Month: March 2025

Source: United States Department of Justice Criminal Division

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.

Source: United States Department of Justice Criminal Division

An indictment was unsealed yesterday charging Mohammad Jawaid Aziz, also known as Jawaid Aziz Siddiqui and Jay Siddiqui, 67, of Pakistan and Canada, with conspiracy to violate U.S. export laws and violating U.S. export laws. Siddiqui was arrested on March 21 in the Western District of Washington while attempting to cross into the United States from Canada. He remains detained, pending transfer to the District of Minnesota.

As alleged, from as early as 2003 through approximately March 2019, Siddiqui operated an illicit procurement network through his Canada-based company Diversified Technology Services. The purpose of the network was to obtain U.S.-origin goods on behalf of prohibited entities in Pakistan that were associated with the country’s nuclear, missile, and Unmanned Aerial Vehicle (UAV) programs.

According to the indictment, Siddiqui, while operating through Diversified Technology Services, procured various goods – including sensitive and restricted items subject to export administration regulations (EAR) and those on the Commerce Control List – from U.S. companies on behalf of the restricted entities in Pakistan. As alleged, Siddiqui and his co-conspirators worked to conceal the true end-users of the goods from U.S. companies, often using front companies and transshipping goods through third countries to evade detection.

Siddiqui is charged with conspiracy to violate the International Emergency Economic Powers Act (IEEPA) and Export Control Reform Act, which carries a maximum statutory penalty of five years in prison; and violating the Export Control Reform Act, which carries a maximum statutory penalty of 20 years in prison. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

Homeland Security Investigations Minneapolis, the FBI Minneapolis Field Office, and the Department of Commerce’s Bureau of Industry and Security (BIS) Chicago Field Office are investigating the case.

Assistant U.S. Attorney Bradley Endicott for the District of Minnesota and Trial Attorney Nicholas Hunter of the National Security Division’s Counterintelligence and Export Control Section are prosecuting the case. They received assistance from Assistant U.S. Attorney Michelle Jensen from the U.S. Attorney’s Office for the Western District of Washington and the Department’s Office of International Affairs.

An indictment is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.