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

How to Get Elevidys Covered by Blue Cross Blue Shield in Pennsylvania: Prior Authorization Guide with Appeals Process

Answer Box: To get Elevidys covered by Blue Cross Blue Shield in Pennsylvania, you need: 1) Confirmed DMD genetic testing showing pathogenic mutation, 2) Age ≥4 years with negative anti-AAVrh74 antibodies, 3) Prior authorization through your BCBS plan's electronic portal (Availity for Highmark, IBX portal for Independence). Most Pennsylvania BCBS plans require administration at Sarepta-certified treatment centers. If denied, Pennsylvania's new external review program overturns about 50% of appeals. Start with SareptaConnect at 1-888-727-3782 to verify treatment centers and insurance requirements.

Table of Contents

What This Guide Covers

This comprehensive guide helps Pennsylvania families navigate Blue Cross Blue Shield coverage for Elevidys (delandistrogene moxeparvovec-rokl), the FDA-approved gene therapy for Duchenne muscular dystrophy (DMD). With a list price around $3.2 million, proper prior authorization is essential.

Who this helps:

  • Families with children diagnosed with DMD
  • Clinicians preparing prior authorization requests
  • Caregivers navigating insurance appeals

What you'll learn:

  • Exact documentation requirements for Pennsylvania BCBS plans
  • Step-by-step prior authorization process
  • How to use Pennsylvania's new external review program (50% success rate)
  • Common denial reasons and how to address them

Before You Start: Plan Verification

Confirm Your BCBS Plan Type

Pennsylvania has three main BCBS plans with different requirements:

Plan Coverage Area PA Portal Specialty Network
Independence Blue Cross (IBX) Philadelphia region IBX provider portal CVS Specialty, Accredo
Highmark Blue Shield Western/Central PA Availity portal CVS Specialty, Accredo
Capital Blue Cross Central PA Provider portal Accredo (primary)
Important: Elevidys requires administration at Sarepta-certified treatment centers, not standard specialty pharmacies. The drug is covered under your medical benefit, not pharmacy benefit.

Verify Network Status

  1. Check treatment center eligibility: Contact SareptaConnect at 1-888-727-3782 to confirm nearby certified centers
  2. Verify in-network status: Use your BCBS plan's provider directory to confirm the treatment center accepts your insurance
  3. Confirm plan benefits: Call the member services number on your ID card to verify Elevidys coverage and your cost-sharing

Gather Required Documentation

Essential Clinical Documentation

Genetic Testing Requirements:

  • Complete DMD genetic test report showing pathogenic mutation in DMD gene
  • Must specify deletion/duplication pattern or sequence variant
  • Lab report should state "pathogenic" or "likely pathogenic" for DMD

Anti-AAV Antibody Testing:

  • Anti-AAVrh74 IgG antibody test results
  • Must show "negative" or "below threshold" status
  • Use Sarepta-designated laboratory when possible

Clinical Status Documentation:

  • Age verification (≥4 years required)
  • Neuromuscular specialist consultation notes
  • Baseline liver function tests (AST, ALT, bilirubin)
  • Cardiac evaluation (echocardiogram summary)
  • Current medication list including corticosteroids

ICD-10 and Billing Codes

Primary Diagnosis:

  • G71.01 - Duchenne or Becker muscular dystrophy
  • Include specific DMD mutation in clinical notes

Supporting Documentation:

  • Recent clinic notes clearly stating "Duchenne muscular dystrophy"
  • Functional assessments (ambulatory status, if available)
  • Treatment history and corticosteroid regimen

Submit Your Prior Authorization

Highmark Blue Shield Process

Highmark requires electronic submission via Availity portal - no paper forms accepted as of 2024.

Steps:

  1. Log into Availity provider portal
  2. Select "Medical Prior Authorization"
  3. Enter member and provider information
  4. Upload all clinical documentation
  5. Include steroid prophylaxis plan
  6. Submit with HCPCS code for Elevidys (verify current code)

Independence Blue Cross Process

IBX requires precertification for Elevidys through their medical policy portal.

