Dear Manufacturer:
Below please find CMS guidance that was distributed to Part D sponsors on May 14, 2012. The purpose of the guidance was to notify Part D sponsors that beginning September 1, 2012, CMS will no longer accept pharmacy prescription claims information known as prescription drug events (PDEs) from Part D sponsors for national drug codes (NDCs) that have NOT BEEN ELECTRONICALLY LISTED WITH THE FOOD AND DRUG ADMINISTRATION (FDA). This requirement is NOT limited to brand name drugs nor to the Coverage Gap Discount Program, and it applies to all package sizes, including inner package sizes.
Starting September 1, 2012, CMS will perform an initial edit on PDEs using the FDA’s new comprehensive NDC SPL Data Elements file (NSDE). If an NDC is not present in this file, the PDE will be rejected. In addition, Part D sponsors may reject prescriptions at the point-of-sale for NDCs not listed in the NSDE file. A manufacturer can consult the NSDE file on the FDA site to determine which NDCs are currently listed at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm.
We remind you that the Medicare Coverage Gap Discount Program agreement requires each participating manufacturer to list and maintain up-to-date electronic listings of all NDCs with the FDA (not just applicable drug NDCs), including the timely removal of discontinued NDCs. Failure to comply with this requirement could result in claims being rejected at the point-of-sale beginning in September. In order to prevent any disruption in coverage of your products under Medicare Part D, manufacturers must ensure that all NDCs representing currently marketed drug products are electronically listed with the FDA prior to August 15, 2012 as CMS will be downloading the NSDE file on August 15, 2012 for implementation on September 1, 2012. Please share this information with the appropriate people within your organization.
Please direct any questions to the cgdpandmanufacturers@cms.hhs.gov mailbox.
Thank you.
PDE Editing on NSDE