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U.S. Attorney warns of gainsharing risks

This article was originally published in The Gray Sheet

Executive Summary

U.S. Attorney James Sheehan warns that gainsharing is "fraught with risk" stemming from the implications of the anti-kickback statute and the Stark law in such arrangements. At the Medical Device Regulatory and Compliance Congress in Cambridge, Mass. on March 29, Sheehan advised device companies to proceed with caution as they move beyond the gainsharing demonstration project called for in the Deficit Reduction Act of 2005. The demonstration project allows physicians to share in hospital cost savings if they agree to follow certain cost-cutting measures, such as using specific products for which hospitals have negotiated lower prices (1"The Gray Sheet" Jan. 2, 2006, p. 10)...

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