By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (lumasiran) Covered by UnitedHealthcare in Michigan: Appeals Guide with Forms and Timelines

Quick Answer: Getting Oxlumo Covered by UnitedHealthcare in Michigan

Oxlumo (lumasiran) requires prior authorization from UnitedHealthcare for primary hyperoxaluria type 1 (PH1). Your fastest path: Have your nephrologist submit a comprehensive PA request with genetic PH1 confirmation, baseline urinary oxalate levels, and medical necessity documentation through the UnitedHealthcare provider portal. If denied, you have 180 days for internal appeals and 127 days for Michigan's external review through DIFS. Start by gathering your genetic testing results, 24-hour urinary oxalate measurements, and complete medical records today.

Table of Contents

Understanding Your Denial Letter

When UnitedHealthcare denies Oxlumo coverage, your denial letter will contain specific reason codes. Here are the most common denial reasons and what they mean:

Denial Reason What It Means What You Need
No PH1 confirmation Missing genetic testing or specialist documentation AGXT mutation results or nephrologist confirmation
Insufficient urinary oxalate levels Baseline measurements don't meet payer thresholds 24-hour urinary oxalate >0.514 mmol/24hr/1.73m²
Non-specialist prescriber Primary care physician submitted request Referral to nephrology or genetics specialist
Missing step therapy Haven't tried required alternatives first Documentation of conservative management attempts
Renewal criteria not met Insufficient response to treatment ≥30% reduction in urinary oxalate from baseline
Note: UnitedHealthcare typically requires prior authorization for specialty medications like Oxlumo, even as they've eliminated PA requirements for many chronic condition drugs.

Common Fixable Issues

Before filing an appeal, check if your denial stems from these easily correctable problems:

Missing Documentation:

  • Genetic testing results confirming AGXT mutations
  • Baseline urinary oxalate measurements
  • Specialist consultation notes from nephrology

Coding Issues:

  • Wrong ICD-10 codes (use E74.818 for PH1)
  • Missing HCPCS codes for administration
  • Incorrect prescriber taxonomy codes

Benefit vs. Medical Policy:

  • Request submitted under wrong benefit (medical vs. pharmacy)
  • Site of care restrictions not addressed
  • Quantity limits exceeded without justification

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who does it: Patient and clinical team
Timeline: 1-2 weeks
What you need:

  • Genetic testing confirming PH1 (AGXT mutations)
  • Baseline 24-hour urinary oxalate levels
  • Complete medical records from nephrology
  • Insurance card and policy information
Tip: The Alnylam Act® PH1 program offers no-cost genetic testing for eligible patients, with results in 2-3 weeks.

2. Specialist Consultation

Who does it: Nephrologist or genetics specialist
Timeline: 2-4 weeks for appointment
Required: Board-certified specialist must document:

  • PH1 diagnosis with genetic confirmation
  • Clinical rationale for Oxlumo
  • Failed or inappropriate alternatives
  • Expected treatment outcomes

3. Prior Authorization Submission

Who does it: Healthcare provider
How to submit: UnitedHealthcare provider portal or OptumRx
Timeline: Decision within 72 hours to 14 days
Required elements:

  • Completed PA form with all clinical documentation
  • Medical necessity letter from specialist
  • Supporting lab results and imaging

4. Monitor Decision Timeline

Standard review: Up to 14 days
Expedited review: 24-72 hours if urgency documented
What to track: PA reference number and submission confirmation

First-Level Appeal Process

If your initial PA request is denied, you have 180 days to file an internal appeal with UnitedHealthcare.

Required Components for Your Appeal:

Medical Necessity Letter Should Include:

  • Clear statement of PH1 diagnosis with genetic confirmation
  • Baseline urinary oxalate levels and target reduction goals
  • Documentation of conservative management attempts
  • Clinical rationale citing FDA prescribing information
  • Expected outcomes and monitoring plan

Supporting Documentation:

  • Complete genetic testing report showing AGXT mutations
  • 24-hour urinary oxalate measurements (baseline and follow-up)
  • Nephrology consultation notes
  • Relevant imaging (ultrasound, CT showing nephrocalcinosis)
  • Prior treatment history and outcomes

Structuring Your Medical Necessity Argument:

  1. Clinical Problem: "Patient has genetically confirmed PH1 with elevated urinary oxalate levels of [X] mmol/24hr/1.73m², significantly above normal range."
  2. Treatment Rationale: "Oxlumo targets HAO1 (glycolate oxidase) to reduce oxalate production independent of AGXT mutation status, with clinical trials showing 65-75% reduction in urinary oxalate."
  3. Alternative Limitations: "Conservative management with dietary modification and increased fluid intake has been insufficient to prevent progressive kidney damage."
  4. Expected Outcomes: "Treatment goal is ≥30% reduction in urinary oxalate to prevent further nephrocalcinosis and preserve kidney function."

Peer-to-Peer Review Strategy

If your appeal is initially denied, request a peer-to-peer review within 7-60 days (varies by plan type).

Scheduling Your Call:

  • Contact number provided in denial letter
  • Alternative: OptumRx provider line at 800-711-4555
  • Calls typically scheduled within 2-5 business days

Preparation Checklist:

  • Have complete medical record available
  • Prepare 5-minute clinical summary
  • Key talking points about medical necessity
  • Relevant guideline citations ready

Concise Talking Points:

"This patient has genetically confirmed primary hyperoxaluria type 1 with AGXT mutations and baseline urinary oxalate levels of [X], which is [Y]x normal. Conservative management has been insufficient to prevent progressive kidney damage. Oxlumo is the FDA-approved targeted therapy that has shown 65-75% reduction in urinary oxalate in clinical trials, directly addressing the underlying pathophysiology."

