By Counterforce Health Team in Hetlioz LQ (tasimelteon oral suspension) —

How to Get Hetlioz LQ (Tasimelteon Oral Suspension) Covered by Aetna CVS Health in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Hetlioz LQ Covered by Aetna CVS Health in Michigan

Hetlioz LQ (tasimelteon oral suspension) requires prior authorization from Aetna CVS Health for pediatric patients (3-15 years) with Smith-Magenis syndrome. Submit electronically via Caremark.com/epa with genetic confirmation, weight-based dosing calculations, and specialist documentation. If denied, you have 127 days to file an external review with Michigan DIFS. Start today: Call the number on your insurance card to verify PA requirements and download the Michigan Prescription Drug PA Request Form.

Table of Contents

  1. Coverage at a Glance
  2. Coding Basics: Medical vs. Pharmacy Benefit
  3. ICD-10 Mapping for Smith-Magenis Syndrome
  4. Product Coding: NDC, Units, and Dosing Math
  5. Clean PA Request Anatomy
  6. Common Denial Reasons & How to Fix Them
  7. Michigan Appeals Process: Internal to External Review
  8. Clinician Corner: Medical Necessity Documentation
  9. Quick Audit Checklist
  10. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Hetlioz LQ requests Aetna provider portal or call member services CVS Caremark PA
Age Requirement 3-15 years for LQ formulation FDA prescribing information FDA Label
Diagnosis Smith-Magenis syndrome with genetic confirmation Chart notes, genetic testing report Washington State HCA
Specialty Pharmacy Must use CVS Specialty for dispensing CVS Specialty network Aetna Medicare
Appeal Deadline 127 days for Michigan external review Michigan DIFS Michigan DIFS

Coding Basics: Medical vs. Pharmacy Benefit

Hetlioz LQ is billed as a pharmacy benefit drug using NDC codes only—no HCPCS J-code exists. This is crucial because many specialty drugs can be billed through either medical or pharmacy benefits, but tasimelteon oral suspension exclusively goes through your prescription drug plan managed by CVS Caremark.

Key Billing Points:

  • Route: Pharmacy claim via CVS Caremark PBM
  • Code Type: NDC only (never use J-codes)
  • Coverage: Part D/commercial prescription benefit
  • Dispensing: CVS Specialty pharmacy required

Understanding this distinction helps avoid the most common billing error: attempting to submit Hetlioz LQ with medical codes rather than pharmacy NDCs.

ICD-10 Mapping for Smith-Magenis Syndrome

Proper diagnosis coding strengthens your PA request by clearly establishing medical necessity. For Smith-Magenis syndrome with associated sleep disturbances, use these ICD-10 codes:

Primary Diagnosis:

  • Q93.5 – Other deletions of part of a chromosome (Smith-Magenis syndrome)

Secondary Sleep Disorder Codes:

  • G47.20 – Circadian rhythm sleep disorder, unspecified
  • G47.23 – Circadian rhythm sleep disorder, irregular sleep-wake type
  • G47.00 – Insomnia, unspecified (if nighttime sleep disturbance is primary complaint)

Documentation Words That Support Coding:

Include these clinical terms in your notes to support the circadian rhythm sleep disorder coding:

  • "Inverted melatonin rhythm"
  • "Frequent nocturnal awakenings"
  • "Early morning awakening"
  • "Excessive daytime sleepiness"
  • "Sleep-wake cycle disruption"

Product Coding: NDC, Units, and Dosing Math

Product Specifications:

  • Hetlioz LQ: Tasimelteon 4 mg/mL oral suspension
  • Primary NDC: 69336-0317-53 (verify current NDC at dispensing)
  • Billing Unit: mL (milliliters)

Weight-Based Dosing Calculations:

For patients ≤28 kg:

  • Dose: 0.7 mg/kg once daily
  • Example: 20 kg child = 20 × 0.7 = 14 mg daily
  • Convert to mL: 14 mg ÷ 4 mg/mL = 3.5 mL daily
  • 30-day supply: 3.5 mL × 30 = 105 mL

For patients >28 kg:

  • Fixed dose: 20 mg (5 mL) once daily
  • 30-day supply: 5 mL × 30 = 150 mL
Tip: Always include the patient's weight and show your math on the prescription and PA forms. This prevents "dose too high" denials.

Clean PA Request Anatomy

A successful Hetlioz LQ prior authorization request includes these essential elements:

1. Patient Information

  • Name, DOB, Aetna member ID
  • Current weight in kg (critical for dosing)
  • Age verification (must be 3-15 years for LQ)

2. Prescriber Information

  • Specialist credentials (sleep medicine, neurology, developmental pediatrics)
  • DEA number and NPI
  • Contact information for peer-to-peer review

3. Clinical Documentation

  • Genetic confirmation of Smith-Magenis syndrome
  • Description of nighttime sleep disturbances
  • Prior treatment failures (melatonin, behavioral interventions)
  • Functional impact on patient and family

4. Prescription Details

  • Exact dose in mg and mL
  • "One hour before bedtime, same time nightly"
  • Total mL for 30-day supply
  • NDC: 69336-0317-53

5. Supporting Attachments

  • Genetic testing report
  • Sleep specialist consultation notes
  • Sleep diary or actigraphy data (if available)
  • Prior medication trial documentation

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Dose exceeds quantity limits" Show weight-based calculation matches FDA label Patient weight, dosing math, FDA prescribing info excerpt
"Missing genetic confirmation" Attach genetic testing report Chromosomal microarray or RAI1 mutation testing
"Age criteria not met" Verify patient is 3-15 years old Birth certificate or recent clinic note with DOB
"Not prescribed by specialist" Get sleep medicine or neurology consultation Specialist referral letter or consultation note
"Prior treatments not documented" List failed therapies with specifics Medication trial log with doses, duration, outcomes
Note: Counterforce Health helps patients and clinicians turn these denials into targeted appeals by analyzing the specific denial language and crafting evidence-backed rebuttals aligned to Aetna's own coverage criteria.

