(Part Two of a Two-Part Analysis)
In February, the U.S. Senate bipartisan “Group of Six” released an eagerly anticipated discussion draft bill and a bill summary/request for more information on the most highly debated issues in the 340B program. The bill, “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act),” is over 50 pages and covers almost every matter that 340B stakeholders care about. As I discussed in a previous column, I expect the bill to get more traction than any other 340B reform bill since 2010, the last time a major 340B bill became law. The senators say they want to enact the bill during this session of Congress. While that is an ambitious goal and one that may not be possible in an election year, it will certainly be the primary 340B legislative vehicle in the 119th Congress which begins in January 2025.
Part 1 of my column focused on the importance of the legislation, the influential lawmakers behind the bill and a few of the critical areas addressed including the intent of the 340B program and the structure and scope of the contract pharmacy program. Part 2 focuses on the other key elements of the bill and the additional areas that the senators are requesting feedback on prior to their April 1 deadline. These areas include: patient definition, child sites, provider transparency, duplicate discount protections, “pickpocketing” protections and user fees.
Patient Definition: The current patient definition is not addressed in statute but is spelled out in HRSA’s 1996 patient definition guidance. A federal court in South Carolina recently ruled that the definition is too narrow and that the 340B statute does not require a covered entity (CE) to have initiated a healthcare service resulting in a prescription filled with a 340B discounted drug. 340B provider groups praised the court’s decision and the drug industry panned it. Read more >
