Tactile Systems Technology has agreed to pay $550,959 to resolve allegations that it submitted false claims to Medicare for medically unnecessary pneumatic compression devices in violation of the federal False Claims Act, according to an April 23 announcement from the U.S. Attorney for the District of Massachusetts.
Tactile markets pneumatic compression devices prescribed by health care professionals for patients with chronic swelling due to lymphedema and chronic venous insufficiency. The company offers two models: a basic device called Entre and an advanced model called Flexitouch. According to the government, between January 1, 2019, and December 31, 2024, certain Tactile sales personnel fabricated or amended health care professionals’ medical records and other clinical documentation used in claims submitted to Medicare. The government said these actions included inserting false statements about patients’ failures with basic compression therapy and forging signatures on doctored medical records. In some cases, sales personnel allegedly altered records to state that patients did not experience significant reduction in swelling after using Entre and therefore required the more expensive Flexitouch device.
Medicare coverage rules require that a pneumatic compression device is reimbursed only after four weeks of conservative therapy have failed and that health care professionals document why basic compression was inadequate. Tactile required its sales staff to collect and retain patient medical records as part of this process.
The claims against Tactile were brought under the whistleblower or qui tam provision of the False Claims Act. This allows private parties—known as relators—to sue on behalf of the government over false claims for government funds and receive a share of any recovery. In this case, relators will receive $129,475 from the settlement proceeds. The lawsuits are captioned United States ex rel. Scarborough, LLC v. Tactile Systems Technology, Inc., No 21-cv-10813, and United States ex rel. Gorham and Gast v. Tactile Systems Technology, Inc., No. 21-cv-11809.
United States Attorney Leah B. Foley and Roberto Coviello, Special Agent in Charge at Health and Human Services-Office of Inspector General, announced the resolution on April 23. Assistant U.S. Attorney Steven Sharobem from the Affirmative Civil Enforcement Unit handled this matter along with Civil Chief Abraham R. George.
The U.S. Attorney for the District of Massachusetts serves all residents across Massachusetts; enforces federal laws through prosecutions including civil rights violations; advances community initiatives on civil rights; employs over 200 attorneys, paralegals and professional staff; maintains offices at several locations including Boston’s John Joseph Moakley United States Federal Courthouse; is a component of the Department of Justice, according to its official website.