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Last week, the 340B community gathered in the sun-soaked city of San Diego to gain insights, exchange best practices, and navigate the evolving complexities surrounding the program. Whether you missed the 340B Coalition winter event altogether or are seeking a recap to share with your team, this article aims to highlight the pivotal developments and discussions that took place, poised to shape the landscape of 340B in the months ahead.
Genesis Healthcare v. Becerra: Unpacking the Implications
Likely the most anticipated and highly attended session of the conference, the 340B Coalition kicked off the Winter Coalition with a panel discussion focused on implications of the recent court ruling, Genesis Healthcare v. Becerra. In November 2023, a South Carolina District Court ruled against HRSA, noting that nothing in the 340B statute or regulations supported HRSA’s interpretation that a 340B prescription had to originate from care at the covered entity. This decision has been interpreted differently among entities, drug manufacturers, various legal counsels, TPAs, and HRSA itself, with the latter noting on its website that the “decision in Genesis Health Care, Inc., v. Becerra […] is applicable solely to Genesis Health Care.”[1] Thoughts from the panel echoed current public sentiment that while the Genesis decision was in favor of the covered entity, HRSA appears steadfast in its interpretation of the 1996 patient definition and is likely to continue enforcing that standard. At least one panelist cautioned, “it can be very expensive to be right,” suggesting entities applying the Genesis ruling to their own organization should be prepared to challenge HRSA legally. While covered entities eagerly await the results of numerous 2023 HRSA audits still not released, the 340B community is left to wonder, can we put this cat back in the bag? And perhaps more importantly, should we?
Ongoing Operational Challenges Amidst Manufacturer Restrictions
Against the backdrop of an increasingly active legislative environment surrounding the 340B program, the conference brought attention to a dominant theme centered on the operational hurdles covered entities must endure to minimize the impact of manufacturer restrictions. The focus is on enhancing patient engagement and reshaping drug distribution through initiatives like the successful implementation of Medication Therapy Management (MTM) and Alternative Distribution Models (ADM). Attendees were keenly interested in ADM models – which are considered a potential solution to some of the challenges posed by manufacturers in the 340B program – but these conversations were limited to private meetings and hallway encounters. Hospitals and other CEs exchanged notes on the details surrounding these solutions, since there was no public forum available for such conversations. Despite this, the conference provided an invaluable space for these experts to discuss and share experiences in navigating the complexities of the 340B program.
Navigating the Legislative Landscape Through Advocacy
Additionally, the conference showcased a growing trend in state-level legislation aimed at safeguarding contract pharmacy arrangements within the 340B program. Could this be the answer? With states like Arkansas, and Louisiana leading the way in enacting laws to protect these crucial arrangements, participants emphasized the need for advocacy groups and states to learn from the legal battles and successes in other jurisdictions.
Furthermore, the conference placed a heightened emphasis on reporting requirements to state governments, reflecting the evolving landscape of 340B policy and the need for greater transparency. In response, attendees engaged in discussions on effective advocacy strategies for 340B providers looking to influence their local legislatures. Strategies such as organizing facility tours to showcase the program’s impact on patient care and communities, along with the development of 340B Impact Profiles, were explored as valuable tools to foster understanding and support among lawmakers, ensuring the continued success of the 340B program on a regional level.
Looking forward, the 340B program is on the cusp of significant developments at both state and national levels, fueled by a newfound momentum with the introduction of the “Senate Group of Six” draft bill. As we collectively navigate these changes, our team remains committed to offering guidance and support on the operational intricacies of the 340B program. Should you have any questions, please do not hesitate to reach out. We look forward to continuing these important conversations and shaping the future of the 340B program together.
[1] https://www.hrsa.gov/opa/educational-resources/patient-definition-resources1
For more information on The Alinea Group or if you would like any guidance on these matters, feel free to reach us at info@alinea-group.com.
