Medical Device Company to Pay $700,000 to Resolve False Claims Act Allegations Concerning Inflated Reimbursements from Medicare and Medicaid

Medical device manufacturer THD America Inc., located in Natick, Massachusetts, and its corporate parent, THD SpA of Italy (collectively, THD), have agreed to pay $700,000 to resolve allegations that THD violated the False Claims Act by knowingly causing physicians to use incorrect codes to obtain inflated reimbursement from Medicare and State Medicaid programs for the use of THD's hemorrhoid removal system called the Slide One Kit (the Kit).

The Kit was sold to physicians for use in transanal hemorrhoidal dearterialization, a surgical procedure that involves cauterizing certain blood vessels. The United States alleged that, between 2014 and 2017, physicians performing procedures using the Kit were required to bill for the procedure using a temporary code, also 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 federal share of the civil settlement is $598,121.23, and the state Medicaid share of the civil settlement is $101,877.77. State Medicaid programs are jointly funded by the federal and state governments.

"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."

"This case is emblematic of the U.S. Attorney's Office's commitment to pursuing and holding accountable those who seek to defraud federal health care programs and to recouping taxpayer dollars obtained falsely," said U.S. Attorney Erek L. Barron for the District of Maryland. "We will continue our efforts tirelessly in prioritizing rooting out fraud and protecting the public fisc."

"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). "HHS-OIG will continue to work with the U.S. Attorney's Office and our law enforcement partners to investigate allegations of companies violating the federal False Claims Act."

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Amber Arthur, a former employee of THD America. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The relator's share from the proceeds of the settlement will be $115,500. The qui tam action is captioned U.S. ex rel. Arthur v. THD America, et al., No. 16-cv-2571 (DMD).

The resolution obtained in this matter was the result of a coordinated effort between 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.

The investigation and resolution of this matter illustrates the government's emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to HHS at 800-HHS-TIPS (800-447-8477).

Assistant U.S. Attorney Tarra DeShields for the District of Maryland and Senior Trial Counsel Jay D. Majors of the Justice Department's Civil Division handled the matter.

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

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