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

How to Get Xembify Covered by Blue Cross Blue Shield in New York: Complete Prior Authorization Guide

Answer Box: Getting Xembify Approved in New York

Xembify (immune globulin subcutaneous) requires prior authorization from Blue Cross Blue Shield in New York for primary immunodeficiency coverage. Submit your PA request through Availity Essentials Authorization app with diagnosis confirmation, lab evidence (low IgG levels), infection history, and weight-based dosing rationale. Empire BlueCross BlueShield typically responds within 15 business days for standard requests, 72 hours for urgent cases. First step today: verify your specific Blue Cross plan and download the PA form from your member portal.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Plan Details
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Understanding Typical Timelines
  7. If You're Asked for More Information
  8. If Your Request Is Denied
  9. Renewal and Re-authorization
  10. Common Denial Reasons & How to Fix Them
  11. New York Appeals Process
  12. Quick Reference Checklist

What This Guide Covers

This guide helps patients with primary humoral immunodeficiency and their healthcare providers navigate the prior authorization process for Xembify with Blue Cross Blue Shield plans in New York. Xembify is a 20% subcutaneous immune globulin (SCIG) replacement therapy that can be administered at home or in clinic settings.

Who this helps:

  • Patients diagnosed with primary immunodeficiency diseases like CVID, X-linked agammaglobulinemia, or other antibody deficiencies
  • Clinicians preparing medical necessity documentation
  • Caregivers managing insurance appeals

Expected outcomes: With proper documentation, most medically appropriate Xembify requests are approved within 2-3 weeks. Denials often stem from incomplete documentation rather than medical necessity concerns.

Note: This guide focuses on commercial Blue Cross Blue Shield plans. Medicaid and Medicare Part D processes may differ.

Before You Start: Verify Your Plan Details

Confirm Your Blue Cross Blue Shield Plan Type

New York has several Blue Cross Blue Shield entities. Your member ID card will show:

  • Empire BlueCross BlueShield (most common commercial plans)
  • Excellus BlueCross BlueShield (upstate regions)
  • HealthNow New York (Buffalo/Western NY)

Each has slightly different prior authorization requirements and preferred drug lists.

Check Xembify's Formulary Status

Plan Type Typical Tier PA Required? Step Therapy?
Empire BCBS Commercial Tier 3-4 Yes IVIG trial often required
Excellus BCBS Tier 3-4 Yes Two SCIG failures required
Most NY Blues Specialty Yes Varies by plan

Action step: Log into your plan's member portal or call the number on your insurance card to confirm Xembify's current formulary status and any step therapy requirements.

Verify In-Network Provider Status

Ensure your prescribing physician is in-network with your specific Blue Cross plan. Out-of-network prescriptions face additional hurdles and may require different forms.

Gather Required Documentation

Essential Clinical Documentation

Primary Immunodeficiency Diagnosis Requirements:

  • Specific ICD-10 code (avoid generic D84.9 "immunodeficiency, unspecified")
  • Use targeted codes like D80.0 (hereditary hypogammaglobulinemia), D83.0-D83.9 (CVID variants), or D80.6 (antibody deficiency with near-normal immunoglobulins)

Laboratory Evidence:

  • Quantitative immunoglobulin levels (IgG, IgA, IgM) before any immune globulin therapy
  • IgG typically <500-600 mg/dL for adults or >2 standard deviations below age-adjusted mean
  • Vaccine response studies showing poor antibody production to protein and polysaccharide antigens
  • Recent lymphocyte subsets (CD19+ B cells, CD3/CD4/CD8 T cells) if available

Infection History Documentation:

  • At least 2 serious bacterial infections (pneumonia, sepsis, meningitis) OR
  • Recurrent sinopulmonary infections over ≥12 months
  • Dates, sites, organisms, and treatment details
  • Evidence of inadequate response to standard antibiotics and vaccinations

Weight-Based Dosing Calculations

Blue Cross plans require proper weight-based dosing to prevent denials:

Dosing Formula:

  • Initial dose: 0.2-0.5 g/kg weekly (1-2.5 mL/kg, given Xembify's 200 mg/mL concentration)
  • For patients with BMI ≥30 or weight >120% of ideal body weight, use adjusted body weight
  • Ideal Body Weight: Male = 50 + 2.3×(inches over 60); Female = 45.5 + 2.3×(inches over 60)
  • Adjusted Body Weight = IBW + 0.4×(actual weight - IBW)

Example: 5'10" male weighing 200 lbs

  • IBW = 73 kg
  • Adjusted weight = 73 + 0.4×(91-73) = 80.2 kg
  • Weekly dose range: 16-40 mL (3.2-8.0 grams)

Submit Your Prior Authorization Request

Digital Submission (Fastest Option)

Empire BlueCross BlueShield:

  1. Access Availity Essentials
  2. Navigate to Authorization app under Patient Registration
  3. Enter HCPCS codes J1569 or J1575 for Xembify
  4. Upload all required documentation
  5. Track status through the portal

Excellus BlueCross BlueShield:

Manual Submission

If digital submission isn't available:

  1. Download PA form from your plan's provider website
  2. Complete all sections thoroughly
  3. Attach clinical documentation
  4. Fax to the number listed on the form (verify current fax number)
  5. Keep fax confirmation receipt

Clean Request Packet Checklist

✓ Completed PA form with all fields filled ✓ Diagnosis with specific ICD-10 code ✓ Lab results showing immunoglobulin levels ✓ Infection history with dates and details ✓ Weight-based dosing calculation ✓ Prior therapy documentation (if step therapy applies) ✓ Prescriber's medical necessity letter

Follow-Up and Tracking

When to Call Your Insurance Plan

  • Day 3-5: Confirm receipt of your PA request
  • Day 10: Check processing status
  • Day 14: If no decision, request expedited review if clinically appropriate

Sample Phone Script

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

Document: Date called, representative name, reference number, and next steps given.

