Health Resources and Services Administration (HRSA) sent the 340B Omnibus Guidance (Mega-Guidance) to the Office of Management and Budget (OMB) on May 6, 2015. Assuming the OMB takes the average 90 days to review, the proposed guidance could be published in the Federal Register for a comment period around mid-August. There is speculation that since the OMB reviewed much of it last year as the “340B Mega-Rule”, the review period may not take as long. There is no minimum period for reviewing the 340B Omnibus Guidance so it is possible for it to be published sooner.
SCA will post an update as soon as the proposed guidance is published in the Federal Register along with our prepared summary.
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