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

Renewing StrataGraft Coverage with Blue Cross Blue Shield in New York: Complete Guide to Documentation, Timelines, and Appeals

Answer Box: Getting StrataGraft Renewal Approved by Blue Cross Blue Shield in New York

StrataGraft renewals require prior authorization as a facility-billed medical service through Blue Cross Blue Shield plans in New York (Anthem, Empire, Excellus, BCBS of WNY). Start renewal requests 2-3 weeks before your next treatment date. Submit updated clinical documentation showing wound progress, ongoing medical necessity, and why additional StrataGraft applications are needed instead of autografting. Use your plan's provider portal or Availity system for fastest processing. If denied, New York offers external appeals through the Department of Financial Services within 4 months.

First step today: Contact your burn center's authorization specialist to confirm your exact BCBS plan and start gathering updated wound photos, progress notes, and measurements.

Table of Contents

  1. Renewal Triggers: When to Start the Process
  2. Evidence Update Requirements
  3. Renewal Documentation Packet
  4. Submission Timeline and Decision Windows
  5. If Coverage Lapses: Bridge Options
  6. Annual Plan Changes to Monitor
  7. Personal Progress Tracker
  8. Appeals Process for New York
  9. FAQ: Common Renewal Questions

Renewal Triggers: When to Start the Process

Timing Windows for StrataGraft Renewal

Most Blue Cross Blue Shield plans in New York treat StrataGraft renewals as continuation authorizations rather than completely new requests. Start your renewal process when:

  • 2-3 weeks before your next planned StrataGraft application
  • Your burn surgeon recommends additional treatment beyond the initial authorization
  • 30 days before your current authorization expires (check your approval letter for exact dates)
  • Wound healing has plateaued and requires additional biologic coverage
Tip: Set calendar reminders based on your original authorization letter. Most initial StrataGraft approvals cover single applications, so any additional treatment typically requires renewal documentation.

Signs You Should Start Early

Begin renewal preparation immediately if:

  • Your burn covers more than 5% total body surface area
  • Initial StrataGraft showed partial success but left untreated areas
  • You have complicating factors (infection, diabetes, immunosuppression)
  • Your plan has a history of requesting additional documentation

Evidence Update Requirements

Response to Initial Therapy Documentation

Your renewal must demonstrate objective progress from the initial StrataGraft application. Required evidence includes:

Wound Measurements and Photography:

  • Current wound size in cm² compared to baseline
  • Percentage of epithelialization achieved
  • Areas of successful graft integration vs. persistent deep partial-thickness burns
  • High-resolution photos with date stamps showing wound progression

Clinical Response Documentation:

  • Improvement in wound bed quality and granulation
  • Reduction in infection or inflammatory markers
  • Functional outcomes (range of motion, pain levels)
  • Any complications or adverse events from initial treatment

Updated Medical Necessity Rationale

Your burn surgeon must document why additional StrataGraft is still medically necessary rather than proceeding with autografting:

  • Limited donor site availability
  • Patient comorbidities making additional surgery high-risk
  • Hemodynamic instability or critical illness
  • Risk-benefit analysis favoring continued biologic coverage

Renewal Documentation Packet

Core Required Documents

Submit this complete package through your BCBS plan's authorization portal:

Document Type Specific Requirements Timeframe
Updated Clinical Note Burn surgeon assessment with wound measurements, progress since initial treatment, and rationale for continued StrataGraft Within 24-72 hours
Photographic Evidence Before/after photos showing partial healing and persistent areas needing treatment Current + baseline comparison
Original Authorization Reference Prior auth number, dates of service, units used from initial approval Copy of approval letter
Operative Reports Initial StrataGraft application note plus any intervening procedures All procedures since baseline
Letter of Medical Necessity Structured LMN addressing continued need and contraindications to autograft Signed by burn surgeon

Letter of Medical Necessity Structure

Your LMN should follow this format for optimal approval odds:

  1. Patient identification and diagnosis (ICD-10 burn codes)
  2. Original indication and FDA-labeled use confirmation
  3. Objective response to initial StrataGraft with measurements
  4. Persistent medical need with specific wound areas requiring coverage
  5. Contraindications to autografting at this time
  6. Treatment plan including number of additional units needed
  7. Risk of non-treatment or delayed healing

Submission Timeline and Decision Windows

Standard Processing Times

Plan Type Standard Review Expedited Review Submission Method
Anthem/Empire Commercial 5-7 business days 72 hours Availity Authorizations Portal
Excellus BCBS 5-10 business days 72 hours Provider portal or ICR system
BCBS of WNY 7-10 business days 72 hours Precertification portal

Optimal Submission Strategy

Week 1: Gather updated clinical documentation and photos Week 2: Submit complete renewal packet with all attachments Week 3: Follow up on decision status; address any additional information requests Treatment Week: Receive approval and schedule procedure

Note: Request expedited review if delaying treatment could jeopardize wound healing or increase infection risk. Include clinical urgency documentation from your burn surgeon.

