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

How to Get StrataGraft Covered by UnitedHealthcare in New York: Prior Authorization Guide with Appeals Process and Documentation Requirements

Quick Answer: Getting StrataGraft Approved by UnitedHealthcare in New York

UnitedHealthcare requires prior authorization for StrataGraft (allogeneic cultured keratinocytes & fibroblasts in murine collagen-dsat) under the medical benefit, not pharmacy. Submit via the UHC Provider Portal with burn depth documentation, TBSA calculations, and proof of failed standard therapies. Standard decisions take 5-15 days; expedited reviews for urgent burns take 24-72 hours. If denied, New York's external appeal through DFS gives you binding review within 30 days (72 hours expedited). First step today: Verify your exact UHC plan type and check current PA requirements for HCPCS J7353 on the provider portal.

Table of Contents

What This Guide Covers

This guide helps patients, families, and clinicians navigate UnitedHealthcare's prior authorization process for StrataGraft in New York. StrataGraft is FDA-approved for deep partial-thickness thermal burns in adults when surgical intervention is clinically indicated—essentially cases where autografting would normally be required.

Who this helps:

  • Burn patients needing StrataGraft coverage through UnitedHealthcare
  • Burn surgeons and wound care specialists preparing PA requests
  • Families navigating insurance denials and appeals
  • Healthcare advocates supporting patients through the process

At Counterforce Health, we help patients and providers turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical evidence to craft targeted rebuttals. Our platform identifies specific denial reasons and drafts point-by-point responses aligned to each plan's own rules.

Before You Start: Plan Verification

Step 1: Confirm Your UnitedHealthcare Plan Type

Your appeal rights and timelines depend on which type of UHC plan you have:

Plan Type PA Requirements Appeals Process
UHC Commercial Standard PA list applies Internal appeal → NY DFS external review
UHC Community Plan (NY Medicaid) NY-specific PA requirements Internal appeal → NY DFS external review OR Medicaid Fair Hearing
UHC Exchange/Marketplace Separate PA updates for individual plans Internal appeal → NY DFS external review

Step 2: Verify StrataGraft is a Medical Benefit

Critical: StrataGraft is billed under UnitedHealthcare's medical benefit as a facility-administered skin substitute, not through pharmacy or OptumRx. Attempting to bill through pharmacy channels typically results in automatic denials.

  • Correct billing: HCPCS J7353 per square centimeter on UB-04 (facility claim)
  • Policy reference: UHC's Skin and Soft Tissue Substitutes policy
  • Setting: Hospital outpatient or burn center operating room

Gather Required Documentation

Core Clinical Documentation Checklist

Diagnosis & ICD-10 Codes:

  • Deep partial-thickness thermal burn codes (T20-T25 series)
  • TBSA extent codes (T31.xx series)
  • External cause codes for mechanism and location

Essential Clinical Information:

  • Burn depth confirmation ("deep partial-thickness thermal burn" explicitly stated)
  • Total body surface area (TBSA) percentage with calculation method
  • Wound measurements in square centimeters for each treatment site
  • High-quality photos with measurement scale and date
  • Mechanism of injury (thermal: flame, scald, contact, etc.)

Treatment History Documentation:

  • Prior standard wound care attempts with dates and outcomes
  • Why conventional treatments failed or were inadequate
  • Clinical rationale for why autografting alone is not optimal
  • Explanation of how StrataGraft will reduce donor site morbidity

Medical Necessity Letter Components

Your burn surgeon should include:

  1. Patient demographics and burn circumstances
  2. Specific anatomical locations requiring StrataGraft
  3. Burn depth assessment with clinical evidence
  4. TBSA calculations using rule of nines or palmar method
  5. Prior therapy failures with specific dates and outcomes
  6. Surgical plan including OR scheduling and post-op care
  7. Literature support referencing FDA approval and clinical trials
From our advocates: We've seen StrataGraft approvals significantly improve when providers include specific measurements (e.g., "15 cm x 10 cm = 150 cm²") rather than general descriptions, and when they explicitly tie the request to FDA-approved indications. Clear documentation of why autograft harvesting poses additional risks often strengthens the medical necessity argument.

Submit Your Prior Authorization Request

Submission Channels

Preferred method: UnitedHealthcare Provider Portal

  • Faster processing (1-5 days standard)
  • Real-time status tracking
  • Electronic document upload

Alternative methods:

  • Fax: Use UHC's medical prior authorization forms
  • Phone: Provider services number on member ID card

Request Packet Checklist

Submit all documents together to avoid delays:

  • Completed PA request form
  • Provider medical necessity letter
  • Clinical notes with burn assessment
  • Wound photographs with measurements
  • TBSA calculation worksheet
  • Prior therapy documentation
  • Operative plan and scheduling information
  • Lab results (if infection concerns)

Expedited Review Criteria

Request expedited processing if:

  • Delay could seriously jeopardize patient's life or health
  • Risk of wound deterioration or infection
  • Functional impairment likely without prompt treatment

Timeline for expedited: 24-72 hours vs. 5-15 business days standard

Follow-Up and Timeline Management

Standard Follow-Up Schedule

  • Day 3: Check portal status or call to confirm receipt
  • Day 7: Follow up if no initial response
  • Day 10: Escalate if approaching standard timeline limit
  • Day 15: Request supervisor review if no decision

Sample Call Script

"This is [Name] from [Burn Center] calling about prior authorization reference #[number] for StrataGraft, HCPCS J7353, for patient [Name], member ID [number]. We submitted this [X] days ago for deep partial-thickness thermal burns. Can you provide a status update and expected decision timeline?"

Document: Date, time, representative name, reference numbers, and any commitments made.

