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# AdvaMed Proposes 2 New Safe Harbors
- URL: https://www.fdaweb.com/advamed-proposes-2-new-safe-harbors/
- Published: 2017-02-28T12:00:00.000Z
- Updated: 2026-09-14T22:08:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138088

AdvaMed is telling the HHS Inspector General that existing federal anti-kickback law safe harbors retain beneficial value-based solutions but some changes are needed. In a 2/27 [letter](https://www.advamed.org/resource-center/advamed-aks-safe-harbor-proposals-value-based-arrangements?ref=fdaweb.com), the trade association lists problems that it says manufacturers and others currently face in seeking to engage in value-based arrangements, including: 

- bundled items and services with rebate based on clinical outcome;
- payment for corrective services if targeted clinical outcome is not achieved;
- provision of ancillary items and services at no additional cost; and
- provision of services under a risk-based compensation model.

The group proposes two new safe harbors for value-based arrangements. It says the first would protect “value-based pricing arrangements” and the second would protect “value-based warranties.” In each proposal, it says, the arrangement would meet certain requirements as discussed in the letter to qualify for protection.

“The proposed safe harbors include/feature concepts from the existing discount and warranty safe harbors, including transparency and disclosure elements, and expand the types of buyers and sellers that may be parties to value-based arrangements to reflect certain industry complexities,” the letter says. “Consistent with the OIG’s criteria for establishing new safe harbors, AdvaMed believes that these proposed safe harbors would promote ‘access, quality, patient choice, appropriate utilization and competition, while protecting against increased costs, inappropriate steering of patients, and harms associated with inappropriate incentives tied to referrals.’”