We previously wrote about the petition Pfizer filed at the Supreme Court of the United States (SCOTUS), seeking the reversal of a lower court decision that prohibited the company from providing financial health to Medicare beneficiaries for its drugs Vyndaqel and Vyndamax, which are used to treat a rare heart condition, transthyretin amyloid cardiomyopathy.
The drug is expensive and patients would need to pay more than $1,000 per month for the prescription, with Medicare covering the balance (which could be more than $200,000). Pfizer was trying to help middle income patients afford the drug, as they would not qualify for low-income copay support but would also be unlikely to be able to afford the high out-of-pocket copays.
However, the Department of Health and Human Services Office of Inspector General (HHS OIG) found that the copayment assistance could violate the Anti-Kickback Statute by inducing patients to use Pfizer’s drug, and then leaving taxpayers to pay the bulk of the cost.
Pfizer sued challenging the findings and saying that the program could only violate the Anti-Kickbacks statute if it were administered with corrupt intent. The United States Court of Appeals for the Second Circuit ruled against Pfizer, and Pfizer appealed to the Supreme Court.
In its petition for a writ of certiorari, Pfizer argued that the Second Circuit violated SCOTUS’ “consistent admonition against overly expansive construction of criminal statutes, limited only by government discretion” and that SCOTUS has “repeatedly rejected expansive constructions of criminal statutes that would punish routine, even desirable, conduct, subject only to government permission.” Pfizer continued on, arguing that the standard principles of statutory construction, applied to the text, structure, and history of the Anti-Kickback Statute, “confirm that Congress only intended to reach arrangements that corrupt the provision of federally funded healthcare” and that the Second Circuit “broke from this Court’s practice in its cursory dismissal of well-recognized canons of interpretation.”
The Department of Health and Human Services filed a brief in opposition, arguing that the Anti-Kickback Statute is clear that “any remuneration” used “to induce” purchases of items and services reimbursable by a Federal health care program is impermissible.
In its reply brief, Pfizer continued to point to the “government’s reading of the [Anti-Kickback Statute] has morphed dramatically in recent years, and further evolved throughout this litigation,” treating the statute as “a policy-driven cost-control statute imposing a virtual per se prohibition on any financial assistance allowing patients to access their federal insurance benefits, limited only by prosecutorial discretion.”
Ultimately, the Supreme Court declined to review the Second Circuit’s ruling, denying Pfizer’s writ of certiorari. This declination to review the lower level decision means it will stand unless and until another case takes the same path to SCOTUS, and SCOTUS elects to review that case. However, as HHS states in its brief in opposition, Pfizer did not identify any “conflict among the courts of appeals that would warrant the Court’s review,” and as such, it isn’t expected for another similar case to come before SCOTUS in the near future.