Answer Box: Getting Orkambi (lumacaftor/ivacaftor) Covered by Cigna in Georgia

Eligibility: Patients ≥1 year old with cystic fibrosis and confirmed F508del homozygous mutation. Fastest path: Submit prior authorization with genetic test results showing F508del/F508del genotype, CF diagnosis documentation, and specialist prescription. First step today: Contact your CF specialist to gather genetic testing reports and request they submit the PA through Cigna's provider portal. Standard approval takes 5 business days; expedited review available for urgent cases (72 hours). If denied, you have 180 days for internal appeal, then 60 days for Georgia DOI external review.

Table of Contents

1. Who Should Use This Guide
2. Member & Plan Basics
3. Clinical Criteria for Approval
4. Coding and Documentation Requirements
5. Documentation Packet Checklist
6. Submission Process
7. Specialty Pharmacy Routing
8. After Submission: What to Expect
9. Appeals Process in Georgia
10. Common Denial Reasons & How to Fix Them
11. Cost and Financial Assistance
12. FAQ

Who Should Use This Guide

This guide is for CF patients and families in Georgia seeking Cigna coverage for Orkambi (lumacaftor/ivacaftor), as well as clinicians preparing prior authorization submissions. You'll need this if you're facing a denial, preparing an initial request, or want to understand the full approval process before starting treatment.

Expected outcome: With proper documentation, most eligible patients receive approval within 5 business days. For denials, Georgia's external review process provides a second chance with independent medical reviewers, and many patients ultimately secure coverage through appeals.

Member & Plan Basics

Active Coverage Requirements:

• Current Cigna health plan (commercial, Medicare Advantage, or Medicaid managed care)
• Prescription drug benefits included in your plan
• Member ID and group number readily available

Plan Type Considerations:

• Commercial plans: Standard prior authorization process applies
• Medicare Advantage: May have additional step therapy requirements
• Medicaid managed care: Follow standard Cigna PA process, not state Medicaid

Authorization Requirements: Prior authorization is required for all Orkambi prescriptions through Cigna, regardless of plan type. The medication is typically managed through Express Scripts/Accredo specialty pharmacy once approved.

Clinical Criteria for Approval

Primary Requirements (All Must Be Met):

Requirement	Specification	Documentation Needed
Age	≥1 year old	Date of birth verification
Diagnosis	Confirmed cystic fibrosis	Clinical diagnosis with supporting evidence
Genetic Status	F508del homozygous (two copies)	Laboratory genetic test report
Prescriber	CF specialist or pulmonologist	Provider credentials and NPI

Genetic Testing Specifications: The genetic test must explicitly show "F508del/F508del" or "homozygous F508del mutation." Vague language like "CF mutations detected" will cause delays. The test must be from a CLIA-certified laboratory using an FDA-cleared CF mutation panel.

Step Therapy Considerations: Orkambi may require trying other CFTR modulators first, depending on your specific plan. Document any prior failures or contraindications to alternatives like Kalydeco or Trikafta.

Coding and Documentation Requirements

ICD-10 Codes:

• Primary: E84.0 (Cystic fibrosis with pulmonary manifestations)
• Alternative: E84.8 (CF with other manifestations) or E84.9 (CF, unspecified)

NDC Numbers:

• Tablets: 51167-0809-01 (lumacaftor 200mg/ivacaftor 125mg)
• Granules: 51167-0900-01 (pediatric formulation)

HCPCS Codes: Orkambi doesn't have a permanent J-code. For rare medical benefit claims, J3490 (miscellaneous drug) may be used alongside the NDC number—verify with Cigna first.

Documentation Packet Checklist

Required Documents:

• Completed Cigna prior authorization form
• Genetic test report showing F508del/F508del
• CF diagnosis confirmation (sweat chloride test, clinical presentation)
• Recent pulmonary function tests (within 6 months)
• Medical necessity letter from CF specialist
• Current medication list and prior CF therapies

Medical Necessity Letter Components:

• Patient demographics and insurance information
• CF diagnosis with ICD-10 code and date of diagnosis
• Genetic testing results with specific F508del homozygous confirmation
• Current clinical status including FEV1 values and exacerbation history
• Treatment goals and expected outcomes
• Prescriber credentials and CF center affiliation

Clinician Corner: When writing the medical necessity letter, reference FDA labeling for F508del homozygous patients and cite clinical studies showing improved lung function. Include baseline and recent pulmonary function data to demonstrate disease progression and need for CFTR modulator therapy.

Submission Process

Electronic Submission (Preferred):

1. Log into Cigna provider portal
2. Navigate to prior authorization section
3. Complete electronic PA form
4. Upload all supporting documents
5. Submit and record confirmation number

Alternative Submission Methods:

• CoverMyMeds platform for electronic submissions
• Fax: (verify current fax number through Cigna provider services)
• Phone: Provider services line for urgent cases

Required Fields That Commonly Cause Rejections:

• Incomplete genetic testing information
• Missing CF specialist credentials
• Vague diagnosis coding
• Insufficient clinical justification
• Missing baseline pulmonary function data

Specialty Pharmacy Routing

Once approved, your prescription automatically transfers to Accredo specialty pharmacy, Cigna's preferred specialty vendor.

