By Counterforce Health Team in Oxlumo (lumasiran) —

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

Quick Answer: To get Oxlumo (lumasiran) covered by Cigna in Michigan, you'll need prior authorization with confirmed PH1 diagnosis, genetic testing (AGXT), nephrologist prescription, and documented urinary oxalate levels. Submit via CoverMyMeds or Cigna portal. If denied, use Michigan's 180-day internal appeal window, then DIFS external review within 127 days. Start gathering genetic test results and specialist notes today.

Table of Contents

  1. Coverage at a Glance
  2. Prior Authorization Requirements
  3. Step-by-Step: Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process in Michigan
  6. Medical Necessity Documentation
  7. Cost and Patient Assistance
  8. When to Escalate
  9. Frequently Asked Questions

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all new and renewal requests Cigna Coverage Policy IP0095 Cigna
Formulary Tier Specialty Tier (4-5) Cigna Prescription Drug List Cigna Formulary
Step Therapy Not required for PH1 Coverage policy Cigna
Specialty Pharmacy Accredo required Express Scripts/Accredo Cigna
Diagnosis Required Primary Hyperoxaluria Type 1 (PH1) only ICD-10: E74.8 FDA Label
Prescriber Nephrologist or urologist required PA form Cigna
Genetic Testing AGXT gene confirmation needed Lab reports Cigna Policy

Prior Authorization Requirements

Cigna's 2024 prior authorization criteria for Oxlumo (lumasiran) require comprehensive documentation to prove medical necessity for Primary Hyperoxaluria Type 1.

Essential Criteria

Diagnosis Confirmation:

  • Confirmed diagnosis of Primary Hyperoxaluria Type 1 (PH1)
  • Genetic testing showing AGXT gene mutations OR biochemical evidence consistent with PH1
  • ICD-10 code E74.8 documented in medical records

Clinical Thresholds:

  • Elevated urinary oxalate/creatinine ratio exceeding age-specific upper limit of normal, OR
  • Plasma oxalate level ≥ 20 µmol/L (especially if eGFR < 30 mL/min/1.73 m²)

Prescriber Requirements:

  • Must be prescribed by or in consultation with a nephrologist or urologist
  • Specialist consultation notes required in submission

Exclusion Criteria:

  • Patient must NOT have previously received a liver transplant for PH1
  • Cannot be used concurrently with Rivfloza (nedosiran)

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Caregiver)

  • Insurance card and member ID
  • Complete medical records showing PH1 diagnosis
  • Genetic testing results (AGXT gene)
  • Lab results: urinary oxalate levels, plasma oxalate if applicable
  • Previous treatment history and failures

2. Specialist Consultation (Within 1-2 weeks)

  • Schedule with nephrologist or urologist familiar with PH1
  • Ensure provider documents medical necessity clearly
  • Request detailed consultation notes for PA submission

3. Submit Prior Authorization (Prescriber/Clinic)

4. Follow Up (Within 3-5 days)

  • Call Cigna at 800-882-4462 for status updates
  • Request peer-to-peer review if initial denial seems likely
  • Document all communication with reference numbers

5. Appeal if Denied (Within 180 days)

  • File internal appeal through Cigna member portal
  • Include additional evidence addressing specific denial reasons
  • Request expedited review if medically urgent

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
No PH1 confirmation Submit genetic testing results AGXT gene analysis report
Insufficient urinary oxalate levels Provide multiple 24-hour collections Lab results showing elevated levels
Non-specialist prescriber Get nephrologist consultation Specialist consultation notes
Lack of medical necessity Submit comprehensive clinical narrative Detailed treatment history, failed alternatives
Missing liver transplant status Confirm no prior transplant Medical history documentation
Tip: The most common denial reason is incomplete genetic documentation. Ensure AGXT testing results are clearly highlighted in your submission.

Appeals Process in Michigan

Michigan offers robust consumer protections for insurance appeals, with specific timelines and external review options.

Internal Appeals (Cigna)

  • Deadline to file: 180 days from denial notice
  • Standard review: 30 days for decision
  • Expedited review: 72 hours (requires physician certification of urgency)
  • Submit via: Cigna member portal or mail to address on denial letter

Michigan External Review (DIFS)

If Cigna upholds their denial after internal appeals, Michigan residents can request an independent external review through the Department of Insurance and Financial Services (DIFS).

