By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (Givosiran) Covered by UnitedHealthcare in Florida: Complete Prior Authorization Guide

Answer Box: Getting Givlaari Covered by UnitedHealthcare in Florida

To get Givlaari (givosiran) covered by UnitedHealthcare in Florida, you must document acute hepatic porphyria with at least 2 qualifying attacks in the past 6 months, show failure/intolerance to hemin therapy, and obtain specialist prescribing. Submit prior authorization through the UnitedHealthcare Provider Portal with biochemical evidence (elevated ALA/PBG levels), attack documentation, and medical necessity letter. Standard decisions take up to 15 business days; expedited reviews for urgent cases resolve within 72 hours. If denied, Florida law guarantees internal appeals within 30 days and concurrent external review for urgent situations.

First step today: Gather attack records from the past 6 months and request recent ALA/PBG lab results from your healthcare provider.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Typical Timeline in Florida
  7. If You Need to Provide More Information
  8. If Your Request Is Denied
  9. Renewal and Reauthorization
  10. Common Denial Reasons & How to Fix Them
  11. Appeals Process in Florida
  12. Frequently Asked Questions
  13. Quick Reference Checklist

What This Guide Covers

This guide helps patients with acute hepatic porphyria (AHP) and their healthcare teams navigate UnitedHealthcare's prior authorization process for Givlaari (givosiran) in Florida. Whether you're facing your first denial or preparing an initial request, you'll find specific requirements, timelines, and appeal strategies tailored to Florida's insurance regulations.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting evidence-backed rebuttals. Their platform helps patients and providers navigate complex prior authorization requirements for specialty medications like Givlaari.

Before You Start: Verify Your Coverage

Check Your Plan Type and Benefits

  1. Confirm your UnitedHealthcare plan type (Commercial, Medicare Advantage, or Medicaid managed care)
  2. Verify Givlaari is covered under your medical benefit (not pharmacy benefit) - it's administered by healthcare providers
  3. Check if your prescribing physician is in-network with UnitedHealthcare
  4. Confirm your plan uses OptumRx for specialty drug management
Tip: Call the member services number on your insurance card to verify these details before starting your prior authorization.

Gather Required Documentation

Essential Documents Checklist

Medical Records (Past 6-12 Months):

  • Hospital discharge summaries from AHP attacks
  • Emergency department visit records
  • Clinic notes documenting attack symptoms and treatment
  • Hemin (Panhematin) administration records

Laboratory Evidence:

  • Recent urinary porphobilinogen (PBG) and aminolevulinic acid (ALA) levels (within past 12 months)
  • Genetic testing results showing pathogenic variants in HMBS, CPOX, PPOX, or ALAD genes

Clinical Documentation:

  • Confirmed AHP diagnosis with appropriate ICD-10 codes (E80.21 for acute intermittent porphyria)
  • Documentation of at least 2 qualifying attacks requiring medical intervention in past 6 months
  • Evidence of hemin failure, intolerance, or contraindication
  • Specialist consultation notes (hematologist or hepatologist)

Coverage Requirements Table

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing UnitedHealthcare Provider Portal UHC Policy
Step Therapy Must try/fail hemin first Medical records, pharmacy claims UHC Givlaari Policy
Specialist Prescribing Hematologist or hepatologist Provider credentials UHC Policy
Attack Documentation ≥2 attacks in 6 months Hospital/clinic records UHC Policy
Biochemical Evidence Elevated ALA/PBG levels Lab reports UHC Policy

Submit Your Prior Authorization Request

Step-by-Step Submission Process

  1. Access the UnitedHealthcare Provider Portal or call 888-397-8129 for provider support
  2. Use HCPCS code J0223 for Givlaari billing
  3. Submit complete documentation package including:
    • Prior authorization form
    • Medical necessity letter from prescribing specialist
    • Attack history documentation
    • Laboratory results
    • Evidence of hemin failure/intolerance
  4. Request expedited review if urgent - clearly state medical urgency in your submission
Note: For injectable medications through OptumRx, you can also contact their Prior Authorization Line at 800-310-6826.

Medical Necessity Letter Checklist

Your specialist should include:

  • Confirmed AHP diagnosis with genetic or biochemical evidence
  • Attack frequency and severity over the past 6 months
  • Prior hemin therapy details and reasons for failure/intolerance
  • Clinical rationale for Givlaari based on FDA labeling and guidelines
  • Dosing plan (2.5 mg/kg monthly subcutaneous injection)
  • Monitoring plan for hepatic and renal function

Follow-Up and Tracking

  • Day 3-5: Call to confirm receipt and completeness of submission
  • Day 7-10: Check status and ask about any additional information needed
  • Day 12-14: Final status check before deadline

Sample Phone Script

"Hi, I'm calling to check the status of a prior authorization request for Givlaari submitted on [date] for patient [name], member ID [number]. Can you confirm you received all required documentation and provide the current status? If approved, when will the authorization be active?"

