TL;DR: Aetna, a CVS Health company, modified CPB 0911 covering gene-based therapy for Duchenne muscular dystrophy (DMD), effective February 14, 2026. Billing teams working with HCPCS codes J1413, J1426, J1427, J1428, and J1429 need to review updated prior authorization criteria and site-of-care requirements before submitting claims.
This policy update tightens the medical necessity criteria across five DMD therapies — casimersen (Amondys 45), delandistrogene moxeparvovec-rokl (Elevidys), eteplirsen (Exondys 51), golodirsen (Vyondys 53), and viltolarsen (Viltepso). The Aetna DMD coverage policy now explicitly addresses sequencing between exon-skipping therapies and gene replacement therapy, adds new age and ambulatory function thresholds, and requires Elevidys administration at a designated GCIT Network facility. If your team bills for any of these drugs under CPT 96365–96368 or 96379, this policy change affects your reimbursement workflow starting February 14, 2026.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Gene-Based Therapy for Duchenne Muscular Dystrophy (DMD) |
| Policy Code | CPB 0911 Aetna |
| Change Type | Modified |
| Effective Date | February 14, 2026 |
| Impact Level | High |
| Specialties Affected | Neurology, Pediatric Neurology, Neuromuscular Medicine, Specialty Pharmacy, Infusion Therapy |
| Key Action | Confirm prior authorization criteria and GCIT site-of-care compliance for all five DMD drugs before billing |
Aetna DMD Gene-Based Therapy Coverage Criteria and Medical Necessity Requirements 2026
The Aetna DMD coverage policy now breaks down medical necessity differently for each drug. That sounds obvious, but the real complexity is in how the criteria interact — especially when a patient has already received one therapy and is moving to another.
Casimersen (Amondys 45) — HCPCS J1426
To get casimersen approved, all six criteria must be met. Aetna requires genetic testing confirming a DMD gene mutation amenable to exon 45 skipping. Treatment must start before age 14. The member must walk at least 300 meters on the 6-Minute Walk Test independently.
The new wrinkle: prior gene replacement therapy is no longer a disqualifier — but it does add conditions. Members who previously received Elevidys can still qualify for casimersen if they've experienced clinical decline, such as loss of ambulatory function. Members who had not received gene replacement therapy qualify under the standard pathway. Dose cannot exceed 30 mg/kg once weekly.
Continuation is approved when the member remains ambulatory — walking with or without assistance, not wheelchair dependent — and the dose ceiling holds.
Delandistrogene Moxeparvovec-rokl (Elevidys) — HCPCS J1413
Elevidys carries the strictest site-of-care requirement in this policy. Unless the member's health plan has opted out, Elevidys must be administered at an Aetna Institutes® GCIT Network facility. Bill J1413 only when you can confirm that site designation. A claim denial from a non-GCIT facility for Elevidys is nearly certain.
Elevidys also carries specific genomic exclusions. Members with a deletion in exon 8 or exon 9 of the DMD gene are excluded — the policy summary was truncated here, but this is a critical eligibility filter. Pull the full CPB 0911 document from the Aetna source before submitting any Elevidys prior authorization.
Eteplirsen (Exondys 51) — HCPCS J1428
Eteplirsen targets exon 51 skipping mutations. The same genetic testing requirement applies — confirmed DMD gene mutation amenable to exon 51 skipping. Age and ambulatory thresholds mirror casimersen. Infusions bill under CPT 96365 (initial infusion) and CPT 96366 (each additional hour) with J1428 on the drug line.
Golodirsen (Vyondys 53) — HCPCS J1429
Golodirsen covers exon 53 skipping mutations. Same genetic confirmation requirement, same age-of-initiation and ambulatory function criteria. Bill J1429 per 10 mg increments. Site-of-care utilization management applies here — Aetna's Site of Care for Specialty Drug Infusions policy governs where infusions can be administered and still receive full reimbursement.
