340B Program Volatility and Manufacturer Data Demands
Key Questions
What legal and regulatory pressures are affecting the 340B program?
PhRMA lawsuits, AstraZeneca litigation, HRSA RFI, CMS survey extensions, and CVS diversion suits are increasing volatility, while IRA and Part B-D rebates raise acquisition cost pressures for LA MCO compliance.
How might 340B reporting mandates impact patient care?
Mandates risk diverting resources from serving Virginia's most vulnerable patients by increasing administrative burdens on community health centers without corresponding support for compliance.
What CMS actions relate to 340B and PBM reform?
CMS issued an RFI on June 16, 2026, seeking guidance on Medicare Part D PBM reform under the CAA 2026, which intersects with 340B acquisition cost and compliance challenges for covered entities.
PhRMA suits/AstraZeneca/HRSA RFI/CMS survey ext; CVS diversion suits; IRA and Part B-D rebates increase 340B acquisition cost pressures for LA MCO compliance.