Broader Medicare Coverage of Leqembi: Claims Processing

The drug lecanemab (Leqembi™) was granted traditional approval by the FDA on July 6, 2023. Leqembi will now be covered under National Coverage Determination (NCD) 200.3, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's.

For dates of service beginning July 6, 2023, Medicare will pay for Leqembi when you submit a valid claim and coding information to provide treatment included in a qualifying clinical study.

Include the following on your Leqembi-related drug and/or PET Scan clinical trial claims:

  • HCPCS code: Leqembi J0174 (Injection, lecanemab-irmb, 1mg)
  • Registry trial number (8-digit number): Use the temporary # 99999999 or the dedicated NCT # 6058234
  • One of these modifiers:
    • Q0 (Investigational clinical service provided in a clinical research study that is an approved clinical research study), or
    • Q1 (Routine clinical service provided in a clinical research study that is 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
  • Condition code 30 (For institutional claims only)

For more information:

CMS Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD)

Provider Fact Sheet – Alzheimers Treatment (PDF)

CMS Statement: Broader Medicare Coverage of Leqembi Available Following FDA Traditional Approval

 

Last Updated Dec 05 , 2023