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

How to Get Xembify Covered by UnitedHealthcare in New York: Prior Authorization, Appeals & Cost Assistance Guide

Answer Box: To get Xembify covered by UnitedHealthcare in New York, you'll need prior authorization through OptumRx. Submit via the UHC Provider Portal with diagnosis documentation (primary immunodeficiency), prior IVIG trials, and dosing justification. If denied, file an internal appeal within 180 days, then request external review through NY Department of Financial Services within 4 months. Start today by calling UHC at 866-889-8054 to verify PA requirements and gather your immunology records.

Table of Contents

  1. What Drives Xembify Costs with UnitedHealthcare
  2. Benefit Investigation: Key Questions to Ask
  3. Prior Authorization Requirements
  4. Assistance Options: Manufacturer & Foundation Programs
  5. Tiering Exceptions and Formulary Appeals
  6. Pharmacy Choice and Coordination
  7. Appeals Process in New York
  8. Annual Renewal Planning
  9. Conversation Scripts
  10. FAQ

What Drives Xembify Costs with UnitedHealthcare

Xembify (immune globulin subcutaneous, human-klhw 20% solution) is a specialty medication that UnitedHealthcare typically covers under both medical and pharmacy benefits, depending on your plan design. Understanding which benefit applies to your situation is crucial for managing costs.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all immune globulin products UHC Provider Portal UHC PA Requirements
Formulary Tier Tier 29 (specialty) on Select Standard Plan documents or member portal Optum Rx Formulary
Step Therapy IVIG trials often required first Medical benefit drug policy UHC Medical Drug Policy
Site of Care Home, clinic, or infusion center Provider authorization Policy varies by plan

Medical vs. Pharmacy Benefit: Xembify is primarily covered under UnitedHealthcare's medical benefit for primary immunodeficiency, using HCPCS code J1556. However, some plans may route it through the pharmacy benefit as a specialty medication. Your cost-sharing will vary significantly between these pathways.

Benefit Investigation: Key Questions to Ask

Before starting treatment, gather this essential information by calling the number on your UnitedHealthcare member ID card:

Questions for UnitedHealthcare Member Services

  1. "Is Xembify covered under my medical benefit or pharmacy benefit?"
  2. "What's my specialty drug coinsurance percentage?"
  3. "Do I have a specialty drug deductible, and what's my out-of-pocket maximum?"
  4. "Is prior authorization required, and who submits it?"
  5. "Are there step therapy requirements for immune globulin?"

Information to Record

  • Policy number and group number
  • Deductible amounts (medical and pharmacy)
  • Coinsurance percentages for specialty drugs
  • Out-of-pocket maximums
  • Preferred infusion sites or specialty pharmacies
Tip: Ask for this information in writing via your member portal or request they mail a summary. Verbal confirmations can be disputed later.

Prior Authorization Requirements

UnitedHealthcare requires prior authorization for Xembify through OptumRx. The process typically takes 3-5 business days for standard requests, or up to 72 hours for urgent cases.

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient)
    • Call UHC at 866-889-8054 (commercial plans)
    • Confirm PA is needed and gather requirements
    • Timeline: Same day
  2. Gather Clinical Documentation (Provider)
    • Primary immunodeficiency diagnosis with ICD-10 codes
    • Immunoglobulin levels and infection history
    • Prior IVIG trials and outcomes
    • Timeline: 1-2 days
  3. Submit PA Request (Provider)
    • Use UHC Provider Portal PA tool
    • Include all required documentation
    • Request peer-to-peer review if available
    • Timeline: Same day submission
  4. Follow Up (Provider/Patient)
    • Check status via provider portal
    • Respond to any additional information requests
    • Timeline: 1-3 business days
  5. Receive Determination (Patient)
    • Approval: Begin treatment coordination
    • Denial: Initiate appeal process immediately
    • Timeline: 3-5 business days from submission

Medical Necessity Criteria

Based on UnitedHealthcare's medical benefit drug policy, Xembify approval typically requires:

