VRTX · News · 20260914N

Litigation and Legal Risk

VERTEX PHARMACEUTICALS INC / MA · 2026-09-14 · Importance 47 · Surprise 60 · In source text

The U.S. Court of Appeals for the D.C. Circuit affirmed that Vertex’s Fertility Support Program would violate the federal Anti-Kickback Statute. The program offered up to $70,000 in fertility services to patients using Vertex’s CASGEVY gene therapy. The court rejected HHS-OIG’s separate finding that the program violated the Beneficiary Inducement Statute, concluding that the agency had not reasonably explained why an exception did not apply. The court also reversed dismissal of Vertex’s challenge to HHS-OIG’s advisory-opinion timing regulations, finding those regulations contrary to law.

Key facts

• The DC Circuit Court of Appeals reversed the dismissal of Vertex's challenge to HHS-OIG's advisory opinion timing regulations, deeming those regulations contrary to law. source
• The DC Circuit Court of Appeals affirmed that Vertex Pharmaceuticals' Fertility Support Program would violate the Anti-Kickback Statute. source
• The DC Circuit Court of Appeals disagreed with HHS-OIG's finding that Vertex's Fertility Support Program violated the Beneficiary Inducement Statute, stating HHS-OIG failed to reasonably explain why an exception did not apply and found their conclusion arbitrary. source
• Vertex Pharmaceuticals' Fertility Support Program offers up to $70,000 for fertility services to patients using its Casgevy gene therapy. source

Impact estimates