It continues to be an eventful and tumultuous time in the 340B Drug Pricing Program space, with little indication that the current environment will change any time soon. Numerous drug manufacturers continue to impose restrictive 340B pricing policies available via 340B contract pharmacy arrangements in contravention of the Health Resources and Services Administration's (HRSA) applicable 340B Program rules and guidance. Ongoing litigation over these manufacturer restrictions, along with separate litigation challenging HRSA’s historic 340B eligible patient requirements,1 has further eroded the agency’s enforcement authority and created significant uncertainty surrounding the manner in which different types of 340B stakeholders can (or must) operate. Increased scrutiny on 340B covered entities’ savings utilization has also become a flashpoint.
A growing number of state legislatures have begun to fill in some of the gaps, introducing laws protecting 340B pricing access via contract pharmacy arrangements for covered entities in their states, as well as legislation requiring covered entities to be more transparent on 340B savings use by implementing reporting requirements.2 However, this piecemeal approach, combined with the continued uncertainty over HRSA’s ability to enforce its current rules and guidance, have arguably triggered a growing appetite in Congress and within 340B stakeholder groups to consider comprehensive federal legislation that would address and solidify the 340B Program’s parameters.
Historically, 340B-related federal legislation intended to modify or supplement the Program has effectively been a nonstarter—no 340B Program-specific federal laws or formal regulations have been passed since the 340B statute itself was enacted back in 1992. However, 6 bipartisan Senators colloquially referred to in 340B Program circles as the “Group of 6” are looking to change that.