Viltolarsen (Viltepso) — HCPCS J1427
Viltolarsen also targets exon 53 skipping and carries the same core criteria as golodirsen. J1427 bills per 10 mg. The same site-of-care policy applies. If your infusion center hasn't confirmed site eligibility for these drugs, do that before February 14, 2026.
Aetna DMD Therapy Exclusions and Non-Covered Indications
Any indication not explicitly listed in CPB 0911 is considered experimental, investigational, or unproven by Aetna. That's a broad catch-all, but it matters for billing.
Elevidys is excluded for members with deletions in exon 8 or exon 9. Pursuing prior authorization for those members will fail — and a denied auth means a denied claim. Don't start the clinical documentation process without confirming the exon deletion status first.
Members who were previously on an exon-skipping therapy, then received Elevidys, and now want to restart the exon-skipping therapy face a higher bar. They must re-meet all initial approval criteria — not just continuation criteria. This is a material change. If your clinical team is managing patients cycling between therapies, flag this to your compliance officer now.
Off-label use of any of these five drugs — for non-DMD diagnoses or for DMD mutations not amenable to the targeted exon skipping — gets no coverage under this policy.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| DMD with exon 45 skip-amenable mutation — casimersen | Covered | J1426, G71.01 | Age < 14 at initiation; ≥ 300m 6MWT; prior auth required |
| DMD post-Elevidys with clinical decline — casimersen | Covered | J1426, G71.01 | Must re-meet all initial criteria; ambulatory decline required |
| DMD with exon 51 skip-amenable mutation — eteplirsen | Covered | J1428, G71.01 | Same age/ambulatory thresholds; site-of-care UM applies |
| DMD with exon 53 skip-amenable mutation — golodirsen | Covered | J1429, G71.01 | Site-of-care UM applies; prior auth required |
| DMD with exon 53 skip-amenable mutation — viltolarsen | Covered | J1427, G71.01 | Site-of-care UM applies; prior auth required |
| DMD — Elevidys (gene replacement therapy) | Covered (with restrictions) | J1413, G71.01 | Must be administered at GCIT Network site; exon 8/9 deletion excluded |
| Elevidys — exon 8 or 9 deletion present | Not Covered | J1413 | Genomic exclusion; prior auth will be denied |
| Any DMD therapy — non-ambulatory member at continuation | Not Covered | All HCPCS | Wheelchair-dependent members fail continuation criteria |
| Off-label / non-DMD use of any listed drug | Experimental | All HCPCS | Explicitly excluded; claim denial expected |
| Re-initiation of exon-skipping therapy post-Elevidys without clinical decline | Not Covered | J1426–J1429 | Must demonstrate worsening clinical status |
Aetna DMD Gene-Based Therapy Billing Guidelines and Action Items 2026
This policy has real financial exposure. These are seven-figure drug costs in many cases. A missed prior authorization or a site-of-care mismatch means writing off tens of thousands of dollars per claim. Here's what to do now.
