Summary of article from Bricker Graydon LLP, by N. Bradford Wells:
The 2024 Final Rule under Section 1557 of the Affordable Care Act reinstates and expands anti-discrimination provisions for healthcare providers and health plans receiving federal reimbursement. Notably, it extends these provisions to entities participating exclusively in Medicare Part B and introduces regulations for the use of Patient Care Decision Support Tools (PCDST), including AI and clinical algorithms. Covered Entities must now ensure these tools do not perpetuate discrimination based on protected characteristics such as race, sex, and disability. This involves understanding the training data and methodologies used in AI tools, conducting regular audits, and implementing compliance programs. The rule emphasizes the need for AI data literacy among providers to prevent biased treatment decisions. Additionally, the rule has broadened the definition of sex discrimination, although enforcement of this expansion is currently under a nationwide injunction. Compliance with these regulations will require significant vigilance and proactive risk management by healthcare entities.