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

Getting StrataGraft Covered by UnitedHealthcare in Texas: Prior Authorization Guide, Appeals Process, and Alternative Options

Answer Box: Getting StrataGraft Covered in Texas

StrataGraft requires prior authorization from UnitedHealthcare as a medical benefit (not pharmacy). Submit PA through the UHC Provider Portal with burn depth documentation, TBSA calculations, and clinical justification that autografting would otherwise be needed. Standard decisions take 5-15 business days; expedited reviews (24-72 hours) available for urgent cases. If denied, Texas residents can appeal through UHC's internal process, then request external review through an Independent Review Organization. Start with UHC Provider Portal or call provider services to verify current PA requirements.

Table of Contents

  1. When StrataGraft Alternatives Make Sense
  2. Typical Alternatives by Category
  3. Coverage Considerations: Pros and Cons
  4. Exception Strategy for StrataGraft
  5. Switching Logistics and Care Coordination
  6. Re-trying for StrataGraft Later
  7. Texas Appeals Process
  8. FAQ

When StrataGraft Alternatives Make Sense

StrataGraft (allogeneic cultured keratinocytes & fibroblasts in murine collagen-dsat) is FDA-approved specifically for deep partial-thickness thermal burns in adults when autografting is clinically indicated. However, UnitedHealthcare may initially deny coverage or require step therapy with other burn treatments.

Alternative approaches make clinical sense when:

  • Initial PA is denied and immediate treatment is needed
  • Step therapy requirements mandate trying other covered options first
  • Patient factors (immunosuppression, diabetes) create contraindications to StrataGraft
  • Burn characteristics fall outside FDA labeling (pediatric, full-thickness, non-thermal)

Coverage Availability by Treatment Type

UnitedHealthcare's Skin and Soft Tissue Substitutes policy governs most biologic alternatives, while traditional surgical options follow standard burn care coverage.

Note: Always verify current formulary status through the UHC Provider Portal, as policies update frequently.

Typical Alternatives by Category

Enzymatic Debridement Options

NexoBrid (bromelain-based)

  • Indication: FDA-approved for eschar removal in deep partial and full-thickness burns
  • Mechanism: Selective enzymatic debridement to preserve viable dermis
  • Coverage: Generally covered with PA when used within FDA labeling
  • Clinical role: May convert graft-requiring wounds to those manageable with advanced dressings

Autologous Cell-Based Treatments

RECELL System

  • Indication: FDA-approved for partial-thickness thermal burns in adults ≥18
  • Mechanism: Spray suspension of autologous skin cells from small biopsy
  • Coverage: Medicare and commercial plans typically cover with appropriate documentation
  • Clinical role: Reduces donor site requirements; 96% of patients avoid traditional grafting in suitable burns

Traditional Surgical Options

Split-Thickness Skin Grafts (STSG)

  • Standard of care for deep partial-thickness burns requiring surgery
  • Coverage: Universally covered when medically necessary
  • Considerations: Donor site morbidity, limited donor skin in large burns

Dermal Substitutes + Grafting

  • Options: Integra, AlloDerm, Matriderm, NovoSorb BTM
  • Coverage: Variable; many covered with PA for specific indications
  • Clinical role: Two-stage process requiring subsequent grafting

Advanced Wound Care

Biologic Dressings

  • Options: Fish skin (acellular), porcine xenografts, synthetic matrices
  • Coverage: Most covered as wound care supplies
  • Clinical role: Temporary coverage while awaiting definitive treatment

Coverage Considerations: Pros and Cons

Access Considerations

Treatment Category Coverage Likelihood PA Requirements Typical Restrictions
Traditional STSG Universal None Must meet surgical criteria
RECELL System High with docs Yes Age ≥18, thermal burns only
NexoBrid High with PA Yes FDA labeling compliance
StrataGraft Variable Yes Deep partial-thickness, thermal, adult
Advanced dressings High Minimal Wound care protocols

Testing and Monitoring Requirements

StrataGraft-Specific:

  • Pre-treatment: Wound depth assessment, TBSA calculation, infection screening
  • Post-treatment: Weekly wound assessments, 3-month durable closure evaluation
  • Documentation: Comparative photos, healing progression, autograft avoidance

Alternative Treatments:

  • RECELL: Cell viability testing, spray application technique training
  • NexoBrid: Allergy screening, controlled application protocols
  • Traditional grafts: Donor site assessment, graft take evaluation
Tip: Maintain detailed photo documentation throughout treatment to support future StrataGraft requests or appeals.

