By Counterforce Health Team in Elelyso (taliglucerase alfa) —

Coding That Helps Get Elelyso (Taliglucerase Alfa) Approved in Washington with UnitedHealthcare: ICD-10, HCPCS J-Code, and Billing Guide

Answer Box: Fast Track to Elelyso Coverage

Getting Elelyso (taliglucerase alfa) covered by UnitedHealthcare in Washington requires precise coding and documentation. Use ICD-10 code E75.22 for Gaucher disease, HCPCS J-code J3060 for billing (10 units per code), and calculate total dose ÷ 10 for billable units. Submit prior authorization through UHC Provider Portal with confirmed enzyme deficiency testing, genetic results, and clinical severity documentation. If denied, file internal appeal within 60 days, then external review through Washington's Independent Review Organization (IRO) within 180 days. Maximum supply limit: 700 billable units per 14-day period.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit Paths

Elelyso follows the medical benefit pathway with UnitedHealthcare, not pharmacy benefit. This means:

  • Drug acquisition: Covered under medical benefit through UHC's designated specialty pharmacy
  • Administration: Billed separately using infusion administration codes
  • Prior authorization: Required through UHC Provider Portal before treatment begins
  • Claims submission: Use medical claims process, never pharmacy point-of-sale
Note: Providers bill only for infusion administration—never for the drug itself, which is covered under the medical benefit.

The medical benefit path typically offers better coverage for expensive specialty biologics but requires more documentation and longer approval timelines than standard pharmacy benefits.

ICD-10 Mapping for Gaucher Disease

Primary Diagnosis Code

E75.22 - Gaucher disease is the billable ICD-10-CM code for all types of Gaucher disease, including Type 1 Gaucher disease treated with Elelyso.

Supporting Manifestation Codes

Include these additional codes to document disease severity and clinical necessity:

Manifestation ICD-10 Code Documentation Requirements
Anemia D64.9 CBC showing hemoglobin levels, iron studies
Thrombocytopenia D69.6 Platelet count <150,000/μL
Hepatomegaly R16.0 Imaging or physical exam measurements
Splenomegaly R16.1 Ultrasound or CT scan measurements
Bone disease M89.9 X-rays, MRI, or bone marrow infiltration

Documentation Words That Support Coding

When documenting for prior authorization, include these specific terms:

  • "Confirmed glucocerebrosidase deficiency"
  • "Genetic testing positive for GBA gene mutation"
  • "Symptomatic Type 1 Gaucher disease"
  • "Progressive organomegaly"
  • "Hematologic manifestations requiring treatment"

Product Coding: HCPCS J-Code and Units

HCPCS J-Code

J3060 - Injection, taliglucerase alfa, 10 units

This is the Medicare-assigned HCPCS code for Elelyso billing. Each unit of J3060 represents 10 units of taliglucerase alfa.

Units Calculation

Standard dosing: 60 units/kg administered intravenously every 2 weeks

Billing calculation: Total dose ÷ 10 = billable units

Example calculation:

  • Patient weight: 70 kg
  • Dose: 70 kg × 60 units/kg = 4,200 units
  • Billable units: 4,200 ÷ 10 = 420 units of J3060

Supply Limits

UnitedHealthcare typically allows a maximum of 700 billable units per 14-day period. This translates to approximately 7,000 units of Elelyso, sufficient for most patients weighing up to 115 kg at standard dosing.

NDC and Product Information

  • Formulation: 200 units per 5 mL vial (40 units/mL)
  • NDC: Contact Pfizer directly for current NDC numbers, as these may change with manufacturing updates

Clean Prior Authorization Request Anatomy

Required Medical Documentation

Diagnosis Confirmation:

  • Enzyme assay results showing glucocerebrosidase deficiency
  • Genetic testing confirming GBA gene mutations
  • Clinical severity assessment with CBC, liver function tests, imaging

Prior Therapy Documentation:

  • Specific trials of alternative ERTs (Cerezyme, VPRIV) with dates, doses, and outcomes
  • Documented adverse reactions or contraindications to formulary options
  • Treatment failure definitions with objective measures

Prescriber Qualifications:

  • Medical license verification
  • Specialty certification (hematology, medical genetics preferred)
  • Experience treating Gaucher disease patients

Example PA Request Structure

Patient: [Name], DOB [Date], Member ID [Number]
Diagnosis: Type 1 Gaucher disease (ICD-10: E75.22)
Requested therapy: Elelyso (taliglucerase alfa) - J3060
Dosing: 60 units/kg IV every 2 weeks
Calculated dose: [Weight] kg × 60 units/kg = [Total] units
Billable units: [Total] ÷ 10 = [Units] of J3060

Clinical justification:
- Confirmed enzyme deficiency: [Lab values, date]
- Genetic testing: [Results, date]
- Disease manifestations: [Specific symptoms with supporting labs/imaging]
- Prior therapy failures: [Specific medications, dates, reasons for discontinuation]

Frequent Coding Pitfalls

Unit Conversion Errors

Common mistake: Billing total units instead of J3060 units Correct approach: Always divide total Elelyso units by 10

Example error: Patient receives 4,200 units, provider bills 4,200 units of J3060 Correct billing: 4,200 ÷ 10 = 420 units of J3060

