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

How to Get StrataGraft Covered by Humana in New Jersey: Prior Authorization Guide and Appeals Process

Answer Box: Quick Path to StrataGraft Coverage

StrataGraft requires prior authorization from Humana Medicare Advantage plans in New Jersey for adults with deep partial-thickness thermal burns. Key steps: 1) Confirm diagnosis with ICD-10 codes T21-T31, 2) Submit PA request via Humana provider portal using HCPCS J7353 with wound measurements and clinical photos, 3) If denied, file internal appeal within 65 days, then pursue New Jersey's IHCAP external review within 180 days. Timeline: Standard PA decision in 15 business days; expedited review available for urgent cases within 24 hours.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Requirements
  3. If You're Likely Eligible
  4. If You're Possibly Eligible
  5. If You're Not Yet Eligible
  6. If Your Request is Denied
  7. Appeals Playbook for New Jersey
  8. Common Denial Reasons & Solutions
  9. FAQ
  10. Resources

How to Use This Guide

This guide helps patients and clinicians navigate StrataGraft coverage through Humana Medicare Advantage plans in New Jersey. StrataGraft (allogeneic cultured keratinocytes & fibroblasts in murine collagen-dsat) is an FDA-approved tissue-engineered product for treating deep partial-thickness thermal burns in adults.

Before you start, gather:

  • Insurance card and policy details
  • Complete burn assessment with measurements
  • Clinical photographs with scale
  • Documentation of prior treatments
  • Any previous denial letters

Eligibility Requirements

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all requests Humana Provider Manual
Age Restriction Adults 18+ only FDA Label
Diagnosis Deep partial-thickness thermal burns (ICD-10: T21-T31) FDA Approval
Billing Code HCPCS J7353 (per square centimeter) CMS Coverage Database
Setting Accredited burn center or qualified facility Humana Medical Policy
Step Therapy May require trial of alternatives (2025) Humana Step Therapy List

Medical Necessity Criteria

You likely qualify if:

  • Adult patient with confirmed deep partial-thickness thermal burns
  • Burns contain intact dermal elements
  • Surgical intervention is clinically indicated
  • Treatment at qualified burn facility
  • Complete wound documentation available

You possibly qualify if:

  • Burn depth assessment is pending
  • Alternative treatments haven't been fully documented
  • Wound measurements need refinement
  • Step therapy requirements unclear

You're not yet eligible if:

  • Patient under 18 years old
  • Burns are superficial or full-thickness only
  • No surgical indication documented
  • Missing required clinical documentation

If You're Likely Eligible

Document Checklist

Clinical Requirements:

  • Wound assessment with total body surface area calculation
  • Precise wound measurements in square centimeters
  • Clinical photographs with measurement scale
  • Burn depth confirmation (deep partial-thickness)
  • Documentation of intact dermal elements
  • Surgical plan and rationale for StrataGraft

Administrative Requirements:

  • ICD-10 codes (T21-T31 series for thermal burns)
  • HCPCS code J7353 for billing
  • Prior authorization form completed
  • Prescriber attestation letter
  • Any contraindications to autograft documented

Submission Process

Step 1: Prepare Documentation Gather all clinical records, photographs, and wound assessments. Ensure measurements are precise as billing is per square centimeter.

Step 2: Submit Prior Authorization Submit via Humana provider portal using medical benefit pathway (not pharmacy). Include all required documentation.

Step 3: Track Timeline

  • Standard review: 15 business days
  • Expedited review: 24 hours (for urgent cases)
  • Follow up if no response within expected timeframe
Tip: For urgent burns requiring immediate treatment, request expedited review and clearly document why delay would cause serious harm.

If You're Possibly Eligible

Tests and Documentation to Request

Additional Clinical Assessment:

  • Burn depth biopsy if assessment unclear
  • Wound culture if infection suspected
  • Nutritional assessment for healing capacity
  • Documentation of autograft contraindications

Timeline Considerations:

  • Allow 2-3 weeks for additional testing
  • Coordinate with burn team for comprehensive evaluation
  • Document any changes in wound status during assessment period

Reapplication Strategy: Once additional documentation is complete, resubmit with enhanced clinical justification addressing any gaps in the initial assessment.

If You're Not Yet Eligible

Alternative Treatment Options

When StrataGraft isn't covered, discuss these alternatives with your burn team:

Standard Burn Care:

  • Split-thickness autograft (gold standard)
  • Temporary biologic dressings
  • Advanced wound dressings per burn protocols
  • Surgical debridement and wound care

Coverage Considerations: Most alternative burn treatments are covered under standard Medicare benefits when medically necessary. Work with your provider to document medical necessity for any chosen alternative.

