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Distributed by Center for Medicaid and CHIP Services (CMCS)
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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:
- 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;
- 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?
- 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:
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