Genetic testing fraud trends.

Abstract

Genetic testing fraud schemes are widespread, impacting patients, healthcare providers, and the US government. Fueled by rapid innovations in genetic testing capabilities and expansion of telehealth services following the pandemic, fraudsters are thriving. The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) enhanced scrutiny of such fraud schemes over a decade ago, and in September 2019, targeted enforcement began with the indictment of 35 individuals on allegations of genetic testing fraud activities totaling $2.1 billion (https://www.justice.gov/archives/opa/pr/federal-law-enforcement-action-involving-fraudulent-genetic-testing-results-charges-against). By the end of 2024, the DOJ and HHS had initiated hundreds of investigations, with litigation across multiple legal jurisdictions involving physicians, telemedicine companies, marketing companies, and genetic testing laboratories. This article investigates the nature and scope of genetic testing fraud and describes the concerted government activity to thwart the proliferation of these schemes. While the actual mechanisms to carry out genetic testing fraud, such as kickbacks and inappropriate coding, are not new, there are multiple characteristics that make this type of healthcare fraud distinctive. We describe three genetic testing features that make genetic testing fraud unique and heighten the potential for fraud on the government: widespread interest in test content; test complexity; and associated billing challenges. The article further contributes to the literature by assessing genetic testing fraud schemes and discussing implications for physicians and the healthcare system, including recommendations to prevent future genetic testing fraud.