By Counterforce Health Team in Elfabrio (pegunigalsidase alfa-iwxj) —

Getting Elfabrio (Pegunigalsidase Alfa-iwxj) Covered by UnitedHealthcare in Ohio: Coding, Prior Authorization, and Appeals Guide

Answer Box: Getting Elfabrio Covered by UnitedHealthcare in Ohio

Elfabrio (pegunigalsidase alfa-iwxj) requires prior authorization through UnitedHealthcare/OptumRx for Fabry disease patients in Ohio. Use ICD-10 code E75.21, HCPCS J2508 (1 mg billing units), and 11-digit NDCs. Submit genetic testing or enzyme assay results confirming Fabry disease diagnosis via the UHC Provider Portal. If denied, file internal appeals within 12 months, then external review through Ohio Department of Insurance within 180 days. Start today: Gather genetic/enzyme test results, clinical notes, and submit PA request with complete documentation to avoid common denial reasons.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Fabry Disease
  3. Product Coding: HCPCS, J-Codes, and NDCs
  4. Clean Prior Authorization Request
  5. Frequent Coding Pitfalls
  6. Verification with UnitedHealthcare Resources
  7. Appeals Process in Ohio
  8. Quick Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Elfabrio is administered intravenously every two weeks and falls under the medical pharmacy benefit rather than retail pharmacy coverage. This means claims are processed through UnitedHealthcare's medical claims system using HCPCS codes rather than traditional pharmacy NDC-only billing.

Key differences:

  • Medical benefit: Provider-administered drugs using HCPCS J-codes with NDC reporting
  • Pharmacy benefit: Patient-filled prescriptions using NDC as primary billing code
  • Site of care: Typically infusion centers or physician offices, not inpatient hospitals unless medically justified

Understanding this distinction is crucial because it determines which prior authorization pathway applies and which documentation requirements must be met.

ICD-10 Mapping for Fabry Disease

The primary diagnosis code for Elfabrio coverage is E75.21 (Fabry [Anderson] disease). This code must be supported by appropriate diagnostic documentation in your clinical notes.

Documentation words that support E75.21 coding:

  • Alpha-galactosidase A deficiency
  • GLA gene mutation
  • Lysosomal storage disorder
  • Acroparesthesias (burning extremity pain)
  • Angiokeratomas
  • Corneal verticillata
  • Anhidrosis or hypohidrosis
  • Family history of Fabry disease

Required diagnostic evidence:

  • Biochemical confirmation: Alpha-galactosidase A enzyme activity <5% of normal in leukocytes, dried blood spots, or serum
  • Genetic confirmation: Pathogenic GLA gene mutations identified through molecular testing
  • Clinical manifestations: At least one documented symptom or physical finding consistent with Fabry disease
Note: Both male and female patients can have Fabry disease, though presentation may vary. Ensure documentation reflects the patient's specific clinical picture.

Product Coding: HCPCS, J-Codes, and NDCs

HCPCS J-Code

J2508: "Injection, pegunigalsidase alfa-iwxj, 1 mg" (effective January 1, 2024)

Billing Units Calculation

  • Dosing: 1 mg/kg body weight every 2 weeks
  • Example: 70 kg patient = 70 mg dose = 70 billing units of J2508
  • Units reported: Total milligrams administered

NDC Codes (11-digit format required)

  • 10122-0160-01
  • 10122-0160-02
  • 10122-0160-05
  • 10122-0160-10

NDC units: Report as "UN1" (1 unit = 1 mg)

Modifiers

  • UD modifier: Required for 340B providers if purchased under 340B agreement
  • Site-specific modifiers: May apply based on administration location

Clean Prior Authorization Request

A complete PA request should include these essential elements:

Patient Information Section

  • Member ID and policy details
  • Patient demographics (age, weight for dosing)
  • ICD-10 diagnosis code: E75.21

Clinical Documentation

  • Genetic testing results showing pathogenic GLA mutations, OR
  • Enzyme assay results demonstrating alpha-galactosidase A deficiency (<5% normal activity)
  • Specialist consultation or attestation from physician experienced in Fabry disease
  • Clinical manifestations documented in progress notes
  • Site of care specification (typically outpatient infusion center)

Prescription Details

  • Drug name: Elfabrio (pegunigalsidase alfa-iwxj)
  • Dosing: 1 mg/kg IV every 2 weeks
  • HCPCS code: J2508
  • NDC codes: Include appropriate 11-digit NDC

Submission method: UnitedHealthcare Provider Portal using Specialty Pharmacy Transactions tile, or contact OptumRx directly.

Processing timeline: Standard PA decisions within 72 hours of complete documentation; expedited requests within 24 hours if clinically justified.

Counterforce Health helps streamline this process by analyzing denial patterns and crafting targeted appeals with the specific evidence UnitedHealthcare requires. Their platform can identify missing documentation elements before submission, reducing denial risk.

