A settlement has been reached in a whistleblower class action lawsuit brought against TranS1 Inc who is accused of causing health care providers to submit false claims to Medicare and other federal health care programs for minimally-invasive spine surgeries.
The whistleblower will receive $1,020,000 from the settlement.
The government's case was based upon a whistleblower lawsuit filed in April of 2011. The federal allegations were that TranS1 knowingly caused health care providers to submit claims with incorrect diagnosis or procedure codes for minimally-invasive spine fusion surgeries using Trans1’s AxiaLIF System. That device was developed as alternative to invasive spine fusion surgeries. The United States further alleged that TranS1 improperly counseled physicians and hospitals to bill for the AxiaLIF System by using incorrect and inaccurate codes intended for more invasive spine fusion surgeries. Additionally, the government alleged that, as a result, health care providers received greater reimbursement than they were entitled to for performing the minimally-invasive AxiaLIF procedures.
Further to those allegations were that TranS1 knowingly paid illegal remuneration to certain physicians for participating in speaker programs and consultant meetings intended to induce them to use TranS1 products, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and thereby caused false claims to be submitted to federal health care programs.
Also alleged by the government were that TranS1 promoted the sale and use of its AxiaLIF System for uses that were not approved or cleared by the U.S. Food and Drug Administration, including use in certain procedures to treat complex spine deformity, and which were thus not covered by federal health care programs.
