J1299, Injection, eculizumab, 2 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Document meningococcal immunization at least 2 weeks prior to the first eculizumab dose or a clinical justification that delaying eculizumab posed greater risk than meningococcal infection.
- For PNH initiation, document flow cytometry confirming PNH and either evidence of clinically significant hemolysis or a documented history of a major adverse vascular event (MAVE) from thromboembolism.
- For aHUS initial trial, document absence of signs of STEC-HUS and that TTP was ruled out (e.g., normal ADAMTS13 activity and no inhibitor), or document a plasma exchange trial that failed to produce clinical improvement.
- If continuing eculizumab after the aHUS initial trial, document clinical improvement such as increased platelet count or laboratory evidence of reduced hemolysis.
Key Coverage Criteria
- Eculizumab is covered for treatment of paroxysmal nocturnal hemoglobinuria (PNH) when flow cytometry confirms PNH and there is either evidence of clinically significant hemolysis or a documented history of a major adverse vascular event (MAVE) from thromboembolism.
- Eculizumab is covered for treatment of atypical hemolytic uremic syndrome (aHUS) as an initial trial (generally 6–12 weeks) when the individual has no signs of STEC-HUS and thrombotic thrombocytopenic purpura (TTP) has been ruled out or a trial of plasma exchange did not produce clinical improvement.
- Eculizumab is covered for biopsy-proven dense deposit disease when elevated serum sC5b-9 (sMAC) levels are documented.
- Eculizumab may be covered for other label and off-label indications supported by recognized compendia or the FDA label when dose and frequency conform to FDA labeling or recognized compendia guidance.
- Medically necessary for initial therapy of aHUS when: documentation ruling out STEC-HUS and TTP; diagnosis with signs of aHUS; treatment-naïve; FDA-labeled dosing for aHUS; prescribed by hematologist/nephrologist; initial authorization up to 12 months. Continuation requires positive clinical response and dosing per FDA labeling, with reauthorization up to 12 months.
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
16 Active Policies
A54548, Billing and Coding: Eculizumab, and Biosimilars: EPYSQLI-eculizumab-aagh, and BKEMV-eculizumab-aeeb
J6
NGS-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
JK
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
RX501.066, Eculizumab and Associated Biosimilar(s)
Related Codes
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