By Counterforce Health Team in Kalydeco (ivacaftor) —

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

Quick Answer: Getting Kalydeco Covered by Humana in Florida

Kalydeco (ivacaftor) requires prior authorization from Humana and is typically placed on Tier 5 (Specialty) with higher cost-sharing. Your cystic fibrosis specialist must submit genetic testing results confirming a responsive CFTR mutation (like G551D or R117H), clinical documentation, and a medical necessity letter. If denied, you have 65 days to appeal. Start by having your CF center contact CenterWell Specialty Pharmacy and submit PA forms to Humana's clinical team at 866-856-8974.

First step today: Contact your CF center to gather genetic test results and request they initiate the prior authorization process with Humana.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Setup
  5. Appeals Process in Florida
  6. Common Denial Reasons & Solutions
  7. Cost-Share Basics
  8. Step-by-Step: Fastest Path to Approval
  9. FAQ
  10. When to Escalate

Plan Types & Coverage Implications

Humana offers several plan types in Florida, each with different coverage rules for Kalydeco:

Medicare Advantage (Part C): Most common Humana plan in Florida. Requires prior authorization for Kalydeco with 30-day standard decision timelines. Network restrictions apply for specialists and specialty pharmacies.

Medicare Part D: Prescription drug coverage with 7-day standard appeal timelines. Kalydeco must be filled through approved specialty pharmacies only.

Medicaid (Healthy Horizons): Requires PCP referrals to pulmonologists and CF centers. Prior authorization needed through clinical intake team at 813-321-7220 (fax).

Note: All Humana plans in Florida require prior authorization for Kalydeco regardless of plan type. Network rules and referral requirements vary by plan.

Formulary Status & Tier Placement

Kalydeco is included on Humana's 2024 formulary as a Tier 5 Specialty drug, meaning higher out-of-pocket costs compared to lower tiers. This placement reflects the medication's annual list price of approximately $369,255.

Key formulary details:

  • Prior authorization required: Yes, for all plan types
  • Step therapy: May apply depending on clinical history
  • Quantity limits: Typically 30-day supply per fill
  • Specialty pharmacy mandate: Must use CenterWell or approved network pharmacy

Alternative CFTR modulators on Humana's formulary include Orkambi, Symdeko, and Trikafta, depending on your specific CFTR mutations and age.

You can verify current formulary status at Humana's drug list search or by calling member services.

Prior Authorization Requirements

Humana requires comprehensive documentation for Kalydeco approval:

Required Clinical Documentation

Document Type Specific Requirements Where to Submit
Genetic Testing CFTR mutation analysis showing responsive mutation (G551D, R117H, etc.) With PA form
Specialist Prescription From CF center pulmonologist or qualified specialist CenterWell Specialty
Medical Necessity Letter Diagnosis, prior treatments, clinical rationale PA team fax
Clinical Notes Recent CF center visit notes, PFTs if available With PA submission

Medical Necessity Letter Checklist

Your prescriber should include:

  • Patient identification and Humana member ID
  • Confirmed CF diagnosis with ICD-10 code
  • Specific CFTR mutation and lab report
  • Previous CF treatments tried and outcomes
  • Clinical rationale for ivacaftor therapy
  • Age-appropriate dosing per FDA label
  • Monitoring and follow-up plan
Clinician Corner: The strongest medical necessity letters cite the FDA prescribing information for mutation-specific indications and include recent pulmonary function tests showing the need for CFTR modulator therapy.

Specialty Pharmacy Setup

Once approved, Kalydeco must be dispensed through Humana's specialty pharmacy network:

Primary option: CenterWell Specialty Pharmacy (Humana's preferred partner)

  • Handles insurance coordination and prior authorization
  • Provides clinical support and adherence monitoring
  • Offers home delivery throughout Florida

Network alternatives: Accredo Health or CVS Specialty may be available with prior approval from Humana. Contact member services to request an exception if you need a specific pharmacy.

Setup process:

  1. Prescriber sends prescription to CenterWell after PA approval
  2. Patient completes insurance verification and delivery setup
  3. CenterWell coordinates with Humana for ongoing refills
  4. Clinical pharmacist provides education and monitoring support

Appeals Process in Florida

If Humana denies coverage for Kalydeco, you have specific rights under Florida and federal law:

Internal Appeal Timeline

  • Filing deadline: 65 days from written denial notice
  • Decision timeline: 7 days for Part D drug appeals, 30 days for Medicare Advantage
  • Who can appeal: You, your prescriber, or appointed representative

Required Appeal Documentation

  • Copy of original denial letter
  • Updated medical necessity letter addressing denial reasons
  • Additional clinical documentation (labs, imaging, specialist notes)
  • Humana Medicare Authorized Representative form if filing on behalf of patient

External Review Process

If the internal appeal is denied, you can request external review through Florida's contracted independent review organization:

  • Filing deadline: 4 months after final internal denial
  • Cost: Free to consumers
  • Decision: Binding on Humana if overturned

Contact Florida's Division of Consumer Services at 877-693-5236 for assistance with the external review process.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing genetic testing Submit CFTR mutation analysis Lab report from certified lab
Not medically necessary Enhanced clinical letter PFTs, treatment history, specialist notes
Step therapy not met Document contraindications/failures Prior medication trials and outcomes
Age restrictions Verify FDA-approved age range Birth certificate, prescriber attestation
Non-formulary status Request formulary exception Comparative effectiveness data
From our advocates: In our experience helping families navigate CF drug approvals, the most successful appeals include a detailed timeline of previous treatments and their outcomes. One family's appeal was approved after their CF center provided documentation showing three failed therapies and declining lung function, directly addressing Humana's step therapy requirements.

