By Counterforce Health Team in Kalydeco (ivacaftor) —

Denied Kalydeco (Ivacaftor) by Cigna in Georgia? Complete Appeals Guide with Forms and Deadlines

Answer Box: Getting Kalydeco Covered by Cigna in Georgia

If Cigna denied your Kalydeco (ivacaftor) prescription, you have 180 days to file an internal appeal and 60 days for external review after final denial. Start today by gathering your CFTR genetic test results, CF specialist's clinical notes, and the denial letter. Submit a medical necessity appeal directly addressing Cigna's coverage criteria—patients with responsive mutations like G551D or R117H typically succeed when documentation is complete. Contact the Georgia Department of Insurance at 1-800-656-2298 for external review forms if your internal appeal fails.

Quick Action Steps:

  1. Request genetic test results showing ivacaftor-responsive CFTR mutation
  2. Get CF specialist to document medical necessity and failed alternatives
  3. Submit internal appeal to Cigna within 180 days with complete clinical records

Table of Contents

Understanding Your Denial

When Cigna denies Kalydeco (ivacaftor), the denial letter contains specific codes that reveal exactly what went wrong. Understanding these codes helps you craft a targeted appeal.

Common Cigna Denial Codes for Kalydeco:

  • Code 75 ("Not covered"): Usually means missing prior authorization or the drug isn't on formulary
  • Code 161/162: Prior authorization missing or incomplete
  • Code 107: Dosing or clinical criteria don't match policy requirements
Note: Kalydeco costs approximately $369,255 annually at list price, making proper documentation critical for approval.

The denial will also specify whether this was processed under your pharmacy benefit (most common for Kalydeco) or medical benefit. This determines which appeal pathway and forms you'll use.

Coverage Requirements at a Glance

Requirement What Cigna Needs Where to Find It Timeline
Prior Authorization Completed PA form with clinical documentation Cigna Provider Portal 72 hours standard review
CFTR Genotype Lab report showing responsive mutation (G551D, R117H, etc.) Genetic testing lab or CF center Required before approval
CF Specialist Prescription from pulmonologist or CF specialist CF Foundation-accredited center preferred Must be prescriber
Age Verification Patient ≥1 month old Medical records FDA requirement
Liver Function ALT/AST ≤3x upper limit normal Recent lab results Baseline required

Step-by-Step: Fastest Path to Approval

1. Gather Essential Documentation (Patient/Family)

Timeline: 1-2 days

  • Request CFTR genetic test results from your CF center
  • Collect recent clinic notes from your CF specialist
  • Obtain lab results showing liver function (ALT/AST)
  • Keep all denial letters and explanation of benefits (EOBs)

2. CF Specialist Writes Medical Necessity Letter (Clinic)

Timeline: 3-5 days

  • Specialist documents CF diagnosis with ICD-10 code
  • Details specific CFTR mutation and FDA-approved responsiveness
  • Lists failed or contraindicated alternative therapies
  • Explains clinical deterioration without Kalydeco

3. Submit Internal Appeal (Patient or Clinic)

Timeline: Submit within 180 days of denial

  • Mail to: Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422
  • Include denial letter, medical necessity letter, genetic test, clinical notes
  • Request expedited review if medically urgent
  • Source: Cigna Appeals Process

4. Request Peer-to-Peer Review if Denied (Physician)

Timeline: Within 5 business days of denial

  • CF specialist calls Cigna to schedule medical director review
  • Prepare concise summary focusing on mutation responsiveness
  • Emphasize FDA approval and CFF guidelines support

5. File External Review if Still Denied (Patient)

Timeline: Within 60 days of final internal denial

  • Contact Georgia DOI Consumer Services: 1-800-656-2298
  • Request external review application form
  • Submit with all appeal documentation
  • Source: Georgia DOI Consumer Services

Clinician Corner: Medical Necessity Letters

For CF specialists writing appeals, address each Cigna criterion directly:

Essential Elements:

  • CF Diagnosis: Include ICD-10 code E84.9 (cystic fibrosis, unspecified) or specific variant
  • CFTR Mutation: Reference genetic test showing responsive mutation per FDA labeling
  • Clinical Status: Document FEV1 decline, hospitalizations, or functional impairment
  • Failed Alternatives: List prior CFTR modulators tried with outcomes/intolerance
  • Monitoring Plan: Confirm liver function monitoring and clinical follow-up

Key Guidelines to Reference:

From Our Advocates: A Georgia CF specialist recently won approval for a 12-year-old with R117H mutation by emphasizing the patient's declining lung function despite standard therapies and including detailed genetic counselor notes confirming mutation responsiveness. The key was directly quoting Cigna's policy criteria and showing how each requirement was met with objective clinical data.

