By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by UnitedHealthcare in Texas: Complete Coding and Appeals Guide

Answer Box: Getting Onpattro Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Onpattro (patisiran) with strict medical necessity criteria including genetic confirmation of hATTR-PN, neurologist evaluation, and specific disease staging. Use ICD-10 code E85.1, HCPCS J0222, and ensure complete documentation before submission. If denied, Texas law guarantees external review through an Independent Review Organization (IRO) at no cost to you.

Three steps to start today:

  1. Gather genetic testing results and neurologist notes documenting mNIS+7 scores
  2. Submit prior authorization via UnitedHealthcare Provider Portal with complete clinical documentation
  3. If denied, file internal appeal within 180 days, then request Texas IRO external review if needed

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for hATTR-PN
  3. Product Coding: HCPCS, J-Codes, and NDC
  4. Clean Prior Authorization Request
  5. Frequent Coding Pitfalls
  6. UnitedHealthcare Verification Steps
  7. Appeals Process in Texas
  8. Quick Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Onpattro is processed under the medical benefit, not pharmacy benefit, because it requires IV infusion in a clinical setting with premedication protocols. This affects your coding approach and prior authorization pathway.

Coverage at a Glance

Requirement Details Documentation Needed
Prior Authorization Required via OptumRx Genetic testing, neurologist evaluation
ICD-10 Code E85.1 (Neuropathic heredofamilial amyloidosis) Pathogenic TTR mutation or biopsy
HCPCS Code J0222 (0.1 mg units) Weight-based dosing calculation
NDC 71336-1000-01 10 mg/5 mL vial
Site of Care Infusion center/hospital Healthcare professional administration
Appeals Deadline 180 days in Texas Internal then external review available

Key insight: UnitedHealthcare's medical benefit coverage means your oncology or neurology practice will handle the billing and prior authorization, not your retail pharmacy.

ICD-10 Mapping for hATTR-PN

The correct ICD-10 code is E85.1 (Neuropathic heredofamilial amyloidosis) for hereditary transthyretin amyloidosis with polyneuropathy. Your documentation must support this specific diagnosis.

Documentation Requirements

Your medical records must include:

  • Genetic testing showing pathogenic TTR mutation (e.g., V30M, V122I)
  • Neurologist evaluation with disease staging (PND score ≤ IIIb or FAP Stage 1-2)
  • Exclusion of other causes (labs ruling out light chain amyloidosis)
  • Functional assessments like mNIS+7 scores and 6-minute walk test
Tip: Document the specific TTR variant in clinical notes. UnitedHealthcare often requires this level of genetic detail for approval.

Product Coding: HCPCS, J-Codes, and NDC

HCPCS J0222 Billing

Onpattro uses HCPCS code J0222 (injection, patisiran, 0.1 mg). This replaced older unclassified codes like J9999 in October 2019.

Dosing calculation:

  • Patients <100 kg: 0.3 mg/kg every 3 weeks
  • Patients ≥100 kg: 30 mg every 3 weeks

Billing example: A 75 kg patient receives 22.5 mg (rounded to 23 mg). Bill 230 units of J0222.

NDC and Units

  • Primary NDC: 71336-1000-01 (10 mg/5 mL single-dose vial)
  • Unit designation: UN1 (1 mg per unit)
  • Bill actual mg administered, not vial quantities

Counterforce Health helps practices navigate these complex billing requirements by automatically generating the correct codes and units based on patient weight and dosing protocols.

Clean Prior Authorization Request

Required Documentation Checklist

Clinical Documentation:

  • Genetic testing report with pathogenic TTR variant
  • Neurologist evaluation with mNIS+7 assessment
  • Disease staging (PND ≤ IIIb or NIS 5-130)
  • Exclusion of contraindications (no liver transplant, NYHA Class ≤ II)
  • Weight-based dosing calculation

Administrative Details:

  • Patient demographics and UnitedHealthcare member ID
  • Prescribing neurologist NPI and contact information
  • Planned infusion site and administration schedule
  • ICD-10 code E85.1 with supporting diagnosis

Submission Process

Submit via the UnitedHealthcare Provider Portal with all supporting documents. Standard review takes 15 business days, but urgent cases can be expedited to 72 hours.

From our advocates: We've seen approval rates improve significantly when practices include a detailed letter of medical necessity that specifically addresses UnitedHealthcare's criteria point-by-point, rather than submitting generic clinical notes.

