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

How to Get Xembify (Immune Globulin SC) Covered by Humana in California: Appeals Guide & Templates

Quick Answer: Getting Xembify Covered by Humana in California

Xembify requires prior authorization from Humana, even though it's a preferred product under their Medicare Advantage plans. The fastest path to approval: gather your primary immunodeficiency diagnosis (IgG <300 mg/dL), document any prior IVIG trials and failures, and submit a complete prior authorization request through Humana's provider portal. If denied, California residents can appeal through Humana's internal process, then escalate to an Independent Medical Review (IMR) with a 55% overturn rate for specialty drugs. First step today: Call Humana at 800-555-2546 to request the prior authorization form and confirm your specific plan's requirements.

Table of Contents

  1. Understanding Your Denial Letter
  2. Common Denial Reasons & Quick Fixes
  3. First-Level Appeal Process
  4. Peer-to-Peer Review Strategy
  5. California External Review (IMR)
  6. Medical Necessity Letter Template
  7. Coverage Requirements at a Glance
  8. Cost Assistance & Patient Support
  9. When to Escalate to State Regulators
  10. Frequently Asked Questions

Understanding Your Denial Letter

When Humana denies Xembify coverage, your denial letter will include specific reason codes that determine your next steps. Here's how to decode the most common ones:

Medical Benefit vs. Pharmacy Benefit: Xembify falls under Medicare Part B DME benefit for subcutaneous infusion via external pump. If denied under pharmacy benefit, request transfer to medical benefit review.

Prior Authorization Required: All immune globulin products require PA under Humana's 2024-2025 preauthorization lists. Missing PA is an automatic denial but easily fixable.

Step Therapy Not Met: Even though Xembify is preferred, many plans still require documented IVIG trials. Look for codes referencing "step therapy" or "preferred alternatives."

Tip: Your denial letter must include appeal deadlines—typically 65 days for Medicare Advantage members. Mark this date immediately and work backward to plan your appeal timeline.

Common Denial Reasons & Quick Fixes

Denial Reason How to Fix Required Documentation
Missing diagnosis codes Submit ICD-10 D80.9 (immunodeficiency) Lab results showing IgG <300 mg/dL
No prior IVIG documentation Provide detailed trial history Dates, doses, adverse events, clinical outcomes
Insufficient medical necessity Submit comprehensive clinical letter Infection history, functional impairment, treatment goals
Wrong benefit category Request Part B medical review Confirm subcutaneous administration method
Quantity limits exceeded Request exception with dosing rationale Weight-based calculations, specialist recommendation

Most Critical Fix: According to coverage experts, failing to document IVIG trials and failures is the most frequent cause of Xembify denials. Even though Xembify is FDA-approved for treatment-naïve patients, most insurance plans still require step therapy documentation.

First-Level Appeal Process

Step 1: Gather Required Documents

  • Complete denial letter with reason codes
  • Insurance card and member ID
  • Prescriber contact information
  • Medical records supporting diagnosis
  • Prior therapy documentation (if applicable)
  • Lab results showing immunoglobulin deficiency

Step 2: Submit Internal Appeal

Timeline: Must be filed within 65 days of denial notice

Submission Options:

  • Phone: 800-555-2546 (Monday-Friday, 8 AM-8 PM ET)
  • Fax: 877-486-2621 with supporting documentation
  • Online: Humana member portal with coverage determination form
  • Mail: CarePlus Health Plans, Attention: Clinical Pharmacy Review, P.O. Box 14601, Lexington, KY 40512-4601

Step 3: Include Medical Necessity Justification

Your appeal must demonstrate that Xembify is more effective than covered alternatives, that formulary drugs would cause adverse effects, or that required step therapy has failed or would be ineffective.

Note: Humana's Medicare Advantage PA denial rate is approximately 3.5%—among the lowest of major plans—but denials often hinge on formulary placement or documentation gaps rather than medical necessity.

Peer-to-Peer Review Strategy

A peer-to-peer review allows your prescriber to speak directly with Humana's medical director. This can be highly effective for complex cases.

How to Request: Call Humana's Clinical Pharmacy Review team and ask to schedule a peer-to-peer discussion. Your prescriber should be prepared with:

  • Specific diagnosis and ICD-10 codes
  • Detailed infection history (frequency, types, severity)
  • Prior treatment failures with dates and outcomes
  • Clinical rationale for Xembify vs. alternatives
  • Dosing calculations and administration plan

Prep Checklist for Your Doctor:

  • Have patient chart and lab results readily available
  • Review FDA labeling for Xembify indications
  • Prepare 2-3 key clinical points supporting medical necessity
  • Know specific adverse events or contraindications to IVIG

One documented case involved a patient with 8 bacterial infections over 6 months despite adequate IVIG dosing—the successful appeal included emergency room records, antibiotic prescriptions, and missed work documentation, resulting in approval within 72 hours of peer-to-peer review.

California External Review (IMR)

If Humana upholds their denial, California residents can request an Independent Medical Review through the Department of Managed Health Care (DMHC).

IMR Success Rates

California's IMR process has approximately 55% success rates for medical necessity denials of specialty drugs, with some insurers seeing even higher overturn rates. For Anthem specifically, 68.6% of medical necessity denials were overturned by DMHC.

