Q&A: Billing for drugs without a specific HCPCS code
Q: We are confused on the reporting of HCPCS code C9399 (unclassified drugs or biologicals) for new diagnostic radiopharmaceuticals and contrast agents that are approved by the FDA but don’t yet have a HCPCS code. CMS guidance states that this HCPCS code should be used until a specific HCPCS code for the item has been assigned, but we have one that is going on two years and there is not a new HCPCS code assigned yet. When we ask about it, the answers have varied.
A: HCPCS code C9399 has instructions from CMS that it is to be used for new drugs or biologicals that are approved by the FDA but for which pass-through status has not been approved, and a C-code and APC payment have not been assigned.
If it has been two years, and there is not a HCPCS code assigned, then check with the manufacturer/supplier on the situation and query the CMS website for the specific item. CMS is usually timely with the decision and assignment of HCPCs codes on a quarterly basis, so it would be expected that a decision has been made.
In Transmittal 3685, CMS summarizes the appropriate reporting for new diagnostic radiopharmaceuticals and contrast agents, as most of these are packaged under OPPS payment policy, and HCPCS C9399 does not apply. There are other options for reporting new diagnostic radiopharmaceuticals. HCPCS codes A9597, A9598, A9599, or J3490 is applicable for a diagnostic radiopharmaceutical until pass-through status has been granted and a new HCPCS code is assigned. Payment for diagnostic agents are packaged into the procedure until CMS makes a determination. The codes are defined as:
- A9597, positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified
- A9598, positron emission tomography radiopharmaceutical, diagnostic, for non-tumor identification, not otherwise classified
- A9599, radiopharmaceutical, diagnostic, for beta-amyloid positron emission tomography (PET) imaging, per study dose
- J3490, unclassified drugs
CMS notes in the transmittal that J6490 is “applicable to all new diagnostic radiopharmaceuticals used in non-beta-amyloid PET imaging.”
Contrast agents are diagnostic agents, and new agents should be reported with A9698 or A9700 until the agent has been granted pass-through status and a specific HCPCs code has been assigned. Both codes are assigned status indicator N and payment is packaged into the associated procedure. Those codes are defined as:
- A9698, non-radioactive contrast imaging material, not otherwise classified, per study
- A9700, supply of injectable contrast material for use in echocardiography, per study
CMS has updated the reporting of new diagnostic agents as the packaging methodology has expanded over the past few years. You should review your reporting processes to ensure that new items are reported according to updated guidance.
Editor’s note: Denise Williams, RN, CPC-H, senior vice president of revenue integrity services at Revant Solutions, in Fort Lauderdale, Florida, answered this question.
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