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.
While the contents of the guidelines are unknown, we are optimistic that any clarification as to the regulations is good for 340B covered entities