More From Our Sponsor:
RxStrategies

SPONSORED CONTENT

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: 

1. 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.

SPONSORED CONTENT

On February 2, six senators known as the “Gang of Six” – John Thune, Debbie Stabenow, Shelley Moore Capito, Tammy Baldwin, Jerry Moran and Ben Cardin – unveiled a discussion draft bill intended to preserve the 340B program and codify in statute many of its operational provisions. The draft bill, titled Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act or SUSTAIN Act), was accompanied by an explanatory statement and request for information (RFI), with many questions for Covered Entities (CEs) to review and provide further responses to the Gang of Six.

Stakeholders were asked to review the RFI and provide additional responses, with comments due by April 1. As we approach the deadline for comments, it’s crucial to delve into the most critical elements of the bill and discuss next steps for 340B stakeholders.

340B’s Purpose (Section 2)