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LymphoSeek® (technetium Tc 99m tilmanocept)
Question:
Could you please tell us how to code the FDA approved (March 13, 2013) Lymphatic Mapping procedure and radiopharmaceutical LymphoSeek? This to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma? Additionally, on June 13, 2014 the FDA expanded use for guiding sentinel lymph node (SNL) biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity.
Answer:
The coding for the new FDA approved diagnostic radiopharmaceutical Tc-99m Technetium Tilmanocept, trade name LymphoSeek, will evolve as with any new drug. We expect this to continue over the next year or two and we encourage SNMMI members to check SNMMI's website regularly for updates. We also call to your attention that the various codes and reimbursement rates will change based on the billing setting, payer and date of service during this early evolution of a new drug. 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 13, 2013), hospital outpatient departments should bill Medicare for Tc-99m Technetium tilmanocept, using HCPCS code A4641 Radiopharmaceutical, diagnostic, not otherwise classified for LymphoSeek as it was a new FDA approved drug without a more specific HCPCS code. The appropriate unit of measure for an unlisted code is (1) one unit. When using HCPCS code A4641, be sure to include NDC #52579-1600-05 for LymphoSeek, on the claim form so that the payer can identify the drug. Pass-through specific codes and rates are announced quarterly (January, April, July or October.) Effective for claims with date of service October 1, 2013 to December 31, 2013 those billing in the hospital outpatient setting will report C1204Technetium TC 99m tilmanocept, diagnostic, up to 0.5 millicuries. Effective for claims with a date of service January 1, 2014 and beyond, CMS replaced C1204 with A9520 Technetium TC 99m tilmanocept, diagnostic, up to 0.5 millicuries.
For claims with dates of service prior to January 1, 2014 for IDTF, physician offices, and TPP should use HCPCS code A4641 Radiopharmaceutical, diagnostic, not otherwise classified for Tc-99m Technetium tilmanocept. When using HCPCS code A4641, be sure to include the 11 digit NDC on the claim form. The appropriate unit of measure for an unlisted code is (1) one unit. Physician offices and IDTFs should work with the local carrier or private payers to educate them on the product, provide peer reviewed articles, and discuss adequate reimbursement. Invoice cost for Tc-99m Technetium tilmanocept 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.
For all setting and payers, on or after January 1, 2014, report the HCPCS level II code A9520 Technetium TC 99m tilmanocept, diagnostic, up to 0.5 millicuries.
Regarding coding for the imaging procedure, SNMMI recommends CPT code 78195 Lymphatics and lymph nodes imaging for all settings and payers. When Tc 99m tilmanocept is injected for lymph node mapping without imaging, use CPT code 38792 Injection procedure; radioactive tracer for identification of sentinel node. More information regarding sentinel node procedures and coding details are provided in the coding Q&A located at http://www.snmmi.org/IssuesAdvocacy/QandADetail.aspx?ItemNumber=1800.
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.