Physician and Wife to Pay $1.2 Million to Settle False Claims Act Allegations for Billing Medicare and Medicaid for Unapproved Drugs

GREENEVILLE, Tenn. – Dr. Anindya Sen and Patricia Posey Sen will pay $1.208 million to resolve state and federal False Claims Act allegations that their medical practice billed Medicare and Tennessee Medicaid (TennCare) for anticancer and infusion drugs that were produced for sale in foreign countries and not approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States, the Department of Justice announced today. Dr. Sen owns and operates East Tennessee Cancer & Blood Center and East Tennessee Hematology Oncology and Internal Medicine located in Greeneville and Johnson City, Tennessee. Mrs. Sen managed Dr. Sen’s medical practice from 2009 through 2012.

“Billing for foreign drugs that are not approved by the FDA undermines federal health care programs and could potentially risk patient safety,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice is committed to maintaining the integrity of the health care system and ensuring that patient safety, not physician misconduct, determines health care decisions.”

“Medical providers and practitioners that distribute and disseminate unapproved and potentially unsafe drugs—especially those used in cancer treatment—put at risk the health and safety of the American consumer,” said U.S. Attorney Nancy Stallard Harr. “This settlement reflects our ongoing commitment to safeguard the federal health care programs and vital care that they provide.”

“When healthcare providers cut corners to make a profit, it is the patient that suffers,” Attorney General Herbert H. Slatery III said. “We will continue to work with the U.S. Attorney’s Office to hold individuals and companies accountable when they jeopardize the health of Tennesseans.”

The United States alleged that the unapproved drugs that the Sens provided to patients and billed to Medicare and TennCare were not reimbursable under those programs. The United States further alleged that the Sens purchased unapproved drugs because they were less expensive than the drugs approved by FDA for marketing in the United States. The Sens thus allegedly profited by administering the cheaper unapproved drugs.

This investigation was a coordinated effort by the Civil Division’s Commercial Litigation Branch, U.S. Attorney’s Office for the Eastern District of Tennessee, Department of Health and Human Services Office of General Counsel, Food and Drug Administration Office of Criminal Investigations and Office of Chief Counsel, FBI’s Knoxville Division and Tennessee Bureau of Investigation.

The claims settled by this agreement are allegations only; there has been no determination of liability.

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