By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Cigna in Georgia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Oxlumo (Lumasiran) Covered by Cigna in Georgia

Cigna requires prior authorization for Oxlumo (lumasiran) with strict PH1 criteria: genetic AGXT confirmation, elevated urinary oxalate, and specialist prescriber. Submit the Cigna Oxlumo PA form via CoverMyMeds or fax to 855-840-1678. If denied, request peer-to-peer review by calling 1-800-882-4462, then file internal appeals within 180 days. For final denials, Georgia residents can request free external review through the Georgia Department of Insurance within 60 days. Start today by confirming your AGXT genetic test results and gathering baseline urinary oxalate labs.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization PA required on most Cigna plans Member portal or ID card Cigna PA Requirements
Diagnosis Primary Hyperoxaluria Type 1 only ICD-10: E74.8 Cigna Oxlumo Policy
Genetic Testing AGXT biallelic variants required CLIA-certified lab report Cigna Oxlumo Policy
Prescriber Nephrologist or urologist Specialist documentation Cigna Oxlumo Policy
Lab Values Elevated urinary oxalate baseline 24-hour urine or spot ratio Cigna Oxlumo Policy
Specialty Pharmacy Accredo or approved SP Prescription routing Express Scripts Formulary
Appeals Deadline 180 days from denial Internal appeal window Cigna Appeals Process
External Review (GA) 60 days from final denial Georgia DOI application Georgia DOI Consumer Services

Step-by-Step: Fastest Path to Approval

1. Confirm PH1 Diagnosis and Testing (Patient/Clinic)

2. Gather Required Lab Documentation (Clinic)

  • 24-hour urinary oxalate or spot oxalate:creatinine ratio above normal
  • Plasma oxalate levels (especially if eGFR <30)
  • Baseline kidney function (eGFR, creatinine)
  • Timeline: Can be done concurrently with genetic testing

3. Obtain Specialist Documentation (Patient/Clinic)

  • Nephrologist or urologist consultation note documenting:
    • PH1 diagnosis and disease burden
    • Failed conservative therapy (hydration, citrate, vitamin B6)
    • Medical necessity for Oxlumo
  • Timeline: 1-2 weeks for appointment and documentation

4. Complete Cigna PA Submission (Clinic)

  • Form: Cigna Oxlumo PA form
  • Submit via: CoverMyMeds or fax to 855-840-1678
  • Include: Genetic test, labs, specialist note, patient weight for dosing
  • Timeline: 1-5 business days for decision

5. Track and Follow Up (Clinic/Patient)

  • Check status: Cigna provider portal or call 1-800-882-4462
  • If approved: Prescription routes to Accredo specialty pharmacy
  • If denied: Proceed to appeals process below

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Documents Needed
"No genetic confirmation of PH1" Submit complete AGXT test report CLIA lab report with variant interpretation
"Insufficient specialist documentation" Get detailed nephrology/urology note Letter addressing medical necessity, failed alternatives
"Urinary oxalate not elevated" Provide baseline labs with reference ranges 24-hour urine or spot ratio compared to age norms
"Prior liver transplant exclusion" Clarify transplant history Medical records confirming no prior liver transplant for PH1
"Concurrent Rivfloza use" Document medication list Current med list showing no nedosiran
From Our Advocates: We've seen PH1 patients initially denied for "insufficient documentation" get approved within days after submitting a comprehensive nephrology note that specifically addressed each Cigna criterion point-by-point. The key is having your specialist directly reference the payer's policy language in their medical necessity letter.

Appeals Playbook for Cigna in Georgia

Internal Appeals Process

Level 1 Appeal

  • Deadline: 180 days from denial date
  • How to file:
    • Online: Cigna provider portal
    • Fax: Number on denial letter (mark "EXPEDITED" if urgent)
    • Mail: Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422
  • Timeline: 30 days standard, 72 hours expedited
  • What to include: Denial letter, medical records, specialist letter addressing denial reasons

Peer-to-Peer Review

  • When: Before or during Level 1 appeal
  • How: Call 1-800-882-4462, request peer-to-peer with Cigna medical director
  • Preparation: Have Cigna Oxlumo policy open, cite specific criteria met
  • Success rate: 80-85% when supported by policy-compliant evidence

Level 2 Appeal

  • Deadline: 60 days from Level 1 denial
  • Process: Escalates to different medical director/committee
  • Timeline: 30 days standard, 72 hours expedited

Georgia External Review

If internal appeals fail, Georgia residents can request binding external review through the Georgia Department of Insurance.

