United States Settles False Claims Act Allegations Against Pharmaceutical Distributor for Paying Kickbacks Through Inventory Management Systems

ASD Specialty Healthcare LLC (ASD), doing business as Besse Medical (Besse), has agreed to pay $1.67 million to resolve allegations that it violated the Anti-Kickback Statute and False Claims Act by providing inventory management systems to retina practices at no cost to induce them to purchase drugs from Besse. ASD, headquartered in Carrollton, Texas, distributes specialty medical and pharmaceutical products nationwide, including ophthalmological injections that treat neovascular age-related macular degeneration (wet AMD).

As part of the settlement agreement, ASD admits that it acquired a commercially available inventory management system, known as PODIS, in May 2017. Through November 2023, ASD offered PODIS at no cost to customers who met certain purchase requirements, including that they purchase branded Wet AMD drugs from ASD and convert to an ASD customer if not a current customer. The government alleges that ASD caused physicians to submit false claims to Medicare, TRICARE and the Department of Veterans Affairs induced by these kickbacks.

The Anti-Kickback Statute prohibits any person, including specialty medical and pharmaceutical suppliers, from offering or paying, directly or indirectly, any remuneration — which includes money or anything of value, such as free inventory management systems — to induce the purchase of a drug that Medicare pays for.

“According to the allegations in today’s settlement, ASD purchased a commercially available product and leveraged it to gain business in violation of the AKS,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “We will pursue kickbacks at all levels of the distribution chain to preserve the integrity of federal health care programs.”

“Pharmaceutical distributors cannot violate the law to gain a financial advantage,” said U.S. Attorney Joshua S. Levy for the District of Massachusetts. “Offering improper incentives to health care customers can increase health care costs and disadvantage competitors who are playing by the rules. Our office is committed to continue pursuing these investigations with our federal law enforcement partners.”

“Improper financial inducements can compromise medical judgement and threaten the integrity of the Medicare program,” said Special Agent in Charge Roberto Coviello of the U.S. Department of Health and Human Services Office of Inspector General. “We are committed to pursuing allegations of kickbacks and false claims as we work to protect the integrity of the taxpayer-funded Medicare program, and we encourage the public to come forward with information about such conduct.”

“Investigating schemes that undermine the integrity of TRICARE, the healthcare system for military members and their families, is a top priority for the Department of Defense Office of Inspector General’s Defense Criminal Investigative Service (DCIS),” said Special Agent in Charge Patrick J. Hegarty of the DCIS Northeast Field Office. “Today’s announcement demonstrates our commitment to work with our partner agencies and the Justice Department to pursue those individuals and corporations that submit false claims to the TRICARE system.”

“Investigations such as these help safeguard the integrity of the healthcare industry marketplace and protect taxpayer funds,” said Special Agent in Charge Christopher Algieri of the Department of Veterans Affairs Office of Inspector General (VA OIG)’s Northeast Field Office. “The VA OIG thanks the Justice Department and our federal law enforcement partners for their collaboration in this joint investigation.”

The settlement resolves claims brought under the whistleblower or qui tam provisions of the FCA by Julianne Nunnelly and Matthew Shanks. Ms. Nunnelly and Mr. Shanks are former employees of Regeneron Pharmaceuticals Inc., which manufactures and sells a drug to treat wet AMD. Under the FCA, private parties may sue on behalf of the government for false claims for government funds and receive a share of any recovery. Mr. Shanks and Ms. Nunnelly will receive $250,705.20 from the proceeds of the settlement. The lawsuit is captioned United States ex rel. Nunnelly et al. v. Regeneron Pharmaceuticals, Inc. et al., No. 20-cv-11401-PBS (Dist. Mass.). The United States filed a complaint in intervention against Regeneron Pharmaceuticals, Inc., on March 28, that remains pending.

The investigation of this matter was the result of a coordinated effort between the Civil Division’s Commercial Litigation Branch, Fraud Section, and the U.S. Attorneys’ Offices for the District of Massachusetts, with assistance from the Department of Health and Human Services Office of Inspector General, FBI, DCIS, VA-OIG and the Office of Personnel Management Office of Inspector General.

The investigation and resolution of these matters illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the FCA. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

Trial Attorneys Douglas Rosenthal and Samuel Lehman of the Justice Department’s Civil Division and Assistant U.S. Attorneys Diane Seol and Lindsey Ross for the District of Massachusetts handled the matter.

The claims resolved by the settlement are allegations only, and there has been no determination of liability.

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Source: Justice.gov