Michigan Appeals Process: Internal to External Review

Step 1: Internal Appeal with Aetna

  • Timeline: 15 calendar days for standard PA decision
  • Expedited: 72 hours if delay would jeopardize health
  • How to Submit: Electronic via Caremark.com/epa or fax to 1-866-249-6155

Step 2: External Review with Michigan DIFS

If Aetna issues a final denial, you can request an independent external review:

  • Deadline: 127 days from final internal denial
  • Form: Michigan DIFS External Review Request
  • Timeline: Up to 60 days for standard review; 72 hours for expedited
  • Binding: Yes—if approved, Aetna must cover the medication
  • Cost: Free to patients

Required for External Review:

  • Copy of Aetna's final denial letter
  • Completed DIFS external review form
  • Medical records supporting necessity
  • Prescriber letter explaining urgency (for expedited review)
From our advocates: We've seen Michigan external reviews succeed when families include a detailed timeline showing how long they've been managing severe sleep disruption and the specific ways standard treatments failed. The independent medical reviewers appreciate seeing the progression from behavioral interventions through melatonin trials to the need for tasimelteon.

Clinician Corner: Medical Necessity Documentation

Essential Elements for Your Medical Necessity Letter:

1. Establish the Diagnosis

  • "Patient has genetically confirmed Smith-Magenis syndrome with [specific mutation/deletion]"
  • "Diagnosis established by [genetic testing method] on [date]"

2. Document Sleep Disturbance Severity

  • Frequency and duration of nighttime awakenings
  • Total sleep time vs. age-appropriate norms
  • Impact on daytime functioning and behavior
  • Caregiver burden and family sleep disruption

3. Prior Treatment History

  • Behavioral interventions tried (sleep hygiene, environmental modifications)
  • Melatonin trials: doses, timing, duration, outcomes
  • Other sleep medications attempted
  • Reasons for discontinuation or inadequacy

4. Clinical Rationale for Hetlioz LQ

  • Weight-based dosing requirement for pediatric population
  • FDA approval specifically for SMS nighttime sleep disturbances
  • Mechanism of action addressing inverted melatonin rhythm
  • Expected outcomes and monitoring plan

5. Guideline Support Cite relevant sources such as:

  • FDA prescribing information for tasimelteon
  • Sleep medicine society guidelines on circadian rhythm disorders
  • Published literature on SMS sleep management

Quick Audit Checklist

Before submitting your Hetlioz LQ PA request, verify:

Patient Eligibility:

  • Age 3-15 years
  • Smith-Magenis syndrome diagnosis
  • Genetic testing confirmation attached

Prescription Accuracy:

  • Weight-based dose calculation shown
  • mL per dose and total mL specified
  • NDC 69336-0317-53 (or current equivalent)
  • "One hour before bedtime" timing included

Clinical Documentation:

  • Sleep specialist involvement documented
  • Prior treatment failures listed with specifics
  • Functional impact described
  • ICD-10 codes: Q93.5 + G47.2x

Submission Details:

  • Electronic submission via Caremark portal
  • All attachments uploaded
  • Expedited request marked if urgent
  • Contact information for peer-to-peer review

FAQ

Q: How long does Aetna CVS Health PA take in Michigan? A: Standard prior authorization decisions are made within 15 calendar days. Expedited requests (when delay would jeopardize health) are decided within 72 hours. Michigan law requires automatic approval if Aetna doesn't respond within these timelines.

Q: What if Hetlioz LQ is non-formulary on my plan? A: You can request a formulary exception by documenting medical necessity and prior treatment failures. The process is similar to PA but may require additional clinical justification for why formulary alternatives aren't appropriate.

Q: Can I request an expedited appeal? A: Yes, if waiting for standard review timelines would seriously jeopardize the patient's health. Include a physician letter certifying the urgency. Both Aetna internal appeals and Michigan DIFS external reviews offer expedited options.

Q: Does step therapy apply if we've tried treatments outside Michigan? A: Yes, document all prior treatments regardless of where they were tried. Include medication names, doses, duration, and specific reasons for failure or discontinuation.

Q: What's the difference between Hetlioz capsules and Hetlioz LQ? A: Hetlioz LQ is the oral suspension formulation specifically approved for pediatric patients 3-15 years with SMS. The capsules are for adults and patients ≥16 years. They're not interchangeable and have different NDCs.

Q: How much does Hetlioz LQ cost without insurance? A: Retail prices are frequently around $24,678 per bottle, though this varies by bottle size and pharmacy. Check with Counterforce Health for assistance with manufacturer copay programs and patient assistance options.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance plan. Coverage decisions depend on individual circumstances and plan benefits. For personalized assistance with your specific situation, contact your insurance plan directly or consult with a healthcare coverage advocate.

Need help with your appeal? Counterforce Health specializes in turning insurance denials into successful approvals by analyzing denial letters, plan policies, and clinical evidence to create targeted, evidence-backed appeals that speak directly to payer requirements.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.