Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make more informed decisions about their health, and providing physicians with clinically actionable information about their patients.
However, manufacturers and laboratories that offer manufacturer-sponsored genetic testing programs should take care to ensure that they do not run afoul of the federal Anti-Kickback Statute (AKS).
In December 2023, Ultragenyx Pharmaceutical Inc. (“Ultragenyx”) agreed to pay $6 million to resolve allegations it violated the False Claims Act by paying kickbacks through its sponsored genetic testing program.[1] This marks the first major settlement involving a sponsored genetic testing program after the U.S. Department of Health and Human Services, Office of Inspector General (OIG), issued Advisory Opinion 22-06 (the “opinion”) in April 2022, which addressed a separate sponsored genetic testing program.[2] The juxtaposition of the Ultragenyx settlement with the favorable opinion that preceded it offers several compliance considerations for companies that wish to offer a sponsored genetic testing program.
In April 2022, OIG issued a favorable opinion wherein a biopharmaceutical company (the “company”) offered a free genetic testing program to screen for specific genetic mutations associated with an...
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