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The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects industry calls for broader protections.
The Anti-Kickback Statute (AKS) is a criminal statute that can also result in significant civil penalties and exclusion by HHS-Office of Inspector General (OIG). Consequently, the healthcare industry, including healthcare product manufacturers and buyers of their products, are greatly influenced by OIG’s interpretation of the AKS as well as the legal protections the agency affords to financial and other arrangements under the AKS safe harbors. Although compliance with safe harbors is voluntary, with the high stakes for noncompliance, many manufacturers and other vendors to healthcare buyers have long tried to structure their sales transactions to meet or com