The Supreme Court’s June 28 decision to overturn a long-standing principle known as the Chevron doctrine beefed up the power of courts and diminished the power of federal agencies, particularly ones that oversee medicine and public health.

The basis of a 1984 Supreme Court decision in a case involving the Chevron Corporation and the National Resource Defense Council, the Chevron doctrine called for courts to defer to the judgment of regulatory agency experts in cases where ambiguous language in a law left questions about how to interpret that law.

The rationale for allowing the deference was that federal agencies have specific subject expertise that the courts lack, and thus may be better suited to resolve uncertainties in laws about the fields they regulate.

The decision to overturn the doctrine 40 years later — in a case involving a group of fishing companies — has been denounced by many health policy scholars. They argue that the Chevron doctrine helped federal agencies to ensure the safety and effectiveness of drugs and medical devices, respond to crises like the COVID-19 pandemic, and oversee both private insurance plans and the Medicare and Medicaid programs.

For any journalist who covers health care in America, it’s important to understand the possible consequences of overturning the Chevron doctrine. In this article, we will discuss:

• A brief history of the Chevron doctrine and examples of how courts deferred to regulatory experts in health-related cases before the Supreme Court voted to overturn it.
• How the Chevron doctrine was overturned.
• How the Supreme Court’s decision relates to an ongoing dispute about gender identity discrimination.
• What journalists can learn from amicus (friend of the court) briefs when covering the implication of Supreme Court decisions. In this case, the amicus briefs make clear the broader clash of interests, with a coalition of medical groups defending the Chevron doctrine and conservative and business groups seeking to upend it.
• Recently published papers in medical and policy journals, in which legal scholars and public health experts discuss the potential implications of the Chevron decision.

A brief history of the Chevron doctrine

The Chevron doctrine emerged from a disagreement about how Environmental Protection Agency Administrator Anne Gorsuch, working under then President Ronald Reagan’s administration, was carrying out Clean Air Act mandates.

Chevron favored the Reagan administration’s approach to implementing the rule. The Natural Resources Defense Council, a large environmental advocacy group, did not. Their battles made it all the way to the Supreme Court. At issue was a disagreement about what constituted a stationary source of pollution, something that Congress had not explicitly defined in the language of the Clean Air Act.

In the 1984 case known as Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., the Supreme Court sided with the EPA. Thus, the EPA’s definition could serve, the Supreme Court said. This established a precedent for allowing deference to federal agencies in cases where laws were not clear. Application of the Chevron doctrine is often called “Chevron deference.”

Interesting fact: Anne Gorsuch was the mother of current Supreme Court Justice Neil Gorsuch. See USA Today’s story “Mother doesn't always know best: Supreme Court Justice Gorsuch overturns his mom's victory” for more details on this.

Chevron in action: historical examples

This Chevron deference was considered particularly important in areas where federal agencies possessed technical subject expertise that members of Congress and their staff were unlikely to rival. These agences included the Food and Drug Administration and Centers for Medicare and Medicaid Services.

Most of the cases relying on the Chevron doctrine were settled in federal circuit courts and didn’t rise to the Supreme Court.

When asked to suggest historical cases that relied on Chevron, Andrew Twinamatsiko, the director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute, cited the 2006 decision in Bellevue Hospital v. Leavitt. (Michael Leavitt was then the Secretary of Health and Human Services. The case was settled in the U.S. Court of Appeals, Second Circuit in New York.)

This case involved adjustment to Medicare payments to reflect differences in hospital wage levels across “geographic areas.” The term “geographic area” in the Medicare statute was not clearly defined by law and, under the Chevron doctrine, the court deferred to the CMS decision to use Metropolitan Statistical Areas formulated by the Office of Management and Budget.

Another example: In a 2020 case known as Teva Pharm. USA, Inc. v. FDA, a federal district court judge in the U.S. District Court for the District of Columbia cited Chevron in backing the agency’s view on a protein definition in a case about follow-on copies of biotech drugs.

