On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register.1 Although many aspects of the Notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program. In addition, the Notice presages a more robust – if still somewhat ill-defined – oversight and enforcement environment for both covered entities and manufacturers participating in the program.
In this Client Alert, we provide an overview of the Notice, highlight significant policy issues that it raises, and identify potential areas that 340B program stakeholders may wish to comment on. HRSA will be accepting public comments through October 27, 2015.
Read the full Client Alert by downloading the .PDF below.
- 80 Fed. Reg. 52300 (Aug. 28, 2015).