NDC Requirements
Origination Date: May 1, 2022
Last Review Date: November 1, 2025
Description
The National Drug Code (NDC) was created under the direction of the United States Federal Food, Drug, and Cosmetic Act. NDC numbers are the industry standard identifier for drugs and provide full transparency to the medication administered. The NDC number identifies the manufacturer, drug name, dosage, strength, package size and quantity.
Policy
Blue Cross Blue Shield North Carolina (Blue Cross NC) will require a valid National Drug Code (NDC) according to the criteria outlined in this policy.
Reimbursement Guidelines
A valid NDC number for the administered drug will be required for reimbursement of professional drug claims on unlisted drugs on a CMS-1500 Claim Form, and on a UB-04 Claim Form for outpatient drug claims.
NDC information that is invalid, missing, or not matching the HCPCS or CPT® code submitted, will not be eligible for reimbursement.
Rationale
The United States Federal Food, Drug, and Cosmetic Act, under Title 21, Chapter 9, Subchapter V, created unique numeric identifiers for the manufacturer, product, and package size to establish unique NDCs.
In accordance with CMS, Blue Cross NC requires unlisted drug codes to be submitted with a valid NDC to be eligible for reimbursement.
Requiring NDCs will enable Blue Cross NC to identify and reimburse for provided services more accurately.
Billing and Coding
Please refer to the Blue Book Medicare Provider Manual for code filing instructions.
Applicable codes are for reference only and may not be all inclusive. For further information on reimbursement guidelines, please see the Blue Cross NC web site at www.bcbsnc.com.
| HCPCS Code | Description |
| C9399 | Unclassified drugs or biologicals |
| J3490 | Unclassified drugs |
| J3590 | Unclassified biologics |
| J3591 | Unclassified drug or biological used for ESRD on dialysis |
| J7199 | Hemophilia clotting factor, not otherwise classified |
| J7599 | Immunosuppressive drug, not otherwise classified |
| J7999 | Compounded drug, not otherwise classified |
| J9999 | Not otherwise classified, antineoplastic drugs |
Related policy
Drugs and Biologicals
References
21 USC CHAPTER 9, SUBCHAPTER V: DRUGS AND DEVICES
https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&path=%2Fprelim%40title21%2Fchapter9%2Fsubchapter5&req=granuleid%3AUSC-prelim-title21-chapter9-subchapter5&num=0&saved=L3ByZWxpbUB0aXRsZTIxL2NoYXB0ZXI5L3N1YmNoYXB0ZXI1%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGUyMS1jaGFwdGVyOS1zdWJjaGFwdGVyNQ%3D%3D%7C%7C%7C0%7Cfalse%7Cprelim
The Blue Book Medicare Provider Manual
https://www.bluecrossnc.com/sites/default/files/document/attachment/providers/public/pdfs/Provider_Manual.pdf
MCM Chapter 4 (cms.gov)
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf
History
5/17/2022 New policy developed. Medical Director approved. Notification on 5/17/2022 for effective date 7/26/2022. (ckb)
12/31/2022 Routine Policy Review. Minor revisions only. (cjw)
11/1/2025 Updated Application section to include Healthy Blue + Medicare (HMO-POS D-SNP). Notification on 11/1/2025 for effective date 1/1/2026. (dc)
Application
These reimbursement requirements apply to all Blue Medicare HMO, Blue Medicare PPO, Blue Medicare Rx members, Healthy Blue + Medicare (HMO-POS D-SNP), and members of any third-party Medicare plans supported by Blue Cross NC through administrative or operational services.
This policy relates only to the services or supplies described herein. Please refer to the Member’s Evidence of Coverage (EOC) for availability of benefits. Member's benefits may vary according to benefit design; therefore, member benefit language should be reviewed before applying the terms of this policy.