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

The Requirements Checklist to Get Elevidys Covered by UnitedHealthcare in Washington: Complete Prior Authorization Guide

Answer Box: Getting Elevidys Covered by UnitedHealthcare in Washington

UnitedHealthcare requires prior authorization for Elevidys (delandistrogene moxeparvovec-rokl) through OptumRx with strict criteria: confirmed DMD genetic mutation, anti-AAVrh74 antibody titer ≤1:400, failed corticosteroid trial, and treatment at an approved center of excellence. First step: Call OptumRx at 1-800-711-4555 to confirm your plan's coverage and obtain PA forms. Submit via UHC Provider Portal with complete documentation including genetic testing, antibody results, and steroid history. If denied, Washington residents have strong appeal rights including external review through an Independent Review Organization (IRO) within 180 days.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet
  6. Submission Process
  7. After Submission: What to Expect
  8. Appeals Process in Washington
  9. Common Denial Reasons & How to Fix Them
  10. Printable Checklist

Who Should Use This Checklist

This guide is for Duchenne muscular dystrophy (DMD) patients and their families navigating UnitedHealthcare coverage for Elevidys, a one-time gene therapy with a list price of approximately $3.2 million. You'll also find this useful if you're a clinician submitting prior authorization requests or appealing denials for this treatment.

Expected outcome: Following this checklist increases your chances of first-time approval and helps you navigate Washington's robust appeal process if initially denied. Washington residents benefit from strong consumer protections and an independent external review system that can override insurer denials.

Member & Plan Basics

Verify Active Coverage

Before starting the prior authorization process:

  • Confirm active UnitedHealthcare coverage by checking your member ID card or logging into the UHC member portal
  • Identify your plan type: Commercial, Medicare Advantage, or Medicaid (coverage requirements may vary)
  • Check your deductible status and specialty drug benefits through OptumRx

Authorization Requirements

UnitedHealthcare requires prior authorization for Elevidys under their specialty drug policy. The medication is considered investigational for some indications, so meeting all clinical criteria is essential for approval.

Note: Prior authorization is NOT required for emergency room visits, observation units, urgent care, or during inpatient stays.

Clinical Criteria Requirements

Primary Eligibility Criteria

Requirement Details Documentation Needed
DMD Diagnosis Confirmed pathogenic DMD gene mutation with elevated creatine kinase Genetic testing report, lab results
Age ≥4 years (ambulatory or non-ambulatory per updated FDA labeling) Clinical notes confirming age
Antibody Test Anti-AAVrh74 antibody titer ≤1:400 (within 30-90 days) Recent lab results (mandatory)
Baseline Labs Liver function tests, CBC, renal function, hepatitis B/C screen Complete lab panel
Cardiac Assessment Ejection fraction ≥40% Echocardiogram results
Step Therapy Documented corticosteroid trial with failure, progression, or contraindications Prescription records, clinical notes

Functional Assessments

For ambulatory patients, include:

  • 6-Minute Walk Test (6MWT) results
  • North Star Ambulatory Assessment (NSAA) scores
  • Pulmonary function tests if available

Center of Excellence Requirement

Treatment must occur at a UnitedHealthcare-approved center of excellence equipped for gene therapy administration and monitoring. Contact OptumRx to verify approved facilities in Washington.

Coding & Billing Information

Primary Codes

  • HCPCS Code: J1413 (Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose)
  • ICD-10: G71.0 (Muscular dystrophy) or G71.01 (Duchenne muscular dystrophy)
  • CPT Codes: 96365 (IV infusion, initial ≤1 hour), 96366 (each additional hour)

NDC Numbers

Elevidys kits are weight-specific. Common NDC examples:

  • 10.0-10.4 kg: 60923-0501-10
  • 17.0-17.4 kg: 60923-0508-17
  • 40.5-41.4 kg: 60923-0532-41

Full NDC list available in the Elevidys billing guide.

Documentation Packet

Provider Note Elements

Your neuromuscular specialist's clinical note should include:

  • DMD diagnosis confirmation with genetic testing results
  • Disease progression and current functional status
  • Prior corticosteroid treatment history, duration, response, and reasons for discontinuation
  • Treatment goals and expected outcomes
  • Safety monitoring plan including hepatic function surveillance

Letter of Medical Necessity Components

The medical necessity letter should address:

  1. Clinical rationale based on FDA labeling and DMD care guidelines
  2. Patient-specific factors supporting treatment urgency
  3. Alternative treatments tried and their outcomes
  4. Prognosis without treatment and expected benefits
  5. Safety monitoring protocols your center will implement

Required Attachments

  • Genetic testing report confirming pathogenic DMD mutation
  • Anti-AAVrh74 antibody titer results (≤1:400)
  • Baseline laboratory results (liver function, CBC, renal)
  • Cardiac evaluation (echocardiogram)
  • Corticosteroid treatment history
  • Functional assessments (6MWT, NSAA if applicable)

Submission Process

Preferred Method: Online Portal

  1. Log into UHC Provider Portal at UHCprovider.com
  2. Select Prior Authorization tab and choose the appropriate form
  3. Complete all required fields - incomplete submissions cause delays
  4. Upload all supporting documents in PDF format
  5. Submit and record confirmation number

Alternative Methods

  • Phone: Call OptumRx at 1-800-711-4555 for form requests
  • UnitedHealthcare Community Plan: Call 866-889-8054
Tip: Online submission is fastest and provides immediate confirmation. Avoid fax submissions when possible as they're prone to processing delays.

