Billing Monoclonal Antibodies Directed Against Amyloid for Alzheimer's Disease

Medicare covers monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease with traditional FDA approval when a prescribing clinician or their staff decides the Medicare coverage criteria is met. The clinician or staff also submits information to help answer treatment questions in a qualifying study. You can participate in the CMS National Patient Registry (or another CMS-approved study) to get Medicare payment for treating your patients with Leqembi™ (lecanemab) or Kisunla™ (donanemab).

The Food and Drug Administration (FDA) granted traditional approval to Leqembi™ (lecanemab) on July 6, 2023, and Kisunla™ (donanemab) on July 2, 2024. As a result, these drugs are covered in accordance with National Coverage Determination (NCD) 200.3, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD). The coverage for Leqembi is for dates of service on and after July 6, 2023. For Kisunla, it’s for dates of service on and after July 2, 2024.

While these drugs may slow or delay symptoms of Alzheimer’s, it’s important that patients understand they don’t cure or reverse Alzheimer’s disease. 

Billing Instructions

• Use HCPCS code Leqembi J0174 (Injection, lecanemab-irmb, 1mg)
   
• Use HCPCS code Kisunla J0175 (Injection, donanemab-azbt, 2 mg)
   
• Report the registry trial number (eight-digit number) [Use “99999999” or a dedicated NCT number] in Field 19 of the paper CMS-1500 claim form or for electronic claims, Loop 2300 REF02 (REF01=P4)
   
• Append the appropriate modifier: 
   
  • Q0 (Investigational clinical service provided in a clinical research study that is in an approved clinical research study); or,
  • Q1 (Routine clinical service provided in a clinical research study that is in an approved clinical research study)
     
• Diagnosis Codes: 
   
  • Z00.6 (noting a registry) AND one of the following dx codes:
     
    • G30.0 Alzheimer’s disease w/early onset
       
    • G30.1 Alzheimer’s disease w/late onset
       
    • G30.8 Other Alzheimer’s disease
       
    • G30.9 Alzheimer’s disease, unspecified
       
    • G31.84 mild cognitive impairment, so stated

Claims will be returned as unprocessable when these drugs are submitted without the appropriate coding. 

Resources

• CMS announces new details of plan to cover new Alzheimer’s drugs (Fact Sheet)
• MM12950 — National Coverage Determination 200.3: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (PDF)
• MM13598 — National Coverage Determination 200.3: Monoclonal Antibodies for the Treatment of Alzheimer’s Disease (PDF)