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

Getting StrataGraft Covered by Cigna in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Getting StrataGraft Covered by Cigna in North Carolina

StrataGraft requires prior authorization from Cigna for deep partial-thickness thermal burns in adults. The fastest path to approval involves submitting a complete PA request with burn specialist documentation, wound measurements, and photos using HCPCS code J7353. If denied, North Carolina residents can appeal internally within 180 days, then request external review through Smart NC. Start by having your burn center submit the PA with comprehensive clinical documentation showing medical necessity and failed standard therapy.

Table of Contents

  1. Understanding StrataGraft Coverage
  2. ICD-10 and Medical Coding Requirements
  3. Prior Authorization Process
  4. Common Denial Reasons and Solutions
  5. Appeals Process in North Carolina
  6. Smart NC External Review
  7. Clinician Documentation Requirements
  8. Costs and Patient Support Options
  9. FAQ

Understanding StrataGraft Coverage

StrataGraft is a tissue-engineered skin substitute approved by the FDA for adults with deep partial-thickness thermal burns. Unlike traditional pharmacy benefits, StrataGraft is covered under Cigna's medical benefit and billed as a facility-based procedure using HCPCS code J7353.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all cases Cigna Provider Portal
Age Restriction Adults 18+ only FDA labeling
Indication Deep partial-thickness thermal burns FDA labeling
Billing Code J7353 (per 100 cm²) CMS HCPCS database
Appeal Deadline 180 days from denial Cigna EOB/denial letter
External Review Available through Smart NC NC Department of Insurance

Medical vs. Pharmacy Benefit

StrataGraft is not processed through Express Scripts or Accredo like typical specialty drugs. Instead, it's billed by hospitals and burn centers as a medical procedure. This means:

  • Your facility handles the prior authorization
  • Billing occurs under your medical benefit, not prescription coverage
  • Copays and deductibles follow your medical benefit structure
  • Appeals follow medical benefit procedures

ICD-10 and Medical Coding Requirements

Proper coding is essential for StrataGraft approval. Documentation must support specific ICD-10 codes that demonstrate medical necessity.

Required ICD-10 Codes

Burn Location and Depth (T20-T25 series):

  • T20.xxx - Burns of head and neck
  • T21.xxx - Burns of trunk
  • T22.xxx - Burns of shoulder and upper limb
  • T23.xxx - Burns of wrist and hand
  • T24.xxx - Burns of hip and lower limb
  • T25.xxx - Burns of ankle and foot

The sixth character specifies burn depth:

  • .2 = Second degree (partial thickness)
  • .3 = Third degree (full thickness)

Example: T24.212A = Burn of second degree of left lower limb, initial encounter

Total Body Surface Area (T31 series): Document percentage of body burned using the "rule of nines":

  • T31.10 = Burns involving 10-19% of body surface
  • T31.20 = Burns involving 20-29% of body surface

Documentation Requirements

Your medical records must clearly document:

  1. Anatomical location with laterality when applicable
  2. Burn depth confirmed as deep partial-thickness
  3. Total body surface area percentage using standardized calculations
  4. Wound measurements in cm² for each area to be treated
  5. External cause of injury (optional but recommended)
Tip: Take photographs of burn wounds with rulers for scale. This visual documentation strengthens your case and helps with unit calculations for billing.

Prior Authorization Process

Cigna requires prior authorization for all StrataGraft applications. The process typically takes 14-15 business days for standard requests.

Step-by-Step PA Submission

  1. Gather Clinical Documentation
    • Burn specialist evaluation and treatment plan
    • Wound measurements and photographs
    • Documentation of failed standard therapy
    • Patient demographics and insurance information
  2. Complete Cigna's PA Form
    • Use Cigna's tissue-engineered skin substitute PA form
    • Include all required fields and attachments
    • Double-check patient and provider information
  3. Submit Through Preferred Channel
    • Electronic: Cigna provider portal (fastest)
    • Fax: 1-866-873-8279 (standard PA fax line)
    • Keep confirmation numbers and submission records
  4. Follow Up Proactively
    • Check status after 5-7 business days
    • Respond promptly to requests for additional information
    • Track reference numbers for all communications

Required Clinical Documentation

  • Provider attestation confirming deep partial-thickness burns
  • Surgical plan detailing debridement and application procedure
  • Prior therapy documentation showing failure of standard wound care
  • Wound measurements with photographic evidence
  • Patient eligibility confirmation (age 18+, thermal burn etiology)

Counterforce Health specializes in helping patients and clinicians navigate complex prior authorization processes like these, turning insurance denials into targeted, evidence-backed appeals that align with payer policies.

Common Denial Reasons and Solutions

Understanding why StrataGraft requests get denied helps you submit stronger initial applications and successful appeals.

Top Denial Reasons and Fixes

Denial Reason Solution Required Documentation
"Not medically necessary" Provide burn specialist letter with clinical rationale Wound assessment, treatment goals, specialist recommendation
"Experimental/investigational" Submit FDA approval documentation FDA labeling showing approved indication
"Insufficient documentation" Include comprehensive clinical records Photos, measurements, surgical notes, prior therapy records
"Wrong billing pathway" Ensure facility billing with correct HCPCS code Confirm J7353 coding and medical benefit billing
"Quantity/units error" Verify unit calculations match wound area Precise cm² measurements, unit calculation worksheet

Unit Calculation Common Errors

StrataGraft is billed per 100 cm² construct. Common billing errors include:

  • Billing cm² instead of constructs: A 250 cm² wound needs 3 units (constructs), not 250 units
  • Duplicate billing: Only one entity (facility OR physician) should bill J7353
  • Insufficient wound measurement: Document exact dimensions with photographic evidence

Appeals Process in North Carolina

If Cigna denies your StrataGraft request, North Carolina offers robust appeal rights through both internal and external review processes.

