CMS is publishing this Companion Guide to provide technical instructions and define data specifications for submitting data elements from Part D 340B claims to the 340B repository. The statements included on this web page are intended to provide information on Medicaid Drug Rebate Program Data and do not in any way revise or modify the requirements set forth in Section 1927 of the Act, the national drug rebate agreement (NDRA), subsequent program releases, or regulations. In addition, we are providing the following information regarding the required reporting of some specific types of NDCs that manufacturers may not have previously submitted for inclusion in the Medicaid Drug Rebate Program (MDRP) given the packaging of the drugs. Frequently Asked Questions: Medicare Prescription Drug Inflation Rebate Program Rebate Reports This document provides summary information to drug manufacturers about the process, deadlines, and content for Part B and Part D Medicare Prescription Drug Inflation Rebate reporting. You will be required to provide accurate Unit Rebate Amounts (URAs) to CMS for any quarterly pricing that was not reported and/or certified prior to termination from the MDRP, so that states are able to calculate the amount of any unpaid rebates and/or interest, if applicable. How market access and billing teams read a National Drug Code at the package level to prevent billing-unit, formulary, and rebate mismatches — with a field-by-field FDA NDC Directory workflow. This article is editorial analysis for biopharma professionals. A Preliminary Rebate Report will be provided to each manufacturer of a Part D rebatable drug at least 1 month prior to the issuance of the Rebate Report as set forth in paragraph (c) of this section for an applicable period. A Preliminary Rebate Report will be provided to each manufacturer of a Part B rebatable drug at least 1 month prior to the issuance of the Rebate Report as set forth in paragraph (c) of this section for an applicable calendar quarter. Historically, the infrastructure to report at the claim and NDC level across every manufacturer contract simply didn’t exist at scale. Reporting caught up to what was possible, not to what was ideal. If CMS determines that an NDC-11 is likely to be in shortage, CMS will apply any reduction of the rebate amount as determined under paragraphs (b) (1) and (2) of this section to the generic Part D rebatable drug at the NDC-9 level.