There were also cases in which the Supreme Court cited the Chevron doctrine in decisions that sided with federal agencies. But in the decade leading up to overturning it, the Supreme Court had moved away from backing Chevron, which had been long under attack by opponents of government regulation. The Supreme Court had not relied on the Chevron doctrine to rule in favor of an agency since 2016, a fact noted in the majority opinion that overturned it.

How the Chevron doctrine was overturned

The case that led to the end of the Chevron doctrine ostensibly began with a complaint from three New Jersey fishermen about a 2020 federal rule change. The new rule made them responsible for the salaries of the federal employees paid to monitor their herring catch. In a lawsuit, they contended that the National Marine Fisheries Service didn’t have legal authority to make them pay the salaries of these government observers, a cost they claimed imperiled their small businesses.

The U.S. Court of Appeals for the D.C. Circuit invoked the Chevron doctrine, deferring to NMFS’ interpretation of the law. The fishermen challenged the decision. Backing these three fishermen were many conservative groups, which had long pressed for an end to the Chevron doctrine. The case ultimately reached the Supreme Court.  Known as Loper Bright Enterprises v. Raimondo, the case involved several consolidated similar complaints from fishing companies.

On June 28, six out of nine Supreme Justices, all of whom were nominated to the Court by Republican presidents, voted to overturn the Chevron doctrine via the Loper Bright case, describing it as an overreach of federal agency power.

“Chevron’s presumption is misguided because agencies have no special competence in resolving statutory ambiguities. Courts do,” writes Chief Justice John Roberts in the majority opinion.

In a concurring decision, Justice Neil Gorsuch maintains that the Chevron doctrine was “at odds with our separation of powers,” giving extra clout to an already-powerful litigant, the federal government.

“Along the way, Chevron deference guarantees ‘systematic bias’ in favor of whichever political party currently holds the levers of executive power,” Gorsuch writes.

In a dissenting opinion, Justice Elena Kagan writes, “In one fell swoop, the majority today gives itself exclusive power over every open issue — no matter how expertise-driven or policy-laden — involving the meaning of regulatory law. As if it did not have enough on its plate, the majority turns itself into the country’s administrative czar.”

She describes this decision by the majority of her colleagues as having moved the judiciary well beyond not only its intended role, but also beyond its capabilities — citing multiple health-related examples from caselaw in which subject expertise played a role.

For example, Kagan cites a recent case about a Food and Drug Administration decision regarding a drug for multiple sclerosis. The dispute centered on a question about whether a certain kind of amino acid qualifies as a protein.

“I don’t know many judges who would feel confident resolving that issue. (First question: What even is an alpha amino acid polymer?),” Kagan writes. “But the FDA likely has scores of scientists on staff who can think intelligently about it, maybe collaborate with each other on its finer points, and arrive at a sensible answer.”

The upending of theChevron doctrine could leave the United States struggling to manage public health programs and regulate artificial intelligence, Kagan writes.

Legal scholars and experts in health policy see the decision as part of a larger trend.

Federal courts have for years been seeking to restrict the power of government agencies, which may hamper agencies’ attempts to respond to emerging health threats, write Michael S. Sinha of St. Louis University, Wendy E. Parmet of Northeastern University and Gregg S. Gonsalves of Yale University in a recent “Perspective” article in the New England Journal of Medicine. For example, they cite recent decisions blocking vaccine mandates for federal contractors and the Center for Disease Control and Prevention’s mask mandate for public transportation.

“Such rulings mean that federal health agencies would most likely need explicit authorization from Congress before they could take critical measures to slow the spread of a new pandemic in the United States,” they write.

Citation of the Supreme Court decision in a gender discrimination case

Less than a week after the Supreme Court delivered Loper Bright decision, three federal judges cited the decision in cases meant to block a gender-identity discrimination policy of the Biden administration.

Still at issue is the interpretation of Sec. 1557 in the Affordable Care Act of 2010, which broadly prohibits discrimination in medical care for any entity that receives federal funds. Democratic and Republican presidents have disagreed about how these protections apply to questions of gender identity.

In 2016, the Obama administration issued a rule intended to apply Sec. 1557 protections clearly to cases involving gender identity.

The Trump administration in 2020 reversed this stance, issuing a rule that limited the definition of sex to the “biological binary of male and female that human beings share with other mammals.” That rule faced legal challenges.

