How to Get Filsuvez (Birch Triterpenes Topical Gel) Covered by UnitedHealthcare in New Jersey: Complete Prior Authorization Guide with Forms and Appeals
Answer Box: Getting Filsuvez Covered by UnitedHealthcare in New Jersey
Who's eligible: Patients 6+ months with dystrophic or junctional epidermolysis bullosa (confirmed by genetic testing) who have qualifying wounds (10-50 cm², present 3+ weeks).
Fastest path: Submit UnitedHealthcare's Filsuvez prior authorization form with genetic test results, wound photos/measurements, and dermatologist notes through the provider portal. Standard review takes 15-30 days; expedited (72 hours) available for urgent cases.
First step today: Contact your EB specialist to gather genetic testing results and current wound documentation. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review within 180 days.
Table of Contents
- Who Should Use This Guide
- Member & Plan Basics
- Clinical Criteria for Coverage
- Coding and Billing Information
- Documentation Packet Requirements
- Submission Process
- Specialty Pharmacy Network
- After Submission: Tracking Your Request
- Common Denial Reasons & How to Fix Them
- Appeals Process in New Jersey
- Quick Reference Checklist
- Frequently Asked Questions
Who Should Use This Guide
This guide is for New Jersey patients with epidermolysis bullosa (EB) who need Filsuvez (birch triterpenes topical gel) covered by UnitedHealthcare, plus their families and healthcare providers. You'll also find this helpful if you've already been denied and need to appeal.
Expected outcome: With proper documentation meeting UnitedHealthcare's criteria, most patients with confirmed dystrophic or junctional EB and qualifying wounds receive approval. If initially denied, New Jersey's robust external review process gives you a strong second chance—about half of external appeals nationwide favor patients.
Member & Plan Basics
Coverage Requirements
| Requirement | Details | Where to Verify |
|---|---|---|
| Active UnitedHealthcare coverage | Commercial, Medicare Advantage, or Medicaid managed care | Member ID card, online portal |
| Pharmacy benefit | Filsuvez covered under prescription benefit (not medical) | OptumRx formulary |
| Prior authorization required | All plans require PA; no exceptions | UnitedHealthcare PA notification |
| Specialty pharmacy only | Must use OptumRx specialty network | Approval letter provides pharmacy contact |
Note: Even if you have a high-deductible plan, prior authorization is still required before the deductible applies.
Clinical Criteria for Coverage
UnitedHealthcare requires all of the following criteria to be met for initial 12-month authorization:
Patient Requirements
- Age: 6 months or older
- Diagnosis: Dystrophic EB (DEB) or Junctional EB (JEB)
- Genetic confirmation: Documented pathogenic mutation (see specific genes below)
Genetic Testing Requirements by EB Subtype
| EB Subtype | ICD-10 Code | Required Genes | Example Mutations |
|---|---|---|---|
| Dystrophic EB | Q81.1 (Q81.11 dominant, Q81.12 recessive) | COL7A1 | Pathogenic variants in collagen VII gene |
| Junctional EB | Q81.2 (Q81.21 Herlitz, Q81.22 other) | LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3 | Laminin-332 complex defects |
Wound Criteria
- Type: Partial-thickness wounds only
- Size: 10-50 cm² (measured and documented)
- Duration: Present for at least 3 weeks but less than 9 months
- Condition: Clean, non-infected, no skin cancer at application site
- Documentation: Photographs recommended
Prescriber Requirements
- Must be prescribed by or in consultation with a dermatologist with EB expertise
- Cannot be used concurrently with Vyjuvek on the same wound(s)
Coding and Billing Information
NDC and Billing Codes
| Code Type | Number | Details |
|---|---|---|
| Primary NDC | 76431-0310-01 | 23.4g tube, birch triterpenes 10% |
| 11-digit format | 76431-0310-01 | Required for CMS/payer billing |
| Billing unit | GM (gram) | 23.4 billable units per tube |
| HCPCS J-code | J3490 or J3590 | Unclassified drugs (no specific code yet) |
| RxNorm | 2675592 | For electronic prescribing |
Documentation Packet Requirements
Provider Note Elements
