By Counterforce Health Team in Pemazyre (pemigatinib) —

The Requirements Checklist to Get Pemazyre (Pemigatinib) Covered by UnitedHealthcare in Michigan: Forms, Appeals, and Approval Steps

Answer Box: Quick Path to Pemazyre Coverage

Getting Pemazyre (pemigatinib) covered by UnitedHealthcare in Michigan requires prior authorization with specific clinical documentation. The fastest path: (1) Submit PA request through UHC Provider Portal with FGFR2 fusion test results and prior therapy records, (2) Include ophthalmology monitoring plan and drug interaction assessment, (3) If denied, file internal appeal within 180 days, then external review with Michigan DIFS within 127 days. Most approvals happen within 72 hours for standard requests when all clinical criteria are met.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Essentials
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & How to Fix Them
  10. Appeals Process in Michigan
  11. Printable One-Page Checklist
  12. FAQ

Who Should Use This Checklist

This guide is designed for patients, caregivers, and healthcare providers navigating UnitedHealthcare coverage for Pemazyre (pemigatinib) in Michigan. You'll need this checklist if:

  • Your doctor has prescribed Pemazyre for cholangiocarcinoma with FGFR2 fusion or myeloid/lymphoid neoplasms with FGFR1 rearrangement
  • You've received a prior authorization denial from UnitedHealthcare
  • You're preparing an initial coverage request
  • You need to appeal a coverage decision

Expected outcome: Following this checklist increases your likelihood of approval by ensuring all UnitedHealthcare requirements are met upfront, potentially avoiding the 33% denial rate seen with marketplace plans.

Member & Plan Basics

Coverage Verification

Before starting the prior authorization process:

✓ Confirm active UnitedHealthcare coverage

  • Log into myuhc.com or call the number on your member ID card
  • Verify your plan includes prescription drug coverage (most do, but check)

✓ Identify your plan type

  • Commercial/Employer plans: Standard PA process
  • Medicare Advantage: May have additional step therapy requirements starting 2025
  • Individual/Family (ACA): Subject to marketplace formulary rules

✓ Check deductible status

  • Specialty medications like Pemazyre often apply to your deductible
  • High-deductible plans may require significant out-of-pocket costs before coverage begins
Note: UnitedHealthcare designates Pemazyre as a specialty medication requiring prior authorization and 30-day supply limits across all plan types.

Clinical Criteria Requirements

UnitedHealthcare's prior authorization policy requires specific clinical documentation:

FDA-Approved Indications

✓ Cholangiocarcinoma Requirements:

  • Unresectable locally advanced, resected with gross residual disease (R2), or metastatic
  • FGFR2 fusion or other rearrangement confirmed by FDA-approved test
  • Previously treated (not first-line therapy)

✓ Myeloid/Lymphoid Neoplasms:

  • Relapsed or refractory disease
  • FGFR1 rearrangement documented

Step Therapy Considerations

✓ Prior Therapy Documentation:

  • For cholangiocarcinoma: Must have tried/failed gemcitabine-based regimens
  • Document specific treatments, dates, and reasons for discontinuation
  • Include adverse events or contraindications to standard therapies

✓ Exception Pathways:

  • Existing users (claims within past 365 days) may be exempt from new step therapy requirements
  • Clinical contraindications to preferred alternatives can override step therapy

Monitoring Requirements

✓ Ophthalmology Plan:

  • Baseline eye exam before treatment initiation
  • Plan for regular monitoring (every 6-12 weeks recommended)
  • Documentation of provider's plan to manage ocular toxicities

✓ Drug Interaction Assessment:

  • Review all current medications for CYP3A4 interactions
  • Plan to avoid or adjust concomitant medications as needed

Coding and Billing Essentials

ICD-10 Diagnosis Codes

✓ Primary Diagnosis:

  • Intrahepatic cholangiocarcinoma: C22.1
  • Extrahepatic cholangiocarcinoma: C24.0
  • Myeloid/lymphoid neoplasms with FGFR1: C94.80, C94.81, C94.82

Drug Identification

✓ NDC Numbers (verify current packaging):

  • 4.5 mg tablets: 50881-077-30
  • 13.5 mg tablets: 50881-076-30

✓ HCPCS/J-Codes:

  • J9273: Injection, pemigatinib, 0.25 mg (for billing purposes)
  • Use NDC for oral formulations in most cases

Documentation Packet

Provider Clinical Note Elements

✓ Complete History:

  • Pathology-confirmed diagnosis with staging
  • Complete treatment history with dates and outcomes
  • Current performance status (ECOG score)
  • Recent imaging showing disease status

✓ Molecular Testing:

  • FDA-approved companion diagnostic results
  • Clear documentation of FGFR2 fusion/rearrangement or FGFR1 rearrangement
  • Laboratory performing the test and methodology

Medical Necessity Letter Components

✓ Essential Elements:

  • Patient identification and insurance information
  • Specific diagnosis with ICD-10 code
  • FDA approval status and NCCN guideline reference
  • Prior therapy failures with specific details
  • Planned dosing: 13.5 mg once daily, 21-day cycles (14 days on, 7 days off)
  • Ophthalmology monitoring plan
  • Drug interaction management strategy
From our advocates: "The most successful Pemazyre appeals we've seen include a complete timeline of prior treatments with specific dates and clear documentation of why each therapy was discontinued. Generic statements like 'failed prior therapy' often result in denials, while detailed treatment histories with adverse events or progression dates typically get approved."

