By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (Ivacaftor) Covered by Cigna in Florida: Complete Coding, Prior Authorization & Appeals Guide

Quick Answer: Kalydeco requires prior authorization from Cigna with documented CFTR mutation testing (G551D, R117H, or other responsive mutations) and ICD-10 code E84.0-E84.9. Your CF specialist must submit genetic testing results, medical necessity documentation, and complete prior authorization within 72 hours for standard review. If denied, Florida residents have 180 days to file internal appeals and can request external review through the Florida Department of Financial Services.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Kalydeco (ivacaftor) is typically covered under Cigna's pharmacy benefit rather than medical benefit, which affects how claims are processed and what documentation is required. Understanding this distinction is crucial for successful billing.

Pharmacy Benefit Coverage:

  • Requires prior authorization through Express Scripts (Cigna's pharmacy benefit manager)
  • Standard review timeline: 5 business days
  • Expedited review available for urgent cases: call (800) 882-4462
  • Submission through CoverMyMeds, SureScripts, or fax (855) 840-1678

The pharmacy benefit pathway means your CF specialist's office will handle the prior authorization request rather than submitting medical claims directly to Cigna.

ICD-10 Mapping for Cystic Fibrosis

Proper ICD-10 coding is essential for Kalydeco coverage approval. Florida Blue's guidelines specify that cystic fibrosis documentation must include appropriate diagnostic codes:

ICD-10 Code Description When to Use
E84.0 Cystic fibrosis with pulmonary manifestations Most common; includes lung infections, bronchiectasis
E84.8 Cystic fibrosis with other manifestations GI symptoms, pancreatic insufficiency, liver disease
E84.9 Cystic fibrosis, unspecified When specific manifestations aren't documented
Documentation Tip: Include specific symptoms and manifestations in clinical notes to support the most appropriate ICD-10 code selection. This strengthens the medical necessity case for Kalydeco.

Supporting Documentation Words:

  • "CFTR gene mutation confirmed"
  • "Pulmonary exacerbations requiring hospitalization"
  • "Progressive lung function decline"
  • "Pancreatic enzyme replacement therapy"
  • "Positive sweat chloride test"

Product Coding: HCPCS, NDC, and Units

While specific HCPCS J-codes and NDC numbers for Kalydeco weren't available in our research, your pharmacy will handle the product coding. However, understanding the basics helps ensure accurate billing:

Available Formulations:

Dosing Documentation: When requesting dosing exceeding 2 packets/tablets per day, providers must supply clinical justification including:

  • Past doses tried and outcomes
  • Prior medications attempted
  • Relevant patient history supporting higher dosing
Important: Contact Cigna's pharmacy department at (800) 882-4462 to verify current NDC numbers and billing codes for your specific Kalydeco formulation.

Clean Request Anatomy

A successful Kalydeco prior authorization request includes these essential components:

Required Clinical Documentation

  1. CFTR Genetic Testing
  2. Medical History
    • CF diagnosis with appropriate ICD-10 codes
    • Clinical notes documenting disease progression
    • Prior treatment failures or inadequate responses
    • Hospitalization records related to CF complications
  3. Prescriber Requirements
    • Must be prescribed by or in consultation with a CF specialist or pulmonologist
    • Medical necessity letter explaining treatment rationale
    • Clinical monitoring plan

Submission Checklist

  • Current Cigna member ID and insurance information
  • Genetic testing lab report
  • Medical necessity letter from CF specialist
  • Treatment history documentation
  • Current medications list
  • Recent clinical notes (last 6-12 months)

Frequent Billing Pitfalls

Avoid these common errors that delay Kalydeco approval:

Missing Genetic Testing Documentation

Incomplete Medical Necessity Letters

  • Solution: Include specific mutation type, prior treatment failures, and clinical decline without treatment

Wrong Prescriber Type

  • Solution: Ensure prescription comes from pulmonologist or CF specialist, not primary care

Insufficient Clinical History

  • Solution: Provide at least 6-12 months of documented symptoms and treatment responses
From our advocates: We've seen cases where initial denials were overturned simply by resubmitting with complete genetic testing documentation. One family's appeal was successful after their CF center provided detailed mutation analysis that wasn't included in the first request. While outcomes vary, thorough documentation significantly improves approval chances.

Verification with Cigna Resources

Before submitting your request, verify current requirements:

Cigna Provider Resources:

  • Cigna Healthcare Provider Portal for current formulary status
  • Express Scripts Pharmacy Help Desk: (800) 922-1557 (available 24/7)
  • Clinical inquiries: (800) 882-4462

Pre-Submission Verification:

  1. Confirm Kalydeco's current formulary tier
  2. Check for any updated prior authorization criteria
  3. Verify correct submission fax number and forms
  4. Review member's specific benefit design for quantity limits

Prior Authorization Requirements

Cigna requires prior authorization for Kalydeco before dispensing. The process involves:

Step-by-Step Approval Process

  1. Schedule CF Specialist Appointment (Patient)
    • Review genetic testing results
    • Document current symptoms and treatment history
    • Timeline: 1-2 weeks
  2. Genetic Testing Verification (Clinic)
    • Confirm responsive CFTR mutations on file
    • Order new testing if needed (Quest Diagnostics or equivalent)
    • Timeline: 1-2 weeks if new testing required
  3. Prior Authorization Submission (Clinic)
    • Complete Cigna PA form with all required documentation
    • Submit via CoverMyMeds, SureScripts, or fax (855) 840-1678
    • Timeline: Same day submission possible
  4. Cigna Review (Cigna)
    • Standard review: 5 business days
    • Expedited review: 72 hours (urgent cases)
    • Timeline: As specified above
  5. Approval or Denial Notification (Cigna to Clinic/Patient)
    • Written notification with approval details or denial reasons
    • Timeline: Within review period

Appeals Process in Florida

If your Kalydeco request is denied, Florida residents have specific appeal rights under state and federal law.