Your EB specialist must document:
- Confirmed EB subtype with genetic testing results
- Current wound assessment (size, location, duration, condition)
- Previous treatments attempted and outcomes
- Clinical rationale for Filsuvez therapy
- Treatment goals and monitoring plan
Medical Necessity Letter Components
Include these key elements in your provider's letter:
- Patient identification: Name, DOB, UnitedHealthcare member ID
- Diagnosis: Specific EB subtype with ICD-10 code and genetic mutation
- Wound details: Size, duration, location, photographic evidence
- Failed treatments: Prior wound care attempts with dates and outcomes
- Clinical justification: Why Filsuvez is medically necessary
- Prescriber expertise: Documentation of EB specialization
Required Attachments Checklist
- Completed UnitedHealthcare Filsuvez PA form
- Genetic testing report confirming EB subtype
- Recent clinical notes from EB specialist
- Wound photographs and measurements
- Medical necessity letter
- Insurance verification and member ID copy
Submission Process
Step-by-Step Submission
- Gather documentation (Patient/Family): Collect insurance card, genetic test results, recent photos of wounds
- Schedule appointment (Patient): See your EB dermatologist for current assessment and documentation
- Complete PA form (Provider): Fill out UnitedHealthcare's form with all required clinical information
- Submit package (Provider): Upload through UnitedHealthcare provider portal or fax to number on denial letter
- Track submission (Both): Record confirmation number and check status weekly
Submission Methods
| Method | Best For | Timeline | Notes |
|---|---|---|---|
| Provider Portal | Standard requests | 5-7 business days processing | Preferred method, instant confirmation |
| Fax | Urgent cases | Same day receipt | Use fax number from denial letter |
| Last resort | 7-10 days delivery + processing | P.O. Box 30778, Salt Lake City, UT 84130-0778 |
Tip: For expedited review (72 hours), call UnitedHealthcare provider services at 1-888-842-4571 and explain medical urgency.
Specialty Pharmacy Network
Filsuvez is dispensed exclusively through UnitedHealthcare's specialty pharmacy network managed by OptumRx. Once approved:
- Pharmacy assignment: OptumRx will contact you with your assigned specialty pharmacy
- First fill coordination: The pharmacy will call to schedule delivery and provide patient education
- Ongoing refills: Set up automatic refills 5-7 days before running out
- Patient support: Specialty pharmacists provide dosing guidance and side effect monitoring
Key contact: Optum Specialty Pharmacy at 855-427-4682
After Submission: Tracking Your Request
Timeline Expectations
- Standard review: 15-30 calendar days
- Expedited review: 24-72 hours (requires medical urgency documentation)
- Notification method: Letter, phone call, or provider portal update
What to Record
- Submission date and confirmation number
- Provider portal case number
- Contact person at your clinic handling the request
- Expected decision date
Status check schedule: Weekly for standard requests, daily for expedited
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| "Insufficient genetic testing documentation" | Submit complete genetic report showing pathogenic mutation | Lab report with specific gene variant and interpretation |
| "Wound criteria not met" | Provide updated measurements and photos | Current wound assessment with ruler for scale |
| "Missing EB specialist consultation" | Get evaluation from certified dermatologist | Notes from provider with documented EB expertise |
| "Step therapy not completed" | Document Vyjuvek trial failure or contraindication | Treatment records showing inadequate response |
| "Not medically necessary" | Strengthen clinical justification with guidelines | Medical necessity letter citing EB treatment guidelines |
From our advocates: We've seen cases where initial denials for "insufficient documentation" were overturned simply by resubmitting the same genetic test report with a cover letter highlighting the specific pathogenic mutation. Sometimes it's about making the key information more visible to reviewers.
