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

The Requirements Checklist to Get Xembify (Immune Globulin, SC) Covered by Aetna (CVS Health) in Michigan

Answer Box: Getting Xembify Covered by Aetna in Michigan

Eligibility: Patients with primary immunodeficiency needing subcutaneous immune globulin replacement therapy.

Fastest Path: Submit prior authorization via Aetna's provider portal or fax to 888-267-3277 with complete clinical documentation including IgG levels, infection history, and prior IVIG/SCIG trials. Approval typically takes 30-45 days for standard requests, 72 hours for urgent cases.

First Step Today: Gather your recent IgG lab results, infection history from the past 12 months, and documentation of any prior immunoglobulin treatments. Contact your immunologist to begin the prior authorization process.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission
  9. Denial Prevention Tips
  10. Michigan Appeals Process
  11. FAQ
  12. Printable Checklist

Who Should Use This Checklist

This checklist is designed for:

  • Patients with primary immunodeficiency who need Xembify (subcutaneous immune globulin) covered by Aetna (CVS Health) in Michigan
  • Clinicians treating patients with hypogammaglobulinemia, CVID, or other antibody deficiencies
  • Caregivers and advocates helping navigate the prior authorization process

Expected Outcome: When you follow this checklist completely, you'll significantly increase your chances of getting Xembify approved on the first submission, avoiding delays that could leave you without essential treatment.

Member & Plan Basics

Coverage Verification Checklist

Before starting the prior authorization process:

  • Confirm active Aetna coverage through member services: 1-800-872-3862
  • Verify plan type: Fully insured (Michigan-regulated) vs. self-funded (ERISA)
  • Check formulary status: Xembify typically requires prior authorization on all Aetna plans
  • Understand deductible: Medical benefit drugs may apply to medical deductible
  • Confirm specialty pharmacy requirement: Most Aetna plans require CVS Specialty Pharmacy
Tip: Save time by calling Aetna's immunoglobulin precertification line directly at 866-752-7021 to verify coverage details specific to your plan.

Clinical Criteria Requirements

Aetna requires documentation of all the following criteria for Xembify approval:

Primary Indication

  • Confirmed primary immunodeficiency with appropriate ICD-10 code (D80.x, D83.x series)
  • Documented hypogammaglobulinemia with specific lab values and reference ranges
  • Recurrent serious infections requiring antibiotics or hospitalization

Step Therapy Documentation

According to Aetna's SCIG policy, you must show:

  • Prior IVIG trial with specific products, dates, doses, and outcomes
  • Clinical failure or intolerance of IVIG (not just patient preference)
  • Contraindication to IVIG (poor venous access, severe reactions, etc.)

Dosing Requirements

  • Weight-based dosing: Typically 150 mg/kg/week for treatment-naïve patients
  • Clinical justification for doses above FDA recommendations
  • Site of care appropriateness for subcutaneous self-administration

Coding and Billing Information

ICD-10 Diagnosis Codes

Primary immunodeficiency codes commonly accepted by Aetna:

Code Description
D80.0 Hereditary hypogammaglobulinemia
D80.1 Nonfamilial hypogammaglobulinemia
D83.0-D83.9 Common variable immunodeficiency variants
D80.6 Antibody deficiency with near-normal immunoglobulins

HCPCS and Billing

  • HCPCS Code: J1558 (Injection, immune globulin [Xembify], 100 mg)
  • Billing Units: 1 unit = 100 mg (10 g dose = 100 units)
  • Modifiers: -JB (administered subcutaneously) for DME MAC claims

Documentation Packet

Provider Note Elements

Your immunologist's note should include:

  • Specific PID diagnosis with onset and clinical course
  • Quantitative immunoglobulin levels (IgG, IgA, IgM) with dates and reference ranges
  • Infection history: frequency, severity, hospitalizations in past 12 months
  • Prior treatment failures: specific IVIG products tried, doses, duration, reasons for discontinuation
  • Clinical rationale for choosing Xembify over alternatives

Letter of Medical Necessity Components

Include these key elements:

  1. Patient demographics and insurance information
  2. Primary diagnosis with ICD-10 code
  3. Clinical history of recurrent infections
  4. Laboratory evidence of immune deficiency
  5. Treatment history and failures
  6. Medical necessity statement for Xembify specifically
  7. Planned dosing regimen and monitoring

Required Attachments

  • Recent lab results (≤6 months old)
  • Specialist consultation notes
  • Hospital records for serious infections
  • Previous IVIG infusion records
  • Vaccine response testing (if available)

Submission Process

Correct Form and Portal

  • Primary method: Aetna provider portal via Availity
  • Alternative: Fax to 888-267-3277 (immunoglobulin precertification line)
  • Phone support: 866-752-7021

Required Fields That Commonly Cause Rejections

  • Complete patient demographics including member ID and group number
  • Specific drug name and strength: "Xembify (immune globulin subcutaneous, human) 20%"
  • Exact dosing: mg/kg/week with patient weight
  • Duration of therapy: initial approval period requested
  • Prescriber DEA and NPI numbers
Note: Incomplete forms are the #1 cause of delays. Double-check every required field before submission.

