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

How to Get StrataGraft Approved by Cigna in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting StrataGraft Covered by Cigna in New York

StrataGraft requires prior authorization under Cigna's medical benefit (not pharmacy) in New York. The fastest path to approval: 1) Confirm your provider is in-network, 2) Submit Cigna's tissue-engineered skin substitute PA form with complete burn documentation (deep partial-thickness thermal burns, failed conventional therapy, surgical indication), and 3) Follow up within 5-7 business days. If denied, New York offers strong external appeal rights through the Department of Financial Services within 4 months. Start today: Contact your burn surgeon to initiate the medical PA request via Cigna's provider portal.

Table of Contents

What This Guide Covers

This comprehensive guide helps New York patients and their healthcare providers navigate Cigna's prior authorization process for StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat). Whether you're facing an initial PA requirement or appealing a denial, we'll walk you through each step with specific forms, timelines, and New York state appeal rights.

StrataGraft is a tissue-engineered skin substitute FDA-approved for deep partial-thickness thermal burns in adults when surgical intervention is clinically indicated. Given its specialized nature and cost, Cigna requires thorough documentation of medical necessity before approval.

From our advocates: We've seen many StrataGraft approvals succeed when providers include detailed wound photography, clear documentation of why autografting isn't optimal, and specific references to FDA labeling criteria. The key is demonstrating that conventional treatments have failed or are contraindicated.

Before You Start: Essential Verification Steps

Confirm Your Coverage Type

  • Medical vs. Pharmacy Benefit: StrataGraft is billed under your medical benefit using HCPCS code J7353, not through pharmacy benefits like Express Scripts or Accredo
  • Network Status: Verify your treating facility and surgeon are in-network with your Cigna plan
  • Plan Type: Commercial, Medicare Advantage, and Medicaid managed care plans all have different PA requirements

Check Your Benefits

Call Cigna member services at the number on your insurance card to confirm:

  • Prior authorization is required for tissue-engineered skin substitutes
  • Your annual deductible and coinsurance for medical procedures
  • Any specific requirements for burn treatment facilities

Coverage Requirements at a Glance

Requirement Details Where to Find It
Prior Authorization Required under medical benefit Cigna Coverage Policy MM-0068
Covered Indication Deep partial-thickness thermal burns in adults FDA labeling, Cigna policy
Site of Care In-network hospital or burn center Your plan's provider directory
Billing Code HCPCS J7353 CMS HCPCS database
Step Therapy Documentation of failed conventional therapy Provider clinical notes
Appeals Deadline 180 days for internal, 4 months for external New York DFS guidelines

Step-by-Step: Fastest Path to Approval

1. Provider Initiates PA Request (Day 1)

Who: Your burn surgeon or wound care specialist
What: Complete Cigna's tissue-engineered skin substitute prior authorization form
How: Submit via Cigna provider portal or fax (verify current number with provider services)
Timeline: Same day submission recommended

2. Clinical Documentation Assembly (Days 1-2)

Who: Medical team
What: Gather burn assessment, photos, failed treatment records, surgical plan
How: Comprehensive medical records review
Timeline: 1-2 business days for complete packet

3. Submission and Confirmation (Day 3)

Who: Provider's authorization team
What: Submit complete PA packet with all supporting documents
How: Electronic submission preferred, with confirmation receipt
Timeline: Same day confirmation required

4. Cigna Review Period (Days 4-18)

Who: Cigna medical reviewers
What: Clinical review against coverage criteria
How: Internal medical necessity assessment
Timeline: Up to 14 business days (expedited: 72 hours if urgent)

5. Decision and Next Steps (Day 19+)

Who: Cigna and your care team
What: Approval letter or denial with reason codes
How: Written notification to provider and patient
Timeline: Decision communicated within 24 hours of determination

What to Gather Before Submitting

Essential Clinical Documentation

  • Burn Assessment: Location, depth (deep partial-thickness), total body surface area percentage
  • ICD-10 Codes: Specific anatomical burn codes (T20-T25 series) plus extent codes (T31.x) and external cause
  • Wound Photography: Clear images showing wound characteristics and depth
  • Failed Treatments: Documentation of conventional therapies attempted and outcomes
  • Surgical Indication: Clinical rationale for why autografting isn't optimal

Supporting Medical Records

  • Hospital admission notes (if applicable)
  • Daily wound assessments and progress notes
  • Laboratory results (if infection or complications present)
  • Anesthesia clearance (for surgical procedures)
  • Social history and patient factors affecting healing

Insurance Information

  • Current Cigna member ID and group number
  • Provider NPI numbers for all treating physicians
  • Facility tax ID and NPI for treatment location
  • Any previous PA reference numbers for related treatments

Submitting Your Request

Provider Portal Submission

Most Cigna providers use the online portal for PA submissions. The portal allows:

  • Real-time status tracking
  • Document upload capabilities
  • Automated confirmation receipts
  • Direct communication with reviewers

Required Forms and Attachments

  • Cigna tissue-engineered skin substitute PA form (verify current version)
  • Clinical summary letter from treating physician
  • Relevant medical records and imaging
  • Wound photographs with measurements
  • Documentation of failed conventional therapies
Tip: Submit requests early in the week (Monday-Wednesday) to ensure full business days for processing before weekends.

Follow-Up and Timelines

Standard Review Timeline

  • Initial Review: 14 business days from complete submission
  • Additional Information Requests: 5 business days to respond
  • Final Decision: Within 2 business days of receiving additional info

When to Follow Up

  • Day 7: Confirm receipt and completeness of submission
  • Day 12: Check review status if no communication received
  • Day 16: Escalate if approaching deadline without decision

Sample Follow-Up Script

"I'm calling to check the status of prior authorization request #[reference number] for StrataGraft for [patient name], DOB [date]. The submission was complete as of [date]. Can you provide the current review status and expected decision timeline?"

