Drug manufacturer Astra-Zeneca Pharmaceuticals, which last week paid $355 million in criminal fines and civil liabilities on charges that it defrauded Medicare and Medicaid, has entered into a five-year corporate integrity agreement with federal officials.
The HHS Office of Inspector General announced the agreement Tuesday, though Astra-Zeneca signed the document June 4.
The OIG says the Wilmington, Del.-based U.S. subsidiary of the British drugmaker already has established a voluntary compliance program, including a corporate compliance officer and committee, a code of conduct for all employees, employee training and a confidential disclosure system. The integrity agreement incorporates all these elements.
Under the agreement AstraZeneca must report average sale prices for drugs eligible for reimbursement by federal health plans. The list includes Cefotan, Faslodex, Foscavir, Merrem, injectible Tenormin, injectible Xylocaine and Zolodex.
The pact also calls on AztraZeneca to report prices for Elavil injection, a product it stopped making and selling in February, according to the document.
AstraZeneca got in trouble for providing free samples of Zolodex, a prostate cancer drug, to urologists, who then illegally billed Medicare, Medicaid and other federal health plans, according to an AstraZeneca guilty plea entered last week. Three urologists already have agreed to plead guilty to fraud and federal prosecutors say several hundred more physicians remain under investigation.