340B and the Business of Pharmacy Workshop

340B Strategic Implementation Challenges

Due to both increased audit activity and increased clinical integration across the care spectrum driven by payment system and care modality changes, 340B Covered Entities are dealing increasingly complex 340B Program strategic implementation challenges.  Often, these issues go beyond 340B-specific compliance, implicating issues including Medicare provider-based standards, Medicaid billing, tax-exemption and Medicare payment methodology changes.  This presentation will address major 340B Program legal compliance issues and implications related to integrated delivery systems for historically institutional, clinical and retail providers.  Among other topics, we will discuss provider integration drivers and considerations, related 340B considerations, and the future of 340B in light of these factors and the soon-to-be-released HRSA OPA Omnibus 340B Program Guidance.