By Counterforce Health Team in Filsuvez (birch triterpenes topical gel) —

How to Get Filsuvez (Birch Triterpenes Topical Gel) Covered by Humana in Michigan: Complete Appeals Guide 2025

Answer Box: Getting Filsuvez Covered by Humana in Michigan

Filsuvez (birch triterpenes topical gel) requires prior authorization from Humana Medicare Advantage plans. To get coverage in Michigan: (1) Submit a complete prior authorization request with genetic testing confirming dystrophic or junctional epidermolysis bullosa, (2) Document failed treatments including wound care trials, and (3) If denied, file an internal appeal within 65 days, then request external review through Michigan DIFS within 127 days. Most approvals require confirmation of EB subtype, wound size 10-50 cm², and specialist prescriber.

First step today: Contact your dermatologist to gather genetic testing results and documentation of previous wound care failures before submitting Humana's prior authorization form.

Table of Contents

  1. Understanding Filsuvez Coverage Requirements
  2. Step-by-Step: Prior Authorization Process
  3. Medical Necessity Letter Essentials
  4. Common Denial Reasons and Solutions
  5. Humana Appeals Process in Michigan
  6. Michigan External Review Rights
  7. Cost-Saving Options
  8. FAQ

Understanding Filsuvez Coverage Requirements

Filsuvez is a specialty topical gel for wound care in epidermolysis bullosa (EB), approved by the FDA in December 2024. With costs reaching approximately $27,631 for common quantities according to GoodRx, prior authorization is standard across Medicare Advantage plans like Humana.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Age limit Patient must be ≥6 months old Birth certificate or medical records FDA labeling
Diagnosis Confirmed junctional or dystrophic EB Genetic testing results (COL7A1, LAMA3, etc.) UnitedHealthcare PA criteria
Wound criteria 10-50 cm², present 21 days to 9 months Clinical measurements and photos Maryland Physicians Care policy
Prescriber Dermatologist or wound care specialist Provider credentials and specialty Chiesi access guide
Prior treatments Failed standard wound care or Vyjuvek Treatment records and outcomes AvMed PA form

Step-by-Step: Prior Authorization Process

1. Gather Required Documentation (Patient and Clinic)

  • Genetic testing results confirming EB subtype
  • Clinical notes documenting wound characteristics
  • Prior treatment records showing failures or intolerances
  • Recent photos of wounds with measurements

Timeline: 1-2 weeks to collect all documents

2. Complete Prior Authorization Form (Prescriber)

Access Humana's prior authorization search tool at provider.humana.com to download the current Filsuvez form.

Key sections to complete:

  • Patient demographics and Humana member ID
  • Detailed diagnosis with ICD-10 codes
  • Wound assessment and measurements
  • Prior therapy documentation
  • Clinical rationale for medical necessity

Timeline: Same day once documents are gathered

3. Submit Request (Prescriber or Staff)

Submit via Humana's provider portal or fax to the number specified on the form. Electronic submissions typically receive faster processing.

Timeline: Humana pledges responses within one business day for 95% of electronic requests

4. Track Decision (Patient and Clinic)

Monitor submission status through the provider portal or member portal. Humana must provide written notice of approval or denial.

Timeline: Standard decisions within 30 days for Medicare Part C; 72 hours for expedited requests

Medical Necessity Letter Essentials

Your prescriber's medical necessity letter is crucial for approval. Here's what Humana reviewers need to see:

Clinical Documentation Checklist

  • Patient identification: Name, DOB, Humana member ID
  • Diagnosis confirmation: "Patient has genetically confirmed [junctional/dystrophic] epidermolysis bullosa with mutation in [specific gene]"
  • Wound description: Location, size (must be 10-50 cm²), duration (21 days to 9 months), infection status
  • Prior treatments: Specific therapies tried, duration, and reasons for failure
  • Medical necessity: Why Filsuvez is appropriate for this patient's condition
  • Prescriber credentials: Board certification in dermatology or wound care
Clinician Tip: Include exact measurements and use standardized wound assessment terminology. Vague descriptions like "large wound" often lead to denials.

Supporting Evidence to Include

According to payer policies, strengthen your request with:

  • Genetic testing report with specific mutations identified
  • Clinical photos showing wound characteristics
  • Treatment timeline documenting previous therapies
  • Specialist consultation notes if referred from primary care

Common Denial Reasons and Solutions

Based on typical payer policies for Filsuvez, here are the most frequent denial reasons and how to address them:

Denial Reason Solution Documentation Needed
EB subtype not confirmed Submit genetic testing results Lab report with specific gene mutations
Wound size outside criteria Re-measure and document properly Clinical notes with precise measurements
Insufficient prior therapy trials Document all previous treatments Medical records showing dates, durations, outcomes
Non-specialist prescriber Transfer prescription or get consultation Referral to dermatologist or wound care specialist
Missing clinical rationale Provide detailed medical necessity Comprehensive letter explaining treatment goals

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting targeted responses. Their platform helps identify specific denial reasons and generates evidence-backed rebuttals aligned with each plan's requirements.

