Diopsys Inc. Agrees to Pay up to $14.25 Million to Resolve Alleged Federal False Claims Act and State Law Violations Relating to Vision Testing

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 U.S. Food and Drug Administration (FDA) cleared for visual evoked potential (VEP) testing. The United States alleged that, during the period from Jan. 1, 2015 through Dec. 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.

“Today’s 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. “Health care 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 is based on Diopsys’ financial condition.

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Dr. Atul Jain, a California ophthalmologist. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery.  Approximately $1,120,000 of the guaranteed payment and up to approximately $11,900,000 of the contingent payments constitute the federal portion of the recovery. Dr. Jain will receive at least approximately $207,000 as his share of the federal recovery in this case.

The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the District of New Jersey, with assistance from the U.S. Department of Health and Human Services Office of Inspector General.

The investigation and resolution of this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

The matter was handled by Assistant U.S. Attorney David Simunovich of the Health Care Fraud Unit in the U.S. Attorney’s Office for the District of New Jersey, and Trial Attorney Daniel Meyler of the Civil Division’s Commercial Litigation Branch, Fraud Section.

The case is captioned United States ex rel. Jain v. Diopsys Inc., et al., Civil Action No. 21-18151 (D.N.J.).

The claims resolved by the settlement are allegations only. There has been no determination of liability.