EyePoint Pharmaceuticals, Inc. has reached a settlement with the federal government to resolve allegations that it violated the False Claims Act by paying kickbacks to ambulatory surgery centers to encourage the use of its drug DEXYCU. The company will pay more than $4.6 million to the United States as part of the agreement announced on Friday by the Department of Justice.
According to the government, between January 2019 and March 2023, EyePoint allegedly induced surgery centers to purchase and dispense DEXYCU, an injectable treatment for inflammation following cataract surgery. The tactics reportedly included an Assurance Program that reimbursed centers when insurers denied claims or paid below cost, along with the distribution of excessive free samples.
“Kickbacks by pharmaceutical companies increase the cost of drugs used by patients and paid for by federal health care programs,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The Civil Division will hold accountable anyone who pays unlawful kickbacks.”
United States Attorney Leah B. Foley for the District of Massachusetts added, “As we have for years, our Office will continue to hold pharmaceutical manufacturers accountable for paying illegal kickbacks. Through these efforts, we protect patients by removing providers’ financial incentives to prescribe or dispense products that may not be medically necessary for the patient and protect the public from fraud, waste and abuse.”
The settlement also includes a five-year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General. EyePoint will make additional payments to certain states under separate agreements.
This case was brought under the whistleblower provisions of the False Claims Act by a relator who will receive a share of the recovery. The investigation involved coordination among multiple federal agencies, including the FBI and HHS OIG.
Such cases highlight the enormous resources the government spends fighting health care fraud. The False Claims Act remains one of the most effective tools for recovering taxpayer dollars and deterring improper marketing practices in the pharmaceutical industry. Officials stressed that such schemes ultimately raise costs for patients and federal programs like Medicare.
EyePoint has not admitted liability as part of the settlement. Likely, the company will put in place stronger compliance steps as part of the Corporate Integrity Agreement to prevent future problems.
The resolution is part of a continuing wave of enforcement actions against drug makers. Federal officials have said they will aggressively pursue alleged kickbacks that drive medical decisions based on financial rather than patient considerations.
The message is clear for the healthcare industry. Marketing practices that cross the line into illegal inducements constitute a major financial and reputational risk. With the government increasing its scrutiny, companies are facing pressure to make sure their sales and distribution practices are fully in line with federal law.
“When these matters are resolved, it is good for patients and the taxpayers. Every dollar recovered helps safeguard the integrity of programs millions of Americans rely on for critical medical care. “Settlements like this one put a lid on some allegations, but also call attention to the need for high ethical standards across the pharmaceutical industry.
© Eyepoint Pharmaceuticals, Inc.