Required Attachments

✓ Documentation Checklist:

  • Pathology report confirming diagnosis
  • Molecular testing report (FGFR status)
  • Treatment history records
  • Recent imaging reports
  • Baseline ophthalmology exam results
  • Current medication list
  • FDA label or NCCN guideline excerpts

Submission Process

UnitedHealthcare Provider Portal

✓ Online Submission (Preferred Method):

  • Access through UHCProvider.com
  • Use "Specialty Pharmacy Transactions" tile
  • Upload all required documentation
  • Obtain confirmation number

✓ Alternative Submission Methods:

  • Phone: 888-397-8129 (OptumRx support)
  • Fax: Confirm current fax number through provider portal

Required Fields That Commonly Cause Rejections

✓ Complete Patient Information:

  • Exact name matching insurance card
  • Correct member ID number
  • Current address and contact information

✓ Prescriber Details:

  • NPI number
  • DEA number (if applicable)
  • Complete contact information including direct phone/fax

✓ Clinical Information:

  • Specific FGFR alteration type
  • Prior therapy start/stop dates
  • Clear statement of medical necessity

Specialty Pharmacy Requirements

UnitedHealthcare Preferred Network

✓ Specialty Pharmacy Routing:

  • Optum Specialty Pharmacy is the primary UHC-owned option
  • Verify current network through member portal or by calling member services
  • Some plans may allow other contracted specialty pharmacies

✓ Transfer Process:

  • Prescription must be sent directly to specialty pharmacy
  • Patient enrollment may be required
  • Verify shipping address and preferred delivery schedule

✓ Shipment Verification:

  • Confirm receipt of medication
  • Review dosing instructions
  • Schedule follow-up appointments for monitoring

After Submission: What to Expect

Timeline and Status Tracking

✓ Standard Timeline:

  • 72 hours for routine prior authorization decisions
  • 24 hours for expedited requests (with clinical justification)
  • Status updates available through provider portal

✓ Confirmation Documentation:

  • Record confirmation number from submission
  • Save approval or denial letter
  • Note any conditions or limitations on approval

✓ Status Check Schedule:

  • Day 1: Confirm submission received
  • Day 3: Check for decision if standard timeline
  • Day 7: Follow up if no decision received

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
"No documented FGFR alteration" Submit FDA-approved companion diagnostic results Complete molecular testing report with clear FGFR2/FGFR1 status
"Step therapy not completed" Document prior therapy failures or contraindications Detailed treatment history with dates, outcomes, and adverse events
"Not medically necessary" Provide comprehensive clinical rationale Medical necessity letter with guideline references and monitoring plan
"Missing clinical information" Complete all required fields Full clinical note with diagnosis, staging, performance status
"Experimental/investigational" Cite FDA approval and guidelines FDA label excerpt and NCCN guideline reference

Appeals Process in Michigan

Internal Appeals (UnitedHealthcare)

✓ Timeline: 180 days from denial date to file ✓ Levels: Typically 1-2 internal review levels ✓ Expedited Process: Available for urgent medical situations (72-hour decision)

External Review (Michigan DIFS)

If internal appeals are unsuccessful:

✓ Timeline: 127 days from final internal denial to file with Michigan Department of Insurance and Financial Services (DIFS) ✓ Process:

  • File online through DIFS External Review portal (verify current link)
  • Submit required forms and documentation
  • Independent Review Organization (IRO) conducts medical review

✓ Expedited External Review: 72 hours for urgent cases with physician letter supporting urgency

✓ Contact Information:

  • DIFS Consumer Hotline: 877-999-6442
  • External review decisions are binding on the insurer

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's own rules.

Printable One-Page Checklist

Before You Start

  • Active UnitedHealthcare coverage verified
  • Plan type identified (Commercial/Medicare/ACA)
  • Deductible status checked

Clinical Requirements

  • FDA-approved indication confirmed
  • FGFR2/FGFR1 testing completed with results
  • Prior therapy documented with dates and outcomes
  • Ophthalmology monitoring plan established
  • Drug interactions reviewed

Documentation Ready

  • Medical necessity letter completed
  • Pathology report attached
  • Molecular testing results attached
  • Treatment history records attached
  • Recent imaging reports attached
  • Baseline eye exam results attached

Submission Complete

  • Prior authorization submitted through UHC Provider Portal
  • Confirmation number recorded
  • Status check scheduled
  • Specialty pharmacy routing confirmed

FAQ

How long does UnitedHealthcare prior authorization take for Pemazyre in Michigan? Standard requests are decided within 72 hours, expedited requests within 24 hours. Complex cases requiring additional review may take longer.

What if Pemazyre is not on my UnitedHealthcare formulary? Pemazyre is typically covered as a specialty medication but requires prior authorization. Non-formulary status may require additional documentation or appeals.

Can I request an expedited appeal in Michigan? Yes, both UnitedHealthcare internal appeals and Michigan DIFS external reviews offer expedited processes for urgent medical situations with physician support.

Does step therapy apply if I've failed treatments outside Michigan? Treatment history from any location is typically accepted. Ensure complete documentation of prior therapies regardless of where they were received.

What counts as medical necessity for Pemazyre? FDA-approved indication, appropriate patient selection (FGFR alteration), failure of or contraindication to standard therapies, and adequate monitoring plan.

How much will Pemazyre cost with UnitedHealthcare coverage? Costs vary by plan type and deductible status. Specialty medications typically have higher copays, but manufacturer assistance programs may be available through IncyteCARES.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual circumstances, plan specifics, and clinical factors. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with Michigan insurance issues, contact the Department of Insurance and Financial Services at 877-999-6442.

Whether you're starting the prior authorization process or appealing a denial, Counterforce Health can help analyze your specific situation and develop a targeted strategy that addresses your plan's exact requirements and increases your chances of approval.

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