Tactile Systems Technology to Pay $550K to Resolve Allegations

BOSTON—Tactile Systems Technology agreed to pay $550,959 to resolve allegations that it submitted false claims to Medicare seeking reimbursement for medically unnecessary pneumatic compression devices in violation of the federal False Claims Act.

Tactile markets pneumatic compression devices that healthcare professionals prescribe to treat patients suffering from chronic swelling due to lymphedema and chronic venous insufficiency. Pneumatic compression devices apply rhythmic, sequential pressure to body parts to enhance blood flow, lymphatic flow, reduce swelling and prevent venous thromboembolism. Tactile markets two pneumatic compression devices: a basic model called the Entre and an advanced model called the Flexitouch.

Medicare will cover the cost of a pneumatic compression device only after a lymphedema or chronic venous insufficiency patient fails to receive adequate relief from swelling after four weeks of conservative therapy, including basic compression. A healthcare professional prescribing a pneumatic compression device for a Medicare patient must document in medical records why basic compression failed to adequately treat a patient’s condition. Tactile required sales personnel to collect and retain the patient’s medical records.

The government contends that between Jan. 1, 2019 and Dec. 31, 2024, certain Tactile sales personnel fabricated or amended healthcare professionals’ medical records and other clinical documentation that Tactile used to submit claims to Medicare for payment for dispensing the pneumatic compression devices. In particular, various Tactile sales personnel, many of whom Tactile terminated upon learning of the conduct, allegedly inserted false statements into the medical records about patients’ failures to experience relief through basic compression therapy or forged healthcare professionals’ signatures on doctored medical records to make it appear as though the healthcare professionals had prescribed the Entre or Flexitouch devices. 

In other instances, Tactile sales personnel allegedly fabricated and amended healthcare professionals’ medical records and other clinical documentation to falsely state that patients did not experience a significant reduction in swelling after using the Entre and, therefore, required use of the more expensive Flexitouch device.