By Counterforce Health Team in Elevidys (delandistrogene moxeparvovec-rokl) —

Get Elevidys Covered by Cigna in North Carolina: Prior Authorization, Appeals, and Billing Codes (2025 Guide)

Answer Box: Getting Elevidys Covered by Cigna in North Carolina

Elevidys (delandistrogene moxeparvovec-rokl) requires prior authorization through Cigna's specialty pharmacy network. The fastest path to approval involves submitting complete documentation including genetic confirmation of DMD, prior therapy failures, and AAVrh74 antibody testing. If denied, North Carolina offers strong external review rights through Smart NC within 120 days.

First steps today:

  1. Have your doctor submit PA via CoverMyMeds or ExpressPAth
  2. Gather genetic testing results and treatment history
  3. Ensure infusion site meets center-of-excellence requirements

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Elevidys is covered under the medical benefit, not pharmacy benefit. This means it's billed through your doctor's office using buy-and-bill procedures, similar to infused cancer treatments or other specialty biologics.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all patients Cigna specialty pharmacy
Formulary Status Medical benefit, not pharmacy Cigna member portal
Billing Code HCPCS J1413 AAPC code lookup
Site of Care Designated infusion center Provider network directory
Age Restriction ≥4 years old FDA prescribing information

Key difference: Unlike typical prescription drugs picked up at a pharmacy, Elevidys is administered once as an IV infusion at a qualified medical facility and billed directly to your medical insurance.

ICD-10 and Documentation Requirements

Primary Diagnosis Code

Use ICD-10 code G71.01 for Duchenne or Becker muscular dystrophy. This specific code replaced the more general G71.0 and is required for proper reimbursement.

Essential Documentation

Your medical record must include:

  • Genetic confirmation of DMD mutation - PCR, MLPA, or other molecular testing results
  • Mutation type and testing date - Specific exon deletions or point mutations
  • Current functional status - Ambulatory vs. non-ambulatory
  • Prior therapy history - Corticosteroids, other DMD treatments tried/failed
  • Weight-based dosing calculation - Patient weight and corresponding vial count
Tip: Incomplete genetic documentation is a leading cause of denials. Ensure test results are clearly documented in the patient chart before submitting the PA request.

Product Coding: HCPCS J1413 and NDCs

HCPCS Billing Code

J1413: Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose

  • 1 billing unit = 1 complete therapeutic dose (not per vial)
  • Single administration covers the entire treatment episode
  • No repeat dosing - Elevidys is a one-time therapy

NDC Codes by Patient Weight

Elevidys kits contain different numbers of vials based on patient weight:

Patient Weight Rounded Weight Vials Needed Example NDC
10.0-10.4 kg 10 kg 10 vials 60923-0501-10
27.0-27.9 kg 28 kg 28 vials 60923-0528-28
40.5-41.4 kg 41 kg 41 vials 60923-0532-41
≥69.5 kg Fixed dose 70 vials 60923-0570-70

Dosing Calculation

For patients <70 kg:

  • Dose (mL) = Patient weight (kg) × 10
  • Round weight to nearest kilogram first
  • Number of vials = Total mL ÷ 10

For patients ≥70 kg:

  • Fixed dose of 9.31 × 10¹⁵ vector genomes
  • Always 70 vials regardless of weight

Clean Prior Authorization Request

Submission Methods

Cigna accepts PA requests through multiple electronic portals:

  1. CoverMyMeds - Free ePA portal with immediate criteria questions
  2. ExpressPAth - CareContinuum portal for new requests and appeals
  3. EviCore by Evernorth - Specialty medication PA system
  4. Phone: 1-800-882-4462 if electronic submission isn't available

Required Information

Prescriber Details:

  • NPI number and license number
  • For NPs/PAs: supervising physician name
  • Complete office contact information

Clinical Information:

  • Primary diagnosis: ICD-10 G71.01
  • Patient weight and date obtained
  • AAVrh74 antibody test status (critical requirement)
  • Previous DMD treatments and outcomes
  • Drug allergies (NKDA or specific allergies)
  • Concurrent medications

Infusion Site:

  • Qualified center name and affiliation
  • Complete address and contact details
  • Confirmation of center-of-excellence status

Common Coding and Billing Pitfalls

Calculation Errors

❌ Wrong: Using exact patient weight (27.3 kg × 10 = 273 mL) ✅ Correct: Round weight first (27.3 kg → 27 kg × 10 = 270 mL)

