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Leqembi for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease

Effective for dates of service on and after July 6, 2023, Medicare will pay for Leqembi (lecanemab-irmb) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease. 

This drug is covered under NCD 200.3 - Monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease (AD).

Medicare covers the drugs with traditional FDA approval in this class 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.

Part A billing instructions 

Institutional claims:

  • For dates of service on or after July 6, 2023, use HCPCS code Leqembi J0174 (Injection, lecanemab-irmb, 1mg).
  • Type of Bill: 12X, 13X, or 85X
  • Revenue Code: 0636
  • Condition Code: 30
  • Value Code: D4 with the national clinical trial (NCT) number "99999999" or a dedicated NCT number
  • Report one of the following modifiers:
    • 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

Part B billing instructions 

  • For dates of service on or after July 6, 2023, use HCPCS code Leqembi J0174 (Injection, lecanemab-irmb, 1mg).
  • Report the registry trial number (8-digit number) using "99999999" or a dedicated NCT number in the narrative description field (Item 19) or the electronic claim in Loop 2300 REF02 (REF01=P4)
    • To ensure claims are submitted and processed correctly, please review the reporting information with your software vendor.
    • Click here to view the CMS-1500 (02/12) data element requirements and electronic claim loop mapping.
  • Report one of the following modifiers:

    • 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
  • The diagnosis code pointer should be used to indicate the primary diagnosis on the claim form.
 Report the registry trial number (8-digit number) using "99999999" or the dedicated NCT number in the narrative description field (Item 19) or the electronic claim in Loop 2300 REF02 (REF01=P4)

 

References