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

How to Get Orkambi (lumacaftor/ivacaftor) Covered by UnitedHealthcare in Washington: Prior Authorization, Appeals, and Coding Guide

Answer Box: Getting Orkambi Covered in Washington

UnitedHealthcare requires prior authorization for Orkambi (lumacaftor/ivacaftor) based on confirmed cystic fibrosis diagnosis, homozygous F508del CFTR mutation documentation, and prescription by a CF specialist. Submit through OptumRx with genetic lab results, ICD-10 E84.0-E84.9, and clinical notes. If denied, Washington residents can appeal through internal review, then external Independent Review Organization (IRO) under RCW 48.43.535—which is free and binding if overturned.

First step today: Verify your genetic test results show homozygous F508del mutation and gather CF specialist documentation before submitting your prior authorization request.

Table of Contents

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans OptumRx PA form + attachments UHC PA Policy
Diagnosis Cystic fibrosis with ICD-10 E84.0-E84.9 Clinical notes, sweat test results UHC PA Form
Genetic Testing Homozygous F508del CFTR mutation Lab report on letterhead UHC PA Policy
Age Requirement Patient ≥1 year old Birth certificate or medical record FDA Label
Prescriber CF specialist or pulmonologist NPI credentials, specialist note UHC PA Policy
Benefit Type Pharmacy benefit only NDC codes (no J-codes) Counterforce Health Guide

ICD-10 and Coding Essentials

Primary Diagnosis Codes

Use the most specific cystic fibrosis code that matches your clinical presentation:

  • E84.0 - Cystic fibrosis with pulmonary manifestations (most common)
  • E84.1 - Cystic fibrosis with intestinal manifestations
  • E84.8 - Cystic fibrosis with other manifestations
  • E84.9 - Cystic fibrosis, unspecified
Tip: E84.0 is preferred for patients with lung involvement, which includes most Orkambi candidates.

Documentation Requirements

Your medical records should clearly state:

  • "Cystic fibrosis due to homozygous F508del CFTR mutation"
  • Previous treatments tried and their outcomes
  • Current symptoms and functional status
  • Rationale for Orkambi therapy

The genetic testing report must show the c.1521_1523delCTT (p.Phe508del) mutation on both alleles from a CLIA-certified laboratory.

NDC Codes and Pharmacy Benefit Details

Orkambi is covered under UnitedHealthcare's pharmacy benefit only—never the medical benefit. Use these specific NDC codes:

Available Formulations

  • Tablets (200mg/125mg): NDC 51167-0809-01 (112 tablets per bottle)
  • Granules: NDC 51167-0900-01 (56 packets per carton)

Billing Notes

  • No HCPCS J-codes exist for Orkambi
  • Dispense through specialty pharmacy only
  • Standard dosing: 2 tablets twice daily (4 tablets total) or 1 packet twice daily
  • 28-day supply typical for initial fills
Important: Using incorrect NDC codes or attempting to bill under medical benefit are common denial triggers.

Step-by-Step: Fastest Path to Approval

1. Verify Genetic Testing (Patient/Family)

Timeline: Same day

  • Locate your CFTR genetic testing report
  • Confirm it shows "homozygous F508del" or "F508del/F508del"
  • If missing, request copy from original testing lab

2. Schedule CF Specialist Visit (Patient)

Timeline: 1-2 weeks

  • Book appointment with pulmonologist or CF specialist
  • Bring genetic testing, recent lung function tests, and treatment history
  • Request detailed clinical note supporting Orkambi

3. Submit Prior Authorization (Clinic Staff)

Timeline: 1-2 business days

  • Complete UnitedHealthcare PA form
  • Attach genetic lab report, specialist note, and recent clinic visit notes
  • Submit via UnitedHealthcare provider portal or OptumRx

4. Track Decision (Patient/Clinic)

Timeline: 72 hours standard, 24 hours expedited

  • Monitor portal for updates
  • Request expedited review if health declining
  • Prepare appeal materials if denied

5. Appeal if Denied (Patient/Clinic)

Timeline: Within 60 days of denial

  • File internal appeal with additional clinical documentation
  • Consider peer-to-peer review with UnitedHealthcare medical director
  • Escalate to external IRO if internal appeals fail

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix Required Documentation
Missing genetic testing Submit lab report showing homozygous F508del CLIA-certified genetic test results
Non-specialist prescriber Add CF specialist consultation or co-signature Pulmonologist note with NPI/credentials
Insufficient clinical documentation Provide detailed CF history and current status Lung function tests, symptom assessment, treatment goals
Age verification needed Submit proof of age ≥1 year Birth certificate or medical record with DOB
Wrong benefit category Resubmit under pharmacy benefit with NDC codes Correct NDC, remove any J-codes

