Long Awaited Medicaid Rebate Rule Under Review by OMB

By Alan M. Kirschenbaum –

Yesterday, CMS’s final Medicaid Drug Rebate Program rule arrived on the doorstep of OMB’s Office of Information and Regulatory Affairs (OIRA) for review under Executive Order 12866.  Under the Executive Order, OIRA ordinarily has 90 days to complete its review, with the possibility of one 30-day extension with the written approval of the Director of OMB.  Of course, OIRA may complete its review sooner.  The current Unified Agenda of Regulatory and Deregulatory Actions still identifies August 2015 as the expected time of publication, as it has since May.  Note that the expected “final action” date published in the regulatory agenda has been missed multiple times since CMS published the proposed rule in February 2012.  However, we can now be relatively confident that the final rule will be published within the next several months.  We will be watching for it and will keep our readers posted.