J1413, Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose
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
- Submission of medical records (e.g., chart notes, laboratory values) confirming both of the following: o A mutation in the DMD gene; and o The mutation is not a deletion in exon 8 or exon 9
- Patient is aged 4 or 5 years of age; and Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
- Prescriber attests that liver function (clinical exam, GGT, and total bilirubin) will be monitored weekly for the first 3 months following Elevidys administration and thereafter in accordance with the Food and Drug Administration (FDA) approved labeling
- Patient does not have a left ventricle ejection fraction (LVEF) < 40%; and Prescriber attests that troponin-I will be monitored weekly for the first month following Elevidys administration and thereafter in accordance with the FDA approved labeling
Key Coverage Criteria
- A one-time infusion ofdelandistrogene moxeparvovec-rokl (ELEVIDYS) is consideredmedically necessaryin individuals who meetallof the following criteria:
- Diagnosis of Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene;and
- No deletion in exon 8 or exon 9 in DMD gene;and
- Ambulatory;and
- Age 4 through 5 years (at least 4 years 0 days and less than 6 years old);and
- Anti-AAVrh74 total binding antibody titers less than 1:400;and
4 Active Policies
ANTHEM-MED.00144, MED.00144 Gene Therapy for Duchenne Muscular Dystrophy
UHC-POL-elevidys, Elevidys (Delandistrogene Moxeparvovec-Rokl)
UMR-POL-UMR-elevidys, Elevidys (Delandistrogene Moxeparvovec-Rokl)
SUREST-POL-SUREST-elevidys, Elevidys (Delandistrogene Moxeparvovec-Rokl)
Related Codes
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