Lutathera® (lutetium Lu-177 dotatate)

Question:
Could you please tell us how to code the new FDA approved (January 26, 2018) therapeutic injection procedure and radiopharmaceutical Lutathera®? This is for the treatment of somatostatin receptor positive gastroenteropanceatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Answer:

The coding for the new FDA approved therapeutic radiopharmaceutical Lutetium Lu-177 dotatate, trade name Lutathera®, 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 the SNMMI 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, 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 January 26, 2018 – June 30, 2018), hospital outpatient departments should bill Medicare for Lutetium Lu-177 dotatate using HCPCS code C9399 Unclassified drugs or biological for Lutathera® as it is a new FDA approved therapeutic radiopharmaceutical without a more specific HCPCS code. The appropriate unit of measure for an unlisted code is (1) one unit. When using HCPCS code C9399, be sure to include NDC # 69488-0003-01 for Lutathera® on the claim form so that the payer can identify the therapeutic radiopharmaceutical.

For dates of service July 1, 2018 hospital outpatient departments should bill Medicare for Lutetium Lu-177 dotatate using the new HCPCS code C9031 Lutetium Lu-177, dotatate, Therapeutic, 1 millicurie, and APC status G in APC group 9067, as anticipated by the SNMMI this product qualified for pass-through status. Pass-through specific codes and rates are announced quarterly (January, April, July or October). We caution you regarding the code description of per millicurie, rather than per treatment dose, therefore, be sure you list the number of millicuries administered and any waste following the waste guidance and the JW modifier.

More information on waste coding and billing see the revised Q&A: http://www.snmmi.org/IssuesAdvocacy/QandADetail.aspx?ItemNumber=1861&navItemNumber=24950

Of note, effective for claims with DOS on or after January 1, 2017, Medicare requires the use of the JW modifier for wasted drugs or radiopharmaceuticals. Additionally, effective for claims with DOS on or after July 1, 2023, Medicare requires the use of JW and JZ for single use drugs or radiopharmaceuticals for tracking and payment. For more information and CMS Q&A on the JW and JZ modifiers go to https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf

As of the writing of this Q&A the payment rate is not yet posted on the CMS web site.  As noted in Transmittal 2718 Change Request 8338 published on June 7, 2013 CMS will pay for therapeutic radiopharmaceuticals at 95 percent of the published average wholesale price (AWP) until average sale price (ASP) data is available and updated by CMS in their quarterly OPPS files.

Physician offices, and TPP should use HCPCS code A9699 Radiopharmaceutical, therapeutic, not otherwise classified for lutetium Lu-177 dotatate. When using HCPCS code A9699, be sure to include the 11 digit NDC on the claim form NDC # 69488-0003-01 for Lutathera®. 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 Lutetium Lu-177 dotatate is likely to be paid by many of the Medicare contractors in the office setting; however there are some that continue to pay based on a percentage of AWP 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 the therapeutic injection procedure, the SNMMI recommends CPT code 79101 Radiopharmaceutical therapy, by intravenous administration for all settings and payers. Of note, the protocol for this nuclear medicine therapy also includes administration of an antiemetic (physicians’ selection) as well as an amino acid, either of those drugs may result in billing for CPT 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour. The National Correct Coding Initiative (NCCI) effective at the time of writing of this article [79101(Column 1) conflicts with Code 96365 (Column 2)] shows a relationship when these services are provided on the same day by the same physician. Therefore, we recommend that you place the modifier 59 on the 96365 when billed with the 79101. The modifier 59 tells the payer that the 96365 is for the separate administrations of the amino acid and the antiemetic.

Note: Independent diagnostic testing facilities (IDTF) would not perform therapeutic services. CMS states, “An IDTF shall not be allowed to bill for any CPT or HCPCS codes that are solely therapeutic.”

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.