Getting StrataGraft Covered by Aetna CVS Health in Texas: Prior Authorization, Appeals & Cost-Saving Strategies
Answer Box: Getting StrataGraft Covered by Aetna CVS Health in Texas
StrataGraft requires prior authorization through Aetna's medical benefit (not pharmacy) for adults with deep partial-thickness thermal burns. The fastest path: 1) Confirm your burn meets FDA criteria with your physician, 2) Submit prior authorization with complete medical documentation to Aetna before treatment, 3) If denied, file internal appeal within 180 days, then external review through Texas IRO if needed. Start today: Contact your burn center's billing department to initiate the prior authorization process, as StrataGraft is facility-billed, not dispensed through CVS Caremark or specialty pharmacies.
Table of Contents
- What Drives StrataGraft Costs
- Investigating Your Aetna Benefits
- Prior Authorization Requirements
- Cost Assistance Options
- Appeals Process in Texas
- Medical Necessity Documentation
- Common Denial Reasons & Solutions
- When to Escalate
- FAQ
What Drives StrataGraft Costs
StrataGraft (allogeneic cultured keratinocytes & fibroblasts in murine collagen-dsat) is a tissue-engineered skin substitute that costs significantly more than traditional burn treatments. Understanding how Aetna structures coverage helps you navigate the approval process effectively.
Key Cost Factors:
- Facility-based billing: Unlike typical medications, StrataGraft is billed through your hospital's medical benefit, not the pharmacy benefit
- Prior authorization requirement: All Aetna plans require pre-approval with detailed clinical documentation
- Medical necessity criteria: Coverage depends on meeting specific FDA-approved indications for deep partial-thickness thermal burns in adults
- Single-use limitation: Most policies cover one application per burn episode
Note: StrataGraft cannot be obtained through CVS Caremark, Aetna Specialty Pharmacy, or any retail pharmacy. It's supplied directly to approved burn centers and hospitals.
Investigating Your Aetna Benefits
Before pursuing StrataGraft coverage, gather essential information about your specific Aetna plan benefits.
Information to Collect:
- Plan type: Commercial, Medicare Advantage, or ACA marketplace plan
- Medical benefit deductible: How much you'll pay before coverage begins
- Coinsurance percentage: Your share after deductible is met
- Out-of-network penalties: Whether your burn center is in Aetna's network
- Prior authorization status: Confirm StrataGraft requires pre-approval (it does for all Aetna plans)
Where to Find This Information:
- Aetna member portal at aetna.com
- Your Summary of Benefits and Coverage (SBC) document
- Member services phone line on your insurance card
Prior Authorization Requirements
Aetna requires prior authorization for StrataGraft under their Clinical Policy Bulletin 0244 covering skin substitutes.
Coverage at a Glance
| Requirement | What It Means | Documentation Needed |
|---|---|---|
| Age restriction | Patient must be 18+ years old | Date of birth verification |
| Diagnosis | Deep partial-thickness thermal burns with intact dermal elements | Clinical assessment, photos, burn depth documentation |
| Surgical indication | Provider attestation that surgical intervention is clinically indicated | Letter from burn specialist |
| Allergy screening | No allergy to murine, bovine, or porcine products | Medical history review |
| Facility billing | Must be billed as medical procedure, not pharmacy | Correct billing codes (J7353) |
Step-by-Step: Fastest Path to Approval
- Clinical Assessment (Physician): Document burn depth, location, and percentage of total body surface area affected
- Prior Authorization Submission (Facility): Submit request with complete medical records to Aetna medical management
- Review Period (Aetna): Standard review takes 10-14 business days; expedited review available for urgent cases
- Approval Notification (Aetna): Receive written authorization before scheduling StrataGraft application
- Treatment Scheduling (Facility): Coordinate StrataGraft delivery with approved treatment date
- Billing Submission (Facility): Submit claims using appropriate medical codes after treatment
- Follow-up (Patient): Monitor EOB statements and coordinate any additional appeals if needed
Cost Assistance Options
Unfortunately, Mallinckrodt (StrataGraft's manufacturer) does not currently offer a patient assistance program or copay card specifically for StrataGraft. However, other options may help reduce your financial burden.
Available Assistance:
- Hospital charity care programs: Many burn centers offer financial assistance based on income
- Payment plans: Negotiate extended payment terms with your facility's billing department
- Foundation grants: Organizations like the National Burn Foundation may provide emergency assistance
- Clinical trials: Some patients may qualify for expanded access programs at participating centers
From our advocates: We've seen families successfully negotiate payment plans that spread StrataGraft costs over 12-24 months with zero interest. Start these conversations early—before treatment when possible—as billing departments are often more flexible with proactive patients than those already in collections.
When traditional assistance isn't available, Counterforce Health helps patients and providers build stronger prior authorization requests and appeals by analyzing denial patterns and crafting evidence-based responses that address payers' specific concerns.
Appeals Process in Texas
Texas provides strong patient protections for insurance appeals, with specific timelines and an independent external review process.