Mismatched Codes

Avoid: Using generic enzyme replacement codes or incorrect J-codes Use: Specific J3060 code for taliglucerase alfa only

Missing Start Dates

Required: Exact treatment initiation date for coverage determination Include: Planned infusion schedule and monitoring timeline

Documentation Gaps

Common omissions:

  • Incomplete genetic testing results
  • Missing enzyme assay values
  • Inadequate prior therapy documentation
  • Absent contraindication explanations

Verification with UnitedHealthcare Resources

Provider Portal Verification

  1. Log into UHC Provider Portal at uhcprovider.com
  2. Navigate to Prior Authorization section
  3. Verify current formulary status for Elelyso
  4. Check quantity limits and coverage criteria updates
  5. Confirm required documentation checklist

Cross-Check Resources

  • UHC Commercial PDL: Verify formulary tier and restrictions
  • Medical Policy: Search for "taliglucerase alfa" or "Gaucher disease"
  • Coverage Criteria: Review step therapy requirements and exceptions
Tip: UnitedHealthcare updates formularies quarterly. Always verify current status before submitting requests.

Contact Options

  • Provider Services: 1-888-397-8129 for prior authorization questions
  • Specialty Pharmacy: Coordinate with UHC's designated specialty pharmacy for drug sourcing

Pre-Submission Audit Checklist

Documentation Review

  • ICD-10 E75.22 listed as primary diagnosis
  • Supporting manifestation codes included where applicable
  • J3060 units calculated correctly (total dose ÷ 10)
  • Enzyme deficiency results attached with normal ranges
  • Genetic testing report included
  • Prior therapy history documented with specific dates and outcomes
  • Contraindications to alternatives clearly explained
  • Clinical severity indicators supported by lab values and imaging
  • Prescriber credentials verified and specialty noted
  • Treatment plan includes monitoring schedule and response measures

Submission Requirements

  • UHC Provider Portal submission completed
  • All required attachments uploaded
  • Patient demographics verified
  • Insurance eligibility confirmed
  • Specialty pharmacy coordination initiated

Counterforce Health specializes in transforming insurance denials into successful appeals by identifying the specific denial basis and crafting targeted, evidence-backed rebuttals. Our platform helps clinicians navigate complex prior authorization requirements and produces letters that meet procedural requirements while tracking deadlines and required documentation.

Appeals Process in Washington

Internal Appeals with UnitedHealthcare

Timeline: Submit within 60 days of denial notice Method: UHC Provider Portal or written appeal Response time: 30 days for standard, 72 hours for urgent

Required documents:

  • Original denial letter
  • Medical necessity letter addressing specific denial reasons
  • Updated clinical documentation
  • Peer-reviewed literature supporting treatment choice

Peer-to-Peer Review

Request immediately after denial—available within 24 hours Participants: Prescribing physician and UHC medical director Outcome: Often resolves coverage disputes without formal appeal

External Review in Washington

If internal appeals fail, Washington residents can request external independent review through a certified Independent Review Organization (IRO).

Timeline: Request within 180 days of final internal denial Process: Submit to UnitedHealthcare, who notifies Washington's assigned IRO Decision timeline: 20 days for standard review, 72 hours for expedited Outcome: IRO decision is binding on UnitedHealthcare

Contact for assistance: Washington State Office of the Insurance Commissioner at 1-800-562-6900

When to Escalate

Contact Washington's Insurance Commissioner if:

  • UnitedHealthcare fails to respond within required timelines
  • Procedural violations occur during appeals process
  • Pattern of inappropriate denials for rare disease medications

FAQ

How long does UnitedHealthcare prior authorization take for Elelyso in Washington? Standard PA decisions take 7-30 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Elelyso is non-formulary with my UnitedHealthcare plan? Non-formulary medications can still be covered through medical necessity appeals. Document why formulary alternatives (Cerezyme, VPRIV) are inappropriate for your specific case.

Can I request an expedited appeal in Washington? Yes, if delay would seriously jeopardize your health. Expedited appeals must be decided within 72 hours by UnitedHealthcare and IROs.

Does step therapy apply if I've tried alternatives outside Washington? Prior therapy trials from other states count toward step therapy requirements. Provide complete documentation of previous treatments and outcomes.

What happens if UnitedHealthcare denies my external review request? UnitedHealthcare cannot deny your right to external review after exhausting internal appeals. Contact Washington's Insurance Commissioner if this occurs.

How do I calculate billing units correctly? Divide total Elelyso units by 10. Example: 6,000 units ÷ 10 = 600 billable units of J3060.

What genetic tests are required for coverage? Glucocerebrosidase enzyme assay and GBA gene mutation analysis. Both tests help confirm Type 1 Gaucher disease diagnosis.

Can specialty pharmacies help with prior authorization? Yes, Counterforce Health and other specialty services can assist with documentation, appeal letters, and tracking deadlines for complex rare disease medications.

From our advocates: We've seen many Elelyso appeals succeed when providers include specific enzyme levels, detailed prior therapy timelines, and clear contraindication explanations for alternatives. The key is addressing UnitedHealthcare's exact denial reasons with objective clinical data rather than general medical necessity statements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and coding requirements. It is not medical advice, legal advice, or a guarantee of coverage. Always consult with your healthcare provider and insurance company for specific coverage decisions. For additional help with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900 or visit insurance.wa.gov.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.