EyePoint Pharmaceuticals agrees $4.6 million False Claims Act settlement over DEXYCU kickback allegations
Federal healthcare fraud enforcement remains a focus for U.S. authorities as EyePoint Pharmaceuticals agrees to pay $4.66 million to resolve allegations tied to marketing of its cataract-surgery drug DEXYCU. The settlement covers claims that the Massachusetts-based company used reimbursement support and free samples to encourage ambulatory service centers to buy and dispense the drug between 2019 and 2023.
Highlights
- EyePoint Pharmaceuticals will pay $4,657,463.18 to resolve U.S. False Claims Act allegations of providing kickbacks via its DEXYCU Assurance Program and excessive free samples.
- The settlement includes EyePoint entering a five-year Corporate Integrity Agreement with HHS OIG and paying an additional $21,518.68 to certain participating states.
- AFCE LLC, as whistleblower under the False Claims Act, will receive $791,768.74, highlighting an intensified federal campaign targeting healthcare fraud and abuse.
Settlement terms and alleged sales practices
As reported by U.S. Department of Justice, EyePoint agrees 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 centers to induce purchases and use of DEXYCU, an injectable treatment for ocular inflammation following cataract surgery.U.S. authorities allege that after DEXYCU's commercial launch in 2019, the company put in place an Assurance Program under which it reimbursed or compensated ambulatory service centers when insurers denied claims for the drug or reimbursed below the centers' purchase cost. The government also alleges that EyePoint offered excessive free samples to stimulate orders of the product.
In connection with the settlement, EyePoint enters into a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General. Under separate agreements, the company will also pay an additional $21,518.68 to certain participating states.
Whistleblower payout and broader enforcement push
The civil settlement also resolves claims brought under the False Claims Act's whistleblower provisions by AFCE LLC in a case filed in the District of Massachusetts. Under the resolution, the relator will receive $791,768.74 from the settlement proceeds.Officials say the matter reflects a coordinated enforcement effort involving the Justice Department's Civil Division, the U.S. Attorney's Office for the District of Massachusetts, the Federal Bureau of Investigation and the U.S. Department of Health and Human Services Office of Inspector General. Assistant Attorney General Brett A. Shumate, U.S. Attorney Leah B. Foley and Acting Deputy Inspector General for Investigations Scott J. Lampert say unlawful kickbacks raise costs, distort medical decision-making and undermine the integrity of federal healthcare programs.
The department says the case underscores the government's broader campaign against fraud, waste and abuse in federal programs. The settlement resolves allegations only, and there has been no determination of liability.
In our earlier article on Scotiabank’s $10.45 million class action settlement over NSF fees, we explained how the resolution removed a key legal and financial overhang and provided clarity on the expected payout. We also noted that while the settlement reduced headline risk, mixed technical indicators kept the near-term outlook uncertain despite the stock trading above key moving averages.
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