On September 26, 2025, the Department of Justice announced that device manufacturer Semler Scientific had agreed to pay nearly $30 million, and its former distributor Bard Peripheral Vascular had agreed to pay an additional $7.2 million, in connection with the settlement of a whistleblower lawsuit filed under the qui tam provisions of the federal False Claims Act (FCA).
The settlement involves allegations that the defendants submitted false claims to Medicare for photoplethysmography tests in connection with the diagnosis of peripheral arterial disease (PAD). Photoelectric plethysmography – also known as photoplethysmography – uses a light sensor to detect changes in blood volume. According to the government’s press release, the only method that Medicare has approved to test for PAD is the ankle brachial index (ABI) test using CPT codes 93922, 92923, and 93924; Medicare does not cover noninvasive vascular tests that use photoplethysmography.
The whistleblowers alleged that for 14 years, Semler manufactured, and along with Bard, marketed, and distributed two devices – FloChec and QuantaFlo – to customers in connection with the diagnosis of PAD. According to the qui tam complaint and the government’s press release, Semler and Bard knew that the tests performed by these devices did not meet Medicare’s requirements because they did not perform an ABI. The government alleges that, notwithstanding this knowledge, Semler and Bard represented to healthcare providers that Medicare would reimburse the tests using the ABI codes and continued to do so even after receiving concerns from third parties regarding reimbursement.
The government’s press release notes that, as part of the settlement, Bard admitted certain of the allegations, and also received cooperation credit under DOJ guidelines, although it does not specify the details of that cooperation. The press release also notes that Semler also agreed to enter into a 5-year Corporate Integrity Agreement with HHS-OIG.
The allegations that lead to this settlement were contained in a qui tam complaint filed by vascular diagnostic industry experts Robert Kane and Franklin West. They and their attorneys will share $6.5 million as part of the settlement. The complaint was filed in the Middle District of Florida, where a district judge recently held that the qui tam provisions of the FCA are unconstitutional. That decision is currently pending appeal before the Eleventh Circuit.
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The attorneys at Chilivis Grubman represent businesses and individuals in connection with government investigations and False Claims Act litigation, including cases brought under the FCA’s qui tam whistleblower provisions. If you need assistance with such a case, please contact us.