MSP Recovery Claims, Series LLC v. Actelion Pharmaceuticals US, Inc.

District Court, N.D. California·Decided September 5, 2023·No. 3:22-cv-07604·Unknown

Opinion

MSP RECOVERY CLAIMS, SERIES LLC, Case No. 22-cv-07604-JSC et al., Plaintiffs, ORDER RE: MOTION TO DISMISS v. Re: Dkt. No. 43 ACTELION PHARMACEUTICALS US, INC., et al., Defendants. This lawsuit concerns an alleged scheme to raise prices for defendant Actelion Pharmaceuticals’ pulmonary hypertension drugs. Plaintiffs are a series of entities (collectively, “MSP entities”). Plaintiffs buy “claims” from insurers that participate in the Medicare system and attempt to collect on those claims through various legal means. Here, Plaintiffs allege Defendants violated the Racketeering Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C. §§ 1962, 1964, along with various state laws. Defendant Actelion moves to dismiss. After carefully reviewing the voluminous briefing in this matter and conducting oral argument on August 3, 2023, the Court GRANTS Actelion’s motion to dismiss with leave to amend in part. Plaintiffs have not plausibly alleged their receipt of valid assignments of causes of action. Defendant Actelion is a pharmaceutical company. (Dkt. No. 38 ¶ 46.) Actelion manufacturers and markets drugs used to treat hypertension, such as Tracleer, Opsumit, Veletri, and Ventavis. (Id. ¶¶ 1, 46.) Plaintiffs describe themselves as “companies that assist Government Healthcare Plans in detecting claims payments that are subject to reimbursement[.]” (Id. ¶ 29.) Medicare is a government health-insurance program that primarily covers people aged 65 and over and others with certain disabilities or illnesses. Medicare consists of five parts: A provided by private insurance companies—referred to as “Medicare Advantage”), D (prescription drug coverage), and E (miscellaneous provisions). (Id. ¶ 75). Like Part C, Medicare Part D is based on a private-market model, in which Medicare contracts with private entities, known as Part D “sponsors.” (Id. ¶ 77.) Sponsors administer prescription drug plans. Plan sponsors must provide qualified prescription drug coverage. (Id.) A Part D sponsor submits a “bid” to the Centers for Medicare and Medicaid Services (“CMS”) the year before it is to deliver Part D benefits. (Id.¶ 78.) The bid contains a per member, per month cost estimate for providing Part D benefits to an average Medicare beneficiary in the geographic area. (Id.) CMS then provides each Part D plan sponsor with advance monthly payments equal to the Part D plan sponsor’s standardized bid. (Id. ¶ 79.) After the close of each plan year, CMS determines “whether sponsors have been overpaid or whether Medicare owes them money” through a process called “reconciliation.” (Dkt. No. 45-16 at 51; see also United States ex rel. Baer v. Ludden, No. 13-CV-223-JDP, 2016 WL 1259432, at *1 (W.D. Wis. Mar. 30, 2016) (taking judicial notice of the congressional research reports concerning how Medicare operates when, as here, both parties cited the same reports)). Medicare limits plan sponsors’ potential losses, or gains, by financing some higher-than- expected costs or recouping some excessive profits, relative to the amount the plan originally bid to offer Part D. (Dkt. No. 45-16 at 51-52.) For example, a plan that had higher-than-expected costs in 2021 was required to cover all benefit spending up to 105% of its standardized bid. (Id.) A plan with costs above 105% and up to 110% of its bid covered 50% of the costs within that range, and CMS paid the other 50%. (Id.) The same applies for the savings. A plan with costs amounting to 95% of its bid could keep all of the savings. (Id.) And so on. Patient Assistance Programs To buy prescription drugs, Part D plans generally require patients pay an out-of-pocket price, commonly known as “co-pay.” (Dkt. No. 38 ¶ 18.) Once the co-payment is made, pharmacies bill the sponsor (the “third party payor”) for the full drug cost. (Id. ¶ 5.) However, because many patients cannot afford co-pays, “patient assistance programs” help financially needy These arrangements are susceptible to abuse. In short, a pharmaceutical company could manipulate the