By Counterforce Health Team in Hetlioz (tasimelteon) —

The Requirements Checklist to Get Hetlioz (Tasimelteon) Covered by UnitedHealthcare in Georgia

Answer Box: Getting Hetlioz Covered by UnitedHealthcare in Georgia

UnitedHealthcare requires prior authorization for Hetlioz (tasimelteon) through OptumRx, with step therapy typically requiring a melatonin trial first. Your fastest path to approval: (1) Gather genetic testing for Smith-Magenis Syndrome or blindness documentation for Non-24-Hour Sleep-Wake Disorder, (2) Document failed melatonin therapy, and (3) Submit via the UnitedHealthcare Provider Portal with complete medical necessity documentation. If denied, you have 180 days for internal appeals and 60 days for Georgia's external review.

Table of Contents

Who Should Use This Checklist

This guide helps patients and clinicians navigate UnitedHealthcare's prior authorization process for Hetlioz (tasimelteon) in Georgia. Use this if you're dealing with:

  • Non-24-Hour Sleep-Wake Disorder in totally blind adults
  • Smith-Magenis Syndrome sleep disturbances (ages 3+ for Hetlioz LQ, ages 16+ for capsules)
  • Initial denials requiring appeals or peer-to-peer reviews

Expected outcome: With complete documentation, most medically appropriate cases get approved within 2-14 business days. Appeals success rates improve significantly with proper clinical evidence.

Member & Plan Basics

Coverage Requirements

Requirement Details Verification
Active UnitedHealthcare Coverage Must be current member in good standing Check member ID card, call 1-800-842-3210
OptumRx Pharmacy Benefits Hetlioz requires specialty pharmacy coverage Verify via UHC member portal
Prior Authorization Required for all Hetlioz formulations Submit before dispensing
Plan Type Commercial, Medicare Advantage, or Medicaid Different forms may apply
Note: UnitedHealthcare processes Hetlioz through their OptumRx specialty program, not standard retail pharmacy benefits.

Clinical Criteria Requirements

FDA-Approved Indications

Hetlioz Capsules (20mg):

  • Non-24-Hour Sleep-Wake Disorder in adults who are totally blind
  • Nighttime sleep disturbances in Smith-Magenis Syndrome (ages 16+)

Hetlioz LQ Oral Suspension:

  • Nighttime sleep disturbances in Smith-Magenis Syndrome (ages 3-15)

Step Therapy Requirements

UnitedHealthcare typically requires documentation of:

  1. Failed melatonin therapy (≥6 months at appropriate doses)
  2. Sleep hygiene measures attempted
  3. Other sleep medications tried when clinically appropriate (e.g., ramelteon)

Diagnosis Documentation

For Non-24-Hour Sleep-Wake Disorder:

  • ICD-10 code: G47.24 (Circadian rhythm sleep disorder, free-running type)
  • Total blindness confirmation (no light perception)
  • Sleep logs/actigraphy showing daily drift pattern (2-4 weeks minimum)
  • Symptoms present ≥3 months with functional impairment

For Smith-Magenis Syndrome:

  • ICD-10 code: Q93.88 (Other microdeletions)
  • Genetic testing confirming 17p11.2 deletion or RAI1 mutation
  • Documentation of nighttime sleep disturbances (difficulty falling asleep, frequent awakenings)
  • Sleep pattern documentation

Coding & Billing Information

Key Codes

  • ICD-10: G47.24 (Non-24) or Q93.88 (SMS)
  • HCPCS: J0401 (Injection, tasimelteon, 0.1 mg - used for billing reference)
  • NDC Examples: 59522-0201-20 (20mg capsules, 30-count)

Billing Units

  • 1 unit = 0.1 mg tasimelteon
  • Standard 20mg daily dose = 200 units per day
  • Bill based on actual mg dispensed

Documentation Packet Essentials

Medical Necessity Letter Components

Your prescriber's letter must include:

  1. Patient identification (name, DOB, member ID)
  2. Diagnosis with ICD-10 code
  3. Clinical history and symptom documentation
  4. Failed therapies with specific drugs, doses, durations, and reasons for failure
  5. Medical necessity statement referencing FDA labeling
  6. Dosing plan per manufacturer guidelines
  7. Monitoring plan and reauthorization timeline

Required Attachments

  • Sleep diary/actigraphy data (2-4 weeks)
  • Genetic testing results (for SMS)
  • Documentation of blindness (for Non-24)
  • Prior medication trial records
  • Specialist consultation notes
Clinician Corner: Reference the American Academy of Sleep Medicine guidelines and FDA labeling in your medical necessity letter. UnitedHealthcare reviewers look for evidence-based justification aligned with published criteria.