Key Considerations:

  • IBX has an 18-month non-coverage policy for some accelerated-approval therapies starting January 2025
  • Verify current Elevidys coverage status before proceeding
  • Check if your specific plan has adopted the non-coverage stance

Submission Process:

  1. Access IBX medical policy portal
  2. Review current Elevidys policy requirements
  3. Submit via provider portal with complete documentation
  4. Include attestation of one-time lifetime treatment

Follow-Up and Timeline Management

Expected Timelines

Standard Review:

  • Initial determination: 15 business days (commercial plans)
  • Expedited review: 72 hours (urgent medical necessity)
  • Additional information requests: 5-10 business days to respond

Follow-Up Schedule:

  • Day 3: Confirm receipt and completeness
  • Day 10: Check status if no updates
  • Day 14: Request timeline update if approaching deadline

Sample Phone Script

"I'm calling to check the status of prior authorization request #[number] for Elevidys gene therapy for [patient name], DOB [date]. This is a time-sensitive, one-time treatment. Can you provide the current status and expected decision date?"

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
"Experimental/investigational" Cite FDA approval and medical necessity FDA label, clinical guidelines
"Missing genetic confirmation" Submit complete genetic test report Lab report with pathogenic variant
"Age restriction" Reference updated FDA label (≥4 years) Age documentation, current label
"Anti-AAV antibodies positive" Retest if borderline; appeal threshold Repeat lab results, clinical rationale
"Not medically necessary" Comprehensive medical necessity letter Specialist letter, functional decline data

Medical Necessity Letter Checklist

For clinicians preparing appeals:

  • Problem statement: Confirmed DMD with specific genetic mutation
  • Prior treatments: Corticosteroid history, supportive care
  • Clinical rationale: Why Elevidys is appropriate now
  • Evidence base: FDA approval, clinical trial data
  • Monitoring plan: Safety monitoring and follow-up schedule

Pennsylvania Appeals Process

Pennsylvania's External Review Advantage

Pennsylvania launched its Independent External Review program in January 2024, achieving a 50% overturn rate for appealed denials.

Process Overview:

  1. Complete internal appeals with your BCBS plan first
  2. Receive Final Adverse Benefit Determination letter
  3. File external review within 4 months at no cost
  4. Submit supporting evidence within 15 days of IRO assignment
  5. Receive decision within 45 days (72 hours for expedited)

When to Use External Review

Best candidates for external review:

  • Strong clinical evidence supporting medical necessity
  • Plan denied based on "experimental" determination
  • Age or eligibility criteria disputes
  • Clear documentation of DMD genetic confirmation
From our advocates: In our experience with gene therapy appeals, families who submit comprehensive genetic testing documentation and specialist letters citing current FDA labeling see higher success rates. The key is addressing each specific denial reason with targeted evidence rather than generic appeals.

Getting Help with Appeals

Pennsylvania Resources:

Costs and Financial Support

Manufacturer Support Programs

SareptaConnect Patient Support offers:

  • Insurance verification and prior authorization assistance
  • Financial assistance programs (income-based eligibility)
  • Appeals support and documentation help
  • Treatment center coordination

Contact: 1-888-727-3782

Additional Resources

  • Muscular Dystrophy Association: Financial assistance programs
  • Parent Project Muscular Dystrophy: Advocacy and support resources
  • State pharmaceutical assistance programs: Check Pennsylvania-specific options

FAQ

How long does BCBS prior authorization take in Pennsylvania? Standard review is 15 business days for commercial plans. Expedited review (for urgent cases) takes 72 hours. Timeline starts when complete documentation is received.

What if Elevidys is considered non-formulary? Request a formulary exception with medical necessity documentation. Focus on FDA approval status and lack of therapeutic alternatives for DMD.

Can I request an expedited appeal if initially denied? Yes, if delay would seriously jeopardize health. Document clinical urgency and progressive nature of DMD in your expedited request.

Does step therapy apply to Elevidys? Most BCBS plans don't require step therapy for gene therapies, but may require documentation of standard DMD care (corticosteroids). Check your specific plan policy.

What happens if my external review is successful? Your BCBS plan must immediately cover Elevidys, including retroactive coverage if you paid out-of-pocket during the appeal process.

How do I find a Sarepta-certified treatment center in Pennsylvania? Contact SareptaConnect at 1-888-727-3782. They maintain the current list of certified centers and can help verify insurance acceptance.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, plan policies, and clinical evidence to create targeted, evidence-backed appeals that address specific payer requirements. We understand the complexities of gene therapy coverage and can help streamline your Elevidys appeal process.

For families navigating complex gene therapy coverage decisions, Counterforce Health provides the expertise needed to present compelling cases that align with payer-specific criteria and maximize approval chances.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For additional help with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department's consumer assistance line.

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