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

How to Get Xembify Covered by Humana in Florida: Prior Authorization Forms, Timelines, and Appeal Steps

Answer Box: Getting Xembify Covered by Humana in Florida

Xembify requires prior authorization from Humana in Florida. The fastest path to approval: (1) Submit complete PA documentation including primary immunodeficiency diagnosis (ICD-10 codes D80.x), immunoglobulin lab values, and prior therapy records via Humana's provider portal, (2) Include HCPCS code J1558 and NDC numbers, (3) Allow 7 days for decision under new CMS rules. If denied, you have 65 days to appeal with Florida's external review as backup. Start today: Contact your prescriber to initiate the PA request and gather your immunodeficiency lab results.

Table of Contents

What This Guide Covers

This comprehensive guide helps Florida residents with Humana insurance—including Medicare Advantage, Medicaid (Healthy Horizons), and commercial plans—navigate the prior authorization process for Xembify (immune globulin, subcutaneous). Whether you're a patient, caregiver, or healthcare provider, you'll find step-by-step instructions, required forms, appeal strategies, and Florida-specific resources.

Xembify is a 20% subcutaneous immune globulin replacement therapy for primary humoral immunodeficiency (PID), with retail costs ranging from $196 for 5mL to $1,889 for 50mL. Given these costs, Humana requires prior authorization for all plans, making proper documentation essential for approval.

Before You Start: Plan Verification

Confirm Your Humana Plan Type

Different Humana plans have varying requirements:

  • Medicare Advantage/Part D: Prior authorization required; may be covered under Part B (if administered in medical facility) or Part D (home use)
  • Medicaid (Healthy Horizons): Prior authorization mandatory; specialty pharmacy required
  • Commercial plans: Prior authorization with formulary restrictions

Check Formulary Status

Xembify is listed on Humana's Medicare formulary as a preferred immune globulin product, meaning it doesn't require step therapy if you're continuing prior therapy within 365 days.

Coverage at a Glance

Requirement Details Where to Find Source
Prior Authorization Required for all plans Humana PA Search Tool Humana Provider Portal
HCPCS Code J1558 Medical claims Florida Medicaid PA List
Specialty Pharmacy Required (not retail) Humana Pharmacy Finder Humana Website
Decision Timeline 7 days (CMS requirement) PA submission Dual PAL Guide
Appeal Deadline 65 days from denial Denial letter Medicare Guidelines

Gather Required Documentation

Essential Clinical Information

Your healthcare provider must compile comprehensive documentation:

Primary Immunodeficiency Diagnosis

  • Specific ICD-10 codes: D80.0 (hereditary hypogammaglobulinemia), D80.1 (nonfamilial hypogammaglobulinemia), D80.2 (IgA deficiency), D80.3 (IgG subclass deficiency), or other relevant D80.x-D81.x codes
  • Recent immunoglobulin levels showing deficiency (IgG <400 mg/dL typically indicates hypogammaglobulinemia)

Clinical Justification

  • History of recurrent infections
  • Poor vaccine response documentation
  • Prior IVIG or SCIG therapy records (if applicable)
  • Contraindications to intravenous therapy (if relevant)

Administrative Details

  • Humana member ID and demographics
  • Provider NPI and TIN numbers
  • Anticipated service dates
  • NDC numbers for specific Xembify vials
  • Site of administration (home, clinic, or office)
Clinician Corner: Medical necessity letters should reference FDA labeling for Xembify's approved indication (primary humoral immunodeficiency) and include quantitative immunoglobulin levels. Humana's IVIG policy specifically covers primary humoral immunodeficiency when properly documented.

Submit the Prior Authorization Request

Step-by-Step Submission Process

1. Access the Correct Form

2. Complete All Required Fields

  • Member information (ID, DOB, contact details)
  • Provider details (NPI, TIN, contact information)
  • Clinical information (diagnosis, ICD-10 codes, treatment rationale)
  • Service details (HCPCS J1558, NDC, quantity, frequency)

3. Submit Documentation

  • Fax: Use the number provided on your specific plan's PA form
  • Portal: Upload through Humana's secure provider portal
  • Phone: Clinical review line at 877-486-2621 for urgent cases

4. Attach Supporting Documents

  • Lab results showing immunoglobulin deficiency
  • Prior therapy records
  • Medical necessity letter from prescribing physician
  • Chart notes documenting infections or complications

Follow-Up and Tracking

Monitoring Your Request

  • Reference numbers: Document all confirmation numbers from submissions
  • Timeline tracking: Mark calendar for 7-day decision deadline
  • Status checks: Call Humana customer service (number on member ID card) for updates

Sample Follow-Up Script

"I'm calling to check the status of a prior authorization request for Xembify submitted on [date]. The member ID is [number] and the reference number is [if available]. Can you tell me the current status and expected decision date?"

