By Counterforce Health Team in Kalydeco (ivacaftor) —

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

Quick Answer: Getting Kalydeco (ivacaftor) Covered by Humana in Georgia

Kalydeco requires prior authorization from Humana and is covered as a Tier 5 specialty drug. The fastest path to approval: 1) Have your CF specialist submit a prior authorization request with CFTR genotype testing results through Humana's provider portal, 2) Ensure documentation includes your specific ivacaftor-responsive mutation and failed alternative therapies, 3) If denied, file an internal appeal within 65 days. Georgia residents can access external review through the federal Independent Review Entity if needed. Start today by calling your CF center to confirm they have your complete genotype results.

Table of Contents

Coverage Basics

Is Kalydeco (ivacaftor) Covered by Humana?

Yes, Kalydeco is covered by Humana plans but requires prior authorization for all prescriptions. The medication is classified as a Tier 5 specialty drug, meaning higher out-of-pocket costs compared to lower tiers.

Which Humana Plans Cover Kalydeco?

All Humana Medicare Advantage and Part D plans require prior authorization for Kalydeco. Coverage applies to:

  • Humana Medicare Advantage plans
  • Humana Part D prescription drug plans
  • Dual Special Needs Plans (D-SNPs)

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all plans Humana PA Lists
Formulary Tier Tier 5 (specialty) Humana formulary documents
Quantity Limits 60 packets per 30 days Humana coverage policies
Specialty Pharmacy CenterWell Specialty required Humana network requirements
Age Coverage 1 month and older (per FDA label) FDA Access Data

Prior Authorization Process

Who Submits the Prior Authorization?

Your cystic fibrosis specialist or pulmonologist must submit the prior authorization request. Patients cannot submit these requests directly.

Step-by-Step: Fastest Path to Approval

  1. Confirm CFTR Genotype Results (Patient/Family)
    • Ensure your CF center has complete genetic testing showing ivacaftor-responsive mutations
    • Timeline: Same day
    • Document needed: CFTR genotype report
  2. Gather Clinical Documentation (CF Center Staff)
    • Collect diagnosis confirmation, prior therapy history, and current clinical status
    • Timeline: 1-2 business days
    • Documents: Medical records, lab results, treatment history
  3. Submit Prior Authorization (Prescribing Physician)
    • Submit through Availity provider portal or call 800-523-0023
    • Timeline: Same day submission
    • Required: Completed PA form with supporting documentation
  4. Track Request Status (CF Center/Patient)
    • Monitor through provider portal or member services
    • Timeline: Check within 48-72 hours
    • Contact: Humana member services for status updates
  5. Receive Determination (All Parties)
    • Standard requests: 72 hours for most cases
    • Expedited requests: 24 hours if urgent
    • Outcome: Approval, denial, or request for additional information

Timing and Deadlines

How Long Does Prior Authorization Take?

  • Standard requests: 72 hours typical response time
  • Expedited requests: 24 hours when medical urgency documented
  • Part B drug requests: 7 calendar days maximum

What If It's Urgent?

Request expedited review if waiting would jeopardize your health. Your CF specialist must provide documentation explaining why delay poses serious risk.

Tip: For urgent situations, your doctor can request a 72-hour expedited review by clearly documenting medical necessity and potential harm from delay.

Medical Necessity Criteria

Clinician Corner: Medical Necessity Letter Checklist

When submitting prior authorization, ensure documentation includes:

Essential Elements:

  • CFTR genotype confirmation showing ivacaftor-responsive mutations (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H)
  • Cystic fibrosis diagnosis with supporting clinical evidence
  • Age verification (1 month or older per FDA labeling)
  • Specialist consultation from pulmonologist or CF specialist
  • Treatment goals and expected clinical outcomes

Supporting Documentation:

  • Pulmonary function tests and clinical status
  • Prior CFTR modulator therapy history (if applicable)
  • Contraindications to alternative therapies
  • Current treatment regimen and response

What Counts as Step Therapy for Kalydeco?

Step therapy requirements vary by mutation type. For patients with ivacaftor-responsive mutations, Kalydeco may be first-line therapy. Documentation should show:

  • Why alternative CFTR modulators aren't appropriate for the patient's genotype
  • Previous therapy failures or intolerances (if applicable)
  • Clinical rationale for ivacaftor selection

Costs and Patient Assistance

Out-of-Pocket Costs with Humana

As of 2025, Medicare Part D has eliminated the coverage gap ("donut hole"). Key cost information:

  • Annual out-of-pocket cap: $2,000 maximum
  • Catastrophic coverage: 100% plan coverage after reaching cap
  • Tier 5 copays: Varies by plan; check your specific formulary

Patient Assistance Programs

Vertex Pathways Program:

Medicare Extra Help (Low-Income Subsidy):

  • Significantly reduces or eliminates copays
  • Apply through Social Security Administration
  • May qualify for $0 copays even for specialty drugs

