This post has been archived and contains information that may be out of date.
CHA has released the attached summary, prepared by Health Policy Alternatives, Inc., detailing the 340B omnibus guidance released Aug. 28 by the Health Resources and Services Administration (HRSA). The notice with comment period provides guidance for covered entities enrolled in the 340B program and drug manufacturers required by section 340B of the Public Health Service Act to make their drugs available to covered entities under the 340B program.
The guidance incorporates existing practice as enumerated in various policy releases, including memorandums to participating entities and manufacturers, guidance, and frequently asked questions and answers. In addition, however, the guidance seeks to clarify and strengthen policies, addressing concerns about inadequate oversight, drug diversion and duplicate discounts. Among its clarifications are proposed changes to the definition of a patient and covered outpatient drugs, a process for notice and hearing, specifications for covered entity and manufacturer responsibilities, and increased transparency.
CHA will convene its 340B work group in the coming weeks to help inform its comments. The comment period closes Oct. 27.
