Cassidy proposes five-year Medicare payment test for autonomous clinical AI
The PATIENT AI Act remains a discussion draft, not law. It would test reimbursement while leaving payment rates, covered tasks and responsibility for harm unsettled.
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The PATIENT AI Act remains a discussion draft, not law. It would test reimbursement while leaving payment rates, covered tasks and responsibility for harm unsettled.
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The draft would have CMS’s Innovation Center select applications and providers for a five-year test, weighing clinical promise, safety, evidence gaps and potential benefit rather than granting every autonomous tool reimbursement. It requires a coverage framework, billing codes and payment methods, but defines neither autonomy nor covered tasks, rates or patient cost-sharing. The model would measure clinical and spending outcomes; the draft leaves liability under existing law and calls for a nonprofit study. Cassidy is seeking comments through December 1, 2026; the draft has not been introduced or voted on.
The payment model would begin no later than 24 months after enactment, and Medicare would publish criteria for selecting applications and providers.
Participants would have to notify beneficiaries about AI use and establish accountability and escalation arrangements; joining the test could not reduce appeal rights.
The proposal also calls for rolling FDA review of AI software, possible review by certified third parties for lower- and moderate-risk software, and HIPAA privacy guidance.
Sen. Bill Cassidy has proposed a Medicare payment experiment for AI that performs clinical work without a doctor reviewing every result in real time. His PATIENT AI Act discussion draft would create a five-year test, pairing a route to reimbursement with patient protections—but leaving key payment and responsibility questions unresolved.
Cassidy, the Louisiana Republican who chairs the Senate Health, Education, Labor and Pensions Committee, released the draft on October 29, 2026. It has not been formally introduced or voted on. The payment experiment is part of a larger proposal covering healthcare AI review, privacy and federal agency responsibilities.
The draft would direct the CMS Innovation Center to run the model, beginning no later than 24 months after enactment. Its focus would be applications capable of performing a clinical function autonomously: software doing part of a clinician’s work without a physician interpreting each result at the same time.
Medicare would select participating applications and providers using published criteria. Those criteria would include clinical promise, patient safety, gaps in the evidence and potential benefit to Medicare patients. Selection would therefore be part of the experiment, rather than an automatic payment entitlement for every autonomous tool.
Alongside that test, the package would require a framework for deciding whether Medicare should cover AI-based services. It also calls for payment methods and billing codes. These provisions address both whether an AI service qualifies for coverage and how providers would bill for it.
Important terms remain unwritten. The draft does not define “autonomously,” identify the conditions or clinical tasks the model would cover, or set payment rates. It also does not specify patients’ out-of-pocket costs. Those omissions leave the proposed experiment’s practical scope and financial terms unresolved.
The proposed model includes requirements governing what patients are told and how participating providers handle clinical concerns. It would also preserve an existing route for patients to challenge Medicare decisions.
Evaluation would extend beyond spending. The model would measure effects on patient outcomes, safety, access and patient experience as well as cost. That makes clinical results and patients’ encounters with the tools explicit parts of the proposed assessment.
The draft does not settle who is liable when autonomous AI causes harm. Instead, it would have the Department of Health and Human Services engage a nonprofit organization to examine healthcare AI liability and recommend changes. It also says it does not alter liability under federal or state law.
The same draft would reshape parts of medical-software oversight. It proposes a rolling FDA review process for AI software, alongside provisions addressing device review, certification and monitoring after deployment. Certified third parties could review low- to moderate-risk software. The package also calls for privacy guidance on AI use under HIPAA.
Other provisions would support adoption inside healthcare organizations and government. HHS would work with the National Institute of Standards and Technology and sector stakeholders on training materials. Its chief information officer would build datasets for AI-supported healthcare research, while the Comptroller General would examine proposals for transparency and explainability.
Cassidy is seeking input from industry stakeholders, clinicians and policy experts. His office is accepting public comments through December 1, 2026, at patientai@help.senate.gov, giving respondents a chance to weigh in on the proposed payment pathway and its safeguards before the draft advances.
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