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OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07
On July 2, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-07, which concluded that a pharmaceutical manufacturer’s proposed arrangement to sponsor a free, FDA-approved companion diagnostic test for eligible patients would not implicate the Federal Anti-Kickback Statute (AKS) or the Beneficiary Inducements civil monetary penalties (CMP)….
By: Robinson+Cole Health Law Diagnosis