Denials and Appeals Process

Common Denial Reasons and Solutions

Denial Reason How to Overturn
Missing genotype documentation Submit complete CFTR mutation analysis report
Lack of specialist consultation Provide CF specialist evaluation and recommendation
Age restrictions Confirm patient meets FDA age requirements (1+ months)
Non-responsive mutation Verify mutation is ivacaftor-responsive per FDA labeling
Insufficient clinical documentation Submit comprehensive medical records and treatment history

Appeals Playbook for Humana in Georgia

Level 1: Internal Appeal (Reconsideration)

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for standard appeals, 72 hours for expedited
  • How to file: Written request to Humana appeals department
  • Required: Denial letter, supporting medical documentation

Level 2: External Review (Independent Review Entity)

  • Automatic: Humana forwards upheld denials to federal IRE (MAXIMUS)
  • Timeline: 30 days standard, 72 hours expedited
  • Cost: Free to patient
  • Contact: MAXIMUS Medicare Managed Care, 3750 Monroe Avenue, Suite 702, Pittsford, NY 14534-1302
Note: Georgia Medicare Advantage appeals follow federal Medicare processes, not state-specific external review procedures.

When to Escalate

Contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298 if you experience:

  • Procedural violations in the appeals process
  • Failure to meet required timelines
  • Lack of response from Humana appeals department

Annual Renewals

When to Re-authorize

Initial Kalydeco authorization typically covers 12 months. Renewal requirements:

  • No new genotype testing needed (CFTR mutations don't change)
  • Clinical status update from CF specialist
  • Treatment response documentation
  • Continued medical necessity confirmation

What Changes Year to Year

Monitor these potential changes during annual plan reviews:

  • Formulary tier placement
  • Prior authorization requirements
  • Specialty pharmacy network
  • Copay amounts

Specialty Pharmacy Requirements

Why Was My Prescription Transferred?

Humana requires Kalydeco dispensing through CenterWell Specialty Pharmacy for:

  • Medication management and adherence monitoring
  • Prior authorization coordination
  • Patient education and support services
  • Insurance benefit optimization

CenterWell Specialty Pharmacy Contact

  • Phone: Contact through Humana member services for transfer
  • Services: Home delivery, refill reminders, clinical support
  • Coordination: Direct communication with your CF center

Troubleshooting Common Issues

Provider Portal Problems

Portal Access Issues:

  • Confirm Availity registration and Humana network participation
  • Contact Humana provider services for technical support
  • Use alternative submission methods (phone, fax) if portal unavailable

Missing Forms or Documentation

Common Missing Items:

  • Complete CFTR genotype report
  • CF specialist consultation notes
  • Prior therapy documentation
  • Current pulmonary function tests

Quick Fix: Contact your CF center's prior authorization specialist to verify all required documents are submitted.

Status Check Problems

If You Can't Track Your Request:

  • Call Humana member services with your prior authorization reference number
  • Ask for written confirmation of submission and expected timeline
  • Request expedited review if medically urgent

FAQ

How long does Humana prior authorization take for Kalydeco in Georgia? Standard requests typically receive decisions within 72 hours. Expedited requests are processed within 24 hours when medical urgency is documented.

What if Kalydeco is non-formulary on my plan? Request a formulary exception with supporting documentation from your CF specialist explaining medical necessity and why covered alternatives aren't appropriate.

Can I request an expedited appeal in Georgia? Yes, expedited appeals are available when waiting would seriously jeopardize your health. Your CF specialist must document the urgent medical need.

Does step therapy apply if I've tried other CFTR modulators outside Georgia? Yes, document all prior CFTR modulator therapy regardless of where treatment occurred. This supports medical necessity for ivacaftor.

What happens if I miss the 65-day appeal deadline? Missing the deadline may forfeit your appeal rights. Contact Humana immediately if you're approaching the deadline or have missed it due to exceptional circumstances.

How do I check if my CF specialist is in Humana's network? Use Humana's provider directory online or call member services. Out-of-network specialists may require additional authorization steps.

What documents should I keep during the appeals process? Maintain copies of: denial letters, appeal submissions, medical records, correspondence with Humana, and tracking numbers for all submissions.

Can Counterforce Health help with my Kalydeco appeal? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform can help identify denial reasons and draft point-by-point rebuttals aligned to Humana's specific requirements.

From Our Advocates: We've seen cases where initial Kalydeco denials were overturned simply by submitting the complete CFTR genotype report that clearly showed ivacaftor-responsive mutations. Many denials occur because the genetic testing results weren't specific enough or didn't explicitly list the patient's mutation status. Always ensure your CF center submits the detailed genetic analysis, not just a summary report.

For complex cases or persistent denials, Counterforce Health provides specialized support in developing comprehensive appeals that address Humana's specific coverage criteria and procedural requirements.

Sources and Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeals processes. It is not medical advice and does not guarantee coverage outcomes. Always consult with your healthcare providers and insurance plan for specific coverage determinations and medical treatment decisions. Coverage policies and procedures may change; verify current requirements with Humana directly.

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