Lexology December 28, 2023
On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held position that the provision of value-added items and services implicates fraud and abuse laws, including the Federal Anti-Kickback Statute (AKS)[1] and the Beneficiary Inducement Civil Monetary Penalty[2] (CMP) law. Manufacturers, distributors, and other life sciences companies that seek to improve outcomes through the provision of value-added items and services to their customers continue to face challenges in developing compliant models.
The OIG historically has carefully scrutinized value-added arrangements, often taking the position that value-added items and services that have a value separate and apart from the purchased product raise fraud and abuse concerns...
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