May 2022

Use C9399 to bill new drugs and biologicals for first year after FDA approval for Medicare Advantage members

Be sure to use HCPCS code C9399 when billing drugs and biologicals that have been approved by the U.S. Food and Drug Administration but haven’t been assigned a specific HCPCS code.

C9399 should be used for new drugs and biologicals. After the first year, the code will typically be replaced by a specific code.

If no specific code has been established after the first year, you should bill with one of these codes:

Use HCPCS code J3490 for unclassified or NOC drugs.
Use HCPCS code J3590 for unclassified or NOC biologics.

These instructions are based on coding guidelines published by the Centers for Medicare & Medicaid Services. They apply to Medicare Plus Blue℠ and BCN Advantage℠ members.

For additional information, refer to the document titled CMS Article A55913: Billing and Coding: Hospital Outpatient Drugs and Biologicals Under the Outpatient Prospective Payment System (OPPS).**

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*CPT codes, descriptions and two-digit numeric modifiers only are copyright 2021 American Medical Association. All rights reserved.