Appeals Playbook for Cigna in Georgia

Internal Appeals (First Level)

  • Deadline: 180 days from denial date
  • Timeline: 30 days for standard review, 72 hours for expedited
  • How to Submit: Mail to Chattanooga address or use Cigna provider portal
  • Required: Denial letter, medical records, prescriber attestation

Internal Appeals (Second Level)

  • Automatic: If first appeal denied, second-level review occurs
  • Timeline: Additional 30 days
  • Reviewer: Different medical director than first level

External Review (Georgia DOI)

  • Deadline: 60 days after final internal denial
  • Cost: Free to patient
  • Timeline: 30 days standard, 72 hours expedited
  • Contact: Georgia DOI at 1-800-656-2298
  • Outcome: Binding on Cigna if approved

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
Missing genetic test Submit CFTR mutation analysis Lab report showing responsive mutation
Not prescribed by specialist Get CF specialist to co-sign or rewrite Pulmonologist or CF center prescription
Step therapy not met Document failed alternatives or contraindications Prior therapy records, adverse event notes
Age restriction Confirm patient ≥1 month old Birth certificate or medical record
Elevated liver enzymes Provide current normal ALT/AST Recent lab results within 30 days

Scripts & Templates

Patient Phone Script for Cigna

"I'm calling about my Kalydeco prior authorization denial. My member ID is [ID]. I need to understand the specific reason for denial and how to file an appeal. Can you transfer me to the appeals department and provide the mailing address for my appeal documents?"

Clinic Staff Peer-to-Peer Request

"I'm requesting a peer-to-peer review for [patient name], member ID [ID], for Kalydeco denial. The prescribing physician is Dr. [Name], a CF specialist. When can we schedule a call with your medical director? This is for a patient with a confirmed responsive CFTR mutation."

When Appeals Fail: Alternative Options

If both internal and external appeals are unsuccessful:

Manufacturer Support:

  • Vertex Patient Services: Copay assistance and patient access programs
  • Income-based free drug programs for eligible patients

Alternative Therapies:

  • Other CFTR modulators based on specific genotype (Trikafta, Orkambi, Symdeko)
  • Clinical trials through ClinicalTrials.gov

Legal Options:

  • Contact Georgia Legal Services for insurance law violations
  • File complaint with Georgia DOI for improper denial practices

FAQ

How long does Cigna prior authorization take in Georgia? Standard PA decisions take up to 72 hours after complete documentation is received. Expedited reviews for urgent cases can be completed within 24 hours.

What if Kalydeco isn't on Cigna's formulary? Request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. Include genetic test results showing mutation only responsive to ivacaftor.

Can I request an expedited appeal? Yes, if delay in treatment poses serious health risks. Your CF specialist must document the urgency and potential harm from delayed therapy.

Does step therapy apply if I've tried modulators outside Georgia? Yes, prior therapy records from any state count toward step therapy requirements. Provide complete documentation of previous CFTR modulator trials and outcomes.

What happens if I miss the 60-day external review deadline? You lose the right to state-supervised independent review. However, you may still pursue other options like filing a complaint with Georgia DOI for procedural violations.

Counterforce Health helps patients and clinicians turn insurance denials into successful appeals by creating evidence-backed, policy-specific documentation that addresses each payer's unique requirements. Our platform streamlines the appeals process by identifying denial reasons and generating targeted rebuttals aligned with plan policies.

When navigating Cigna's complex prior authorization and appeals process for Kalydeco in Georgia, having the right documentation and understanding specific deadlines can mean the difference between approval and ongoing denials. The key is addressing each of Counterforce Health's identified criteria systematically while building a compelling case for medical necessity.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance company for specific guidance regarding your situation.

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