  • Confirmed primary immunodeficiency diagnosis with appropriate testing
  • Documentation of recurrent infections or hypogammaglobulinemia
  • Trial of IVIG (unless contraindicated) with documented inadequate response, intolerance, or access issues
  • Appropriate dosing based on weight and clinical response
  • Provider specialization in immunology, hematology, or related field

Assistance Options: Manufacturer & Foundation Programs

Xembify Connexions Copay Program

Grifols offers substantial copay assistance for commercially insured patients through the Xembify Connexions program:

  • Coverage: Up to $10,000 per calendar year toward copays, deductibles, and coinsurance
  • Eligibility: Commercial insurance, valid prescription, US residents
  • Exclusions: Medicare, Medicaid, TRICARE, and other federal programs
  • Enrollment: Call 1-855-636-8715 or enroll through your specialty pharmacy
Note: This program can potentially reduce your out-of-pocket costs to $0 for eligible patients with commercial insurance.

Patient Assistance Foundations

Counterforce Health helps patients navigate these foundation programs and can assist with applications when multiple options are available.

Currently Active Programs (enrollment status changes frequently):

  • The Assistance Fund: Primary immunodeficiency program covering copays and premiums
  • Good Days: CGD medication assistance up to $3,500
  • HealthWell Foundation: Check for open immune globulin funds
  • Patient Access Network (PAN): Disease-specific copay assistance
  • NORD RareCare: Over 100 rare disease programs

Application Strategy:

  1. Check enrollment status for all programs simultaneously
  2. Apply the same day if funds are open (they fill quickly)
  3. Join waitlists for closed programs
  4. Consider related conditions (CGD, hypogammaglobulinemia) if primary immunodeficiency funds are closed

New York State Resources

New York residents have additional options:

  • Medicaid/Essential Plan: May provide better coverage than commercial insurance for some families
  • Child Health Plus: Comprehensive coverage for children
  • Premium assistance programs: Help with marketplace plan costs

Tiering Exceptions and Formulary Appeals

If Xembify is placed on a high-cost tier or excluded from your formulary, you can request an exception based on medical necessity.

When to Request a Tiering Exception

  • Alternative immune globulin products have failed or caused adverse reactions
  • Xembify offers specific advantages for your condition (e.g., subcutaneous vs. intravenous administration)
  • Step therapy requirements are inappropriate for your clinical situation

Required Documentation

  • Provider letter explaining medical necessity
  • Clinical notes documenting treatment history
  • Literature support for Xembify's advantages in your specific case
  • Adverse reaction documentation for alternative products

Pharmacy Choice and Coordination

UnitedHealthcare typically requires specialty pharmacies for immune globulin products. Your choice can impact costs and convenience.

Specialty Pharmacy Options

  • OptumRx Specialty: UnitedHealthcare's preferred specialty pharmacy
  • Network alternatives: Verify coverage and copay differences
  • Home infusion services: May be covered under medical benefit

Coordination Tips

  1. Verify network status before selecting a pharmacy
  2. Compare copays between specialty pharmacy and medical benefit coverage
  3. Coordinate with infusion services if receiving treatment at home or in clinic
  4. Confirm refrigeration and shipping requirements with your pharmacy

Appeals Process in New York

New York has strong patient protections for insurance appeals, with binding external review available through the Department of Financial Services.

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial to file internal appeal

Required Steps:

  1. Submit appeal via UHC member portal or mail
  2. Include supporting documentation: provider letters, medical records, literature
  3. Request peer-to-peer review with same-specialty physician
  4. Follow up within 5-7 business days

Success Rate: Well-documented internal appeals achieve 67-75% overturn rates with UnitedHealthcare when they cite specific coverage criteria.

