The PrudentRx lawsuit is a proposed federal class action accusing PrudentRx LLC and CVS Caremark of running a copay assistance program that promises patients $0 out-of-pocket costs on specialty drugs while diverting manufacturer assistance money — allegedly hundreds of millions of dollars — to insurers and plan sponsors instead of applying it to patients’ cost-sharing. The case, Gluesing v. PrudentRx LLC, was filed in December 2024 in the District of Rhode Island and remains tied up in an early fight over whether the patient’s claims must go to arbitration.
What the PrudentRx Program Does
PrudentRx calls its service a “copay optimization program” and runs it in partnership with CVS Caremark and CVS Specialty Pharmacy. Patients prescribed eligible specialty medications — treatments for cancer, autoimmune disease, and other chronic conditions — are automatically enrolled. PrudentRx signs those patients up for the manufacturer copay assistance cards attached to their drugs and applies the assistance when prescriptions are filled at CVS Specialty. Stay enrolled and you pay $0. Opt out, or fail to finish enrollment, and you owe 30% coinsurance on the drug, which for specialty medications can run into thousands of dollars per fill.
The financial mechanics matter. Payments made through manufacturer assistance cards under the program do not count toward the patient’s annual deductible or out-of-pocket maximum. PrudentRx’s program materials explain this by saying those payments don’t reflect the member’s “true” out-of-pocket cost. To reach that result under the Affordable Care Act, the program classifies the specialty medications as “non-essential health benefits.” The ACA requires insurers to cap patient spending on essential health benefits, so the non-essential label is what lets the program keep manufacturer dollars off the patient’s accumulator.
Who Sued and What They’re Alleging
Sheila Gluesing, an Iowa resident insured through Wellmark, filed the complaint on December 26, 2024, in the United States District Court for the District of Rhode Island (Case No. 1:24-cv-00549). She takes Dupixent, which carries a manufacturer copay program called Dupixent MyWay, and she alleges that PrudentRx intercepted the benefits of that assistance and steered the money to her insurer rather than her deductible. The named defendants are PrudentRx LLC, Caremark Rx LLC, and CVS Specialty Pharmacy. The complaint asks for treble damages and an injunction shutting the program down.
The ERISA Claims
The ERISA count argues that PrudentRx and Caremark act as fiduciaries of employer-sponsored health plans and have breached those duties. Specifically, the complaint alleges they fail to count prescription drug copays toward the cost-sharing limits the ACA imports into ERISA, issue pharmacy claim denials without proper notice or appeal rights, and misrepresent material facts when instructing patients on how to obtain manufacturer assistance.
The RICO Claims
The RICO count labels the arrangement the “PrudentRx Copay Assistance Fraud Enterprise.” It alleges the defendants use mail and wire fraud to induce manufacturer assistance programs to pay out for patients who are effectively ineligible, coerce patients into enrolling through threats of financial hardship, and split the proceeds — roughly 25% kept by the defendants, the rest routed to health plan sponsors and insurers. The complaint puts the diverted total at “hundreds of millions, if not billions, of dollars.”
Who the Class Would Cover
Gluesing seeks to represent everyone enrolled in the PrudentRx Copay Program since January 1, 2020, who was prescribed a brand-name drug covered by the program with no available generic, and who paid more in healthcare expenses than they would have without the program. A separate ERISA subclass covers members of non-grandfathered employer-sponsored plans governed by ERISA.
Where the Case Stands
The case has not reached class certification, settlement, or any ruling on the underlying claims. On February 6, 2025, the court appointed Lockridge Grindal Nauen as interim lead class counsel.
Most of the activity since then has revolved around arbitration. CVS Specialty Pharmacy’s online Terms of Use include an arbitration clause, and the defendants moved to force the dispute out of court. Gluesing responded that she accepted the terms under duress, because CVS Specialty would not release her prescriptions unless she agreed, and that the clause is unconscionable. The defendants counter that patients can fill prescriptions by telephone without accepting the online terms at all.
A magistrate judge denied Gluesing’s motion for discovery tied to the arbitration issue in December 2025. She objected, and on February 24, 2026, Chief Judge John J. McConnell Jr. vacated that ruling and granted the discovery motion. As of June 2026, a renewed motion to compel arbitration is pending.
The Parallel SaveOnSP Case
A near-identical patient class action targets a separate program. Gurwitch v. Save On SP LLC, filed January 3, 2025, in the Western District of New York (Case No. 1:25-cv-00006), was brought by Annabelle Gurwitch, a California resident diagnosed with stage 4 lung cancer in 2020. She alleges she lost the benefit of AstraZeneca’s copay assistance program starting in January 2022 because her health plan participated in the SaveOn Program.
The defendants are SaveOnSP LLC, Express Scripts Inc., and Accredo Health Group Inc. — Express Scripts is the pharmacy benefit manager owned by Cigna, and Accredo is its specialty pharmacy. The complaint tracks the PrudentRx theory: specialty drugs reclassified as non-essential health benefits, inflated copays designed to drain manufacturer assistance, 25% kept by the defendants and the rest sent to plan sponsors. Both cases are being handled by Lockridge Grindal Nauen.
Why These Programs Still Operate
The lawsuits sit inside an unresolved regulatory fight. In September 2023, the U.S. District Court for the District of Columbia struck down a 2021 federal rule that had let insurers broadly exclude manufacturer copay assistance from patients’ out-of-pocket maximums. The ruling in HIV and Hepatitis Policy Institute v. HHS reinstated an earlier rule: insurers may exclude manufacturer assistance only for brand-name drugs that have a generic equivalent available. If there is no generic, the assistance is supposed to count toward the patient’s cap.
Enforcement has not followed. The 2026 Notice of Benefit and Payment Parameters, finalized by HHS in January 2025, did not address copay accumulators or maximizers. HHS said it intends to propose future rulemaking but set no timeline, and stated that in the interim it will not take enforcement action against plans based on how they treat manufacturer assistance.
State law fills part of the gap. At least 25 states, the District of Columbia, and Puerto Rico have enacted laws requiring insurers to count manufacturer copay assistance toward patients’ out-of-pocket limits. Most of those laws reach only state-regulated fully insured plans and do not apply to self-funded employer plans governed by ERISA — the category of plan the Gluesing lawsuit is built around.
In Congress, the bipartisan HELP Copays Act (S. 864), introduced in March 2025 by Senators Roger Marshall, Tim Kaine, Thom Tillis, and Lisa Murkowski among others, would require all manufacturer and nonprofit copay assistance to count toward out-of-pocket maximums, classify all covered prescription drugs as essential health benefits, and ban accumulator programs in federally regulated plans. The bill remains in committee.