Understanding Timelines

Florida-Specific Requirements

Under new CMS rules effective January 2026, Humana must make prior authorization decisions within 7 calendar days for medical items and services. This accelerated timeline means complete documentation is crucial for avoiding delays.

Standard Process:

  • Day 0: Submit complete PA request
  • Day 1-7: Humana clinical review
  • Day 7: Decision notification (approval or denial)

Expedited Process:

  • Available for urgent medical situations
  • Decision within 72 hours
  • Requires physician attestation of urgency

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient diagnosis documentation Provide specific ICD-10 codes and lab values Immunoglobulin levels, infection history
Missing prior therapy information Document IVIG trials or contraindications Treatment records, adverse reaction notes
Quantity/dosing concerns Justify weight-based dosing Body weight, BSA calculations, dosing guidelines
Site of care issues Clarify administration location Home infusion plan or clinic protocols

Counterforce Health specializes in turning these common denials into successful appeals by identifying the specific denial basis and crafting targeted, evidence-backed responses that align with Humana's own coverage policies.

Appeals Process in Florida

Internal Appeals (First Level)

If your prior authorization is denied, you have 65 days from the denial notice to file an internal appeal with Humana.

Required Steps:

  1. Submit written appeal with denial letter
  2. Include additional clinical documentation
  3. Request peer-to-peer review if needed
  4. Track the 30-day decision timeline

External Review (Second Level)

Florida contracts with independent review organizations for external appeals when internal appeals fail.

Process Overview:

Expedited Appeals

For urgent situations, you can request expedited internal and external reviews simultaneously, with decisions possible within 72 hours.

Specialty Pharmacy Considerations

Xembify requires fulfillment through Humana's specialty pharmacy network, not standard retail pharmacies.

Preferred Specialty Pharmacies in Florida:

  • CenterWell Specialty Pharmacy (Humana-owned): Home delivery available
  • OptumRx: Listed for Florida Medicaid specialty medications
  • Use Humana's Pharmacy Finder to locate in-network specialty pharmacies by ZIP code

Important Notes:

  • Most retail pharmacies (CVS, Walgreens, Publix) cannot dispense Xembify
  • Prior authorization must be approved before specialty pharmacy fulfillment
  • Home delivery coordination available through approved specialty pharmacies
From Our Advocates: "We've seen many Florida patients successfully obtain Xembify coverage by ensuring their immunoglobulin lab results clearly show deficiency levels and their physicians document specific infection patterns. The key is presenting a complete clinical picture that aligns with Humana's medical necessity criteria from the initial submission."

FAQ

How long does Humana prior authorization take for Xembify in Florida? Under new CMS rules, Humana must decide within 7 calendar days of receiving complete documentation. Incomplete requests may take longer due to additional information requests.

What if Xembify is non-formulary on my plan? Xembify is listed as a preferred immune globulin on Humana Medicare formularies. For non-formulary situations, your physician can request a formulary exception with medical necessity documentation.

Can I get expedited approval for urgent situations? Yes, expedited prior authorization is available for urgent medical needs, with decisions within 72 hours. Your physician must attest to the urgency and medical necessity.

Does step therapy apply if I've used other immune globulins? If you're continuing therapy within 365 days, step therapy requirements may not apply under Medicare Part B policies. Document prior therapy clearly in your PA request.

What happens if I'm denied coverage? You have 65 days to file an internal appeal with Humana, followed by external review through Florida's independent review process if needed.

Are there cost assistance programs for Xembify? Check with Grifols (Xembify's manufacturer) for patient assistance programs and copay support options for eligible patients.

How do I know if my administration site affects coverage? Coverage may vary between home administration (typically Part D) and clinic/office administration (potentially Part B). Verify with Humana based on your specific plan and intended administration location.

What if my physician needs to do a peer-to-peer review? Physicians can request peer-to-peer reviews by calling Humana's clinical review line at 877-486-2621. This allows direct discussion of medical necessity with Humana's medical directors.

For patients and providers navigating complex prior authorization requirements, Counterforce Health offers specialized support in preparing comprehensive appeals that address specific denial reasons with targeted, evidence-backed documentation.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with insurance appeals and prior authorization challenges, contact Florida's Insurance Consumer Helpline at 877-693-5236.

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