Elevidys (delandistrogene moxeparvovec-rokl) gene therapy coverage
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Defines Wellmark/Wellmark Blue Cross and Blue Shield's coverage stance for Elevidys gene therapy for Duchenne muscular dystrophy (DMD) and how benefit determinations are applied to members.
Policy states Elevidys is considered not medically necessary for all indications, including treatment for DMD, due to insufficient evidence to demonstrate clinical efficacy.
J1413 (Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose) listed as billing code effective 1/1/2024.
Coverage Criteria
Not Medically Necessary
Covered when ALL of the following are met:
Benefit determinations are based on the applicable contract language in effect at the time services were rendered; exclusions, limitations, or exceptions may apply. Individual member benefits must be verified because benefits may vary by contract. This policy may not apply to Federal Employee Program (FEP) members; FEP benefits are determined by the Federal Employee Program.
Elevidys (delandistrogene moxeparvovec-rokl) is considered not medically necessary for all indications, including the treatment for DMD, because there is insufficient evidence to demonstrate clinical efficacy.
Coding
| J1413 | Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose (effective 1/1/2024) |
Provider Actions and Operational Notes
Prior Authorization / Billing Code
Prior authorization is required before scheduling therapy. Use billing code J1413 for delandistrogene moxeparvovec-rokl (effective 1/1/2024). Verify prior authorization requirements with the payer and include the therapeutic dose details on the request.
- Prior authorization required at policy level
- Billers: use HCPCS J1413 for claims dated on/after 2024-01-01
Benefit Verification and Documentation
Confirm member eligibility and benefit applicability before providing services. Document the contract terms that support coverage decisions and retain copies of benefit verification.
- Verify individual member benefits and document contract applicability
- Note exceptions may apply for specific contract types (e.g., FEP)
Provider Action: Submission & Documentation
Contact the payer's prior authorization department and follow their operational instructions (submission forms, required clinical documentation, and timelines). Ensure requests reference the policy number 05.05.08 and include clinical rationale tied to the member's contract.
- Include clinical rationale and contract details on the authorization request
- Reference policy number 05.05.08 on all communications
Denial Risk
Claims for Elevidys (delandistrogene moxeparvovec-rokl) will be denied as not medically necessary for all indications, including Duchenne muscular dystrophy (DMD). Do not submit claims without an approved prior authorization; unsupported claims are subject to denial.
- Claims denied as not medically necessary for all indications including DMD
- Do not bill without an approved prior authorization; expect denial if coverage/exclusion applies
Background
Elevidys (delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy delivering a micro-dystrophin transgene as a one-time intravenous infusion intended for pediatric patients with Duchenne muscular dystrophy (DMD). It was developed to provide micro-dystrophin expression as a potential surrogate for clinical benefit, but per this policy the therapy is not medically necessary due to insufficient evidence of clinical efficacy.
Definitions
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