Several important updates have been issued to the Medicaid Drug Rebate and 340B Drug Pricing Programs in the month of November.

• Medicaid Drug Rebate Program. On November 7, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed notice announcing changes to the Medicaid National Drug Rebate Agreement (NDRA) used by the Secretary of the Department of Health and Human Services (HHS) and pharmaceutical manufacturers under the Medicaid Drug Rebate Program (MDRP). In addition, on November 14, 2016, CMS issued an interim final rule with comment period that delays the inclusion of the U.S. territories in the definition of “States” and “United States” under the MDRP until April 1, 2020. This is an important opportunity for pharmaceutical manufacturers participating in the MDRP to comment on the proposed changes.
• 340B Drug Pricing Program. On November 1, 2016, the Health Resources and Services Administration (HRSA) released a new addendum (Addendum) to the Pharmaceutical Pricing Agreement (PPA) used by the Secretary of HHS and pharmaceutical manufacturers under the 340B Drug Pricing Program (340B Program). This document is considered final, and manufacturers participating in the 340B Program should sign and return the Addendum by December 31, 2016.

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