By Counterforce Health Team in Oxervate (cenegermin) —

Coding That Helps Get Oxervate (cenegermin) Approved by UnitedHealthcare in California: ICD-10, HCPCS, and NDC Guide

Answer Box: Getting Oxervate Covered by UnitedHealthcare in California

Oxervate (cenegermin) requires prior authorization from UnitedHealthcare with specific coding requirements. Use ICD-10 codes H16.231-H16.233 for stage 2/3 neurotrophic keratitis, HCPCS code J3590, and NDC 71923-019-01. Submit through OptumRx with documented artificial tear failure and ophthalmologist prescription. If denied, California's Independent Medical Review (IMR) through DMHC offers binding external appeals with ~40% success rates.

First step today: Verify your diagnosis staging and gather artificial tear failure documentation before submitting the prior authorization.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for Neurotrophic Keratitis
  3. Product Coding: HCPCS, J-Code, and NDC
  4. Clean Request Anatomy
  5. Frequent Coding Pitfalls
  6. Verification with UnitedHealthcare Resources
  7. Pre-Submission Audit Checklist
  8. Appeals Process in California
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit Paths

Oxervate (cenegermin) can be processed under either the medical benefit or pharmacy benefit depending on your UnitedHealthcare plan and site of administration. Most patients receive home administration, making the pharmacy benefit the primary pathway.

Pharmacy Benefit (Most Common)

  • Processed through OptumRx (UnitedHealthcare's pharmacy benefit manager)
  • Requires prior authorization for all plans
  • Uses NDC coding with quantity limits
  • Home administration standard

Medical Benefit (Less Common)

  • Used when administered in clinical settings
  • Requires HCPCS coding (J3590) plus NDC
  • May require separate facility and professional claims
  • Still needs prior authorization
Tip: Check your patient's benefit summary or call UnitedHealthcare member services to confirm which benefit applies before coding your claim.

ICD-10 Mapping for Neurotrophic Keratitis

Primary diagnosis codes for Oxervate coverage require stage 2 or 3 neurotrophic keratitis documentation:

ICD-10 Code Description Documentation Required
H16.231 Neurotrophic keratoconjunctivitis, right eye Stage 2/3, right eye only
H16.232 Neurotrophic keratoconjunctivitis, left eye Stage 2/3, left eye only
H16.233 Neurotrophic keratoconjunctivitis, bilateral Stage 2/3, both eyes
H16.239 Neurotrophic keratoconjunctivitis, unspecified eye Use when laterality unclear

Documentation Words That Support Coding

Your clinical notes should include these specific terms to support the ICD-10 assignment:

  • Stage 2: "epithelial defect," "stromal swelling," "Descemet's membrane folds," "reduced corneal sensitivity"
  • Stage 3: "stromal melting," "stromal lysis," "corneal perforation risk," "anterior chamber involvement"
  • Both stages: "neurotrophic keratitis," "poor epithelial healing," "corneal anesthesia"
Note: The ICD-10 codes don't specify staging—your clinical documentation must clearly state "stage 2" or "stage 3" using the Mackie classification system.

Product Coding: HCPCS, J-Code, and NDC

HCPCS/J-Code Information

  • Primary code: J3590 (Unclassified biologics)
  • Why J3590: No specific J-code exists for cenegermin
  • Billing requirement: Must include NDC number on claim line

NDC Number

  • FDA-approved NDC: 71923-019-01
  • Package size: 28 single-dose vials per carton
  • Strength: 0.002% ophthalmic solution

Units Calculation

Standard dosing: 1 drop to affected eye(s) 6 times daily for 8 weeks

Scenario Vials Needed Billing Units Duration
Unilateral (one eye) 56 vials 56 units 8 weeks
Bilateral (both eyes) 112 vials 112 units 8 weeks
Monthly supply (one eye) 28 vials 28 units 4 weeks
Important: Some payers require billing in milliliters (0.4 mL per vial). Always verify unit requirements with UnitedHealthcare before submitting.

Clean Request Anatomy

Example Prior Authorization Request

Patient: Jane Smith, DOB: 01/15/1965
Member ID: ABC123456789
Prescriber: Dr. Sarah Johnson, Ophthalmologist

Diagnosis: H16.232 - Neurotrophic keratoconjunctivitis, left eye (Stage 3)

Medication Request:
- Drug: Oxervate (cenegermin-bkbj) 0.002%
- NDC: 71923-019-01
- Quantity: 56 vials (8-week supply)
- Directions: 1 drop to left eye 6 times daily
- Duration: 8 weeks

Prior Therapy Documentation:
- Systane Ultra: Used 4 times daily for 6 weeks (ineffective)
- Refresh Optive: Used 6 times daily for 4 weeks (insufficient improvement)
- Dates of therapy: 03/15/2024 - 05/30/2024

Clinical Justification:
Stage 3 neurotrophic keratitis with persistent epithelial defect and stromal thinning despite adequate artificial tear therapy. Patient demonstrates reduced corneal sensitivity and poor epithelial healing consistent with neurotrophic etiology.