Appeals Process in New Jersey
Internal Appeals with UnitedHealthcare
Timeline: 180 days from denial date for commercial plans, 65 days for Medicare Advantage
How to submit:
- Online: Through UnitedHealthcare provider or member portal
- Mail: P.O. Box 30778, Salt Lake City, UT 84130-0778
- Fax: Use number provided in denial letter
Required documents:
- Original denial letter
- Updated medical necessity letter addressing denial reasons
- Any new clinical documentation
- Completed appeal form
New Jersey External Review (IHCAP)
If UnitedHealthcare upholds their denial after internal appeals, New Jersey's Independent Health Care Appeals Program (IHCAP) provides an independent review.
Eligibility: You must complete UnitedHealthcare's internal appeal process first
Timeline:
- File within: 180 days of final internal denial
- Decision: Within 45 days for standard cases, expedited available for urgent situations
How to file: Submit directly to Maximus Federal Services (the state's contracted review organization)
Contact information:
- Phone: 1-888-393-1062 (IHCAP hotline)
- General NJ insurance help: 1-800-446-7467 (DOBI Consumer Hotline)
Cost: Free to patients (insurers pay all review costs)
Success rate: Approximately 50% of external appeals nationwide favor patients
Important: New Jersey's external review process is binding on insurers. If IHCAP overturns UnitedHealthcare's denial, they must cover your Filsuvez treatment.
Quick Reference Checklist
Before you start:
- Active UnitedHealthcare coverage confirmed
- Genetic testing results available
- Current wound photos and measurements
- EB specialist appointment scheduled
For submission:
- PA form completed and signed
- Medical necessity letter addressing all criteria
- All required attachments included
- Submission method chosen (portal preferred)
- Confirmation number recorded
After submission:
- Weekly status checks scheduled
- Appeal deadline noted (180 days from denial)
- Specialty pharmacy contact information ready
- New Jersey IHCAP information saved for potential external appeal
Frequently Asked Questions
Q: How long does UnitedHealthcare prior authorization take in New Jersey? A: Standard review takes 15-30 calendar days. Expedited review (for urgent medical situations) takes 24-72 hours.
Q: What if Filsuvez is not on my UnitedHealthcare formulary? A: Filsuvez requires prior authorization on all UnitedHealthcare plans but is covered with PA approval. Non-formulary exceptions are possible with strong medical necessity documentation.
Q: Can I request an expedited appeal if I'm denied? A: Yes, if a delay in treatment would cause serious harm to your health. Call 1-888-842-4571 and explain the medical urgency, then submit written documentation within 48 hours.
Q: Does step therapy apply if I've failed similar treatments outside New Jersey? A: Yes, UnitedHealthcare accepts documentation of failed treatments from any state. Include complete records showing dates, duration, and reasons for discontinuation.
Q: What counts as "EB expertise" for the prescribing physician? A: UnitedHealthcare looks for dermatologists who regularly treat EB patients, are affiliated with EB centers, or have documented experience with rare genetic skin disorders.
Q: How much will Filsuvez cost with UnitedHealthcare coverage? A: With prior authorization approval, your cost depends on your plan's specialty drug tier copay or coinsurance. Contact member services for your specific benefit details.
About Counterforce Health
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Their platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific payer criteria. For complex cases like Filsuvez coverage, where genetic testing and wound documentation requirements are precise, having expert support can make the difference between approval and denial.
If you're facing a UnitedHealthcare denial for Filsuvez, Counterforce Health's system can help identify exactly why your request was denied and craft a point-by-point rebuttal using the right medical evidence and payer-specific language.
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for coverage determinations.
Sources & Further Reading:
- UnitedHealthcare Filsuvez Prior Authorization Form
- New Jersey Independent Health Care Appeals Program (IHCAP)
- OptumRx Formulary Information
- Epidermolysis Bullosa Diagnosis Guidelines
- Filsuvez NDC and Billing Information
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