Exception Strategy for StrataGraft

When to Request an Exception

File a formulary exception or medical necessity appeal when:

  1. Standard alternatives have failed or are contraindicated
  2. Limited donor sites make traditional grafting high-risk
  3. Functional/cosmetic considerations (face, hands, joints) favor autograft-sparing approach
  4. Patient factors (elderly, multiple comorbidities) increase surgical risks

Evidence That Strengthens Appeals

Clinical Documentation:

  • Wound depth confirmation via clinical assessment or biopsy
  • TBSA calculations with anatomic diagrams
  • Prior treatment failures with dates, doses, and outcomes
  • Contraindications to formulary alternatives

Supporting Literature:

  • FDA approval documentation showing 96% autograft avoidance
  • Phase 3 STRATA2016 trial data: 83.1% durable closure without autografting
  • Peer-reviewed publications on StrataGraft efficacy in deep partial-thickness burns

Medical Necessity Letter Template

Include these key elements:

  • Patient demographics and burn mechanism
  • Clinical assessment: "Deep partial-thickness thermal burn, [X]% TBSA, requiring surgical intervention"
  • Standard care rationale: "Patient would typically require excision and split-thickness autografting"
  • StrataGraft justification: "FDA-approved alternative shown to achieve comparable closure (83.1%) while eliminating autograft need in 96% of cases"
  • Alternative contraindications: Document why other covered options are inappropriate

Switching Logistics and Care Coordination

Medical vs. Pharmacy Benefit Coordination

StrataGraft Classification:

  • Billed as medical benefit (facility/physician claim)
  • Requires operating room application during surgical procedure
  • Uses facility-specific HCPCS codes, not retail pharmacy dispensing

Care Team Coordination:

  • Plastic/burn surgeons: Primary prescribers and applicators
  • Wound care specialists: Pre- and post-treatment assessment
  • Hospital utilization management: PA submission and approval tracking
  • Revenue cycle: Medical benefit billing, not pharmacy claims

Switching from Alternatives

From Advanced Dressings:

  • Document inadequate healing progression over 2-3 weeks
  • Photograph wound bed preparation and depth assessment
  • Justify need for definitive closure intervention

From Other Biologics:

  • Detail specific failures (poor integration, infection, inadequate coverage)
  • Compare mechanisms of action and suitability for patient's burn characteristics
  • Highlight StrataGraft's unique bilayer construct advantages
Clinician Corner: When switching treatments, maintain continuity in wound bed preparation and infection control. StrataGraft requires a clean, well-vascularized wound bed for optimal integration.

Counterforce Health Support

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform ingests denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to UnitedHealthcare's specific coverage criteria. For complex StrataGraft cases involving prior authorization or appeals, their system can identify the denial basis and pull relevant FDA labeling, peer-reviewed studies, and clinical documentation requirements.

Re-trying for StrataGraft Later

Documentation During Alternative Trials

Track Key Metrics:

  • Healing progression: Weekly wound measurements and photos
  • Complications: Infection rates, graft failures, donor site issues
  • Functional outcomes: Range of motion, pain scores, return to activities
  • Resource utilization: OR time, length of stay, readmissions

Build Your Case:

  • Treatment failures: "Patient failed to achieve closure with [alternative] after [timeframe]"
  • Complications: "Developed [specific issue] requiring additional interventions"
  • Quality of life impact: Document functional limitations or cosmetic concerns
  • Economic factors: Calculate total costs of failed alternatives vs. StrataGraft

Optimal Timing for Re-request

Clinical Windows:

  • After documented failure of initial alternative (typically 3-4 weeks)
  • Before wound deterioration requires more extensive intervention
  • When patient condition stabilizes and surgical risks are acceptable