External Review (New York Department of Financial Services)

If UnitedHealthcare upholds the denial, New York residents can request binding external review:

Timeline: 4 months from internal appeal denial Cost: Maximum $25 (waived for financial hardship) Process: Independent medical experts review the case Success Rate: External reviewers overturn UnitedHealthcare denials 40-50% of the time

Expedited Review: Available for urgent medical situations with decisions within 72 hours

When to Escalate

Contact the New York Department of Financial Services if:

  • UnitedHealthcare misses appeal deadlines
  • You suspect pattern denials without proper review
  • The insurer requests inappropriate documentation

Annual Renewal Planning

Plan changes can affect Xembify coverage, so prepare for annual renewals:

What Can Change

  • Formulary placement: Xembify may move to different tiers
  • Prior authorization requirements: Criteria may become more restrictive
  • Network providers: Your immunologist or infusion center may change status
  • Copay assistance: Manufacturer programs reset annually

Renewal Checklist

  • Review new formulary for Xembify placement
  • Verify provider network status
  • Re-enroll in copay assistance programs
  • Update prior authorization if required
  • Budget for potential cost changes

Conversation Scripts

Patient Script for UnitedHealthcare Member Services

"Hi, I need to verify coverage for Xembify, spelled X-E-M-B-I-F-Y, for primary immunodeficiency. Can you tell me if this requires prior authorization, what my specialty drug coinsurance is, and whether it's covered under medical or pharmacy benefits? I also need to know about any step therapy requirements."

Provider Script for Peer-to-Peer Review

"I'm requesting a peer-to-peer review for Xembify approval for my patient with primary immunodeficiency. They've had inadequate response to IVIG with [specific issues: access problems/infusion reactions/poor venous access]. Subcutaneous administration with Xembify is medically necessary for [specific clinical reasons]. When can we schedule the peer-to-peer discussion?"

Appeal Letter Key Points

When Counterforce Health helps draft appeals, they focus on these critical elements:

  • Point-by-point response to denial reasons
  • Citation of UnitedHealthcare's own coverage criteria
  • Clinical evidence supporting medical necessity
  • Documentation of failed alternatives or contraindications

FAQ

How long does UnitedHealthcare prior authorization take for Xembify in New York? Standard requests take 3-5 business days. Urgent requests must be processed within 72 hours. You can check status via the UHC provider portal.

What if Xembify is non-formulary on my plan? Request a formulary exception with medical necessity documentation. If denied, you can appeal through UnitedHealthcare's internal process and then external review through New York DFS.

Can I request an expedited appeal in New York? Yes, if your health is at serious risk without treatment. New York requires expedited external appeals to be decided within 72 hours (24 hours for urgent drug denials).

Does step therapy apply if I've failed IVIG outside New York? Yes, UnitedHealthcare will typically accept documentation of IVIG failure from any provider, regardless of location, as long as it's properly documented in medical records.

How much does Xembify cost without insurance? Retail cash prices range from approximately $196 (5 mL/1 g) to $1,889 (50 mL/10 g), but most patients qualify for manufacturer assistance or foundation support.

What happens if I move from New York to another state? Appeal rights vary by state. Some states have stronger external review processes than others. Check your new state's insurance department website for specific appeal procedures.

Can I use both manufacturer copay cards and foundation assistance? Generally no - most programs prohibit combining assistance. However, you may be able to use different programs for different aspects of care (e.g., drug costs vs. administration fees).

What ICD-10 codes support Xembify coverage? Common codes include D80.0-D80.9 (immunodeficiency disorders), but your immunologist should select the most specific code for your condition.

From our advocates: One patient successfully overturned a UnitedHealthcare denial by requesting a peer-to-peer review and having their immunologist explain why subcutaneous administration was essential due to poor venous access from years of IVIG. The key was documenting specific clinical challenges with the previous therapy route.

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always verify current requirements with your insurer and consult healthcare providers for medical decisions.

For personalized assistance navigating UnitedHealthcare appeals and prior authorization requirements, Counterforce Health provides evidence-based support to help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through targeted documentation and payer-specific strategies.

Sources & Further Reading

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