Coding for Dopamine Transporter Imaging with I-123 Ioflupane

In 2011, the FDA approved the diagnostic radiopharmaceutical I-123 ioflupane (DaTscan, GE Healthcare) for dopamine transporter imaging. The main use for the radiopharmaceutical is to allow for better separation of patients with essential tremor from those with pre-synaptic Parkinsonian syndromes, as well as differentiating between some causes of parkinsonism.

As with any new drug, coding for the radiopharmaceutical will evolve, and it is expected that this will continue over the next year or two. The various codes and reimbursement rates for 123I ioflupane will change based on the billing setting and date of service during this early evolution of a new drug. It is important to pay attention to the setting; Medicare hospital outpatient, Medicare physician fee schedule, independent diagnostic testing facilities (IDTF) or third-party payors (TPP); and the date of service of the procedure for appropriate billing instructions.

For dates of service immediate post-FDA approval (beginning Jan. 14, 2011), hospital outpatient departments should bill Medicare for I-123 ioflupane using HCPCS code C9399, Unclassified drug or biological for I-123 ioflupane, as it is a new FDA-approved drug without a more specific HCPCS code that is anticipated to receive pass-through status. Pass-through specific codes and rates are announced quarterly (January, April, July or October). From July 1, 2011, to Dec. 31, 2011, those billing in the hospital outpatient setting will report C9406 Iodine I-123 ioflupane, diagnostic, per-study dose, (up to 5 millicuries). Effective Jan. 1, 2012 and beyond, CMS replaced C9406 with A9584 Iodine I-123 ioflupane, diagnostic, per-study dose, up to 5 millicuries.  

IDTF, physician offices and TPP use HCPCS code A4641 Radiopharmaceutical, diagnostic, not otherwise classified for I-123 ioflupane prior to Jan. 1, 2012. When using HCPCS code A4641, be sure to include the NDC 17156-210-01 on the claim form, so that the payor can identify the drug more easily. Physician offices and IDTFs should work with the local carrier or private payors to educate them on the product, provide peer-reviewed articles and discuss adequate reimbursement. Invoice cost for I-123 ioflupane is likely to be paid by many of the Medicare contractors in the office or IDTF setting; however, there are some that continue to pay based on a percentage of average wholesale price, as listed in the Red Book. Payment policy can vary among payors; therefore, you should check with your individual payors for their policies on how they pay for diagnostic radiopharmaceuticals.

For all setting and payors, on or after Jan. 1, 2012, report the new HCPCS level II code A9584 Iodine I-123 ioflupane, diagnostic, per study dose (up to 5 millicuries).

Regarding coding for the procedure, the Society of Nuclear Medicine (SNM) recommends CPT code 78607 Brain imaging, tomographic (SPECT), for all settings and payors.

The opinions referenced are those of the members of the SNM Coding and Reimbursement Committee and their consultants based on their coding experience. They are based on the commonly used codes in nuclear medicine, which are not all inclusive.

Always check with your local insurance carriers as policies vary by region. The final decision for the coding of a procedure must be made by the physician considering regulations of insurance carriers and any local, state or federal laws that apply to the physician’s practice. SNM and its representatives disclaim any liability arising from the use of these opinions.

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