The OIG solicited proposals for new safe harbors to the federal anti-kickback statute last December; the Advanced Medical Technology Association submitted its proposal yesterday focused on value-based healthcare arrangements.
Here are five things to know:
1. AdvaMed's proposal would establish two new safe harbors for value based arrangements:
• Protection for value-based pricing arrangements
• Protection for value-based warranties
2. The value-based pricing arrangement safe harbor would allow for price adjustments and bundled services with the product sold or leased. The arrangements would be subject to the appropriate safeguards and dependent upon achieving measurable clinical and/or cost outcomes.
3. The value-based warranty safe harbor would allow companies to make clinical and/or cost outcome assurances and provide appropriate remedy when the outcomes aren't achieved.
4. The safe harbors would include some concepts from the existing discount and warranty safe harbors, such as price transparency and disclosure concepts. However, they would expand the types of buyers and sellers that could be parties to value-based arrangements.
5. If an alternative is necessary, AdvaMed proposed modifying the existing discount and warranty safe harbor for greater flexibility and clarity for buyers and sellers to enter into value-based arrangements.