How to Get Givlaari (givosiran) Covered by UnitedHealthcare in Georgia: Complete Coding, Prior Authorization & Appeals Guide
Answer Box: Getting Givlaari Covered by UnitedHealthcare in Georgia
UnitedHealthcare requires prior authorization for Givlaari (givosiran) in Georgia using HCPCS code J0223, ICD-10 E80.21 for acute intermittent porphyria, with documented ≥2 attacks in 6 months, hemin failure, and specialist prescriber. Submit via UnitedHealthcare Provider Portal with medical necessity letter, attack records, and lab results. If denied, file internal appeal within 180 days, then Georgia external review within 60 days through the Department of Insurance (800-656-2298). Standard PA decisions take 2-15 business days; expedited reviews complete within 72 hours for urgent cases.
First step today: Verify your UnitedHealthcare plan covers Givlaari under medical benefit and gather attack documentation from the past 6 months.
Table of Contents
- Coding Basics: Medical vs. Pharmacy Benefit
- ICD-10 Coding for Acute Hepatic Porphyria
- Product Coding: HCPCS J0223 and NDC
- Clean Prior Authorization Request
- Common Coding Pitfalls
- UnitedHealthcare Verification Steps
- Pre-Submission Audit Checklist
- Appeals Process in Georgia
- FAQ
Coding Basics: Medical vs. Pharmacy Benefit
Givlaari (givosiran) is covered under UnitedHealthcare's medical benefit, not the pharmacy benefit, because it requires healthcare provider administration and monitoring. This means:
- Billing path: Provider submits claims using HCPCS codes
- Prior authorization: Required through UnitedHealthcare's medical review team
- Specialty pharmacy: OptumRx coordinates delivery to provider office
- Patient responsibility: Medical deductible and coinsurance apply
Note: Some UnitedHealthcare plans may handle Givlaari through OptumRx for prior authorization coordination, but billing remains under the medical benefit.
ICD-10 Coding for Acute Hepatic Porphyria
Primary Diagnosis Codes
| ICD-10 Code | Description | Documentation Requirements |
|---|---|---|
| E80.21 | Acute intermittent (hepatic) porphyria | Elevated ALA/PBG levels, genetic testing, attack history |
| E80.29 | Other porphyria | For hereditary coproporphyria, variegate porphyria, ALA dehydratase deficiency |
Supporting Documentation Language
Your medical records should include specific terminology that supports the ICD-10 coding:
- Attack symptoms: "Severe abdominal pain," "neurological symptoms," "autonomic dysfunction"
- Biochemical evidence: "Elevated urinary ALA and PBG during attack," "5-fold increase above normal"
- Genetic confirmation: "HMBS gene mutation," "pathogenic variant identified"
- Treatment response: "Required IV hemin," "hospitalization for porphyria attack"
The ICD-10 classification E80.21 specifically covers acute intermittent porphyria, which represents the most common form of acute hepatic porphyria.
Product Coding: HCPCS J0223 and NDC
HCPCS Coding
J0223 - Injection, givosiran, 0.5 mg
Dosing Calculations
Givlaari is dosed at 2.5 mg/kg subcutaneously monthly. Here's how to calculate units:
Example: 70 kg patient
- Total dose: 70 kg × 2.5 mg/kg = 175 mg
- Units to bill: 175 mg ÷ 0.5 mg = 350 units of J0223
NDC Numbers
| Strength | NDC | Package Size |
|---|---|---|
| 189 mg/mL | 71336-1001-01 | Single-dose vial |
Modifier Considerations
- No modifiers typically required for standard administration
- Use -53 if administration is discontinued due to patient reaction
- Document injection site and any adverse reactions
Clean Prior Authorization Request
Required Elements Checklist
Patient Information:
- UnitedHealthcare member ID
- Patient demographics (age, weight for dosing)
- Primary diagnosis: ICD-10 E80.21
Clinical Documentation:
- ≥2 documented AHP attacks in past 6 months
- Hospital discharge summaries or ER records
- Elevated urinary ALA/PBG levels (within 12 months)
- Genetic testing results (if available)
Step Therapy Documentation:
- Prior hemin (Panhematin) trials with dates
- Hemin failure/intolerance documentation
- Pharmacy records or administration logs
Prescriber Requirements:
- Hematologist, hepatologist, or gastroenterologist
- Provider credentials and specialty certification
- Medical necessity letter with clinical rationale
Sample PA Request Structure
Patient: [Name], DOB [Date], Member ID [Number]
Diagnosis: Acute intermittent porphyria (ICD-10: E80.21)
Medication: Givlaari (givosiran) - HCPCS J0223
Dose: 2.5 mg/kg (XXX mg) subcutaneous monthly
Units: XXX units of J0223 per month
Clinical Justification:
- Confirmed AHP with [genetic/biochemical evidence]
- Attack frequency: X attacks requiring [hospitalization/hemin] in past 6 months
- Prior hemin therapy: [dates, outcomes, reasons for discontinuation]
- Specialist prescriber: [name, credentials]
Common Coding Pitfalls
Unit Conversion Errors
Mistake: Billing 175 units instead of 350 units for a 175 mg dose Fix: Remember J0223 = 0.5 mg, so divide total dose by 0.5
Mismatched Diagnosis Codes
Mistake: Using E80.20 (unspecified porphyria) instead of E80.21 Fix: Ensure specific AHP subtype documentation supports E80.21
Missing Attack Documentation
