SaveOnSP Suffers a Second Complaint

SaveOnSP has designed and administers a program that coordinates the use of pharmaceutical manufacturer patient assistance programs to fund high cost drugs and reduce the amount an employer health plan sponsor would spend on these drugs. The SaveOnSP program has identified a number of drug therapies which, without violating the Affordable Healthcare Act (ACA, can be deemed "non-essential" and associated with high copays. Express Scripts markets the SaveOnSP program to its commercial health plan sponsors. When a member has a prescription adjudicatred for one of the non-essential medications, a SaveOnSP team member provides support to coordinate patient assistance through the pharma manufacturer. These programs have been referred to as copay maximizer programs (JMCP recently published a review of alternative funding programs such as copay maximizers).

IQVIA reviewed the use of copay maximizer programs and found that in 2019 14% of commercially insured patients were enrolled in a copay maximizer program, and by 2022 33% of commercially insured patients were enrolled in an accumulator program. Pharmaceutical manufacturers who offer patient assistance programs, expectedly, claim that maximizer programs such as SaveOnSP divert assistance resources away from patients who truly need the assistance and increase drug costs. Additionally, since patient assistance is not counted toward deductibles and out-of-pocket maximums, patients using high cost drugs, their advocacy groups and specialist prescribers contend that patients are placed in jeopardy should they exceed the limits of the patient assistance program and have formed the All Copays Count Coalition.

In 2022, Johnson & Johnson (a pharmaceutical manufacturer that provides patient assistance for prescriptions) filed suit against SaveOnSP claiming that the SaveOnSP program inappropriately takes advantage of a loophole in the ACA regulations regarding the classification of essential benefits and that the process used to enroll patients into the program is deceptive.

"Defendant's alleged scheme has two elements. First, Plaintiff alleges that the drugs at issue are reclassified from essential to non-essential health benefits under the Affordable Care Act ("ACA"), which decisions are made without assessing a patient's medical needs; rather, the drugs are redesignated to avoid the ACA's co-pay limits and annual out of pocket limits, which caps the amount a patient with private insurance can be required to pay for medical care each year. (Id. ?? 9-10, 53-55, 57-58.) With regards to non-essential drugs, the SaveOnSP Program “increases the patient's copay amount for the given drug to an artificially high amount--often thousands of dollars per dose.” (Id. ? 10.) According to Plaintiff, the inflated co-pays are key to the alleged scheme because the higher amounts essentially force patients into the Program.

The second aspect of the scheme is to target patients by instituting an outreach campaign to enroll patients in the Program. (Id. ? 61.) Plaintiff alleges that Defendant's representatives inform patients that they will be responsible for the entire copay amount unless they join the Program; if the patients join the Program, the copay will be paid. (Id. ?? 60-61.) Essentially, patients are, according to Plaintiff, tricked into enrolling in the SaveOnSP Program because they are under the false impression that they will be responsible for the very high co-pay if they do not participate."

In the last days of December of 2024, a lung cancer patient using Tagrisso filed a class action complaint - Gurwitch v. Save on SP LLC, et al. - against SaveOnSP (and Express Scripts and Accredo). In her complaint the patient contends that SaveOnSps program is a "scheme" with five elements (1) SaveOnSP, Express Scripts, and Accredo inappropriately manipulate the copay costs for specialty medications (2) the program inflates copays for targeted medications for the express purpose of maximizing funds available in patient assistance programs (3) the program uses the threat of expensive copays to "coerce" patients into enrolling (4) the SaveOnSP program "diverts" assistance meant for patients to health plan sponsors and retains 25% of the funds for themselves, and (5) The program can place patients in the positioning of having to bear additional healthcare expenses.

The complaint asks the court to:

• Enjoin SaveOnSP from continuing program operations, claiming that the program operates in violation of ACA/ERISA
• Have SaveOnSP make restitution for the financial burden it has place on patients enrolled in the program. This latest complaint goes a step beyond the Johnson & Johnson complaint and contends that the SaveOnSP program is an "illicit racketeering enterprise" in violation of RICO.

It will be interesting to watch how these complaints progress through the courts. The outcomes should be especially interesting to employer health plan sponsors who have authorized the use of maximizer programs. To date employer health plan sponsors have not been named in these complaints, but it would not be unheard of for employees to sue employers who they believe have abrogated their fiduciary responsibilities under ERISA (see my August 2024 article).

Note - A similar complaint was filed in late December against PrudentRx, a copay maximizer that works with CVS Caremark. As with the Gurwitch case, this complaint includes allegations of both ERISA and RICO violations.