DTC Telehealth Platforms -
Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed legislation targeting promotional statements, specifically the Protecting Patients from Deceptive Drugs Ads Online Act (the “Act”), and fraud and abuse scrutiny from legislators. The structure of telehealth arrangements, as well as promotional material involving the same, are ripe for additional scrutiny and enforcement in the upcoming year.
The Telehealth Climate -
Attention to telehealth arrangements is not new and began during the COVID-19 public health emergency when the use of telehealth expanded and concerns around controlled substance tele-prescribing grew. In 2022, the Health and Human Services (“HHS”) OfÏce of Inspector General (“OIG”) released a Fraud Alert which warned practitioners about potential fraud schemes involving telemedicine platforms in violation of the federal Anti-Kickback Statute. Focus on these arrangements has continued in light of increased online and DTC advertisements by social media influencers and telehealth providers, especially as semaglutide and GLP-1 drugs became pervasive in recent years.
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