WISeR in 2026: Legal, Compliance, and AI Challenges That Could Reshape Prior Authorization for Skin Substitutes

HMP Global January 27, 2026
Stephen D. Bittinger, JD

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.

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