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

How to Get StrataGraft Approved by Aetna CVS Health in Pennsylvania: Timeline, Appeals, and Prior Authorization Guide

Answer Box: Getting StrataGraft Covered by Aetna CVS Health in Pennsylvania

Fastest path to approval: Submit prior authorization through Aetna's provider portal with complete burn documentation, medical necessity letter, and clinical photos within 3-5 days of assessment. StrataGraft requires PA as a facility-billed medical benefit (not pharmacy). If denied, Pennsylvania's new external review program overturns ~50% of denials. First step: Verify you have a fully insured (not self-funded) Aetna plan and gather burn surgeon documentation showing deep partial-thickness thermal burns where autograft is clinically indicated.

Table of Contents

  1. What Affects StrataGraft Approval Timing
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Additional Information Requests (1-7 Days)
  5. Decision Window and Outcomes
  6. If Denied: Pennsylvania Appeals Process
  7. Renewal Cycles and Re-Authorization
  8. Timeline Visual and Milestones
  9. Time-Saving Tips for Faster Approval

What Affects StrataGraft Approval Timing

Several factors determine how quickly Aetna CVS Health approves StrataGraft in Pennsylvania:

Benefit Type: StrataGraft is billed as a medical benefit (HCPCS J7353 or facility-specific codes), not through CVS Caremark specialty pharmacy. This means approval goes through Aetna's medical utilization management, not pharmacy benefits.

Complexity of Criteria: Aetna requires documentation that the patient is an adult (≥18 years) with deep partial-thickness thermal burns where autografting is clinically indicated. The more complete your initial submission, the faster the review.

Documentation Completeness: Missing burn measurements, clinical photos, or inadequate justification for why autograft isn't appropriate causes delays. Aetna's Skin and Soft Tissue Substitutes Policy (CPB 0244) requires specific clinical elements.

Note: Pennsylvania's strengthened insurance appeals system means if Aetna denies coverage, you have robust state-level review options with a 50% success rate for overturning denials.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

From the Burn Surgeon (Required):

  • Detailed burn assessment with total body surface area (TBSA) percentage
  • Wound measurements in square centimeters for each proposed StrataGraft site
  • Clinical photographs with measurement scales visible
  • ICD-10 burn codes from T21-T31 series (burn by site + extent codes)
  • Justification why autograft is not viable (insufficient donor sites, hemodynamic instability, etc.)
  • Confirmation of no active wound infection (culture results or clinical assessment)
  • Operative plan confirming complete excision and hemostasis before placement

Facility Requirements:

  • Confirm burn center is accredited and in-network with Aetna
  • Verify surgeon is board-certified in burns or plastic surgery
  • Check current Aetna precertification lists for StrataGraft requirements

Verify Plan Type

Contact your HR department or call the number on your Aetna card to confirm:

  • Is this a fully insured or self-funded plan?
  • What's your exact Aetna product (commercial, Medicare Advantage, or Aetna Better Health PA)?

This determines which appeals process you'll use if denied.

Submission to Initial Review (1-5 Days)

Pennsylvania-Specific Submission Process

For Aetna Commercial/Medicare Plans:

  • Submit through Aetna provider portal (preferred method)
  • Include all documentation from the checklist above
  • Request expedited review if surgical timing is critical

For Aetna Better Health Pennsylvania (Medicaid/CHIP):

What Reviewers Check First

Aetna's initial review focuses on:

  1. Age verification (≥18 years for StrataGraft approval)
  2. Burn type (must be deep partial-thickness thermal burns)
  3. Clinical indication for surgical intervention
  4. Provider credentials and facility accreditation
  5. Network status of treating facility and surgeon

Additional Information Requests (1-7 Days)

If Aetna requests more information, respond within 24-48 hours to avoid delays. Common requests include:

Missing Documentation:

  • More detailed wound measurements or photos
  • Clearer justification why autograft isn't appropriate
  • Additional burn depth assessment
  • Infection status confirmation

Clinical Clarifications:

  • Total area requiring StrataGraft treatment
  • Expected number of applications needed
  • Timeline for surgical intervention
  • Post-operative monitoring plan
Tip: Prepare responses to common questions in advance. Keep digital copies of all burn photos, measurements, and clinical notes readily accessible.

Decision Window and Outcomes

Typical Timeline Expectations

Review Type Standard Timeline Expedited Timeline
Commercial Plans 7-10 business days 2-3 business days
Medicare Advantage ≤72 hours (urgent) ≤24 hours
Aetna Better Health PA Per state Medicaid rules Expedited available

Reading Your Approval Letter

If Approved: The letter will specify:

  • Approved amount/area of StrataGraft
  • Valid dates for treatment
  • Any special conditions or requirements
  • Your expected cost-sharing (deductible/coinsurance)

If Denied: Look for the specific reason:

  • "Not medically necessary"
  • "Experimental/investigational"
  • "Step therapy required"
  • "Non-formulary status"

If Denied: Pennsylvania Appeals Process

Pennsylvania's Independent External Review Program launched in 2024 and has overturned approximately 50% of insurance denials in its first year.

