Coding That Helps Get StrataGraft Approved in Pennsylvania with Blue Cross Blue Shield (ICD-10, HCPCS J7353, NDC)

Quick Answer: StrataGraft requires prior authorization from Blue Cross Blue Shield in Pennsylvania, billed under HCPCS code J7353 as a medical benefit (not pharmacy). Use ICD-10 codes T20-T25 for burn location plus T31 for body surface area. Calculate units as actual cm² treated (each unit = 100 cm²). Submit PA with wound measurements, failed standard therapy documentation, and FDA-approved indication (deep partial-thickness thermal burns). If denied, Pennsylvania's external review program overturns about 50% of appeals.

Table of Contents

1. Coding Basics: Medical vs. Pharmacy Benefit
2. ICD-10 Mapping for Burns
3. Product Coding: J7353 Units and NDC
4. Clean Prior Authorization Request
5. Frequent Billing Pitfalls
6. Verification with Blue Cross Blue Shield
7. Pre-Submission Audit Checklist
8. Appeals Process in Pennsylvania
9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

StrataGraft is always billed as a medical benefit, not through pharmacy channels. This tissue-engineered skin substitute is administered during surgical procedures and falls under facility-based billing protocols.

Coverage at a Glance

Requirement	What It Means	Where to Find It
Prior Authorization	Required for all Blue Cross plans in PA	Highmark PA medical policies
HCPCS Code	J7353 per square centimeter	CMS billing guidelines
Medical Benefit	Billed through facility, not pharmacy	Blue Cross provider manuals
FDA Indication	Deep partial-thickness thermal burns only	FDA StrataGraft labeling
Documentation	Wound measurements, failed therapies	Payer PA forms

Key Difference: Unlike oral medications that go through pharmacy benefits, StrataGraft is classified as a surgical supply or biologic dressing, making it subject to medical benefit rules and facility billing procedures.

ICD-10 Mapping for Burns

Accurate ICD-10 coding is crucial for StrataGraft approval. Pennsylvania Blue Cross plans require specific documentation of burn depth, location, and extent.

Primary Burn Codes (T20-T25 Series)

• T20.2: Second-degree burn of head, face, and neck
• T21.2: Second-degree burn of trunk
• T22.2: Second-degree burn of shoulder and upper limb
• T23.2: Second-degree burn of wrist and hand
• T24.2: Second-degree burn of hip and lower limb
• T25.2: Second-degree burn of ankle and foot

Body Surface Area Documentation (T31 Series)

Document total body surface area (TBSA) involved:

• T31.10: Burns involving 10-19% of body surface
• T31.20: Burns involving 20-29% of body surface
• T31.30: Burns involving 30-39% of body surface

Documentation Requirements

Your medical records must include:

• Specific anatomical location (e.g., "anterior thigh," not just "leg")
• Burn depth assessment confirming deep partial thickness
• TBSA calculation using rule of nines or palmar method
• Encounter type (initial = A, subsequent = D, sequela = S)
• External cause codes (X00-Y99 for mechanism of injury)

Tip: Take photographs and measure wounds in centimeters. Blue Cross reviewers often request visual documentation for high-cost biologics like StrataGraft.

Product Coding: J7353 Units and NDC

StrataGraft uses HCPCS code J7353 with specific unit calculations that frequently cause billing errors.

Units Calculation

Each StrataGraft construct covers approximately 100 cm² (8 cm × 12.5 cm). Units billed = total wound area ÷ 100 cm².

Example: 180 cm² wound = 1.8 units, but you bill 1 unit (round down for partial units unless payer specifies otherwise).

Required Modifiers

• -JW: Document any discarded/wasted material
• -59: Distinct procedural service if multiple sites
• -RT/-LT: Right/left anatomical modifiers when applicable

NDC Information

While J7353 is the primary billing code, some Blue Cross plans require the National Drug Code for tracking:

• NDC: Available on product packaging (verify with current FDA labeling)
• Note: Medical benefit claims focus on HCPCS over NDC, but have it ready

Clean Prior Authorization Request

Pennsylvania Blue Cross plans (Highmark, Independence Blue Cross) require comprehensive PA documentation for StrataGraft approval.

Step-by-Step PA Submission

1. Gather Clinical Documentation (Patient/Clinic)
   • Burn assessment photos
   • Wound measurements in cm²
   • Treatment history and failures
   • Timeline: 1-2 days
2. Complete PA Forms (Clinic Staff)
   • Submit via provider portal
   • Include ICD-10 codes and J7353
   • Timeline: Same day
3. Medical Necessity Letter (Physician)
   • FDA-approved indication confirmation
   • Failed standard therapy documentation
   • Timeline: 1-2 days
4. Submit Supporting Evidence (Clinic)
   • Operative notes if applicable
   • Lab results ruling out infection
   • Timeline: Same day as PA

Medical Necessity Checklist

Your physician's letter should address:

• Problem: Deep partial-thickness thermal burn with specific location and TBSA
• Prior treatments: Standard wound care attempts and outcomes
• Clinical rationale: Why StrataGraft is medically necessary vs. alternatives
• FDA indication: Confirm use aligns with approved labeling
• Dosing: Units needed based on wound measurements
• Monitoring plan: Follow-up care and assessment criteria

