HCPCS code C9399-Unclassified drugs or biologicals, can be used to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004 when a product-specific HCPCS code has not yet been assigned when furnished in hospital outpatient departments. (Medicare Claims Processing Manual, pg 63).

This C9399 tool includes the generic and brand names, approval dates, manufacturer, and a link to the prescribing information (PI) for injectable drugs that have been approved by the FDA but have not been assigned a HCPCS code by CMS. This list will be updated each quarter to reflect newly released HCPCS codes. These “Not-otherwise-classified codes” (e.g. C9399) should only be used when a more specific HCPCS code has not been assigned.

*Please note that the FDA approves new drugs daily. If a “new drug” has been approved since our list was last updated, please submit a question to us via our CONTACT US page. We’ll research the drug and respond.*

What do I need to know about billing with C9399?

• HCPCS code C9399 is billed with a quantity of “1” (one) on the claim which is essentially a placeholder and directs the payer to review additional information in the NOTES/REMARKS section of the 837I claim.
• For Medicare and some other payers, discarded waste from separately payable single-dose vials must be recorded in the patient’s medical record. When reporting C9399, a separate charge line on the claim with the JW modifier should NOT be reported. Instead the amount administered and amount wasted (if documented) is reported in the NOTES/REMARKS section of the claim.
• For Medicare outpatients, when reporting C9399, hospitals must also report the National Drug Code (NDC) and quantity administered (expressed in the NDC unit of measure) as well as the date the drug was furnished in the NOTES/REMARKS section.
• For Medicare outpatients, the MAC will manually calculate the payment for the drug or biological at 95 percent of the average wholesale price (AWP). The MAC will pay 80 percent of the calculated payment to the hospital and the beneficiary will be responsible for the 20 percent co-pay after the deductible is met. Drugs/biologicals manually priced at 95 percent of AWP are not eligible for outlier payment. Other payers may pay similarly to Medicare or have an established fee schedules for new drugs.
• Some payers may provide alternate billing instructions (e.g. J3490, J3590) and they should be followed when available.

Please note that physician offices are not eligible to bill using HCPCS codes beginning with “C”, and must select a different unclassified code, e.g. “J” code. (Transmittal R976CP, June 9, 2006)

Why have some drugs been approved for years, and still don’t have a HCPCS code assigned?

The HCPCS Workgroup assigns HCPCS code quarterly and holds an annual Public Meeting to gain feedback on their preliminary decisions. Typically a manufacturer or insurer submits an on-line application requesting a HCPCS code assignment. Approved codes are posted on the CMS HCPCS Quarterly update page.

What else should I know about these drugs that don’t have an assigned HCPCS code?

Medicare may consider some of these drugs that are administered subcutaneously as “self-administered” and therefore not covered in a hospital outpatient department. For other payers, the drugs may be covered in a hospital outpatient department, or covered as a pharmacy benefit rather than the medical benefit.

Medicare has also provided different instructions for billing diagnostic radiopharmaceuticals and contrast agents when a specific code has not been assigned. These instructions are available in the January 2017 OPPS update.

Shoutouts! 1. Pharmacy should review these 46 C9399-eligible drugs to determine if they are in use and if so, ensure that the HCPCS code C9399 is used for billing with revenue code 636. (Exception: Brexucabtagene autoleucel (Tecartus™) should be reported in revenue code 891).

1. Finance should review payments for C9399 to determine if payers are reimbursing at 95% AWP (Medicare and payers like Medicare), or at a contracted fee schedule rate.

2. Revenue Integrity should review any drugs in use to ensure they are not on the facility’s “Self-Administered Drug” listing from the MAC, and therefore not covered when furnished in a hospital outpatient department.

3. Managed Care Contracting should ensure that all “new” drugs are covered in contracts and reimbursed as a percentage of AWP, percentage of charges, or identified in separately paid fee schedules.