OIG states that a manufacturer is unlikely to violate the AKS when providing DTC access to patients as long as (i) the prescription drug is not billed to a Federal health care program, (ii) the sale of the prescription drug is not conditioned on the current or future order or purchase of any other item or service that is or could become billable to a Federal health care program, (iii) the arrangement aligns with the other characteristics [of the AKS requirements]. While the OIG limited its AKS analysis to the patient-manufacturer relationship as it relates to DTC programs, OIG noted that it intends to expand its analysis to other manufacturer relationships (e.g., with physicians, pharmacies, and PBMs) and will issue separately a request for information to seek public feedback with respect to rulemaking or guidance, if any, that is needed regarding the application of certain fraud and abuse laws to such arrangements as they relate to DTC sales. State PBM Legislation and Litigation Recently Enacted State Legislation Between October 2025 and mid-February 2026, several states enacted legislation imposing new requirements on PBMs across a wide range of regulatory areas.[1] These enactments reflect the continued expansion and refinement of state PBM oversight frameworks, with significant implications for PBMs, pharmacies, health insurers, and other stakeholders in the prescription drug supply chain

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Scientific References The physiology of glucagon-like peptide 1 (Holst JJ, 2007)