By Counterforce Health Team in Hetlioz (tasimelteon) —

Hetlioz (Tasimelteon) Approval with Blue Cross Blue Shield in Virginia: Complete Coverage Guide

Quick Answer: Getting Hetlioz Covered by Blue Cross Blue Shield in Virginia

Hetlioz (tasimelteon) requires prior authorization from Blue Cross Blue Shield Virginia (Anthem HealthKeepers) for Non-24-hour sleep-wake disorder and Smith-Magenis syndrome. Submit via Anthem's Interactive Care Reviewer (ICR) in Availity with sleep specialist documentation, diagnosis confirmation, and evidence of failed alternatives like melatonin or ramelteon. If denied, Virginia's Bureau of Insurance provides external review within 45 days. Start by having your doctor check Anthem's Prior Authorization Lookup Tool and gather sleep logs showing circadian rhythm disruption.

First step today: Contact your sleep specialist to initiate PA submission through Availity or fax to 844-512-7020 for pharmacy benefits.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Cost Considerations
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Virginia External Review Process

Coverage Basics

Is Hetlioz Covered by Blue Cross Blue Shield Virginia?

Yes, but with restrictions. Hetlioz requires prior authorization under Anthem Blue Cross Blue Shield Virginia's pharmacy benefits for both formulations:

  • Hetlioz capsules (20mg): Ages 16+ for Non-24-hour sleep-wake disorder
  • Hetlioz LQ oral suspension: Ages 3-15 for Smith-Magenis syndrome sleep disturbances

Coverage depends on your specific benefit plan and formulary tier. Most BCBS plans classify Hetlioz as a non-preferred specialty medication requiring step therapy through lower-cost alternatives first.

Which Plans Cover Hetlioz?

Blue Cross Blue Shield Virginia (operated by Anthem HealthKeepers, Inc.) covers Hetlioz across commercial, ACA marketplace, and some Medicare Advantage plans. Coverage specifics vary by:

  • Commercial/employer plans: Standard PA requirements
  • Individual marketplace: May have additional quantity limits
  • Medicare Part D: Different formulary placement and appeals process

Check your specific plan's formulary using Anthem's drug lookup tool.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

1. Specialist Consultation (Patient) Schedule with a sleep medicine physician or neurologist at an AASM-accredited sleep center. Bring 2-4 weeks of completed sleep logs showing delayed sleep patterns.

2. Diagnosis Documentation (Clinician) Obtain formal diagnosis using ICSD-3-TR criteria:

  • Clinical history of progressive sleep delays ≥3 months
  • Sleep logs and actigraphy for ≥14 days
  • ICD-10 code G47.24 (Non-24-hour sleep-wake disorder)

3. Prior Authorization Submission (Clinician) Submit via Anthem's Interactive Care Reviewer (ICR) in Availity portal, or fax to 844-512-7020 for retail pharmacy requests.

4. Documentation Package (Clinician) Include:

  • Medical necessity letter with step therapy trials
  • Sleep logs/actigraphy results
  • Failed alternative medications (melatonin, ramelteon)
  • Genetic testing (for SMS cases)

5. Review Process (Anthem) Standard review takes 5-15 business days. Urgent cases can request expedited review within 72 hours with physician certification.

Required Documentation Checklist

Document Type Details Source
Diagnosis confirmation ICSD-3-TR criteria met, ICD-10 G47.24 Sleep specialist
Sleep monitoring 14+ days of logs/actigraphy showing irregular patterns Patient/clinic
Step therapy trials Failed melatonin (≥30 days) or ramelteon Medical records
Specialist attestation Board-certified sleep medicine physician AASM-accredited center
Age verification Capsules ≥16 years, LQ suspension 3-15 years Medical records

Timing and Deadlines

Standard Timeline

  • PA submission to decision: 5-15 business days
  • Expedited review: 72 hours (with urgency certification)
  • Appeal deadline: 180 days from denial notice
  • External review filing: 120 days from final internal appeal

When to Request Expedited Review

Contact Anthem Provider Services at 800-901-0020 for expedited processing if:

  • Patient experiencing severe sleep disruption affecting daily function
  • Delay could worsen medical condition
  • Physician certifies urgency in writing

Medical Necessity Criteria

Non-24-Hour Sleep-Wake Disorder Requirements

Clinical Criteria:

  • Documented sleep-wake cycle delays of 1-2 hours daily
  • Inability to maintain 24-hour schedule despite sleep hygiene
  • Symptoms lasting ≥3 months
  • Functional impairment in work, school, or daily activities

Failed Alternatives:

  • Over-the-counter melatonin (documented 30-day trial)
  • Ramelteon (Rozerem) if tolerated
  • Light therapy attempts (if applicable)

Smith-Magenis Syndrome (Pediatric) Requirements

Additional Documentation:

  • Genetic testing confirming 17p11.2 deletion or RAI1 mutation
  • Documented inverted melatonin rhythm
  • Sleep disturbances despite behavioral interventions
  • Weight-based dosing calculation (0.7 mg/kg for ≤28 kg patients)
Clinician Corner: Include peer-reviewed citations in your medical necessity letter. Key references include FDA labeling data, AASM practice guidelines for circadian rhythm disorders, and SMS-specific sleep management protocols from genetics journals.

