Direct to Consumer Telehealth: An Enforcement Warning Shot
In a pivotal decision, the U.S. Court of Appeals for the First Circuit has raised the bar for proving False Claims Act (FCA) violations tied to kickbacks. The ruling has significant implications for pharmaceutical and biotech companies. In U.S. v. Regeneron Pharmaceuticals Inc., the court introduced a tougher “but-for causation” standard that could reshape how the government and […]
FCA Kickback Ruling: What It Means for Pharma and Biotech
Four U.S. Senators have released the results of a nine-month investigation into direct-to-consumer (DTC) telehealth arrangements linked to pharmaceutical brand sites. Their findings? According to the report, high prescription conversion rates, limited clinical encounters, payment structures, and patient data flowing back to manufacturers could be viewed as remuneration intended to induce prescribing of federally reimbursable drugs. […]