In October 2022, Pfizer filed a petition with the Supreme Court of the United States, seeking to overturn a lower court decision that prohibited Pfizer from providing financial help to Medicare beneficiaries access Vyndaqel and Vyndamax. In its petition, Pfizer is challenging the United States Department of Health and Human Services’ (HHS’) interpretation of the anti-kickback statute and is seeking to establish that the anti-kickback statute is only violated if the person offering the remuneration to induce purchase of a federally reimbursed healthcare item intends to corrupt the recipient’s medical decision-making.
Vyndaqel and Vyndamax are used to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a rare but life-threatening heart disease, and currently cost $225,000 per year, with estimated patient co-pays around $13,000 per year. Pfizer’s proposed assistance program would lower that out-of-pocket cost to just $35 per month.
Pfizer believes that its proposed patient assistance program “poses no risk of corrupting independent medical decision-making,” as the Vyndaqel and Vyndamax brands are the only FDA-approved drugs to treat ATTR-CM. They argue that the only way patients would be able to obtain a prescription for the medication is if a doctor has already given the patient an ATTR-CM diagnosis and prescription for the medication. Additionally, since these drugs are the only ones FDA-approved, there is no way for Pfizer to induce improper utilization through this particular program.
In 2019, Pfizer requested an advisory opinion on the legality of its proposed program from HHS Office of Inspector General. In December 2019, HHS OIG found that Pfizer’s proposed program to help Medicare patients pay for the drugs would violate the anti-kickback statute and despite Pfizer attempting to persuade HHS otherwise, in September 2020, HHS-OIG issued their advisory opinion explaining that the proposed program “plainly would” involve prohibited conduct under the anti-kickback statute as it would “present more than a minimal risk of fraud and abuse under the Federal anti-kickback statute” and is “highly suspect…because one purpose of the [proposed program]-perhaps the primary purpose-would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”
Pfizer attempted to have that overruled, but two courts have since agreed with HHS-OIG that such an arrangement violates the Anti-Kickback Statute (the United States District Court for the Southern District of New York and the United States Court of Appeals, Second Circuit).
In its petition to SCOTUS, Pfizer argues that the anti-kickback statute requires an element of corrupt intent for financial support to Medicare patients to be considered illegal. They argue that HHS’ interpretation is overly broad and “outlaws a wide swath of routine, beneficial conduct.” They also note that the statute’s “text, structure, and history,” including Congress’ use of words such as “kickback, bribe, or rebate” show that there is a corrupt intent component to the law. Pfizer also stated its belief that the way HHS and lower courts have construed the law is in violation of the Supreme Court’s “longstanding efforts to ensure that criminal laws do not sweep more broadly than intended.” However, as noted above, HHS and the two lower courts disagree, finding that ill intent is not a necessary component for those payments to be considered kickbacks.
Additionally, Pfizer notes that its proposed program would not “induce” any improper utilization of the drugs, but would instead “influence” a patient’s ability to access them. HHS, however, argues that the program would still break the law as it does induce a patient to purchase the drug by removing a financial obstacle.
What’s Next?
The Supreme Court has until November 14, 2022, to decide whether to hear the case. Pfizer may believe that the current Supreme Court justices will be amenable to hearing their argument, but only time will tell if this case makes it to the docket.