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

Get Elevidys Gene Therapy Covered by Aetna CVS Health in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Elevidys Covered by Aetna CVS Health in Virginia

Eligibility: Aetna covers Elevidys for DMD patients age 4+ with confirmed genetic mutation (excluding exon 8/9 deletions), anti-AAVrh74 antibodies <1:400, and normal liver function. Fastest path: Submit prior authorization via Availity.com with complete documentation to a GCIT-designated center. First step today: Call the number on your Aetna card to verify specialty pharmacy benefits and confirm your plan's specific requirements. If denied, Virginia's external review process through the State Corporation Commission provides independent oversight within 45 days.

Table of Contents

  1. Start Here: Verify Your Plan and Coverage
  2. Required Forms and Documentation
  3. Submission Portals and Electronic Options
  4. Fax Numbers and Mailing Addresses
  5. CVS Specialty Pharmacy Enrollment
  6. Support Phone Numbers and What to Ask
  7. Virginia Appeals and External Review
  8. Coverage at a Glance
  9. Common Denial Reasons and Solutions
  10. FAQ

Start Here: Verify Your Plan and Coverage

Before submitting any paperwork, confirm your specific Aetna plan details. Virginia residents may have Aetna commercial insurance, Medicare Advantage, or Medicaid managed care through Aetna Better Health of Virginia.

Step 1: Check Your Coverage Type

  • Call the member services number on your Aetna ID card
  • Ask specifically about specialty drug coverage and whether Elevidys requires prior authorization
  • Confirm if your plan uses CVS Specialty Pharmacy for gene therapy administration
  • Verify that your intended treatment center is an Aetna-designated GCIT (Gene-Based, Cellular, and Other Innovative Therapy) facility
Note: Self-funded employer plans may have different requirements. Ask if your plan follows standard Aetna policies or has custom coverage rules.

Required Forms and Documentation

Aetna requires prior authorization for Elevidys through a comprehensive submission process. Based on Aetna's 2025 precertification requirements, you'll need:

Core Documentation Checklist:

  • Completed prior authorization form (obtain current version from Availity or CVS Specialty)
  • Genetic testing results confirming DMD mutation (excluding exon 8/9 deletions)
  • Anti-AAVrh74 total binding antibody results (<1:400 titer required)
  • Baseline laboratory results: liver function, platelet count, troponin levels
  • Patient weight and dosing calculations
  • Corticosteroid treatment plan (before and after infusion)
  • Medical necessity letter from treating physician
  • Confirmation of ambulatory status (able to walk without assistive devices)

Additional Requirements:

  • Patient must be 4 years of age or older
  • Treatment must occur at an Aetna GCIT-designated center
  • ICD-10 diagnosis code G71.01 (Duchenne or Becker muscular dystrophy)

Submission Portals and Electronic Options

Primary Electronic Submission Methods:

  1. Availity.com (Preferred)
    • Create provider account at Availity.com
    • Navigate to prior authorization section
    • Upload all required documentation as PDF attachments
    • Track submission status in real-time
  2. CVS Specialty Enrollment
    • Access the CVS Specialty enrollment portal
    • Download the Duchenne Muscular Dystrophy enrollment form
    • Complete electronic submission with clinical documentation
  3. CoverMyMeds Platform
    • Alternative electronic submission option
    • Integrates with many EMR systems
    • Provides status updates and communication tools
Tip: Electronic submissions typically process faster than fax or mail. Aim to submit at least two weeks before the intended treatment date.

Fax Numbers and Mailing Addresses

For Prior Authorization Submissions:

  • Confirm current specialty drug fax number by calling Aetna at 1-855-240-0535
  • Include a detailed cover sheet with member ID, provider contact information, and urgency level

For Appeals:

  • Appeals Fax: 1-866-207-8901
  • Mailing Address: Aetna Better Health of Virginia
    Attn: Member Services
    PO Box 818044
    Cleveland, OH 44181-8044

Cover Sheet Best Practices:

  • Include member's full name and ID number
  • List all attached documents
  • Provide direct provider contact information
  • Mark "URGENT" if expedited review is needed
  • Include reference to Elevidys (delandistrogene moxeparvovec-rokl) in subject line

CVS Specialty Pharmacy Enrollment

Most Aetna members receive Elevidys through CVS Specialty Pharmacy. The enrollment process includes:

Step 1: Provider Enrollment

  • Complete the CVS Specialty provider enrollment if not already registered
  • Obtain the specific Duchenne Muscular Dystrophy enrollment form
  • Submit patient-specific clinical information

Step 2: Patient Enrollment

  • Patient or caregiver completes CVS Specialty patient enrollment
  • Provides insurance information and delivery preferences
  • Schedules coordination with infusion center

Step 3: Benefits Verification

  • CVS Specialty verifies coverage and obtains prior authorization
  • Coordinates with Aetna for approval status
  • Manages specialty pharmacy logistics

Contact CVS Specialty at 1-800-237-2767 for enrollment assistance.

