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

How to Get Xembify (Immune Globulin, SC) Covered by Aetna CVS Health in New Jersey: Prior Authorization, Appeals, and Cost Assistance

Answer Box: Getting Xembify Covered by Aetna CVS Health in New Jersey

Xembify (immune globulin subcutaneous) requires prior authorization from Aetna CVS Health for primary immunodeficiency. Submit via Availity portal or fax (888) 267-3277 with diagnosis documentation, IgG levels, and prior treatment failures. Most approvals process within 24-48 hours. If denied, you have 180 days to appeal internally, then 4 months for New Jersey's external review through Maximus Federal Services. Start the PA process 60-90 days before needed therapy to avoid treatment gaps.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Understanding Your Benefit Design
  4. Investigating Your Coverage
  5. Cost Assistance and Copay Support
  6. Formulary Exception Process
  7. CVS Specialty Pharmacy Coordination
  8. Appeals Process for New Jersey
  9. Common Denial Reasons & Solutions
  10. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory for all Xembify prescriptions Aetna Precertification Lists Aetna 2024/2025 Precert Lists
Formulary Tier Non-preferred; may require step therapy Plan-specific formulary document Aetna Drug Guides
Diagnosis Requirement Primary immunodeficiency with ICD-10 codes Clinical Policy Bulletin #0206 Aetna Medical Policy
Step Therapy Trial of preferred IG products first PA submission forms SCIG Step Criteria Form
Quantity Limits Weight-based dosing caps (150 mg/kg/week) Clinical Policy Bulletin Aetna CPB #0206
Site of Care Home or clinic administration Medical benefit coverage CVS Specialty coordination

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (1-2 days)

Who: Your prescribing physician and clinic staff
Documents needed:

  • Complete medical records showing primary immunodeficiency diagnosis
  • Recent IgG levels and immunology workup
  • History of recurrent infections with dates and treatments
  • Documentation of prior IVIG/SCIG trials and outcomes (if applicable)

2. Complete Prior Authorization Submission (Same day)

Who: Prescriber or CVS Specialty Pharmacy
How to submit:

Required forms: Aetna SCIG Step Criteria Form

3. CVS Specialty Enrollment (1-2 days post-approval)

Who: Patient or prescriber
Process: CVS Specialty handles most Aetna specialty medications exclusively
Contact: Plan-specific number on member ID card

4. Benefits Verification and Cost Calculation (1 day)

Who: CVS Specialty pharmacy team
Timeline: Within 24 hours of approval

5. Delivery and Training Setup (3-5 days)

Who: CVS Specialty and nursing team
Includes: Home delivery, self-injection training, ongoing support

Tip: Start this process 60-90 days before you need Xembify to avoid any treatment delays, especially if step therapy documentation is required.

Understanding Your Benefit Design

Aetna CVS Health typically covers Xembify under your medical benefit rather than pharmacy benefit, which affects your cost-sharing structure. Here's what drives your out-of-pocket costs:

Formulary Tiering Impact

Xembify is generally classified as a non-preferred specialty medication, meaning:

  • Higher copayments compared to preferred alternatives
  • Step therapy requirements may apply
  • Prior authorization is mandatory

Benefit Structure Factors

  • Deductible: You'll pay the full cost until your annual deductible is met
  • Coinsurance: Typically 10-40% of the drug cost after deductible
  • Out-of-pocket maximum: Your annual limit for covered services

Investigating Your Coverage

Before starting treatment, gather this key information by calling the member services number on your insurance card:

Questions to Ask Aetna

  1. "Is Xembify covered under my medical or pharmacy benefit?"
  2. "What's my specialty medication deductible and coinsurance?"
  3. "Does my plan require step therapy for immune globulin products?"
  4. "What's my annual out-of-pocket maximum?"
  5. "Is CVS Specialty my required pharmacy for this medication?"

