By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by Blue Cross Blue Shield in Virginia: Complete Coding, Appeals & Timeline Guide

Answer Box: Getting Onpattro Covered in Virginia

Blue Cross Blue Shield (Anthem) in Virginia requires prior authorization for Onpattro (patisiran) under the medical benefit using HCPCS J0222. Success depends on proper coding (ICD-10 E85.1), genetic confirmation of TTR mutation, and neurologist evaluation. If denied, Virginia's State Corporation Commission provides external review within 45 days. Start today: Verify your genetic test results include the specific TTR variant name and ensure your neurologist documents polyneuropathy symptoms with functional assessments (mNIS+7 or 6MWT if available).

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for hATTR Polyneuropathy
  3. Product Coding: HCPCS, NDC, and Units
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. Verification with Blue Cross Blue Shield
  7. Appeals Process in Virginia
  8. Quick Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Onpattro (patisiran) is always billed under the medical benefit, not pharmacy. This IV infusion requires administration in a clinical setting every three weeks, making it a "buy and bill" medication for providers.

Key Coverage Details:

  • Benefit type: Medical (not pharmacy)
  • Prior authorization: Required by Anthem Blue Cross Blue Shield Virginia
  • Site of care: Infusion center or specialty clinic
  • Billing method: Provider purchases, administers, then bills insurance
Note: Unlike oral medications that go through pharmacy benefits, Onpattro follows medical benefit rules, which often have different deductibles, copays, and approval processes.

ICD-10 Mapping for hATTR Polyneuropathy

The correct diagnosis code is crucial for approval. Use E85.1 - Neuropathic heredofamilial amyloidosis, which specifically includes transthyretin-related (ATTR) familial amyloid polyneuropathy.

Documentation Requirements

Your medical records must clearly support this diagnosis with:

  • Genetic confirmation: Documented pathogenic TTR gene mutation
  • Clinical symptoms: Progressive sensorimotor neuropathy, autonomic dysfunction
  • Exclusion criteria: Rule out AL (light chain) amyloidosis
  • Functional impact: Documented disability from polyneuropathy

Documentation language that supports E85.1:

  • "Hereditary transthyretin amyloidosis with polyneuropathy"
  • "Pathogenic TTR variant confirmed by genetic testing"
  • "Progressive sensorimotor neuropathy consistent with hATTR"
  • "Familial amyloid polyneuropathy, TTR-related"

Product Coding: HCPCS, NDC, and Units

Essential Billing Codes

Code Type Code Description Units
HCPCS J0222 Injection, patisiran, 0.1 mg 1 unit = 0.1 mg
NDC 71336-1000-1 10 mg/5 mL single-dose vial Per vial

Dosing and Units Calculation

Standard dosing:

  • Patients <100 kg: 0.3 mg/kg every 3 weeks
  • Patients ≥100 kg: 30 mg (maximum dose) every 3 weeks

Units calculation example:

  • 70 kg patient: 70 × 0.3 = 21 mg dose
  • J0222 units: 21 mg ÷ 0.1 mg = 210 units

When Modifiers Apply

  • -JW: Document drug wastage if entire vial isn't used
  • -JZ: Zero drug amount discarded (rare with single-dose vials)
  • Site-specific modifiers: May be required based on infusion location

Clean Prior Authorization Request

A complete prior authorization includes all required documentation upfront. Here's what Anthem Blue Cross Blue Shield Virginia expects:

Required Clinical Documentation

  1. Genetic test results showing specific TTR mutation
  2. Neurologist consultation or evaluation notes
  3. Baseline functional assessments (mNIS+7, 6MWT when available)
  4. Diagnosis confirmation with ICD-10 E85.1 support
  5. Treatment history documenting other therapies tried or contraindicated

Sample Request Components

Patient information:

  • Name, DOB, member ID
  • Diagnosis: hATTR polyneuropathy (E85.1)
  • Prescribing provider: Neurologist or specialist

Clinical justification:

  • TTR gene mutation: [specific variant name]
  • Functional status: [mNIS+7 score or clinical description]
  • Prior treatments: [list with outcomes]
  • Contraindications to alternatives: [if applicable]

Billing details:

  • HCPCS: J0222
  • NDC: 71336-1000-1
  • Planned dosing: [mg per infusion based on weight]
  • Frequency: Every 3 weeks

Common Coding Pitfalls

Unit Conversion Errors

Wrong: Billing 1 unit for a 21 mg dose Right: Billing 210 units (21 mg ÷ 0.1 mg per unit)

Mismatched Benefit Types

Wrong: Submitting to pharmacy benefit Right: Medical benefit billing with J-code

Missing Start Dates

Always include the planned treatment start date in your prior authorization request. Anthem may deny requests without clear timelines.

