By Counterforce Health Team in Hetlioz (tasimelteon) —

How to Get Hetlioz (Tasimelteon) Covered by Blue Cross Blue Shield in Ohio: Prior Authorization Forms, Appeals, and Coding Guide

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

Hetlioz (tasimelteon) requires prior authorization from Blue Cross Blue Shield in Ohio. The fastest path to approval involves: 1) Submit a complete PA form with specialist documentation for Non-24 Sleep-Wake Disorder (ICD-10: G47.24) or Smith-Magenis Syndrome (Q93.82), 2) Include evidence of failed melatonin trials and sleep logs, and 3) Use NDC 69336-0317-53 for Hetlioz LQ through pharmacy benefits. If denied, you have 180 days to appeal through Ohio's external review process. Start today by downloading the Anthem Ohio PA forms or calling member services.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Coding Basics: Medical vs. Pharmacy Benefit Paths
  3. ICD-10 Mapping for Sleep Disorders
  4. Product Coding: NDC and Billing Details
  5. Clean Request Anatomy
  6. Common Denial Reasons & Solutions
  7. Appeals Process in Ohio
  8. Verification Steps
  9. Pre-Submission Checklist
  10. FAQ
  11. Sources & Further Reading

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Hetlioz prescriptions Anthem Ohio PA Requirements Anthem Ohio
Age Restrictions Adults 18+ for Non-24; Ages 3-15 for SMS with Hetlioz LQ FDA labeling FDA Access Data
Specialist Requirement Sleep specialist or consultation required BCBS PA criteria Anthem PA Forms
Step Therapy Must try melatonin first (3-6 months) BCBS formulary policy Washington State HCA Policy
Diagnosis Documentation Sleep logs, actigraphy, or biomarker tests Clinical criteria Premera Medical Policy
Appeals Deadline 180 days from final denial Ohio state law Ohio Department of Insurance

Coding Basics: Medical vs. Pharmacy Benefit Paths

Hetlioz is covered exclusively under the pharmacy benefit, not the medical benefit. This is crucial for proper billing and avoiding claim rejections.

Pharmacy Benefit Path (Correct)

  • Coverage: Medicare Part D or commercial pharmacy benefits
  • Billing method: NDC codes through pharmacy claims
  • Prior authorization: Required through pharmacy benefit management
  • Typical copay: Varies by formulary tier (often specialty tier with higher cost-sharing)

Medical Benefit Path (Incorrect)

  • Why it fails: Hetlioz has no HCPCS J-code for medical billing
  • Common mistake: Attempting to bill through Medicare Part B or commercial medical benefits
  • Result: Automatic claim rejection
Important: Always route Hetlioz claims through pharmacy benefits using NDC codes. Medical benefit submissions will be denied due to lack of applicable J-codes.

ICD-10 Mapping for Sleep Disorders

Accurate diagnosis coding is essential for Hetlioz approval. Use these specific ICD-10 codes based on the patient's condition:

Primary Diagnosis Codes

Non-24-Hour Sleep-Wake Disorder

  • ICD-10 Code: G47.24 (Circadian rhythm sleep disorder, free running type)
  • Documentation requirements: Daily sleep logs for ≥14 days, actigraphy data, or circadian biomarker measurements
  • Key phrases: "persistent daily drift in sleep timing," "inability to maintain 24-hour sleep-wake cycle," "alternating periods of insomnia and excessive sleepiness"

Smith-Magenis Syndrome with Sleep Disturbances

  • Primary code: Q93.82 (Smith-Magenis syndrome, deletion 17p11.2)
  • Secondary code: G47.24 (for associated circadian rhythm disorder)
  • Documentation requirements: Genetic testing confirmation, behavioral sleep disturbances, nighttime awakening patterns

Supporting Documentation Language

When documenting for insurance approval, include these specific clinical descriptors:

  • "Chronic circadian rhythm misalignment"
  • "Failed response to conventional sleep hygiene measures"
  • "Functional impairment in work/school performance"
  • "Documented melatonin trial failure or intolerance"
  • "Objective sleep monitoring data"

