Digital and privacy rights nonprofit Electronic Frontier Foundation is suing the Centers for Medicare & Medicaid Services (CMS) to get more information about a multi-state program that is using artificial intelligence to evaluate requests for medical care.
The nonprofit filed a Freedom of Information Act (FOIA) lawsuit against CMS seeking the disclosure of records pertaining to the Wasteful and Inappropriate Service Reduction (“WISeR”) Model. The WISeR Model uses AI to evaluate prior authorization claims.
CMS rolled out the Innovation Center model in June to test new prior authorization requirements in traditional Medicare. It launched January 1 and will conclude at the end of 2031.
The pilot program uses AI to assess prior authorization requests from Medicare beneficiaries and it expands the scope of prior auth in traditional Medicare, which has mostly eschewed prior authorization. The pilot program has rolled out in Arizona, Ohio, Oklahoma, New Jersey, Texas and Washington.
WISeR participants use AI to expedite prior auth for certain services deemed “vulnerable” to waste, fraud and abuse. This includes skin and tissue substitutes, a growing target of federal investigators.
The White House argues that this move is aimed at addressing fraud and waste, while clinicians and Democrat lawmakers have voiced concerns about the use of AI in prior auth decisions. In a letter, 42 Democratic lawmakers said the model incentivizes higher rates of prior authorization because private insurers are paid “based on a share of averted expenditures” and encourages health plans to use artificial intelligence to make haphazard determinations.
There is little information about how the AI algorithms used in WISeR work, including what training data they rely on, according to the Electronic Frontier Foundation. "It remains unclear whether WISeR has any safeguards against systemic flaws such as algorithmic bias, privacy violations, and wrongful denials of care," EFF executives wrote in a statement.
"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, in a statement. "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."
By design, WISeR incentivizes contracted companies to deny prior approval against the best interests of patients, according to EFF. Vendors are compensated, in part, on the volume of healthcare services they deny and are entitled to as much as 20% of the associated savings, the organization said.
Patients, doctors and other lawmakers have also been critical of what they see as delay-or-deny tactics, which can slow down or block access to care, causing irreparable harm and even death, KFF Health News reported.
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, the organization said.
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.”