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NDC Requirements

Medicare Reimbursement Policy

Origination: 05/2022

Last Review: 11/2025

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 CodeDescription
C9399Unclassified drugs or biologicals
J3490Unclassified drugs
J3590Unclassified biologics
J3591Unclassified drug or biological used for ESRD on dialysis
J7199Hemophilia clotting factor, not otherwise classified
J7599Immunosuppressive drug, not otherwise classified
J7999Compounded drug, not otherwise classified
J9999Not 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.