340B Blog
Latest News
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Is OPA Reducing 340B Patient Eligibility? Sat Sep 05, 2015
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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HRSA Tries Again for Omnibus Guidance Thu May 07, 2015
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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Will the 340B Program Be Cancelled? Fri Apr 17, 2015
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.