Cost-Share Basics

As a Tier 5 specialty drug, Kalydeco typically involves significant cost-sharing:

Typical cost-sharing structures:

  • Deductible: May apply before coverage begins
  • Coinsurance: Usually 25-40% for specialty tier
  • Out-of-pocket maximum: Provides annual cap on total costs

Financial assistance options:

  • Vertex Patient Services: Manufacturer copay assistance program
  • CF Foundation Compass: Financial assistance for eligible patients
  • Florida Medicaid: May provide additional coverage for dual-eligible members
Important: These are educational examples only. Your actual costs depend on your specific plan design. Contact Humana member services for precise cost-sharing information.

Step-by-Step: Fastest Path to Approval

  1. Gather genetic testing results (Patient/Family)
    • Contact your CF center for CFTR mutation analysis
    • Ensure testing shows responsive mutation for ivacaftor
    • Timeline: 1-2 days if already on file
  2. Schedule CF specialist appointment (Patient)
    • Discuss Kalydeco therapy with pulmonologist
    • Request prescription and medical necessity letter
    • Timeline: 1-2 weeks for appointment
  3. Submit prior authorization (CF Center/Prescriber)
    • Complete Humana PA forms
    • Fax to clinical team: 813-321-7220 (Medicaid) or 866-856-8974 (Medicare)
    • Timeline: Same day submission possible
  4. Set up specialty pharmacy (CF Center)
    • Send prescription to CenterWell Specialty Pharmacy
    • Coordinate patient insurance verification
    • Timeline: 1-2 business days
  5. Track PA decision (Patient/Prescriber)
    • Standard decision: 7 days (Part D) or 30 days (Medicare Advantage)
    • Expedited available for urgent cases: 72 hours
    • Check status via Humana provider portal
  6. Complete pharmacy setup (Patient)
    • Verify insurance coverage with CenterWell
    • Arrange delivery and clinical support services
    • Timeline: 2-3 business days after approval
  7. Monitor and maintain coverage (Patient/Prescriber)
    • Track refill authorizations and renewals
    • Maintain regular CF center follow-up
    • Report any access issues immediately

FAQ

How long does Humana prior authorization take for Kalydeco in Florida? Standard PA decisions are made within 7 days for Part D plans and 30 days for Medicare Advantage. Expedited reviews are available within 72 hours for urgent cases.

What if Kalydeco is non-formulary on my Humana plan? You can request a formulary exception by having your prescriber submit documentation showing medical necessity and lack of suitable alternatives on the formulary.

Can I request an expedited appeal in Florida? Yes, expedited appeals are available for urgent medical situations. Your prescriber must document that standard timelines would seriously jeopardize your health.

Does step therapy apply if I've tried other CF medications outside Florida? Yes, treatment history from other states counts toward step therapy requirements. Provide documentation of all prior CF therapies and their outcomes.

What happens if CenterWell Specialty Pharmacy isn't available in my area? Contact Humana member services to request an exception for another network specialty pharmacy like Accredo or CVS Specialty.

How do I get help with the appeals process? Contact Florida's State Health Insurance Assistance Program (SHIP) for free Medicare appeals counseling, or call the Division of Consumer Services at 877-693-5236.

When to Escalate

Contact Florida regulators if you experience:

  • Repeated inappropriate denials despite meeting criteria
  • Failure to meet required decision timelines
  • Lack of response to appeals or external review requests

Florida Division of Consumer Services

  • Phone: 877-693-5236
  • Online complaint: MyFloridaCFO.com
  • Required documents: Denial letters, appeal submissions, correspondence with Humana

For Medicare-related issues, contact the Centers for Medicare & Medicaid Services at 1-800-MEDICARE (1-800-633-4227).

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Kalydeco. Our platform analyzes denial letters and payer policies to create targeted, evidence-based appeals that address specific coverage criteria. We help patients, clinicians, and specialty pharmacies navigate the prior authorization process more effectively, reducing delays in accessing critical treatments.

For families facing Kalydeco denials, Counterforce Health can help identify the specific documentation gaps and craft appeals that directly address Humana's coverage requirements, improving approval rates and reducing time to therapy.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan details and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance regarding your situation. Appeal rights and timelines may vary based on your specific plan type and state regulations.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.