By Counterforce Health Team in Kalydeco (ivacaftor) —

The Requirements Checklist to Get Kalydeco (ivacaftor) Covered by UnitedHealthcare in Pennsylvania: Complete PA Guide with Forms and Appeals

Answer Box: Fast Track to Kalydeco Coverage

To get Kalydeco (ivacaftor) covered by UnitedHealthcare in Pennsylvania: Submit prior authorization through OptumRx with confirmed cystic fibrosis diagnosis, FDA-cleared CFTR genetic test showing responsive mutation (like G551D or R117H), and CF specialist documentation. If denied, use Pennsylvania's Independent External Review—launched in 2024, it overturns 50% of denials. Start today: Contact your CF center for genetic testing if missing, then submit PA via UnitedHealthcare provider portal.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Pennsylvania Appeals Process
  11. Printable Quick Reference

Who Should Use This Checklist

This guide helps Pennsylvania residents with cystic fibrosis (CF) who need Kalydeco (ivacaftor) covered by UnitedHealthcare. You'll need this if:

  • You have CF with a CFTR mutation responsive to ivacaftor
  • Your doctor prescribed Kalydeco but UnitedHealthcare requires prior authorization
  • You received a denial and need to appeal
  • You're switching from another CFTR modulator

Expected outcome: With complete documentation, most Kalydeco prior authorizations are approved within 72 hours to 2 weeks. Pennsylvania's new external review process has a 50% success rate for overturning denials.

Member & Plan Basics

Coverage Requirements

Requirement Details Verification
Active UnitedHealthcare coverage Commercial, Medicare Advantage, or Medicaid Check member ID card
Plan type Not self-funded employer plans Contact HR if employer plan
Specialty pharmacy benefit OptumRx manages specialty drugs Verify via UHC provider portal
Prior authorization required Yes, mandatory for all plans UnitedHealthcare PA policy
Note: Pennsylvania's external review only applies to commercial plans, not self-funded employer plans. Check with your employer if unsure.

Clinical Criteria Requirements

Primary Requirements

Diagnosis: Confirmed cystic fibrosis with ICD-10 code E84.0 (CF with pulmonary manifestations) or E84.9 (CF unspecified).

Genetic Testing: FDA-cleared CFTR mutation test showing at least one responsive mutation, including:

Age Requirements: 1 month and older per FDA labeling.

Prescriber: CF specialist or pulmonologist, preferably from an accredited CF Care Center.

Clinical Documentation Needed

  • Baseline liver function tests (ALT/AST <3x upper limit of normal)
  • Sweat chloride test ≥60 mmol/L (if available)
  • Recent pulmonary function tests (FEV1/FVC)
  • Documentation of CF-related complications or symptoms
Important: UnitedHealthcare does NOT require step therapy (trying other CFTR modulators first) for Kalydeco, unlike some other specialty drugs.

Coding and Billing Information

Required Codes

Code Type Code Description
ICD-10 E84.0 Cystic fibrosis with pulmonary manifestations
ICD-10 E84.9 Cystic fibrosis, unspecified
HCPCS J8499 Prescription drug, oral, non-chemotherapeutic, NOS

Dosing Information

  • Adults/children ≥6 years: 150 mg every 12 hours
  • Reduce dose with moderate/severe liver disease or strong CYP3A inhibitors
  • Pediatric dosing: Weight-based per FDA labeling

Documentation Packet Essentials

Provider Documentation Checklist

Medical Necessity Letter must include:

  • CF diagnosis with ICD-10 code
  • Specific CFTR mutation(s) from genetic testing
  • Age verification
  • Clinical rationale for ivacaftor therapy
  • Baseline lab values
  • Treatment goals and monitoring plan

Required Attachments:

  • CFTR genetic test results from FDA-cleared laboratory
  • CF specialist consultation notes
  • Recent pulmonary function tests
  • Liver function tests (within 6 months)
  • Insurance verification and member ID

Genetic Testing Documentation

The genetic test report must show:

  • Laboratory certification (FDA-cleared assay)
  • Specific mutation identified
  • Confirmation of responsiveness to ivacaftor
  • Patient identification matching insurance records
Tip: If genetic testing is incomplete, contact your CF center immediately. Many have in-house genetic counselors who can expedite testing.

Submission Process

Step-by-Step Submission

  1. Gather Documentation (1-2 days)
    • Complete genetic testing if needed
    • Obtain specialist consultation
    • Collect required lab results
  2. Complete PA Form (Same day)
  3. Submit via Provider Portal (Same day)
    • Log into UnitedHealthcare provider portal
    • Upload all documentation
    • Alternative: Fax to number provided in portal
  4. Confirmation (Within 24 hours)
    • Record confirmation number
    • Note submission date and time

Common Submission Errors to Avoid

  • Missing genetic test results
  • Non-responsive CFTR mutation
  • Non-specialist prescriber
  • Incomplete liver function tests
  • Wrong PA form version

Specialty Pharmacy Routing

Optum Specialty Pharmacy Process

Kalydeco is dispensed exclusively through Optum Specialty Pharmacy for UnitedHealthcare members.

