WISeR in 2026: Legal, Compliance, and AI Challenges That Could Reshape Prior Authorization for Skin Substitutes
Key Takeaways
- AI-Driven Medical Necessity Decisions Face Legal Uncertainty
The use of AI tools to determine medical necessity lacks clear constitutional, statutory, or regulatory authority, potentially exposing WISeR to potential litigation and challenges over whether non-clinician systems can lawfully replace human judgment. - Validation, Traceability, and Evidence Standards Remain Undefined
There is currently no established framework for validating AI decision-making, tracing how determinations are reached, or effectively challenging AI-generated evidence in appeals and enforcement actions. - Resource Imbalance Could Disadvantage Providers and Suppliers
The speed and scale of AI-driven WISeR determinations may overwhelm providers unless they invest in equally sophisticated tools, potentially creating inequities between large, well-resourced organizations and smaller practices.
What do you see as some of the biggest challenges associated with the WISeR program in 2026?
Validity testing and traceability of the decisions that the WISeR AI tool will be making on prior authorizations involving medical necessity is a primary challenge. Secondly, in my observation and experience, the legality of the AI tool to make medical necessity decisions on preauthorization is strongly in question and likely to face significant litigation challenges.
Are there any unique legal or compliance ramifications associated with WISeR that stakeholders may not be yet considering?
Numerous! First, we have no constitutional, statutory, or regulatory framework on how to evaluate and challenge evidence produced by an AI tool that is replacing a qualified clinician. Second, the speed and volume of the WISeR decisions will likely only be able to be combatted by providers and suppliers with significant resources to build their own tools to match the speed and complexity.
Overall, I do not see the foundational legal grounds for many of the clinical actions that the tool will be taking.
Stephen Bittinger is an attorney with a focus on the law surrounding the use of statistical sampling and extrapolation and the use of artificial intelligence (AI) software tools as evidence in health care reimbursement disputes. He focuses his practice on federal Administrative Procedure Act (APA) litigation but often serves as subject matter counsel, or an expert witness, on statistical sampling and AI-as-evidence disputes in False Claims Act (FCA) proceedings, health care criminal proceedings, commercial litigation with payors, and government payors fraud, waste, and abuse audits and investigations.
