Diopsys, Inc., a medical device company based in Middletown, Pennsylvania, has agreed to pay up to $14.25 million to resolve allegations that the company violated the federal False Claims Act and various state laws by knowingly submitting or causing others to submit false claims for payment to Medicare and Medicaid in connection with certain vision testing services. The settlement resolves allegations relating to Diopsys’ NOVA device, an electrophysiological device that the US Food and Drug Administration (FDA) cleared for visual evoked potential (VEP) testing.
The United States alleged that, during the period from January 1, 2015, through December 31, 2021, Diopsys caused healthcare providers to submit false claims to Medicare and Medicaid for services in which the NOVA device was utilized for medically unnecessary uses, specifically electroretinography (ERG) vision testing, a substantially different vision test for which the NOVA device lacked FDA clearance. The government further contended that Diopsys made substantial changes to the NOVA device that it never submitted to FDA for clearance or approval despite knowing that such a submission was required. Under the terms of the settlement, Diopsys will make guaranteed payments of $1,225,000 and contingent payments of up to $13,025,000. The settlement is based on Diopsys’ financial condition.
