By Counterforce Health Team in Xembify (immune globulin, SC) —

Do You Qualify for Xembify Coverage by UnitedHealthcare in Washington? Decision Tree & Next Steps

Answer Box: Your Fastest Path to Xembify Coverage

If you have primary immunodeficiency with low immunoglobulin levels, UnitedHealthcare typically requires prior authorization for Xembify. Your fastest path: 1) Confirm your IgG levels are documented below normal ranges for your age, 2) Have your doctor submit a prior authorization through the UnitedHealthcare Provider Portal with complete lab results and diagnosis codes, 3) If denied, file an internal appeal within 180 days. Washington residents can request external review through an Independent Review Organization if internal appeals fail. Start today by gathering your immunoglobulin lab results and insurance card.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternative Paths
  6. If Denied: Appeal Path Chooser
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Fixes
  9. Washington-Specific Appeal Rights
  10. Frequently Asked Questions

How to Use This Decision Tree

This guide helps patients and clinicians navigate UnitedHealthcare's prior authorization process for Xembify (immune globulin subcutaneous) in Washington state. Work through each section in order to determine your eligibility and next steps.

Before you start, gather these items:

  • Insurance card and policy details
  • Complete immunoglobulin lab results (IgG, IgA, IgM)
  • Documentation of primary immunodeficiency diagnosis
  • Records of prior treatments tried
  • Any previous denial letters

Eligibility Triage: Do You Qualify?

✅ Likely Eligible

You probably qualify for Xembify coverage if you have:

  • Confirmed primary humoral immunodeficiency diagnosis with ICD-10 codes
  • Low immunoglobulin levels: IgG <600 mg/dL in adults, or >2 standard deviations below age-matched norms
  • Documented infections or clinical symptoms related to immunodeficiency
  • Failed or contraindicated IVIG therapy (if required by your plan's step therapy)

⚠️ Possibly Eligible

You may qualify but need additional documentation if you have:

  • Borderline immunoglobulin levels (300-600 mg/dL IgG)
  • Suspected but unconfirmed primary immunodeficiency
  • Missing functional antibody testing or IgG subclass analysis
  • Incomplete records of prior therapy attempts

❌ Not Yet Eligible

You likely need more preparation if you have:

  • Normal immunoglobulin levels without functional defects
  • Secondary immunodeficiency from other causes
  • No documented clinical symptoms or infection history
  • Haven't tried required first-line therapies

If "Likely Eligible": Document Checklist

Your doctor should submit prior authorization with these documents:

Required Clinical Documentation

  • Primary immunodeficiency diagnosis with specific ICD-10 code
  • Quantitative immunoglobulin levels (IgG, IgA, IgM) with reference ranges
  • Clinical history documenting recurrent infections or symptoms
  • Weight-based dosing calculation per FDA labeling
  • Site of care plan (home vs. clinic administration)

Additional Supporting Evidence

  • IgG subclass testing if applicable
  • Specific antibody responses to vaccines (if available)
  • Prior therapy documentation including IVIG trials and outcomes
  • Contraindications to alternatives if step therapy applies

Submission Process

  1. Online: Submit through UnitedHealthcare Provider Portal
  2. Phone: Call 888-397-8129 for commercial plans
  3. Timeline: Expect 14-30 days for standard review
  4. Follow up: Track status through provider portal

If "Possibly Eligible": Tests to Request

Work with your immunologist to complete this workup:

Essential Lab Tests

  • Repeat quantitative immunoglobulins if levels are borderline
  • IgG subclass analysis (IgG1, IgG2, IgG3, IgG4)
  • Specific antibody testing to pneumococcal or tetanus vaccines
  • Lymphocyte subset analysis by flow cytometry

Clinical Documentation

  • Infection history log with dates, types, and treatments
  • Response to antibiotics and infection resolution times
  • Family history of immunodeficiency
  • Growth and development assessment in pediatric patients

Timeline to Re-apply

  • Allow 4-6 weeks for complete immunology workup
  • Schedule follow-up with immunologist to review results
  • Re-submit PA once all supporting documentation is available

If "Not Yet": Alternative Paths

Explore Other Coverage Options

  • IVIG therapy if you haven't tried intravenous immunoglobulin
  • Other SCIG products like Hizentra or Cuvitru that may have different coverage criteria
  • Clinical trials for investigational therapies

Exception Request Strategy

  • Medical necessity letter emphasizing unique clinical circumstances
  • Peer-to-peer review between your doctor and UnitedHealthcare medical director
  • Compassionate use programs from Grifols (Xembify manufacturer)

