CMS delays enforcement of certain Medicaid drug rule provisions

The Centers for Medicare & Medicaid Services has delayed until July 1 enforcement of certain provisions of its final rule changing the Medicaid Drug Rebate Program and Medicaid reimbursement for covered outpatient drugs. The rule took effect April 1. The enforcement delay applies to provisions specific to identifying and calculating average manufacturer prices for “5i drugs” – inhalation, infusion, instilled, implanted or injectable drugs that are not generally dispensed through retail community pharmacies. CMS said the transition period will give manufacturers “additional time to make necessary modifications and test their systems to calculate and report the AMP for 5i drugs in accordance with the requirements established in the final rule.” The agency also plans to issue a Frequently Asked Questions document and operational guidance to address questions received since the final rule was published. Additional questions on the final rule or enforcement delay may be emailed to rxdrugpolicy@cms.hhs.gov.