By Counterforce Health Team in Orkambi (lumacaftor/ivacaftor) —

The Complete Requirements Checklist to Get Orkambi (lumacaftor/ivacaftor) Covered by Humana in Pennsylvania

Answer Box: Getting Orkambi Covered by Humana in Pennsylvania

Orkambi (lumacaftor/ivacaftor) requires prior authorization from Humana in Pennsylvania. Your fastest path to approval: 1) Confirm F508del homozygous cystic fibrosis diagnosis with genetic testing, 2) Have your CF specialist submit Humana's prior authorization form with complete medical necessity documentation to 1-877-486-2621, and 3) If denied, use Pennsylvania's external review process within four months for a 50% chance of overturning the decision. Start today by gathering your genetic test results and recent pulmonary function tests.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Documentation Packet Essentials
  5. Submission Process
  6. Specialty Pharmacy Routing
  7. After Submission: What to Expect
  8. Common Denial Reasons & How to Fix Them
  9. Appeals Process in Pennsylvania
  10. Quick Reference Checklist

Who Should Use This Checklist

This guide is designed for patients with cystic fibrosis and their healthcare providers seeking Orkambi coverage through Humana Medicare Advantage or Part D plans in Pennsylvania. You'll need this if:

  • You have F508del homozygous cystic fibrosis
  • Your doctor has prescribed Orkambi (lumacaftor/ivacaftor)
  • You have active Humana coverage in Pennsylvania
  • You're facing a prior authorization requirement or denial

Expected outcome: With proper documentation following this checklist, most medically appropriate Orkambi requests are approved. If initially denied, Pennsylvania's external review process has overturned approximately 50% of appealed denials.

Member & Plan Basics

Coverage Requirements

✓ Active Humana Coverage: Verify your Medicare Advantage or Part D enrollment is current
✓ Plan Type Confirmation: Orkambi is covered under both Humana Medicare Advantage and standalone Part D plans
✓ Prior Authorization Required: All Orkambi prescriptions require PA approval before dispensing
✓ Specialty Tier Placement: Orkambi is typically placed on Tier 5 (specialty) with higher copays

Note: New Humana Medicare members may have a 90-day grace period for ongoing CF treatments, but submitting full PA documentation prevents claim delays.

Clinical Criteria Requirements

Primary Indication

  • FDA-Approved Use: Cystic fibrosis in patients age 2 and older who are homozygous for the F508del mutation
  • Genetic Confirmation Required: Laboratory report showing F508del/F508del genotype (both alleles)
  • Age Verification: Patient must meet FDA age requirements per current labeling

Step Therapy Considerations

Humana may require documentation of:

  • Previous CFTR modulator use (if applicable)
  • Treatment failures or contraindications to alternatives
  • Clinical rationale for Orkambi over other available therapies

Clinical Status Documentation

  • Current pulmonary function tests (FEV1 values)
  • Recent CF-related hospitalizations or exacerbations
  • Pseudomonas aeruginosa colonization status
  • Current CF treatment regimen and response

Documentation Packet Essentials

Medical Necessity Letter Components

Your CF specialist's letter must include:

  1. Patient Demographics & Insurance Information
    • Full name, date of birth, Humana member ID
    • Prescriber NPI and contact information
  2. Diagnosis Documentation
    • Primary diagnosis: Cystic fibrosis with F508del homozygous mutation
    • Relevant ICD-10 codes (E84.0 - Cystic fibrosis with pulmonary manifestations)
    • Date of initial CF diagnosis
  3. Genetic Testing Results
    • Laboratory report confirming F508del/F508del genotype
    • Testing facility and date of results
  4. Clinical Justification
    • Current disease status and severity
    • Prior CF treatments tried and outcomes
    • Medical necessity statement referencing FDA labeling
    • Expected treatment goals and monitoring plan
  5. Prescription Details
    • Orkambi dosing based on age/weight
    • NDC number and quantity requested
    • Duration of therapy

Required Attachments

  • Recent clinic notes (within 6 months)
  • Genetic testing report
  • Current pulmonary function tests
  • Prior authorization form (verify current version)

Submission Process

Humana Prior Authorization Submission

  • Primary Method: Fax completed forms to 1-877-486-2621
  • Alternative: Submit through Humana provider portal or CoverMyMeds
  • Phone Support: Available Monday-Friday, 8 a.m.-8 p.m. EST

Critical Form Requirements

  • Use current Humana Medicare PA form (verify version on Humana's website)
  • Complete all required fields to avoid automatic rejections
  • Include prescriber signature and date
  • Attach all supporting documentation
Tip: Double-check that genetic testing results clearly state "F508del homozygous" or "F508del/F508del" - vague language can cause delays.

