How to Get Filsuvez Covered by Blue Cross Blue Shield in Pennsylvania: Coding, Prior Authorization, and Appeals Guide

Answer Box: Getting Filsuvez Covered by Blue Cross Blue Shield in Pennsylvania

Filsuvez (birch triterpenes topical gel) requires prior authorization from Blue Cross Blue Shield in Pennsylvania for epidermolysis bullosa (EB) patients 6+ months old. Use ICD-10 codes Q81.1 (junctional EB) or Q81.2 (dystrophic EB) and HCPCS code J3490 with the exact NDC. First step today: Contact your Blue Cross plan (Highmark or Independence Blue Cross) to get the current PA form and confirm formulary status. If denied, Pennsylvania's new external review program has a 50% overturn rate for appeals.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for Epidermolysis Bullosa
  3. Product Coding: HCPCS, NDC, and Units
  4. Clean Prior Authorization Request
  5. Frequent Coding Pitfalls
  6. Blue Cross Blue Shield Pennsylvania Resources
  7. Appeals Process in Pennsylvania
  8. Pre-Submission Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Filsuvez typically falls under the pharmacy benefit for most Blue Cross Blue Shield plans in Pennsylvania, but coding requirements differ between Highmark and Independence Blue Cross (IBX).

Pharmacy Benefit Path (Most Common):

  • Requires prior authorization through pharmacy benefits manager
  • Uses HCPCS J-codes for billing
  • NDC submission mandatory
  • Quantity limits apply based on wound count and frequency

Medical Benefit Path (Less Common):

  • May apply for in-office administration or specialty clinic dispensing
  • Uses CPT codes for administration
  • Still requires drug-specific HCPCS coding
  • Site-of-care restrictions may apply
Tip: Contact your Blue Cross plan's pharmacy benefits department first to confirm which pathway applies to your patient's coverage.

ICD-10 Mapping for Epidermolysis Bullosa

Accurate diagnosis coding is critical for Filsuvez approval. Blue Cross Blue Shield requires specific EB subtypes with supporting documentation.

Primary ICD-10 Codes

Code Description Documentation Required
Q81.1 Epidermolysis bullosa letalis (junctional EB) Genetic testing showing LAMA3, LAMB3, LAMC2, or COL17A1 mutations
Q81.2 Epidermolysis bullosa dystrophica Genetic testing showing COL7A1 mutations
Q81.8 Other specified epidermolysis bullosa Rare subtypes with specialist confirmation
Q81.9 Epidermolysis bullosa, unspecified Avoid - most payers require subtype specification

Documentation Words That Support Coding

When submitting prior authorization requests, include these specific terms in clinical notes:

  • For Junctional EB (Q81.1): "junctional epidermolysis bullosa," "basement membrane zone defect," "laminin-332 deficiency," "type XVII collagen deficiency"
  • For Dystrophic EB (Q81.2): "dystrophic epidermolysis bullosa," "anchoring fibril defect," "type VII collagen deficiency," "COL7A1 mutation"
Note: Both Highmark and Independence Blue Cross typically require genetic confirmation or specialized dermatology/genetics consultation notes to support these codes.

Product Coding: HCPCS, NDC, and Units

HCPCS Code Assignment

Filsuvez currently uses J3490 ("unclassified drugs") for billing. This may change if CMS assigns a permanent J-code.

Current Billing Requirements:

  • HCPCS Code: J3490
  • Drug Name: Filsuvez (birch triterpenes topical gel)
  • Strength: 10% gel
  • NDC: Include exact NDC from dispensed package
  • Units: Based on 25 mL tubes dispensed

Units Calculation

Each Filsuvez tube contains 25 mL and covers approximately 190 cm² (two business envelope-sized wounds):

Dosing Formula:

  • 1 mm thick layer per wound
  • One tube per wound per dressing change
  • Maximum once daily per wound

Monthly Quantity Calculation:

Number of wounds × Daily dressing changes × 30 days = Monthly tubes needed

Example: Patient with 2 wounds, daily dressing changes = 60 tubes/month

NDC Requirements

Always include the complete 11-digit NDC on all claims and prior authorization requests. This is mandatory for J3490 billing to prevent claim rejections.

Clean Prior Authorization Request

Highmark Prior Authorization

Form Access: Download from Highmark Provider Resource Center

Required Elements:

  • Patient demographics and Highmark member ID
  • Prescriber information and NPI
  • ICD-10 diagnosis code (Q81.1 or Q81.2)
  • Genetic testing results or specialist consultation
  • Current wound assessment (location, size, duration >21 days)
  • Documentation of no squamous cell carcinoma at treatment sites
  • Prior therapy history (if step therapy applies)

Independence Blue Cross Prior Authorization

Submission Methods:

  • Online portal (preferred)
  • Fax: 1-888-671-5285
  • Provider questions: 1-888-678-7012

Documentation Package:

  • Completed PA form
  • Clinical progress notes showing EB diagnosis
  • Genetic testing results
  • Wound photography (if available)
  • Treatment response documentation (for renewals)
From our advocates: We've seen the fastest approvals when providers include a one-page summary highlighting the patient's specific EB subtype, genetic confirmation, wound characteristics, and why standard wound care isn't sufficient. This upfront clarity helps reviewers quickly identify medical necessity.

