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

The Complete Guide to Getting StrataGraft Covered by Cigna in New Jersey: Prior Authorization, Appeals, and Documentation Requirements

Answer Box: Getting StrataGraft Covered by Cigna in New Jersey

StrataGraft requires prior authorization from Cigna for deep partial-thickness thermal burns in adults. Submit PA via Cigna's provider portal with burn specialist notes, wound photos, measurements, and proof of failed conventional therapy. If denied, file internal appeals within 180 days, then pursue New Jersey's Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services within 4 months. Start today: Call Cigna member services (number on your card) to verify benefits and PA requirements.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Coverage Criteria
  4. Coding and Billing Requirements
  5. Documentation Package
  6. Prior Authorization Submission
  7. Appeals Process in New Jersey
  8. Common Denial Reasons & Solutions
  9. Costs and Financial Assistance
  10. Frequently Asked Questions
  11. Quick Reference Checklist

Who Should Use This Guide

This guide is designed for patients with severe thermal burns and their healthcare teams seeking StrataGraft coverage through Cigna in New Jersey. You'll find this most helpful if you:

  • Have deep partial-thickness thermal burns requiring surgical intervention
  • Need an alternative to traditional autografting due to limited donor sites or high morbidity risk
  • Face a Cigna denial for StrataGraft and need to appeal
  • Want to maximize approval chances on your first submission

Expected outcome: With proper documentation and adherence to Cigna's medical policy MM-0068, many initial denials can be overturned through appeals, especially when supported by burn specialist evaluations and clinical photography.

Member & Plan Basics

Verify Your Coverage

Before proceeding, confirm these essential details:

Active Coverage Status

  • Call Cigna member services (1-800-88CIGNA) to verify your plan is active
  • Confirm your burn treatment facility is in-network
  • Ask specifically about tissue-engineered skin substitute coverage

Plan Type Considerations

  • Commercial plans: Standard PA process applies
  • Medicare Advantage: Follow Medicare guidelines with Cigna-specific forms
  • Medicaid managed care: May have additional state requirements

Financial Responsibility

  • StrataGraft is covered under the medical benefit, not pharmacy
  • Typical member responsibility: deductible plus coinsurance (often 10-20%)
  • Pre-authorization reduces risk of claim denial but doesn't guarantee coverage
Tip: Document your coverage verification call, including the representative's name and reference number.

Clinical Coverage Criteria

Cigna's Medical Coverage Policy MM-0068 outlines specific requirements for StrataGraft coverage:

Coverage Requirements Table

Requirement Details Documentation Needed
Patient Age Adults 18+ years Date of birth verification
Indication Deep partial-thickness thermal burns requiring surgery ICD-10 burn codes, depth assessment
Failed Conservative Therapy Standard burn care inadequate Treatment history, outcomes
Surgical Indication Autografting clinically indicated but suboptimal Burn surgeon evaluation
Site of Care In-network burn center or hospital Provider directory verification

Medical Necessity Criteria

Your case must demonstrate:

  • Burn depth: Deep partial-thickness confirmed by burn specialist
  • Mechanism: Thermal injury (heat, flame, scalding)
  • Surgical need: Excision and grafting required
  • Autograft limitations: Insufficient donor sites, contraindications, or high morbidity risk

Coding and Billing Requirements

Primary Codes

  • HCPCS: J7353 (StrataGraft, per square centimeter)
  • NDC: 73612-200-01 (11-digit format: 73612020001)
  • ICD-10: Appropriate burn codes (T20-T25 series with depth and extent)

Billing Structure

StrataGraft is billed under the medical benefit using:

  • Units: Actual wound surface area treated in cm²
  • NDC reporting: Required with N4 qualifier
  • Facility billing: Hospital or ASC submits product cost
  • Professional billing: Surgeon bills application procedures separately
Note: Never submit as a pharmacy claim. This will result in automatic denial.

Documentation Package

Core Medical Records

Your PA submission must include:

Burn Assessment Documentation

  • Initial burn evaluation with depth, mechanism, and total body surface area (TBSA)
  • Serial wound measurements and photography
  • Evidence of failed conservative therapy (dressings, topical treatments)

Surgical Planning

  • Burn surgeon's evaluation and treatment plan
  • Rationale for StrataGraft over traditional autografting
  • Expected outcomes and follow-up plan

Medical Necessity Letter Components

Your physician's letter should address:

  1. Patient identification and burn history
  2. Clinical presentation with specific burn characteristics
  3. Treatment failures with conventional therapy
  4. Surgical indication and why autograft alone is insufficient
  5. StrataGraft rationale aligned with FDA labeling
  6. Expected benefits and treatment goals

When preparing appeals, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals that align with payer policies and clinical guidelines.

