The Centers for Medicare and Medicaid Services (CMS) have proposed new guidelines to ensure that artificial intelligence (AI) tools used in Medicare Advantage plans promote equitable access to healthcare services. These proposed “guardrails” emphasize that AI and other automated systems must not discriminate or create unnecessary barriers to care. Instead, they must align with existing regulations that prohibit denying or limiting healthcare based on health status. This initiative reflects growing concerns over the role of AI in healthcare and the need to safeguard fairness as technology becomes increasingly integral to decision-making in the sector.
The proposal builds on an October 2023 executive order from the Biden administration, which directed federal agencies to address the potential inequities and biases introduced by AI systems across industries, including healthcare. According to CMS, these tools must be implemented in a way that ensures culturally competent and non-discriminatory care for all enrollees. Additionally, the proposal calls for Medicare Advantage insurers to remove unnecessary hurdles caused by inappropriate use of prior authorization practices tied to AI systems. While no new regulations are being introduced, CMS seeks to clarify and reinforce the application of existing rules to AI-powered healthcare solutions.
Concerns about the misuse of AI in healthcare have already led to legal challenges. In one prominent case, the estates of two deceased Medicare Advantage policyholders filed a federal class-action lawsuit against UnitedHealthcare, alleging that the insurer used an AI tool to improperly deny coverage for essential post-acute care services. These claims have intensified scrutiny over whether AI tools prioritize cost-cutting measures over patient welfare, potentially violating federal healthcare regulations. The proposed guardrails aim to prevent such scenarios by ensuring that AI is used to enhance care delivery rather than restrict it.
CMS plans to publish the proposed rule in the Federal Register on December 10, giving stakeholders an opportunity to provide feedback. However, the future of these guidelines could be uncertain. With a new administration taking office in January 2025, there is potential for changes to Biden-era executive orders and pending regulatory actions. Despite this uncertainty, CMS has underscored the importance of ensuring that technological innovation in healthcare does not come at the expense of equity and fairness. By taking a proactive approach, the agency hopes to address emerging challenges and create a framework for the responsible use of AI in Medicare Advantage plans.
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