Frequent Billing Pitfalls

Common errors that lead to Blue Cross denials:

Unit Calculation Errors

Error	Impact	Solution
Overbilling units	Automatic denial	Bill only actual wound area treated
Rounding up partial units	Claim rejection	Round down unless payer specifies otherwise
Billing unused constructs	Fraud risk	Use -JW modifier for documented waste

Documentation Failures

• Missing wound measurements: Include precise cm² calculations
• Inadequate photos: Submit clear images showing burn depth
• Incomplete treatment history: Document all failed standard therapies
• Wrong diagnosis codes: Use specific T20-T25 codes, not generic wound codes

Site-of-Service Mismatches

StrataGraft must be billed appropriately for the care setting:

• Inpatient: Hospital revenue codes with J7353
• Outpatient: Facility billing with proper place of service codes
• Never: Pharmacy claims or home infusion billing

Verification with Blue Cross Blue Shield

Before submitting claims, verify current requirements with your specific Blue Cross plan.

Pre-Authorization Verification

1. Check formulary status via provider portal
2. Confirm PA requirements for your patient's plan
3. Verify coding guidelines for facility vs. outpatient
4. Review quantity limits and frequency restrictions

Highmark Pennsylvania Specifics

Highmark requires PA for bioengineered skin substitutes with documentation of:

• Burn depth assessment
• Failed standard wound care
• Medical necessity for biological dressing
• (Verify current policy at provider portal)

Independence Blue Cross Requirements

IBC follows similar protocols but may have different:

• Application frequency limits
• Required supporting documentation
• Approval timelines
• (Confirm current guidelines through IBC provider resources)

Pre-Submission Audit Checklist

Review these elements before submitting your StrataGraft claim:

Clinical Documentation

• ICD-10 codes match wound location and depth
• TBSA calculation documented
• Wound measurements in cm² recorded
• Photos showing burn characteristics included
• Failed standard therapy attempts documented

Coding Accuracy

• J7353 units = actual wound area ÷ 100 cm²
• Appropriate modifiers applied (-JW, -59, -RT/-LT)
• NDC available if required by plan
• Site-of-service codes match care setting

Prior Authorization

• PA approved before service (except emergencies)
• All required forms completed
• Medical necessity letter attached
• Supporting clinical evidence included

Appeals Process in Pennsylvania

If Blue Cross denies your StrataGraft claim, Pennsylvania offers robust appeal rights with a new state-supervised external review program.

Internal Appeals (Required First Step)

1. File within 60 days of denial notice
2. Submit additional documentation addressing denial reason
3. Request peer-to-peer review if clinical disagreement
4. Timeline: 30 days for standard review, 72 hours for urgent

Pennsylvania External Review

Pennsylvania launched its Independent External Review Program in January 2024, providing state oversight of insurance appeals.

Success Rate: Approximately 50% of external reviews result in overturned denials, with patients receiving coverage for initially denied treatments.

External Review Process

1. Eligibility: Must have Final Adverse Benefit Determination from internal appeal
2. Timeline: File within 4 months of final denial
3. Review period: 45 days standard, 72 hours expedited
4. Cost: No fee to patient
5. Decision: Binding on insurer

Submit requests via: Pennsylvania Insurance Department external review portal

From our advocates: We've seen Pennsylvania external reviews succeed when families include comprehensive wound photos, detailed treatment timelines, and clear physician statements about why StrataGraft was the appropriate choice over alternatives. The independent medical reviewers appreciate seeing the complete clinical picture, not just the initial PA paperwork.

FAQ

How long does Blue Cross PA take for StrataGraft in Pennsylvania? Standard PA reviews take 14 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if StrataGraft is non-formulary on my Blue Cross plan? Request a formulary exception with medical necessity documentation. Include evidence of failed standard therapies and FDA labeling support.

Can I request an expedited appeal if my burn is worsening? Yes. Both internal appeals and Pennsylvania external reviews offer expedited processes for urgent medical situations.

Does step therapy apply to StrataGraft? Most Blue Cross plans require documentation of failed standard wound care before approving advanced biologics like StrataGraft.

What happens if I paid out-of-pocket during the appeal? If your appeal succeeds, Blue Cross must reimburse covered expenses, including retroactive payment for services received during the appeal period.

How do I calculate StrataGraft units for billing? Measure wound area in cm², divide by 100 (each unit covers ~100 cm²), and round down for partial units unless your payer specifies otherwise.

What's the difference between Highmark and Independence Blue Cross requirements? Both require PA for StrataGraft, but specific forms, timelines, and documentation requirements may vary. Check your plan's provider manual for details.

Can I appeal to Pennsylvania if my Blue Cross plan is self-insured? Self-insured employer plans are governed by federal ERISA law, not state insurance regulations. Check your plan documents for appeal procedures.

When Coverage Gets Complex

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Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by specific Blue Cross Blue Shield plan and can change. Always verify current requirements through official payer resources and consult with healthcare professionals regarding treatment decisions.

Need Help? Contact the Pennsylvania Insurance Department's consumer services at pa.gov for assistance with insurance appeals and external reviews.

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