Health Care Handcuffed?

Last July, the U.S. Supreme Court handed down an opinion that many expect will have a significant effect on the operations of U.S. federal regulatory agencies, including those that are responsible for health care.

In Loper Bright Enterprises v. Raimondo, in a 6-2 decision (with Justice Ketanji Brown Jackson recused), the court overturned what is known as the Chevron deference doctrine (see SIDEBAR).¹ The Chevron doctrine stemmed from Chevron U.S.A. Inc. v. Natural Resources Defense Council, a case the Supreme Court decided in 1984, that allowed federal judges to defer to regulatory agencies’ expertise on how to interpret legislative statutes.²

“When Congress passes a law, they leave gaps — sometimes intentionally and sometimes unintentionally — and federal agencies are left to fill in those gaps so the legislation functions the way it was intended,” said Alexander McCourt, JD, PhD, MPH, assistant professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health.

To do that, Dr. McCourt said, the federal agencies employ experts who have worked in the field — health care, environmental sciences, technology, etc. — to make decisions about what the law intended.

“For decades there has been pushback on the idea that courts defer to the agencies,” Dr. McCourt said. “That culminated in Loper Bright, where, by overruling the Chevron doctrine, the court essentially pulled that power away from agencies and said that courts are making decisions to interpret ambiguous statutes.”

Why Overturn?

The decision set forth in Chevron U.S.A. Inc. v. Natural Resources Defense Council required courts to use a two-step framework to interpret statutes. First, the court had to assess if “Congress has directly spoken to the precise question at issue.” If the “statute is silent or ambiguous with respect to the specific issue,” then the court would defer to the agency’s interpretation. In the majority opinion for Loper Bright, the justices wrote that Chevron “prevents judges from judging” and “has proved to be fundamentally misguided.”¹

However, in the dissenting opinion for Loper Bright, the justices noted that “Congress knows that it does not — in fact, cannot — write perfectly complete regulatory statutes” and that “some interpretive issues arising in the regulatory context involve scientific or technical subject matter. Agencies have expertise in those areas; courts do not.”¹

So who wins with this decision? According to Andrew J. Twinamatsiko, JD, director of the Health Policy and the Law Initiative at O’Neill Institute for National and Global Health Law at Georgetown University, the decision is a win for those who desire less regulation.

“We have seen a trajectory in the last few years with courts taking away the authority that federal agencies have to respond to different phenomena,” Mr. Twinamatsiko said, citing examples of when the Supreme Court said the Centers for Disease Control and Prevention did not have the authority to impose a ban on evictions during the COVID-19 pandemic³ or the Occupational Safety and Health Administration could not mandate COVID-19 vaccination.⁴

“This decision is an outgrowth of those same forces, both within the business industry and the courts, trying to rein in what agencies can do to protect different public interests,” Mr. Twinamatsiko said.

Effects on Health Care

Many in the field of health policy were following Loper Bright, Dr. McCourt said, but it still came as a “bit of a shock to have this doctrine not narrowed or changed, but completely struck down.” This was especially true, he said, because the Chevron doctrine is so relevant to public health.

“We expect to see a flood of litigation to challenge all sorts of agency actions, whether with the U.S. Food and Drug Administration (FDA) and drug approvals or having to do with Medicare policies,” Dr. McCourt said. “Basically, anything that agencies touch could potentially be up for grabs.”

Erica N. White, JD, MPH, the Public Service and Leadership Development Fellow at Sandra Day O’Connor College of Law at Arizona State University, agreed. “Given that health care statutes like the Affordable Care Act (ACA) and those governing the Medicare and Medicaid programs are some of the most complex and, historically, some of the most politically contentious, health care agencies are among the most impacted federal agencies, both immediately post-Loper Bright and in the future.”

As an example, Mr. Twinamatsiko discussed a decision unveiled by the Department of Health and Human Services (HHS) early in April 2024 that clarified and reaffirmed the prohibition on discrimination on the basis of sex — including sexual orientation and gender identity — in specific health and human services programs.⁵ This interpretation was based on the ruling in Bostock v. Clayton County, in which the Supreme Court decided that Title VII of the Civil Rights Act of 1964, which prohibited employment discrimination on the basis of sex, also included sexual orientation.⁶

“The ACA incorporates protections based on sex into health care, and HHS said that based on the Court’s interpretation of discrimination [in Bostock], we are going to read that the ACA also protects against discrimination for LGBTQ+ individuals,” Mr. Twinamatsiko said.

However, shortly after Chevron was struck down, three courts in Texas, Mississippi, and Florida blocked the HHS rule, arguing that “sex” did not include gender identity.^7,8

“What this court said was that HHS does not have the authority to interpret this rule,” Mr. Twinamatsiko said. “The Loper Bright decision said the courts are best suited to determine how to read the statute.”

Agencies are most secure where power is given to them most explicitly, Dr. McCourt said, but even that is not foolproof. For example, the FDA is, among other things, granted authority to ensure “the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices”.⁹

“But what is a ‘medical device’? If a statute didn’t define it or only gives examples, in the past it would be up to the agency to say based on expertise or evidence, but now that may come down to whether a judge or a court thinks they can regulate it,” Dr. McCourt said.

