By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Cigna in Virginia: Complete Coding, Appeals & External Review Guide

Quick Answer: Getting Givlaari (givosiran) Covered by Cigna in Virginia

Eligibility: Adults with acute hepatic porphyria (AHP) who have documented elevated ALA/PBG levels and ≥2 attacks in 6 months. Fastest path: Have your specialist submit prior authorization with ICD-10 code E80.21, attack logs, and lab results showing elevated porphobilinogen. First step today: Call Cigna at 1-800-244-6224 to confirm if Givlaari is covered under your pharmacy or medical benefit, then request the specific prior authorization form. If denied, Virginia's Bureau of Insurance offers external review using Form 216-A within 120 days.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping and Documentation Requirements
  3. Product Coding: HCPCS, NDC, and Unit Calculations
  4. Clean Prior Authorization Anatomy
  5. Common Denial Reasons and How to Fix Them
  6. Appeals Process: Cigna to Virginia External Review
  7. Pre-Submission Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Cigna may cover Givlaari (givosiran) under either the medical benefit (billed by your provider using J-codes) or the pharmacy benefit (dispensed through specialty pharmacy). Understanding which path applies to your plan is crucial for successful approval.

Medical Benefit Coverage

  • Billing: Provider uses HCPCS code J0223 (injection, givosiran, 0.5 mg)
  • Administration: Billed with CPT code 96372 for subcutaneous injection
  • Prior authorization: Required through Cigna's medical management
  • Documentation: Must include specialist notes, lab results, attack history

Pharmacy Benefit Coverage

  • Dispensing: Through Express Scripts or Accredo specialty pharmacy
  • Billing: Uses NDC code 71336-1001-01 (189 mg/mL vial)
  • Prior authorization: Separate PA process through specialty pharmacy
  • Delivery: Medication shipped to clinic for administration
Tip: Call Cigna member services at 1-800-244-6224 before starting the PA process to confirm which benefit applies to your specific plan.

ICD-10 Mapping and Documentation Requirements

Proper diagnosis coding is essential for Givlaari approval. Virginia providers must use specific ICD-10 codes that clearly identify acute hepatic porphyria.

Primary ICD-10 Codes

Code Description When to Use
E80.21 Acute intermittent (hepatic) porphyria Most common AHP subtype
E80.20 Unspecified porphyria When subtype unclear
E80.29 Other porphyria Hereditary coproporphyria, variegate porphyria

Required Documentation for E80.21

According to Cigna's medical necessity criteria, your medical records must include:

  • Biochemical confirmation: Elevated urinary or plasma porphobilinogen (PBG) or delta-aminolevulinic acid (ALA) within past 12 months
  • Attack documentation: Detailed records of ≥2 symptomatic attacks in past 6 months
  • Specialist involvement: Consultation notes from hematologist, hepatologist, or porphyria specialist
  • Symptom details: Severe abdominal pain, neurovisceral symptoms, psychiatric changes
  • Prior treatments: Documentation of hemin use, trigger avoidance, supportive care

Product Coding: HCPCS, NDC, and Unit Calculations

Accurate coding and unit calculations prevent common billing errors that lead to denials.

HCPCS J-Code Billing

  • J0223: Injection, givosiran, 0.5 mg (permanent code effective July 1, 2020)
  • Unit calculation: Patient weight (kg) × 2.5 mg/kg ÷ 0.5 mg = billing units
  • Example: 68 kg patient = 68 × 2.5 = 170 mg ÷ 0.5 = 340 units

NDC and Administration Codes

  • NDC: 71336-1001-01 (11-digit format required)
  • Administration: CPT 96372 for subcutaneous injection
  • Modifiers: JW (drug discarded) or JZ (zero discarded) per Medicare requirements

Dosing Calculation Steps

  1. Calculate total dose: Weight (kg) × 2.5 mg/kg
  2. Convert to volume: Total mg × (1 mL ÷ 189 mg)
  3. Round to nearest 0.1 mL for administration
  4. Calculate billing units: Total mg ÷ 0.5 mg per unit
Note: Always verify unit calculations before submitting claims. Incorrect units are a leading cause of denials.

Clean Prior Authorization Anatomy

A successful Givlaari PA submission includes specific elements that address Cigna's coverage criteria.

Essential Components

  1. Completed PA form (obtain from Cigna provider portal)
  2. Specialist letter of medical necessity including:
    • Confirmed AHP diagnosis with subtype
    • Attack frequency and severity documentation
    • Lab results showing elevated ALA/PBG levels
    • Prior treatment failures or contraindications
    • Expected clinical outcomes with Givlaari
  3. Supporting documentation:
    • Hospital/ER records from recent attacks
    • Laboratory reports with reference ranges
    • Specialist consultation notes
    • Insurance card copy

Medical Necessity Letter Template Elements

Your specialist should address these key points:

  • Patient's specific AHP subtype and genetic/biochemical confirmation
  • Detailed attack history with dates, symptoms, and interventions required
  • Impact on quality of life and functional status
  • Rationale for Givlaari over alternative treatments
  • Monitoring plan and expected outcomes

Common Denial Reasons and How to Fix Them

Understanding typical denial reasons helps you prepare stronger initial submissions and appeals.