Michigan External Review Process

If UnitedHealthcare's internal appeals are exhausted, Michigan residents can request external review through the Department of Insurance and Financial Services (DIFS).

Timeline and Eligibility:

  • Deadline: 127 days from final internal denial
  • Standard review: Decision within 60 days
  • Expedited review: 72 hours with physician urgency letter
  • Cost: Free to consumers

How to File:

  1. Complete DIFS External Review form FIS 0018
  2. Attach final denial letter from UnitedHealthcare
  3. Include all relevant medical records
  4. For expedited review: physician letter stating medical urgency
  5. Submit online, by mail, fax, or email to DIFS

Contact Information:

  • Phone: 877-999-6442 (8 a.m.–5 p.m., Mon–Fri)
  • Online portal: Available through DIFS website
  • Decision is binding: If approved, UnitedHealthcare must provide coverage
Important: DIFS external review is available for medical necessity disputes but not for self-funded plans or federal programs like Medicare.

Appeal Templates and Scripts

Patient Phone Script for UnitedHealthcare:

"Hello, I'm calling about a denied prior authorization for Oxlumo (lumasiran) for primary hyperoxaluria type 1. My member ID is [X] and the PA reference number is [Y]. I'd like to understand the specific denial reason and request information about filing an appeal. Can you also tell me if a peer-to-peer review is available?"

Medical Necessity Letter Template:

"[Patient Name] is a [age]-year-old with genetically confirmed primary hyperoxaluria type 1 (PH1) based on [genetic testing results]. Current 24-hour urinary oxalate levels are [X] mmol/24hr/1.73m², which is significantly elevated above normal range (≤0.514). Conservative management including dietary modification and increased fluid intake has been insufficient to prevent [clinical progression/symptoms]. Oxlumo (lumasiran) is medically necessary as the FDA-approved targeted therapy that directly reduces oxalate production through HAO1 inhibition, with clinical trials demonstrating 65-75% reduction in urinary oxalate levels."

Cost Assistance Programs

While pursuing coverage appeals, explore these financial assistance options:

Manufacturer Programs:

  • Alnylam Assist: Patient support program offering copay assistance and case management
  • Eligibility: Varies by insurance type and income
  • Contact: Available through prescriber or Alnylam website

Foundation Support:

  • National Organization for Rare Disorders (NORD) patient assistance programs
  • HealthWell Foundation grants for rare disease treatments
  • Patient Advocate Foundation copay relief programs

Specialty Pharmacy Benefits:

  • Many specialty pharmacies offer financial counseling
  • Case management services to navigate insurance requirements
  • Alternative funding source identification

When to Escalate

If standard appeals fail, consider these escalation options:

File a Complaint with Michigan DIFS:

  • For procedural violations or unreasonable delays
  • Use DIFS complaint portal or call 877-999-6442
  • Document all communications and timelines

Contact State Representatives:

  • Michigan legislators can sometimes intervene in insurance disputes
  • Particularly effective for rare disease access issues
  • Provide complete case summary and documentation

Regulatory Oversight:

  • File complaints with appropriate oversight bodies
  • Document patterns of inappropriate denials
  • Consider joining patient advocacy groups for collective action

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Oxlumo. Their platform analyzes denial letters, identifies specific coverage criteria, and drafts point-by-point rebuttals aligned to each payer's requirements, helping patients and providers navigate the complex prior authorization landscape more effectively.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Oxlumo in Michigan? Standard PA decisions are issued within 72 hours to 14 days. Expedited reviews for urgent cases can be completed within 24-72 hours.

What if Oxlumo is not on UnitedHealthcare's formulary? Non-formulary medications can still be covered through medical exception processes. Your provider must demonstrate medical necessity and that formulary alternatives are inappropriate or ineffective.

Can I request an expedited appeal in Michigan? Yes, both UnitedHealthcare and Michigan DIFS offer expedited reviews when delays would seriously jeopardize health. Requires supporting physician documentation of urgency.

What urinary oxalate levels qualify for Oxlumo coverage? Most payers require baseline levels above normal range (>0.514 mmol/24hr/1.73m²) and expect ≥30% reduction for renewal authorization.

Does step therapy apply if I've failed treatments outside Michigan? Documentation of prior treatment failures from any location should satisfy step therapy requirements, provided records are complete and accessible.

What happens if my appeal is denied at all levels? Consider alternative coverage through Medicaid (if eligible), manufacturer assistance programs, or clinical trial participation. Some patients pursue coverage through different insurance plans during open enrollment.

How do I prove medical necessity for Oxlumo? Key elements include genetic confirmation of PH1, elevated baseline urinary oxalate levels, specialist consultation documenting treatment rationale, and evidence that conservative management is insufficient.

Can a primary care physician prescribe Oxlumo? While technically possible, most payers require specialist consultation (nephrology, genetics, or endocrinology) for rare disease medications like Oxlumo.

Sources and Further Reading

For complex prior authorization challenges, Counterforce Health provides specialized support in converting insurance denials into successful appeals through targeted, evidence-based advocacy tailored to each payer's specific requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and appeal procedures may change; verify current requirements with your insurer and state insurance department.

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