Internal Appeals with Cigna

First-Level Appeal:

  • Deadline: 180 days from denial date
  • Process: Submit written appeal with supporting documentation
  • Timeline: Cigna has 30 days to respond (expedited: 72 hours for urgent cases)

Second-Level Appeal:

  • Deadline: 60 days from first-level denial
  • Process: Additional clinical review, may include peer-to-peer consultation
  • Timeline: 30 days for standard review

Required Appeal Documentation

Your appeal should include:

  • Copy of original denial letter
  • Medical necessity letter from prescribing physician
  • Additional clinical evidence supporting StrataGraft use
  • Relevant medical literature or guidelines
  • Patient impact statement (optional but helpful)
From our advocates: We've seen many StrataGraft denials overturned when families include clear photographs showing wound progression and detailed documentation of failed standard therapies. The visual evidence combined with specialist attestation often tips the scales toward approval, especially when the clinical rationale directly addresses the payer's stated denial reason.

Smart NC External Review

North Carolina residents have strong external review rights through Smart NC, administered by the NC Department of Insurance.

When You Can Request External Review

  • After completing Cigna's internal appeal process
  • For denials based on medical necessity
  • For experimental/investigational determinations
  • Within 120 days of final internal denial

How to Request External Review

  1. Contact Smart NC
  2. Submit Required Forms
    • External review application
    • Copy of all denial letters
    • Supporting medical documentation
  3. Timeline and Process
    • Standard review: Decision within 45 days
    • Expedited review: Decision within 72 hours for urgent cases
    • Independent Review Organization (IRO) makes binding decision

Smart NC Advantages

  • Free advocacy support to help navigate the process
  • Binding decisions that insurers must follow
  • Fast turnaround for urgent medical needs
  • High success rate for well-documented cases

Smart NC can also help gather additional medical evidence and coordinate with your healthcare providers during the review process.

Clinician Documentation Requirements

Healthcare providers play a crucial role in securing StrataGraft approval. Strong clinical documentation is essential for both initial authorization and appeals.

Medical Necessity Letter Checklist

Your burn specialist or treating physician should include:

  • Patient diagnosis with specific ICD-10 codes
  • Burn characteristics: depth, location, total body surface area
  • Treatment history: prior therapies attempted and outcomes
  • Clinical rationale: why StrataGraft is medically necessary
  • Alternative treatments considered and reasons for rejection
  • Expected outcomes and treatment goals
  • Dosing and application plan

Supporting Clinical Evidence

Include relevant medical literature and guidelines:

  • FDA labeling for StrataGraft
  • American Burn Association treatment guidelines
  • Peer-reviewed studies on tissue-engineered skin substitutes
  • Institutional burn protocols supporting StrataGraft use

Procedural Documentation

For billing and reimbursement:

  • Detailed surgical notes describing wound preparation
  • Precise measurements of treatment area
  • Number of StrataGraft constructs applied
  • Post-application care plan and monitoring

Costs and Patient Support Options

StrataGraft treatment costs vary significantly based on wound size and facility charges. Understanding your financial options helps reduce out-of-pocket expenses.

Insurance Coverage Factors

  • Medical deductible: StrataGraft counts toward your annual medical deductible
  • Coinsurance: Typically 10-30% after deductible is met
  • Out-of-network penalties: Ensure your burn center is in Cigna's network

Patient Assistance Programs

Manufacturer Support:

  • Contact Mallinckrodt patient services for available programs
  • Some facilities offer financial counseling services
  • Hospital charity care programs may apply for qualifying patients

State and Federal Programs:

  • Medicaid coverage (if eligible)
  • State victim compensation programs for burn injuries
  • Social services support for medical expenses

Counterforce Health can also help identify coverage gaps and appeal strategies that maximize your insurance benefits while minimizing personal costs.

Frequently Asked Questions

How long does Cigna prior authorization take for StrataGraft in North Carolina? Standard PA review takes 14-15 business days. Expedited reviews for urgent cases can be completed within 24-72 hours when properly documented.

What if StrataGraft is considered experimental by Cigna? Submit FDA approval documentation showing StrataGraft's approved indication for deep partial-thickness thermal burns. This directly counters experimental/investigational denials.

Can I request an expedited appeal if my wound is deteriorating? Yes. North Carolina allows expedited appeals when delays would jeopardize health outcomes. Your physician must certify the urgent medical need.

Does step therapy apply to StrataGraft? Typically yes - you must document failure or contraindications to standard burn treatments like conventional dressings before StrataGraft is approved.

What happens if Smart NC external review denies my case? The IRO decision is final for administrative appeals. You may still have legal options, but the insurance administrative process is complete.

How do I calculate the number of StrataGraft units needed? Each StrataGraft construct covers 100 cm². Divide your total wound area by 100 and round up to the nearest whole number. A 225 cm² wound requires 3 constructs.

Can StrataGraft be used for non-burn wounds? No. Cigna (and FDA approval) limits StrataGraft to thermal burns. Off-label use requests are typically denied.

What if my burn center is out-of-network with Cigna? You'll face higher out-of-pocket costs and potentially more complex authorization requirements. Consider requesting a network exception if no in-network burn specialists are available.

Sources and Further Reading

Medical Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with qualified healthcare providers. Coverage decisions depend on individual circumstances, policy terms, and clinical factors. Always consult with your healthcare team and insurance company for personalized guidance regarding your specific situation.

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