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.
- NGS covers leuprolide acetate (LHRH analog) as palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.
- A drug use is covered if it is an FDA-approved labeled indication or is a medically accepted off-label indication supported by one of the accepted compendia at the specified levels (AHFS-DI supportive; NCCN Category 1 or 2A; Micromedex DrugDex Class I/IIa/IIb or Clinical Pharmacology supportive; Lexi-Drugs Evidence Level A) or by articles or LCDs published by National Government Services (NGS).
16 Active Policies
A54548 — Billing and Coding: Eculizumab, and Biosimilars: EPYSQLI-eculizumab-aagh, and BKEMV-eculizumab-aeeb
J06
L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J06
UHC-POL-complement-inhibitors — Complement Inhibitors
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.