By Counterforce Health Team in Xenpozyme (olipudase alfa-rpcp) —

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

Answer Box: Quick Start Guide

Xenpozyme (olipudase alfa-rpcp) requires prior authorization from all Blue Cross Blue Shield plans in New York. Success depends on three key elements: confirmed ASMD diagnosis with genetic testing, comprehensive baseline assessments, and specialist involvement. First step today: Verify your specific BCBS plan's formulary status and gather genetic confirmation of SMPD1 mutation. Most approvals take 15-30 business days with complete documentation. If denied, New York's external appeal process through the Department of Financial Services offers binding review within 72 hours for urgent cases.

Table of Contents

  1. Before You Start: Plan Verification
  2. What You Need to Gather
  3. Step-by-Step Submission Process
  4. Following Up on Your Request
  5. Understanding Timelines
  6. Handling Additional Information Requests
  7. If You're Denied: Appeal Options
  8. Renewal and Re-authorization
  9. New York Appeal Rights
  10. Quick Reference Checklist

Before You Start: Plan Verification

Confirm Your Blue Cross Blue Shield Plan Type

New York has multiple BCBS affiliates with varying policies. Your member ID card will show whether you have:

  • Excellus BlueCross BlueShield (Central/Western NY)
  • Empire BlueCross BlueShield (Downstate/NYC area)
  • HealthNow New York (Western NY)
  • BCBS Medicare Advantage plans
Tip: Each plan maintains its own formulary and prior authorization criteria. Don't assume requirements are identical across plans.

Verify Xenpozyme's Coverage Status

Xenpozyme requires prior authorization for all BCBS New York plans in 2024-2025. The medication is:

  • Formulary status: Specialty tier (typically Tier 4 or 5)
  • Medical vs. pharmacy benefit: Covered under medical benefit when provider-administered
  • Site of care: Must be administered at approved outpatient infusion centers
  • Specialty pharmacy: Distributed through contracted networks like Accredo

Check your specific plan's drug list through your member portal or by calling the pharmacy benefits number on your card.

What You Need to Gather

Essential Documentation Checklist

Diagnostic Confirmation:

  • ICD-10 codes: E75.244 (Niemann-Pick disease type A/B) or E75.241 (type B)
  • Genetic testing results: Confirmed pathogenic variants in SMPD1 gene
  • Enzyme activity assay: Acid sphingomyelinase deficiency documentation
  • Specialist consultation: Metabolic or lysosomal storage disease specialist involvement

Clinical Evidence:

  • Baseline assessments: Spleen volume, lung function tests, liver enzymes
  • Laboratory values: Complete blood count, comprehensive metabolic panel
  • Imaging studies: Abdominal MRI or CT showing organomegaly
  • Progress notes: Documentation of non-CNS symptoms and functional impact

Exclusion Criteria Verification: Your documentation must confirm the patient does NOT have:

  • Invasive ventilatory support requirements
  • Platelet count < 60,000/µL
  • INR > 1.5 or AST/ALT > 250 IU/L
  • Total bilirubin > 1.5 mg/dL (unless Gilbert Syndrome)
  • Previous major organ transplant
  • Acute neurological symptoms

Step-by-Step Submission Process

Step 1: Access Your Plan's Prior Authorization System

For most BCBS NY plans:

  • Log into your provider portal or member account
  • Navigate to "Prior Authorization" or "Utilization Management"
  • Search for "olipudase alfa" or "Xenpozyme"

Alternative submission methods:

  • Electronic PA through CoverMyMeds or Surescripts
  • Fax submission (verify current fax numbers with your plan)
  • Phone-based PA for urgent cases

Step 2: Complete the Medical Necessity Form

Required information includes:

  • Patient demographics and insurance details
  • Prescribing physician information and NPI
  • Diagnosis with ICD-10 codes
  • Requested dosing: Weight-based (3 mg/kg every 2 weeks)
  • Site of administration details
  • Clinical justification narrative

Step 3: Submit Supporting Documentation

Attach all gathered materials:

  • Specialist consultation notes
  • Genetic testing and enzyme assay results
  • Baseline imaging and laboratory studies
  • Treatment plan with monitoring schedule
Note: Incomplete submissions are the leading cause of delays. Double-check all required fields before submitting.

Step 4: Coordinate with Specialty Pharmacy

Once PA is approved, your provider will:

  • Contact the designated specialty pharmacy
  • Arrange drug shipment to infusion site
  • Schedule administration appointments
  • Coordinate insurance billing under medical benefit

Following Up on Your Request

When to Call

  • Day 5: Confirm receipt and completeness
  • Day 10: Check processing status
  • Day 15: Escalate if no determination

Sample Call Script

"Hi, I'm calling to check on prior authorization request [reference number] for Xenpozyme for patient [name]. Can you provide the current status and expected timeline? Are any additional documents needed?"

Document everything: Date, time, representative name, reference numbers, and next steps.