If You're Asked for More Information

Common Additional Requests

Medical necessity questions:

  • More detailed burn depth assessment
  • Additional photos from different angles
  • Clearer TBSA documentation
  • Specific prior therapy failure details

Administrative requests:

  • Updated demographics or insurance verification
  • Correct facility and provider information
  • Proper ICD-10 and HCPCS coding

Response Strategy

  • Respond within 24 hours to maintain processing timeline
  • Address each specific question rather than providing general information
  • Include supporting literature when medical necessity is questioned
  • Reference FDA labeling and clinical trial data for StrataGraft

If Your Request is Denied

Understanding Denial Letters

Common UnitedHealthcare denial reasons for StrataGraft:

Denial Code/Reason What It Means How to Appeal
Not medically necessary UHC believes standard care is adequate Provide stronger clinical rationale, literature support
Experimental/investigational UHC questions FDA-approved status Submit FDA labeling, clinical trial data
Administrative denial Missing information or incorrect billing Correct documentation, resubmit
Site of care issue Wrong facility or provider type Verify network status, correct billing

Internal Appeal Process

Timeline: 180 days from denial date (verify in your denial letter)

Required elements:

  • Written appeal letter addressing specific denial reasons
  • Additional clinical documentation
  • Point-by-point rebuttal of denial rationale
  • Updated photos or measurements if relevant

Submission: Same portal/fax as original PA request

New York External Appeal Process

If UnitedHealthcare upholds the denial after internal appeal, New York law provides powerful external review rights through the Department of Financial Services (DFS).

Eligibility and Timeline

  • Deadline: 4 months from final adverse determination
  • Cost: Maximum $25 (waived for financial hardship or Medicaid)
  • Decision: Binding on UnitedHealthcare

Expedited External Appeals

For urgent burn cases where 30-day delay could seriously jeopardize health:

  • Timeline: 72 hours for decision
  • Requirement: Physician attestation of urgency
  • Contact: Call DFS at 888-990-3991 when faxing application

How to File

Online: NY DFS External Appeal Portal

By fax: (800) 332-2729

Required documents:

  • DFS External Appeal Application
  • UHC's final denial letter
  • Clinical records supporting medical necessity
  • Physician letter explaining urgency (if expedited)

The external appeal agent assigns independent medical experts to review your case using generally accepted medical standards. If they overturn UHC's denial, the insurer must cover StrataGraft and may refund your appeal fee.

Renewal and Re-Authorization

StrataGraft is typically a one-time application, but you may need re-authorization if:

  • Initial treatment area requires additional coverage
  • New burn sites develop
  • Complications require extended treatment

Documentation for renewal:

  • Healing progress photos
  • Updated wound measurements
  • Clinical assessment of treatment response
  • Justification for additional StrataGraft application

Common Denial Reasons & Solutions

Issue Solution Documentation Needed
Insufficient burn depth documentation Explicit "deep partial-thickness" language Clinical notes, photos, possibly biopsy
Missing TBSA calculations Detailed body surface area assessment Rule of nines worksheet, anatomical diagrams
Inadequate prior therapy documentation Comprehensive treatment history Dated records of failed standard care
Wrong benefit category Correct to medical benefit billing Facility billing setup, HCPCS J7353
Network/facility issues Verify contracted burn center Provider directory, facility participation

FAQ: StrataGraft Coverage in New York

How long does UnitedHealthcare prior authorization take in New York? Standard PA decisions take 5-15 business days. Expedited reviews for urgent burns are completed within 24-72 hours when medical urgency is documented.

What if StrataGraft is considered experimental by UHC? StrataGraft has FDA approval for deep partial-thickness thermal burns. Submit FDA labeling and clinical trial data showing safety and efficacy. If denied, New York's external appeal process has overturned many "experimental" determinations.

Can I request an expedited appeal in New York? Yes. Both internal UHC appeals and NY DFS external appeals offer expedited timelines (72 hours) when delay could seriously jeopardize your health. Requires physician attestation.

Does step therapy apply to StrataGraft? UHC typically requires documentation of failed or inadequate standard wound care before approving StrataGraft. This isn't formal "step therapy" but functions similarly.

What if my employer plan is self-funded? Self-funded ERISA plans aren't subject to NY DFS external appeals. You'd use federal external review processes instead. Check your plan documents or call member services to confirm.

How much will StrataGraft cost me? Costs depend on your deductible, coinsurance, and out-of-pocket maximum. StrataGraft is expensive (institutional pricing), so you'll likely reach your annual maximum quickly. Contact Mallinckrodt about patient assistance programs.

Printable Checklist

Before Starting:

  • Verify UHC plan type (commercial, Medicaid, exchange)
  • Confirm in-network burn center
  • Identify correct billing pathway (medical benefit, not pharmacy)

Documentation to Gather:

  • Deep partial-thickness burn diagnosis with ICD-10 codes
  • TBSA percentage and calculation method
  • Wound measurements in square centimeters
  • High-quality photos with measurement scale
  • Prior therapy attempts and failure documentation
  • Medical necessity letter from burn surgeon

Submission:

  • Submit via UHC Provider Portal (preferred)
  • Include all documents in single submission
  • Request expedited review if medically urgent
  • Document submission date and reference numbers

Follow-Up:

  • Check status at 3, 7, and 10 days
  • Respond to requests for additional information within 24 hours
  • Prepare appeal documentation if denied

If Denied:

  • File internal appeal within 180 days
  • Prepare NY DFS external appeal if needed (within 4 months)
  • Consider expedited appeal for urgent cases

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage decisions depend on your specific plan and clinical circumstances. Always consult with your healthcare providers and insurance representatives for guidance tailored to your situation.

For additional support with insurance appeals and prior authorization challenges, Counterforce Health provides specialized assistance in turning denials into approvals through evidence-based appeal strategies.

Sources & Further Reading

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