market for its own drugs by paying the co-payments for patients (through an intermediary patient assistance program), only to then reap the larger financial reward (the full sale price). By one estimate, for every $100 million given to a patient assistance program, pharmaceutical manufacturers yield $1 billion in increased sales. (Id. ¶ 74.) The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, prohibits pharmaceutical companies from paying remuneration to induce Medicare beneficiaries to purchase, or their physicians to prescribe, drugs that are reimbursed by Medicare. Defendant Caring Voice Coalition, (“Caring Voice”), was a patient assistance program. The Department of Health and Human Services’ Office of the Inspector General issued an advisory letter to patient assistance programs like Caring Voice, setting forth certain requirements to avoid Anti-Kickback Statute liability. (Id. ¶ 106.) In 2006 and 2014, Caring Voice certified it would comply with those regulations. (Dkt. No. 38-28; Dkt. No. 38-29.) Based on those representations, the HHS Inspector General issued an advisory opinion to Caring Voice “certifying” its patient assistance program. (Id.) The DOJ Settlement Between 2006 and 2017, Actelion gave Caring Voice $270 million. (Dkt. No. 38 ¶ 165.) Caring Voice, in turn, helped patients afford co-pays for drugs—including Actelion’s drugs. (Id. ¶ 149.) After an investigation, the United States Department of Justice alleged Actelion engaged an illegal kickback scheme through its relationship with Caring Voice and certain pharmacies. (See Dkt. No. 38-2.) The Department of Justice contended: Actelion made donations to [Caring Voice’s Pulmonary Arterial Hypertension] fund and used it as a conduit to pay the copay obligations of thousands of Medicare patients taking the Subject Drugs and to induce those patients’ purchases of the Subject Drugs, because it knew that the prices Actelion set for the Subject Drugs otherwise could pose a barrier to those purchases. From January 1, 2014, through August 2015, Actelion routinely obtained data from [Caring Voice] detailing how many patients on each Subject Drug [Caring Voice] had assisted, how much [Caring Voice] had spent on those patients, and how much [Caring Voice] expected to spend on Actelion used this information to budget for future payments to [Caring Voice] on a drug-specific basis and to confirm that its contribution amounts to [Caring Voice] were sufficient to cover the copays of patients taking the Subject Drugs, but not of patients taking other manufacturers’ [Pulmonary Arterial Hypertension] drugs. Actelion engaged in this practice even though [Caring Voice] warned the company against receiving data concerning [Caring Voice’s] expenditures on copays for the Subject Drugs. (Id. at 2 ¶ E.) During that same period, according to the government, Actelion did not permit Medicare patients to participate in its free drug program—which was open to other financially needy patients. (Id.) Rather, Actelion directly referred Medicare patients to Caring Voices. (Id.) The government’s allegations covered conduct that ended “prior to the acquisition of Actelion by Johnson & Johnson on June 16, 2017.” (Id.) Actelion and the United States settled in December 2018. Actelion paid the United States over $360 million. (Id. ¶ 1.) Plaintiffs’ Assignments Plaintiffs “obtain[] assignments from their Assignors to recover reimbursement or payment from Defendants for the claims paid as a result of Defendants’ fraud, waste, and abuse.” (Dkt. No. 38 ¶ 29.) The “Assignors” here are health insurers, pursuant to Medicare Part C and Part D, which made payments “on behalf of, or otherwise became financially responsible for the cost of illegally inflated,[Anti-Kickback Statute]-tainted, and exces

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MSP Recovery Claims, Series LLC v. Actelion Pharmaceuticals US, Inc., (N.D. Cal. 2023).

MSP Recovery Claims, Series LLC v. Actelion Pharmaceuticals US, Inc. (MSP Recovery Claims, Series LLC v. Actelion Pharmaceuticals US, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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