HCPCS code C9399 is reserved for use to indicate drugs or biologicals that are typically administered in outpatient hospital settings. It is commonly used in cases where newly released pharmaceuticals, which lack established coding, are provided within a clinical setting., When billing for waste, the JW modifier must be used. The total quantity of the drug/biological being billed for waste must also be provided. If requested, the provider must send additional documentation to support the coverage of the drug or biological being billed as C9399., To report new drugs and biologicals, approved by the Food and Drug Administration, for which there are no specific HCPCS codes assigned, use HCPCS code C9399, "unclassified drugs or biologicals". This code applies only to hospital outpatient departments who bill under the Outpatient Prospective Payment System (OPPS), 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., AVSOLA INJ (infliximab-axxq), To report new drugs and biologicals, approved by the Food and Drug Administration, for which there are no specific HCPCS codes assigned, use HCPCS code C9399, "unclassified drugs or biologicals". This code applies only to hospital outpatient departments who bill under the outpatient prospective payment system (OPPS)..