Understanding Timelines

Standard Processing Times

Request Type Timeline Notes
Standard PA 15-30 business days Complete applications only
Expedited PA 72 hours Requires clinical urgency documentation
Additional info requested 14 days to respond Clock stops until received
Appeal determination 30 days internal 72 hours expedited

What Speeds Up Decisions

  • Complete documentation on first submission
  • Specialist involvement and detailed clinical notes
  • Clear medical necessity justification
  • Proper ICD-10 coding and diagnostic confirmation

Handling Additional Information Requests

Common Follow-Up Requests

"Please provide additional clinical justification"

  • Submit detailed progress notes showing disease progression
  • Include functional impact assessments
  • Reference FDA approval and breakthrough therapy designation

"Specialist consultation required"

  • Arrange evaluation with metabolic disease specialist
  • Ensure consultation addresses ASMD diagnosis and treatment rationale
  • Include specialist's treatment plan and monitoring protocol

"Baseline assessments needed"

  • Provide comprehensive organ function studies
  • Document spleen size, pulmonary function, liver status
  • Include laboratory trending over time

If You're Denied: Appeal Options

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
"Experimental/investigational" Cite FDA approval (2022) and breakthrough designation
"Not medically necessary" Submit robust organ dysfunction data and specialist support
"Incomplete diagnosis" Provide genetic confirmation and enzyme assay results
"No specialist involvement" Arrange metabolic specialist consultation
"Alternative therapy required" Clarify no FDA-approved alternatives exist for ASMD

Internal Appeal Process

  1. File within 180 days of denial notice
  2. Submit appeal letter addressing specific denial reasons
  3. Include new supporting evidence if available
  4. Request peer-to-peer review between specialists
  5. Track appeal status through member portal

Peer-to-Peer Review Strategy

When requesting peer-to-peer:

  • Ensure your specialist (not primary care) participates
  • Prepare talking points addressing denial rationale
  • Have clinical data readily available
  • Document outcomes and next steps

New York Appeal Rights

External Appeal Through DFS

If your internal appeal is denied, New York law provides additional protection through the Department of Financial Services external appeal process.

Key benefits:

  • Independent medical review by external experts
  • Binding decisions on insurance companies
  • Expedited timeline: 72 hours for urgent cases, 24 hours for specialty drug denials
  • Low cost: Maximum $25 fee, waived for financial hardship

How to File External Appeal

  1. Timing: Submit within 4 months of final internal denial
  2. Form: Complete New York State External Appeal Application
  3. Documents: Include denial letters, medical records, and physician attestation
  4. Submission: Mail to NYS DFS, 99 Washington Avenue, Box 177, Albany NY 12210 or fax (800) 332-2729

For urgent cases requiring Xenpozyme:

  • Check "expedited appeal" on application
  • Include physician attestation of medical urgency
  • Decision rendered within 24-72 hours

Getting Help with Appeals

Free assistance available:

  • Community Health Advocates: 888-614-5400
  • DFS Consumer Helpline: 1-800-400-8882
  • New York external appeals database: Research similar successful cases

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each insurer's specific requirements, potentially improving your chances of approval.

Renewal and Re-authorization

Planning for Ongoing Coverage

Xenpozyme requires periodic re-authorization (typically every 6-12 months):

  • Calendar reminders: Set alerts 60 days before expiration
  • Updated documentation: Include treatment response data
  • Continued specialist involvement: Maintain regular follow-ups
  • Outcome measures: Document improvements in organ function

What to Include in Renewal Requests

  • Response to treatment: Spleen size reduction, improved pulmonary function
  • Tolerability data: Infusion reaction management, safety monitoring
  • Functional improvements: Quality of life measures, activity tolerance
  • Continued medical necessity: Ongoing ASMD symptoms requiring treatment

Quick Reference Checklist

Before Submitting PA Request

  • Verify BCBS plan type and formulary status
  • Confirm genetic diagnosis (SMPD1 mutation)
  • Obtain specialist consultation
  • Gather baseline assessments
  • Verify exclusion criteria compliance
  • Identify approved infusion site

PA Submission Essentials

  • Complete prior authorization form
  • Medical necessity letter from specialist
  • Genetic testing and enzyme assay results
  • Baseline imaging and laboratory studies
  • Treatment and monitoring plan
  • Site of care coordination

If Denied

  • File internal appeal within 180 days
  • Request peer-to-peer review
  • Consider external appeal through NY DFS
  • Gather additional supporting evidence
  • Contact patient advocacy resources
From our advocates: We've seen successful Xenpozyme appeals in New York when families work closely with metabolic specialists to document clear disease progression and treatment response. One key strategy is submitting comprehensive baseline data upfront rather than waiting for requests, which can shave weeks off approval timelines. While outcomes vary, thorough preparation and understanding of your plan's specific criteria significantly improve approval odds.

Cost Support Options

Beyond insurance coverage, consider these financial assistance programs:

  • Sanofi Patient Support: Check manufacturer assistance programs
  • Foundation grants: Research rare disease organizations
  • State programs: New York may offer additional coverage through Medicaid
  • Specialty pharmacy support: Many offer copay assistance coordination

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and is not medical advice. Coverage policies vary by plan and individual circumstances. Always consult your healthcare provider about treatment decisions and verify current requirements with your specific insurance plan. Counterforce Health offers specialized support for complex prior authorization and appeal cases, helping patients navigate insurance requirements more effectively.

For additional questions about New York insurance rights, contact the Department of Financial Services at 1-800-400-8882 or visit their website for current forms and procedures.

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