Support Phone Numbers and What to Ask

Aetna Member Services (Virginia-specific):

  • Medicaid (Aetna Better Health of Virginia): 1-800-279-1878 (TTY: 711) — available 24/7
  • Medicare and Dual Plans: 1-855-652-8249 (TTY: 711)
  • General Provider Support: 1-888-792-3862 (TTY: 711), Monday–Friday, 7 AM to 11 PM ET

Questions to Ask When You Call:

  1. "Does my plan cover Elevidys gene therapy, and what's the prior authorization process?"
  2. "Which GCIT centers are in-network for gene therapy administration?"
  3. "What's the current status of my prior authorization request?" (if already submitted)
  4. "Can you provide the direct fax number for specialty drug appeals?"
  5. "What documentation is needed for an expedited review?"

Virginia Appeals and External Review

Virginia provides robust consumer protection through the State Corporation Commission (SCC) Bureau of Insurance. If Aetna denies coverage, you have multiple appeal options:

Internal Aetna Appeals:

  • Timeline: Must be filed within 180 days of denial
  • Standard Review: 30-45 days for decision
  • Expedited Review: ≤72 hours for urgent medical needs
  • Submission: Use appeals fax (1-866-207-8901) or member portal

Virginia External Review Process:

  • Eligibility: After exhausting internal appeals, denials based on medical necessity or experimental/investigational determinations
  • Timeline: Submit Form 216-A within 120 days of final Aetna denial
  • Process: Independent review organization (IRO) conducts clinical review
  • Decision Timeline: 45 days for standard review, 72 hours for expedited
  • Binding: IRO decisions are final and binding on Aetna

How to File External Review:

  1. Download Form 216-A from Virginia SCC
  2. Attach copy of Aetna's final denial letter
  3. Include medical record release form
  4. Submit to: Virginia SCC Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
  5. Or fax to: (804) 371-9915

Contact Virginia SCC Consumer Services at 1-877-310-6560 for guidance on the external review process.

Coverage at a Glance

Requirement Details Where to Find Source
Prior Authorization Required for all members Availity.com or provider portal Aetna Precert List
Age Eligibility 4 years or older FDA label requirements Aetna Medical Policy
Genetic Testing DMD mutation confirmed, excluding exon 8/9 deletions Laboratory reports Aetna Clinical Criteria
Anti-AAV Antibodies <1:400 titer required Specialized lab testing Aetna Medical Policy
Site of Care GCIT-designated center only Aetna provider directory Aetna Institutes Network
Appeals Deadline 180 days from denial Denial letter instructions Aetna Appeals Process
Virginia External Review 120 days from final denial Form 216-A Virginia SCC

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Missing genetic confirmation Submit comprehensive genetic testing results DMD mutation analysis excluding exon 8/9 deletions
Anti-AAV antibodies too high Retest if results are borderline; document clinical necessity Anti-AAVrh74 titers <1:400 from certified lab
Non-GCIT center Transfer care to designated facility Confirmation of GCIT network participation
Inadequate corticosteroid plan Provide detailed pre/post-treatment protocol Physician attestation of steroid management plan
"Experimental/investigational" Cite FDA approval and clinical evidence FDA label, peer-reviewed studies, medical necessity letter
Baseline lab abnormalities Address and retest concerning values Normal liver function, platelet count, troponin levels
From Our Advocates: "We've seen multiple Elevidys appeals succeed when families provided comprehensive documentation upfront, including detailed genetic testing and a compelling medical necessity letter that specifically addressed the patient's functional decline and lack of alternative treatments. The key is demonstrating that all FDA criteria are met while emphasizing the urgency of early intervention in DMD progression."

FAQ

How long does Aetna prior authorization take for Elevidys in Virginia? Standard review takes 30-45 days from complete submission. Expedited review (for urgent medical needs) is completed within 72 hours. Submit at least two weeks before planned treatment.

What if Elevidys is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. Aetna must review non-formulary requests when no suitable alternatives exist on formulary.

Can I request an expedited appeal in Virginia? Yes, if your physician certifies that delay could jeopardize your health. Both Aetna internal appeals and Virginia external review offer expedited timelines for urgent cases.

Does step therapy apply to Elevidys? Typically no, as Elevidys is a first-line gene therapy. However, Aetna may require documentation of current or prior supportive DMD treatments.

What happens if my employer plan is self-funded? Self-funded plans may opt into Virginia's external review process. If not, you may have federal external review rights through HHS. Contact the Virginia SCC to determine your options.

How much does Elevidys cost without insurance? The list price is approximately $3.2 million for the one-time treatment. Counterforce Health can help navigate insurance denials and identify alternative funding sources.

Can I appeal to Virginia regulators before exhausting Aetna's internal appeals? Generally no, except for certain urgent situations. Virginia requires completing internal appeals first, but expedited external review may be available for urgent medical needs.

What support is available for families navigating this process? Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like gene therapies. Their platform helps identify denial reasons and craft evidence-backed responses aligned with payer policies.

About Counterforce Health: Counterforce Health transforms insurance denials into targeted appeals for patients seeking coverage of prescription medications. The platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals supported by FDA labeling, peer-reviewed studies, and specialty guidelines. For gene therapies like Elevidys, Counterforce Health helps ensure submissions include the operational details payers expect while meeting procedural requirements and tracking critical deadlines.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan benefits, medical circumstances, and payer policies. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with complex appeals, consider working with specialized advocacy services like Counterforce Health that focus on insurance coverage for specialty medications.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.