Takeaways from the 340B Coalition Winter Conference 2021
By Kristin Fox-Smith and Justin Ott
340B Health held their second virtual Coalition meeting since the pandemic took effect.
Admiral Pedley presented at the Coalition and discussed multiple topics:
- HRSA is unable to comment on ongoing litigation efforts related to manufacturers and 340B pricing availability. Manufacturers continue to pursue 340B price elimination of select products, with select manufacturers continuing to urge covered entities to utilize their own retail pharmacies instead of contract pharmacy partners. Additionally, Eli Lilly and Sanofi have attempted to block the new administrative dispute resolution (ADR) process.
- HRSA continues to support covered entities in need of assistance due to COVID-19. The COVID-19 resource page that HRSA created remains available for sites to reference and utilize. Congress has been reviewing details about DSH covered entities regarding fluctuation of DSH percentages as the result of the pandemic. No official action has been taken and 340B Health is conducting a survey of DSH covered entities that may be affected by the DSH threshold.
- HRSA has completed over 1,500 covered entity audits since FY2012 and plans to conduct an additional 200 covered entity audits in FY2021. HRSA has conducted 26 manufacturer audits and plans to conduct five in FY2021.
340B Health concluded that growth, in terms of registered covered entities, from 2019 to 2020 was significantly slower than in recent years.