Frequent Coding Pitfalls

Unit Conversion Errors

  • Mistake: Billing per vial instead of per milligram
  • Fix: Always calculate total mg administered and bill that number of J2508 units

Mismatched Codes

  • Mistake: Using temporary codes (J3490, J3590) when specific J2508 is available
  • Fix: Use J2508 for all Elfabrio claims effective January 1, 2024

Missing NDC Information

  • Mistake: Submitting HCPCS code without required 11-digit NDC
  • Fix: Include both J2508 and appropriate NDC with UN1 units

Incomplete Diagnosis Documentation

  • Mistake: Using E75.21 without supporting clinical evidence
  • Fix: Ensure genetic or enzyme testing results are documented and attached

Site of Care Issues

  • Mistake: Billing for inpatient administration without medical justification
  • Fix: Document why outpatient infusion center is inappropriate, if applicable

Verification with UnitedHealthcare Resources

Before submitting claims or PA requests, verify current requirements:

UnitedHealthcare Provider Portal

  • Access current prior authorization requirements
  • Check formulary status and tier placement
  • Review site of care restrictions
  • Submit PA requests electronically

OptumRx Resources

  • Specialty pharmacy prior authorization forms
  • Drug-specific clinical criteria
  • Step therapy requirements (if applicable)

Cross-Check Items

  • ✓ Current HCPCS code (J2508 as of 2024)
  • ✓ Accepted NDC codes for billing
  • ✓ Prior authorization requirements
  • ✓ Site of care limitations
  • ✓ Age restrictions (Elfabrio approved for adults ≥18 years)

Appeals Process in Ohio

If your Elfabrio prior authorization is denied, Ohio provides a structured appeals process:

Internal Appeals (UnitedHealthcare)

  1. Reconsideration request: Within 12 months of denial
  2. Formal appeal: After reconsideration denial, within 12-month timeframe
  3. Peer-to-peer review: Optional, request within 3 business days (inpatient) or 21 days (outpatient)

Submission: UnitedHealthcare Provider Portal or API

External Review (Ohio)

After exhausting internal appeals:

  • Timeline: Request within 180 days of final denial
  • Process: Independent Review Organization (IRO) evaluation
  • Authority: Ohio Department of Insurance oversees process
  • Decision: Binding on UnitedHealthcare if overturned

Ohio Department of Insurance Consumer Services: 1-800-686-1526

From our advocates: We've seen success when providers include both genetic testing results AND documented clinical manifestations in their initial PA requests. This comprehensive approach addresses UnitedHealthcare's medical necessity criteria upfront, reducing the need for appeals. One case involved a patient whose initial denial was overturned after the provider submitted enzyme assay results alongside documented acroparesthesias and family history.

Quick Audit Checklist

Before submitting your Elfabrio request, verify:

Clinical Documentation

  • ICD-10 code E75.21 documented with supporting evidence
  • Genetic testing OR enzyme assay results attached
  • Specialist consultation or attestation included
  • Clinical manifestations documented in progress notes
  • Patient weight recorded for dosing calculation

Coding Requirements

  • HCPCS J2508 for billing
  • Correct 11-digit NDC included
  • NDC units reported as UN1
  • Billing units calculated as total mg administered
  • Appropriate modifiers applied (UD for 340B if applicable)

Administrative Elements

  • Site of care specified and appropriate
  • Prior authorization submitted via correct portal
  • All required forms completed
  • Submission within required timeframes

Appeal Preparation (if needed)

  • Denial letter reviewed for specific reasons
  • Additional clinical evidence gathered
  • Appeal submitted within 12-month deadline
  • External review timeline noted (180 days in Ohio)

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific evidence gaps that led to denial and crafting targeted responses using payer-specific criteria.

FAQ

How long does UnitedHealthcare prior authorization take for Elfabrio in Ohio? Standard PA decisions are made within 72 hours of receiving complete clinical documentation. Expedited requests can be processed within 24 hours if clinically justified.

What if Elfabrio is non-formulary on my UnitedHealthcare plan? Non-formulary drugs may still be covered through the prior authorization process with appropriate medical necessity documentation. Include evidence that preferred alternatives are inappropriate or have failed.

Can I request an expedited appeal if my PA is denied? Yes, expedited appeals are available if waiting would seriously jeopardize your health. Document the urgent medical need in your appeal request.

Does step therapy apply to Elfabrio for Fabry disease? UnitedHealthcare may require trial of other enzyme replacement therapies first. Document any failures, intolerances, or contraindications to preferred agents like agalsidase beta (Fabrazyme).

What happens if UnitedHealthcare denies my external review request? In Ohio, you can appeal the insurer's eligibility determination directly to the Ohio Department of Insurance, which has authority to override the insurer's decision and order an external review.

Are there financial assistance programs for Elfabrio? Yes, Chiesi offers patient assistance programs through Chiesi Total Care. Contact them directly for eligibility requirements and application processes.

Can I bill Elfabrio in an inpatient hospital setting? Generally, UnitedHealthcare restricts coverage to outpatient infusion centers. Inpatient administration requires additional medical justification documenting why outpatient care is inappropriate.

What documentation do I need for an Ohio external review? Include the denial letter, all clinical records, genetic/enzyme testing results, specialist consultations, and any additional evidence supporting medical necessity.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with healthcare providers and verify current insurance policies and requirements. Coverage decisions are made by individual insurers based on their policies and your specific clinical situation. For personalized assistance with insurance appeals and prior authorization, consider consulting with Counterforce Health, which specializes in helping patients and providers navigate complex coverage challenges for specialty medications.

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