Blase N. Polite, MD, MPP, FASCO
Martin Palmeri, MD, MBA
Dominic Sawaya, JD, MPPA
Rebecca Spence, JD, MPH
It is not often that the oncology community looks to the Supreme Court to forecast its future. In 2024, two decisions seemingly unrelated to health care were issued that are likely to have a monumental impact on oncology care delivery. The Court’s rulings—on June 28, Loper Bright Enterprises et al v Raimondo, Secretary of Commerce et al1 and on July 1, Corner Post, Inc. v Board of Governors of the Federal Reserve System2—changed the way federal laws and regulations that govern cancer care, cancer research, and health care as a whole are made. ASCO has voiced serious concerns about these rulings, which destabilize the administrative state and the regulatory framework on which the U.S. health-care system is built.
In Loper Bright, the Supreme Court overturned the “Chevron doctrine” or “Chevron deference,” which compelled federal courts to defer to a federal agency’s reasonable interpretation of a law as delegated by Congress. The Chevron doctrine came from the 1984 Supreme Court case Chevron U.S.A. v Natural Resources Defense Council, which established a 40-year precedent that addressed the way judges should review federal agency regulations.3 In the Loper Bright ruling, the Supreme Court indicated that cases already decided would be safe.1 However, it is possible for the Supreme Court to take a look at old rules that are challenged by new cases.
The second major decision by the Court this past summer is likely to increase the volume of such new cases. In the Corner Post decision, the Supreme Court effectively removed the time limit for challenging regulations under the Administrative Procedure Act (APA).2
Now, any plaintiff who believes he has been harmed by a regulation can go to court to challenge it within 6 years from when the harm occurred—rather than the prior standard of 6 years from when the regulation was issued. This means that unless Congress fixes the statute, there could be opportunities for a cascade of federal lawsuits to challenge many longstanding regulations on which the health-care system relies. Instability in decades-old regulations could have a destabilizing effect on health-care delivery.
How Overturning the Chevron Doctrine May Impact Cancer Care Delivery
ASCO has identified the following scenarios that could affect cancer care delivery:
- Agencies make rules at the national level. Without Chevron, there could be disputes among lower courts on programs such as Medicare and Medicaid, resulting in “regulated parties [being] subject to different rules in different parts of the country.”4
- Barriers to implementing key health-care protections such as prescription drug affordability in Medicare
- Challenges to public health and infection control regulations
- Weaker consumer protections in some private health insurance plans
- The authority of the U.S. Food and Drug Administration (FDA) over safety and efficacy of prescription drugs and laboratory-developed tests
- Eligibility determinations for public health insurance programs such as Medicare and Medicaid
- Decisions related to physician and hospital payment at the Centers for Medicare & Medicaid Services (CMS) such as cuts to the Medicare Physician Fee Schedule and related calculations.5
“These decisions now call into question the FDA’s authority over prescription drugs, the ability of the CMS to determine eligibility for critical public health insurance programs as well as essential physician and hospital payments, and many other federal agencies’ authority to implement important guardrails for people with cancer in this country,” said ASCO Board Chair Eric P. Winer, MD, FASCO, in a statement from ASCO about the ruling.6
“Deferring to judges and courts rather than expert administrative agencies such as FDA, CMS, and others could harm people with cancer and the providers who care for them. Furthermore, Congress and the courts cannot be expected to act with the speed and scope necessary to address every complex regulatory issue involved in administering health care in the U.S.,” added Dr. Winer.
ASCO Is Monitoring Potential Fallout From the Chevron Ruling
Given these changes to federal regulatory authority, increased litigation is expected to determine appropriate interpretation of health law and regulation. Several areas are emerging as being at risk for the Biden administration, and future administrations, in terms of potential challenges from a health regulatory perspective. At the FDA, ASCO is monitoring laboratory-developed tests, artificial intelligence/augmented intelligence tools, digital health technology, and human tissue product rules. At the CMS, ASCO is tracking the Chevron ruling’s impact on payment and reimbursement rules and the implementation of the No Surprises Act, to help protect consumers from surprise medical bills,7 and the Inflation Reduction Act of 2022, which aims to lower prescription drug prices, among other priorities.8 ASCO will be present to represent the profession of oncology and cancer care in all areas of government, including Congress, federal agencies, and the courts, as necessary.
Although this is a legal and regulatory sea change, oncologists do not yet need to adjust anything in their practices because of these developments. ASCO will continue to provide education, analysis, and advocacy to protect clinicians and patients as the landscape shifts.
DISCLOSURE: The authors reported no conflicts of interest.
REFERENCES
1. Supreme Court of the United States: Syllabus: Loper Bright Enterprises et al v Raimondo, Secretary of Commerce, et al. Available at www.supremecourt.gov/opinions/23pdf/22-451_7m58.pdf. Accessed September 20, 2024.
2. Supreme Court of the United States: Syllabus: Corner Post, Inc. v Board of Governors of the Federal Reserve System. Available at www.supremecourt.gov/opinions/23pdf/22-1008_1b82.pdf. Accessed September 20, 2024.
3. Library of Congress: U.S. Reports: Chevron U.S.A. v Natural Res. Def. Council, 467 U.S. 837 (1984). Available at www.loc.gov/item/usrep467837. Accessed September 20, 2024.
4. Ravi S: The Future of Chevron and Health Policy: Recapping the Supreme Court’s Oral Arguments in Loper and Relentless; O’Neill Institute for National and Global Health Law, 5. Georgetown University Law Center; 2024; Available at https://oneill.law.georgetown.edu/the-future-of-chevron-and-health-policy-recapping-the-supreme-courts-oral-arguments-in-loper-and-relentless. Accessed September 20, 2024.
5. Sachs RE, Fuse Brown EC: Supreme power—The loss of judicial deference to health agencies. N Engl J Med 391:777-779, 2024.
6. ASCO in Action: Supreme Court Ruling Upends Country’s Regulatory Framework, Threatens to Complicate and Delay Health Care Delivery. June 28, 2024. Available at https://society.asco.org/news-initiatives/policy-news-analysis/supreme-court-ruling-upends-us-regulatory-framework. Accessed September 20, 2024.
7. Centers for Medicare & Medicaid Services: Surprise billing & protecting consumers. September 10, 2024. Available at www.cms.gov/nosurprises/Ending-Surprise-Medical-Bills. Accessed September 20, 2024.
8. The White House: Inflation Reduction Act Guidebook. Available at www.whitehouse.gov/cleanenergy/inflation-reduction-act-guidebook. Accessed September 20, 2024.
Dr. Polite is Professor of Medicine, Hematology and Oncology, at the University of Chicago Medicine. Dr. Palmeri is a medical oncologist at Messino Cancer Centers in Asheville, North Carolina. Mr. Sawaya is Associate Director, Federal Regulatory Affairs Advocacy at ASCO. Ms. Spence is Chief Ethics Counsel at ASCO.
