Deadline for Final 340B Mega-Guidance Released

HRSA has set a goal of September 2016 for issuing final 340B mega-guidance. This date was published in the Department of Health and Human Services’ agenda of upcoming regulatory actions. The proposed guidance, released in August of this year, has received both praise and criticism from industry stakeholders. Federal health officials will take these comments – over 1,000 submitted to date – into consideration when drafting the final guidance.

Though not all of the language in the proposed guidance will be in the final version, it is important to understand the consequences of the proposed guidance and how it may potentially affect your program.

Also published in the most recent agenda is a May 2016 proposed deadline for the implementation of financial sanctions for drug manufacturers who overcharge 340B participating providers. It is also estimated that a standard calculation for 340B ceiling price will be established by this date.

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Hudson Headwaters 340B Pharmacy Services