By Counterforce Health Team in Pombiliti (cipaglucosidase alfa-atga) —

How to Get Pombiliti (cipaglucosidase alfa-atga) Covered by Humana in Michigan: Prior Authorization, Appeals, and Cost Assistance

Quick Answer: Getting Pombiliti Covered by Humana in Michigan

Pombiliti (cipaglucosidase alfa-atga) typically requires prior authorization through Humana. Start by having your physician submit a prior authorization request to Humana Clinical Pharmacy Review at 1-800-555-2546, documenting late-onset Pompe disease diagnosis, lack of improvement on current enzyme replacement therapy, and medical necessity for the combination with Opfolda. If denied, you can appeal through Humana's internal process within 65 days, then request an external review through Michigan's Department of Insurance and Financial Services within 127 days. Contact Counterforce Health for expert assistance with prior authorization and appeal documentation.

Table of Contents

Understanding Pombiliti Coverage Requirements

Pombiliti (cipaglucosidase alfa-atga) is a specialized enzyme replacement therapy approved for adults with late-onset Pompe disease who weigh at least 40 kg and aren't improving on their current treatment. The medication must be used in combination with Opfolda (miglustat) and costs approximately $650,000 annually for the combination therapy.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before coverage Humana Prior Authorization Humana Clinical Review
Specialty Pharmacy Must use CenterWell Specialty CenterWell Specialty Humana Network
Diagnosis Requirements Late-onset Pompe disease, adult ≥40kg FDA labeling FDA Approval
Combination Therapy Must be prescribed with Opfolda Pombiliti HCP Site Manufacturer
Appeals Deadline 65 days from denial Humana Appeals Medicare Part D Rules

Humana's Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Physician Submits Prior Authorization (Day 1)
    • Who: Your prescribing physician or specialist
    • Document: Prior authorization request form
    • Submit: Online portal, fax, or phone to Humana Clinical Pharmacy Review
    • Timeline: Humana has 7 days to decide
    • Source: Humana Prior Authorization Process
  2. Include Required Medical Documentation (Day 1)
    • Late-onset Pompe disease diagnosis with genetic confirmation
    • Documentation of current/prior enzyme replacement therapy
    • Evidence of inadequate response to current treatment
    • Weight verification (≥40 kg requirement)
    • ICD-10 codes for Pompe disease
    • Source: Prior Authorization Requirements
  3. Expedited Review if Urgent (Day 1, if applicable)
    • Request 24-hour decision if delay would harm health
    • Physician must provide supporting statement
    • Check expedited box on request form
    • Source: Medicare Part D Expedited Coverage
  4. Monitor Status (Days 2-7)
    • Track through Humana provider portal
    • Call 1-800-555-2546 for updates
    • Member receives written determination
    • Source: Humana Clinical Review

Clinician Corner: Medical Necessity Letter

Your physician's prior authorization request should include:

Required Clinical Elements:

  • Diagnosis: Late-onset Pompe disease with genetic/enzyme confirmation
  • Prior Treatments: Detailed history of previous enzyme replacement therapies (Lumizyme, Nexviazyme)
  • Treatment Response: Objective measures showing inadequate improvement (6-minute walk test, pulmonary function, muscle strength assessments)
  • Contraindications: Any medical reasons why alternative ERTs are inappropriate
  • Dosing Plan: Pombiliti 20 mg/kg IV every 2 weeks plus Opfolda pre-treatment
  • Monitoring Plan: Safety monitoring for hypersensitivity reactions

Supporting Guidelines:

  • FDA Pombiliti Label (verify with source)
  • Pompe disease treatment guidelines from neuromuscular societies
  • Published clinical trial data supporting combination therapy

What Drives Your Out-of-Pocket Costs

Understanding Humana's benefit design helps you plan for costs and identify savings opportunities.

Formulary Tier Placement

Pombiliti's specific tier placement varies by Humana plan. Contact Humana Clinical Pharmacy Review at 1-800-555-2546 to verify your plan's coverage. Most specialty medications like Pombiliti are placed on higher tiers with significant cost-sharing.

Cost-Sharing Structure

  • Specialty tier copays: Often 25-40% coinsurance
  • Deductible: May apply before coverage begins
  • Coverage gap: "Donut hole" in Medicare Part D plans
  • Catastrophic coverage: After reaching out-of-pocket maximum

Financial Assistance Options

Manufacturer Support Programs

AMICUS ASSIST Copay Card

  • Eligible patients with commercial insurance may pay as little as $0 per month
  • Not valid for Medicare, Medicaid, VA, TRICARE, or other government programs
  • Contact: 1-833-AMICUS-A (1-833-264-2872)
  • Hours: Monday-Friday, 8AM-8PM ET
  • Source: AMICUS ASSIST Program

AMICUS Patient Assistance Program

  • Free medication for qualifying uninsured/underinsured patients
  • Available for Medicare beneficiaries not eligible for copay assistance
  • Enrollment through Patient Referral Form
  • Source: Patient Assistance Program

Pompe Disease Foundations

Michigan-Specific Resources:

  • Pompe Foundation of Northern Michigan: Local support for charitable and educational needs
  • United Pompe Foundation: Assists with medical needs not covered by insurance (Fresno, CA)
  • Pompe Alliance: Provides financial assistance for durable medical equipment

Contact these organizations directly for assistance with medication costs and related expenses.