Courts could also question how agencies complete the responsibilities they are tasked with, as was seen in FDA v. Alliance for Hippocratic Medicine.¹⁰ This lawsuit challenged the FDA’s regulation of the abortion pill mifepristone and called for nationwide restrictions on the drug’s availability. The suit was rejected because the justices ruled there wasn’t standing to sue, but they didn’t close the door for others to bring similar suits.

These court decisions could even affect the health insurance industry, according to Ms. White, where even the simplest terms can arguably be ambiguous.

“For example, considering the Medicare Drug Price Negotiation Program, drug companies questioned the definition of ‘drug’ in the law. Who is the expert to determine what a drug is — Centers for Medicare and Medicaid Services and FDA, or federal courts?” Ms. White said. “As Justice Elena Kagan said during oral argument in January 2024, ‘Sometimes law runs out. Sometimes there’s a gap. Sometimes there’s a genuine ambiguity ... In that case, I would rather have people at HHS telling me whether this new product was a dietary supplement or a drug.’”

Another example of the types of gaps in legislation that could be questioned includes a Medicaid statute requiring that medical assistance “be furnished with reasonable promptness to all eligible individuals,” with applications required to be processed in 45 days. However, a recent blog post from Leonardo Cuello, JD, at Georgetown University McCourt School of Public Policy questioned, what does reasonable promptness mean? Who defines that? According to Loper Bright, a judge.¹¹

“The worst of these judges will issue nationwide injunctions, effectively one-man vetoes of entire agencies in real time based on personal opinion,” Mr. Cuello wrote.

Why Is This Dangerous?

“Courts can now vacate rules nationwide,” Mr. Twin­amatsiko said. “For folks who are anti-regulation, the world is now their oyster.”

Adding to the concern about Loper Bright was another July Supreme Court decision in Corner Post, Inc. v. Board of Governors, FRS, which extended the time frame for suing federal agencies. Previously, people had a six-year time frame in which to file lawsuits challenging regulations; that time frame began when the regulation was issued. In Corner Post, the court’s decision said that the six-year time frame for suit begins not when the agency issues the rule, but instead when the regulation first affects a company.¹²

“[Corner Post] coupled with Chevron opens up a lot of things,” Mr. Twinamatsiko said.

As an example, Mr. Twinamatsiko discussed an April 2024 HHS Final Rule titled, “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” that prohibits the disclosure of health information related to lawful reproductive health care in certain circumstances.¹³

“In other words, if I live in Iowa or Texas and I go to Minnesota and obtain an abortion, which is lawful there, Texas can’t subpoena the information from a provider in Minnesota to get that information,” Mr. Twinamatsiko said.

However, the Texas Attorney General is now challenging the 2024 Privacy Rule and a 2000 Privacy Rule, arguing that “the 2024 Privacy Rule’s restrictions on reproductive health-related [protected health information] disclosures are intended to obstruct state law enforcement efforts, asserting that the rule was designed to frustrate state enforcement efforts in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.”¹⁴ So, Corner Post seems to allow Texas to go back 24 years to challenge a rule that was finalized in 2000, Mr. Twinamatsiko said.

“This opens up challenges to a whole range of health, environmental, or consumer protection regulations; all you have to do is identify an injury and handpick a judge,” Mr. Twinamatsiko said, referring to a “sea change” in the composition of the federal judiciary and the practice of filing a lawsuit in a jurisdiction with judges who might have biases that align with certain interests.

Indeed, Ms. White said that “early cases show a trend of judges using this new ‘tool’ to strike down federal regulatory regimes, especially those that are considered politically contentious.”

With Chevron overturned, judges are left to make decisions about a variety of topics in which they have no expertise, Dr. McCourt said.

A recent example of how this is a slippery slope comes from the Supreme Court itself. The court recently decided Ohio v. EPA, which blocked the Environmental Protection Agency (EPA) from enforcing a “Good Neighbor” rule that requires certain states to reduce air pollution traveling to downwind states.¹⁵

In Justice Neil Gorsuch’s opinion, there were five instances where nitrogen oxide, a pollutant, was confused with nitrous oxide, commonly referred to as laughing gas.¹⁶ Other examples exist as well, including Justice Antonin Scalia confusing troposphere with stratosphere in 2006 oral arguments and admitting, “I’m not a scientist.”¹⁷

“That is how dangerous this is,” Mr. Twinamatsiko said.

Make Your Voice Heard

As for what hematologists or physicians can do to mitigate the effects of Chevron decision, there may not be much, Mr. Twinamatsiko said.

After the Loper Bright decision was announced, a group of medical organizations, including the American Cancer Society, the American Academy of Pediatrics, the Leukemia & Lymphoma Society, and others, released a joint statement expressing disappointment in the decision that “explicitly ends the use of sensible doctrine.”¹⁸ The organizations expressed their commitment to continuing work “to ensure that health care laws are implemented in ways that benefit the public health.”