If Coverage Lapses: Bridge Options

Immediate Steps for Coverage Gaps

If your renewal is denied or delayed:

  1. File internal appeal immediately within 180 days of denial
  2. Request peer-to-peer review between your burn surgeon and plan medical director
  3. Apply for hospital charity care or financial assistance programs
  4. Contact Mallinckrodt Patient Services about patient assistance programs

Bridge Therapy Considerations

While appeals are pending, discuss these options with your burn team:

  • Temporary biologic dressings to maintain wound bed quality
  • Conservative wound care with antimicrobial dressings
  • Limited autografting for highest-priority areas
  • Hospital emergency fund coverage for urgent cases

Counterforce Health specializes in turning insurance denials into successful appeals for complex biologics like StrataGraft. Their platform helps identify specific denial reasons and crafts evidence-backed rebuttals aligned to your plan's own policies, potentially reducing the time between denial and approval.

Patient Assistance Programs

Mallinckrodt Corporate PAP:

  • Free medication for patients with little or no insurance
  • Income-based eligibility requirements
  • Applications processed through hospital financial counselors

Medicare NTAP Benefits:

  • Additional reimbursement for hospitals using StrataGraft in eligible inpatients
  • Reduces hospital financial risk and increases willingness to provide treatment

Annual Plan Changes to Monitor

Formulary and Policy Updates

Blue Cross Blue Shield plans may change StrataGraft coverage annually. Monitor for:

January 1 Changes:

  • New prior authorization requirements
  • Updated medical policies for skin substitutes
  • Changes in facility network status
  • Modified documentation requirements

Mid-Year Updates:

  • Quarterly formulary revisions
  • New utilization management criteria
  • Updated billing code requirements (HCPCS J7353)

What to Re-Verify Annually

  • In-network status of your burn center
  • Current medical policy for bioengineered skin substitutes
  • Authorization requirements and submission processes
  • Appeals deadlines and external review options

Personal Progress Tracker

Documentation Checklist

Use this template to track your renewal preparation:

☐ Clinical Documentation

  • Updated wound measurements (date: _____)
  • Progress photos (date: _____)
  • Burn surgeon note (date: _____)
  • Lab results if applicable (date: _____)

☐ Authorization Details

  • Original auth number: _____
  • Expiration date: _____
  • Units approved: _____
  • Plan contact person: _____

☐ Submission Tracking

  • Renewal submitted (date: _____)
  • Confirmation received (date: _____)
  • Decision received (date: _____)
  • Appeal filed if needed (date: _____)

Appeals Process for New York

Internal Appeals with BCBS Plans

Timeline: 180 days from denial date Submission: Written appeal with supporting documentation Decision: 30 days for standard, 72 hours for expedited

External Appeals Through NY DFS

New York offers strong external appeal rights through the Department of Financial Services:

Eligibility: Medical necessity or experimental/investigational denials Timeline: 4 months from final internal denial Cost: Up to $25 (waived for financial hardship) Decision: 30 days standard, 72 hours expedited

Success Rate: Approximately 50% of external appeals overturn denials

From our advocates: We've seen StrataGraft denials successfully overturned when families included detailed wound progression photos and peer-reviewed literature supporting the FDA-approved indication. The key is demonstrating that standard autografting isn't feasible due to specific patient factors, not just general preference for biologic coverage.

To file an external appeal:

  1. Complete the NY External Appeal Form
  2. Submit online via the DFS Portal
  3. Include all denial letters and supporting clinical evidence

FAQ: Common Renewal Questions

How long does BCBS renewal take in New York? Standard renewals take 5-10 business days. Expedited reviews for urgent cases are decided within 72 hours when clinical urgency is documented.

What if StrataGraft becomes non-formulary? StrataGraft is billed as a medical procedure (J7353), not a pharmacy benefit, so formulary changes typically don't apply. Check your plan's medical policy for coverage criteria.

Can I request expedited renewal? Yes, if delaying treatment could worsen healing or increase infection risk. Include documentation from your burn surgeon explaining the clinical urgency.

Does step therapy apply to StrataGraft renewals? Most plans require documentation of failed conventional burn care before initial approval. Renewals focus on ongoing medical necessity rather than additional step therapy.

What happens if my plan changes during treatment? Contact your new plan immediately to transfer authorization or file a new request. COBRA coverage may bridge gaps between plans.

How do I find my plan's current StrataGraft policy? Check your specific BCBS plan's medical policy section for "bioengineered skin substitutes" or "cellular and tissue-based products." Policies vary by state and plan type.

About Coverage Navigation

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements for specialty treatments like StrataGraft. Their platform analyzes denial letters and plan policies to create targeted appeals that address specific coverage criteria, improving approval rates for medically necessary treatments.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and specific plan policies. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. For additional help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

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