April 30, 2024
Billing for Leqembi
On July 6, 2023, the Food and Drug Administration (FDA) granted traditional approval for the drug lecanemab (Leqembi™). As a result, Leqembi is covered under National Coverage Determination (NCD) 200.3, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD). See CMS MLN Matters article MM12950 for additional information.
Also, reference the CMS Coverage with evidence development page for details about how to participate in the CMS National Patient Registry (or another CMS-approved study) to get Medicare payment for treating your patients with Leqembi.
Part A Institutional Claim Instructions
For dates of service on or after July 6, 2023, report:
- Type of Bill 12X, 13X or 85X
- Condition Code 30
- Value Code D4 with a dedicated National Clinical Trial (NCT) number or 99999999
- Revenue Code 0636
- HCPCS Code J0174 (Injection, lecanemab-irmb, 1 mg)
- NOTE: If a different drug is FDA-approved under NCD 200.3, report the dedicated HCPCS code for that drug. If a HCPCS code is not assigned, report HCPCS Code C9399.
- Modifier Q0 or Q1
- Diagnosis Code Z00.6 and one of the following:
- 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)
Part B Professional Claim Instructions
For dates of service on or after July 6, 2023, report:
- A dedicated NCT number or 99999999 in the narrative description field (Item 19 or Loop 2300 REF02 (REF01=P4))
- HCPCS Code J0174 (Injection, lecanemab-irmb, 1 mg)
- NOTE: If a different drug is FDA-approved under NCD 200.3, report the dedicated HCPCS code for that drug. If a HCPCS code is not assigned, report HCPCS Code J3490 or J3590.
- Modifier Q0 or Q1
- Diagnosis Code Z00.6 and one of the following:
- 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)