By Counterforce Health Team in Kalydeco (ivacaftor) —

How to Get Kalydeco (ivacaftor) Covered by UnitedHealthcare in Georgia: Complete Coding, Prior Authorization & Appeals Guide

Answer Box: Getting Kalydeco Covered by UnitedHealthcare in Georgia

UnitedHealthcare requires prior authorization for Kalydeco (ivacaftor) in Georgia, but no step therapy is required for patients with ivacaftor-responsive CFTR mutations. Approval depends on proper coding and complete genetic documentation.

Three steps to approval:

  1. Submit genetic test results showing FDA-approved responsive mutation (G551D, R117H, etc.)
  2. Use correct ICD-10 code (E84.0 for CF with pulmonary manifestations)
  3. File via UnitedHealthcare provider portal with CF specialist attestation

Timeline: 3-14 days standard review, 72 hours expedited. If denied, you have 180 days for internal appeal and 60 days for Georgia DOI external review.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Coding for Cystic Fibrosis
  3. NDC Numbers and Product Coding
  4. Prior Authorization Requirements
  5. Common Coding Pitfalls
  6. Appeals Process in Georgia
  7. Cost-Saving Options
  8. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Kalydeco is almost always covered under the pharmacy benefit through UnitedHealthcare's OptumRx specialty pharmacy network. There's no permanent J-code for medical billing, making pharmacy benefit the standard path.

Pharmacy Benefit Coverage:

  • NDC-based billing through specialty pharmacy
  • Prior authorization required via OptumRx
  • 12-month initial approval periods
  • Quantity limits per FDA labeling

Medical Benefit (Rare):

  • Only in exceptional circumstances
  • NDC billing without J-code
  • Requires additional medical necessity documentation
Tip: Always verify benefit coverage by calling UnitedHealthcare member services at the number on your insurance card before starting the authorization process.

ICD-10 Coding for Cystic Fibrosis

Proper ICD-10 coding is critical for Kalydeco approval. UnitedHealthcare requires specific, billable codes that match your clinical presentation.

Primary ICD-10 Codes for CF

ICD-10 Code Description When to Use
E84.0 Cystic fibrosis with pulmonary manifestations Most common; lung involvement
E84.11 Meconium ileus in cystic fibrosis Newborns with intestinal obstruction
E84.19 Cystic fibrosis with other intestinal manifestations GI symptoms beyond meconium ileus
Important: Generic code E84 alone is not billable in 2025. Always use the most specific code that describes the patient's condition.

Documentation Requirements

Your medical records must support the chosen ICD-10 code with:

  • Confirmed CF diagnosis from genetic testing
  • Clinical manifestations matching the code
  • Specialist evaluation and ongoing care
  • Baseline pulmonary function tests (for E84.0)

NDC Numbers and Product Coding

Kalydeco comes in multiple formulations with specific NDC numbers required for accurate billing.

Current NDC Numbers

Tablets:

  • 51167-200-01 (25mg)
  • 51167-200-02 (75mg)
  • 51167-300-01 (150mg)

Granules:

  • 51167-770-01 (25mg packets)
  • 51167-785-01 (50mg packets)

Billing Units

  • Each tablet = 1 billing unit
  • Each granule packet = 1 billing unit
  • Standard supply = 28-day fill per authorization
Note: Always use the 11-digit NDC format for claims submission (e.g., 51167-0785-01).

Prior Authorization Requirements

UnitedHealthcare's OptumRx requires comprehensive documentation for Kalydeco approval. Here's what you need:

Required Documentation Checklist

✓ CFTR Genetic Testing

✓ Clinical Documentation

  • CF diagnosis with appropriate ICD-10 code
  • Clinical notes from CF specialist
  • Current pulmonary function tests
  • Baseline liver function tests

✓ Patient Information

  • Age ≥1 month (FDA requirement)
  • No concurrent CFTR modulators
  • Insurance and contact details

Submission Process

  1. Electronic submission via UnitedHealthcare provider portal (fastest)
  2. Standard review: 3-14 business days
  3. Expedited review: 72 hours for urgent cases
  4. Initial approval: 12 months
  5. Renewal: Requires clinical response documentation

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial patterns and crafting targeted appeals with the right clinical evidence. Their platform specifically identifies UnitedHealthcare's approval criteria and generates point-by-point rebuttals when denials occur.

