Chevron Doctrine is a ‘punch in the gut’ to US healthcare…

In a far-reaching ruling, the Supreme Court’s conservative supermajority in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce ruled last week that the opposite rule should apply, meaning that courts have the final say even on highly technical rules.

“This was a gut punch for health, safety and the environment in the United States,” said Prof. Lawrence O’Gostin, a health law expert and professor at the O’Neill Institute at Georgetown Law. “There will be no area where agencies operate to protect public health, safety or the environment that this ruling will not negatively impact.”

Liberal Justice Elena Kagan predicted the decision would “shake up” the legal system because it would dismantle a framework that had become part of the “warp and woof of modern government.”

Coupled with a second, less publicized ruling that extended the time to sue the agency, experts say the end of the Chevron Doctrine will certainly be felt in the everyday lives of Americans.

For example, the tobacco industry might have an easier time challenging controversial regulations on vaping products; drugmakers might confront new uncertainties by investing millions in new research and development; and doctors might have an easier time challenging regulations that ban sending patients surprise bills for medical treatment. In turn, agencies could redirect funds from experts like scientists to lawyers who can defend their decisions.

Meanwhile, the court’s opinion was praised by big business and Republican allies. Senator Mitch McConnell said the decision “leaves no room for an unelected bureaucracy to seize this power for itself,” CNBC reported.

The Chevron Doctrine is named for the 1983 Supreme Court case Chevron v. Natural Resources Defense Council (NRDC). At the heart of the Reagan administration’s deregulation drive, the court sided with the U.S. Environmental Protection Agency (EPA), which at the time had issued a regulation that environmentalists viewed as industry-friendly.

Chevron quickly became a landmark in opinion. By the late 1980s, the Chevron frame appeared in 40% of Supreme Court opinions, rising to 60% in the 1990s. One of the doctrine’s biggest advocates was conservative Justice Antonin Scalia, according to an article by Columbia Law School professor Thomas Merrill, a Federalist Society fellow and expert on the subject. As of 2014, Chevron was garnering about 1,000 new legal challenges per year from lower courts.

“It is no exaggeration to say that Chevron has become one of the few decisions—along with Marbury v Madison, Brown v Board of Education, and Roe v Wade—that provide material for an ongoing collective meditation on the role of courts, and indeed of law itself, in the governance of our society,” Merrill wrote.

What has changed philosophically for conservatives is a matter of debate. The Supreme Court has not cited Chevron in its last eight years of rulings, ScotusBlog reported.

There’s no doubt how the political landscape has changed since the 1980s, when the courts were handed over to Reagan’s deregulatory agencies. The country’s courts are now much more conservative, as the Trump administration has effectively appointed nearly a third of the federal judiciary.

In a dissenting opinion by liberal Justice Elena Kagan, joined by liberal colleagues Ketanji Brown Jackson and Sonya Sotomayor, the judge wrote that the court had “in one fell swoop” asserted “exclusive authority over every open question — no matter how expert-based or policy-laden — involving the meaning of regulatory law.”

Experts say the decision could have particularly dire consequences for agencies involved in highly technical work, such as the FDA, the Environmental Protection Agency (EPA) and the Centers for Medicare & Medicaid Services (CMS).

“This case has profound implications, especially for the FDA, because over time the agency has had a lot of new developments,” said Dr. Reshma Ramachandran, an assistant professor of family medicine at Yale School of Medicine and an expert in health policy.

Were it not for the Chevron doctrine, which requires courts to defer to agency expertise, judges could be the final arbiters on how to regulate a new cell or gene therapy “that really falls outside the statutory definitions” of the 1960s, she said.

“This goes back to one of the questions (the judges) asked the lawyers who questioned Chevron’s deference,” Ramachandran said. “Do you think the courts have enough expertise for judges to be able to determine the difference between a drug and a dietary supplement?”

Or, to name a few more technical legal issues, what is a medical device for regulatory purposes? Is a diagnostic test a medical device? Or, to take the example Kagan used, how should Medicare measure geographic area for the purpose of determining payments to physicians?

Repealing the Chevron Act likely won’t completely collapse administrative agencies overnight—agencies will still be able to enact regulations, collect data, and issue regulations and guidance.

“It’s still a little early to tell how Congress is going to change the rules and the laws,” said Jeffrey Davis, a health policy consultant at McDermott Consulting, a lobbying and policy firm in Washington.

But Davis said the ruling would put more pressure on Congress to be clearer about its intentions. And more pressure on Congress could mean greater influence from special interests as the bill is drafted.

Health care is already the most profitable industry group in Washington. In 2023, pharmaceutical and health product companies spent $382 million lobbying federal lawmakers, according to OpenSecrets, a research group that tracks spending.

The ruling could also increase “court shopping,” as lawyers seek out friendly venues. In one recent example of court shopping, lawyers seeking to challenge the FDA’s approval of the abortion drug mifepristone took their case to a highly conservative Texas district court, where a judge known for his anti-abortion views ultimately ruled in their favor.

“There are going to be a lot, a lot of work in some courts around the country,” Davis said.