When Humana Denies Coverage: Appeals Process

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Diagnosis not confirmed Submit genetic testing results Enzyme activity levels, genetic analysis
Inadequate prior therapy documentation Provide detailed treatment history Prior ERT records, response measurements
Age/weight requirements not met Verify eligibility criteria Medical records confirming adult status, weight ≥40kg
Missing specialist involvement Include specialist consultation Neuromuscular specialist evaluation

Internal Appeals Process

  1. File Appeal Within 65 Days
    • Submit "Request for Medicare Prescription Drug Coverage Determination"
    • Fax to 877-486-2621 with supporting documents
    • Include physician's updated medical necessity letter
    • Source: Humana Appeals Process
  2. Gather Additional Evidence
    • Updated clinical assessments
    • Published literature supporting combination therapy
    • Peer consultation letters
    • Patient's functional decline documentation
  3. Request Peer-to-Peer Review
    • Have your physician request direct discussion with Humana medical director
    • Often resolves complex cases more efficiently
    • Schedule through Humana Clinical Pharmacy Review

Michigan External Review Process

If Humana upholds their denial after internal appeals, Michigan offers robust external review rights.

Filing External Review

  • Timeline: 127 days from final internal denial
  • Authority: Michigan Department of Insurance and Financial Services (DIFS)
  • Process: Independent medical experts review your case
  • Cost: No charge to patient
  • Decision: Binding on Humana if overturned

How to File

  1. Online: Use DIFS External Review Request form (verify current link with DIFS)
  2. Phone: 877-999-6442 for assistance
  3. Mail/Fax: Submit paper form to DIFS
  4. Timeline: 60 days maximum for standard review, 72 hours for expedited

Expedited External Review

Available when delay would seriously harm your health. Requires physician letter stating medical urgency.

Contact Michigan DIFS:

  • Phone: 877-999-6442
  • Resource: "How to Appeal a Health Insurance Decision" brochure
  • Source: Michigan Insurance Appeals (verify with source)

Specialty Pharmacy Requirements

Humana requires most specialty medications to be dispensed through CenterWell Specialty Pharmacy.

CenterWell Specialty Services

  • Phone: 1-800-486-2668 (TTY: 711)
  • Hours: Monday-Friday 8 AM to 11 PM, Saturday 8 AM to 6:30 PM ET
  • Services: 24/7 pharmacist availability, medication education, monitoring support
  • Benefits: Coordination with infusion centers, insurance navigation
  • Source: CenterWell Specialty Pharmacy

Infusion Coordination

Since Pombiliti requires IV administration every 2 weeks:

  • CenterWell coordinates with approved infusion centers
  • Scheduling and delivery logistics managed by specialty pharmacy
  • Pre-medication protocols coordinated with your care team

Conversation Scripts and Templates

Script: Calling Humana for Prior Authorization Status

"Hello, I'm calling to check on a prior authorization request for Pombiliti for my late-onset Pompe disease. My member ID is [ID number]. The request was submitted by Dr. [Name] on [date]. Can you tell me the current status and if any additional information is needed?"

Key questions to ask:

  • What specific documentation is missing?
  • Can this be expedited due to medical urgency?
  • What's the expected timeline for decision?
  • How will I be notified of the determination?

Email Template: Requesting Clinical Documentation

Subject: Prior Authorization Documentation Request - Pombiliti Coverage

"Dear [Provider Name],

Humana requires additional documentation for my Pombiliti prior authorization. Could you please provide:

  • Updated assessment of my response to current ERT
  • Objective measures of disease progression
  • Medical necessity letter addressing combination therapy rationale

The prior authorization reference number is [number]. Please fax to 877-486-2621 or submit through Humana's provider portal.

Thank you for your assistance."

FAQ: Common Questions

How long does Humana prior authorization take in Michigan? Standard prior authorization decisions are made within 7 calendar days. Expedited requests (for urgent medical situations) are decided within 24 hours when supported by physician documentation.

What if Pombiliti isn't on Humana's formulary? You can request a formulary exception through the same prior authorization process. Your physician must document why all formulary alternatives are medically inappropriate or ineffective.

Can I get help with prior authorization documentation? Yes. Counterforce Health specializes in turning insurance denials into evidence-backed appeals, helping patients and clinicians navigate complex prior authorization requirements for specialty medications.

Does Michigan have special protections for rare disease medications? Michigan's Patient's Right to Independent Review Act provides strong external review rights. The 127-day appeal window is longer than the federal minimum, giving patients more time to gather evidence.

What happens if I start Pombiliti before approval? If you fill your prescription without prior authorization approval, you may be responsible for the full cost (~$650,000 annually). Always wait for approval or confirm emergency coverage provisions.

Can my doctor request an urgent review? Yes. If waiting for standard review could seriously harm your health, your physician can request expedited processing (24-hour decision) by documenting medical urgency in their request.

About Counterforce Health Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific requirements, significantly improving approval rates for complex specialty medications like Pombiliti.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan benefits and medical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For official Michigan insurance appeals information, contact the Department of Insurance and Financial Services at 877-999-6442.

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