  • Deadline: 127 days from final Cigna denial
  • Standard decision: 45 days maximum
  • Expedited decision: 72 hours with physician urgency letter
  • Submit: DIFS External Review Request form
  • Contact: 877-999-6442 for assistance
Note: Michigan's 127-day deadline is longer than the federal 120-day standard, giving consumers extra time to prepare their external review request.

Medical Necessity Documentation

For Prescribers: Letter of Medical Necessity Checklist

Patient Information:

  • Demographics and insurance details
  • Confirmed PH1 diagnosis with ICD-10 code E74.8
  • Genetic testing results (AGXT mutations)

Clinical Rationale:

  • Baseline urinary oxalate levels (include specific values)
  • Failed conservative management attempts
  • Risk of progressive kidney damage without treatment
  • Expected clinical outcomes with Oxlumo therapy

Supporting Evidence:

  • Reference FDA approval for PH1 indication
  • Cite relevant clinical guidelines
  • Include peer-reviewed studies supporting efficacy

Treatment Plan:

  • Weight-based dosing schedule (loading and maintenance phases)
  • Monitoring plan (urinary oxalate, kidney function)
  • Expected duration of therapy

Cost and Patient Assistance

Oxlumo carries a significant financial burden, with annual costs exceeding $400,000. Several assistance programs can help reduce out-of-pocket expenses:

Manufacturer Support

  • Alnylam Assist: Patient assistance program for eligible individuals
  • Copay assistance: May reduce patient responsibility for commercially insured patients
  • Contact: Visit manufacturer website or call patient services

Foundation Assistance

  • HealthWell Foundation
  • Patient Access Network (PAN) Foundation
  • National Organization for Rare Disorders (NORD)
From our advocates: We've seen families successfully combine manufacturer copay cards with foundation grants to reduce monthly costs from thousands to under $100. Start applications early, as funding can be limited and first-come, first-served.

When to Escalate

State Regulator Contact

If appeals through Cigna and DIFS external review are unsuccessful, contact:

Michigan Department of Insurance and Financial Services

  • Consumer hotline: 877-999-6442
  • File complaint online at michigan.gov/difs
  • Include all denial letters, appeal responses, and supporting medical documentation

Additional Resources

  • Michigan Attorney General: Health Care Fraud/Consumer Protection
  • State Insurance Commissioner: For policy interpretation questions

Frequently Asked Questions

How long does Cigna prior authorization take in Michigan? Standard PA decisions are made within 14 days. Urgent requests requiring expedited review must be decided within 72 hours. You can check status through the Cigna member portal or by calling customer service.

What if Oxlumo is not on my Cigna formulary? Request a formulary exception along with your PA. Cigna must respond within 72 hours for standard exceptions and 24 hours for expedited requests due to medical urgency.

Can I request an expedited appeal if my condition is urgent? Yes. If your physician certifies that waiting for standard appeal timelines would seriously jeopardize your health, both Cigna internal appeals and Michigan external reviews can be expedited to 72-hour decisions.

Does step therapy apply if I've tried treatments outside Michigan? Step therapy is not required for Oxlumo in PH1, but you should document any previous treatments and their outcomes to strengthen your medical necessity case.

What happens if my appeal is denied at every level? After exhausting Cigna appeals and Michigan external review, you can file a complaint with DIFS or consult with a healthcare attorney specializing in insurance coverage disputes.

How much will Oxlumo cost with Cigna coverage? Costs depend on your specific plan's specialty tier copay or coinsurance. Typical specialty tier costs range from $100-500 monthly copays to 20-40% coinsurance. Contact Cigna member services for your exact benefit details.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address payers' specific criteria. By combining clinical expertise with payer-specific knowledge, we help families access life-changing treatments like Oxlumo more efficiently.

For complex cases like PH1 treatments, having expert support can make the difference between a successful appeal and continued coverage barriers. Counterforce Health provides the specialized knowledge needed to navigate Cigna's requirements and Michigan's appeal processes effectively.

Sources & Further Reading

Disclaimer: This article provides general information about insurance coverage and appeals processes. It is not medical advice or legal counsel. Coverage decisions depend on individual policy terms and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For specific legal questions about insurance coverage, consider consulting with a healthcare attorney.

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