On May 14, 2012, CMS issued guidance to Part D sponsors instructing them that as of September 1, 2012 CMS will no longer accept Part D claims' information they are required to report to CMS if such information includes national drug codes (NDCs) that have not been electronically listed (elisted) with the FDA.  CMS is implementing this requirement to help ensure that the Medicare Part D program only pays for Part D drugs that are currently and legally on the market and that submitted claims information represents the products actually being dispensed from pharmacies.

The effect of this guidance likely means that Part D sponsors will begin rejecting pharmacy claims that include NDCs that have not been elisted with the FDA beginning on September 1, 2012.  While according to CMS records only a small percentage of Part D claims currently involve unlisted NDCs, some pharmacies could be affected more than others depending upon which NDCs they currently stock and/or submit claims for. Pharmacy systems that permit the selection of outdated or unlisted product codes will be affected the most.  CMS is continuing to alert manufacturers of the upcoming change and we are contacting those manufacturers with any significant volume of Part D claims for products that have not been elisted with the FDA.  CMS urges Part D network pharmacies to work with their wholesalers and manufacturers to ensure drug products they stock are elisted with the FDA to minimize any potential disruption. 

To view the CMS guidance document, click here.