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