340B Blog

Latest News

  • 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.

  • We think the 340B program will remain in place, with improvements, at least over the next several years.  In order for the drug discount program to be completely eliminated, Congress would have to revoke or rewrite the existing legislation.  Even a complete overturn of the Affordable Care Act would eliminate several eligibility categories that the legislation created, but would leave Disproportionate Share Hospitals, family planning clinics, STD clinics, and most of the others.  And even in that case, the Supreme Court has not undertaken any cases for which it’s addressing the 340B aspects of the ACA.

  • The challenges for 340B covered entities attempting to comply with the orphan drug exclusion are two-fold:  First, the list of orphan drugs issued by HRSA is description-based, and does not include NDCs necessary to definitively identify which drugs carry the orphan exclusion and should therefore be excluded from the program.  Second, a covered entity wishing to obtain 340B pricing on orphan-designated drugs used for non-orphan conditions must match the dispenses of the drug against patient diagnoses to identify the context of “usage”.