Eyepoint Pharmaceuticals, headquartered in Massachusetts, has agreed to pay the United States $ 4,657,463.18 to resolve allegations that it violated the False Claims Act by paying kickbacks to certain Ambulatory Service Centres (ASCs) to induce those ASCs to purchase and dispense DEXYCU, an injectable drug approved for the treatment of ocular inflammation following cataract surgery, between January 1, 2019 and March 1, 2023.  

The United States alleges that following the commercial launch of DEXYCU in 2019, EyePoint induced ASCs to purchase and dispense DEXYCU by implementing an Assurance Program—whereunder EyePoint would reimburse or compensate ASCs if health insurers denied a claim for DEXYCU or reimbursed DEXYCU below the ASCs’ purchase cost—and by offering excessive free samples of DEXYCU to ASCs.

Kickbacks by pharmaceutical companies increased the cost of drugs used by patients and paid for by federal health care programs, said assistant attorney general Brett Shumate of the Justice Department’s Civil Division.

In connection with the settlement, EyePoint entered into a five-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General.  

Through separate agreements, EyePoint will pay an additional $21,518.68 to certain participating states.

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by AFCE LLC.  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. AFCE LLC, et al., v. EyePoint Pharmaceuticals, Inc., No. 21-CV-12071 (D. Mass.)  Under the resolution, the Relator will receive $791,768.74 from the settlement.

“As we have for years, our Office will continue to hold pharmaceutical manufacturers accountable for paying illegal kickbacks,” noted U.S. attorney Leah Foley.

Pharmaceutical companies that “attempt to boost profits through unlawful kickbacks undermine the integrity of federal health care programmes and betray the patients who rely on them,” acting deputy inspector-general for investigations Scott Lampert of the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) pointed and vowed that the agency would “aggressively pursue any entity that seeks to corrupt medical decision-making and will not hesitate to hold them accountable”.