Administrative Timing:

  • After internal appeal resolution (if initial denial was appealed)
  • With new clinical documentation supporting changed circumstances
  • When policy updates may have expanded coverage criteria

Texas Appeals Process

UnitedHealthcare Internal Appeals

Level 1 - Standard Internal Appeal:

  • Deadline: 180 days from denial notification
  • Timeline: 30 days for pre-service requests, 60 days for post-service
  • Submission: UHC Provider Portal or member services
  • Required: Original denial letter, enhanced clinical documentation, prescriber letter

Level 2 - Expedited Review:

  • When available: Urgent medical situations where delay could harm health
  • Timeline: 24-72 hours for decision
  • Justification required: Physician statement of urgency and potential harm from delay

Texas External Review Process

If UnitedHealthcare denies internal appeals, Texas law provides Independent Review Organization (IRO) review:

Eligibility:

  • Denial based on medical necessity, appropriateness, or experimental/investigational classification
  • Completed UHC internal appeal process
  • Request filed within 4 months of final internal denial

Process:

  • Cost: Paid by UnitedHealthcare, no patient expense
  • Timeline: 20 days standard, 5 days for urgent cases
  • Decision: Binding on UnitedHealthcare if overturned
  • Scope: Medical necessity and clinical appropriateness

Texas Resources for Assistance

Texas Department of Insurance (TDI):

Office of Public Insurance Counsel (OPIC):

  • Help line: 1-877-611-6742
  • Detailed appeals guidance and consumer advocacy
Note: ERISA self-funded employer plans, Medicare, and Medicaid follow federal appeal rules, not Texas state IRO process.

FAQ

How long does UnitedHealthcare prior authorization take for StrataGraft in Texas? Standard PA decisions typically take 5-15 business days with complete documentation. Expedited reviews for urgent burn cases can be completed within 24-72 hours when justified by clinical urgency.

What if StrataGraft is considered experimental by UnitedHealthcare? Appeal with FDA approval documentation and Phase 3 trial data showing 96% autograft avoidance and 83.1% durable closure rates. Emphasize FDA's RMAT and orphan drug designations supporting clinical necessity.

Can I request expedited appeal for burn treatment? Yes, if delay would jeopardize health or limb function. Provide physician documentation of urgency and potential harm from treatment delays. Texas allows concurrent expedited internal and external reviews when appropriate.

Does step therapy apply to StrataGraft in burn treatment? UnitedHealthcare may require documentation of why standard autografting or other covered skin substitutes are inappropriate. Unlike chronic wound treatments, acute burn care often bypasses typical step therapy due to time-sensitive nature.

What documentation strengthens a StrataGraft appeal? Include burn depth assessment, TBSA calculations, clinical photos, treatment history, contraindications to alternatives, and peer-reviewed evidence. Reference FDA labeling and clinical trial outcomes showing comparable efficacy to autografting.

How does medical vs. pharmacy benefit affect StrataGraft coverage? StrataGraft is typically covered under medical benefits as a surgical procedure, not pharmacy benefits. This means facility-based PA submission and billing, with different appeal processes than retail pharmacy denials.

What alternatives does UnitedHealthcare typically prefer for deep partial-thickness burns? Standard split-thickness skin grafts remain first-line. Other covered options may include RECELL system, NexoBrid for debridement, and various dermal substitutes depending on specific plan formulary.

Can I appeal to Texas state regulators if UnitedHealthcare denies StrataGraft? For state-regulated plans, yes. Complete UHC's internal appeals first, then request IRO review through Texas Department of Insurance. Federal plans (ERISA, Medicare, Medicaid) follow different appeal processes.

This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about appropriate treatment options and work with your insurance company to understand your specific coverage. For additional support with complex appeals, Counterforce Health offers specialized assistance in turning insurance denials into evidence-backed appeals.

Disclaimer: This information is for educational purposes only and does not constitute medical, legal, or insurance advice. Coverage policies change frequently; always verify current requirements with UnitedHealthcare and consult healthcare professionals for clinical decisions.

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