Friday, September 25, 2020

CMS Releases Guidance to Drug Manufacturers Participating in the Medicaid Drug Rebate Program on the Importation of Certain Drugs under FDA section 801 of the Federal Food Drug and Cosmetic Act (FFDCA) on Reimported Drugs and the Medicaid Drug Rebate

 

 

View in browser | Distributed by Center for Medicaid and CHIP Services (CMCS)

Medicaid.gov

Today, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers that participate in the Medicaid Drug Rebate Program (MDRP) on the MDRP requirements relating to the importation of certain drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) Section 801 importation guidance.  This section was recently updated by the Food and Drug Administration’s Importation of Prescription Drugs final guidance.  

Specifically, this guidance addresses three main topic areas:

  1. Whether the imported products (referred to as Multi Market Approved, MMA products) described in the FDA final guidance be considered covered outpatient drugs and, therefore, subject to the requirements set forth in section 1927 of the Social Security Act (the Act) and therefore eligible for rebates; 
  2. Should the manufacturer report a separate average manufacturer price (AMP) for the MMA product that is different from the other FDA-approved version of the same drug marketed under the same NDA?  
  3. Should the manufacturer’s best price, as defined at § 1927(c)(1)(C) of the Act and 42 C.F.R. § 447.505 take into account the sales of the manufacturer’s MMA product.  

To learn more about this guidance please use the link below:

 


Stay connected with Medicaid.gov and CMS:

Get email updates

Twitter

YouTube

RSS

FAQ

No comments:

Post a Comment