Diopsys Inc. has agreed to pay up to $14.25 million to resolve allegations it violated the federal False Claims Act and various Pennsylvania state laws by knowingly submitting or causing others to submit false Medicare and Medicaid claims for certain vision testing services.
The settlement resolves allegations relating to Diopsys’ NOVA device, an electrophysiological product cleared by the U.S. Food and Drug Administration (FDA) for visual evoked potential (VEP) testing. From Jan. 1, 2015 through Dec. 31, 2021, Diopsys allegedly caused healthcare providers to submit false claims to Medicare and Medicaid for services in which the NOVA device was used for medically unnecessary purposes, specifically electroretinography (ERG) vision testing, a substantially different vision test for which the NOVA device lacked FDA clearance, federal prosecutors claimed. The U.S. government further contended that Diopsys made substantial changes to the NOVA device that it never submitted to FDA for clearance or approval despite knowing such a submission was required.
“This resolution reaffirms our commitment to protect the integrity of the Medicare and Medicaid programs,” said U.S. Attorney John Giordano for the District of New Jersey. “Healthcare companies must not encourage doctors to submit claims for payment for medically unnecessary tests.”
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...
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