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The OIG has officially shifted the goalposts for Direct-to-Consumer (DTC) and Direct-to-Patient (DTP) programs. For years, federal healthcare discounts were a "no-go zone," but a new dual-track strategy is emerging—if you know how to build the firewall. In this episode, Darshan Kulkarni breaks down the three core regulatory pillars required to bypass PBM middlemen without triggering federal anti-kickback statutes. We discuss the "one-year commitment" rule, the "seeding" trap, and why your current marketing strategy might be an unintentional red flag for regulators. If you are in Life Sciences commercialization, the "wait and see" approach is now your biggest liability.
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