HRSA‘s Omnibus Guidance (Mega-Reg) is Here!

By September 1, 2015News

September 1, 2015 — The long awaited “Mega-Reg” is here and it could impact your 340B Program in significant ways. This Omnibus Guidance attempts to clarify current 340B Program requirements for covered entities. The document itself is 90 pages long and applies to all 340B Programs, not just hemophilia Treatment Centers with 340B Outpatient Factor Programs.

Red Chip Enterprises works closely with the attorneys at Epstein, Becker & Green in Washington D.C. to remain current and informed about 340B legislation and regulations. EBGLaw has reviewed the complete HRSA guidance document and provided a summary of key points. We are happy to share their summary with you as it may help clarify some of the key issues applicable to your 340B Outpatient Factor Program.