Required Attachments

  • Ophthalmology consultation notes
  • Slit lamp examination findings
  • Corneal sensitivity testing results
  • Photos of corneal defect (if available)
  • Documentation of artificial tear failures

Frequent Coding Pitfalls

Unit Conversion Errors

  • Mistake: Billing 28 units for bilateral treatment
  • Correct: 56 units (28 per eye for 4 weeks) or 112 units (full 8-week course)

Mismatched Codes

  • Mistake: Using dry eye ICD-10 codes (H04.12x)
  • Correct: Neurotrophic keratitis codes (H16.23x)

Missing Start Dates

  • Mistake: Leaving therapy start date blank
  • Correct: Include specific start date for 8-week authorization period

Incomplete Prior Therapy Documentation

  • Mistake: "Patient tried artificial tears"
  • Correct: "Systane Ultra 4x daily for 6 weeks (03/15-04/26/2024), inadequate response"

Wrong Prescriber Type

  • Mistake: Primary care physician prescription without specialist involvement
  • Correct: Ophthalmologist or optometrist prescription or consultation

Verification with UnitedHealthcare Resources

Provider Portal Check

  1. Log into UnitedHealthcare Provider Portal
  2. Navigate to "Prior Authorization" section
  3. Search for "Oxervate" or "cenegermin"
  4. Download current PA notification form
  5. Review medical necessity criteria

OptumRx Formulary Verification

  • Check if Oxervate is on your patient's specific formulary
  • Verify tier placement and any quantity limits
  • Confirm prior authorization requirements haven't changed
Note: UnitedHealthcare is expanding automated prior authorization approvals as of May 2025, potentially reducing approval times to under 30 seconds for qualifying requests.

Pre-Submission Audit Checklist

Before submitting your Oxervate prior authorization:

✅ Diagnosis Requirements

  • ICD-10 code matches affected eye(s)
  • Clinical notes specify "stage 2" or "stage 3"
  • Ophthalmology consultation documented

✅ Prior Therapy Documentation

  • At least one OTC artificial tear documented
  • Specific product names, frequencies, and durations listed
  • Failure or inadequate response clearly stated
  • Dates of therapy attempts included

✅ Coding Accuracy

  • NDC 71923-019-01 included
  • Units calculated correctly (56 for unilateral, 112 for bilateral)
  • HCPCS J3590 if billing medical benefit
  • Prescriber specialty verified (ophthalmologist/optometrist)

✅ Administrative Details

  • All PA form sections completed
  • Supporting documentation attached
  • Patient demographics match insurance card
  • Submission deadline met (if reauthorization)

Appeals Process in California

If your Oxervate prior authorization is denied, California offers robust appeal rights through a two-tier system.

Internal Appeals (UnitedHealthcare)

Timeline: 180 days from denial date Process: Submit through provider portal or mail Required: Completed appeal form, clinical documentation, denial letter

Independent Medical Review (IMR)

When to use: After unsuccessful internal appeal Regulator: California Department of Managed Health Care (DMHC) Timeline: 30 days for standard review, 72 hours for urgent cases Success rate: Approximately 40% of drug coverage denials overturned Cost: Free to patients and providers

How to Request IMR

  1. Complete internal UnitedHealthcare appeal first
  2. File IMR application at healthhelp.ca.gov
  3. Include all clinical documentation and correspondence
  4. DMHC assigns independent physician reviewers
  5. Decision is binding on UnitedHealthcare
From our advocates: We've seen Oxervate denials successfully overturned at IMR when providers submitted comprehensive documentation showing stage 3 neurotrophic keratitis with photographic evidence and detailed artificial tear failure records. The key was demonstrating medical necessity with objective findings rather than just subjective symptoms.

For assistance with IMR applications, contact the DMHC Help Center at 888-466-2219.

Cost-Saving Resources

Manufacturer Support

  • Dompé Farmaceutici Patient Assistance: Contact manufacturer directly for eligibility
  • Copay assistance programs: May be available for commercially insured patients

Foundation Grants

California-Specific Programs

  • Medi-Cal coverage: Available for eligible low-income patients
  • Covered California plans: Subject to same prior authorization requirements

FAQ

How long does UnitedHealthcare prior authorization take for Oxervate? Standard prior authorization decisions are typically made within 72 hours for non-urgent requests. With OptumRx's new automated system launching in 2025, qualifying requests may be approved in under 30 seconds.

What if Oxervate is non-formulary on my plan? Non-formulary drugs can still be covered through the prior authorization process if medical necessity is demonstrated. You may need to pay a higher tier copay.

Can I request an expedited appeal for urgent cases? Yes, if the patient has stage 3 neurotrophic keratitis with risk of perforation, you can request expedited review, typically decided within 72 hours.

Does step therapy apply if my patient failed artificial tears outside California? Yes, documented artificial tear failures from any location are acceptable, provided you have adequate documentation of the specific products used and treatment outcomes.

What happens if the 8-week course is insufficient? Repeat courses may be authorized with documentation of partial response and continued medical necessity. This requires additional prior authorization with detailed clinical justification.

How do I code for bilateral treatment that starts at different times? Submit separate prior authorization requests for each eye with appropriate ICD-10 codes (H16.231 for right eye, H16.232 for left eye) and corresponding unit calculations.

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific denial basis, and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements—making the appeals process more efficient for complex medications like Oxervate.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions are ultimately made by your insurance plan based on your specific policy terms and clinical circumstances. For personalized assistance with appeals, consult with your healthcare provider or contact Counterforce Health for specialized support with insurance denials and appeals.

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