Cassidy Releases Draft Bill on AI Oversight, Medicare Payment Pathway
Sen. Bill Cassidy, chair of the Senate HELP Committee, released an Oct. 29 discussion draft of the PATIENT AI Act, which would clarify FDA versus ONC oversight of healthcare AI tools and build a federal payment pathway for AI-based services. The bill would give FDA a risk-based review process for software devices, let HHS certify third parties to review low- to moderate-risk software, and preempt state product liability laws for these tools. On payment, HHS would develop a coverage evaluation framework, propose reimbursement methodologies, and create HCPCS Level II codes for AI services, while the Center for Medicare and Medicaid Innovation would test a payment model for autonomous AI care. HHS would also issue HIPAA guidance for AI use and commission liability recommendations. Cassidy is accepting stakeholder comments through Dec. 1.