William R. Kincaid and East Tennessee Hematology-Oncology Associates, P.C., d/b/a McLeod Cancer and Blood Center Agreed to be Excluded for 10 Years for Allegedly Purchasing Foreign Source Drugs

In connection with the resolution of False Claims Act liability, an oncology medical group practice agreed to be excluded from participating in Federal health care programs for ten years under 42 U.S.C. § 1320a-7(b)(7). OIG alleged that the oncology medical group practice purchased drugs from a foreign drug distributor in Canada that obtained the drugs from foreign sources. OIG alleged that these drugs, sometimes with labeling in foreign languages or without dosage information, were not manufactured in establishments that were registered with the United States Food and Drug Administration (FDA). OIG alleged that the versions of the drugs that the oncology medical group practice purchased were not the subject of, and did not comply with, a new drug application, abbreviated new drug application, or biologics license application approved by the FDA for commercial marketing and, therefore, the drugs were not covered by Federal health care programs because the drugs had not received final marketing approval from the FDA.

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