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

How to Get Orkambi (lumacaftor/ivacaftor) Covered by UnitedHealthcare in Michigan: Appeals Guide with Forms and Timelines

Answer Box: Getting Orkambi Covered by UnitedHealthcare in Michigan

UnitedHealthcare requires prior authorization for Orkambi (lumacaftor/ivacaftor) in Michigan patients with cystic fibrosis who are homozygous for the F508del CFTR mutation, aged ≥1 year, and prescribed by a CF specialist. Submit genetic lab results confirming F508del homozygosity, clinical notes, and specialist prescription via OptumRx portal. If denied, you have 180 days to appeal internally, then 127 days to file external review with Michigan DIFS. Start today: Verify your genetic test results show "F508del homozygous" and schedule a CF specialist visit to document medical necessity.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Orkambi prescriptions UnitedHealthcare provider portal UHC PA Requirements
Age Requirement Patient must be ≥1 year old FDA label, birth certificate FDA Orkambi Label
Genetic Testing F508del homozygous mutation confirmed CLIA-certified lab report UHC PA Medical Necessity Form
Prescriber CF specialist (pulmonologist) required Physician credentials, NPI UHC PA Medical Necessity Form
Diagnosis Codes E84.0-E84.9 (Cystic Fibrosis) Medical records, claim forms UHC PA Medical Necessity Form
Approval Duration 12 months initially, renewable PA approval letter UHC PA Medical Necessity Form

Step-by-Step: Fastest Path to Approval

1. Verify Genetic Testing (Same Day)

Who: Patient or clinic staff
What: Obtain lab report showing "F508del homozygous" or "F508del/F508del"
How: Contact your CF center or order through CF Foundation if needed
Timeline: Same day if report exists

2. Schedule CF Specialist Visit (1-2 Weeks)

Who: Patient
What: Appointment with pulmonologist specializing in CF
How: Call your CF center; mention Orkambi PA needed
Timeline: 1-2 weeks for appointment

3. Gather Clinical Documentation (During Visit)

Who: CF specialist
What: Medical necessity letter, lung function tests, treatment history
How: Physician documents diagnosis, prior therapies, current status
Timeline: Completed during visit

4. Submit Prior Authorization (Same Day)

Who: Clinic staff or physician
What: Complete PA form with all attachments
How: OptumRx provider portal or fax
Timeline: Standard decision in 72 hours, expedited in 24 hours

5. Track Status (Daily)

Who: Patient or clinic
What: Monitor PA decision
How: Check portal or call 1-877-542-8997
Timeline: Response within 72 hours

6. If Approved: Fill Prescription (2-3 Days)

Who: Patient
What: Obtain medication from specialty pharmacy
How: OptumRx will coordinate with designated pharmacy
Timeline: 2-3 business days for delivery

7. If Denied: File Appeal (Within 180 Days)

Who: Patient or physician
What: Internal appeal with additional documentation
How: Follow appeals process below
Timeline: Must file within 180 days of denial

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing genetic testing Submit CLIA lab report Original lab report showing F508del homozygous
Non-specialist prescriber Add CF specialist co-signature Specialist note with NPI and credentials
Insufficient clinical documentation Provide comprehensive medical history Lung function tests, exacerbation history, symptoms
Age requirement not met Verify patient age ≥1 year Birth certificate or medical records
Step therapy not completed Document prior CFTR modulator trials Records of Kalydeco or other modulator use/failure
Not medically necessary Strengthen clinical justification CF Foundation guidelines, declining lung function
From Our Advocates: We've seen successful appeals where families initially received denials for "insufficient documentation" but won approval after their CF specialist submitted a detailed letter citing specific CF Foundation guidelines and including 6 months of lung function trends showing decline. The key was demonstrating that standard therapies weren't preventing disease progression.

Appeals Playbook for UnitedHealthcare in Michigan

Level 1: Internal Appeal

  • Deadline: 180 days from denial date
  • How to File: UnitedHealthcare member portal, mail, or fax (check denial letter for specific instructions)
  • Timeline: 30 days for standard, 15 days for expedited
  • What to Include: Denial letter, medical necessity letter, genetic testing, clinical notes

Level 2: Second Internal Appeal

  • Eligibility: After Level 1 denial
  • Process: Same as Level 1 with additional evidence
  • Timeline: 30 days for decision

External Review: Michigan DIFS

  • Deadline: 127 days after final internal denial
  • How to File: DIFS Online External Review Form or FIS 0018 form
  • Timeline: Standard varies, expedited within 72 hours
  • Contact: 877-999-6442 (8am-5pm ET, Mon-Fri)
  • Required: Physician letter for expedited review stating health jeopardy

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and drafting targeted rebuttals backed by clinical evidence. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeals processes more effectively.

