How to Get Xembify (Immune Globulin, SC) Covered by Humana in Texas: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Xembify Covered by Humana in Texas
Xembify (immune globulin, SC) requires prior authorization from Humana with documentation of primary immunodeficiency diagnosis, IgG levels <2 standard deviations below normal, and ≥2 serious infections annually. Submit through Humana's provider portal with complete clinical records. Standard decisions take 30 days; expedited reviews 72 hours. If denied, you have 65 days to appeal internally, then external review through Texas Department of Insurance. First step: Verify your plan type and gather lab results showing low immunoglobulin levels.
Table of Contents
- What This Guide Covers
- Before You Start: Verify Your Coverage
- Gather Required Documentation
- Submit Your Prior Authorization Request
- Follow-Up and Timeline Management
- If You're Asked for More Information
- If Your Request is Denied
- Texas-Specific Appeal Rights
- Renewal and Re-authorization
- Quick Reference Checklist
- Frequently Asked Questions
What This Guide Covers
This comprehensive guide helps patients with primary immunodeficiency and their healthcare teams navigate Humana's prior authorization process for Xembify (immune globulin subcutaneous) in Texas. Whether you're dealing with your first PA request or appealing a denial, you'll find step-by-step instructions, required forms, and Texas-specific appeal rights.
Xembify is a 20% subcutaneous immune globulin replacement therapy manufactured by Grifols, used to treat primary humoral immunodeficiency disorders. With retail prices ranging from $196 for a 1g vial to $1,889 for a 10g vial, securing insurance coverage is crucial for most patients.
Before You Start: Verify Your Coverage
Step 1: Confirm Your Plan Type
Humana offers several plan types in Texas, and your coverage pathway depends on which one you have:
- Medicare Advantage (Part C): Most common Humana plan type
- Medicare Part D: Prescription drug coverage
- Dual Special Needs Plans: For Medicare-Medicaid eligible patients
- Commercial/Employer plans: Follow different rules than Medicare
Call the member services number on your insurance card or log into your MyHumana account to verify your specific plan.
Step 2: Check Formulary Status
Xembify requires prior authorization across all Humana plans and is typically billed under HCPCS code J1558. Use Humana's drug list lookup tool to confirm coverage status for your specific plan.
Note: Xembify is not listed on standard formulary tiers in most Humana plans, meaning you'll likely need a formulary exception based on medical necessity.
Gather Required Documentation
Clinical Documentation Checklist
Before submitting your PA request, ensure you have:
Laboratory Results:
- Complete immunoglobulin panel (IgG, IgA, IgM, IgE levels)
- IgG subclass levels if available
- Complete blood count (CBC) with differential
- Results showing IgG <2 standard deviations below age-adjusted norms
Medical History:
- Primary immunodeficiency diagnosis with appropriate ICD-10 code (D80-D84 series)
- Documentation of ≥2 serious infections per year requiring antibiotics or hospitalization
- Prior IVIG therapy records showing failure, intolerance, or contraindication
- Current infection history and treatment responses
Treatment Plan:
- Weight-based dosing calculations (typically 150 mg/kg/week initially)
- Site of care justification (home vs. clinic administration)
- Monitoring plan and treatment goals
- Prescriber's medical necessity letter
ICD-10 Codes for Primary Immunodeficiency
Common diagnosis codes include:
- D80.0: Hereditary hypogammaglobulinemia
- D80.6: Antibody deficiency with near-normal immunoglobulins
- D81.9: Combined immunodeficiency, unspecified
- D83.9: Common variable immunodeficiency, unspecified
Submit Your Prior Authorization Request
How to Submit
- Provider Portal: Healthcare providers should use Humana's provider portal for fastest processing
- Phone: Call 1-800-833-6917 for plan-specific PA forms and submission guidance
- Fax: Submit to the fax number provided on your specific PA form (varies by plan)
Required Forms
Download the appropriate prior authorization form through Humana's provider portal or request by phone. The general Medicare Advantage PA form applies to most plans, but some may have medication-specific requirements.
Submission Timeline
- Standard review: 30 days from complete submission
- Expedited review: 72 hours for urgent medical necessity
- Complete documentation upfront to avoid delays (Humana's denial rate is approximately 3.5%, often due to incomplete submissions)
Follow-Up and Timeline Management
When to Call
Contact Humana if you haven't received a decision within:
- 5 business days of submission (to confirm receipt)
- 20 days for standard requests
- 48 hours for expedited requests
Sample Call Script
"Hello, I'm calling to check on the status of a prior authorization request for Xembify submitted on [date] for patient [name], member ID [number]. Can you provide an update on the review status and expected decision timeline?"
Document everything: Get reference numbers, representative names, and follow-up dates.
If You're Asked for More Information
Humana may request additional documentation to support medical necessity. Common requests include:
- More detailed infection history: Provide specific dates, treatments, and outcomes
- Alternative therapy documentation: Explain why other immune globulin products aren't appropriate
- Dosing justification: Include weight-based calculations and FDA labeling references
- Site of care rationale: Justify home vs. clinic administration
Respond promptly to avoid delays in your review timeline.