Specialty Pharmacy Routing

CVS Specialty Pharmacy Requirements

Most Aetna plans require Xembify to be dispensed through their specialty network:

  • Phone: 800-237-2767
  • Fax: 800-323-2445
  • NCPDP ID: 1466033 for e-prescribing

Transfer Steps

  1. Obtain PA approval from Aetna first
  2. Send prescription to CVS Specialty with approval number
  3. Coordinate delivery and nursing support if needed
  4. Verify insurance benefits and copay assistance eligibility

At Counterforce Health, we help patients and clinicians navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies the specific denial basis and drafts point-by-point rebuttals aligned to each payer's own rules, significantly improving approval rates for specialty medications like Xembify.

After Submission

Tracking Your Request

  • Record confirmation number from portal or fax receipt
  • Calendar follow-up date: 10 business days after submission
  • Set renewal reminder: 30-45 days before approval expires
  • Document all communications with dates and reference numbers

Expected Timelines

  • Standard review: 30-45 days from complete submission
  • Expedited review: 72 hours for urgent medical situations
  • Approval communication: 1-2 days after decision

Denial Prevention Tips

Five Common Pitfalls and How to Avoid Them

  1. Incomplete step therapy documentation
    • Fix: Provide specific IVIG product names, dates, doses, and detailed failure reasons
  2. Missing infection history details
    • Fix: Include exact number of infections, hospitalizations, and antibiotic courses in past 12 months
  3. Outdated lab values
    • Fix: Submit IgG levels from within 6 months; repeat if necessary
  4. Vague medical necessity statements
    • Fix: Link each clinical fact to specific Aetna coverage criteria
  5. Wrong specialty pharmacy routing
    • Fix: Verify CVS Specialty is in-network before prescribing

Michigan Appeals Process

If Aetna denies your Xembify request, Michigan offers strong appeal protections:

Internal Appeals (Aetna)

  • Deadline: 180 days from denial date
  • Timeline: 30-60 days for standard appeals, 72 hours for expedited
  • Submit to: Same portal/fax as original PA request

External Review (Michigan DIFS)

For fully insured Michigan plans:

  • Deadline: 127 days from final Aetna denial
  • Timeline: 60 days for standard review, 72 hours for expedited
  • Contact: Michigan DIFS at 877-999-6442
  • Binding decision: Aetna must comply with favorable IRO decisions
Important: Michigan's external review process is particularly effective for specialty drug denials when proper clinical evidence is submitted.

FAQ

Q: How long does Aetna prior authorization take for Xembify in Michigan? A: Standard requests take 30-45 days. Expedited requests for urgent medical situations are decided within 72 hours.

Q: What if Xembify is non-formulary on my plan? A: Request a formulary exception with your PA submission, emphasizing medical necessity and failed alternatives.

Q: Can I request an expedited appeal if denied? A: Yes, if delay would jeopardize your health. Your doctor must provide a letter supporting medical urgency.

Q: Does step therapy apply if I tried IVIG outside Michigan? A: Yes, prior treatment history from any location counts. Provide complete documentation of all prior therapies.

Q: What's the difference between Aetna appeals and Michigan DIFS review? A: Aetna appeals are internal company reviews. DIFS external review uses independent medical experts and decisions are binding on Aetna.

Printable Checklist

Before You Start

  • Active Aetna coverage confirmed
  • Primary immunodeficiency diagnosis established
  • Recent IgG levels available (≤6 months)
  • Infection history documented (past 12 months)
  • Prior IVIG/SCIG trials documented

Documentation Packet

  • Letter of medical necessity completed
  • Lab results attached
  • Specialist notes included
  • Prior treatment records gathered
  • ICD-10 and dosing information verified

Submission

  • PA form completely filled out
  • Submitted via Aetna portal or fax (888-267-3277)
  • Confirmation number recorded
  • Follow-up date calendared

After Approval

  • Prescription sent to CVS Specialty (800-237-2767)
  • Delivery and nursing support arranged
  • Renewal reminder set (30-45 days before expiration)

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. For assistance with Michigan insurance appeals, contact Michigan DIFS at 877-999-6442.

Sources & Further Reading

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