In September 2024, Sanford Heisler Sharp McKnight and the U.S. Government settled a whistleblower action brought under the False Claims Act (“FCA”) and California Insurance Frauds Prevention Act against Massachusetts-based medical device manufacturer THD America and its corporate parent, THD SpA of Italy (collectively, “THD”). THD agreed to pay the Government and the California Insurance Commissioner $1 million. Sanford Heisler Sharp McKnight represented the whistleblower, a former employee of THD America.

THD America manufactures the Slide One Kit (“the Kit”), a device used by physicians in transanal hemorrhoidal dearterialization procedures. Colorectal and general surgeons using the Kit in procedures were required to bill Medicare and Medicaid using only the temporary code, or “T-Code,” which designated the Kit as a new and emerging service. As the THD procedure was considered experimental, reimbursement for use of the Kit was often denied. The Complaint alleged that between 2014 and 2017, THD America defrauded Medicare, Medicaid, and California private payers by knowingly encouraging physicians to use the T-Code plus an additional Current Procedural Terminology (CPT) code (“upcoding”) or to bill for CPT codes other than the T-code (“unbundling”), in order to secure reimbursement.