Covidien was an Irish-headquartered global health care products company and manufacturer of medical devices and supplies. It was purchased by Medtronic in a transaction that closed in 2015.
Covidien has agreed to pay $17,477,947 to resolve allegations that it violated the False Claims Act by providing free or discounted practice development and market development support to physicians located in California and Florida to induce purchases of Covidien’s vein ablation products.
Under the settlement agreement, Covidien will pay an additional $1,474,892 to California and $1,047,160 to Florida for claims settled by these state Medicaid programs. The Medicaid program is a jointly funded federal and state program.
The United States alleged that Covidien violated the Anti-Kickback Statute and, correspondingly, the False Claims Act by providing practice development and market development support to health care providers located in California and Florida from Jan. 1, 2011, through Sept. 30, 2014, to induce those providers to purchase ClosureFASTTM radiofrequency ablation catheters that were billed to Medicare and to the California and Florida Medicaid programs.
ClosureFastTM catheters are used in procedures that treat venous reflux disease, a disease often marked by the presence of varicose veins.
The practice and market development support Covidien provided included customized marketing plans for specific vein practices; scheduling and conducting “lunch and learn” meetings and dinners with other physicians to drive referrals to specific vein practices; and providing substantial assistance to specific vein practices in connection with planning, promoting, and conducting vein screening events to cultivate new patients for those practices.
The Anti-Kickback Act prohibits the payment of remuneration to induce the referral or use of items or services paid for by federal health care programs. Remuneration includes not only cash payments but also offers or payments made “in kind.”
The settlement resolves allegations contained in lawsuits filed by Erin Hayes and Richard Ponder (former sales managers for Covidien) and Shawnea Howerton (a former employee of one of Covidien’s customers), which are pending in federal court in San Francisco, California.
The lawsuits were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the United States for false claims and to share in any recovery. Mr. Hayes and Mr. Ponder will receive $3,146,030 as their share of the federal recovery.