Frequent Coding Pitfalls

Common Mistakes to Avoid

1. Unspecified EB Coding

  • ❌ Using Q81.9 (unspecified EB)
  • ✅ Use Q81.1 or Q81.2 with genetic documentation

2. Missing NDC Information

  • ❌ Submitting J3490 without NDC
  • ✅ Include complete 11-digit NDC on all claims

3. Incorrect Unit Calculations

  • ❌ Calculating by mL instead of tubes
  • ✅ Bill by number of 25 mL tubes dispensed

4. Inadequate Wound Documentation

  • ❌ "Patient has EB wounds"
  • ✅ "Two 4x5 cm partial thickness wounds on bilateral lower extremities, present for 28 days, requiring daily dressing changes"

5. Missing Age Verification

  • ❌ No age documentation
  • ✅ Confirm patient ≥6 months old in clinical notes

Blue Cross Blue Shield Pennsylvania Resources

Highmark (Western Pennsylvania)

  • Provider Portal: providers.highmark.com
  • Formulary Check: Available through provider portal
  • PA Status: Track through online system
  • Appeals: Submit through provider portal or mail

Independence Blue Cross (Eastern Pennsylvania)

Verification Steps

  1. Confirm formulary status through your plan's online portal
  2. Check current PA requirements (criteria may change annually)
  3. Verify submission methods (online vs. fax preferences)
  4. Review quantity limits for your specific plan

Appeals Process in Pennsylvania

Pennsylvania's new external review program launched in January 2024 with impressive results: 50% of appeals are overturned, making it one of the most patient-friendly systems in the country.

Internal Appeal Process

Step 1: Internal Review

  • Deadline: Submit within timeframe specified in denial letter (typically 60-180 days)
  • Method: Online portal, mail, or fax as specified by your Blue Cross plan
  • Timeline: 30 days for standard review, 72 hours for urgent

Step 2: Internal Appeal

  • Deadline: 60 days after internal review decision
  • Additional Evidence: Include new clinical information, peer-reviewed studies, or specialist opinions
  • Outcome: Final Adverse Benefit Determination letter

Pennsylvania External Review

Eligibility: Must complete internal appeals and receive Final Adverse Benefit Determination

How to File:

Timeline:

  • Standard Review: 45 days
  • Expedited Review: 72 hours for urgent cases
  • Additional Evidence: 15 days after IRO assignment

Success Rate: 50% overturn rate in 2024 (259 out of 517 cases)

Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific criteria.

When to Escalate

Contact the Pennsylvania Insurance Department if:

  • Blue Cross fails to respond within required timeframes
  • Procedural violations occur during review process
  • Coverage is denied despite meeting all published criteria

Pennsylvania Insurance Department:

  • Consumer Services: Available through pa.gov
  • Complaint Filing: Online portal or written submission
  • Free Assistance: Pennsylvania Health Law Project provides appeal support

Pre-Submission Audit Checklist

Before Submitting Your Prior Authorization

Patient Information

  • Patient ≥6 months old with age documented
  • Current Blue Cross Blue Shield member ID verified
  • Correct plan type identified (Highmark vs. IBX)

Clinical Documentation

  • ICD-10 code Q81.1 or Q81.2 with genetic confirmation
  • Wound assessment with location, size, and duration ≥21 days
  • Documentation of no carcinoma at treatment sites
  • Prior therapy history (if step therapy required)

Coding Accuracy

  • HCPCS J3490 with drug name "Filsuvez"
  • Complete 11-digit NDC included
  • Correct unit calculation (tubes, not mL)
  • Appropriate quantity for wound count and frequency

Submission Requirements

  • Correct PA form for your Blue Cross plan
  • All required attachments included
  • Legible provider signature and NPI
  • Submission method confirmed (portal vs. fax)

Follow-Up Preparation

  • Tracking number or confirmation receipt saved
  • Calendar reminder set for follow-up date
  • Appeal strategy prepared if denial expected

Coverage at a Glance

Requirement Highmark Independence Blue Cross Source
Prior Authorization Required Required Plan policies
Age Requirement ≥6 months ≥6 months FDA label
Diagnosis Codes Q81.1, Q81.2 Q81.1, Q81.2 ICD-10 manual
HCPCS Code J3490 J3490 CMS guidelines
Quantity Limits 1 tube/wound/day 1 tube/wound/day Plan formularies
Step Therapy May apply May apply Plan policies
Appeals Deadline Plan-specific Plan-specific Member handbooks

FAQ

How long does Blue Cross Blue Shield PA take in Pennsylvania? Standard prior authorization reviews take 15-30 days. Expedited reviews for urgent cases are completed within 72 hours. Both Highmark and Independence Blue Cross offer online tracking.

What if Filsuvez is non-formulary? Request a formulary exception with medical necessity documentation. Include genetic testing, specialist consultation, and evidence that formulary alternatives aren't appropriate for EB.

Can I request an expedited appeal? Yes, if the delay could seriously jeopardize your health. Document the urgency in your appeal request and include physician attestation of medical necessity.

Does step therapy apply to Filsuvez? Some Blue Cross plans require documented trials of standard wound care therapies first. Include contraindication or failure documentation to bypass step therapy requirements.

What happens if I pay out-of-pocket during appeals? If your appeal is successful, Blue Cross must provide retroactive coverage. Keep all receipts and documentation of payments made during the appeals process.

Patient Assistance Options

Manufacturer Support:

  • Chiesi Total Care Program provides prior authorization assistance and patient support
  • Copay assistance may be available for eligible commercial insurance patients
  • Contact through Filsuvez.com patient resources

State Resources:

  • Pennsylvania Health Law Project offers free appeals assistance
  • Pennie marketplace consumer hotline for marketplace plan issues
  • Pennsylvania Insurance Department consumer services for complaints

The appeals process can feel overwhelming, but Pennsylvania's new external review system gives patients real leverage. With proper coding, thorough documentation, and strategic appeals when needed, most eligible EB patients can access Filsuvez coverage through Blue Cross Blue Shield.

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial patterns and crafting targeted appeals that address each insurer's specific criteria, increasing approval rates for specialty medications like Filsuvez.


Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult healthcare professionals for medical decisions.

Sources & Further Reading:

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