Product Coding: NDC and Billing Details

Hetlioz Capsules (20 mg)

  • NDC: 69336-0250-30 (30-count bottle)
  • Billing: Pharmacy benefit only
  • Typical quantity: 30 capsules per 30 days
  • Dosing: One capsule daily, same time each night

Hetlioz LQ Oral Suspension (4 mg/mL)

  • NDC: 69336-0317-53
  • Indication: Smith-Magenis Syndrome, ages 3-15
  • Weight-based dosing:
    • ≤28 kg: 0.7 mg/kg/day
  • Prescription requirements: Include patient weight and calculated dose in mg and mL
28 kg: 20 mg (5 mL) daily
Billing Tip: Always verify the correct NDC with your pharmacy before submission. Hetlioz capsules and LQ suspension are not interchangeable and have different NDCs.

Clean Request Anatomy

A successful prior authorization request for Hetlioz should include these essential elements:

Patient Information Section

  • Full name, date of birth, member ID
  • Primary and secondary insurance details
  • Contact information for follow-up

Prescriber Information

  • Physician name and NPI number
  • Specialty designation (sleep medicine preferred)
  • Practice address and contact information
  • DEA number if required

Clinical Justification

  1. Primary diagnosis with ICD-10 code
  2. Symptom duration and severity
  3. Previous treatments tried with specific dates and outcomes
  4. Contraindications to alternative therapies
  5. Functional impact on daily activities
  6. Treatment goals and monitoring plan

Supporting Documentation

  • Sleep study reports or actigraphy data
  • Sleep diary logs (minimum 14 days)
  • Previous medication trial records
  • Specialist consultation notes
  • Genetic testing results (for SMS)

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit detailed clinical rationale with sleep disorder severity Sleep logs, functional impact assessment, specialist notes
"Step therapy not completed" Document melatonin trial failure or contraindication Medication history, adverse reaction reports, clinical notes
"Age criteria not met" Verify patient age matches FDA indication Birth certificate, medical records showing age-appropriate indication
"Insufficient documentation" Provide complete diagnostic workup Sleep study, actigraphy, biomarker testing, genetic confirmation
"Non-formulary drug" Request formulary exception with clinical justification Comparative effectiveness data, alternative therapy failures

Step Therapy Override Strategies

Ohio follows step therapy reform regulations that allow overrides when:

  • Patient has tried and failed the preferred drug
  • Preferred drug is contraindicated
  • Patient has had adverse reactions to preferred therapy
  • Preferred drug is not expected to be effective

Timeline for step therapy decisions: Blue Cross must respond within 5 calendar days for standard requests, 72 hours for urgent requests.

Appeals Process in Ohio

If your Hetlioz prior authorization is denied, Ohio provides a structured appeals process with specific timelines and rights.

Level 1: Internal Appeal

  • Timeline: Must file within 180 days of denial
  • Process: Submit written appeal with additional clinical evidence
  • Response time: 30 days for standard, 72 hours for expedited
  • Required: Address specific denial reasons in appeal letter

Level 2: External Review

  • Eligibility: Available after exhausting internal appeals
  • Timeline: 180 days from final internal denial
  • Process: Filed with your health plan, forwarded to Ohio Department of Insurance
  • Review body: Independent Review Organization (IRO) with medical experts
  • Decision timeline: 30 days standard, 72 hours expedited
  • Binding: IRO decision is final and binding on the insurer

Ohio-Specific Appeal Rights

Ohio law provides additional consumer protections:

  • Independent eligibility determination: ODI can override insurer's claim that case isn't eligible for external review
  • Consumer assistance: ODI Consumer Services Division hotline at 1-800-686-1526
  • No cost: External review is provided at no charge to the patient
From Our Advocates: We've seen successful Hetlioz appeals when families submitted comprehensive sleep logs showing the dramatic daily shift in sleep timing, combined with documentation of failed melatonin trials and functional impairment at school or work. The key was painting a complete picture of how the circadian disorder affected daily life, not just sleep quality.