If Your Request is Denied
Common Denial Reasons and Solutions
| Denial Reason | How to Address |
|---|---|
| Incomplete documentation | Submit all missing lab results, infection history, and prior therapy records |
| Step therapy not met | Provide detailed IVIG failure/intolerance documentation |
| Quantity limits exceeded | Justify weight-based dosing with FDA guidelines |
| Wrong benefit category | Confirm subcutaneous administration falls under Part B coverage |
Internal Appeal Process
You have 65 days from the denial notice to file an internal appeal with Humana Medicare Advantage plans. Required documents include:
- Original denial letter
- Complete medical records
- Prescriber's medical necessity letter
- FDA labeling for Xembify
- Any new supporting clinical evidence
Submit through the Humana member portal or mail to the address provided in your denial letter.
Texas-Specific Appeal Rights
External Review Through Texas Department of Insurance
If your internal appeal is denied, Texas law provides additional protection through Independent Review Organizations (IROs).
Key Rights:
- Request external review within 4 months of final internal denial
- Available when denial is based on medical necessity or experimental treatment determination
- Free to you - the insurer pays IRO costs
- Binding decision - if IRO approves, Humana must cover the treatment
Timeline:
- Standard external review: 20 days
- Urgent cases: 5 days
- Can request expedited external review concurrent with internal appeal if delay would jeopardize health
How to Access External Review
- Humana must provide IRO request form with final denial
- Complete form and submit within 4 months
- Include all medical records and supporting documentation
Texas Resources:
- Texas Department of Insurance: 1-800-252-3439
- Office of Public Insurance Counsel: 1-877-611-6742
- IRO information line: 1-866-554-4926
Important: ERISA self-funded employer plans, Medicare, and Medicaid follow federal appeal rules, not Texas IRO process.
Renewal and Re-authorization
When to Start Renewal Process
Begin renewal 60-90 days before your current authorization expires. Humana typically requires:
- Updated lab values showing continued immunodeficiency
- Current infection history and treatment response
- Any changes in dosing or administration
- Continued medical necessity documentation
What to Include
- All documentation from initial approval
- New clinical evidence supporting continued treatment
- Updated treatment goals and monitoring results
- Any changes in clinical status
Quick Reference Checklist
Before Starting:
- Verify Humana plan type and formulary status
- Confirm in-network specialty pharmacy (CenterWell Specialty: 1-800-486-2668)
- Gather complete lab results and infection history
For Submission:
- Download PA form from provider portal or call 1-800-833-6917
- Include weight-based dosing calculations
- Attach medical necessity letter from prescriber
- Submit via provider portal for fastest processing
If Denied:
- File internal appeal within 65 days
- Include all required documentation
- Consider Texas external review if internal appeal fails
- Contact Texas DOI (1-800-252-3439) for assistance
Frequently Asked Questions
How long does Humana PA take in Texas? Standard decisions are made within 30 days of complete submission. Expedited reviews for urgent medical necessity are completed within 72 hours.
What if Xembify is non-formulary on my plan? Submit a formulary exception request with detailed clinical rationale explaining why preferred alternatives are inappropriate for your specific condition.
Can I request an expedited appeal? Yes, if a delay in treatment would jeopardize your health. Both internal appeals and Texas external reviews offer expedited timelines.
Does step therapy apply if I've tried IVIG outside Texas? Prior IVIG therapy from any state counts toward step therapy requirements. Document specific outcomes, failures, or intolerances.
What specialty pharmacies does Humana prefer in Texas? CenterWell Specialty Pharmacy is Humana's preferred specialty network, offering mail-order delivery nationwide including Texas.
How much does Xembify cost with Humana coverage? Costs vary by plan type and coverage tier. Contact CenterWell Specialty at 1-800-486-2668 for specific pricing under your plan.
From our advocates: We've seen the strongest approval outcomes when patients work closely with their immunologist to submit comprehensive documentation upfront, including detailed infection timelines and clear explanations of why subcutaneous therapy is medically necessary over intravenous alternatives. Complete submissions typically avoid the back-and-forth that can delay treatment starts.
Getting Xembify covered requires patience and thorough documentation, but Texas residents have strong appeal rights if initially denied. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific requirements.
For complex cases or repeated denials, consider working with Counterforce Health to ensure your appeal addresses the specific denial basis with appropriate clinical evidence and payer-compliant formatting.
Sources & Further Reading
- Humana Prior Authorization Lists
- Humana Medicare Drug Lists
- Texas Department of Insurance Appeals Guide
- CenterWell Specialty Pharmacy
- Xembify Prescribing Information (FDA)
Disclaimer: This guide provides general information about insurance coverage and appeal processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance representative. Coverage policies and procedures may change. Always verify current requirements with your specific plan and healthcare team.
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