Submission Process

Step-by-Step Submission

  1. Complete UnitedHealthcare PA form via Provider Portal
  2. Attach medical necessity letter and supporting documentation
  3. Submit to OptumRx through the portal or designated fax line
  4. Confirm receipt and obtain reference number
  5. Track status through provider portal

Timeline Expectations

  • Standard review: 2-14 business days
  • Expedited review: 72 hours (for urgent medical situations)
  • Automated approval possible based on claim history and diagnosis codes

Specialty Pharmacy Routing

UnitedHealthcare requires Hetlioz to be dispensed through Optum Specialty Pharmacy. The process includes:

  1. PA approval must be obtained first
  2. Prescription routing to Optum Specialty automatically after approval
  3. Patient contact by pharmacy for shipment coordination
  4. Direct-to-patient delivery with special handling requirements

Support: Contact HETLIOZ Solutions™ at 1-844-438-5469 for prescription coordination assistance.

After Submission: What to Expect

Confirmation Steps

  • Record your PA reference number
  • Set calendar reminders for status checks (day 7, day 14)
  • Monitor provider portal for status updates
  • Prepare appeal documentation in case of denial

Status Check Schedule

  • Day 3: Confirm receipt
  • Day 7: Check initial review status
  • Day 14: Follow up if no decision
  • Day 16+: Consider peer-to-peer review request

Common Denial Reasons & How to Avoid Them

Denial Reason Prevention Strategy Documentation Fix
Insufficient diagnosis documentation Include complete sleep studies and specialist notes Add actigraphy data, genetic testing
Step therapy not met Document all failed alternatives with specific reasons Provide medication trial logs with dates/doses
Age criteria not met Verify correct formulation (capsules vs LQ) Submit age-appropriate prescription
Missing medical necessity Include detailed clinical justification Reference FDA labeling and guidelines
Incomplete prior authorization Use current forms and complete all fields Double-check portal submission requirements

Appeals Process in Georgia

Internal Appeals (UnitedHealthcare)

  • Timeline: 180 days from denial date
  • Process: Submit via UHC Provider Portal or member services
  • Response time: 30 days standard, 72 hours expedited
  • Peer-to-peer option: Call 866-889-8054 (commercial) or 877-842-3210 (Medicare Advantage)

Georgia External Review

If internal appeals fail:

  • Timeline: 60 days from final internal denial
  • Process: Submit to Georgia Department of Insurance
  • Cost: Free for patients
  • Decision time: 45 days standard, 72 hours expedited
  • Outcome: Binding on UnitedHealthcare
Georgia-Specific Protection: The Georgia DOI Consumer Services hotline (1-800-656-2298) can assist with appeals questions and ensure proper processing of your external review request.

Counterforce Health helps patients and clinicians navigate complex insurance appeals by turning denials into targeted, evidence-backed rebuttals. Our platform identifies specific denial reasons and drafts point-by-point responses aligned to each payer's own rules, pulling the right medical evidence and clinical documentation to support your case. Visit www.counterforcehealth.org to learn more about our appeals assistance services.

Quick Reference Checklist

Before You Start ✓

  • Active UnitedHealthcare coverage verified
  • Correct diagnosis code (G47.24 or Q93.88)
  • Sleep diary/actigraphy (2-4 weeks)
  • Genetic testing results (SMS) or blindness documentation (Non-24)
  • Failed melatonin trial documentation
  • Specialist consultation notes

Submission Requirements ✓

  • Complete PA form via UHC Provider Portal
  • Medical necessity letter with all required elements
  • All supporting clinical documentation attached
  • Reference number obtained and recorded
  • Status check reminders set

After Submission ✓

  • Confirmation of receipt verified
  • Regular status monitoring scheduled
  • Appeal documentation prepared (if needed)
  • Specialty pharmacy coordination confirmed

FAQ

How long does UnitedHealthcare prior authorization take for Hetlioz in Georgia? Standard review takes 2-14 business days, with expedited review available in 72 hours for urgent medical situations.

What if Hetlioz is not on my UnitedHealthcare formulary? Non-formulary medications can still be covered through the medical exception process with strong clinical justification and failed alternatives documentation.

Can I request an expedited appeal in Georgia? Yes, both UnitedHealthcare internal appeals and Georgia external reviews offer expedited processing for urgent medical situations.

Does step therapy apply if I've tried melatonin outside Georgia? Yes, documented trials from any location count toward step therapy requirements, as long as proper documentation is provided.

What happens if I miss the 60-day external review deadline in Georgia? Contact Georgia DOI Consumer Services at 1-800-656-2298 immediately - they may be able to assist depending on circumstances.

How much does Hetlioz cost with UnitedHealthcare coverage? Costs vary by plan, but typical retail prices range from $5,895 for capsules to $24,678 for Hetlioz LQ. Check your specific plan benefits and consider manufacturer support programs.

Who can help me with the appeals process in Georgia? Georgians for a Healthy Future provides consumer assistance, and the Georgia Legal Services Program can help with complex cases.

What's the difference between Hetlioz capsules and Hetlioz LQ? Capsules are for ages 16+ (both Non-24 and SMS), while LQ oral suspension is specifically for SMS patients ages 3-15. They are not interchangeable.

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. For official appeals guidance, contact the Georgia Department of Insurance at 1-800-656-2298.

Sources & Further Reading:

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