Prior Authorization Submission

Step-by-Step Process

1. Gather Documentation (Day 1)

  • Complete medical records
  • Wound photographs
  • Treatment history
  • Burn specialist evaluation

2. Submit PA Request (Day 2-3)

  • Use Cigna's tissue-engineered skin substitute form
  • Submit via Cigna provider portal
  • Include all required attachments
  • Request expedited review if clinically urgent

3. Follow Up (Day 5-7)

  • Confirm receipt with Cigna
  • Provide additional information if requested
  • Track status through provider portal

4. Receive Decision (Day 10-15)

  • Standard review: 5-14 business days
  • Expedited review: 72 hours for urgent cases
  • Document decision and rationale

Appeals Process in New Jersey

Internal Appeals with Cigna

First-Level Appeal

  • Timeline: File within 180 days of denial
  • Review period: 30 days (72 hours if expedited)
  • Required documents: Denial letter, enhanced medical necessity letter, updated clinical data

Second-Level Appeal (if available)

  • Timeline: 60 days from first-level denial
  • Process: Independent medical review within Cigna
  • Enhanced documentation: Additional literature, specialist opinions

New Jersey External Review (IHCAP)

If Cigna's internal appeals fail, New Jersey offers robust external review rights through the Independent Health Care Appeals Program:

Process Overview

  • Eligibility: After completing internal appeals
  • Timeline: 4 months (180 days) from final denial
  • Submission: Direct to Maximus Federal Services
  • Cost: Free to patients (insurers pay all fees)

How It Works

  1. Submit external appeal request to Maximus
  2. Preliminary review (5 business days)
  3. Independent physician panel review
  4. Binding decision on Cigna (typically within 45 days)

Success Factors

  • Complete medical records
  • Detailed physician letter addressing denial reasons
  • Alignment with FDA labeling and burn care guidelines
  • Clear documentation of medical necessity
From our advocates: We've seen external reviews succeed when the clinical team provides comprehensive wound photography showing burn depth and failed conventional therapy, combined with a detailed letter explaining why StrataGraft is medically necessary per FDA guidelines. The key is demonstrating that the denial contradicts established burn care standards.

Common Denial Reasons & Solutions

Denial Reason Solution
Insufficient documentation Resubmit with complete burn assessment, photos, and measurements
Not medically necessary Provide detailed letter explaining autograft limitations and StrataGraft benefits
Experimental/investigational Confirm on-label use for deep partial-thickness thermal burns in adults
Wrong benefit type Ensure billing under medical benefit (J7353), not pharmacy
Missing step therapy Document failed conventional burn care and outcomes

Peer-to-Peer Review Strategy

If initially denied, request a peer-to-peer review between your burn surgeon and Cigna's medical director. This often resolves denials when clinical rationale is clearly communicated.

Costs and Financial Assistance

Typical Member Costs

  • Deductible: Varies by plan (often $1,000-$5,000)
  • Coinsurance: 10-20% after deductible
  • Out-of-pocket maximum: $3,000-$8,000 annually

Financial Assistance Options

  • Mallinckrodt patient assistance: Check manufacturer programs
  • Hospital financial aid: Many burn centers offer payment plans
  • State programs: New Jersey may have additional resources

For complex cases requiring specialized support, Counterforce Health helps patients and clinicians navigate insurance denials by creating evidence-backed appeals that address specific payer requirements and clinical guidelines.

Frequently Asked Questions

How long does Cigna prior authorization take in New Jersey? Standard PA reviews take 5-14 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if StrataGraft is denied as experimental? Emphasize FDA approval for deep partial-thickness thermal burns in adults. Provide FDA labeling and ensure your case fits approved indications.

Can I request an expedited appeal? Yes, if delay would cause serious harm to your health. Your physician must certify the urgency.

Does step therapy apply if I've failed treatments outside New Jersey? Yes, Cigna accepts documentation of failed therapy from any qualified provider, regardless of location.

What happens if I need additional StrataGraft applications? New authorizations are typically required for additional procedures. Submit updated documentation showing medical necessity.

How do I contact New Jersey's insurance department for help? Call the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or the IHCAP-specific line at 1-888-393-1062.

Quick Reference Checklist

Before You Start

  • Insurance card and member ID
  • Burn specialist evaluation
  • Complete treatment history
  • Wound photographs and measurements
  • Failed therapy documentation

PA Submission Requirements

  • Cigna tissue-engineered skin substitute form
  • Medical necessity letter
  • ICD-10 burn codes documented
  • HCPCS J7353 and NDC specified
  • In-network provider verification

If Denied

  • Request detailed denial rationale
  • File internal appeal within 180 days
  • Enhance documentation package
  • Consider peer-to-peer review
  • Prepare for external review if needed

New Jersey External Review

  • Complete internal appeals first
  • Submit to Maximus within 4 months
  • Include comprehensive medical records
  • Provide physician letter addressing denial
  • Reference FDA labeling and guidelines

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for specific guidance. For additional support with complex appeals, consider consulting with healthcare coverage advocates who specialize in payer policies and clinical documentation requirements.

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