Internal Appeals Timeline
Standard Appeal:
- Deadline to file: 180 days from denial date
- Aetna decision timeline: 30 days for pre-service requests, 60 days for post-service
- Required documentation: Original denial letter, medical records, physician letter of support
Expedited Appeal:
- When to use: Life-threatening situations or urgent medical needs
- Decision timeline: 72 hours maximum
- Filing method: Call Aetna member services immediately, follow up in writing
External Review (IRO) Process
If Aetna denies your internal appeal, Texas law provides access to an Independent Review Organization (IRO).
Key Details:
- Deadline: 4 months from final internal denial
- Review timeline: 15 working days (standard), 72 hours (urgent)
- Cost: Free to patients—Aetna pays the IRO fee
- Decision: Binding on Aetna if overturned
Texas Resources:
- Texas Department of Insurance: (800) 252-3439
- IRO information line: (866) 554-4926
- Office of Public Insurance Counsel: (877) 611-6742
Medical Necessity Documentation
Strong medical necessity documentation significantly improves approval chances. Your burn specialist should include these elements in their prior authorization request:
Required Clinical Documentation
Patient Information:
- Age verification (18+ years required)
- Burn mechanism and date of injury
- Total body surface area (TBSA) affected
- Burn depth assessment with photos
Medical Justification:
- Why surgical intervention is clinically indicated
- How StrataGraft will reduce or eliminate need for autograft harvesting
- Absence of contraindications (allergies, active infection)
- Treatment goals and expected outcomes
Supporting Evidence:
- FDA labeling supporting use for deep partial-thickness thermal burns
- Clinical trial data showing equivalent outcomes to autograft
- Burn center protocols incorporating StrataGraft
Common Denial Reasons & Solutions
| Denial Reason | How to Overturn |
|---|---|
| "Experimental/Investigational" | Cite FDA approval (June 2021) and include FDA label documentation |
| "Not medically necessary" | Provide detailed burn assessment showing surgical indication and StrataGraft appropriateness |
| "Alternative treatments available" | Document why autograft is suboptimal (donor site morbidity, patient factors) |
| "Pharmacy benefit billing" | Redirect to medical benefit with proper facility billing codes |
| "Insufficient documentation" | Submit complete medical records, photos, and specialist attestation |
When to Escalate
Contact Texas regulators if you experience unreasonable delays or denials that don't follow proper procedures.
Texas Department of Insurance:
- Phone: (800) 252-3439
- Website: tdi.texas.gov
- File complaints online for processing delays or procedural violations
When to escalate:
- Aetna misses appeal deadlines
- Denials lack medical review
- Procedural requirements aren't followed
- IRO decisions aren't implemented
For complex cases involving multiple denials or systemic issues, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals that address payers' specific coverage criteria and procedural requirements.
FAQ
How long does Aetna prior authorization take for StrataGraft in Texas? Standard prior authorization takes 10-14 business days. Expedited reviews for urgent burn cases are completed within 72 hours.
What if StrataGraft is considered non-formulary by Aetna? StrataGraft is covered as a specialty medical procedure, not a formulary drug. Coverage depends on meeting medical necessity criteria under Aetna's skin substitute policy.
Can I request an expedited appeal for burn treatment? Yes. Texas law requires expedited appeals for life-threatening conditions to be decided within 72 hours. Severe burns often qualify for expedited review.
Does step therapy apply to StrataGraft? Step therapy typically doesn't apply to surgical procedures like StrataGraft. However, Aetna may require documentation that conservative treatments were attempted first.
What happens if my burn center isn't in Aetna's network? Out-of-network treatment may require higher cost-sharing. However, if no in-network burn center offers StrataGraft, you may request an exception for in-network coverage rates.
How much will I pay out-of-pocket for StrataGraft? Costs depend on your specific plan's deductible and coinsurance. Since StrataGraft is facility-billed, expect costs similar to other inpatient/outpatient surgical procedures.
Can I appeal if I'm already receiving treatment? Yes. You can file post-service appeals up to 180 days after receiving your Explanation of Benefits (EOB) showing the denial or unexpected charges.
What if Aetna requests peer-to-peer review? Your burn specialist can participate in a peer-to-peer call with Aetna's medical director. This often resolves coverage issues when clinical expertise is directly communicated.
Counterforce Health transforms the complex world of insurance approvals into clear, actionable strategies. Our platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. We analyze denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's own rules. Learn more at counterforcehealth.org.
Sources & Further Reading
- Aetna Clinical Policy Bulletin 0244 - Skin Substitutes
- Aetna 2024 Specialty Drug List
- Texas Department of Insurance Appeals Information
- StrataGraft FDA Prescribing Information
- Office of Public Insurance Counsel - Texas
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan, and requirements may change. Always verify current policies with your insurer and consult with qualified healthcare professionals regarding treatment decisions. For personalized assistance with insurance appeals and prior authorizations, consider consulting with healthcare advocates or legal professionals experienced in insurance matters.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.