Transfer Process:

  1. Provider submits approved prescription to Optum Specialty
  2. Patient contacted by Optum for insurance verification
  3. Medication shipped directly to patient's home
  4. 24/7 pharmacist support available

Contact Information:

  • Patient transfers: 1-855-427-4682
  • Provider fax: 866-940-7328
  • Refill support: Available via phone or online portal

Shipment and Delivery

  • Standard delivery: 2-3 business days
  • Expedited options: Available for urgent needs
  • Temperature control: Maintained throughout shipping
  • Refill reminders: Automated system prevents gaps

After Submission: What to Expect

Timeline Expectations

Stage Timeframe Action Required
Initial review 24-72 hours None
Additional info request 3-5 business days Respond promptly
Final determination 5-14 business days Check portal daily
Urgent/expedited 24-72 hours Request if medically necessary

Status Monitoring

Check status via:

  • UnitedHealthcare provider portal
  • OptumRx website
  • Phone: 1-866-889-8054

Document everything:

  • Confirmation numbers
  • Representative names and dates
  • Any additional requests

Common Denial Prevention Tips

Five Critical Pitfalls and Solutions

  1. Missing Genetic Documentation
    • Problem: No CFTR mutation test results
    • Solution: Include complete genetic panel from FDA-cleared lab
  2. Non-Responsive Mutation
    • Problem: Mutation not on approved list
    • Solution: Verify mutation against current FDA labeling
  3. Non-Specialist Prescriber
    • Problem: Primary care or non-CF specialist prescribing
    • Solution: Obtain CF specialist consultation or co-signature
  4. Incomplete Clinical Information
    • Problem: Missing baseline labs or clinical rationale
    • Solution: Include comprehensive medical necessity letter
  5. Wrong Form or Process
    • Problem: Using outdated PA form or wrong submission method
    • Solution: Always use current OptumRx forms and provider portal

Pennsylvania Appeals Process

Pennsylvania launched its Independent External Review Program in January 2024, providing a powerful tool for overturning insurance denials.

Internal Appeals First

UnitedHealthcare Internal Process:

  • Timeline: 45 days to submit after denial
  • Levels: Usually 1-2 internal review levels
  • Expedited: Available for urgent medical needs (72 hours)
  • Submission: Via provider portal or written appeal

Pennsylvania External Review

If internal appeals fail, Pennsylvania's external review has shown exceptional success:

Key Statistics:

  • 50.1% success rate in first year (259 of 517 reviews approved)
  • Free process for Pennsylvania residents
  • Independent medical review by qualified physicians

Eligibility Requirements:

  • Commercial insurance plan (not self-funded employer plans)
  • Completed internal appeals with Final Adverse Benefit Determination
  • Submit within 4 months of final denial

Process Steps:

  1. Submit online at pa.gov/reviewmyclaim
  2. PID processes within 1 business day
  3. Independent review assigned within 1 business day
  4. Submit additional evidence within 15 business days
  5. Final decision within 45 calendar days

Expedited Review:

  • Available when health is at immediate risk
  • Decision within 72 hours
  • Implementation within 24 hours of approval
Contact Pennsylvania Insurance Department: 1-877-881-6388 for assistance with the external review process.

Printable Quick Reference

Pre-Submission Checklist

Clinical Requirements:

  • Confirmed CF diagnosis (ICD-10 E84.0 or E84.9)
  • CFTR genetic test showing responsive mutation
  • CF specialist consultation
  • Baseline liver function tests
  • Medical necessity letter

Documentation:

  • Completed OptumRx PA form
  • Genetic test results
  • Specialist notes
  • Lab results
  • Insurance verification

Submission:

  • Provider portal access confirmed
  • All documents uploaded
  • Confirmation number recorded
  • Follow-up schedule set

Emergency Contacts

  • UnitedHealthcare PA: 1-866-889-8054
  • Optum Specialty Pharmacy: 1-855-427-4682
  • Pennsylvania Insurance Department: 1-877-881-6388

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Kalydeco. Our platform helps patients, clinicians, and pharmacies navigate complex prior authorization requirements by providing evidence-based appeal strategies tailored to specific payer policies and state regulations.

If you're facing challenges with your Kalydeco coverage, Counterforce Health can help streamline the appeals process with targeted documentation that addresses UnitedHealthcare's specific criteria and leverages Pennsylvania's favorable external review system.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and contact your insurance company or the Pennsylvania Insurance Department for specific coverage questions. Coverage criteria and processes may change; verify current requirements with official sources.

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