Cost Considerations

Typical Costs and Coverage

  • Hetlioz capsules: ~$5,895 for 30-day supply (retail)
  • Hetlioz LQ: ~$24,678 for standard bottle size
  • Your cost: Depends on formulary tier and copay/coinsurance structure

Financial Assistance Options

Manufacturer Support:

  • Hetlioz Solutions Program offers copay assistance for eligible patients
  • Patient assistance programs for uninsured/underinsured

Additional Resources:

  • Virginia Medicaid (if eligible after 2019 expansion)
  • Patient advocate foundations for rare disease medications
  • Hospital charity care programs

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Address Required Documentation
Insufficient diagnosis documentation Obtain comprehensive sleep study AASM-accredited center report
Step therapy not completed Document failed melatonin/ramelteon trials Pharmacy records, physician notes
Age restrictions Verify appropriate formulation Birth certificate, medical records
Not medically necessary Strengthen clinical rationale Peer-reviewed literature, guidelines

Internal Appeals Process

Level 1: Standard Appeal

  • File within 180 days of denial
  • Submit via Anthem member portal or mail
  • Include new clinical evidence and physician letter
  • Decision within 30 days (15 for urgent)

Level 2: Peer-to-Peer Review Request physician-to-physician discussion through Provider Services at 800-901-0020. Your sleep specialist can directly discuss the case with Anthem's medical director.

Virginia External Review Process

If Anthem upholds the denial after internal appeals, Virginia's State Corporation Commission Bureau of Insurance provides independent external review.

Filing External Review

Eligibility Requirements:

  • Exhausted Anthem's internal appeals process
  • Medical necessity or experimental treatment denial
  • Virginia-issued plan or opted-in self-funded plan

How to File:

  1. Complete Form 216-A (External Review Request)
  2. Submit within 120 days of final denial notice
  3. Fax to (804) 371-9915 or email to SCC Bureau of Insurance

Timeline:

  • Standard review: 45 days
  • Expedited review: 72 hours (with physician urgency certification)
  • Decision is binding on Anthem
Note: Virginia's external review process is free and has helped many patients obtain coverage for specialty medications when clinical evidence supports medical necessity.

Specialty Pharmacy Requirements

Why Hetlioz Requires Specialty Pharmacy

Hetlioz is typically dispensed through specialty pharmacies due to:

  • High cost and limited distribution
  • Patient monitoring requirements
  • Prior authorization complexity
  • Temperature-controlled shipping needs

Common Specialty Pharmacy Partners

  • CVS Specialty
  • Accredo (Cigna)
  • OptumRx Specialty
  • BriovaRx

Your prescription will automatically transfer to Anthem's preferred specialty pharmacy network. Contact the pharmacy directly for delivery scheduling and adherence support.

Renewal Requirements

When to Reauthorize

Most Hetlioz approvals require renewal every 6-12 months. Start the renewal process 30 days before expiration to avoid treatment gaps.

Renewal Documentation

  • Updated sleep logs showing continued benefit
  • Physician assessment of treatment response
  • Confirmation of ongoing medical necessity
  • Documentation of any dose adjustments

Troubleshooting Common Issues

Portal and System Problems

Availity Portal Issues:

  • Clear browser cache and cookies
  • Try different browser (Chrome, Firefox)
  • Contact Availity support at 800-AVAILITY

Missing Forms:

Communication Delays

If you haven't received a PA decision within the standard timeframe:

  1. Call Provider Services at 800-901-0020
  2. Reference your PA tracking number
  3. Request status update and expected decision date

When to Contact Virginia Regulators

If you believe Anthem has improperly denied coverage or violated Virginia insurance law, contact:

State Corporation Commission Bureau of Insurance

  • Consumer Services: (877) 310-6560
  • File complaints online or via mail
  • Free consultation on appeal rights

Virginia Office of the Managed Care Ombudsman

  • Assists with HMO and managed care issues
  • Can facilitate informal resolution
  • Same contact number as SCC Consumer Services

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. The platform identifies specific denial reasons and drafts point-by-point responses aligned with each plan's own coverage rules, pulling the right medical citations and clinical evidence to support approval requests.

Frequently Asked Questions

How long does BCBS Virginia PA take for Hetlioz? Standard review takes 5-15 business days. Expedited review (with physician urgency certification) takes 72 hours.

What if Hetlioz is non-formulary on my plan? Request a formulary exception with step therapy documentation and medical necessity letter. Non-formulary doesn't mean uncoverable.

Can I request an expedited appeal in Virginia? Yes, both Anthem internal appeals and Virginia external review offer expedited processing for urgent medical situations.

Does step therapy apply if I failed alternatives in another state? Previous pharmacy records from other states count toward step therapy requirements. Provide documentation to your Virginia provider.

What's the success rate for Hetlioz appeals in Virginia? While specific Virginia statistics aren't published, external review processes typically overturn 20-40% of internal denials when strong clinical evidence supports medical necessity.

Sources and Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice or a guarantee of coverage outcomes. Always consult with your healthcare provider about treatment decisions and contact your insurance plan directly for the most current policy information. For personalized assistance with complex appeals, consider consulting with healthcare coverage advocates or legal professionals specializing in insurance law.

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