Humana Appeals Process in Michigan

If your initial prior authorization is denied, you have multiple levels of appeal available under Medicare regulations.

Internal Appeal (Redetermination)

Deadline: 65 days from denial notice date
Humana response time: 7 days standard, 72 hours expedited
How to file: Online through member portal, by mail, or fax

Required information:

  • Your name, address, and Medicare number
  • Name of denied drug (Filsuvez)
  • Reasons for appealing
  • Supporting clinical documentation
  • Appointment of Representative form if someone is filing for you

Access forms at humana.com/member/exceptions-and-appeals.

Level 2: Independent Review Entity (IRE)

If Humana upholds the denial, the next step is review by an Independent Review Entity.

Deadline: 60 days from redetermination denial
IRE response time: 7 days standard, 72 hours expedited
Process: Automatic forwarding if you request it; IRE conducts independent medical review

Michigan External Review Rights

Michigan offers additional protection through the Department of Insurance and Financial Services (DIFS) external review process.

When to Use DIFS External Review

  • After completing Humana's internal appeals
  • For coverage disputes involving medical necessity
  • When you believe the denial was inappropriate under your policy

Filing Process

Deadline: 127 days from final Humana denial
How to file: Online at difs.state.mi.us
Review timeline: 14 days for standard review, 72 hours for expedited

Required documentation:

  • Final denial letter from Humana
  • Clinical records supporting medical necessity
  • Completed DIFS external review request form
  • Physician statement for expedited review (if urgent)

Contact DIFS: 877-999-6442 (8 a.m. to 5 p.m., Monday-Friday)

Important: The 127-day deadline is firm. Don't wait—file as soon as you receive Humana's final denial.

Cost-Saving Options

While pursuing coverage, explore these financial assistance programs:

Manufacturer Support

Chiesi Global Rare Diseases offers patient assistance programs for eligible patients. Contact Chiesi TotalCare at chiesitotalcare.com for current program details.

Foundation Grants

Organizations supporting rare disease patients may provide grants:

  • DEBRA International: Resources for EB patients and families
  • National Organization for Rare Disorders (NORD): Patient assistance programs
  • HealthWell Foundation: Copay assistance for chronic conditions

State Programs

Michigan residents may qualify for additional support through:

  • Healthy Michigan Plan: Medicaid expansion program
  • Michigan Department of Health and Human Services: Emergency assistance programs

FAQ

How long does Humana prior authorization take for Filsuvez in Michigan?

Standard prior authorization decisions are made within 30 days for Medicare Part C coverage. Electronic submissions through Humana's provider portal typically receive responses within one business day. Expedited requests are decided within 72 hours when urgency is documented.

What if Filsuvez is not on Humana's formulary?

Non-formulary drugs can still be covered through the exceptions process. Your prescriber must demonstrate medical necessity and why formulary alternatives are inappropriate. This requires the same documentation as prior authorization but may have additional requirements for trying preferred alternatives first.

Can I request an expedited appeal if my wounds are worsening?

Yes, expedited appeals are available when waiting for standard review could seriously harm your health. Your physician must provide a written statement explaining the urgency and potential consequences of delay. Both Humana internal appeals and Michigan DIFS external reviews offer expedited options with 72-hour decision timelines.

Does step therapy apply to Filsuvez in Michigan?

Step therapy requirements vary by plan. Some insurers require trying Vyjuvek first for dystrophic EB patients, while others may require standard wound care trials. Check your specific plan documents or contact Humana directly to understand your requirements.

What happens if Michigan DIFS overturns Humana's denial?

DIFS external review decisions are binding. If the Independent Review Organization determines that Filsuvez is medically necessary and should be covered under your policy, Humana must comply with the decision and provide coverage as directed.

From Our Advocates: We've seen cases where patients initially received denials due to incomplete genetic testing documentation, only to gain approval after submitting comprehensive lab reports with specific gene mutations. The key is ensuring your specialist provides detailed clinical rationale that directly addresses the payer's coverage criteria. While outcomes vary by individual circumstances, thorough documentation consistently improves approval chances.

For complex cases involving multiple denials or unclear coverage criteria, Counterforce Health helps patients and clinicians navigate the appeals process by analyzing payer policies and crafting evidence-backed responses tailored to each plan's specific requirements.

Sources & Further Reading

Medical 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 benefits. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. For assistance with insurance appeals in Michigan, contact DIFS at 877-999-6442.

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