HRSA Finalizes 340B Program Orphan Drug Exclusion RulesEmily J. CookDavid S. Ivill
HRSA Releases Proposed Rule Governing the Administrative Dispute Resolution Process for 340B-Related ClaimsMichael H. Hinckle
of 340B agency.]]>Reports on the United States Health Resources and Services Administration's (HRSA) overhaul of the Office of Pharmacy Affairs (OSA). Review of drug purchases; Failure of HRSA to have protocols for ensuring that entities enrolled in OSA receive appropriate discounts from drug...
Richard P. Church
HRSA Issues Interpretive Rule on 340B Drug Pricing ProgramClaire Marblestone
Ken ChoeAlice B. LeiterJouya RastegarChristopher H. SchottAlice Valder Curran
[d] 340B drugs on the basis of these previous transactions.'' While the proposed guidance would not prohibit this so-called ``bank- ing'' practice, it does provide that if a covered en- tity ``wishes to re-characterize a previous purchase as 340B,'' it ``should first notify ...
Department of Health and Human Services (HHS) on July 23, 2013. The regulation increases the number of entities to which pharmaceutical manufacturers must sell orphan drugs at statutory ceiling prices under the 340B program. Hospitals added to the 340B program are advised to review their existing...
HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public CommentJoseph W. Metro
Rogers, Daniel R