By Counterforce Health Team in Firdapse (amifampridine) —

How to Get Firdapse (Amifampridine) Covered by Humana in Michigan: Complete Guide to Prior Authorization and Appeals

Quick Answer: Firdapse (amifampridine) requires prior authorization from Humana Medicare Advantage/Part D in Michigan. You'll need confirmed LEMS diagnosis by a neuromuscular specialist, EMG results showing >60% CMAP increment, VGCC antibody testing, and cancer screening. Submit through Humana's provider portal with complete clinical documentation. If denied, you have 65 days to appeal, with expedited 72-hour reviews available for urgent cases. Michigan's DIFS provides external review after internal appeals are exhausted.

Table of Contents

Coverage Basics

Is Firdapse covered by Humana?

Yes, but with strict requirements. Firdapse (amifampridine) is covered under Humana Medicare Part D as a Tier 5 specialty drug. It's the only FDA-approved amifampridine product for Lambert-Eaton myasthenic syndrome (LEMS) after Ruzurgi's withdrawal in 2022.

Which Humana plans cover it?

All Humana Medicare Advantage and standalone Part D plans include Firdapse on their formularies, but prior authorization is always required. Commercial Humana plans may vary by employer group.

Coverage Type Formulary Status Prior Auth Required Specialty Pharmacy
Medicare Part D Tier 5 (Specialty) Yes, always Yes
Medicare Advantage Tier 5 (Specialty) Yes, always Yes
Commercial (varies) Check plan formulary Usually yes Usually yes

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm diagnosis - Have your neuromuscular specialist document confirmed LEMS with ICD-10 codes G70.80 or G70.81
  2. Gather test results - Collect EMG/repetitive nerve stimulation results and VGCC antibody testing
  3. Complete cancer screening - Obtain chest CT or PET-CT results (required for all new LEMS diagnoses)
  4. Submit PA request - Provider submits through Humana provider portal with all documentation
  5. Track status - Monitor approval status; standard timeline is 15 days, expedited is 72 hours
  6. Fill at specialty pharmacy - Once approved, prescription must be filled at an in-network specialty pharmacy
  7. Plan for renewal - Set calendar reminder for annual reauthorization

Who submits the prior authorization?

Your prescribing physician or their office staff submits the PA request. Patients cannot submit directly, but you can check status by calling Humana member services at the number on your insurance card.

Required Documentation

For Firdapse approval, Humana requires comprehensive clinical documentation proving LEMS diagnosis and medical necessity.

Essential Clinical Documentation:

  • Neuromuscular specialist evaluation with explicit LEMS diagnosis
  • EMG/nerve conduction studies showing CMAP increment >60% (often >100%) after brief exercise or high-frequency stimulation
  • VGCC antibody testing results (P/Q-type preferred; negative results don't exclude diagnosis if EMG is confirmatory)
  • Clinical examination findings documenting proximal muscle weakness, diminished reflexes, and functional impairment
  • Cancer screening results - chest CT or PET-CT (LEMS is often paraneoplastic)
  • ICD-10 diagnosis codes - G70.80 (LEMS, unspecified) or G70.81 (LEMS with specific subtype)
Clinician Corner: Your medical necessity letter should address: (1) confirmed LEMS diagnosis with supporting test results, (2) functional impairment and symptom severity, (3) contraindications to alternative therapies if applicable, (4) expected treatment goals and monitoring plan. Include references to FDA labeling and current neuromuscular guidelines supporting amifampridine as first-line therapy for LEMS.

Timing and Urgency

Standard timeline: 15 calendar days from complete submission

Expedited review: 72 hours for urgent medical situations where waiting could seriously jeopardize health

How to request expedited review:

  • Provider calls Humana at the number on the patient's insurance card
  • Must provide clinical justification for urgency
  • Document why delay would harm the patient's health or functional status

Filing deadlines:

  • Initial PA requests: No specific deadline, but submit before prescription is needed
  • Appeals: Must file within 65 calendar days of denial notice

Coverage Criteria

Humana's coverage criteria align with FDA labeling and clinical guidelines for LEMS treatment.

Medical Necessity Requirements:

✅ Confirmed LEMS diagnosis by neuromuscular specialist ✅ Age ≥6 years (FDA-approved age range) ✅ Maximum daily dose ≤100 mg (updated FDA labeling limit) ✅ No seizure history or other contraindications ✅ Appropriate cancer screening completed

Step Therapy Considerations:

Some Humana plans may require documentation of previous therapies, though amifampridine is generally considered first-line for LEMS. Be prepared to document:

  • Prior trials of pyridostigmine (if applicable)
  • IVIG or plasmapheresis attempts
  • Immunosuppressive therapy trials (for autoimmune LEMS)

Costs and Copays

Typical out-of-pocket costs for Tier 5 specialty drugs:

  • Coinsurance: 25-33% of drug cost
  • Monthly cost estimate: $2,000-$8,000+ until reaching Medicare Part D catastrophic coverage
  • After catastrophic threshold: 5% coinsurance

Cost-Saving Options:

  • Catalyst Cares Patient Assistance Program - Income-based support for eligible patients
  • Medicare Extra Help/Low Income Subsidy - Reduces Part D costs for qualifying beneficiaries
  • State pharmaceutical assistance programs - Check Michigan-specific programs
Tip: Apply for manufacturer assistance early in the year before reaching the Part D coverage gap ("donut hole").