Preparing for Exception Requests

If standard alternatives aren't suitable:

  1. Document specific contraindications to autograft
  2. Detail failed standard treatments
  3. Obtain peer-reviewed literature supporting StrataGraft use
  4. Consider consultation with burn specialists for additional opinions

If Your Request is Denied

Internal Appeals Process

Timeline: 65 days from denial notice to file appeal

Required Documents:

  • Original denial letter
  • Appeal request form
  • Additional clinical documentation
  • Medical necessity letter from prescriber

Submission: Use Humana appeals process or provider portal

Peer-to-Peer Review

Request a peer-to-peer review during the internal appeal process. This allows your physician to speak directly with Humana's medical director to discuss the clinical rationale.

Appeals Playbook for New Jersey

Level 1: Humana Internal Appeal

  • Timeline: 65 days to file; 30-60 days for decision
  • Process: Submit via Humana member portal or provider system
  • Required: Denial letter, clinical records, medical necessity justification

Level 2: New Jersey External Review (IHCAP)

New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review after internal appeals are exhausted.

Key Details:

  • Timeline: 180 days (4 months) from final internal denial
  • Process: Submit directly to Maximus Federal Services (contracted by NJ DOBI)
  • Cost: Free to patients (insurer pays all fees)
  • Decision: Binding on insurance company

IHCAP Contact Information:

Required Documentation:

  • Final internal denial letter
  • Complete medical records
  • Physician letter explaining medical necessity
  • IHCAP application form
Note: New Jersey's external review system is considered one of the most patient-friendly in the nation, with decisions typically favoring consumers in about half of cases.

Medicare Appeals (Federal Process)

For Medicare Advantage plans, you may also pursue federal Medicare appeals:

  • Level 1: Redetermination (plan review)
  • Level 2: Independent Review Entity (IRE)
  • Timeline: Various deadlines apply at each level

Contact Medicare.gov for detailed federal appeals guidance.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient clinical documentation Submit complete wound assessment with photos Detailed measurements, clinical photos, burn depth confirmation
Missing medical necessity Provide enhanced physician letter Literature review, clinical guidelines, treatment rationale
Improper billing code Correct submission pathway Use HCPCS J7353 under medical benefit, not pharmacy
Step therapy not met Document contraindications to alternatives Failure/intolerance to standard treatments, clinical justification
Age restriction Verify patient age Birth certificate or ID confirming adult status

FAQ

How long does Humana prior authorization take in New Jersey? Standard review takes 15 business days; expedited review for urgent cases is completed within 24 hours.

What if StrataGraft is considered non-formulary? StrataGraft is billed under the medical benefit (HCPCS J7353), not pharmacy, so formulary status doesn't apply. Coverage depends on medical necessity criteria.

Can I request an expedited appeal in New Jersey? Yes, both Humana internal appeals and New Jersey's IHCAP process offer expedited reviews when delays could cause serious harm.

Does step therapy apply if I failed treatments outside New Jersey? Yes, document any prior treatment failures regardless of where they occurred. Include complete medical records and physician attestation.

What happens if IHCAP overturns Humana's denial? The decision is legally binding. Humana must provide coverage and cannot appeal the IHCAP decision.

Are there cost assistance programs for StrataGraft? Contact Mallinckrodt (the manufacturer) directly to inquire about patient assistance programs. Hospital financial counselors may also help identify funding options.

Clinician Corner: Medical Necessity Letter

When preparing medical necessity documentation, include:

Clinical Assessment:

  • Detailed burn history and mechanism of injury
  • Total body surface area affected
  • Burn depth assessment with supporting evidence
  • Wound measurements and photographic documentation

Treatment Rationale:

  • Why autografting alone is insufficient or contraindicated
  • Expected outcomes with StrataGraft treatment
  • Comparison to alternative treatment options
  • Timeline for treatment and follow-up care

Supporting Evidence:

  • FDA labeling and approved indications
  • Clinical trial data showing efficacy
  • Peer-reviewed literature supporting use
  • Professional society guidelines when applicable

From Our Advocates

"We've seen the strongest StrataGraft approvals when providers submit comprehensive wound documentation upfront, including precise measurements and high-quality clinical photographs with measurement scales. Taking time to document contraindications to autograft or step therapy alternatives often prevents denials entirely. When appeals are needed, New Jersey's IHCAP process has been particularly effective for burn cases with strong clinical justification."

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through targeted, evidence-backed strategies. Our platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with each payer's specific requirements. For complex cases like StrataGraft coverage, we provide the clinical evidence and procedural expertise needed to navigate prior authorization and appeals processes effectively. Learn more at www.counterforcehealth.org.

Resources

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan specifics, and medical necessity. Always consult with your healthcare provider and insurance plan for personalized guidance. New Jersey insurance regulations and Humana policies may change; verify current requirements with official sources.

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