By Counterforce Health Team in Elelyso (taliglucerase alfa) —

How to Get Elelyso (taliglucerase alfa) Covered by Blue Cross Blue Shield in New York: Complete Guide to Prior Authorization, Appeals, and Medical Necessity

Quick Answer: Getting Elelyso Covered in New York

Empire BlueCross BlueShield requires prior authorization for Elelyso (taliglucerase alfa). You'll need confirmed Type 1 Gaucher disease diagnosis (enzyme assay or genetic testing), specialist prescriber, and documented failure/intolerance of preferred ERTs like Cerezyme or VPRIV due to step therapy requirements. First step: Have your specialist submit a prior authorization request with complete clinical documentation. If denied, you have 180 days to appeal internally, then 4 months for external review through New York State DFS. Most approvals come after demonstrating medical necessity and step therapy compliance.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Medical vs. Pharmacy Benefit Pathways
  4. ICD-10 and Documentation Requirements
  5. HCPCS/J-Code and NDC Billing
  6. Clean Prior Authorization Request
  7. Common Coding Pitfalls
  8. Appeals Process in New York
  9. Cost-Saving Programs
  10. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Elelyso requests Empire BCBS Provider Portal
Diagnosis Type 1 Gaucher disease (ICD-10: E75.22) Enzyme assay or genetic testing
Specialist Prescriber Metabolic disease or lysosomal storage disorder specialist Provider credentialing required
Step Therapy Trial/failure of Cerezyme or VPRIV first BCBS Step Therapy Guidelines
Age Requirement 4 years and older FDA labeling requirement
Billing Code HCPCS J3060 (10 units per billable unit) CMS HCPCS Guidelines

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Documentation

Who: Your specialist physician
What: Gather enzyme assay or genetic testing confirming Type 1 Gaucher disease
Timeline: 1-2 weeks if tests needed
Source: Empire BCBS PA Criteria

2. Document Step Therapy Requirements

Who: Clinic staff
What: Compile records of Cerezyme/VPRIV trials, failures, or contraindications
Timeline: 2-3 days
Key: Include specific adverse events, lack of efficacy, or medical contraindications

3. Submit Prior Authorization Request

Who: Prescribing physician or delegate
What: Complete PA form with all supporting documentation
Where: Empire BCBS provider portal or designated specialty pharmacy
Timeline: Submit 5-7 days before needed start date

4. Follow Up on Decision

Who: Patient or clinic
Timeline: Empire BCBS has 72 hours for expedited, 15 days for standard PA decisions
Next step: If approved, coordinate with specialty pharmacy; if denied, proceed to appeals

Medical vs. Pharmacy Benefit Pathways

Elelyso coverage depends on your specific Blue Cross Blue Shield plan design:

Medical Benefit (Most Common)

  • Administered in infusion centers or physician offices
  • Billed using HCPCS J3060
  • Subject to medical deductible and coinsurance
  • Prior authorization through medical management

Pharmacy Benefit (Some Plans)

  • Dispensed through specialty pharmacies
  • May have separate specialty tier copays
  • Different PA pathway through pharmacy benefits manager
Tip: Call the member services number on your insurance card to confirm which benefit handles Elelyso before starting the PA process.

ICD-10 and Documentation Requirements

Primary Diagnosis Code

E75.22 - Gaucher disease, type 1

This code must be supported by:

  • Beta-glucocerebrosidase enzyme assay showing deficiency
  • Genetic testing confirming GBA gene mutations
  • Clinical presentation consistent with Type 1 Gaucher disease

Documentation Words That Support Medical Necessity

Include these clinical terms in provider notes:

  • "Confirmed Type 1 Gaucher disease"
  • "Enzyme replacement therapy indicated"
  • "Failed prior trial of [Cerezyme/VPRIV]"
  • "Contraindicated due to [specific reason]"
  • "Medically necessary for symptom management"

Source: ICD-10-CM Guidelines

HCPCS/J-Code and NDC Billing

Billing Code Breakdown

  • HCPCS Code: J3060
  • Description: Injection, taliglucerase alfa, 10 units
  • Billing Units: Divide total dose by 10
  • Example: 4,200 unit dose = 420 billable units

Dosing Calculations

Standard dosing: 60 units/kg every 2 weeks

For a 70 kg patient:

  • Total dose: 60 × 70 = 4,200 units
  • Billable units: 4,200 ÷ 10 = 420 units
  • Maximum allowed: 700 units (7,000 total units) per 14-day period

NDC Codes

Elelyso NDC varies by package size. Common example:

