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. The lawsuit represents a growing backlash against Medicare’s controversial WISeR pilot program, which launched January 1 and has already sparked widespread physician complaints and Democratic opposition.

Many physicians and medical societies have reported delays, denials, and communication breakdowns since WISeR — the Wasteful and Inappropriate Service Reduction program — launched on January 1 in select states. Now, a lawsuit against the Centers for Medicare & Medicaid Services (CMS) is underway.

The pilot program, set to run through 2031, is now being tested in Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington.

The program applies to a subset of treatments — including nerve stimulators, epidural steroid injections, and some types of wound care — that CMS says may harm patients or involve fraud, waste, and abuse.

The EFF’s complaint centers on CMS’s refusal to disclose critical information about how the AI systems operate. 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.

Early data suggests the program is creating significant barriers to care. In Texas, only 62% of requests under the pilot were initially approved, rising to 84% once a human reviewed them, the nonprofit said, citing a Washington Post article published this month.

In comparison, 92% of prior authorization requests were fully or partially approved nationwide in MA.

The disparity has created chaos for physicians like Dr. David Crooks, an Arizona interventional pain specialist. “Medicare has denied payment for any epidural steroid injections since the rollout, even for procedures with valid authorization numbers,” Crooks said. “This system is completely nonfunctional and unsustainable, and we have been given no guidance to navigate it.”

For Crooks, president of the Arizona Society of Interventional Pain Physicians, the program has been far from seamless. He said the authorization vendor and Medicare’s payment systems appear to not communicate well, with each side directing providers back to the other when claims are denied. The result has been hundreds of delayed claims and a growing administrative burden that, he said, is affecting “every interventional pain practice I’ve spoken with in Arizona.”

The financial incentives built into WISeR have raised additional concerns. According to EFF, the companies participating in the WISeR pilot are compensated, in part, by the “associated savings” they generate from denying medical claims.

The list of participants in the pilot includes Cohere Health, Genzeon Corporation, Humata Health, Innovaccer, Virtix Health and Zyter.

WISeR represents a dramatic shift for traditional Medicare, which has historically operated without prior authorization requirements. WISeR marks a major change for traditional Medicare, which has historically allowed physicians to provide most covered services without authorization.

The program emerged despite the Trump administration’s previous criticism of prior authorization practices. In June, the Trump administration even extracted a pledge from major health insurers to streamline and reduce prior authorization. “Americans shouldn’t have to negotiate with their insurer to get the care they need,” U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said in a June statement announcing the pledge.

Congressional Democrats have mobilized against the program. “WISeR will likely limit beneficiaries’ access to care, increase burden on our already overburdened health care work force, and create perverse incentives to put profit over patients,” said the 17 Democrat signatories, making reference to how prior authorization has impacted clients putting in claims under Medicare Advantage. The lawmakers argued that “many patients choose Traditional Medicare because they know their care will be determined by their doctors and not by insurance companies.”

In November, congressional representatives from Ohio, Washington and other states introduced a bill to repeal the WISeR model.

The EFF’s legal challenge focuses on transparency concerns surrounding the AI algorithms. “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.”

“Outdated, incomplete, or biased training data can result in disproportionate denials of care to underserved populations and protected classes,” the EFF wrote. “And it is unclear whether the WISeR Model has any safeguards against systemic flaws such as algorithmic bias, privacy violations, and wrongful denials of care.”

CMS has defended the program as necessary to combat healthcare waste. Medicare spent as much as