| # | Action Item |
|---|---|
| 1 | Audit every active DMD patient's authorization against the February 14, 2026 effective date. Any patient currently receiving casimersen, eteplirsen, golodirsen, or viltolarsen needs a coverage policy review. Check whether their current auth covers continuation criteria under the updated policy — specifically, confirm they're still ambulatory. |
| 2 | Confirm GCIT site designation before billing J1413. Elevidys claims submitted from non-designated facilities will be denied. Call Aetna's GCIT team and get written confirmation of your facility's designation status. Don't rely on verbal confirmation. |
| 3 | Pull the complete CPB 0911 document before submitting any Elevidys prior auth. The policy summary available here is truncated on Elevidys exclusions. The full clinical criteria — including the exon 8 and exon 9 deletion exclusions and any additional genomic criteria — are in the complete bulletin at the Aetna source. Submitting an incomplete auth is the fastest path to a claim denial. |
| 4 | Update your charge capture for infusion CPT codes. The infusion drug billing guidelines here use CPT 96365 for initial IV infusions, CPT 96366 for additional infusion hours, and CPT 96379 for unlisted IV/intra-arterial injections when applicable. Pair these with the correct HCPCS drug code (J1413, J1426, J1427, J1428, or J1429). Confirm your billing system links the right drug HCPCS to the right infusion CPT. |
| 5 | Flag any patient who received Elevidys and is now requesting re-initiation of an exon-skipping therapy. These patients must re-meet all initial criteria — not just continuation criteria. Your prior authorization documentation needs to show clinical decline since the Elevidys administration. A continuation-level auth package will be rejected. |
| 6 | Verify site-of-care compliance for Amondys 45, Exondys 51, Vyondys 53, and Viltepso infusions. Aetna's Site of Care for Specialty Drug Infusions utilization management policy applies to these four drugs. Infusions delivered at non-approved sites may be denied or reimbursed at a lower rate. Check the current approved site list and document it in the patient file. |
| 7 | Call the GCIT precertification line before any new DMD therapy initiation. The number is (866) 752-7021. Fax requests to (888) 267-3277. For Statement of Medical Necessity forms, pull from Aetna's Specialty Pharmacy Precertification page. Prescriptions from specialists without DMD expertise may not satisfy the prescribing specialty requirement — confirm the ordering provider qualifies. |
If you manage a mixed payer population and aren't certain how CPB 0911 interacts with your specific plan designs, talk to your compliance officer before the effective date. Some plan designs may have elected out of the GCIT network requirement for Elevidys — that needs to be confirmed at the plan level, not assumed.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for DMD Gene-Based Therapy Under CPB 0911
Covered HCPCS Drug Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J1413 | HCPCS | Injection, delandistrogene moxeparvovec-rokl (Elevidys), per therapeutic dose |
| J1426 | HCPCS | Injection, casimersen (Amondys 45), 10 mg |
| J1427 | HCPCS | Injection, viltolarsen (Viltepso), 10 mg |
| J1428 | HCPCS | Injection, eteplirsen (Exondys 51), 10 mg |
| J1429 | HCPCS | Injection, golodirsen (Vyondys 53), 10 mg |
CPT Infusion Administration Codes
| Code | Type | Description |
|---|---|---|
| 96365 | CPT | Intravenous infusion, for therapy, prophylaxis or diagnosis (initial, up to 1 hour) |
| 96366 | CPT | Intravenous infusion, for therapy, prophylaxis or diagnosis (each additional hour) |
| 96367 | CPT | Intravenous infusion, for therapy, prophylaxis or diagnosis (additional sequential infusion) |
| 96368 | CPT | Intravenous infusion, for therapy, prophylaxis or diagnosis (concurrent infusion) |
| 96369 | CPT | Subcutaneous infusion, for therapy or prophylaxis (initial, up to 1 hour) |
| 96370 | CPT | Subcutaneous infusion, for therapy or prophylaxis (each additional hour) |
| 96371 | CPT | Subcutaneous infusion, for therapy or prophylaxis (additional pump insertion) |
| 96372 | CPT | Subcutaneous infusion, for therapy or prophylaxis (therapeutic, prophylactic, or diagnostic injection) |
| 96379 | CPT | Unlisted therapeutic, prophylactic, or diagnostic intravenous or intra-arterial injection or infusion |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| G71.01 | Duchenne or Becker muscular dystrophy |
| K70.10–K77 | Diseases of liver |
A note on K70.10–K77: The liver disease ICD-10 range appearing in CPB 0911 is unusual given the primary DMD focus. This likely reflects hepatotoxicity monitoring requirements or contraindication screening for these therapies. Don't use these codes as primary diagnosis codes on DMD drug claims. If you see them, they're almost certainly supporting or monitoring codes. Confirm their role in documentation with your clinical team before coding.
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