By Counterforce Health Team in Brineura (cerliponase alfa) —

Getting Brineura (Cerliponase Alfa) Approved by Humana in Michigan: Complete PA Guide and Appeals Process

Answer Box: Quick Path to Brineura Coverage

Brineura (cerliponase alfa) requires prior authorization from Humana for all plans. To get approved in Michigan: (1) Your pediatric neurologist submits PA documentation including CLN2 diagnosis confirmation, Hamburg scale scores, and genetic testing results, (2) Humana reviews within 72 hours for standard requests, and (3) if denied, you have 65 days to appeal internally, then 127 days for Michigan DIFS external review. Start today: Contact your child's neurologist to begin PA submission through Humana's provider portal.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals in Michigan
  7. Renewal Requirements
  8. Specialty Pharmacy Network
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Brineura Covered by Humana?

Yes, Brineura appears on Humana's 2025 Medicare Prior Authorization List, meaning it's covered for eligible patients who meet medical necessity criteria. However, prior authorization is required for all Humana plans before treatment can begin.

Which Humana Plans Cover Brineura?

Brineura is typically covered under the medical benefit (not pharmacy benefit) due to its intraventricular administration method. This applies to:

  • Humana Medicare Advantage plans
  • Humana commercial insurance plans
  • Humana Medicaid plans (where applicable)

Coverage varies by specific policy, so verify your plan's formulary and benefits with Humana customer service at the number on your insurance card.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Schedule with Pediatric Neurologist (Patient/Family)
    • Must be board-certified in pediatric neurology or genetics
    • Document: Specialist consultation notes
    • Timeline: Schedule ASAP, as specialist availability may be limited
  2. Complete Diagnostic Testing (Healthcare Team)
    • Document: Genetic testing showing biallelic TPP1 mutations
    • Document: Enzyme activity testing (leukocytes, fibroblasts, or dried blood spots)
    • Timeline: 2-4 weeks for results
  3. Baseline Assessments (Healthcare Team)
    • Document: Hamburg CLN2 scale scoring (motor and language domains)
    • Document: Age verification (≥3 years required)
    • Timeline: Same visit as specialist consultation
  4. Submit Prior Authorization (Healthcare Provider)
    • Submit via: Humana provider portal or fax
    • Required documents: All diagnostic and assessment documentation
    • Timeline: Provider should submit within 1-2 business days of completing assessments
  5. Humana Review (Insurance Company)
    • Standard review: 72 hours maximum
    • Expedited review: 24 hours (if urgency documented)
    • Decision notification: Via phone and written notice
  6. If Approved: Coordinate Care (Healthcare Team + Patient)
    • Arrange specialty pharmacy dispensing
    • Schedule intraventricular device placement surgery
    • Begin treatment at approved facility
  7. If Denied: Begin Appeal (Patient/Provider)
    • Timeline: Must file within 65 days of denial notice
    • Process: Follow appeals section below

Timing and Deadlines

Humana Review Timeframes

Request Type Humana Decision Timeline When to Use
Standard PA 72 hours maximum Routine requests
Expedited PA 24 hours maximum Medical urgency documented by physician
Appeal (Internal) 30 days for pre-service, 60 days for post-service After initial denial

Michigan-Specific Appeal Deadlines

  • Internal Appeal: 65 days from Humana's denial notice
  • External Review: 127 days from Humana's final adverse determination
  • Expedited External Review: 72 hours (with physician urgency certification)

Medical Necessity Criteria

Humana's Coverage Requirements

Based on Humana's policy documentation, Brineura approval requires:

Diagnosis Requirements:

  • Confirmed late infantile neuronal ceroid lipofuscinosis type 2 (CLN2)
  • Demonstrated deficient TPP1 enzyme activity
  • Identified pathogenic mutations in both TPP1/CLN2 gene alleles

Patient Criteria:

  • Minimum age: 3 years old
  • Disease severity: Hamburg CLN2 scale score of 3-6 with ≥1 point in each domain (motor and language)

Prescriber Requirements:

  • Prescribed by or in consultation with pediatric neurologist or geneticist
  • Specialist must have experience with CLN2 disease management

Administration Requirements:

  • Treatment at facility capable of intraventricular infusions
  • Dosing: 300 mg every 2 weeks via surgically implanted device
  • Quantity limit: 2 packages (4 vials total) per 28 days
Clinician Corner: When preparing your medical necessity letter, include specific Hamburg CLN2 scale scores, genetic testing lab reports with mutation details, and a clear statement about the patient's current functional status. Reference the FDA label for approved indications and dosing.

Costs and Financial Assistance

Understanding Your Out-of-Pocket Costs

Brineura's list price is approximately $27,000 per biweekly infusion ($702,000 annually), plus additional facility and procedure costs. Your actual cost depends on:

  • Coinsurance: Typically 20-50% for specialty medications
  • Deductible: Must be met before coverage begins
  • Out-of-pocket maximum: Caps your annual costs

Financial Assistance Programs

BioMarin RareConnections

  • Provides benefits verification and financial assistance
  • May cover copays/coinsurance for eligible patients
  • Contact: Available through your treating physician or BioMarin's website

Michigan State Programs

  • Children's Special Health Care Services (CSHCS)
  • Medicaid coverage for eligible families
  • Contact your hospital social worker for assistance with applications

When dealing with complex specialty medications like Brineura, Counterforce Health helps patients and clinicians navigate insurance denials by creating evidence-backed appeals tailored to specific payer requirements. Their platform analyzes denial letters and drafts targeted rebuttals using the right clinical evidence and procedural requirements.

