DOJ Secures $4.7 Million Settlement With EyePoint Over Alleged Drug Kickbacks

Key Takeaways

• $4.66 Million Settlement: EyePoint Pharmaceuticals agreed to pay $4,657,463.18 to resolve False Claims Act allegations related to DEXYCU marketing practices.
• Alleged Kickback Scheme: The Justice Department alleged the company used an Assurance Program and excessive free drug samples to induce ambulatory surgery centers to purchase and dispense DEXYCU.
• Four-Year Enforcement Period: The allegations concern conduct between Jan. 1, 2019, and March 1, 2023, following the commercial launch of DEXYCU.
• Compliance Oversight: As part of the resolution, EyePoint entered into a five-year Corporate Integrity Agreement with the HHS Office of Inspector General.
• State Resolution Included: The company will also pay an additional $21,518.68 to certain participating states under separate agreements.

Deep Dive

A Massachusetts-based drugmaker,  EyePoint Pharmaceuticals, has agreed to pay $4,657,463.18 to resolve allegations that it violated the False Claims Act by paying kickbacks to certain ambulatory surgery centers to encourage them to purchase and dispense DEXYCU, an injectable treatment approved for ocular inflammation following cataract surgery. The alleged conduct spans from Jan. 1, 2019, through March 1, 2023. Under separate agreements, EyePoint will also pay an additional $21,518.68 to certain participating states.

At the center of the government's case is not the drug itself but the economics surrounding it. Federal prosecutors allege that after DEXYCU reached the market, EyePoint introduced an Assurance Program under which ambulatory surgery centers would be reimbursed or otherwise compensated if insurers either denied claims for the drug or reimbursed them below the centers' purchase cost. The government further alleges that EyePoint supplied excessive free samples of DEXYCU to those facilities.

Taken together, prosecutors contend, those practices reduced the financial risk associated with using the drug while creating an unlawful incentive for providers to purchase and dispense it.

"Kickbacks by pharmaceutical companies increase the cost of drugs used by patients and paid for by federal health care programs," Assistant Attorney General Brett A. Shumate of the Justice Department's Civil Division said in announcing the settlement. "The Civil Division will hold accountable anyone who pays unlawful kickbacks."

For the Justice Department, the case fits comfortably within a long-running enforcement strategy that treats financial arrangements capable of influencing medical decision-making as a threat not only to federal healthcare spending but also to clinical independence. U.S. Attorney Leah B. Foley said her office would continue pursuing pharmaceutical manufacturers that pay illegal kickbacks, arguing that such enforcement removes financial incentives that may affect prescribing or dispensing decisions while protecting public healthcare programs from fraud, waste, and abuse.

The Department of Health and Human Services Office of Inspector General struck the same theme. Acting Deputy Inspector General for Investigations Scott J. Lampert said pharmaceutical companies that seek higher profits through unlawful kickbacks undermine the integrity of federal healthcare programs and compromise the medical judgment on which patients depend.

The settlement resolves the government's allegations without a determination of liability.

The financial payment is only part of the resolution. EyePoint also entered into a five-year Corporate Integrity Agreement with the HHS Office of Inspector General, a compliance mechanism that places companies under enhanced oversight and requires them to maintain more rigorous compliance controls for years after the settlement itself has been paid.

Cases like this rarely turn on whether a company wanted physicians or surgery centers to adopt a new therapy. Every manufacturer does. They turn instead on how far a company can go in removing the financial friction that stands between a provider and a prescribing decision. The government's allegation is that EyePoint went too far by replacing ordinary reimbursement risk with assurances backed by the manufacturer itself. That distinction, technical as it may seem, remains one of the clearest lines federal healthcare fraud enforcement continues to defend.

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