CMS Issued Guidance Regarding Transition Period Prior to Enforcement of 5i AMP Provisions

The Centers for Medicare & Medicaid Services (CMS) published CMS-2345-FC Covered Outpatient Drugs Final Rule with Comment (“Final Rule”) on February 1, 2016 with an effective date of April 1, 2016.  This Final Rule addresses key areas of Medicaid drug reimbursement and details changes made to the Medicaid Drug Rebate (MDR) program by the Affordable Care Act.  These regulations are codified at 42 CFR 447 Subpart I.

Since the publication of the final rule with comment, CMS has received requests to delay the implementation of certain provisions of the rule.  CMS has issued Manufacturer Release #96 and State Release #174 at https://www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/program-releases.html to address these requests.