In May 2024, the Biden administration’s Department of Health and Human Services finalized a federal rule that broadly addressed discrimination in health care services included a section intended to solidify protection of transgender people. That rule was meant to go into effect in July.

But on July 3, three U.S. district court decisions were issued to block the section of the rule applying to gender-identity issues. All three decisions cited the Loper Bright decision that overturned the Chevron doctrine, something for journalists to keep in mind as they track the issue both locally and nationally.

• Judge Louis Guirola Jr. of the U.S. District Court, for the Southern District of Mississippi issued a nationwide injunction, citing the overturning of Chevron to argue that HHS had overstepped in issuing the rule. The plaintiffs argued that the policies would compel use of taxpayer funds to pay for gender-transition interventions through Medicaid and state health plans. This case is known as Tennessee vs. Becerra; Xavier Becerra is the secretary of HHS. (Joining Tennessee in this case were Mississippi, Alabama, Georgia, Indiana, Kansas, Kentucky, Louisiana, Nebraska, Ohio, Oklahoma, South Carolina, South Dakota, Virginia, and West Virginia.)
  

• Judge Jeremy Daniel Kernodle of the United States District Court for the Eastern District of Texas issued a stay, or a halt, of the gender-discrimination parts of the rule in Texas and Montana. Kernolde focused on the states having banned transgender medical care for minors, saying the federal rule was intended to force them to pay for prohibited treatments. In his July 3 order, which also cited the overturning of Chevron, Kernold wrote that “federal agencies are attempting to impose a sweeping new social policy by manipulating and perverting the statutory text that constrains them.” This case is known as Texas v. Becerra.
  

• Judge William F. Jung of the United States District Court for the Middle District of Florida blocked the anti-gender discrimination section of the rule from taking effect in that state. In his decision, Jung referred to this case as showing “the wisdom of Loper’s statement that ‘agencies have no special competence in resolving statutory ambiguities’.’” That case is known as Florida vs. HHS.
  

Amicus briefs as journalistic source documents

Before deciding a case, courts routinely accept written filings from parties that establish they have a valid interest in cases, even if they are not directly involved in them. These filings, known as amicus curiae briefs, are submitted in hopes that the courts will consider them when in their decisions.

The Supreme Court posts the amicus briefs it receives on its website, organized by case. If you’re a journalist who covers health care or legal systems in the U.S., consider following up with people who submitted briefs.

Journalists seeking local angles for stories on the impact of the June 8 decision may find them in these amicus briefs. For example, there was a brief filed by the state of West Virginia, in which 26 other Republican-led states argued in favor of overturning  the Chevron doctrine. Another brief, filed by the District of Columbia and several mostly Democrat-led states, argued in favor of keeping Chevron. There also were briefs from individual members of Congress and law professors from different parts of the nation.

Conservative groups including the Cato Institute used amicus briefs to urge the Supreme Court to use the fishermen’s case to overturn the Chevron doctrine, a goal they had long supported.

In a December 2022 brief, Cato argues that Chevron was “ahistorical” in American law, stating, “It was not until the mid-twentieth century that courts ever gave substantial deference to an agency’s interpretation simply because it was the agency’s interpretation.”

In its amicus brief, the Chamber of Commerce also urges the Supreme Court to overturn the Chevron doctrine. In addition to echoing arguments about overreach by federal agencies, the chamber argued the Chevron doctrine was “bad for free enterprise.”

“Today’s morass of regulations, aggravated and encouraged by the expansion of Chevron, imposes astronomical costs in compliance, lost productivity, and higher prices,” the Chamber of Commerce states.

A brief filed on behalf of the companies who make electronic nicotine delivery systems, such as vapes, argues that the Chevron doctrine helped the FDA overreach authority granted under the federal Family Smoking Prevention and Tobacco Control Act (TCA). They criticize the FDA for focusing on the health risks to youth and discounting the use of e-cigarettes to help adults quit smoking tobacco cigarettes.