Denials and Appeals in Michigan

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Age requirement not met Provide birth certificate Official age verification
Insufficient diagnostic evidence Submit complete genetic testing Lab reports showing TPP1 mutations
Prescriber not qualified Letter from pediatric neurologist Board certification documentation
Facility not appropriate Hospital capability letter Facility accreditation for IV infusions
Not medically necessary Updated clinical notes Hamburg scale scores, progression documentation

Michigan Appeals Process

Level 1: Humana Internal Appeal

  • Deadline: 65 days from denial notice
  • How to file: Humana member portal, phone, or written request
  • Timeline: 30 days for pre-service decisions
  • Required: Copy of denial letter, additional medical documentation

Level 2: Michigan DIFS External Review

  • Deadline: 127 days from Humana's final denial
  • How to file: Michigan DIFS External Review Portal
  • Timeline: 60 days maximum (72 hours if expedited)
  • Contact: DIFS Consumer Hotline at 877-999-6442
  • Cost: Free to patients
Tip: For expedited external review in Michigan, your physician must certify in writing that waiting for a standard review could seriously jeopardize your child's health.

Scripts for Common Situations

Calling Humana for PA Status: "Hello, I'm calling to check the status of a prior authorization request for my child [Name], member ID [number]. The request is for Brineura (cerliponase alfa) for CLN2 disease, submitted by Dr. [Name] on [date]. Can you tell me the current status and expected decision timeline?"

Requesting Peer-to-Peer Review: "We'd like to request a peer-to-peer review for the denied Brineura prior authorization. Dr. [Name] is available [days/times] to speak with your medical director about the medical necessity of this treatment for CLN2 disease."

Renewal Requirements

Annual Reauthorization

Humana typically approves Brineura for 12-month periods with required renewal documentation:

  • Updated Hamburg CLN2 scale assessments
  • Clinical notes documenting treatment response or stable disease
  • Continued specialist oversight confirmation
  • Safety monitoring results (MRI, infection screening)

When to Start Renewal Process

Begin reauthorization 60 days before your current approval expires to avoid treatment interruptions. Your specialty pharmacy and treatment center should coordinate renewal timing.

Specialty Pharmacy Network

Approved Dispensing

Brineura must be obtained through Humana's approved specialty pharmacy network. The medication requires:

  • Cold chain storage and handling
  • Coordination with your treatment facility
  • Delivery timing aligned with infusion schedules

Contact Humana customer service to identify your assigned specialty pharmacy, as this may be automatically determined based on your treatment center's preferences.

Troubleshooting Common Issues

Portal and System Problems

Humana Provider Portal Down:

  • Alternative: Fax PA requests to number provided in your provider manual
  • Backup: Call Humana provider services for phone submission

Missing Required Forms:

  • Download from Humana provider website
  • Request by phone through provider services
  • Use generic CMS forms if Humana-specific forms unavailable

Documentation Delays

Genetic Testing Results Pending:

  • Request expedited processing from lab
  • Provide preliminary results if available
  • Ask lab for estimated completion date

Specialist Scheduling Delays:

  • Contact hospital patient navigator
  • Request urgent consultation given treatment needs
  • Consider telemedicine consultation if available

Frequently Asked Questions

How long does Humana PA take for Brineura in Michigan? Standard requests are decided within 72 hours. Expedited requests (with physician urgency documentation) are decided within 24 hours.

What if Brineura is non-formulary on my Humana plan? Request a formulary exception through the same PA process. Your physician must document why formulary alternatives are ineffective or inappropriate.

Can I request an expedited appeal in Michigan? Yes, both Humana and Michigan DIFS offer expedited reviews. You need physician certification that delay could seriously jeopardize health.

Does step therapy apply to Brineura? No, Brineura is the only FDA-approved disease-modifying treatment for CLN2. There are no alternative medications to try first.

What happens if my child turns 18 during treatment? Coverage typically continues if treatment was initiated appropriately in childhood. Discuss transition planning with your care team and insurance coordinator.

Can I appeal if my treatment center isn't in Humana's network? Yes, you can request a network adequacy exception if no in-network facilities can provide appropriate CLN2 care in your area.

How do I find pediatric neurologists experienced with CLN2 in Michigan? Major centers include C.S. Mott Children's Hospital (University of Michigan) and Corewell Health Helen DeVos Children's Hospital. Ask for referrals to metabolic or lysosomal storage disease specialists.

What if Humana requests additional information after initial submission? Respond promptly with requested documentation. The review timeline may restart from when you provide the additional information.

For complex prior authorization challenges, platforms like Counterforce Health can help create comprehensive appeals that address specific payer requirements and include appropriate medical evidence for rare disease treatments.

Sources and Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company directly for coverage determinations. Coverage policies and procedures may change; verify current requirements with your insurer and state regulators.

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