Medical Necessity Letter Template

For CF Specialists

RE: Medical Necessity Appeal – Orkambi (lumacaftor/ivacaftor)

Patient: [Full Name], DOB: [Date], Member ID: [ID]
Denial Date: [Date]
Insurer: UnitedHealthcare

Dear UnitedHealthcare Medical Review Team,

I am [Physician Name], [Credentials], NPI [Number], practicing at [CF Center Name], requesting approval for Orkambi (lumacaftor/ivacaftor) for my patient with cystic fibrosis.

**Patient Meets FDA Criteria:**
- Age: [X years] (≥1 year required)
- Genetic testing: F508del homozygous (attached CLIA lab report)
- Diagnosis: Cystic fibrosis (ICD-10: E84.0)

**Clinical Justification:**
Current lung function: FEV1 [X]% predicted (declined from [Y]% over [Z] months)
Exacerbations: [Number] in past 12 months requiring [hospitalizations/IV antibiotics]
Current symptoms: [Describe impact on daily activities]

**Treatment History:**
[Detail any prior CFTR modulators tried, outcomes, reasons for discontinuation]
Standard CF therapies (airway clearance, bronchodilators, antibiotics) are insufficient to prevent disease progression.

**Evidence Base:**
Orkambi addresses the underlying CFTR protein defect in F508del homozygous patients per CF Foundation guidelines. Clinical trials demonstrate improved lung function and reduced exacerbations in this population.

**Request:**
Approve Orkambi at FDA-labeled dosing: [specify dose based on age/weight]

Sincerely,
[Physician Signature]
[Contact Information]

Michigan External Review Process

Michigan's Patient's Right to Independent Review Act (PRIRA) provides binding external review for health insurance denials.

Eligibility

  • Patient was covered when service was needed
  • Service appears medically necessary
  • Internal appeals exhausted or insurer delayed beyond timeframes

Filing Process

  1. Complete Form: Use FIS 0018 form or online submission
  2. Attach Documents: Denial letters, medical records, physician letters
  3. Submit: Online, fax, or mail within 127 days of final denial
  4. DIFS Review: Department assigns to Independent Review Organization (IRO)
  5. IRO Decision: Binding determination by medical experts

Expedited Review (72 Hours)

Available when physician documents that delay would jeopardize patient's life, health, or ability to regain maximum function. Requires supporting physician letter.

Cost-Saving Options

Manufacturer Support

  • Vertex Patient Services: Copay assistance and patient support programs
  • Income-based aid: Available for eligible patients
  • Contact: Visit Vertex website or call patient services

Foundation Programs

  • CF Foundation Compass: Financial assistance for CF medications
  • State pharmacy assistance: Michigan may offer programs for rare diseases
  • Nonprofit grants: Various organizations support CF patients

Insurance Strategies

  • Formulary exceptions: Request if Orkambi is non-formulary
  • Medical exception: Appeal based on medical necessity even with coverage
  • Specialty pharmacy: Use UnitedHealthcare's designated specialty pharmacy for better coverage

When traditional appeals fail, services like Counterforce Health can analyze your specific denial and craft evidence-based appeals that directly address your plan's coverage criteria, increasing the likelihood of approval.

FAQ

How long does UnitedHealthcare prior authorization take in Michigan? Standard PA decisions are made within 72 hours. Expedited requests (when health is at risk) are decided within 24 hours. Complex cases may take up to 15 business days.

What if Orkambi is not on my UnitedHealthcare formulary? Request a formulary exception by demonstrating medical necessity. Your CF specialist can argue that covered alternatives are inappropriate for your F508del homozygous genotype.

Can I request an expedited appeal in Michigan? Yes. If your physician documents that delay would harm your health, you can request expedited internal appeals (15 days) and expedited external review through DIFS (72 hours).

Does step therapy apply if I failed other CFTR modulators outside Michigan? Yes, documented failures of other CFTR modulators (like Kalydeco) from any state count toward step therapy requirements. Provide complete records from previous providers.

What happens if DIFS external review approves my appeal? The decision is binding. UnitedHealthcare must provide coverage as directed by the Independent Review Organization. DIFS will send written notice to both you and the insurer.

How much does Orkambi cost without insurance? The wholesale acquisition cost is approximately $23,239 for a 28-day supply, or about $302,107 annually. Patient assistance programs can significantly reduce this cost.

Can my CF specialist file appeals for me? Yes, with your written consent. Physicians can file both internal appeals with UnitedHealthcare and external reviews with Michigan DIFS on behalf of patients.

What if I'm on a UnitedHealthcare Medicare Advantage plan? The process is similar, but you may have additional appeal rights under Medicare. Contact Medicare at 1-800-MEDICARE for guidance on Medicare-specific appeal pathways.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with your insurance provider and consult with your healthcare team for medical decisions. For personalized assistance with insurance appeals, contact Michigan DIFS at 877-999-6442.

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