OIG Permits Drug Manufacturer to Sponsor Genetic Testing and Counseling

The OIG determined that the Arrangement implicates the Federal Anti-Kickback Statute and the civil monetary penalty provision prohibiting inducements to beneficiaries due to potential remuneration to providers that could induce drug prescriptions and remuneration to beneficiaries that could influence them to seek follow-up care from the healthcare professional who ordered the genetic testing and assay. However, the OIG concluded that the fraud and abuse risks associated with the Arrangement are low for the following reasons:

1. There are safeguards against overutilization as the tests are narrowly focused on rare conditions, often ruling out diagnoses rather than confirming them.

2. There is minimal influence on clinical decision-making as providers are not incentivized to prescribe or recommend the manufacturer’s products.

3. There is a low risk of fraud given that fixed fees are paid for lab and counseling services, genetic counselors focus solely on genetic tests and diseases and avoid treatment discussions, and data provided to the manufacturer does not identify patients or providers.

Accordingly, the OIG stated that it will not take action against the drug manufacturer for activities conducted as part of the Arrangement.

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