Compliance Perspective – False Claims:
The Compliance Officer in collaboration with the pharmacist and the director of nursing, will ensure that medications are provided or obtained from approved sources and do not violate the Federal Food, Drug, and Cosmetic Act (FDCA). If it is discovered during a DOH survey that any person or entity is providing/obtaining foreign medications that are not FDA approved for use by the residents or if the Administrator will make a request based on internal audit findings, the State Agency will make referrals to the appropriate agencies, e.g., the FDA, and others depending on the medication’s classification. Staff education will include an explanation of the requirements for obtaining, dispensing, and administering only drugs obtained from appropriate sources, and how and to whom to report any concerns or identified violations. The Compliance Officer will periodically request that the pharmacy used by the facility provide proof that the medications being supplied are FDA approved.
It is alleged that from January 7, 2009 through May 2, 2012, their medical practice billed Medicare, Tennessee Medicaid (TennCare), and the Federal Employees Health Benefit Program (FEHBP) for foreign-sourced anticancer drugs not approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States. The doctor owned and operated a gynecology-oncology medical practice located in Chattanooga, Tennessee. The doctor’s wife had managed medical practice since its inception.
The United States alleged that the unapproved drugs the physician provided to patients and billed to Medicare, TennCare, and FEHBP were not reimbursable under those programs. The United States further alleged that the couple purchased unapproved drugs because they were less expensive than the drugs approved by FDA for marketing in the United States. Thus, the couple allegedly profited by administering the cheaper unapproved drugs.
The U.S. Attorney pointed out that “administering oncology drugs manufactured in other countries and not approved by the FDA, risks the safety of our citizens” and he vowed to “aggressively, pursue medical providers who improperly put their own financial interests ahead of the safety of their patients and who ignore rules instituted to protect the taxpayer funded healthcare system.”
The claims settled by this agreement are allegations only; there has been no determination of liability.
