By Counterforce Health Team in Givlaari (givosiran) —

Coding That Helps Get Givlaari (Givosiran) Approved by Cigna in Georgia: Complete ICD-10, HCPCS, and NDC Guide

Answer Box: Getting Givlaari (Givosiran) Covered by Cigna in Georgia

Fastest Path to Approval: Givlaari requires prior authorization through Cigna's medical benefit using HCPCS code J0223 and ICD-10 code E80.21 (acute intermittent hepatic porphyria). Submit documentation showing elevated ALA/PBG levels and ≥2 attacks in 6 months via Accredo Specialty Pharmacy. If denied, you have 180 days for internal appeal, then 60 days for Georgia's external review through the Department of Insurance.

First Step Today: Contact your porphyria specialist to gather elevated porphobilinogen lab results and attack documentation, then submit prior authorization via Cigna's portal at covermymecs.com or fax to 855-840-1678.

Table of Contents

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

Coding Basics: Medical vs. Pharmacy Benefit

Givlaari (givosiran) is exclusively covered under the medical benefit, not the pharmacy benefit. This distinction is crucial for proper billing and reimbursement.

Why Medical Benefit Matters

Unlike oral medications dispensed through retail or mail-order pharmacies, Givlaari requires:

  • Healthcare provider administration via subcutaneous injection
  • Monthly clinic visits for dosing at 2.5 mg/kg
  • "Buy and bill" reimbursement through medical claims
  • Site of care restrictions (clinic/hospital outpatient only)

Most Cigna plans require administration in a healthcare facility rather than home delivery, making proper medical benefit coding essential for coverage approval.

ICD-10 Mapping for Acute Hepatic Porphyria

Primary Diagnosis Codes

E80.21 - Acute intermittent (hepatic) porphyria This is the most specific and preferred code for Givlaari coverage requests.

Alternative Codes (if E80.21 doesn't apply):

  • E80.0 - Hereditary erythropoietic porphyria
  • E80.1 - Porphyria cutanea tarda
  • E80.20 - Unspecified porphyria
  • E80.29 - Other porphyria

Documentation Requirements for ICD-10 Support

Your medical records should include specific language that supports the diagnosis:

Biochemical Evidence:

  • Elevated delta-aminolevulinic acid (ALA): typically 20-200 mg/L during attacks
  • Elevated porphobilinogen (PBG): >4 mg/day or mg/L
  • Lab timing: ideally during or shortly after symptom onset

Clinical Manifestations:

  • Severe abdominal pain without clear alternative cause
  • Neurological symptoms (numbness, motor weakness)
  • Cardiovascular instability during episodes
  • Documented attacks requiring emergency care or hemin administration
Tip: Include genetic testing results when available, as many Cigna policies now require either genetic confirmation or elevated biochemical markers for approval.

Product Coding: HCPCS, J-Code, and NDC

Core Billing Codes

HCPCS Code: J0223 (Injection, givosiran, 0.5 mg) NDC: 71336-1001-01 (11-digit format required) Administration Code: CPT 96372 (subcutaneous injection)

Units Calculation

The billing structure is straightforward:

  • 1 billable unit = 0.5 mg of givosiran
  • Patient dose = body weight (kg) × 2.5 mg/kg
  • Billable units = total dose ÷ 0.5

Example: 70 kg patient

  • Dose = 70 kg × 2.5 mg/kg = 175 mg
  • Units to bill = 175 mg ÷ 0.5 mg = 350 units

Vial and Volume Considerations

Givlaari is supplied at 189 mg/mL concentration. Most patients require:

  • 2 vials per month (typical allocation)
  • Maximum 1.5 mL per injection site
  • Multiple injections if dose exceeds 1.5 mL volume

Clean Request Anatomy

Example Prior Authorization Request

Patient Information:

  • Name, DOB, Cigna ID
  • Prescriber: Board-certified hematologist or hepatologist
  • Diagnosis: E80.21 - Acute intermittent hepatic porphyria

Clinical Documentation:

  • Elevated PBG: 8.2 mg/day (normal <4 mg/day)
  • Attack history: 3 documented episodes requiring ER visits in past 6 months
  • Prior hemin therapy: 2 administrations with temporary improvement
  • Weight-based dosing: 2.5 mg/kg monthly (patient weight 65 kg = 162.5 mg dose)

Billing Details:

  • HCPCS: J0223
  • Units: 325 (162.5 mg ÷ 0.5 mg per unit)
  • NDC: 71336-1001-01
  • Administration: CPT 96372
  • Site of care: Hospital outpatient department

Counterforce Health specializes in creating precisely structured prior authorization requests like this, automatically pulling the right evidence and formatting requirements to match Cigna's specific criteria.

