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While federal laws and regulations set the foundation for 340B compliance, state-level laws introduce an additional layer of complexity. Covered entities (CEs) must be vigilant in understanding how these state laws can impact their operations to avoid potential compliance pitfalls. We have outlined a few common nuances our team has run into with CEs across the nation:
- Medicaid Participation: State Medicaid programs play a crucial role in 340B operations, regardless of the state you’re in.
- States vary in their approach to Medicaid, including differences between fee-for-service and managed Medicaid models.
- Certain states may have specific carve-in or carve-out arrangements. For instance, in the state of New York, carve-in arrangements are no longer permitted, significantly impacting 340B programs across the state. Meanwhile, North Carolina allows a carve in option for specific plans but require a code 20 to flag the claim as 340B eligible and to avoid duplicate discounts from the manufacturer.