NETSPOT™ (Ga-68 labeled DOTATATE, Injection)

Question:
Could you please tell us how to code the FDA-approved (June 2, 2016) radiopharmaceutical Ga-68 labeled DOTATATE, injection (NETSPOT™), a PET imaging agent for localization of somatostatin receptor-positive neuroendocrine tumors (NETs).

Answer:

The coding for the new FDA-approved diagnostic radiopharmaceutical Ga-68 DOTATATE will evolve as with any new drug. We expect this evolution to occur 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 and date of service during this early evolution of a new drug and service. It is important to pay attention to the setting; Medicare hospital outpatient, Medicare physician fee schedule, independent diagnostic testing facilities (IDTF), or third-party payers (TPP) and the date of service (DOS) of the procedure for appropriate billing instructions.

Of importance, Medicare currently has a National Coverage Determination for Oncologic PET procedures which allows local contractors to determine coverage for newly approved by FDA PET agents; therefore, for claims with a DOS on or after June 2, 2016, for all Medicare settings, imaging with Ga-68 DOTATATE may be covered at the local Medicare Administrative Contractor (MAC) discretion, providers should communicate with their local MAC for local coverage policies pertaining to this new diagnostic radiopharmaceutical and procedure. To bill Medicare for locally covered PET services use the single most appropriate CPT code 78811 to 78816 based on the imaging area and PET/CT or PET equipment ordered and used for the study. To bill Medicare in any setting for non-covered PET services, providers would choose HCPCS Level II code G0235 PET imaging, any site, not otherwise specified. Billing Medicare with this code should result in a claim denial. Providers who choose to have their patients sign Advanced Beneficiary Notices, prior to performing the studies, could then bill the patient for the non-covered Medicare service.

Regarding the Radiopharmaceutical coding, for DOS immediate post-FDA approval (beginning on or after May 31, 2016), hospital outpatient departments IDTFs, physician offices, and TPPs use HCPCS Level II code J3490 Drug, injection, not otherwise classified for Ga-68 DOTATATE. When using HCPCS code J3490, be sure to include the NDC (69488-001-40) on the claim form so that the payer can identify the drug more easily.

For dates of service January 1, 2017 and beyond, CMS has established a permanent HCPCS code that should be use in both the HOPPS and MPFS settings unless payers dictate otherwise.  The new on January 1, 2017 HCPCS level II code and description is A9587 Gallium ga-68, dotatate, diagnostic, 0.1 millicurie. SNMMI is disappointed that this description is not per study dose as requested.

SNMMI recommends the use of the JW modifier to report wasted product and for providers to report the full costs of the ordered dose, along with the patient administered dose. When reporting any HCPCS code, providers must report the number of units per the HCPCS description that are administered to the patient and not the ordered dose. However, the SNMMI recommends reporting any wasted product from ordered dose to administer dose by reporting those units with the HCPCS description followed by the JW modifier. This modifier will identify to the payer that you had product at a cost to the provider that was not administered to the patient and was discarded or wasted. The use of the JW modifier is an important mechanism for providers to be able to report the costs and be paid appropriately for radiopharmaceuticals. More information regarding JW modifiers can be located on a CMS Q&A located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf

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.