When dealing with insurance coverage challenges, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with the insurer's own criteria, incorporating the right clinical evidence and procedural requirements for each payer's workflow.

Verification Steps

Before submitting your Hetlioz prior authorization:

Check Current Requirements

  1. Verify PA form: Download the latest version from Anthem Ohio provider portal
  2. Confirm submission method: Check whether to use Availity portal or fax (800-563-5581 for medical injectables)
  3. Review formulary status: Confirm Hetlioz tier placement and any recent policy changes

Cross-Reference Clinical Criteria

  1. Age requirements: Ensure patient meets FDA age criteria for indication
  2. Diagnosis confirmation: Verify ICD-10 codes match clinical presentation
  3. Prior therapy documentation: Confirm melatonin trial duration and outcomes are adequately documented

Insurance Verification

  • Benefits check: Confirm pharmacy benefit coverage and copay structure
  • Prior authorization status: Check if PA is pending, approved, or requires additional information
  • Appeal rights: Review member handbook for specific appeal procedures and timelines

Pre-Submission Checklist

Use this checklist to ensure your Hetlioz prior authorization is complete:

Patient Information

  • Complete demographics and insurance information
  • Primary and secondary insurance verification
  • Member ID and group numbers confirmed

Clinical Documentation

  • Appropriate ICD-10 diagnosis code (G47.24 or Q93.82)
  • Sleep logs or actigraphy data (minimum 14 days)
  • Specialist consultation or referral
  • Previous treatment history with dates and outcomes
  • Functional impact assessment

Prescription Details

  • Correct NDC code for formulation
  • Appropriate dosing for age/weight
  • Quantity limits verified
  • Prescriber NPI and specialty information

Supporting Evidence

  • Sleep study results if available
  • Genetic testing for SMS cases
  • Medication allergy or contraindication documentation
  • Treatment goals and monitoring plan

For complex cases requiring detailed appeals strategy, Counterforce Health provides specialized support in developing evidence-backed arguments that address specific payer criteria and procedural requirements.

FAQ

How long does Blue Cross Blue Shield prior authorization take in Ohio? Standard prior authorization decisions are typically made within 5-15 business days. Urgent requests must be processed within 72 hours. You can check status through the Availity portal or by calling member services.

What if Hetlioz is non-formulary on my Blue Cross plan? You can request a formulary exception by demonstrating medical necessity and providing evidence that formulary alternatives are inappropriate. Include documentation of failed trials with preferred drugs or contraindications.

Can I request an expedited appeal if my Hetlioz is denied? Yes, expedited appeals are available when a delay would seriously jeopardize your health. Both internal appeals and external reviews can be expedited, with decisions required within 72 hours.

Does step therapy apply if I tried melatonin outside of Ohio? Yes, previous melatonin trials from other states count toward step therapy requirements. Provide complete medication records and clinical notes documenting the trial duration and outcome.

What happens if my external review is denied? While IRO decisions are binding on your insurer, you retain the right to pursue other remedies such as regulatory complaints or legal action. However, external review is typically the final administrative step.

Are there patient assistance programs for Hetlioz? Vanda Pharmaceuticals offers patient support programs. Check their website or contact 1-844-4HETLIOZ for eligibility requirements and application process.

How do I file a complaint with Ohio insurance regulators? Contact the Ohio Department of Insurance Consumer Services Division at 1-800-686-1526 or file online complaints through their website. Include all relevant documentation and correspondence with your insurer.

What's the difference between Hetlioz and Hetlioz LQ? Hetlioz LQ is an oral suspension formulation approved specifically for Smith-Magenis Syndrome in children ages 3-15. The capsule form is for adults with Non-24 Sleep-Wake Disorder. They are not interchangeable and have different NDCs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Coverage policies and requirements may change. Verify current information with official sources before making healthcare decisions.

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