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  • Critical access hospitals, rural referral centers, and sole community hospitals are not permitted to purchase designated “orphan drugs” under 340B prices except where manufacturers have opted to extend their 340B prices to all covered entities. Many of our customers wishing to maximize the value of their 340B program have asked us about the legitimacy of utilizing orphan drugs when administered to patients for conditions other than those for which the drug was granted an orphan designation. Many drugs are used to treat common conditions, although the drug is designated as an orphan for a rare condition. In consultation with our auditing colleagues...

  • 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.

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