Eligibility

  • Must complete Cigna internal appeals first (unless urgent)
  • Applies to Georgia-regulated plans (not self-funded ERISA plans)
  • Denial must be for medical necessity, experimental, or similar utilization review reasons

How to Apply

  • Deadline: 60 days from final Cigna denial letter
  • Form: Contact Georgia DOI at [email protected] for external review application
  • Cost: Free to consumers
  • Timeline: 30 business days standard, 72 hours urgent

Required Documents

  • Completed Georgia DOI external review application
  • All Cigna denial and appeal letters
  • Medical records supporting necessity
  • Written statement from patient/prescriber

Contact Georgia DOI Consumer Services

  • Phone: 1-800-656-2298
  • Purpose: Help with application, confirm deadlines, verify plan eligibility

Scripts & Templates

Patient Script for Cigna Prior Authorization Status

"Hi, I'm calling to check the status of a prior authorization request for Oxlumo for primary hyperoxaluria type 1. My member ID is [ID number], and the request was submitted on [date]. Can you tell me if additional documentation is needed or when I can expect a decision?"

Clinic Script for Peer-to-Peer Request

"I'm Dr. [Name] requesting a peer-to-peer review for [Patient Name], member ID [number], regarding denial of Oxlumo for genetically confirmed PH1. I have the patient's AGXT genetic test results and urinary oxalate data that meet your policy criteria. When can we schedule the clinical discussion with your medical director?"

Medical Necessity Letter Template (Clinician)

Key elements to address:

  1. Patient identification: Name, DOB, member ID, diagnosis (PH1, ICD-10 E74.8)
  2. Genetic confirmation: "Biallelic pathogenic variants in AGXT gene confirmed by [lab name] on [date]"
  3. Clinical presentation: Urinary oxalate levels, kidney function, stone history
  4. Failed alternatives: "Conservative management with increased fluid intake, potassium citrate, and pyridoxine has been insufficient to control disease progression"
  5. Medical necessity: "Oxlumo is medically necessary to prevent further kidney function decline and reduce oxalate burden in this patient with confirmed PH1"
  6. Dosing plan: Weight-based subcutaneous dosing per FDA labeling
  7. Monitoring: "Will monitor urinary oxalate reduction and kidney function per standard PH1 care"

Costs & Patient Support

Manufacturer Support

  • Alnylam Assist: Benefits verification, PA support, appeals assistance
  • Oxlumo Patient Support: Treatment brochures, dosing information
  • Bridge program: Temporary free drug during PA/appeal delays
  • Copay assistance: For commercially insured patients (restrictions may apply)

Financial Assistance

  • Annual cost: Approximately $493,000 list price
  • Vial cost: ~$60,099 per 94.5 mg vial (weight-based dosing)
  • Foundation grants: Patient Access Network Foundation, others may assist

FAQ

How long does Cigna prior authorization take for Oxlumo in Georgia? Standard PA decisions take 1-5 business days when complete documentation is submitted via CoverMyMeds or the Cigna provider portal. Urgent requests can be processed within 72 hours.

What if Oxlumo is non-formulary on my Cigna plan? File a formulary exception request with medical necessity documentation. The same clinical criteria apply as for PA.

Can I request an expedited appeal in Georgia? Yes. Mark appeals "EXPEDITED" and have your physician document that delay would "seriously jeopardize life, health, or ability to regain maximum function." Expedited appeals receive decisions within 72 hours.

Does step therapy apply if I tried treatments outside Georgia? Yes, Cigna accepts documentation of prior therapies regardless of where they were tried. Include records of failed conservative management (hydration, citrate, vitamin B6).

What if my employer plan is self-funded? Self-funded ERISA plans may not be eligible for Georgia external review. Contact the U.S. Department of Labor for federal external review options.

How do I know if I have PH1 vs. other types? PH1 is confirmed by AGXT gene mutations. PH2 involves GRHPR mutations, PH3 involves HOGA1. Only PH1 is covered for Oxlumo. Consider genetic testing panels that test all three genes.

About Counterforce Health

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 procedural details to maximize approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage decisions vary by plan and individual circumstances. Always verify current forms, deadlines, and requirements with your insurer and healthcare providers. For personalized assistance with Georgia insurance appeals, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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