Two medical device companies—Semler Scientific Inc. and Bard Peripheral Vascular Inc.—will pay nearly $37 million to resolve allegations tied to a Medicare Fraud Device Scheme. The U.S. Department of Justice (DOJ) claims both companies knowingly caused healthcare providers to submit false Medicare claims for vascular tests using Semler’s FloChec and QuantaFlo devices. These devices, which rely on photoplethysmography—a method not covered by Medicare—were falsely promoted as qualifying for reimbursement under CPT codes 93922, 93923, and 93924.
The settlement addresses claims that both companies knowingly caused healthcare providers to submit false Medicare claims for tests using Semler’s FloChec and QuantaFlo devices. These devices use photoplethysmography—a light-based method not covered by Medicare—and were falsely marketed as qualifying for reimbursement under CPT codes 93922, 93923, and 93924, which require an ankle brachial index (ABI) test. This fraudulent use of devices exemplifies a significant Medicare scheme.
Despite FDA warnings that FloChec and QuantaFlo do not perform ABI tests and cannot be labeled as “digital ABI,” Semler allegedly continued to promote them as reimbursable. Bard, which distributed the devices from 2012 to 2022, admitted to certain allegations and received cooperation credit in this device-related fraud scheme.
“This case underscores the importance of truthfulness in Medicare billing,” said Assistant Attorney General Brett A. Shumate. “Misrepresentation drains taxpayer-funded resources and undermines trust in our healthcare system.” Hence, understanding the implications of a Medicare fraud device scheme is vital.
Semler has also entered into a five-year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General (HHS-OIG), committing to significant internal compliance reforms. This agreement aims to alleviate involvement in any future device schemes related to Medicare fraud.
The case was initiated by whistleblowers Robert Kane and Franklin W. West under the False Claims Act’s qui tam provisions. They will receive approximately $6.5 million for their role in exposing the fraud device scheme.
The DOJ encourages anyone with knowledge of healthcare fraud to report it via the HHS tip line: 800-HHS-TIPS (800-447-8477). Such reports are crucial to preventing Medicare fraud schemes involving deceptive devices.