Medicine · CMS
CMS for clinical AI workflows
CMS in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.
01 / The rule
What CMS requires
Medicare Advantage organizations and the vendors whose algorithms or AI tools they use for coverage, prior authorization and utilization management decisions.
- 01Base each medical necessity decision on the enrollee's own medical history, physician recommendations and clinical notes (42 CFR 422.101(c)(1)).
- 02Follow Traditional Medicare NCDs and LCDs; use internal criteria only when coverage is not fully established, publicly posted and evidence-based.
- 03Have a physician or appropriate professional with relevant expertise review any expected adverse medical necessity decision before issuing it.
- 04Have a physician-led utilization management committee approve and annually review all UM and prior authorization policies.
- 05Do not use an algorithm's population-level prediction alone to deny admission or end post-acute care.
02 / In this sector
In a clinical AI workflow
CMS's Feb 6, 2024 FAQ says an algorithm or AI tool can assist coverage decisions only if the decision still reflects the individual patient's circumstances, and that predicted length of stay alone cannot justify ending services. Separately, CMS's WISeR model (from Jan 1, 2026) uses AI-assisted prior authorization in Traditional Medicare in six states, with licensed clinicians making non-payment recommendations.
Clinical committees and health system AI governance.
HHS §1557 · HIPAA · FDA PCCP.
03 / Records
Records to keep
- 01Case files showing individual records reviewed for each adverse decision
- 02Clinician person reviewing it credentials and sign-off on denials
- 03UM committee minutes approving algorithm-supported policies
- 04Published internal coverage criteria with supporting evidence
Optional evidence · where Planisphere fits
Keep a record anyone can check
When your team meets a duty, Planisphere can seal the event it reports as a receipt.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
Paste the receipt into Verify. No account or key.
A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.
SOURCES
Go back to the source
Federal Register (CMS)
CMS Innovation Center
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