AdreView (Iobenguane I-123) Cardiac Indication

Question:
Could you please tell us how to code the new FDA approved (March 20, 2013) cardiac procedure and radiopharmaceutical AdreView used for the assessment of myocardial sympathetic innervation (cardiac nerve activity)? This is to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III heart failure and left ventricular ejection fraction (LVEF) less than or equal to 35%?

Answer:

The coding and payment policies for the new FDA approved indication for the diagnostic radiopharmaceutical I-123 Iobenguane, trade name AdreView, will evolve as with any new drug or existing drug with new indication. We expect this to continue over the next year or two and we encourage SNMMI members to check the SNMMI website regularly for updates. We also call to your attention that the various codes and reimbursement rates may change based on the billing setting and date of service during this early evolution of the new indication. It is important to pay attention to the setting and payer; Medicare hospital outpatient, Medicare physician fee schedule, independent diagnostic testing facilities (IDTF), or third party payers (TPP) and the date of service of the procedure for appropriate billing instructions.

For dates of service immediate post-FDA approval (beginning March 20, 2013), hospital outpatient departments should bill Medicare for I-123 Iobenguane using HCPCS code A9582 Iodine I-123 iobenguane, diagnostic, per study dose, up to 15 millicuries, as it is an existing radiopharmaceutical with a new indication approved by the FDA. Since this is an existing product which has already received receive pass through status, we were informed by CMS officials it would not qualify for a second pass-through period.

IDTF, physician offices, and TPP should also report HCPCS code A9582 Iodine I-123 iobenguane, diagnostic, per study dose, up to 15 millicuries. Some payers may request providers to include the NDC #17156-235-01 on the claim form so that the payer can identify the drug. Physician offices and IDTFs should work with the local carrier or private payers to educate them on the new indication and use of the diagnostic radiopharmaceutical, provide peer reviewed articles, and discuss adequate reimbursement. Category III CPT codes do not have national relative value units, therefore MACs and other payers will need comparison procedures to set pricing. Invoice cost for I-123 Iobenguane 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 payers; therefore, you should check with your individual payers for their policies on how they pay for diagnostic radiopharmaceuticals.

Regarding coding for procedure when used for the cardiac indication, the SNMMI recommends for dates of service prior to June 30, 2013, CPT code 78499 Unlisted cardiovascular procedure, diagnostic nuclear medicine for all settings and payers. The appropriate unit of measure for an unlisted code is (1) one unit. For dates of service on or after July 1, 2013 bill one of either of the two new (effective July 1, 2013) Category III CPT codes, 0331T Myocardial sympathetic innervation imaging, planar qualitative and quantitative assessment; or 0332T Myocardial sympathetic innervation imaging, planar qualitative and quantitative assessment; with tomographic SPECT.

The opinions referenced are those of the members of the SNMMI 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 physicians practice. The SNMMI and its representatives disclaim any liability arising from the use of these opinions.