Specialty Pharmacy Routing

Humana Preferred Network

  • CenterWell Specialty Pharmacy: Humana's preferred specialty pharmacy
  • Network Alternatives: Verify in-network specialty pharmacies in Pennsylvania
  • Transfer Process: Your prescriber can initiate transfer from retail to specialty pharmacy

Prescription Routing Steps

  1. PA approval received from Humana
  2. Prescription sent to approved specialty pharmacy
  3. Pharmacy contacts patient for delivery coordination
  4. First shipment typically within 3-5 business days

After Submission: What to Expect

Timeline Expectations

  • Standard Review: 7-14 days for PA decision
  • Expedited Review: 72 hours if urgent medical need documented
  • Confirmation: Request confirmation number when submitting

Status Monitoring

  • Check PA status through MyHumana portal
  • Contact Humana member services for updates
  • Keep records of all submission dates and reference numbers

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
Missing genetic testing Submit F508del homozygous confirmation Laboratory genetic report
Inadequate medical necessity Strengthen clinical justification Updated specialist letter with FDA criteria
Step therapy not met Document contraindications to alternatives Prior treatment history and failures
Age requirements Confirm patient meets FDA age criteria Birth certificate or medical records
Incomplete PA form Resubmit with all required fields Complete current Humana form

Appeals Process in Pennsylvania

Internal Appeals (First Level)

  • Timeline: Must request within 60 days of denial
  • Process: Submit appeal through Humana member services
  • Documentation: Include denial letter and additional supporting evidence

Pennsylvania External Review

Pennsylvania offers one of the most effective external review processes in the nation:

  • Success Rate: Approximately 50% of denials are overturned
  • Timeline: Must request within 4 months of final internal denial
  • Process: Submit request through Pennsylvania Insurance Department
  • Cost: Free to patients
  • Decision Timeline: 45 days for standard review, 72 hours for expedited
From our advocates: We've seen cases where patients initially denied for Orkambi were approved after external review when the independent medical reviewers confirmed that genetic testing clearly supported FDA-approved use. The key was submitting comprehensive clinical documentation that directly addressed the original denial reasons.

When to Contact Pennsylvania Regulators

If you experience procedural issues with your appeal:

  • Pennsylvania Insurance Department Consumer Services: Available for guidance on external review process
  • Contact Information: Available on pa.gov insurance pages
  • Documentation: Keep copies of all correspondence and reference numbers

Quick Reference Checklist

Before Starting

☐ Verify active Humana coverage
☐ Confirm F508del homozygous CF diagnosis
☐ Gather genetic testing report
☐ Collect recent clinic notes and PFTs

Documentation Packet

☐ Completed current Humana PA form
☐ Medical necessity letter from CF specialist
☐ Genetic testing results
☐ Recent pulmonary function tests
☐ Prior treatment history
☐ Prescription with NDC and dosing

Submission

☐ Fax to 1-877-486-2621
☐ Request confirmation number
☐ Schedule follow-up in 7-10 days
☐ Prepare for specialty pharmacy coordination

If Denied

☐ Request internal appeal within 60 days
☐ Strengthen medical necessity documentation
☐ Consider Pennsylvania external review within 4 months
☐ Keep detailed records of all communications

Getting the right coverage for specialty medications like Orkambi can feel overwhelming, but you don't have to navigate this process alone. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and drafting evidence-backed rebuttals that speak directly to payer requirements. Their platform helps patients, clinicians, and specialty pharmacies streamline the prior authorization process and improve approval rates for complex medications.

For additional support with Orkambi coverage challenges, Counterforce Health can help identify the specific reasons for denial and develop targeted strategies for successful appeals, whether through internal processes or Pennsylvania's external review system.

FAQ

How long does Humana prior authorization take for Orkambi in Pennsylvania?
Standard reviews take 7-14 days, while expedited reviews are completed within 72 hours if urgent medical need is documented.

What if Orkambi isn't on my Humana formulary?
You can request a formulary exception with supporting medical necessity documentation. Pennsylvania's external review process is also available if the exception is denied.

Can I get expedited approval for Orkambi?
Yes, if your doctor documents urgent medical need. Submit expedited PA request with clinical justification for immediate treatment need.

Does Pennsylvania's external review apply to Medicare plans?
Pennsylvania's external review primarily covers commercial insurance. Medicare beneficiaries have separate federal appeal rights through CMS.

What happens if I'm denied during step therapy requirements?
Document medical contraindications or previous failures with required step therapy medications. Your CF specialist can request exceptions based on clinical inappropriateness.

How much does Orkambi cost with Humana coverage?
As a Tier 5 specialty drug, copays vary by plan but can be substantial. Check with Vertex Pharmaceuticals about patient assistance programs to help with out-of-pocket costs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance company for personalized guidance. For questions about Pennsylvania's insurance regulations or external review process, contact the Pennsylvania Insurance Department directly.

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