Prepare for Future Application

  • Document all infection episodes with medical records
  • Complete immunology specialist evaluation
  • Consider genetic testing if familial immunodeficiency suspected

If Denied: Appeal Path Chooser

Internal Appeals (Required First Step)

Timeline: 180 days from denial date Process: Submit through UnitedHealthcare member portal or mail written appeal Documentation: Include new clinical evidence, medical necessity letter, peer-reviewed literature

Expedited Appeals

When to use: If delay would jeopardize your health Timeline: 72 hours for urgent cases Contact: Call member services and request expedited review

External Review (Washington State)

When available: After exhausting internal appeals Timeline: 60 days to request from final internal denial Process: Independent Review Organization makes binding decision Contact: Washington Office of Insurance Commissioner at 1-800-562-6900

From our advocates: We've seen patients successfully overturn Xembify denials by providing comprehensive infection histories and functional antibody testing. One patient's appeal was approved after documenting 12 bacterial infections in 18 months despite normal total IgG levels, when IgG subclass testing revealed specific deficiencies.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all immune globulin products UnitedHealthcare formulary UHC PA Requirements
Diagnosis Documentation Primary immunodeficiency with ICD-10 codes Medical records, lab results UHC Immune Globulin Policy
Lab Values Age-adjusted immunoglobulin levels Quantitative Ig testing ARUP Immunoglobulin Reference
Authorization Period Maximum 12 months PA approval letter UHC Immune Globulin Policy
Appeal Deadline 180 days from denial Plan documents Standard UHC policy

Common Denial Reasons & Fixes

Denial Reason How to Overturn
"Diagnosis not established" Submit immunologist consultation with specific ICD-10 codes and clinical criteria
"Lab values don't meet criteria" Provide age-matched reference ranges and functional antibody testing
"Step therapy not completed" Document IVIG trials, side effects, or contraindications with medical records
"Dosing exceeds guidelines" Include weight-based calculations per FDA labeling or published literature
"Not medically necessary" Submit infection history log and response to current therapy

Washington-Specific Appeal Rights

Washington state provides robust protections for patients facing insurance denials:

Internal Appeals

  • Required: At least one level of internal review
  • Timeline: UnitedHealthcare typically allows 180 days to file
  • Process: Submit written appeal with supporting documentation

External Review Process

Washington law (RCW 48.43.535) guarantees independent review:

  • Timeline: 60 days to request after final internal denial
  • Decision timeframe: 30 days for standard review, 72 hours for expedited
  • Binding: Insurance company must accept IRO decision
  • Cost: Free to patients

Getting Help

  • Washington Office of Insurance Commissioner: 1-800-562-6900
  • Consumer advocacy line for appeal assistance
  • Template letters available on OIC website

When dealing with insurance coverage challenges, Counterforce Health helps patients and clinicians turn denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to craft point-by-point rebuttals aligned with payer requirements.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Xembify? Standard review typically takes 14-30 days. Expedited review for urgent cases is completed within 72 hours.

What if Xembify isn't on my formulary? Request a formulary exception with medical necessity documentation. Your doctor can also request a peer-to-peer review with UnitedHealthcare's medical director.

Can I get expedited approval if I'm currently receiving IVIG? Yes, if switching from IVIG to SCIG for medical reasons (access issues, side effects), request expedited review citing continuity of care.

Does step therapy apply if I tried IVIG outside Washington? Medical records from any state showing prior therapy attempts should satisfy step therapy requirements. Include complete documentation of trials and outcomes.

What counts as "medical necessity" for Xembify? Primary immunodeficiency with documented low immunoglobulin levels, recurrent infections, and clinical need for immunoglobulin replacement therapy per established guidelines.

How much does Xembify cost without insurance? Retail prices range from approximately $196 for 5mL (1g) to $1,889 for 50mL (10g) vials. Contact Grifols for patient assistance programs.

Can I appeal to Washington state if my plan is self-funded? Self-funded employer plans follow federal ERISA rules, not state law. However, many employers voluntarily provide external review. Contact the U.S. Department of Labor for ERISA plan appeals.

What happens if the external review upholds the denial? The external review decision is final for insurance purposes. You may still explore other options like manufacturer assistance programs or clinical trials.

For patients navigating complex prior authorization requirements, Counterforce Health specializes in analyzing denial letters and crafting evidence-based appeals that address specific payer criteria, helping ensure patients get access to needed medications like Xembify.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your insurance company and consult with your healthcare provider for medical decisions. For personalized assistance with insurance appeals in Washington, contact the Office of Insurance Commissioner at 1-800-562-6900.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.