Incomplete Genetic Documentation

Insufficient: "Genetic testing positive" Complete: "Heterozygous pathogenic variant c.424G>A (p.Val142Ile) in TTR gene confirmed by [lab name] on [date]"

Verification with Blue Cross Blue Shield

Before submitting your request, verify current requirements:

Provider Resources

  • Prior Authorization Lookup Tool: Check current PA requirements
  • Provider portal: Access forms and submission guidelines
  • Contact numbers:
    • Medical PA: 844-512-7022 (fax)
    • Provider Services: 800-901-0020

Patient Verification Steps

  1. Confirm coverage: Call member services to verify medical benefit coverage
  2. Check formulary status: Ensure Onpattro isn't excluded
  3. Review site-of-care requirements: Some plans limit to specific facilities
  4. Understand cost-sharing: Deductible, coinsurance, and maximum out-of-pocket

When working with specialty pharmacies or patient advocacy organizations like Counterforce Health, these verification steps become part of a comprehensive approach to securing coverage. Counterforce Health helps patients navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical documentation to create targeted appeals that address specific payer concerns.

Appeals Process in Virginia

If your prior authorization is denied, Virginia provides a structured appeals process through the State Corporation Commission.

Internal Appeals (First Step)

Timeline: Submit within plan's specified timeframe (typically 60-180 days) Process: Follow Blue Cross Blue Shield's internal appeal procedures Documentation: Include any new clinical evidence not in original request

External Review (State Level)

Virginia's Bureau of Insurance provides independent external review for denied claims.

Key Details:

  • Deadline: 120 days from final internal denial
  • Form: External Review Request Form 216-A
  • Timeline: Decision within 45 days (72 hours for expedited)
  • Cost: Free to consumers

Submission methods:

  • Fax: (804) 371-9915
  • Email: [email protected]
  • Mail: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218

Required Documents for External Review

  • Completed Form 216-A
  • Copy of insurance card
  • Final denial letter from Blue Cross Blue Shield
  • Medical records release form
  • Supporting clinical documentation
Tip: Virginia allows expedited external review for urgent cases. Your doctor must complete Form 216-C certifying that delays could jeopardize your health.

Quick Audit Checklist

Before submitting your prior authorization or claim, review:

Clinical Documentation:

  • ICD-10 E85.1 supported by genetic testing
  • TTR mutation specifically named
  • Neurologist evaluation included
  • Functional assessments documented
  • Prior treatments listed with outcomes

Coding Accuracy:

  • HCPCS J0222 for billing
  • NDC 71336-1000-1 included
  • Units calculated correctly (dose ÷ 0.1 mg)
  • Medical benefit selected (not pharmacy)

Administrative Requirements:

  • Prior authorization submitted before treatment
  • All required forms completed
  • Provider credentials verified
  • Patient eligibility confirmed

Appeal Preparation (if needed):

  • Internal appeal deadline noted
  • External review forms available
  • Additional evidence gathered
  • Timeline tracking system in place

Clinician Corner: Medical Necessity Documentation

When writing medical necessity letters for Onpattro, include these essential elements:

Problem statement: Clear diagnosis of hATTR polyneuropathy with genetic confirmation Prior treatments: Document other therapies tried, failed, or contraindicated Clinical rationale: Explain why Onpattro is medically necessary for this patient Monitoring plan: Describe how you'll assess treatment response Guideline support: Reference FDA labeling and relevant specialty guidelines

Organizations like Counterforce Health specialize in helping clinicians craft compelling medical necessity letters by analyzing specific payer requirements and incorporating the right evidence to support approval. Their platform identifies common denial reasons and provides targeted responses that align with each plan's criteria.

FAQ

How long does Blue Cross Blue Shield prior authorization take in Virginia? Standard prior authorization decisions are typically made within 14 business days. Urgent requests may be expedited to 72 hours with proper clinical justification.

What if Onpattro is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and showing that formulary alternatives are inappropriate or ineffective for your condition.

Can I request an expedited appeal in Virginia? Yes, if your physician certifies that delays could jeopardize your health. Use Form 216-C for expedited external review, which provides decisions within 72 hours.

Does step therapy apply to Onpattro? Some Blue Cross Blue Shield plans may require trying other hATTR treatments first. However, you can request a step therapy exception if other treatments are contraindicated or medically inappropriate.

What happens if I start treatment before approval? Claims may be denied for services provided before prior authorization approval. Always wait for approval unless it's a true emergency situation.

How much will Onpattro cost with Blue Cross Blue Shield coverage? Costs depend on your specific plan's medical benefit structure, including deductibles, coinsurance, and out-of-pocket maximums. The manufacturer offers patient assistance programs that may help with costs.

Can my doctor handle the prior authorization for me? Yes, your prescribing physician typically submits the prior authorization request. However, you can track the process and provide additional documentation as needed.

What if my external review is denied? External review decisions are final and binding. However, you may still have legal options or could reapply if your clinical situation changes significantly.

This guide provides general information about insurance coverage and appeals processes. It is not medical advice. For specific questions about your coverage, contact your Blue Cross Blue Shield plan directly. For appeals assistance in Virginia, contact the State Corporation Commission Bureau of Insurance at (804) 371-9741.

Sources & Further Reading

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