CMS Sets New Date for Final Medicaid Rebate Regulation Re-Write

By Alan M. Kirschenbaum –

A CMS final regulation implementing changes to the Medicaid Drug Rebate Program (MDRP) is now scheduled to be published in April 2015, according to OMB’s updated current Unified Agenda of Regulatory and Deregulatory Actions.  Before you mark that in your calendar in pen, be aware that CMS has missed at least four previous “final action” dates published in the Unified Agenda since the proposed rule was issued on February 2, 2012.  (You can find our summary of the proposed rule here.)  The final rule has not yet been submitted to OMB for review as of this writing.

In a related development, CMS recently issued a notice that, at or around the same time that CMS publishes the final MDRP rule, it will also release finalized Federal Upper Limits (FULs) calculated pursuant to an Affordable Care Act amendment to the Medicaid statute.  That amendment replaces published prices with average manufacturer price (AMP) as the basis for calculating FULs (as explained at pages 3-4 of our summary.  FULs establish Medicaid payment limits on multiple source drugs where there are at least three A-rated drugs available nationally.  CMS has been issuing monthly draft FULs since 2011, but is waiting until the MDRP rule is finalized before finalizing the FULs.  After the FULs are finalized, CMS is expected to provide a transition period for state Medicaid agencies to implement the new FULs.

If all goes as planned, we will have two important Medicaid drug rebate and payment issuances in April.  If not – April Fools!