SAN FRANCISCO – The Electronic Frontier Foundation (EFF) today filed a Freedom of Information Act (FOIA) lawsuit against the Centers for Medicare & Medicaid Services (CMS) seeking records about a multi-state program that is using AI to evaluate requests for medical care.

"Tasking an algorithm with making determinations about treatment can create unwarranted—and even discriminatory—delays or denials of necessary medical care," said Kit Walsh, EFF’s Director of AI and Access-to-Knowledge Legal Projects. "Given these serious risks, the public requires transparency that it hasn't gotten. We're suing to get badly needed answers about how Medicare's AI experiment works."

Announced by CMS Administrator Dr. Mehmet Oz last year, the pilot program known as WISeR (Wasteful and Inappropriate Service Reduction) uses AI to assess prior authorization requests from Medicare beneficiaries. Previously rare in original Medicare, prior authorization requires medical providers to obtain advance approval from a patient’s health insurer before delivering certain treatments or services as a condition of coverage.

Unfortunately, there is little information about how the AI algorithms used in WISeR work, including what training data they rely on. It remains unclear whether WISeR has any safeguards against systemic flaws such as algorithmic bias, privacy violations, and wrongful denials of care.

Healthcare experts, care providers, and lawmakers have all raised alarms that WISeR may cause serious harm to patients by relying on AI unless it has the necessary safeguards. Despite this widespread criticism, WISeR was rolled out in six states in January, potentially affecting as many as 6.4 million Medicare beneficiaries, according to one estimate.

By design, WISeR incentivizes contracted companies to deny prior approval against the best interests of patients. Vendors are compensated, in part, on the volume of healthcare services they deny and are entitled to as much as 20 percent of the associated savings. Just weeks after WISeR's launch, hospitals and other health care providers started reporting delays in care approval, communication gaps, and administrative strain.

Earlier this year, EFF submitted a FOIA request to CMS asking for records related to WISeR. Among other records, the request sought agreements with software vendors participating in WISeR; records related to any tests for accuracy, bias, or hallucinations in vendors' technology; and records related to any audits, monitoring, or evaluation of WISeR and participating vendors. To date, CMS has not provided any of these records to EFF. EFF's FOIA lawsuit asks for their immediate processing and release.

"The public has a right to know more about the algorithms driving decisions around their healthcare," said Tori Noble, Staff Attorney at EFF. "Without greater transparency, patients, providers, and policymakers will continue to be left in the dark.”

EFF thanks Stanford Law School's Juelsgaard Intellectual Property & Innovation Clinic for their help in preparing this lawsuit.

For the complaint: https://www.eff.org/document/complaint-eff-v-cms-medicare-wiser-foia