Frequent Coding Pitfalls

Unit Conversion Errors

Common Mistake: Billing total mg instead of 0.5 mg units

  • Wrong: 162.5 units for 162.5 mg dose
  • Correct: 325 units (162.5 mg ÷ 0.5 mg per unit)

Mismatched Benefit Categories

Error: Submitting through pharmacy benefit (rejected) Fix: Always bill through medical benefit with J0223 code

Missing Documentation Dates

Problem: Labs from >12 months ago Solution: Obtain recent PBG/ALA levels, ideally during or within 30 days of an acute episode

Site of Care Violations

Issue: Requesting home administration Correction: Specify clinic, hospital outpatient, or infusion center administration

Verification with Cigna Resources

Before Submission

  1. Check formulary status via Cigna provider portal
  2. Verify specialty pharmacy network: Accredo is preferred
  3. Confirm PA requirements at covermymecs.com
  4. Review medical policy for current criteria

Submission Channels

  • Online: covermymecs.com/main/prior-authorization-forms/cigna/
  • Fax: 855-840-1678
  • Phone: 866-759-1557 (verbal authorization)
  • EHR: SureScripts integration

Timeline Expectations

  • Standard review: 5 business days
  • Expedited review: 24 hours (urgent cases)
  • Appeal decision: 30 days (standard) or 72 hours (expedited)

Pre-Submission Audit Checklist

Patient Eligibility:

  • Confirmed AHP diagnosis with genetic or biochemical evidence
  • ≥2 documented attacks in past 6-12 months
  • Specialist prescriber (hematology, hepatology, or genetics)
  • Current weight for dosing calculation

Coding Accuracy:

  • ICD-10: E80.21 (or appropriate alternative)
  • HCPCS: J0223 with correct unit calculation
  • NDC: 71336-1001-01 (11-digit format)
  • Administration: CPT 96372

Documentation Completeness:

  • Recent lab results (PBG, ALA levels)
  • Hospital records or ER visits for attacks
  • Prior therapy attempts (hemin, supportive care)
  • Treatment goals and monitoring plan

Submission Details:

  • Cigna member ID and group number
  • Prescriber NPI and DEA numbers
  • Site of care specified (not home delivery)
  • Contact information for follow-up
From our advocates: "The most successful Givlaari approvals include both biochemical proof and a clear timeline of attacks. One common pattern we see is when providers submit genetic testing results alongside elevated PBG levels from the most recent episode—this combination rarely faces step therapy requirements."

Appeals Process in Georgia

Internal Appeal with Cigna

If your initial request is denied:

Timeline: 180 days from denial notice to file Process: Submit written appeal with additional clinical evidence Decision: 30 days (standard) or 72 hours (expedited) Contact: Use same submission channels as initial PA

Georgia External Review

After exhausting Cigna's internal appeals:

Deadline: 60 days from final internal denial notice Cost: Free to consumer Authority: Georgia Department of Insurance assigns independent reviewer Timeline: 30 business days (standard) or 72 hours (expedited) Contact: Georgia DOI Consumer Services at 1-800-656-2298

Required Documents:

  • Cigna's final denial letter
  • All clinical records supporting medical necessity
  • Completed external review application form
  • Any additional specialist opinions

The external review decision is binding on Cigna—if the independent reviewer approves coverage, Cigna must provide it.

Organizations like Counterforce Health can help structure these appeals with the specific evidence and formatting that external reviewers expect, significantly improving approval rates for complex specialty drugs like Givlaari.

FAQ

How long does Cigna prior authorization take for Givlaari in Georgia? Standard review is 5 business days; expedited review for urgent cases is completed within 24 hours.

What if Givlaari is non-formulary on my Cigna plan? Submit a formulary exception request with the same clinical documentation. Non-formulary status doesn't prevent coverage if medical necessity is demonstrated.

Can I request an expedited appeal if my condition is worsening? Yes. If delay poses serious risk to your health, request expedited review (72-hour timeline) for both internal appeals and external review.

Does step therapy apply if I've failed hemin therapy outside Georgia? Medical records from any state are acceptable. Document prior hemin use, outcomes, and any adverse effects or contraindications.

What counts as "medical necessity" for Givlaari coverage? Confirmed AHP diagnosis, documented attack history, elevated biochemical markers (PBG/ALA), and evidence that current therapy is inadequate.

How do I calculate the correct billing units? Total dose in mg ÷ 0.5 mg per unit = billable units. For a 70 kg patient: (70 × 2.5) ÷ 0.5 = 350 units.

Can my primary care doctor prescribe Givlaari? Most Cigna policies require a specialist (hematologist, hepatologist, or medical geneticist) to prescribe and monitor Givlaari therapy.

What if I need help with the appeals process? Contact Georgia DOI Consumer Services (1-800-656-2298) or organizations like Georgians for a Healthy Future for assistance with appeals and external review.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider regarding treatment decisions and insurance coverage options. Coverage policies vary by plan and may change over time—verify current requirements with your insurer.

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