Vertex Pharmaceuticals Incorporated v. HHS

Summary

The D.C. Circuit affirmed the district court's summary judgment that Vertex's Fertility Support Program violates the Anti‑Kickback Statute, but reversed the judgment on the Beneficiary Inducement Statute and on HHS's advisory‑opinion timing regulations, remanding for further proceedings. The court interpreted "induce" and "remuneration" in their ordinary meanings, held HHS's BIS analysis arbitrary and capricious, and declared the timing provisions unlawful. It also recognized Vertex's standing and ripeness to challenge the regulations.