By SDCN Editor
Pharmaceutical company Pfizer Incorporated on behalf of its wholly-owned subsidiary Biohaven Pharmaceutical Holding Company Ltd., has agreed to pay $59,746,277 to resolve allegations that, before Pfizer acquired the company,
According to the Department of Justice, Biohaven knowingly caused the submission of false claims to Medicare and other federal healthcare programs by paying kickbacks to healthcare providers to induce prescriptions of Biohaven’s drug Nurtec ODT.
“Through this settlement and others, the government has demonstrated its commitment to ensuring that drug companies do not use kickbacks to influence physician prescribing,” said Acting Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The department will use every tool at its disposal to prevent pharmaceutical manufacturers from undermining the objectivity of treatment decisions by health care providers.”
The anti‑kickback statute prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, TRICARE, and other federal healthcare programs. The statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives, the Department of Justice added.
The settlement announced resolves allegations that from March 1, 2020, through Sept. 30, 2022, Biohaven paid improper remuneration, including in the form of speaker honoraria and meals at high-end restaurants, to healthcare professionals to induce them to prescribe the migraine medication Nurtec ODT in violation of the anti-kickback statute. The United States alleged that Biohaven selected certain healthcare providers to be part of the Nurtec speaker bureau and provided them paid speaking opportunities with the intent that the speaker honoraria and meals would induce them to prescribe Nurtec ODT. The government further alleged that certain prescribers who attended multiple programs on the same topic received no educational benefit from attending repeat programs and that certain Biohaven speaker programs were attended by individuals with no educational need to attend, such as the speakers’ spouses, family members, or friends, or colleagues from the speakers’ own medical practice. The United States contends that this conduct persisted until October 2022, when Pfizer acquired Biohaven and terminated the Nurtec speaker programs.
“Patients deserve to know that their doctor is prescribing medications based on their doctor’s medical judgment, and not as a result of financial incentives from pharmaceutical companies,” said U.S. Attorney Trini Ross for the Western District of New York. “This settlement reflects our commitment to hold those who violate the laws accountable, regardless of their status or prestige.”
“Violations of the anti-kickback statute, such as those alleged in this settlement, can unduly influence prescribers and negatively impact taxpayer-funded health care,” said Deputy Inspector General Christian Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG will continue to collaborate with law enforcement partners to ensure that providers and corporations are held accountable if they attempt to bypass laws meant to protect the integrity of federal health care programs.”
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Patrica Frattasio, a former sales representative at Biohaven. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The qui tam case is captioned U.S. ex rel. Patricia Frattasio v. Biohaven Pharmaceutical Holding Company Ltd., No. 6:21-CV-06539 (W.D.N.Y.). Approximately $50.2 million of the settlement constitutes the federal portion of the recovery and $9.5 million constitutes a recovery for State Medicaid programs. Frattasio will receive approximately $8.4 million as her share of the federal recovery.
The resolution obtained was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch Fraud Section, and the U.S. Attorney’s Office for the Western District of New York.