“In a world where Chevron deference is routinely doled out by lower courts, it is no surprise FDA has pushed its interpretation of the TCA to one extreme,” they write. “Chevron signals to agencies they are free to find whatever statutory ambiguity is needed to justify a particular outcome and courts will defer even to those interpretations that land well beyond any common sense reading of a statute.”

Other amicus briefs urge restraint, many noting that the Supreme Court had options for addressing the fishermen’s complaint without striking the Chevron doctrine. 

Among these is a September 2023 brief from a coalition of medical groups, including the American Cancer Society and the American Academy of Pediatrics. The groups argue that Chevron allows needed flexibility for federal officials to manage complex health programs such as Medicaid and Medicare.

“Carrying out that responsibility requires making policy-laden interpretive determinations – including through formal rulemaking, adjudication, informal interpretation, and other means – concerning how each particular statute applies in countless unpredictable real-world settings and circumstances,” the medical groups write.

Other signers to that brief include the American Public Health Association, the American Heart Association and the American Lung Association. The medical groups acknowledge that there will be disagreements at times about the decisions of federal agencies.

Still, “it is constitutionally permissible and vastly preferable for such authority to lie with a centralized agency, staffed with subject matter experts and accountable to the President, Congress and the courts, rather than expect that Congress or the courts would be willing or able to assume such a role,” they write.

The American Association for the Advancement of Science makes a similar argument in another September 2023 amicus brief, arguing that “agencies with scientific and technical expertise are often best placed to handle the rapidly changing nature of science and technology—as well as to take into account and balance the input of myriad stakeholders—in order to develop programs and regulations for fulfilling their statutorily-based missions (e.g., public safety, health, environmental protection, etc.) in the public interest.”

AAAS’s brief specifically cites the challenges of keeping up with the quickly evolving artificial intelligence industry.

TIP: Also keep in mind the Congressional Record. It posts speeches given on the floors of the Senate and House. This is a great place to search when trying to find lawmakers with an interest in any subject. In this case, a search on the word “Chevron” turns up speeches by Majority Leader Charles E. Schumer (D-NY) criticizing the Supreme Court and Rep. Virginia Foxx (R-NC) lauding the Court’s decision.

What health policy scholars say

Below are summaries of some recent articles on the potential impact of the Loper Bright decision, published in prestigious health and medical journals. They look at topics including Medicare coverage decisions and the regulation of medical tests.

Loper Bright And The Death Of Deference In The Administration Of Health Policy
Wendy E. Parmet. Health Affairs, July 2024.

The Loper Bright decision is only one of a recent string of Supreme Court decisions that seek to curb the authority of federal agencies, writes Wendy E. Parmet, faculty director at the Center for Health Policy and Law at Northeastern University.

The Supreme Court for years “chipped away at the Chevron doctrine by articulating what has become known as ‘the major questions doctrine’ under which the Court denies agencies the authority to regulate on so-called major questions without explicit Congressional authorization,” Parmet writes.

In the 2022 decision in the West Virginia v. EPA, the Supreme Court used this major questions doctrine to scuttle Environmental Protection Agency’s efforts to address climate change, Parmet writes. Another decision that year, National Federation of Independent Businesses v. OSHA, overturned an Occupational Safety and Health Administration order requiring larger employers to mandate either COVID vaccines or masking and testing.

The July 2024 decision in Corner Post, Inc. v. Board of Governors is especially concerning, Parmet writes.

In it, the Supreme Court held that the statute of limitations for challenges to agency regulations does not start to run until a person or company is initially subject to the regulation, rather than when the regulation goes into effect. That means newly created entities, including ones created for the purpose of litigation, could challenge long-settled regulations, Parmet writes.

 “Taken together, such rulings invite regulated industries to challenge government regulations. They also make it far more difficult for agencies to protect the nation’s health,” Parmet writes.

Ramifications of the Supreme Court’s Latest Term for Health Regulation
Lee A. Fleisher, Anne Joseph O’Connell and Michelle M. Mello. JAMA, August 2024.

One of the federal government’s most powerful tools for setting health policy is the conditions of participation (often abbreviated as CoPs in health policy documents) set on hospitals to qualify Medicare payments. Most hospitals and health organizations depend heavily on the program’s payments.