Internal Appeals with Cigna

Timeline: 180 days from denial notice to file internal appeal

Submission Methods:

  • Online: myCigna member portal
  • Fax: 1-866-593-4482
  • Mail: Cigna Healthcare, Attn: Medicare Clinical Appeals, P.O. Box 66588, St. Louis, MO 63166-6588

Review Timeline:

  • Standard appeals: 30 days
  • Expedited appeals: 72 hours (for urgent health situations)

External Review in Florida

If internal appeals are unsuccessful, Florida residents can request external review through independent medical experts.

Requirements:

  • Must exhaust internal appeals first (unless Cigna fails to follow proper procedures)
  • Request within 4 months of final internal denial
  • No cost to the consumer

Process:

  1. Contact Florida Department of Financial Services Consumer Helpline: 1-877-MY-FL-CFO (877-693-5236)
  2. Submit external review request with all documentation
  3. Independent medical reviewer evaluates case within federal timelines
  4. Decision is binding on Cigna if overturned
Note: For urgent cases involving life-threatening conditions, you can request expedited internal and external reviews simultaneously, with decisions possible within 72 hours.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing genetic testing Submit FDA-cleared CFTR mutation results Lab report showing responsive mutations
Non-specialist prescriber Transfer prescription to CF specialist New prescription from pulmonologist
Insufficient medical necessity Provide detailed clinical history Treatment failures, hospitalizations, symptoms
Age requirements not met Verify FDA-approved age ranges Birth certificate, current clinical status
Quantity limits exceeded Request quantity limit exception Clinical justification for higher dosing

Formulary Exception Process

If Kalydeco is non-formulary on your specific Cigna plan, you can request a formulary exception. Your physician must:

  1. Call Cigna Healthcare or complete the exception form
  2. Certify that alternative formulary drugs were detrimental or ineffective
  3. Provide clinical documentation supporting Kalydeco's necessity
  4. Receive decision within 72 hours of complete submission

Cost Assistance Programs

Kalydeco's annual list price is approximately $369,255, but several programs can reduce patient costs:

Vertex Patient Services:

  • Copay assistance for eligible patients
  • Free drug programs for uninsured patients meeting income criteria
  • Navigation support for insurance appeals
  • Contact: Visit Vertex Pharmaceuticals patient support website

Cystic Fibrosis Foundation:

  • Compass Program for insurance navigation
  • Emergency financial assistance
  • CF Care Center network support

State Programs:

  • Florida Medicaid coverage (if eligible)
  • State pharmaceutical assistance programs
  • Hospital charity care programs

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into successful appeals for complex specialty medications like Kalydeco. Their platform analyzes denial letters, identifies specific coverage criteria, and helps draft evidence-backed appeals that address each payer's requirements. For patients and families navigating Cigna's prior authorization process, Counterforce Health can provide additional support in building comprehensive appeals that include the right clinical evidence and documentation.

FAQ

How long does Cigna prior authorization take for Kalydeco in Florida? Standard review takes 5 business days, while expedited reviews for urgent cases are completed within 72 hours.

What if Kalydeco is not on my Cigna formulary? You can request a formulary exception through your physician, who must demonstrate that formulary alternatives are inappropriate for your condition.

Can I get a temporary supply while waiting for approval? Some Cigna plans provide a 30-day temporary supply during the prior authorization review process. Check with your pharmacy about emergency fills.

Does step therapy apply to Kalydeco? Step therapy requirements vary by plan. Your CF specialist can request step therapy exceptions if you've previously tried required medications unsuccessfully.

What happens if my appeal is denied? Florida residents can request external review through the state's independent review process at no cost. This decision is binding on Cigna if the external reviewer overturns the denial.

How much will Kalydeco cost with Cigna coverage? Costs depend on your specific plan's formulary tier and benefit design. Contact Cigna member services to verify your exact copay or coinsurance amounts.

Can I appeal if I live in Florida but have Cigna coverage from another state? Yes, Florida residents have appeal rights under state law regardless of where their Cigna plan originated. You can access Florida's external review process.

What if my genetic testing shows multiple CFTR mutations? Include documentation of all identified mutations in your prior authorization request, as some combination therapies may be more appropriate than Kalydeco alone.

This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual plan benefits and clinical circumstances. For personalized guidance, consult your healthcare provider and contact Cigna member services directly. Florida residents seeking assistance with insurance appeals can contact the Florida Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO.

Sources & Further Reading:

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