Filing Timeline

  • Standard decision: 30 days from accepted application
  • Expedited decision: 3-7 days for urgent situations
  • Filing deadline: Within 6 months of final internal denial
  • Cost: No fee to patients—DMHC covers all review costs

How to File

  1. Contact DMHC Help Center: Call 888-466-2219 or visit healthhelp.ca.gov
  2. Complete IMR application: Available online in multiple languages
  3. Submit supporting documents: All denial letters, medical records, specialist letters, clinical guidelines

Required Documentation for Strong IMR Case

  • All denial letters from Humana
  • Complete medical records supporting medical necessity
  • Specialist letters explaining why alternative treatments failed
  • Clinical guidelines supporting Xembify treatment
  • Specific clinical evidence and FDA labeling information
California Advantage: The state's independent review process is highly favorable to patients, with binding decisions that insurers must follow. If IMR overturns the denial, Humana must authorize and pay for Xembify treatment.

Medical Necessity Letter Template

Your prescriber should include these key elements in their medical necessity letter:

Patient Information & Diagnosis

  • Full name, DOB, member ID
  • Primary diagnosis with ICD-10 code (D80.9 for immunodeficiency)
  • Supporting lab values (IgG, IgA, IgM levels)
  • Date of diagnosis confirmation

Clinical History

  • Detailed infection history (frequency, types, severity)
  • Prior hospitalizations or emergency visits
  • Impact on daily functioning and quality of life
  • Previous treatments attempted and outcomes

Treatment Rationale

  • Why Xembify is medically necessary
  • Contraindications or failures with IVIG
  • Expected clinical outcomes
  • Dosing rationale based on weight/clinical response

Supporting Evidence

  • Reference to FDA labeling for primary immunodeficiency
  • Clinical guidelines supporting subcutaneous immunoglobulin therapy
  • Peer-reviewed literature if applicable

Counterforce Health specializes in turning 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 rules. Their platform identifies the exact denial basis and pulls appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines to strengthen medical necessity arguments.

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all immune globulin products Humana PA List 2025
Formulary Status Preferred product, no step therapy for continuations Humana IVIG Policy
Diagnosis Codes D80.9 (immunodeficiency), G11.3 (ataxia-telangiectasia) CMS Coverage Database
Benefit Category Medicare Part B DME for subcutaneous infusion CMS Article A52507
Appeal Deadline 65 days from denial notice Humana Appeals Process

Cost Assistance & Patient Support

Xembify Connexions Program:

  • Phone: 1-844-699-3624 (Monday-Friday, 8 AM-8 PM ET)
  • Copay assistance: Up to $10,000 per calendar year
  • Coverage: Copayments, deductibles, and coinsurance
  • Eligibility: Commercial insurance (not available for government programs)

Additional Support:

  • Insurance navigation and prior authorization assistance
  • ICD-10 code updates and reimbursement guidance
  • Connection to specialty pharmacies and infusion centers

The program can potentially reduce out-of-pocket costs to $0, regardless of whether Xembify is billed under pharmacy or medical benefit.

When to Escalate to State Regulators

If Humana fails to follow proper appeal procedures or timelines, contact California's insurance regulators:

Department of Managed Health Care (DMHC):

  • Phone: 888-466-2219
  • Website: dmhc.ca.gov
  • Jurisdiction: HMOs and most managed care plans

California Department of Insurance (CDI):

  • Phone: 800-927-4357
  • Website: insurance.ca.gov
  • Jurisdiction: PPO and indemnity plans

File a complaint if:

  • Humana exceeds appeal response timelines
  • Required forms or information are not provided
  • Appeals process is not clearly explained
  • Discrimination or unfair treatment occurs

Frequently Asked Questions

How long does Humana prior authorization take for Xembify? Standard PA decisions typically take 30 days for Part C pre-service requests. Expedited reviews can be completed within 72 hours for urgent medical situations.

What if Xembify isn't on my Humana formulary? Request a formulary exception by demonstrating medical necessity. Include documentation that covered alternatives would be less effective or cause adverse effects.

Can I start Xembify without prior IVIG trials? While Xembify is FDA-approved for treatment-naïve patients, most Humana plans still require step therapy documentation. Work with your prescriber to document why IVIG would be inappropriate.

Does California's 90-day transition policy apply to Xembify? New Humana enrollees may receive temporary coverage for active treatments started before enrollment, but this must be reviewed against current PA criteria within the first 90 days.

What's the success rate for Xembify appeals in California? California's IMR process shows approximately 55% success rates for specialty drug medical necessity denials, with higher rates when comprehensive clinical documentation is provided.

Can I request an expedited appeal for Xembify? Yes, if your condition is urgent or if delays would seriously jeopardize your health. Standard expedited timelines are 72 hours for Medicare Part D and 7 days or less for IMR.

What counts as adequate IVIG trial documentation? Include specific dates, doses, duration of treatment, documented adverse events, and clinical outcomes showing inadequate response despite appropriate dosing.

Who can help me prepare my Humana appeal? Your prescriber, Xembify Connexions (1-844-699-3624), California consumer assistance organizations, and specialized services like Counterforce Health that focus on insurance appeals for complex medications.

From our advocates: We've seen cases where patients received 13 initial denials for immune globulin therapy, but comprehensive documentation including detailed infection history, lab results showing functional antibody deficiency, and IVIG intolerance records led to successful external review approval within 30 days. The key is thorough clinical documentation and persistence through the appeals process.

This guide provides general information about insurance appeals and should not be considered medical advice. For specific medical questions, consult your healthcare provider. For insurance-specific guidance, contact Humana directly or seek assistance from California's Department of Managed Health Care at 888-466-2219.

Sources & Further Reading

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