340b changes ahead

Drug Manufacturers May Take Harmful Action: 340B Hospitals

Your 340B savings reduce margins for Big Pharma. Who needs the money more? Five major drug manufacturers have recently taken or threatened to take harmful actions against 340B eligible hospitals. Merck, Sanofi, and Novartis have sent burdensome data requests to hospitals, requests beyond the scope of the 340B Program. They threaten to withhold 340B pricing from hospitals who fail to comply. Two others, Eli Lilly and AstraZeneca, have stated, with very limited exceptions, that they will withhold 340B pricing for their medications filled through contract pharmacies. These actions threaten a crucial revenue source for 340B hospitals and, ultimately, the communities and patients they serve.

These unlawful requests and notices serve as a potential major blow to hospitals hit hardest by the COVID-19 pandemic. The actions taken by these manufacturers contradict the intent of the 340B Program. Such demands are not permitted under the Program statute and associated regulations. In a promising development, HRSA announced yesterday that it is investigating whether these actions violate the 340B statute and whether sanctions may apply. Advis strongly recommends that Covered Entities Act Now:

  • Urge HHS/HRSA to enforce current 340B regulations and put a halt to recent manufacturer activity;
  • Educate congressional representatives about recent manufacturer activity and request advocacy on 340B hospital’s behalf in future legislative discussions; and
  • Contact Merck, Sanofi, and Novartis urging continued good faith discussions about appropriately modifying the scope of future data requests.

Our experts stand ready to assist you with all necessary advocacy outreach efforts. We are available to answer questions regarding the potential impact of these harmful actions and to assist you in drafting and submitting Your urgent requests.

Contact one of Advis’s 340B experts today: Monica Hon, J.D. , Jake Beechy, J.D., MBA, or Kelly Jung, J.D. for help and guidance in these perilous times.

Published: September 3, 2020

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