CERIANNA™ (F-18 labeled Fluoroestradiol, Injection)

Question:
Could you please tell us how to code the FDA-approved (May 20, 2020) radiopharmaceutical F-18 labeled Fluoroestradiol, injection (CERIANNA™), a PET imaging agent for detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer?

Answer:

The coding for the new FDA-approved diagnostic radiopharmaceutical F-18 Fluoroestradiol 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 (NCD) 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 May 20, 2020, for all Medicare settings, imaging with F-18 Fluoroestradiol 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.

Regarding the Radiopharmaceutical Coding, for DOS immediate post-FDA approval (from May 20, 2020 to December 31, 2020), hospital outpatient departments IDTFs, physician offices, and TPPs use HCPCS Level II code A9597 Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified for F-18 Fluoroestradiol. When using HCPCS code A9597, be sure to include the NDC (72874-0001-01) on the claim form so that the payer can identify the drug more easily. Some payers may request J3490 Unclassified drugs which is another unlisted drug code, so do check with the local payer to report the correct temporary billing HCPCS code.

For hospitals only and claims with a date of service October 1, 2020 to December 31, 2020 use temporary HCPCS level ii code C9060 Fluoroestradiol F-18, diagnostic, 1 millicurie.

For claims with a date of service January 1, 2021 and beyond and for all payers in all settings, please use A9591 Fluoroestradiol F-18, diagnostic, 1 millicurie. For Hospitals, HCPCS level II code A9591 has received pass-through status code "G '' effective January 1, 2021 with a rate of $0.752 per millicurie.  As of January 2021, this HOPPS published rate is incorrect per SNMMI's interpretation. Additionally, the rate has spilled into the physician office setting with some MACs listing rates at  $0.752 or 75 cents per millicurie. It is our understanding and interpretation of the Redbook AWP and WAC that the correct rate should be $626.583 per millicurie. Recently, CMS published a HOPPS correction notice confirming their error.

If you are encountering issues with your MAC please notify SNMMI at hpra@snmmi.org. CMS has told us that any corrections would be retroactive to January 1, 2021. SNMMI will notify our members and update this Q&A when any corrections are set to be implemented. Unfortunately, we are likely to see corrections at Quarterly intervals so likely published in March for April 2021 or July 2021 implementation.

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.