If You're Asked for More Information

Cigna may request additional documentation for medical necessity determination. Common requests include:

Clinical Clarifications

  • Burn Depth Confirmation: Additional imaging or biopsy results
  • Treatment History: More detailed records of failed therapies
  • Surgical Plan: Specific procedural details and expected outcomes
  • Alternative Considerations: Why other treatments aren't suitable

How to Respond Effectively

  • Respond Quickly: Submit within the requested timeframe (usually 5 business days)
  • Be Comprehensive: Address each question specifically with supporting evidence
  • Include Literature: Attach relevant peer-reviewed studies or FDA guidance
  • Maintain Communication: Confirm receipt of your additional submission

When responding to medical necessity questions, Counterforce Health can help providers craft evidence-backed responses that align with Cigna's specific coverage criteria and New York regulatory requirements.

Appeals Process for New York Patients

New York offers robust patient protection through its external appeal process administered by the Department of Financial Services (DFS).

Internal Appeal (First Level)

  • Timeline: Must file within 180 days of denial
  • Decision Time: 60 days for standard review, 72 hours for expedited
  • Process: Submit written appeal with additional clinical evidence
  • Cost: No fee for internal appeals

External Appeal Through NY DFS

  • Eligibility: After internal appeal denial or incomplete resolution
  • Timeline: Must file within 4 months of final internal denial
  • Decision Time: 30 days standard, 72 hours expedited
  • Cost: $25 fee (waived for financial hardship or Medicaid enrollees)
  • Success Rate: Approximately 50% of external appeals overturn denials

Required Documentation for Appeals

  • Original denial letter from Cigna
  • Updated medical necessity letter from provider
  • Peer-reviewed literature supporting StrataGraft use
  • Patient clinical records and wound progression photos
  • Completed NY DFS external appeal form

New York Appeal Resources

  • Community Health Advocates: 888-614-5400 (free counseling)
  • NY DFS Consumer Hotline: For external appeal guidance
  • DFS Online Portal: Electronic submission available

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
Experimental/Investigational Provide FDA approval documentation and peer-reviewed efficacy studies
Not Medically Necessary Submit detailed clinical rationale with wound progression photos
Alternative Treatments Available Document failed conventional therapies and contraindications to autografting
Insufficient Documentation Resubmit with complete burn assessment and surgical indication
Out of Network Provider Request single case agreement or transfer to in-network facility
Billing Code Issues Confirm HCPCS J7353 usage and medical benefit routing

Renewal and Re-Authorization

StrataGraft typically requires one-time authorization for the specific burn treatment episode. However, if additional applications are needed:

When to Resubmit

  • Treatment Complications: If initial application fails or complications arise
  • Additional Burn Sites: New injuries requiring separate treatment
  • Extended Treatment: If healing requires longer than initially anticipated

Documentation for Renewals

  • Progress notes from initial StrataGraft application
  • Current wound assessment and photography
  • Clinical rationale for continued or additional treatment
  • Updated treatment plan and expected outcomes

Frequently Asked Questions

How long does Cigna prior authorization take for StrataGraft in New York? Standard review is 14 business days from complete submission. Expedited review (for urgent cases) is decided within 72 hours.

What if StrataGraft isn't on Cigna's formulary? StrataGraft isn't on pharmacy formularies because it's covered under the medical benefit, not pharmacy benefits. Coverage is determined by medical policy criteria.

Can I request an expedited appeal in New York? Yes, both Cigna internal appeals and NY DFS external appeals offer expedited review for urgent medical situations with supporting physician documentation.

Does step therapy apply if I've had failed treatments outside New York? Yes, documentation of failed treatments from any location counts toward step therapy requirements, provided records are complete and verifiable.

What happens if my provider is out-of-network? You can request a single case agreement for coverage at in-network rates, or transfer care to an in-network burn center for treatment.

How much will StrataGraft cost me out-of-pocket? Costs depend on your specific plan's deductible and coinsurance for medical procedures. Contact Cigna member services for your exact benefit details.

Can I appeal a denial if I missed the deadline? New York allows appeals within 180 days for internal appeals and 4 months for external appeals. Late appeals may be accepted in exceptional circumstances.

What if Cigna requests a peer-to-peer review? Your provider can request a peer-to-peer discussion with Cigna's medical director to discuss the clinical rationale for StrataGraft use.

Quick Reference Checklist

Before Submitting

  • Verify in-network provider and facility status
  • Confirm medical benefit coverage (not pharmacy)
  • Gather complete burn documentation and photos
  • Document failed conventional treatments
  • Obtain current Cigna PA form

During Review

  • Track submission with reference number
  • Follow up at day 7 and day 12
  • Respond quickly to any information requests
  • Maintain communication with care team

If Denied

  • Review denial reason codes carefully
  • File internal appeal within 180 days
  • Gather additional supporting evidence
  • Consider peer-to-peer review request
  • Prepare for external appeal if needed

New York Specific

  • Know your external appeal rights through DFS
  • Keep Community Health Advocates number: 888-614-5400
  • Understand 4-month external appeal deadline
  • Prepare $25 appeal fee (or hardship waiver request)

For complex cases or repeated denials, Counterforce Health specializes in turning insurance denials into successful appeals by crafting evidence-backed arguments that align with payer-specific requirements and regulatory standards.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice, legal counsel, or a guarantee of coverage outcomes. Always consult with your healthcare provider about treatment decisions and verify current requirements with your insurance plan. Coverage policies and procedures may change; confirm current information with official sources.

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