Appeals Process in Washington

Washington state provides robust consumer protections for insurance denials. Here's your step-by-step appeals roadmap:

Internal Appeals (Required First)

Step 1: Peer-to-Peer Review (Optional)

  • Request within 24 hours of denial
  • CF specialist discusses case directly with UnitedHealthcare medical director
  • Often resolves denials quickly when clinical rationale is strong

Step 2: Formal Internal Appeal

  • File within 60 days of denial notice
  • Submit additional clinical evidence, CF Foundation guidelines, peer-reviewed studies
  • Include statement: "Patient meets FDA labeling criteria for Orkambi"
  • Timeline: 30-day response for standard appeals

Expedited Internal Appeals:

  • Available if health at serious risk due to CF progression
  • Timeline: 72-hour decision
  • Call 1-877-542-8997 for urgent requests

External Review (After Internal Appeals)

Washington's Independent Review Organization (IRO) process under RCW 48.43.535 provides a final, binding review:

How to Request:

  1. Contact UnitedHealthcare within 180 days of final internal denial
  2. State: "Requesting external review by Independent Review Organization under RCW 48.43.535"
  3. UnitedHealthcare assigns certified IRO within 3 business days

Timeline:

  • Standard: 45 days maximum
  • Expedited: 72 hours if health jeopardized

Outcome:

  • IRO decision is binding on UnitedHealthcare
  • If overturned, coverage must be provided immediately
  • Process is free to patients

For appeals assistance, contact the Washington Office of the Insurance Commissioner at 1-800-562-6900.

Cost Savings and Patient Support

Even with insurance coverage, Orkambi costs can be significant. Here are ways to reduce your out-of-pocket expenses:

Manufacturer Support

  • Vertex Compass patient assistance program
  • Copay assistance for eligible commercial insurance patients
  • Free drug program for uninsured patients meeting income requirements
  • Contact: 1-877-752-5933

Foundation Grants

  • Cystic Fibrosis Foundation Compass emergency assistance
  • HealthWell Foundation grants for CF medications
  • Patient Access Network (PAN) Foundation copay assistance

State Programs

  • Washington Apple Health (Medicaid) may cover Orkambi with prior authorization
  • Washington Prescription Drug Program for additional savings

When to Contact Washington State Regulators

Contact the Washington Office of the Insurance Commissioner (OIC) if:

  • UnitedHealthcare fails to respond to appeals within required timeframes
  • You believe the denial violates Washington state law
  • You need help navigating the external review process
  • You want to file a complaint about claims handling

Contact Information:

From our advocates: We've seen Washington patients successfully overturn Orkambi denials through the IRO process when they provided comprehensive genetic testing documentation and CF specialist support. The key is thorough preparation of your clinical case before submitting to the external reviewer.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and regulatory citations to support coverage requests.

FAQ

How long does UnitedHealthcare prior authorization take for Orkambi in Washington? Standard PA decisions take 72 hours; expedited reviews (when health is at risk) take 24 hours. Submit complete documentation to avoid delays.

What if Orkambi isn't on UnitedHealthcare's formulary? Orkambi requires prior authorization regardless of formulary status. Even if non-formulary, coverage is possible with proper clinical documentation meeting medical necessity criteria.

Can I get expedited coverage if my CF is worsening? Yes. Request expedited review if you're experiencing declining lung function, increased infections, or other urgent CF complications. Call UnitedHealthcare directly at 1-877-542-8997.

Does UnitedHealthcare require step therapy for Orkambi? Current policies don't list specific step therapy requirements for Orkambi, but you may need to document why other CFTR modulators aren't appropriate based on your genotype.

What if I was denied Orkambi by another insurer before switching to UnitedHealthcare? Previous denials don't automatically disqualify you. Each insurer has different criteria, and Counterforce Health can help tailor your new request to UnitedHealthcare's specific requirements.

How much will Orkambi cost with UnitedHealthcare coverage? Costs vary by plan. With coverage, expect specialty pharmacy copays typically ranging from $50-500+ per month. Manufacturer copay assistance may reduce this further for eligible patients.

Can my regular doctor prescribe Orkambi, or do I need a specialist? UnitedHealthcare typically requires prescription by or consultation with a CF specialist (pulmonologist). Your primary doctor can coordinate the referral.

What happens if the external IRO denies my appeal? IRO decisions are final for the insurance dispute, but you can still contact the Washington OIC for guidance or consider legal consultation if you believe your case was mishandled.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional support with complex appeals, consider consulting with healthcare coverage advocates or legal professionals familiar with Washington insurance law.

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