ASD Specialty Healthcare, operating as Besse Medical, has agreed to pay $1.67 million to settle allegations of violating the Anti-Kickback Statute. The company allegedly provided inventory management systems at no cost to retina practices to encourage drug purchases from Besse.
ASD admitted responsibility for specific actions leading to the settlement. In 2017, ASD acquired PODIS, an inventory management system designed for retina practices handling high-cost injectable medications like those treating wet AMD. Until November 2023, ASD offered PODIS for free under "prime vendor agreements," which required a certain percentage of drug purchases from ASD. Practices not entering these agreements had to pay a monthly fee for PODIS access. After acquiring PODIS, ASD stopped providing access to non-ASD customer retina practices that previously used it, even if they were willing to pay a fee.
The government claims these actions led physicians to submit false claims to Medicare, TRICARE, and the Department of Veterans Affairs due to the alleged kickbacks.
"Pharmaceutical distributors cannot violate the law to gain a financial advantage," stated United States Attorney Joshua S. Levy. He emphasized that improper incentives could increase healthcare costs and disadvantage compliant competitors.
Principal Deputy Assistant Attorney General Brian M. Boynton remarked on leveraging commercially available products in violation of AKS: "We will pursue kickbacks at all levels of the distribution chain."
Special Agent in Charge Roberto Coviello noted that improper financial inducements could compromise medical judgment and threaten Medicare's integrity.
FBI Special Agent in Charge Jodi Cohen highlighted this case as part of their commitment against healthcare fraud: "This case highlights the FBI’s commitment... ensuring accountability for those who run afoul of the law."
Patrick J. Hegarty from DCIS emphasized their focus on protecting TRICARE's integrity: "Today’s announcement demonstrates our commitment... pursuing those individuals and corporations that submit false claims."
Christopher Algieri with VA OIG thanked federal partners for collaboration in safeguarding taxpayer funds through such investigations.
The settlement partly resolves claims under the False Claims Act brought by former Regeneron Pharmaceuticals employees against both Regeneron and ASD. The whistleblowers will receive $250,705.20 from the settlement proceeds.
The announcement was made by U.S. Attorney Levy alongside other officials involved in handling this matter.