By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (Ivacaftor) Covered by Humana in Michigan: Complete Appeals Guide with Forms and Timelines

Quick Answer: Getting Kalydeco Covered by Humana in Michigan

Kalydeco (ivacaftor) requires prior authorization from Humana and costs approximately $369,255 annually without coverage. To get approved: (1) Submit PA request with CFTR genetic testing showing responsive mutation (G551D, R117H, etc.), (2) Include specialist documentation from CF center, (3) If denied, file internal appeal within 65 days. For Humana Medicare members, external appeals go through federal review (MAXIMUS), not Michigan DIFS. Start today: Gather your genetic test results and contact your CF specialist to begin the PA process.

Table of Contents

Understanding Kalydeco Coverage Requirements

Kalydeco (ivacaftor) is a Tier 5 specialty medication on Humana formularies, meaning it requires prior authorization and specialized handling. The drug costs approximately $28,404 per 28-day supply ($369,255 annually) without insurance coverage.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must get approval before filling Humana PA List Humana Provider Portal
CFTR Mutation Documentation Genetic test showing responsive mutation Lab results from certified facility FDA labeling requirements
Specialist Prescribing CF specialist or pulmonologist required Provider credentials verification Humana policy guidelines
Age Requirements FDA-approved for 1 month and older Patient medical records FDA Label
Formulary Tier Tier 5 Specialty Humana formulary lookup Member portal

Step-by-Step: Fastest Path to Approval

1. Confirm Your CFTR Mutation Status

Who does it: Patient works with CF specialist
Document needed: Genetic testing report showing responsive mutation
Timeline: 1-2 weeks if testing needed
Submit to: Keep for PA submission

Your doctor needs to confirm you have a CFTR mutation that responds to ivacaftor, such as G551D, R117H, or other FDA-approved responsive mutations.

2. Gather Required Clinical Documentation

Who does it: CF specialist and clinic staff
Documents needed:

  • Current pulmonary function tests
  • CF diagnosis confirmation with ICD-10 codes
  • Prior treatment history
  • Clinical notes supporting medical necessity

Timeline: 3-5 business days
Submit to: Include with PA request

3. Submit Prior Authorization Request

Who does it: Prescribing physician or authorized staff
How to submit: Humana provider portal (preferred) or fax to 1-877-486-2621
Timeline: Submit within 30 days of prescription
Expected response: 7 days standard, 72 hours expedited

Tip: Use Humana's online portal when possible—it's faster and provides real-time status updates.

4. Follow Up on Decision

Who does it: Patient or clinic staff
Timeline: Check status after 5 business days
Contact: Humana member services or provider portal

If approved, your prescription will be processed through Humana's specialty pharmacy network. If denied, proceed immediately to appeals.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Missing genetic documentation Submit complete CFTR testing results Lab report showing specific mutation
Non-specialist prescriber Transfer prescription to CF specialist Provider NPI verification
Insufficient clinical justification Submit detailed medical necessity letter Pulmonary function data, symptom documentation
Age-related denial Verify patient meets FDA age requirements Birth certificate, medical records
Step therapy requirement Document contraindications to alternatives Clinical notes explaining why other treatments failed

Appeals Process for Humana in Michigan

Internal Appeals (First Level)

Timeline: File within 65 days of denial notice
Decision timeframe: 7 days standard, 72 hours expedited
How to file: Written request to Humana appeals department

Include in your appeal:

  • Original denial letter
  • Medical necessity letter from CF specialist
  • Complete CFTR genetic testing results
  • Clinical documentation supporting treatment need

Federal External Review (Humana Medicare)

Important: Michigan DIFS cannot process external reviews for Humana Medicare plans. These go through federal review instead.

Timeline: File within 120 days of final internal denial
Decision timeframe: 60 days standard, 72 hours expedited
How to file: Contact MAXIMUS Federal Services

Contact Information:

Commercial Plan External Review

For non-Medicare Humana plans, Michigan's external review process applies:

Timeline: File within 127 days of final internal denial
Decision timeframe: 60 days standard, 72 hours expedited
Contact: Michigan DIFS
Phone: 877-999-6442

Medical Necessity Letter Template

When appealing a Kalydeco denial, your CF specialist should include these key elements:

Essential Components

Patient Information & Diagnosis

  • Confirmed cystic fibrosis diagnosis with ICD-10 codes
  • Specific CFTR mutation documented by genetic testing
  • Age verification meeting FDA requirements

Clinical Justification

  • Current symptoms and disease progression
  • Pulmonary function trends showing need for intervention
  • Previous treatments tried and outcomes

FDA Alignment

  • Reference to FDA approval for patient's specific mutation
  • Citation of clinical trial data supporting efficacy
  • Explanation of mechanism of action for mutation type

Alternative Treatment Assessment

  • Why other CFTR modulators are not appropriate
  • Contraindications to step therapy requirements
  • Specialist recommendation based on genotype

Sample Language

"Patient [Name] has confirmed cystic fibrosis with documented [specific mutation] CFTR mutation via genetic testing performed at [lab]. This mutation is FDA-approved for ivacaftor therapy per the current prescribing information. Clinical presentation includes [symptoms], with pulmonary function showing [data]. Previous treatments with [alternatives] resulted in [outcomes]. Based on the patient's specific genotype and clinical status, Kalydeco represents the most appropriate targeted therapy."

Costs and Patient Assistance

Financial Support Options

Vertex Patient Services Program

  • Copay assistance for eligible patients
  • Coverage investigation and prior authorization support
  • Contact: 1-877-752-5933

Cystic Fibrosis Foundation Compass

State Programs

From our advocates: "We've seen patients successfully appeal Kalydeco denials by working closely with their CF center's social worker to gather all genetic testing documentation upfront. Having complete mutation analysis results—not just a summary—often makes the difference between approval and denial on the first submission."

When to Escalate and Get Help

Contact Michigan Insurance Regulators

If you're experiencing persistent coverage issues with a non-Medicare Humana plan:

Michigan Department of Insurance and Financial Services (DIFS)

Professional Advocacy

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned to each payer's specific requirements, pulling the right clinical evidence and regulatory citations to support specialty drug approvals.

For complex cases involving bad faith denials:

  • Michigan State Bar Lawyer Referral Service
  • Patient advocacy organizations
  • Pro bono legal clinics

Frequently Asked Questions

How long does Humana prior authorization take for Kalydeco? Standard PA decisions are made within 7 days, expedited within 72 hours. Submit requests through the provider portal for fastest processing.

What if my CFTR mutation isn't on the approved list? Work with your CF specialist to document clinical rationale. Some mutations may qualify for off-label use coverage with strong medical necessity documentation.

Can I get expedited review if my condition is urgent? Yes. If delay would seriously jeopardize your health, request expedited PA and appeals. Your doctor must provide supporting documentation.

Does Humana require step therapy for Kalydeco? This varies by plan. If step therapy is required and other treatments are contraindicated, your doctor can request an exception.

What happens if I'm denied at every level? Consider manufacturer patient assistance programs, clinical trials, or working with advocacy organizations for additional appeal strategies.

How much will I pay out-of-pocket? As a Tier 5 specialty drug, expect higher copays. Exact amounts depend on your specific plan's cost-sharing structure.

Can my family member help with appeals? Yes, but you'll need to designate them as an authorized representative in writing to your insurance company.

What if I move to Michigan with existing Kalydeco coverage? Humana provides transition coverage for new members—typically 30 days—while you work through any coverage changes or PA requirements.

This article provides educational information only and is not medical advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies and requirements may change.

Sources & Further Reading

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