Applied Policy has discussed the broad implications of the recent court reviews of Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce, in which the Supreme Court overruled Chevron deference in a 6-3 vote. Going forward, we expect more agency regulations to be overturned by courts, agencies to decline to issue regulations not required by statute, and legislation from Congress delegating regulations to agencies to be more specific. While the overturn of Chevron will have a significant impact on every aspect of health policy, the impact of the decision on the Federal Government’s ability to regulate and reimburse for the use of artificial intelligence (AI) in healthcare will be somewhat unique.

AI technology is constantly evolving, making it extremely difficult to regulate without some degree of flexibility for agencies. While the use of AI in healthcare has already outpaced regulations, this gap will likely increase following the overturn of Chevron. If agencies only implement regulations required by statute in anticipation of future litigation, then regulations will have to come from Congress, which moves slowly by nature. Instead of vaguely delegating tasks to agencies, any legislation written by Congress will likely need to be extremely specific in its instructions or clearly grant deference to agencies to avoid the ensuing regulations being subject to litigation.

For example, consider the American Medical Innovation and Investment Act of 2024[1], which would order the HHS Secretary to “use existing communications mechanisms to issue guidance on requirements for payment or remote monitoring devices, such as continuous glucose monitors, that— (1) use an artificial intelligence component (such as a continuous adjustment component); and (2) transmit information to a health care provider for purposes of management and treatment of an individual.” Whatever requirements HHS might put forward in this guidance would be more likely to be challenged in court following Chevron.

Given the lack of technical expertise in Congress, and the difficulty the current Congress has in reaching compromise, it is likely that both regulations around the use of AI technologies in healthcare and progress toward a dedicated reimbursement mechanism for these technologies under Medicare will move slowly. In the absence of Federal AI regulations, we may also see more action from states.

[1] https://www.congress.gov/bill/118th-congress/house-bill/8816/text