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HHS Safe Harbor For Value-Based Drug Contracts May Be On Horizon

 
• By Cathy Kelly

US proposed rule establishing new safe harbors from anti-kickback rules for value-based and outcomes-based contracts limits protections to clinicians, providers and certain other groups and expressly excludes pharmaceutical manufacturers. But HHS suggests a separate safe harbor for prescription drug contracts may be forthcoming.

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Safe Harbor For Drugs Not Yet A Reality

A safe harbor from the federal Anti-Kickback Statute to protect value-based arrangements involving prescription drugs may be in the works at the US Health and Human Services Department’s Office of Inspector General, according to a proposed rule released 9 October.

The proposal lays out new anti-kickback safe harbors covering value-based and outcomes-based arrangements involving health care providers but specifically excludes pharma manufacturers (as well as medical device companies

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