Concerned physicians may have to advocate that Congress be much more specific in what they are tasking federal agencies with. The more specific legislation is in the future, the less room there is to be challenged.

“Physicians can help to make sure that policymakers understand the science [behind legislation], including the patient and physician experience,” Dr. McCourt said. That may mean more communication between patient and physician groups and Congress.

“It follows logically that Congress will have to be incredibly specific in writing future laws to authorize specific agency action,” Ms. White said. “But Congress can only be so specific, and any term or phrase can arguably be ‘vague’ or ‘ambiguous.’”

Additionally, Loper Bright applied only to federal agencies, although it could eventually have a downstream effect on state regulatory agencies. For now, though, physicians can advocate at a state level for continued deference to state regulatory agencies, when applicable.

Outside of that, a return to the Chevron doctrine would likely take a change in the makeup of the Supreme Court, Dr. McCourt said.

When he was interviewed for this article in the fall of 2024, Dr. McCourt mentioned that some lawmakers have said they are interested in court reform, “but it is difficult to say how well those efforts would work.”

References

1. Loper Bright Enters. v. Raimondo, No. 22-4751, 2024 WL 3208360 U.S. (2024).
2. Congressional Research Service. Chevron deference: a primer. Updated September 19, 2017. Accessed October 10, 2024. https://crsreports.congress.gov/product/pdf/R/R44954/3.
3. Alabama Association of Realtors, et al. v. Department of Health and Human Services, et al. No. 21A23, U.S. (2021).
4. National Federation of Independent Business, et al., Applicants v. Department of Labor, Occupational Safety and Health Administration, et al.; Ohio, et al., Applicants v. Department of Labor, Occupational Safety and Health Administration, et al. No. 21A244 and No. 21A247, U.S. (2022).
5. Health and Human Services. HHS issues final rule to prevent discrimination in Health and Human Services grant programs. April 30, 2024. Accessed October 10, 2024. https://www.hhs.gov/about/news/2024/04/30/hhs-issues-final-rule-prevent-discrimination-health-and-human-services-grant.html.
6. Bostock v. Clayton County, Georgia. No. 17-1618, U.S. (2020).
7. Pierson B. US judge blocks Biden rule adding gender identity protections to healthcare. Reuters. July 3, 2024. Accessed October 10, 2024. https://www.reuters.com/legal/us-judge-blocks-biden-admin-rule-against-gender-identity-discrimination-2024-07-03/.
8. Osaghae A, Twinamatsiko AJ. Legal challenges against ACA’s Section 1557 Anti-Discrimination Protections. October 1, 2024. Accessed October 10, 2024. https://oneill.law.georgetown.edu/legal-challenges-against-acas-section-1557-anti-discrimination-protections/.
9. U.S. Food and Drug Administration. What we do. November 21, 2023. Accessed October 10, 2024. https://www.fda.gov/about-fda/what-we-do.
10. Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al. No. 23-235, U.S. (2024).
11. Cuello L. Loper Bright decision will collapse on itself, policy evidence is more important than ever before in driving progress. July 31, 2024. Accessed October 10, 2024. https://ccf.georgetown.edu/2024/07/31/loper-bright-decision-will-collapse-on-itself-policy-evidence-is-more-important-than-ever-before-in-driving-progress/.
12. VanSickle A, Liptak A. Supreme Court extends time frame for challenges to regulations. New York Times. July 1, 2024. Accessed October 10, 2024. https://www.nytimes.com/2024/07/01/us/supreme-court-statute-limitations.html.
13. U.S. Department of Health and Human Services. Final rule HIPAA privacy rule to support reproductive health care privacy. Accessed October 10, 2024. https://www.hhs.gov/hipaa/for-professionals/special-topics/reproductive-health/index.html.
14. Fishel SE, Hoard BT, Lutz JM, et al. Texas AG challenges HHS privacy rules. September 12, 2024. Accessed October 10, 2024. https://www.troutman.com/insights/texas-ag-challenges-hhs-privacy-rules.html.
15. Ohio et al v. Environmental Protection Agency et al, No. 23A349, U.S. (2024).
16. Durkee A. Supreme Court corrects EPA opinion after Gorsuch confuses laughing gas with air pollutant. Forbes.com. June 28, 2024. Accessed October 10, 2024. https://www.forbes.com/sites/alisondurkee/2024/06/28/supreme-court-corrects-epa-opinion-after-gorsuch-confuses-laughing-gas-with-air-pollutant/.
17. Reilly S, King P. Post-Chevron era tests courts’ readiness to tackle science. E&E News. July 30, 2024. Accessed October 10, 2024. https://www.eenews.net/articles/post-chevron-era-tests-courts-readiness-to-tackle-science/.
18. American Heart Association. Supreme Court decision to overturn ‘Chevron deference’ threatens to disrupt public health care system. June 28, 2024. Accessed October 10, 2024. https://newsroom.heart.org/news/supreme-court-decision-to-overturn-chevron-deference-threatens-to-disrupt-public-health-care-system.