Denials and Appeals

Common Denial Reasons & Solutions:

Denial Reason How to Fix
Incomplete diagnosis documentation Submit neuromuscular specialist consult notes with explicit LEMS diagnosis
Missing EMG results Provide nerve conduction studies showing characteristic incremental response
Lack of specialist involvement Ensure neurologist or neuromuscular specialist is prescriber of record
Exceeding dose limits Verify daily dose ≤100 mg per updated FDA labeling
Missing cancer screening Submit chest CT or PET-CT results

Appeals Process in Michigan:

  1. Internal Appeal (Level 1)
    • File within 65 days of denial
    • Humana has 30 days to decide (72 hours if expedited)
    • Submit additional clinical documentation addressing denial reasons
  2. Independent Review (Level 2)
    • Automatic if Level 1 upheld
    • External medical reviewer evaluates case
    • 60-day timeline for decision
  3. Michigan DIFS External Review
    • Available after internal appeals exhausted
    • File within 127 days of final internal denial
    • Submit online or call 877-999-6442
    • Decision within 60 days (72 hours if expedited)

Appeal Submission Methods:

  • Online: Humana member portal
  • Phone: Number on insurance card
  • Mail: Address on denial letter
  • Fax: Check current number on Humana provider portal

At Counterforce Health, we help patients and clinicians turn insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and crafting evidence-based rebuttals that address payers' exact requirements. Our platform streamlines the appeal process by pulling the right clinical citations and weaving them into compelling medical necessity arguments.

Renewals and Reauthorization

Renewal frequency: Annual (every 12 months) after initial approval

When to submit renewal:

  • 30-60 days before current authorization expires
  • Set calendar reminders to avoid coverage gaps

Renewal requirements:

  • Continued clinical benefit documentation
  • Specialist attestation of ongoing need
  • Updated functional assessment
  • Confirmation of no new contraindications

What changes might affect renewal:

  • New seizure history
  • Dose increases above approved limits
  • Changes in diagnosis or specialist care
  • Development of contraindications

Specialty Pharmacy Requirements

Why specialty pharmacy is required: Firdapse must be dispensed by an in-network specialty pharmacy due to its high cost, need for patient monitoring, and requirement for specialized handling.

Finding your specialty pharmacy:

  • Check Humana's provider directory
  • Common options include CVS Specialty, Humana Specialty Pharmacy, and Accredo
  • Verify network participation before first fill

Transfer process: If your prescription was sent to a retail pharmacy, it will need to be transferred to a specialty pharmacy. The specialty pharmacy typically handles this transfer process directly.

Troubleshooting Common Issues

Portal access problems:

  • Verify provider has current Humana portal credentials
  • Use phone/fax backup methods if portal is down
  • Contact Humana provider services for technical support

Missing forms or documentation:

  • Download current PA forms from Humana provider portal
  • Verify you're using the most recent version
  • Submit complete packages to avoid processing delays

Communication delays:

  • Follow up if no response within expected timeframes
  • Keep detailed records of all submissions and communications
  • Use certified mail for important appeals documents

FAQ

How long does Humana PA take in Michigan? Standard prior authorization decisions are made within 15 calendar days. Expedited reviews for urgent cases are completed within 72 hours.

What if Firdapse is non-formulary on my specific plan? Firdapse is typically included on all Humana Medicare formularies as a Tier 5 specialty drug. If it appears non-formulary, request a formulary exception through the standard PA process.

Can I request an expedited appeal in Michigan? Yes, if waiting for the appeal decision could seriously jeopardize your health. Your doctor must provide clinical justification for the urgency.

Does step therapy apply if I've tried other treatments outside Michigan? Yes, prior therapy trials from any location count toward step therapy requirements. Provide documentation of previous treatments and their outcomes.

What happens if I move to Michigan mid-treatment? Existing prior authorizations typically remain valid through their expiration date. Notify Humana of your address change and verify your new providers are in-network.

How do I check my appeal status? Log into your Humana member portal, call the member services number on your insurance card, or ask your provider to check status through their portal.

What if my specialist isn't in Humana's network? You may need to obtain a referral to an in-network neuromuscular specialist, or your provider can request a network adequacy exception if no appropriate specialists are available in your area.

Can family members help with the appeal process? Yes, if you've designated them as authorized representatives. Complete Humana's authorization form to allow family members to act on your behalf.

For additional support with complex prior authorizations and appeals, Counterforce Health provides specialized assistance in developing evidence-based arguments that address specific payer requirements and increase approval rates for rare disease medications like Firdapse.

Sources & Further Reading:

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with Humana and consult your healthcare provider for medical decisions. For official Michigan insurance regulatory guidance, contact the Department of Insurance and Financial Services at 877-999-6442.

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