Massachusetts medical device manufacturer pays $700,000 to resolve False Claims Act allegations A Massachusetts medical device manufacturer has agreed to pay the authorities $700,000 to resolve allegations that the company knowingly breached the False Claims Act (FCA). The company in question is...
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A Massachusetts medical device manufacturer has agreed to pay the authorities $700,000 to resolve allegations that the company knowingly breached the False Claims Act (FCA).
The company in question is THD America Inc., which is run by parent company THD SpA of Italy (collectively, THD). THD is footing the bill for the FCA breach caused by physicians knowingly submitting incorrect costing codes and billing to Medicare and State Medicaid for a specific medical procedure.
THD's hemorrhoid removal system is called the Slide One Kit (the Kit), and it was at the center of the breach, with inflated charges and billing being submitted for the medical procedures.
THD to pay $700,000 to resolve False Claims Act allegations
"Accurately billing for services provided to Medicare and Medicaid enrollees is required of all health care companies," said Special Agent in Charge Maureen Dixon of the Department of Health and Human Services Office of the Inspector General (HHS-OIG).
The United States alleged that, between 2014 and 2017, The Side One Kit was sold to physicians for use in transanal hemorrhoidal dearterialization, a surgical procedure that involves cauterizing certain blood vessels.
Physicians performing procedures with the Side One Kit were instructed to bill for the procedure using a temporary code.
According to the Justice Department, this was known as a "T-Code, assigned for new and emerging services. Because a procedure that is assigned such a code is considered experimental, reimbursement for the use of the Kit was often denied. To avoid such denials and increase potential reimbursement, THD allegedly encouraged colorectal and general surgeons improperly to bill Medicare and Medicaid programs using the T-Code plus an additional Current Procedural Terminology (CPT) code or to bill for CPT codes other than the T-code."
The U.S. Attorney's Office for the District of Maryland and the Civil Division's Commercial Litigation Branch, Fraud Section, with assistance from HHS-OIG, achieved the conviction.
"The integrity of federal healthcare programs depends upon compliance with coding and billing rules that are used to make coverage and reimbursement decisions," said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department's Civil Division. "We will hold accountable health care providers that knowingly submit false claims to federal health care programs that do not accurately reflect and bill for the work they perform."
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