Frequent Coding Pitfalls

Common Mistakes to Avoid

  1. Using outdated J-codes: Don't use J9999 or J3490 for Onpattro
  2. Incorrect unit calculations: Remember J0222 is per 0.1 mg, not per mg
  3. Wrong ICD-10 codes: E85.82 is for wild-type ATTR, not hereditary
  4. Missing NDC units: Always include "UN1" designation
  5. Pharmacy benefit submissions: Onpattro goes through medical benefit only

Unit Conversion Examples

Patient Weight Dose (mg) J0222 Units NDC Units
65 kg 19.5 mg 195 20 (UN1)
85 kg 25.5 mg 255 26 (UN1)
110 kg 30 mg 300 30 (UN1)

UnitedHealthcare Verification Steps

Before submitting your prior authorization:

  1. Verify patient eligibility through the UnitedHealthcare Provider Portal
  2. Check formulary status - Onpattro may be non-formulary requiring medical exception
  3. Confirm step therapy requirements - document trials/failures of alternatives like Tegsedi
  4. Review current medical policy for RNA-targeted therapies (policy updates quarterly)

Key verification resource: UnitedHealthcare's medical policy for RNA-targeted therapies, updated June 2025, contains the most current criteria.

Appeals Process in Texas

Internal Appeals (First Step)

If your prior authorization is denied:

  1. Review denial letter for specific reasons and required documentation
  2. File internal appeal within 180 days using UnitedHealthcare appeal form
  3. Include additional evidence addressing denial reasons
  4. Request peer-to-peer review if clinically appropriate

External Review (Texas IRO)

Texas law provides Independent Review Organization (IRO) external review if internal appeals fail:

  • Eligibility: Denials based on medical necessity or investigational status
  • Timeline: Request within 4 months of final internal denial
  • Cost: Free to patient (insurer pays IRO fees)
  • Decision: Binding on UnitedHealthcare if overturned

Contact Texas Department of Insurance: 1-866-554-4926 for IRO guidance.

Expedited Reviews

For urgent medical situations:

  • Standard expedited: 72 hours for internal review
  • External expedited: 5 days for emergency cases
  • Concurrent review: Can run internal and external appeals simultaneously

When dealing with complex prior authorizations and appeals, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals that align with each payer's specific requirements and procedural workflows.

Quick Audit Checklist

Before submission, verify:

  • ICD-10 E85.1 with genetic testing support
  • HCPCS J0222 with correct unit calculation
  • NDC 71336-1000-01 with UN1 designation
  • Weight-based dosing properly calculated and documented
  • Neurologist evaluation includes mNIS+7 and disease staging
  • Medical necessity letter addresses UnitedHealthcare criteria
  • Prior therapy documentation for step therapy requirements
  • Administration plan specifies infusion center and premedication

FAQ

How long does UnitedHealthcare prior authorization take in Texas? Standard review is 15 business days. Urgent cases can be expedited to 72 hours with appropriate clinical justification.

What if Onpattro is non-formulary on my plan? Request a formulary exception with medical necessity documentation. UnitedHealthcare must provide coverage for medically necessary treatments even if non-formulary.

Can I appeal if step therapy requirements weren't met? Yes. Document medical contraindications or failures of required first-line therapies like Tegsedi or Amvuttra.

Does UnitedHealthcare cover genetic testing for hATTR? Generally yes, when ordered by a neurologist with appropriate clinical suspicion and family history.

What's the difference between internal and external appeals in Texas? Internal appeals are reviewed by UnitedHealthcare. External appeals go to independent medical reviewers through Texas IRO system and are binding.

How do I request peer-to-peer review? Contact UnitedHealthcare provider services and request to speak with a medical director in neurology or rare diseases.

What happens if I miss appeal deadlines? Texas allows 180 days for internal appeals and 4 months for external review. Missing deadlines may forfeit appeal rights, so act quickly.

Can I get help with the appeals process? Yes. Contact Texas Department of Insurance (1-800-252-3439) or Office of Public Insurance Counsel (1-877-611-6742) for assistance.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to each payer's specific rules and requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan. Always consult with your healthcare provider and review your specific policy documents. For personalized assistance with insurance appeals in Texas, contact the Texas Department of Insurance or qualified advocacy organizations.

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