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HHS IG should clarify permissible manufacturer/HMO product evaluation affiliations -- FDLI conference.

Executive Summary

MANUFACTURER RELUCTANCE TO FUND "LEGITIMATE PRODUCT EVALUATIONS" in association with managed health care organizations is tied to a concern that the government may misconstrue the relationship as violating anti-kickback regulations, 3M Pharmaceutical Division Counsel Mark Duval maintained at a March 3 Food & Drug Law Institute seminar on anti-kickback issues in Washington, D.C. Duval called on the government to "come in and help us" by confirming that "we're not winking and nodding" and assuring that there is no violation of current anti-kickback regs.

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