Common Coding Pitfalls

Avoid these frequent mistakes that lead to denials or claim rejections:

Coding Errors to Avoid

Wrong ICD-10 Codes:

  • Using generic E84 instead of specific codes
  • Mismatching clinical presentation with code
  • Missing supporting documentation

NDC Issues:

  • Using incorrect NDC for prescribed strength
  • Wrong billing units calculation
  • Missing 11-digit format

Missing Documentation:

  • Incomplete genetic test results
  • Outdated lab values (>90 days old)
  • Non-specialist prescriber without justification

Pre-Submission Audit Checklist

Before submitting your prior authorization:

  • Correct ICD-10 code matches clinical presentation
  • NDC number matches prescribed formulation
  • Genetic test shows responsive mutation
  • All lab results are current (<90 days)
  • CF specialist attestation included
  • Patient meets age requirements (≥1 month)

Appeals Process in Georgia

If UnitedHealthcare denies your Kalydeco request, Georgia law provides strong appeal rights through a two-level process.

Internal Appeals (UnitedHealthcare)

Filing Deadline: 180 days from denial letter Decision Timeline: 30 days standard, 72 hours expedited Required Documents:

  • Original denial letter
  • Updated medical necessity letter
  • Complete genetic testing results
  • Current clinical notes

External Review (Georgia DOI)

Filing Deadline: 60 days after final internal denial Decision Timeline: 30 days standard, 72 hours expedited Cost: Free to patients Binding: Yes, UnitedHealthcare must comply

To file external review:

  • Call Georgia DOI: 1-800-656-2298
  • Request external review application
  • Submit within 60-day deadline
Critical: Missing the 60-day external review deadline eliminates your right to independent review in Georgia.

Appeals Timeline Summary

Step Deadline Decision Time Binding
Internal Appeal 180 days 30 days* No
Expedited Internal 180 days 72 hours No
External Review 60 days 30 days** Yes
Expedited External 60 days 72 hours Yes

*Standard review; **Calendar days

Cost-Saving Options

Kalydeco's annual list price exceeds $369,000, making financial assistance crucial for many patients.

Manufacturer Support

  • Vertex Compass: Patient assistance program
  • Copay assistance: Up to $15,000 annually for eligible patients
  • Free drug program: For uninsured patients meeting income requirements

Foundation Assistance

  • Cystic Fibrosis Foundation Compass: Emergency assistance
  • HealthWell Foundation: Copay assistance for CF medications
  • Patient Access Network Foundation: Additional copay support

State Resources

  • Georgia Medicaid: Coverage for eligible patients
  • PeachCare for Kids: CHIP program for children

From our advocates: "We've seen patients reduce their Kalydeco costs from $3,000+ monthly to under $50 by combining manufacturer copay cards with foundation grants. The key is applying early—many programs have annual funding limits and close applications when funds are exhausted."

FAQ

Q: How long does UnitedHealthcare prior authorization take in Georgia? A: Standard review takes 3-14 business days. Expedited review for urgent cases is completed within 72 hours.

Q: Does step therapy apply to Kalydeco? A: No, UnitedHealthcare does not require step therapy through other CFTR modulators for patients with ivacaftor-responsive mutations.

Q: What if my genetic test doesn't show a responsive mutation? A: Kalydeco will be denied. Your doctor should consider other CFTR modulators like Trikafta, which covers more mutation types.

Q: Can I request an expedited appeal in Georgia? A: Yes, both internal appeals with UnitedHealthcare and external reviews through Georgia DOI can be expedited for urgent medical situations.

Q: What happens if I miss the 60-day external review deadline? A: You lose the right to Georgia DOI's independent, binding review. Always file within 60 days of your final internal denial.

Q: Does UnitedHealthcare cover Kalydeco for all ages? A: Coverage follows FDA labeling—patients must be at least 1 month old with appropriate responsive mutations.

Q: How do I verify my CFTR mutation is responsive? A: Check the FDA prescribing information for the complete list of approved responsive mutations.

Q: What if my CF center isn't in UnitedHealthcare's network? A: You may need a referral or face higher out-of-network costs. Contact member services to discuss options or consider changing to an in-network specialist.

Sources & Further Reading

Disclaimer: This article provides educational information and should not be considered medical advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies and requirements may change—verify current information with UnitedHealthcare and Georgia regulatory authorities.

For complex appeals and denials, Counterforce Health offers specialized support in turning insurance denials into successful approvals through evidence-based appeals tailored to specific payer requirements.

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