Denial Reason Fix Strategy Required Documentation
Insufficient attack history Provide detailed attack log Hospital records, ER visits, hemin administration logs
Missing biochemical proof Submit recent lab results ALA/PBG levels within past 12 months with reference ranges
Non-specialist prescriber Add specialist consultation Hematologist or hepatologist consultation notes
Experimental/investigational Cite FDA approval FDA label showing approved indication
Step therapy not met Document prior treatments Records of hemin use, trigger avoidance, supportive care

From Our Advocates

We've seen many patients succeed after initial denials by working closely with their specialist to document attack patterns more thoroughly. One approach that often helps is creating a detailed timeline showing the progression from intermittent attacks to more frequent episodes requiring intervention. This demonstrates the clear medical necessity for prophylactic treatment.

Appeals Process: Cigna to Virginia External Review

If your initial PA is denied, Virginia offers robust appeal rights through multiple levels.

Cigna Internal Appeals

  • Timeline: 180 days from denial date to file
  • Levels: First-level and second-level internal review
  • Expedited: Available if delay could jeopardize health
  • Submission: Via Cigna provider portal or member services

Virginia External Review Process

When Cigna's internal appeals are exhausted, Virginia's Bureau of Insurance external review provides independent evaluation.

Eligibility Requirements:

  • Virginia-issued plan or opted-in self-funded plan
  • Denial based on medical necessity or experimental treatment
  • Internal appeals completed (or expedited pathway qualifies)

Filing Process:

  1. Complete Form 216-A (verify current form link)
  2. Submit within 120 days of final Cigna denial
  3. Include denial letter, insurance card copy, medical records release
  4. Send to: Bureau of Insurance External Review, P.O. Box 1157, Richmond, VA 23218

Timeline:

  • Standard review: 45 days maximum
  • Expedited review: 72 hours for urgent cases
  • Additional information: 5 business days after case assignment

Contact Information:

Important: Virginia's external review is binding on the insurer. If overturned, Cigna must authorize coverage within 1-3 days.

Pre-Submission Checklist

Use this checklist to ensure your PA submission is complete and accurate:

Patient Information

  • Insurance card copy (front and back)
  • Patient demographics match insurance records exactly
  • Prior authorization form completely filled out

Clinical Documentation

  • ICD-10 code E80.21 (or appropriate subtype) documented
  • Lab results showing elevated ALA/PBG within past 12 months
  • Attack log with dates, symptoms, and interventions
  • Specialist consultation notes confirming AHP diagnosis
  • Hospital/ER records from recent attacks

Coding and Billing

  • Correct HCPCS code J0223 for medical benefit claims
  • Accurate unit calculations (weight × 2.5 ÷ 0.5)
  • NDC code 71336-1001-01 for pharmacy benefit
  • Administration code CPT 96372 if applicable
  • Appropriate modifiers (JW/JZ) for wastage reporting

Submission Requirements

  • Confirmed benefit type (medical vs. pharmacy)
  • PA form specific to your Cigna plan
  • All supporting documents attached
  • Submission via correct channel (portal, fax, mail)

When to Contact Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients seeking coverage of specialty medications like Givlaari. Their platform analyzes denial letters, identifies the specific reasons for rejection, and creates targeted, evidence-backed appeals that address payer requirements point-by-point.

If you're facing a Givlaari denial from Cigna, Counterforce Health can help by:

  • Analyzing your denial letter against Cigna's specific policy requirements
  • Drafting appeals that cite relevant FDA labeling, clinical guidelines, and peer-reviewed evidence
  • Ensuring your documentation meets Virginia's external review standards
  • Tracking deadlines and procedural requirements throughout the appeals process

This targeted approach significantly improves approval rates by addressing the exact criteria payers use to evaluate medical necessity.

Frequently Asked Questions

How long does Cigna prior authorization take for Givlaari in Virginia? Standard PA decisions are typically made within 5-15 business days. Expedited reviews for urgent cases can be completed within 72 hours.

What if Givlaari is non-formulary on my Cigna plan? You can request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. Include specialist documentation supporting the need for Givlaari specifically.

Can I request an expedited appeal if my PA is denied? Yes, if your physician certifies that delaying treatment could seriously jeopardize your health. Both Cigna and Virginia's external review process offer expedited pathways.

Does step therapy apply if I've tried treatments outside Virginia? Yes, prior treatment records from any state are acceptable. Ensure you have documentation of hemin use, trigger avoidance strategies, and treatment outcomes.

What happens after Virginia external review approves my appeal? Cigna must authorize coverage within 1-3 days of the external review decision. The decision is binding on both you and the insurer.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and procedures may change; verify current requirements with Cigna and Virginia regulators before taking action.

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