By Counterforce Health Team in StrataGraft (allogeneic cultured keratinocytes & fibroblasts in murine collagen-dsat) —

How to Get StrataGraft Approved by Aetna CVS Health in Virginia: Complete Prior Authorization & Appeals Guide

Quick Answer: Getting StrataGraft Covered by Aetna CVS Health in Virginia

StrataGraft requires prior authorization from Aetna CVS Health and must be billed as a facility procedure (HCPCS J7353), not through pharmacy benefits. You'll need comprehensive burn documentation, surgical consultation, and medical necessity justification. If denied, Virginia offers binding external review through the State Corporation Commission within 120 days. Start by gathering wound photos, burn measurements, and specialist consultation letters—then submit through Aetna's provider portal.

First step today: Contact your burn surgeon to begin PA documentation while confirming your plan covers facility-based procedures.

Table of Contents

What This Guide Covers

This comprehensive guide helps adult burn patients and their clinical teams navigate Aetna CVS Health's prior authorization process for StrataGraft in Virginia. StrataGraft is an innovative tissue-engineered skin substitute designed for deep partial-thickness thermal burns when surgical intervention is required.

Who this helps:

  • Adult burn patients (18+) with deep partial-thickness thermal burns
  • Burn surgeons and wound care specialists
  • Hospital case managers and billing staff
  • Patient advocates and family caregivers

You'll learn exactly what documentation Aetna requires, how to avoid common pitfalls that lead to denials, and how to leverage Virginia's robust external review process if your initial request is denied.

Before You Start: Plan Verification

Confirm Your Coverage Type

Check these details first:

  • Verify you have Aetna CVS Health coverage (not just CVS Caremark pharmacy benefits)
  • Confirm your plan includes facility-based medical procedures
  • Ensure your burn center is in-network with Aetna
  • Verify you're enrolled in a Virginia-regulated plan (not a self-funded employer plan that may have different rules)
Important: StrataGraft is never covered through CVS Caremark pharmacy benefits. It must be billed as a facility procedure through your medical benefit using HCPCS code J7353.

Insurance Card Information You'll Need

  • Member ID number
  • Group number (if applicable)
  • Plan effective date
  • Customer service phone number

Required Documentation Checklist

Clinical Documentation Requirements

Essential medical records:

  • Burn specialist consultation confirming deep partial-thickness thermal burn diagnosis
  • Total body surface area (TBSA) calculation (typically 3-49% TBSA)
  • Clinical photographs of burn sites showing wound depth and characteristics
  • Wound measurements in square centimeters
  • Documentation that surgical intervention (excision and grafting) is clinically indicated
  • Confirmation of intact dermal elements in burn areas
  • Assessment of adequate donor site availability
  • Allergy history (specifically ruling out murine collagen, bovine, or porcine product allergies)

Administrative Requirements

  • Completed Aetna prior authorization form
  • ICD-10 diagnosis codes (T21-T31 series for burns)
  • Planned HCPCS billing code (J7353)
  • Provider NPI and facility information
  • Insurance verification and eligibility confirmation

Step-by-Step Prior Authorization Process

Step 1: Gather Complete Clinical Documentation (Days 1-3)

Who does it: Burn surgeon and clinical team
What's needed: All items from the documentation checklist above
Timeline: 2-3 days for comprehensive documentation

Work with your burn surgeon to ensure all clinical criteria are thoroughly documented. The medical necessity letter should specifically address why StrataGraft is preferred over standard autografting approaches.

Step 2: Submit Prior Authorization Request (Day 4)

Who does it: Hospital case manager or provider office
How to submit: Aetna provider portal or fax to prior authorization department
Required forms: Aetna's facility-based procedure PA form

Tip: Submit a complete package the first time. Incomplete submissions reset the review clock and delay decisions.

Step 3: Follow Up Within 5 Business Days (Day 9)

Who does it: Provider office or patient
What to ask: Request confirmation of receipt and estimated decision timeline
Document: Keep reference numbers and representative names

Step 4: Respond to Information Requests Promptly (As Needed)

Timeline: Usually within 5-10 business days of initial submission
Common requests: Additional wound photos, specialist letters, or clarification of surgical plans

Step 5: Receive Decision (Days 15-30)

Standard timeline: Up to 15 business days for non-urgent requests
Expedited timeline: 24-72 hours when clinical urgency is documented

Understanding Aetna's Coverage Criteria

Medical Necessity Requirements

StrataGraft is considered medically necessary when:

  • Patient is 18 years or older
  • Diagnosed with deep partial-thickness thermal burns containing intact dermal elements
  • Surgical intervention (excision and grafting) is clinically indicated
  • Treatment prescribed by or in consultation with a burn specialist
  • No known allergies to murine collagen, bovine, or porcine products
  • Wound size falls within approved parameters (up to 2000 cm² per treatment site)
  • Request is for one-time application only

Exclusion Criteria

StrataGraft will NOT be covered for:

  • Full-thickness burns
  • Chronic or non-thermal wounds
  • Burns on face, head, neck, hands, feet, buttocks, or over joints
  • Patients who are pregnant, immunosuppressed, or have active infections at treatment sites
  • Pediatric patients (under 18)

Common Denial Reasons & Solutions

Denial Reason How to Address Required Documentation
Insufficient clinical documentation Submit complete wound assessment with photos and measurements Burn specialist consultation, clinical photos, TBSA calculations
Not meeting step therapy requirements Document contraindications or failures with standard treatments Prior treatment history, reasons autograft isn't suitable
Incorrect billing pathway Ensure facility medical benefit billing, not pharmacy Confirm J7353 HCPCS code and medical benefit submission
Off-label use request Confirm FDA-approved indication alignment Diagnosis confirmation for deep partial-thickness thermal burns
Missing surgical justification Provide detailed surgical plan and necessity rationale Burn surgeon attestation of surgical indication

Virginia Appeals Process

If Aetna denies your StrataGraft request, Virginia provides multiple appeal options with specific timelines and protections.

