AdvaMed Proposes Safe Harbors for Anti-Kickback Statute

March 8, 2017

The Advanced Medical Technology Association (AdvaMed) has asked the HHS Office of Inspector General for two new exceptions to the federal anti-kickback statute.

The proposed safe harbors would allow value-based health care arrangements between device manufacturers and buyers that are designed to save money and improve clinical outcomes. Arrangements that presented significant risk of increased costs, waste, fraud, or abuse to federal health care programs would not be permitted, AdvaMed said in a statement.

One safe harbor would protect value-based pricing arrangements. It would allow for price adjustments and for services to be bundled with the product being sold or leased, subject to safeguards.

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