Pharmacy Question for the Week of August 20, 2018

Question:

For medications used from Canada that have only a DIN and not an NDC, are you aware if there is a generic NDC that can be used or if CMS and other payers ever recognize the DIN on claims?

Answer:

To answer the specific question regarding a “generic” national drug code (NDC), one does not exist. By definition, the first five digits of the NDC are the packager code. These specify who made the drug and are assigned by the Food & Drug Administration (FDA). The second four digits are the product code assigned by the FDA. This product code is specific to each drug and also assigned by the FDA. The last two digits are the package code, assigned by the manufacturer, and designate the size of the product. Therefore, by the very definition of the NDC, there can be no “generic” one number fits all.

That being said, this is a very difficult question to answer. Technically, it is not yet legal to import drugs into the United States without FDA approval. There is currently legislation in the Senate (S.469–Affordable and Safe Prescription Drug Importation Act), but this has yet to be ratified, let alone signed into law.

At this point, drugs imported without an NDC (read FDA approval) cannot be submitted to CMS for reimbursement. This will change should the aforementioned bill be passed into law.