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False Claims Act (FCA) › Genetic Testing › Pharmaceutical Industry

Faegre Drinker Biddle & Reath LLP

The Latest on Pharmaceutical Company-Sponsored Diagnostic Testing Programs

Faegre Drinker Biddle & Reath LLP on

Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

Morrison & Foerster LLP on

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

Epstein Becker & Green on

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

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