Understanding Typical Timelines

New York State Requirements

Request Type Timeline Expedited Option
Standard PA 15 business days 72 hours if urgent
Appeal (Internal) 30 calendar days 72 hours if urgent
External Review 30 days 72 hours (24 hours for urgent drugs)

What speeds decisions:

  • Complete documentation on first submission
  • Clear medical necessity justification
  • Proper weight-based dosing calculations

What slows decisions:

  • Missing lab values or infection history
  • Incomplete step therapy documentation
  • Generic immunodeficiency diagnosis codes

If You're Asked for More Information

Common Information Requests

Medical Necessity Questions:

  • "Why is subcutaneous preferred over intravenous immune globulin?"
  • Document: venous access issues, severe IVIG reactions, need for home therapy, distance to infusion centers

Dosing Justification:

Literature Support: Include citations from:

  • FDA prescribing information for Xembify
  • Primary immunodeficiency treatment guidelines
  • Peer-reviewed studies on SCIG efficacy
Tip: Respond to information requests within 48 hours to avoid delays or automatic denials.

If Your Request Is Denied

Understanding Denial Codes

Common denial reasons and immediate next steps:

Denial Reason Next Step
"Not medically necessary" File internal appeal with additional clinical evidence
"Step therapy not met" Document IVIG trial/failure or contraindication
"Experimental/investigational" Provide FDA approval documentation
"Non-formulary" Request formulary exception with medical necessity

Peer-to-Peer Review

Request a peer-to-peer call with the plan's medical director:

  • Available within 24-48 hours of denial
  • Prepare clinical summary and key talking points
  • Have patient's chart and guidelines readily available

Sample P2P Request: "I'm requesting a peer-to-peer review for [patient name] regarding the Xembify denial. The patient has documented CVID with recurrent infections despite adequate antibiotic therapy. I can discuss the case at your earliest convenience."

Renewal and Re-authorization

When to Submit Renewal

  • Initial approval: Usually 6 months for new patients
  • Renewal: 12-24 months for stable patients
  • Calendar reminder: Submit 30-45 days before expiration

Renewal Documentation Requirements

✓ Updated IgG trough levels ✓ Infection frequency comparison (before vs. during therapy) ✓ Functional status improvements ✓ Any dose adjustments and rationale ✓ Continued medical necessity statement

Common Denial Reasons & How to Fix Them

Step Therapy Requirements

Many Blue Cross plans require IVIG trial before approving SCIG:

If you haven't tried IVIG:

  • Document contraindications: poor venous access, severe reactions to IVIG, need for frequent dosing
  • Provide medical literature supporting SCIG as first-line when appropriate

If IVIG failed:

  • Document specific product names, dates, doses
  • Objective failure criteria: persistent infections, inadequate IgG levels, severe adverse reactions

Dosing Issues

"Dose exceeds guidelines":

  • Recalculate using ideal or adjusted body weight
  • Provide IgG trough levels justifying higher doses
  • Reference published dose ranges for primary immunodeficiency

New York Appeals Process

Internal Appeal (First Level)

File within 180 days of denial:

  1. Submit written appeal to address on denial letter
  2. Include additional medical documentation
  3. Request expedited review if urgent (72-hour decision)

External Review Through NY Department of Financial Services

If internal appeal fails:

  1. File within 4 months of final internal denial
  2. Use DFS external appeal application
  3. Include physician attestation form
  4. $25 fee (waived for Medicaid or financial hardship)

Expedited external review available for:

  • Serious jeopardy to life or health
  • Current treatment with non-formulary drug
  • Decision within 24-72 hours

For free help with appeals, contact Community Health Advocates at 888-614-5400.

Quick Reference Checklist

Before Starting: □ Verify Blue Cross plan type and formulary status □ Confirm provider is in-network □ Check step therapy requirements

Documentation Needed: □ Specific immunodeficiency ICD-10 code □ Pre-therapy immunoglobulin levels □ Infection history with dates □ Weight-based dosing calculation □ Prior therapy documentation

Submission: □ Use digital portal when available □ Include complete documentation packet □ Keep confirmation numbers/receipts □ Follow up within one week

If Denied: □ Review denial reason carefully □ Consider peer-to-peer review □ File internal appeal within 180 days □ Use NY external review if needed

From our advocates: We've seen patients succeed after initial denials by providing more specific infection documentation. Instead of "recurrent infections," include exact dates, sites (sinusitis, pneumonia), organisms when known, and hospitalizations. This objective data strengthens medical necessity arguments significantly.

Frequently Asked Questions

How long does Blue Cross PA take in New York? Standard requests: 15 business days. Urgent requests: 72 hours. Submit complete documentation to avoid delays.

What if Xembify is non-formulary on my plan? Request a formulary exception with medical necessity documentation. If denied, you can appeal through NY's external review process.

Can I request expedited review? Yes, if delay would seriously jeopardize your health or you're currently on treatment. Decisions within 24-72 hours.

Does step therapy apply if I failed IVIG outside New York? Yes, document the trial and failure regardless of where it occurred. Include medical records from the treating facility.

What's the difference between medical and pharmacy benefit? Xembify for home use typically falls under pharmacy benefit. Office/clinic administration may be medical benefit. Check your specific plan.

Counterforce Health helps patients and providers navigate complex insurance approvals by turning denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. Learn more at www.counterforcehealth.org.

When insurance denials feel overwhelming, remember that Counterforce Health specializes in transforming rejection letters into successful appeals using your plan's own coverage criteria and the latest clinical evidence.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and should not be considered medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact your insurance plan directly for the most current requirements. Coverage policies may vary by specific plan and change over time.

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