Step 1: Internal Appeals with Aetna

Timeline: Must complete within 180 days of denial Process:

  • File through Aetna's member portal or provider appeal process
  • Include additional clinical evidence supporting StrataGraft necessity
  • Request peer-to-peer review with a burn specialist

Step 2: Pennsylvania External Review (If Eligible)

Eligibility: Fully insured commercial plans (not self-funded employer plans) Timeline: Request within 4 months of final internal denial Process:

  1. File online at pa.gov external review portal (verify current link)
  2. Submit final denial letter and supporting documentation
  3. Wait for Independent Review Organization (IRO) assignment
  4. Submit additional evidence within 15 business days of IRO assignment
  5. Receive binding decision within 45 calendar days

Contact for Help: Pennsylvania Insurance Department Consumer Services at 1-877-881-6388

Expedited Appeals for Urgent Cases

If delaying StrataGraft treatment could worsen burn outcomes:

  • Request expedited internal appeal with Aetna
  • If denied, request expedited external review through Pennsylvania
  • Include physician documentation of urgent medical need
  • Decisions typically within 72 hours for expedited cases

Renewal Cycles and Re-Authorization

StrataGraft is typically a single-use treatment applied during one surgical procedure, so ongoing renewals aren't usually required. However:

If Additional Treatment Needed:

  • New prior authorization required for additional burn sites
  • Must demonstrate medical necessity for each application
  • Document outcomes from previous StrataGraft use

What Speeds Renewals:

  • Clear documentation of treatment success
  • Evidence that additional sites meet same criteria as initial approval
  • Updated burn assessment and photos

Timeline Visual and Milestones

Day 0-2:    Gather Documentation
Day 1-5:    Submit PA Request
Day 5-12:   Aetna Review & Decision
Day 13-30:  Internal Appeal (if denied)
Day 31-150: PA External Review Process
Day 151+:   Binding IRO Decision

Expected Ranges by Milestone

Milestone Best Case Typical Complex Case
Documentation Gathering 1 day 2 days 3-5 days
PA Submission Processing 3 days 7 days 10+ days
Internal Appeal 15 days 30 days 45 days
External Review 45 days 60 days 90 days

Time-Saving Tips for Faster Approval

Portal Usage Best Practices

  • Use Aetna's provider portal for fastest processing
  • Upload all documents in a single submission
  • Follow naming conventions for uploaded files
  • Track submission confirmation numbers

Bundled Evidence Strategy

  • Submit comprehensive documentation upfront
  • Include peer-reviewed literature supporting StrataGraft use
  • Provide clear before/after treatment plans
  • Attach relevant clinical guidelines citations

Direct Specialty Routing

  • Ensure requests go to Aetna's burn/wound specialty reviewers
  • Request peer-to-peer with board-certified burn specialist
  • Emphasize time-sensitive nature of burn treatment
  • Use expedited pathways when clinically appropriate
From our advocates: "We've seen the strongest approvals when burn surgeons include detailed photos with measurement scales and explain exactly why the patient isn't a candidate for traditional autografting. The more specific the clinical rationale, the faster Aetna typically approves the request."

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Provide detailed burn assessment TBSA measurements, depth analysis, photos
"Experimental treatment" Cite FDA approval and clinical data FDA labeling, peer-reviewed studies
"Step therapy required" Document autograft contraindications Medical reasons why autograft isn't suitable
"Insufficient documentation" Submit complete clinical package All items from preparation checklist

Costs and Patient Support

Manufacturer Support: Contact Mallinckrodt for potential patient assistance programs Facility Financial Counseling: Most burn centers offer payment plan options Pennsylvania Resources: State insurance consumer assistance available through Pennsylvania Insurance Department

When to Escalate to State Regulators

Contact the Pennsylvania Insurance Department if:

  • Aetna exceeds review timelines without explanation
  • You're unable to access the external review process
  • There are procedural violations in the appeals process
  • You need help understanding your rights under Pennsylvania law

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each insurer's specific requirements. We've helped secure coverage for complex specialty treatments by providing the clinical documentation and procedural expertise that payers expect.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Pennsylvania? Standard reviews typically take 7-10 business days for commercial plans, with expedited options available for urgent cases requiring decisions within 72 hours.

What if StrataGraft is considered experimental by Aetna? StrataGraft received FDA approval in June 2021 for deep partial-thickness thermal burns in adults. Include FDA labeling and approval documentation in your appeal to counter experimental/investigational denials.

Can I request an expedited appeal if my burn treatment is time-sensitive? Yes. Both Aetna's internal process and Pennsylvania's external review offer expedited pathways when delays could jeopardize health outcomes. Your physician must document the urgent medical need.

Does step therapy apply if I've tried other treatments outside Pennsylvania? Prior treatment history from other states should be documented and submitted with your PA request. Aetna's step therapy requirements are national, not state-specific.

What happens if my employer plan is self-funded? Self-funded plans don't fall under Pennsylvania's external review program. You'd need to use the federal external review process or your plan's specific ERISA appeal procedures.

How much will StrataGraft cost me if approved? Costs depend on your specific plan's medical benefit structure. Expect to pay your facility deductible plus coinsurance (typically 10-30% for in-network care), not pharmacy copays.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by individual plan and circumstances. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. For personalized help with appeals and prior authorizations, consider working with experienced healthcare advocates like Counterforce Health.

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