Information to Record

  • Reference number from your call
  • Representative's name and date
  • Specific benefit details provided
  • Any step therapy requirements mentioned

Cost Assistance and Copay Support

Xembify Connexions Copay Assistance Program

Eligibility: Commercially insured patients with primary immunodeficiency
Benefit: Up to $10,000 per calendar year toward deductibles, copayments, and coinsurance
Exclusions: Medicare, Medicaid, VA, TRICARE, or other government programs

How to enroll:

  1. Visit Xembify Connexions
  2. Complete enrollment form with insurance information
  3. For pharmacy benefit claims: Use BIN 016664, PCN MEDMONK
  4. For medical benefit claims: Submit through Medmonk portal

Additional Financial Resources

  • Patient Assistance Program: For uninsured patients through Grifols
  • Foundation grants: Contact Primary Immune Deficiency Foundation for assistance programs
  • State programs: New Jersey may offer additional support through NJ FamilyCare

Formulary Exception Process

If Xembify is non-preferred on your plan, you can request a formulary exception:

Medical Necessity Documentation Required

Your prescriber must submit:

  • Letter of medical necessity explaining why Xembify is required over preferred alternatives
  • Clinical evidence of prior treatment failures or adverse reactions
  • Supporting studies or FDA labeling information
  • Specialist consultation notes from immunology

Common Justifications for Exception

  • Adverse reactions to preferred products
  • Inadequate response to step therapy requirements
  • Quality of life improvements with subcutaneous vs. intravenous therapy
  • Medical contraindications to preferred alternatives
From our advocates: We've seen formulary exceptions succeed when prescribers include specific infection rates before and after previous treatments, along with quality of life questionnaires showing the impact of weekly clinic visits for IVIG versus home self-administration with SCIG.

CVS Specialty Pharmacy Coordination

Most Aetna plans require Xembify to be dispensed exclusively through CVS Specialty Pharmacy, which streamlines the process:

CVS Specialty Services Include

  • Prior authorization submission and follow-up
  • Benefits verification and cost estimation
  • Delivery coordination (refrigerated shipping)
  • Nursing support for training and ongoing care
  • Refill management and renewal coordination

Coordination Timeline

  1. PA submission: CVS assists prescriber with documentation
  2. Approval processing: 24-48 hours for standard cases
  3. First shipment: 3-5 business days post-approval
  4. Training setup: Coordinated with delivery for new patients

Appeals Process for New Jersey

If your Xembify prior authorization is denied, New Jersey offers robust appeal rights:

Internal Appeals with Aetna

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard appeals, 72 hours for expedited
  • Required documents: Denial letter, medical records, physician statement

External Review through IHCAP

New Jersey's Independent Health Care Appeals Program (IHCAP) provides binding external review:

  • Managed by: Maximus Federal Services
  • Deadline: 4 months from final internal denial
  • Timeline: 45 days for standard, 48 hours for expedited
  • Cost: Free to patients

Required Documentation for Appeals

  • Complete denial letters from all internal appeal levels
  • Medical records supporting diagnosis and treatment need
  • Physician letter addressing specific denial reasons
  • Evidence of prior treatment failures (if step therapy issue)

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient medical necessity Submit comprehensive clinical documentation IgG levels, infection history, specialist notes
Step therapy not completed Document prior failures or contraindications Treatment records, adverse event reports
Non-formulary status Request formulary exception Medical necessity letter, clinical evidence
Quantity limit exceeded Justify higher dosing needs Weight-based calculations, specialist recommendations
Experimental/investigational Provide FDA approval evidence FDA labeling, published guidelines

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in New Jersey?
Standard approvals typically process within 24-48 hours, with over 95% completed within 24 hours according to Aetna. Expedited reviews for urgent cases are completed within 72 hours.

What if Xembify is not on my formulary?
You can request a formulary exception through the prior authorization process. Include medical necessity documentation and evidence of why preferred alternatives aren't suitable.

Can I request an expedited appeal in New Jersey?
Yes, both Aetna internal appeals and IHCAP external reviews offer expedited processing for urgent medical situations where delays could cause serious harm.

Does step therapy apply if I've tried other products outside New Jersey?
Yes, documented treatment failures from other states are typically accepted. Ensure you have complete medical records from previous providers.

What happens if I miss an appeal deadline?
Contact the New Jersey Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 for guidance on late filing options or alternative recourse.

How much will Xembify cost with Aetna coverage?
Costs vary by plan, but with the Xembify Connexions copay assistance program, eligible patients may pay $0 after insurance and assistance are applied.

For patients and clinicians navigating the complex world of specialty medication approvals, Counterforce Health helps turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and regulatory citations to support your case. Whether you're facing a prior authorization challenge or need help with the appeals process, having the right documentation and strategy can make the difference between approval and denial.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Insurance coverage and policies may vary by plan and change over time. Verify current requirements with your insurer and state insurance department.

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