security and disability benefits.
Health care fraud and abuse laws such as the Anti-Kickback Statute.
Long-term care certification.

The ruling may provide new openings for industry challenges of federal measures such as the introduction of Medicare drug price negotiations, surprise medical billing rules, preventive health care services under the ACA, pandemic-related public health measures, and patient privacy protections under the Health Insurance Portability and Accountability Act.

Here are a few examples of what’s at stake:

According to a report by MedTech Dive, an early indication of how the ruling could be applied is expected in the FDA’s recent move to regulate laboratory-developed tests. A trade group, the American Clinical Laboratory Association, has filed suit to stop the FDA from stepping up oversight of its members’ tests.
Skilled Nursing News reported that the ruling “further opens the door” for the nursing home industry to challenge a recently finalized federal minimum staffing rule for nursing homes.
The Washington Post reported that tobacco companies could use the ruling to resist an attempt by the Biden administration to ban menthol cigarettes.

Braidwood case threatens coverage of preventive services

A ruling issued by the ultra-conservative Fifth Circuit Court of Appeals has put the ACA’s preventive services coverage requirement and the preventive care of millions of Americans in jeopardy, according to attorney Richard Hughes, who wrote about the case in Health Affairs.

The decision backed a lower-court ruling that the role of the U.S. Preventive Services Task Force in determining mandatory preventive coverage under the ACA is unconstitutional. Under the ACA’s mandatory coverage requirement, almost all health insurers must cover a long list of preventive care services without paying a deductible, copayment or coinsurance.

One of the plaintiffs in the case, Braidwood Management, is a Christian-owned business challenging the requirement that most health insurers and employers must cover certain preventive care services at no cost to patients. The defendant is U.S. Secretary of Health and Human Services Xavier Becerra.

As AHCJ’s prior coverage explained, at stake is whether 150 million people with private health insurance through employers and about 80 million Americans with Medicare and Medicaid will continue to have access to preventive care without having to pay out of pocket.

In their ruling, the Fifth Circuit judges wrote that their decision to send the case back to the lower court was a “mixed bag.” As Hughes, a partner in the law firm of Epstein, Becker & Green and a lecturer at The George Washington University Law School, explained, the appeals court held at bay any nationwide injunction of the ACA’s mandate, meaning that part of the law is safe — for now.

However, the plaintiffs could seek another path to strike down the mandate nationwide, and future rulings could affect coverage for disease screenings, vaccines, contraceptives and coverage for pre-exposure prophylaxis (PrEP) drugs that are effective in preventing the transmission of HIV, as we explained in this article.

The case does not address the role of two other agencies that Congress also charged with guiding policy on preventive services coverage: the Advisory Committee on Immunization Practices (ACIP) for vaccines and immunizations and the Health Resources and Services Administration (HRSA) for children’s and women’s preventive services and screenings.

However, the Fifth Circuit’s ruling “provided new legal ammunition to undermine them,” Hughes wrote.