Final Medicaid Rebate Regulation Clears OMB, Bound for Publication

By Alan M. Kirschenbaum –

If you’re looking for Holiday reading, CMS has a gift for you!

OMB’s Office of Information Regulatory Affairs (OIRA) has completed its review of a long-awaited CMS final regulation implementing significant changes to the Medicaid Drug Rebate Program.  Completion of the review was announced on OIRA’s website here.  It typically takes a lengthy regulation from several days to two weeks after OMB release before it is posted for pre-publication review.

We’ll be posting a notice in the FDA Law Blog when the rule is released, and following its release, we’ll be preparing a memo to summarize it.  We’ll also be conducting a webinar on the rule in collaboration with KPMG’s government pricing group.  The date and other details will be announced on this blog in the near future.