Transfer Process:

1. Accredo contacts you within 24-48 hours of approval
2. Verify shipping address and preferred delivery time
3. Complete enrollment and insurance verification
4. Schedule first shipment (typically overnight delivery)
5. Set up automatic refills and adherence monitoring

What Accredo Provides:

• Free overnight shipping
• Medication synchronization
• 24/7 pharmacist support
• Adherence monitoring and reminders
• Insurance coordination for refills

After Submission: What to Expect

Timeline for Standard Review:

• Initial review: 5 business days
• Additional information requests: 3-5 business days for response
• Final determination: Within 15 business days total

Expedited Review: Available for urgent medical situations. Decision required within 72 hours. Request expedited review if delay would seriously jeopardize your health.

Status Tracking:

• Check status via Cigna member portal or app
• Call member services for updates
• Record all confirmation numbers and reference numbers
• Document all phone conversations with dates and representative names

Appeals Process in Georgia

If your initial request is denied, Georgia provides robust appeal rights through multiple levels of review.

Internal Appeal Process:

• Deadline: 180 days from denial date
• Timeline: 30 days for standard review, 72 hours for expedited
• How to file: Cigna member portal, phone, or written request
• Required: Copy of denial letter, additional medical documentation, prescriber support

Georgia External Review: After internal appeal denial, you can request external review through the Georgia Department of Insurance.

Review Type	Timeline	Cost	How to Request
Standard	30 business days	Free	Online application or call 1-800-656-2298
Expedited	72 hours	Free	Mark application as urgent
Concurrent	Immediate	Free	For life-threatening situations

External Review Requirements:

• Must file within 60 days of final internal denial
• Complete Georgia DOI external review application
• Include all medical records and denial correspondence
• Provide clinical justification for medical necessity

Important: Missing the 60-day deadline forfeits your right to external review in Georgia. Mark your calendar immediately upon receiving final internal denial.

Common Denial Reasons & How to Fix Them

Denial Reason	Fix Strategy	Required Documentation
Missing genetic confirmation	Obtain specific F508del/F508del test report	CLIA-certified lab results with explicit genotype
Age requirement not met	Verify patient age ≥1 year	Birth certificate or medical records
Non-specialist prescriber	Transfer prescription to CF center	Pulmonologist or CF specialist prescription
Insufficient medical necessity	Strengthen clinical justification	Updated PFTs, exacerbation history, treatment goals
Step therapy not completed	Document prior failures or contraindications	Treatment history with outcomes and intolerances

Cost and Financial Assistance

Annual Cost: Approximately $302,107 for Orkambi, making insurance coverage essential for most families.

Financial Assistance Options:

• Vertex Patient Services: Copay assistance and patient support programs
• CF Foundation Compass: Insurance navigation and financial assistance
• State pharmaceutical assistance: Georgia may offer programs for eligible residents
• Manufacturer patient assistance: Income-based free drug programs

For assistance navigating these options, Counterforce Health specializes in turning insurance denials into successful appeals by identifying denial reasons and crafting evidence-backed rebuttals aligned to each plan's specific requirements.

FAQ

How long does Cigna prior authorization take for Orkambi in Georgia? Standard review takes 5 business days. Expedited review for urgent cases is completed within 72 hours.

What if Orkambi is non-formulary on my Cigna plan? Request a formulary exception with clinical justification. Document why formulary alternatives are inappropriate for your specific genotype.

Can I request an expedited appeal in Georgia? Yes, both internal appeals with Cigna and external reviews through Georgia DOI offer expedited timelines for urgent medical situations.

Does step therapy apply if I've tried other CFTR modulators outside Georgia? Yes, document all prior therapies regardless of where they were tried. Include dates, outcomes, and reasons for discontinuation.

What happens if I miss the appeal deadline? Missing the 180-day internal appeal deadline or 60-day external review deadline may forfeit your appeal rights. Contact Georgia DOI Consumer Services immediately if you're past deadline.

How do I know if my Cigna plan is self-funded or fully insured? Check your insurance card or member handbook. Self-funded plans follow federal ERISA rules rather than Georgia state protections.

Can I continue current CF medications while appealing? Yes, continue your current treatment regimen. Some plans offer temporary coverage during appeals—ask your prescriber to request this.

What if the external review is denied in Georgia? External review decisions are binding on insurers. If approved, Cigna must cover the medication. If denied, you may have limited legal options or can reapply with additional clinical evidence.

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This guide provides general information about insurance coverage and is not medical advice. Consult your healthcare provider for medical decisions and contact Cigna directly for plan-specific requirements. For additional help with appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific denial reasons, then drafts point-by-point rebuttals with the right medical evidence and procedural requirements for each payer.

Sources & Further Reading

• Cigna Orkambi Coverage Policy (PDF)
• Georgia Department of Insurance External Review
• Cigna Appeals and Grievances Process
• Vertex Patient Services
• CF Foundation Compass Program
• Accredo Specialty Pharmacy

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