Health Resources and Services Administration published the early results of its covered entity audits for its 2013 fiscal year and mentions topics like a hospital mentioned in the report for dispensing 340B program medications not backed by the medical record....
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...
HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered EntitiesElson, Elizabeth
340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered EntitiesMichael H. Hinckle
[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 ...
HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug ManufacturersElizabeth S. Elson
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...
Christopher H. Schott
HRSA Finalizes 340B Program Orphan Drug Exclusion RulesEmily J. CookDavid S. Ivill