The Loper Bright decision may attract more legal challenges to Medicare’s decisions on its conditions of participation, the authors write.

The Social Security Act, a federal law that also governs Medicare, requires that hospitals meet requirements deemed “necessary in the interest of the health and safety of individuals who are furnished services” in these institutes.      

The Centers for Medicare and Medicaid Services has interpreted this as supporting a wide range of conditions that can be set as part of the conditions to participate in their programs. These      requirements have long provoked legal challenges, such as a suit challenging recently finalized nursing home staffing requirements.

But recent Supreme Court decisions such as the upending of the Chevron doctrine will encourage opponents of federal rules to challenge them, Fleisher, O’Connell and Mello write. That raises the risk of successful litigation against bolder CMS initiatives intended to protect public health and address inequities, they write.

“Even if courts ultimately answer such questions in agencies’ favor, increased litigation will create uncertainty among regulated entities about whether both new and old policies will stick. Uncertainty may also prompt agencies to craft narrower policies to reduce the chance of lawsuits, which—win or lose—involve costs,” the authors write.

The Supreme Court’s Loper Bright Ruling: Implications for Clinical Testing, Innovation, and Public Health
David A. Simon, Michael J. Young. JAMA, August 2024.

The Loper Bright decision may make public health agencies like the FDA more cautious and hesitant in addressing new problems facing medicine and society, the authors write.

In their viewpoint article, they look at the long-standing thorny issue of regulations of medical tests.

Congress has largely left it so far to the FDA to try to address concerns about the quality and accuracy of many medical tests.

Some companies get FDA clearances for their products, but others opt for a less burdensome pathway and get CMS to certify the labs where the tests are done. This second class of products are known as lab-developed tests. Lab-developed tests today include many widely used commercial products. Companies have resisted FDA’s attempts to expand its regulation of medical tests, which now play an increasingly large role in fields like oncology.

The Loper Bright decision could force Congress to finally address issues about lab-developed tests, but its effects could be negative in many other ways, Simon and Young write. Courts may try to define or second guess the FDA on decisions about whether drug and medical devices should be sold in the United States, they argue.

“Because judges may have more active roles in defining agency authority, federal agencies may have correspondingly less robust roles in policymaking. Many of these actions may be challenged under Loper Bright and have a better chance of succeeding. If FDA expertise is supplanted by judicial expertise in these or other cases, there is a significant risk that Loper Bright could undermine public health,” the authors write.

Supreme Power — The Loss of Judicial Deference to Health Agencies
Rachel E. Sachs and Erin C. Fuse Brown. New England Journal of Medicine, July 2024.

The Loper Bright case could bring challenges to Medicare’s payment policies, a subject on which courts long deferred to the technical expertise of the CMS staff, Sachs and Fuse Brown write.

They cite as an example previous unsuccessful legal challenges on the question of how to compensate hospitals for time medical residents spend conducting research.

With the Chevron doctrine overturned, there may be judicial decisions that actually disrupt billions of dollars of Medicare reimbursements, they write

“Well-funded industry actors will now have an incentive to challenge every unfavorable payment rule, hoping to convince a court to adopt their preferred interpretation of a particular statute. The result is likely to be greater uncertainty, more litigation, and generalist judges making consequential and often technical determinations about Medicare payment policies,” the authors write.

Additional resources and relevant podcasts

• The Health Care Litigation Tracker from Georgetown’s O’Neill Institute focuses on issues involving health equity and access to care. “We’re lawyers who speak and write like non-lawyers,” say the authors of this website.
• Oyez (pronounced OH-yay) — a free law project from Cornell’s Legal Information Institute, Justia, and Chicago-Kent College of Law — is a multimedia archive of Supreme Court documents and recordings.

Podcasts

• The Chevron Deference is Dead. What Now? w/ Andrew Twinamatsiko, Health Affairs This Week, July 2024.
• SCOTUS Ruling Strips Power from Federal Health Agencies, KFF Health News “What the Health” podcast, June 2024.

• What Are the Implications of the End of Chevron for U.S. Administrative Law? University of Pennsylvania’s Penn Program on Regulation, July 2024.

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