Typical Timeline in Florida

Standard Processing Times

  • Standard Prior Authorization: Up to 15 business days
  • Expedited/Urgent Review: 72 hours maximum
  • Additional Information Requests: 5-7 business days for response
  • Concurrent Review (ongoing treatment): 24 hours

Florida-Specific Appeal Timelines

Under Florida's Patient Timely Access to Healthcare Act (effective October 2024):

  • Internal Appeals: 30 days maximum resolution
  • Expedited Internal Appeals: 4 business days (verbal decision), 48 hours (written follow-up)
  • External Review: Available concurrently for urgent cases

If You Need to Provide More Information

Common Information Requests

  1. Additional attack documentation - Provide detailed records of symptoms, duration, and treatment
  2. Hemin trial details - Include dates, doses, clinical response, and adverse effects
  3. Specialist consultation - Obtain letter from hematologist confirming diagnosis and treatment plan
  4. Updated laboratory values - Submit most recent ALA/PBG levels if older than 12 months
Tip: Respond to information requests within 5 business days to avoid delays or automatic denials.

If Your Request Is Denied

First Steps After Denial

  1. Review the denial letter carefully - identify specific reasons for denial
  2. Contact your healthcare provider to discuss appeal options
  3. File internal appeal within 180 days of denial notice
  4. Consider peer-to-peer review - request direct physician-to-physician discussion

When to Request Expedited Appeal

Request expedited review if:

  • You're currently experiencing frequent AHP attacks
  • Delay would seriously jeopardize your health
  • You're at risk of hospitalization without treatment

Renewal and Reauthorization

Annual Renewal Requirements

  • Updated attack frequency data from the past 12 months
  • Current laboratory values (ALA/PBG levels)
  • Clinical response documentation showing attack reduction
  • Continued medical necessity from prescribing specialist
Calendar Reminder: Set renewal reminder 60 days before authorization expires to ensure continuous coverage.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Insufficient attack history Provide detailed records Hospital discharge summaries, ER visits, clinic notes
Missing biochemical evidence Submit lab results Recent ALA/PBG levels, genetic testing
No hemin trial documented Show prior therapy attempts Pharmacy records, administration logs, intolerance notes
Non-specialist prescriber Get specialist consultation Hematologist or hepatologist letter
Lack of medical necessity Strengthen clinical rationale Detailed specialist letter with guidelines citations

Appeals Process in Florida

Internal Appeal Process

  1. File within 180 days of denial notice
  2. Submit via UnitedHealthcare member portal or mail to address on denial letter
  3. Include new supporting documentation and detailed rebuttal letter
  4. Request expedited review if medically urgent

External Review Option

If internal appeals fail, Florida offers independent external review:

  • Request within 4 months of final internal denial
  • File through Florida Department of Financial Services
  • No cost to consumer
  • Binding decision if reviewer overturns denial

For assistance, contact Florida's Insurance Consumer Helpline at 1-877-MY-FL-CFO (877-693-5236).

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in Florida? A: Standard requests take up to 15 business days; expedited reviews for urgent cases are completed within 72 hours under Florida law.

Q: What if Givlaari isn't on my formulary? A: Givlaari is covered under the medical benefit, not pharmacy benefit. Check with your provider about medical benefit coverage.

Q: Can I request expedited review if I'm having frequent attacks? A: Yes, frequent AHP attacks qualify for expedited review as they can be life-threatening or cause serious health deterioration.

Q: Does step therapy apply if I tried hemin in another state? A: Yes, prior hemin trials from any location count toward step therapy requirements if properly documented.

Q: What happens if I don't respond to a request for more information? A: Failure to respond within the specified timeframe (typically 5-15 business days) may result in automatic denial.

Q: Can my doctor request a peer-to-peer review? A: Yes, physicians can request direct discussion with UnitedHealthcare medical directors to discuss clinical rationale.

Quick Reference Checklist

Before Submitting PA:

  • Verify UnitedHealthcare coverage and in-network status
  • Gather 6 months of attack documentation
  • Obtain recent ALA/PBG lab results
  • Document hemin failure/intolerance
  • Secure specialist prescriber

Submission Package:

  • Prior authorization form
  • Medical necessity letter
  • Attack history records
  • Laboratory results
  • Hemin trial documentation
  • ICD-10 diagnosis codes

After Submission:

  • Track submission receipt
  • Follow up at days 5, 10, and 14
  • Respond quickly to information requests
  • File appeal within 180 days if denied

Getting specialized help with insurance appeals can make the difference between approval and denial. Counterforce Health helps patients and providers navigate complex prior authorization requirements by analyzing payer policies and creating targeted, evidence-backed appeals that address each insurer's specific criteria.

Sources & Further Reading

Disclaimer: This guide is for informational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage information. For official appeals assistance in Florida, contact the Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO.

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