Mistake: Vague references to "porphyria symptoms" Fix: Include specific dates, locations (hospital/ER), and treatment received
Non-Specialist Prescriber
Mistake: Primary care physician submitting PA Fix: Obtain hematologist or hepatologist consultation and prescription
UnitedHealthcare Verification Steps
Pre-Submission Verification
- Check formulary status: Use UnitedHealthcare Provider Portal to verify Givlaari coverage
- Confirm PA requirements: Review current prior authorization list
- Verify specialist network: Ensure prescriber is in-network hematologist/hepatologist
- OptumRx coordination: Call 800-310-6826 for specialty drug PA guidance
During Review Process
- Track PA status: Use provider portal for real-time updates
- Respond to requests: UnitedHealthcare may request additional clinical information
- Peer-to-peer option: Request medical director review if initial denial
Pre-Submission Audit Checklist
Clinical Documentation Review:
- Attack frequency meets ≥2 in 6 months requirement
- Lab results show elevated ALA/PBG during attacks
- Hemin trial documentation is complete with outcomes
- Specialist credentials are current and appropriate
Coding Accuracy:
- ICD-10 E80.21 matches clinical documentation
- HCPCS J0223 units calculated correctly (dose ÷ 0.5 mg)
- NDC number matches strength ordered
- No conflicting or unnecessary modifiers
Submission Requirements:
- PA form completed in provider portal
- Medical necessity letter attached
- All supporting documents uploaded
- Expedited review requested if clinically urgent
Appeals Process in Georgia
Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals that align with each payer's specific requirements.
Internal Appeals with UnitedHealthcare
Timeline: 180 days from denial date How to file:
- Online: UnitedHealthcare member portal
- Phone: Number on member ID card (24/7)
- Mail/Fax: Address provided in denial letter
Required elements:
- Member information and denial letter
- Clinical justification for medical necessity
- Additional supporting documentation
- Request for expedited review if urgent (72-hour decision)
Georgia External Review
If UnitedHealthcare upholds the denial, Georgia law provides external review through the Department of Insurance.
Critical deadline: 60 days from final internal denial How to file:
- Online: oci.georgia.gov
- Phone: 800-656-2298
- Cost: Free for consumers
Decision timeline: 45 days standard, 72 hours expedited Binding result: UnitedHealthcare must accept external reviewer's decision
From our advocates: In complex cases involving rare disease medications like Givlaari, we've seen success when appeals include detailed attack logs, clear hemin failure documentation, and specialist letters that directly address the payer's specific denial reasons. The key is matching your evidence to their exact criteria rather than providing general clinical information.
When to Escalate
Contact Georgia Department of Insurance Consumer Services (800-656-2298) if:
- UnitedHealthcare misses appeal deadlines
- You need help understanding your appeal rights
- You suspect unfair claim practices
FAQ
How long does UnitedHealthcare prior authorization take in Georgia? Standard PA decisions take 2-15 business days. Expedited reviews for urgent cases complete within 72 hours when clinical urgency is documented.
What if Givlaari is non-formulary on my plan? Givlaari requires prior authorization but is typically covered under the medical benefit. Non-formulary status would require a formulary exception with strong clinical justification.
Can I request an expedited appeal in Georgia? Yes, if delay in treatment would jeopardize your health. Provide physician documentation of urgency and request expedited internal appeal (72 hours) and expedited external review if needed.
Does step therapy apply if I tried hemin outside Georgia? UnitedHealthcare accepts hemin trial documentation from any location. Ensure you have pharmacy records or administration logs showing dates and outcomes.
What counts as a qualifying attack for Givlaari coverage? UnitedHealthcare requires ≥2 documented attacks in 6 months. Qualifying attacks include hospitalizations, ER visits, urgent care visits, or episodes requiring IV hemin administration.
How do I find a specialist for Givlaari prescription? Use UnitedHealthcare's provider directory to find in-network hematologists, hepatologists, or gastroenterologists. Many academic medical centers have porphyria specialists.
Sources & Further Reading
- UnitedHealthcare Givlaari Policy - Official coverage criteria
- ICD-10 Code E80.21 - Acute intermittent porphyria coding
- Georgia Department of Insurance - External review process
- UnitedHealthcare Provider Portal - PA submission and status tracking
- Givlaari Prescribing Information - FDA-approved labeling and dosing
For complex cases requiring detailed appeal strategies, Counterforce Health provides specialized support in developing evidence-based appeals that address specific payer denial reasons and policy requirements.
This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Appeal deadlines and requirements may vary by plan type and state regulations.
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