INDUSTRY, HOSPITAL MEDICAID DEALS BECOMING KEY ENFORCEMENT ISSUE

Federal prosecutors will be more aggressively enforcing anti-kickback laws for deals between industry sales reps and hospitals in Medicaid device and drug negotiations, according to a high-ranking Department of Justice (DOJ) official.

U.S. attorneys have begun to pay more attention to industry and group purchasing organization (GPO) negotiation practices, Associate U.S. Attorney James Sheehan said Aug. 23 at the FDA Regulatory and Compliance Symposium at Harvard University, co-sponsored by FDAnews.

This development should increase industry compliance officers' and hospital officials' responsibilities to ensure that all negotiations are appropriate, Sheehan said.

The DOJ is concerned that companies and GPOs have under-the-table deals to provide hospitals with product discounts if certain sales goals are met. Not only are federal prosecutors beginning to look at this practice, but whistleblowers and companies are monitoring it too, Sheehan said. (http://www.fdanews.com/ddl/33_34/)