SAN JOSE – Bay Area physician Dr. Roger Wang has agreed to pay $1,033,666.42 to resolve allegations that he violated the False Claims Act by charging Medicare for non-FDA-approved drugs and associated services, announced United States Attorney Stephanie M. Hinds; Special Agent in Charge, Office of Inspector General for the U.S. Department of Health and Human Services Steven J. Ryan; and Special Agent in Charge of the Food and Drug Administration (FDA), Office of Criminal Investigations, Los Angeles Field Office, Lisa L. Malinowski.
According to the settlement, viscosupplements, such as Synvisc, Synvisc One, and Orthovisc, are FDA-approved drugs injected for the treatment of osteoarthritis pain. The United States has alleged that Wang, a rheumatology specialist practicing in San Francisco, purchased and injected into his patients versions of Synvisc, Synvisc One, or Orthovisc that were not approved by the FDA for distribution in the United States and therefore were not covered by Medicare, and billed Medicare for the drugs and injections. The settlement agreement resolves claims the United States might have brought based upon these allegations.
“When Medicare pays for drugs and services, the government expects doctors to follow the rules in place to protect patient safety,” said U.S. Attorney Stephanie M. Hinds. “In this case, the rules require doctors seeking reimbursement from Medicare for injecting viscosupplements to use FDA-approved drugs. This office will hold accountable anyone who seeks to cut corners by defrauding American taxpayers and risking harm to patients by using unapproved medications.”
“Physicians who bill Medicare for ineligible medications and procedures defy basic requirements for their participation in the program and wrongfully attempt to collect taxpayer funds,” stated HHS-OIG Special Agent in Charge Steven J. Ryan. “We will continue to work closely with our law enforcement partners to investigate bad actors that cheat federal health care programs and flout their safeguards meant to protect patients’ health and well-being.”
“Drugs and devices that are produced and distributed outside the FDA’s oversight present the prospect of harm to the public health,” said Special Agent in Charge Lisa L. Malinowski, FDA Office of Criminal Investigations, Los Angeles Field Office. “We commend DOJ and HHS-OIG for their commitment to protecting American patients.”
According to the settlement, the United States alleged Wang knowingly submitted thousands of false claims for reimbursement for non-FDA-approved Synvisc and Orthovisc and related procedures. Specifically, the United States alleged that Wang used non-FDA-approved drugs that were packaged and labeled for use in foreign markets. At least some of the labeling, according to the settlement, was for additional uses not approved in the United States. In addition, the United States alleged that, from June 30, 2015, to December 1, 2019, Wang knowingly submitted claims to Medicare for reimbursement for non-FDA-approved Synvisc and Orthovisc, and for injection procedures, even though neither the non-FDA-approved drugs nor the injections of those drugs are covered by Medicare. Pursuant to the settlement, the United States agreed to resolve the government’s claims resulting from Wang’s conduct, including the government’s claims under the False Claims Act, codified at 31 U.S.C. §§ 3729-3733, and certain other related claims, for more than $1 million.
The claims resolved by this settlement are allegations only and there has been no determination of liability.
Assistant U.S. Attorney Michael Pyle is handling the matter. The settlement is the result of an investigation by the U.S. Attorney’s Office for the Northern District of California, the U.S. Department of Health and Human Services Office of Inspector General, and the Food and Drug Administration, Office of Criminal Investigations.