J1429, Injection, golodirsen, 10 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
- Medical records (e.g., chart notes, laboratory values) confirming the DMD diagnosis
- Medical records confirming the DMD gene mutation is amenable to exon 53 skipping (genetic test results or equivalent documentation)
- For 6MWT pathway: medical records showing 6-Minute Walk Test (6MWT) >= 300 meters while walking independently prior to starting therapy
- For alternate ambulatory pathway: chart notes documenting the patient is ambulatory without needing an assistive device AND one of: NSAA score > 17 OR time to rise (TTR) < 7 seconds
Key Coverage Criteria
- 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.
- Treatment of Duchenne muscular dystrophy (DMD) in patients who meet ALL of the following:
- Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a neurologist with expertise in the diagnosis of DMD
- Submission of medical records confirming the mutation of the DMD gene is amenable to exon 53 skipping
- Ambulatory criteria — one of the following must be met prior to initiating therapy:
- Submission of medical records confirming a 6-Minute Walk Test (6MWT) >= 300 meters while walking independently (i.e., without side-by-side assist, cane, walker, wheelchair, etc.) prior to beginning Vyondys 53 therapy
5 Active Policies
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
UMR-POL-UMR-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
UMR-POL-UMR-vyondys-53, Vyondys 53 (Golodirsen)
UHC-POL-vyondys-53, Vyondys 53 (Golodirsen)
SUREST-POL-SUREST-vyondys-53, Vyondys 53 (Golodirsen)
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.