Internal Appeals with Aetna

Timeline: Must be filed within 60 days of denial notice
Decision timeframe: 30 days for standard appeals, 72 hours for expedited
How to file: Aetna member portal, phone, or written request

Virginia External Review Process

Virginia's State Corporation Commission Bureau of Insurance offers binding external review for medical necessity denials.

Key Details:

  • Deadline: 120 days from Aetna's final denial
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Cost: Free to Virginia residents
  • Forms: Form 216-A (standard) or Form 216-C (expedited)
  • Contact: (804) 371-9915 fax, [email protected]

Required for External Review:

  • Completed external review form
  • Copy of Aetna's denial letter
  • Insurance card copy
  • Signed medical records release
  • Supporting clinical documentation
Note: The external review decision is binding on Aetna. If approved, Aetna must provide coverage within 1-3 days.

Expedited Review Criteria

Request expedited review if your physician certifies that waiting would:

  • Seriously jeopardize your life or health
  • Jeopardize your ability to regain maximum function
  • Subject you to severe pain that cannot be adequately managed

Timeline Expectations

Standard Prior Authorization Timeline

  • Submission to decision: 15 business days
  • Information requests: Additional 5-10 days
  • Total process: 20-25 business days typically

Expedited Prior Authorization

  • Clinical urgency required: Life-threatening or limb-threatening situations
  • Decision timeline: 24-72 hours
  • Documentation needed: Physician certification of urgency

Appeals Timeline in Virginia

  • Internal appeal: 30 days from filing
  • External review: 45 days from filing (72 hours if expedited)
  • Implementation: 1-3 days after approval

Cost Considerations

StrataGraft is a facility-billed product with costs typically covered under your medical benefit's inpatient or outpatient procedure coverage. Specific cost-sharing depends on your plan design.

Potential out-of-pocket costs:

  • Deductible amounts (if not yet met)
  • Coinsurance percentage for facility procedures
  • Copayments for specialist consultations

Financial assistance options:

  • Hospital charity care programs
  • Mallinckrodt expanded access programs (for clinical trial participants)
  • State and local burn foundation grants
From our advocates: "We've seen patients successfully appeal StrataGraft denials by emphasizing the one-time nature of the treatment and providing compelling before-and-after wound photos. The key is showing why standard autografting wouldn't achieve the same functional outcome. This approach helped overturn denials even when initial PA requests were incomplete."

FAQ: StrataGraft Coverage in Virginia

Q: How long does Aetna's prior authorization take in Virginia?
A: Standard PA decisions take up to 15 business days. Expedited reviews (when clinical urgency is documented) are completed within 24-72 hours.

Q: What if StrataGraft isn't on Aetna's formulary?
A: StrataGraft isn't a pharmacy benefit drug—it's billed as a facility procedure. Formulary status doesn't apply; medical necessity criteria determine coverage.

Q: Can I request an expedited appeal in Virginia?
A: Yes. Both Aetna internal appeals and Virginia external reviews offer expedited processes when your physician certifies that delays would jeopardize your health.

Q: What happens if my burn center isn't in Aetna's network?
A: You may request a network exception if no in-network facility offers StrataGraft treatment. Document the lack of in-network alternatives.

Q: Does step therapy apply to StrataGraft?
A: Aetna may require documentation of why standard autografting isn't suitable. This isn't traditional step therapy but rather medical necessity justification.

Q: How many StrataGraft applications will Aetna cover?
A: Coverage is typically for one-time application per burn event. Additional applications require separate medical necessity review.

Q: What if I have both Medicare and Aetna coverage?
A: Coordination of benefits rules apply. Medicare may be primary for the facility procedure, with Aetna potentially covering secondary costs.

Q: Can family members help with the appeals process?
A: Yes, but you'll need to complete an authorized representative form allowing them to speak with Aetna and Virginia regulators on your behalf.

When to Contact Virginia Regulators

Contact the Virginia State Corporation Commission Bureau of Insurance if:

  • Aetna violates appeal timelines
  • You receive inadequate denial explanations
  • You need guidance on external review eligibility
  • You suspect unfair claims practices

Contact Information:

The Bureau can provide informal resolution assistance and ensure compliance with Virginia insurance laws.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based advocacy. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, identifying coverage gaps, and crafting targeted rebuttals aligned with payer policies. For challenging cases like StrataGraft coverage, having expert support can make the difference between denial and approval.

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 terms, medical circumstances, and current payer policies. Always verify current requirements directly with your insurer and consult with qualified healthcare providers about treatment decisions. For personalized assistance with complex appeals, consider consulting with healthcare advocates or attorneys specializing in insurance coverage disputes.

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