340B Blog

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  • Rural Referral Centers, Critical Access Hospitals, Cancer Centers, and some Children’s Hospitals will no longer be able to purchase orphan drugs at 340B prices, even if the application of those drugs is for non-orphan conditions.  Prozac, for example, is classified as an orphan drug for its treatment of body dysmorphic disorder, although its typical application is for depression.  This week’s ruling means that Prozac and all other listed drugs must be completely excluded for these covered entity categories. What Does This Mean? Many Critical Access Hospitals we’ve worked with have already been excluding all drugs indicated as orphan without regard to the...

  • Friday's (August 28, 2015) released guidance from HRSA in the Federal Register had a number of points of clarification which would make 340B compliance clearer and therefore easier, but a handful of "guidance" points actually sound like big changes.
  • Yesterday HRSA formally submitted to the Office of Management and Budget (OMB) a review of its omnibus guidelines on the 340B drug discount program.  HRSA had previously promised a review of its new guidelines, but withdrew them in November 2014 after the agency’s rule-making authority was challenged.  The current submission of its guidelines is identified as “interpretative” rather than regulatory.  The OMB has 90 days to review before a public comment period begins.
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