After Submission: What to Expect

Timeline

  • Standard review: Up to 30 days for determination
  • Expedited review: Available for urgent cases (typically ≤72 hours)
  • Status checks: Use UHC Provider Portal or call member services

What to Record

  • Confirmation number and submission date
  • Case reference number (if provided)
  • Names of representatives you speak with
  • Follow-up dates and next steps

If Additional Information is Requested

Respond promptly to any requests for additional documentation. Common requests include:

  • Updated antibody titers
  • More detailed steroid treatment history
  • Clarification of treatment center credentials

Appeals Process in Washington

Washington residents have robust appeal rights if Elevidys is initially denied.

Internal Appeals (Required First Step)

  1. File within 180 days of denial notice
  2. Submit through UHC member portal or mail/fax per denial letter instructions
  3. Include new evidence supporting medical necessity
  4. Request peer-to-peer review with a neuromuscular specialist

External Review (Independent Review Organization)

If internal appeals are unsuccessful:

  1. File within 180 days of final internal denial
  2. Contact Washington Insurance Commissioner at 1-800-562-6900 for guidance
  3. Submit to assigned IRO - decision is binding on UnitedHealthcare
  4. Timeline: Standard review within 30 days; expedited within 72 hours for urgent cases
Washington Advantage: The state's IRO system uses independent medical specialists who can override insurer denials based on medical necessity, even if the plan's definition is restrictive.

At Counterforce Health, we help patients and clinicians turn insurance denials into successful appeals by creating targeted, evidence-backed submissions that address each payer's specific requirements and denial reasons.

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix Required Documentation
Incomplete steroid history Provide detailed records of all corticosteroid trials Prescription records, clinical notes, duration and outcomes
Anti-AAV titer >1:400 Retest if results are outdated; consider appeal if test methodology differs Recent lab results from approved laboratory
Non-approved treatment center Transfer care to approved facility or request network exception Center credentials, capability documentation
Insufficient genetic confirmation Provide complete genetic testing report Full genetic analysis showing pathogenic DMD mutation
Missing baseline assessments Complete all required safety evaluations Lab results, cardiac echo, functional assessments

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Elevidys? Standard review takes up to 30 days. Expedited review is available for urgent cases and typically completes within 72 hours.

What if my preferred treatment center isn't in UnitedHealthcare's network? You can request out-of-network authorization by demonstrating that network providers cannot provide the specialized care needed.

Can I appeal if my anti-AAV antibody titer is slightly above 1:400? Yes. Include evidence about test methodology, timing, and clinical judgment from your specialist about safety and efficacy despite the elevated titer.

Does Washington have special protections for gene therapy denials? Washington's external review system allows independent medical specialists to override insurer denials, providing strong consumer protection for innovative treatments like gene therapy.

What happens if I miss the appeal deadline? Contact the Washington Insurance Commissioner at 1-800-562-6900 immediately. They may provide options for late filing in exceptional circumstances.

Printable Checklist

Before You Start

  • Verify active UnitedHealthcare coverage
  • Confirm OptumRx specialty drug benefits
  • Identify approved treatment centers in your area
  • Gather insurance cards and member information

Clinical Requirements

  • DMD genetic testing report (pathogenic mutation confirmed)
  • Anti-AAVrh74 antibody titer ≤1:400 (within 30-90 days)
  • Baseline labs: liver function, CBC, renal, hepatitis B/C
  • Cardiac evaluation with ejection fraction ≥40%
  • Corticosteroid treatment history documented
  • Functional assessments (6MWT, NSAA if ambulatory)

Documentation Package

  • Medical necessity letter completed
  • All lab results attached
  • Genetic testing report included
  • Treatment center verification
  • Prior therapy documentation

Submission

  • Submit via UHC Provider Portal (preferred)
  • Record confirmation number
  • Set calendar reminder for status check
  • Prepare for potential follow-up requests

If Denied

  • File internal appeal within 180 days
  • Request peer-to-peer review
  • Contact Washington Insurance Commissioner if needed
  • Consider external IRO review

Working with experienced advocates like those at Counterforce Health can significantly improve your chances of approval by ensuring your submission addresses all payer-specific requirements and includes the strongest possible medical necessity argument.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage details. For assistance with insurance appeals and prior authorization, contact the Washington Insurance Commissioner at 1-800-562-6900.

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