  • 00069-0106-01: 200-unit vial (20 billable units)

Verify current NDC-HCPCS crosswalk

Clean Prior Authorization Request

Essential Components Checklist

  • Completed PA form with all required fields
  • ICD-10 code E75.22 clearly documented
  • Specialist prescriber information and credentials
  • Enzyme assay or genetic testing results
  • Documentation of step therapy compliance
  • Dosing rationale (60 units/kg every 2 weeks)
  • Clinical notes supporting medical necessity
  • Prior therapy failure documentation (if applicable)

Medical Necessity Letter Template Elements

Your specialist should include:

  1. Problem statement: "Patient has confirmed Type 1 Gaucher disease"
  2. Prior treatments: Specific ERTs tried, duration, outcomes
  3. Clinical rationale: Why Elelyso is medically necessary
  4. FDA labeling support: Reference to approved indication
  5. Monitoring plan: How treatment will be assessed

Common Coding Pitfalls

Unit Conversion Errors

Wrong: Billing 200 units for a 200-unit vial
Right: Billing 20 units (200 ÷ 10)

Mismatched Diagnosis Codes

Wrong: Using E75.2 (unspecified Gaucher disease)
Right: Using E75.22 (Type 1 Gaucher disease)

Missing Prior Authorization

Problem: Submitting claims without PA approval
Solution: Always obtain PA before first infusion

Incorrect Site of Care

Problem: Billing for home infusion when only office/clinic approved
Solution: Verify approved administration sites with Empire BCBS

Appeals Process in New York

Internal Appeal Timeline

  • Deadline: 180 days from denial date
  • Decision timeframe: 30 days (72 hours if expedited)
  • How to file: Empire BCBS member portal or written request

External Review Through New York DFS

  • Deadline: 4 months after final internal denial
  • Decision timeframe: 30 days standard, 72 hours expedited
  • Cost: $25 maximum (waived for financial hardship)
  • Contact: New York DFS External Appeal Portal
Note: New York's external review decisions are binding on the insurer and publicly searchable for precedent.

Expedited Appeals

Request expedited review if:

  • Patient's health is at serious risk
  • Standard timeline could jeopardize health outcomes
  • Physician certifies urgency

Expedited decisions: 24-72 hours depending on urgency level

Cost-Saving Programs

Manufacturer Support

Pfizer offers patient assistance programs for eligible individuals. Contact Pfizer RxPathways for current programs and eligibility requirements.

State Resources

Community Health Advocates (CHA)

  • Free insurance counseling and appeals assistance
  • Helpline: 888-614-5400
  • Serves all New York residents

Foundation Support

National Organization for Rare Disorders (NORD) and other rare disease foundations may offer financial assistance for Gaucher disease treatments.

When to Escalate

Contact New York State Department of Financial Services if:

  • Empire BCBS misses appeal deadlines
  • You believe the denial violates state insurance law
  • The insurer fails to follow proper procedures

DFS Consumer Hotline: 1-800-342-3736

From our advocates: "We've seen the strongest Elelyso approvals come when the specialist clearly documents why Cerezyme and VPRIV aren't suitable options—whether due to specific adverse reactions, supply issues, or clinical contraindications. The key is being specific about the medical rationale rather than just stating 'patient requests Elelyso.'"

FAQ

How long does Empire BCBS prior authorization take in New York? Standard PA decisions: 15 days. Expedited decisions: 72 hours. Submit requests 5-7 days before needed start date.

What if Elelyso is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. This requires additional justification beyond standard PA requirements.

Does step therapy apply if I failed other ERTs outside New York? Yes, documented failures from other states count toward step therapy requirements. Include complete medical records from previous providers.

Can I appeal directly to external review? No, you must complete the internal appeal process first. External review is available after receiving a final adverse determination.

What counts as "failure" of Cerezyme or VPRIV? Documented adverse reactions, lack of clinical improvement after adequate trial period, or medical contraindications to continued use.

Are there alternatives if all appeals fail? Consider clinical trials, expanded access programs, or working with patient advocacy organizations for additional appeal support.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through targeted, evidence-backed strategies. Our platform analyzes denial letters and plan policies to craft point-by-point rebuttals that align with each payer's specific requirements, improving approval rates for complex specialty medications like Elelyso.

For additional support with your Elelyso coverage challenges, visit www.counterforcehealth.org to learn more about our appeal assistance services.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with your specific insurance plan and consult with your healthcare provider for medical decisions. For official appeals guidance, contact the New York State Department of Financial Services.

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