❌ Wrong: Billing per vial (28 units for 28 vials) ✅ Correct: Bill per dose (1 unit for complete treatment)

❌ Wrong: Using pediatric formula for 75 kg patient ✅ Correct: Fixed dose for all patients ≥70 kg

Documentation Mistakes

  • Missing genetic confirmation - Always include molecular testing results
  • Incomplete prior therapy history - Document all previous DMD treatments
  • Wrong ICD-10 code - Use G71.01, not the general G71.0
  • Partial vial calculations - Always round up to whole vials

Billing Unit Confusion

Remember: 1 billing unit = 1 therapeutic dose, not per vial or per mL. This is a one-time treatment that cannot be repeated.

Cigna Verification Resources

Before Submitting

  1. Check formulary status via Cigna member portal
  2. Verify infusion site is in-network and qualified
  3. Confirm PA requirements haven't changed
  4. Review patient's specific benefit design for any additional restrictions

Provider Resources

  • Coverage policies: Search Cigna's medical policy database for current Elevidys criteria
  • Prior authorization status: Track requests through provider portal
  • Appeals guidance: Cigna coverage decisions page

Pre-Submission Audit Checklist

Clinical Documentation:

  • Genetic testing confirms DMD mutation
  • Patient age ≥4 years documented
  • Weight recorded and calculation verified
  • AAVrh74 antibody test completed (must be <1:400)
  • Prior therapy failures documented
  • Current functional status noted

Coding Accuracy:

  • ICD-10 G71.01 for primary diagnosis
  • HCPCS J1413 for billing
  • Correct NDC for patient weight/kit size
  • 1 billing unit per dose (not per vial)

Administrative Requirements:

  • Qualified infusion center confirmed
  • All prescriber information complete
  • PA submitted via approved electronic portal
  • Supporting documents attached

Appeals Process in North Carolina

If Cigna denies your Elevidys request, North Carolina offers robust appeal rights through a two-tier system.

Internal Appeals (Cigna)

Timeline: 180 days from denial to file Process:

  1. First-level internal review
  2. Second-level internal review if first denied
  3. Expedited reviews available for urgent cases

Standard review: Decision within 72 hours of complete documentation Expedited review: Decision within 24 hours if delay risks serious harm

External Review (Smart NC)

If internal appeals are exhausted, North Carolina's external review provides independent oversight.

Contact Smart NC: 1-855-408-1212 Timeline: 120 days after final internal denial Process:

  1. Submit external review request form
  2. Independent Review Organization (IRO) assigned
  3. Decision within 45 days (standard) or 72 hours (expedited)

Key advantage: IRO decisions are binding on Cigna - if they approve coverage, Cigna must pay within 3 business days.

Note: Smart NC staff can help you complete the external review form and gather supporting documentation at no cost.

When Coverage Gets Complex

Getting a $3.2 million gene therapy approved requires expertise in insurance navigation and appeals strategy. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and payer policies to draft point-by-point rebuttals using the right clinical evidence and procedural requirements for each insurer's specific workflow.

For complex cases like Elevidys, having professional support can mean the difference between a denial and life-changing treatment access.

FAQ

How long does Cigna prior authorization take for Elevidys? Standard reviews take up to 72 hours once complete documentation is submitted. Expedited reviews are decided within 24 hours if medical urgency is demonstrated.

What if Elevidys isn't on Cigna's formulary? Elevidys is covered under the medical benefit, not pharmacy formulary. Your doctor can request a formulary exception with detailed medical necessity documentation if needed.

Can I get an expedited appeal in North Carolina? Yes, both Cigna internal appeals and Smart NC external reviews offer expedited timelines (24-72 hours) when delay would seriously jeopardize health or function.

Does step therapy apply to Elevidys? Many payers require documentation of prior DMD therapies (corticosteroids, other treatments) but formal step therapy protocols vary. Your doctor can request step therapy overrides based on medical necessity.

What happens if I move from North Carolina during the appeal process? External review rights depend on where your insurance is regulated, not your current residence. If your plan is NC-regulated, you retain Smart NC appeal rights even if you relocate.

How much will Elevidys cost with Cigna coverage? Costs depend on your specific benefit design. Even with coverage, high-cost gene therapies may have significant copays or coinsurance. Check with Cigna member services and explore manufacturer support programs.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with North Carolina insurance issues, contact Smart NC at 1-855-408-1212.

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