Billing and Coding: Hospital Outpatient Drugs and Biologicals Under the Outpatient Prospective Payment System (OPPS)

C9399 (Unclassified drug or biological) is limited to new FDA-approved drugs/biologics approved on or after 2004-01-01 that have not yet been assigned a specific HCPCS code; such items billed with C9399 are separately payable and priced using AWP/CMS methodology. If a drug/biologic does not meet the 'new' definition or no longer has a C-code (generally after ~1 year), it must be billed with NOC codes J3490 (drug) or J3590 (biologic), which are packaged and not separately payable; all OPPS drug/biologic claims must report NDC, total quantity, and date administered and be billed under revenue code 0636 using the current HCPCS Level II codes.

"HCPCS C9399 may be used only for new FDA-approved drugs or biologicals approved on or after 2004-01-01 that have not yet been assigned a specific HCPCS code."

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