By Counterforce Health Team in Hetlioz (tasimelteon) —

How to Get Hetlioz (Tasimelteon) Covered by Cigna in Michigan: Complete PA Guide and Appeals Process

Quick Answer: Getting Hetlioz Covered by Cigna in Michigan

Hetlioz (tasimelteon) requires prior authorization from Cigna for both Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome. Your physician must document failed step therapy with preferred sleep medications (typically ramelteon and melatonin), submit weight-based dosing calculations, and include genetic testing for SMS patients. Standard PA decisions take 72 hours. If denied, you have 180 days for internal appeals and 127 days for external review through Michigan DIFS. Start by having your doctor call Cigna or submit through the provider portal.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Coding Basics: Medical vs. Pharmacy Benefit
  3. ICD-10 Mapping and Documentation
  4. Product Coding: NDC Numbers and Dosing Units
  5. Clean Prior Authorization Request
  6. Common Billing Pitfalls
  7. Appeals Process in Michigan
  8. Cost-Saving Programs
  9. Verification Steps
  10. Pre-Submission Checklist

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all indications Cigna Policy
Formulary Status Specialty tier, non-preferred Cigna Formulary
Step Therapy Must fail ramelteon and preferred sleep medication Cigna PA Policy
Age Limits Adults for Non-24; Ages 3-15 for SMS (LQ formulation) FDA Label
Specialty Pharmacy Managed through Express Scripts/Accredo Cigna Provider Resources
Quantity Limits 5 mL per day for LQ formulation Cigna Coverage Policy

Coding Basics: Medical vs. Pharmacy Benefit

Hetlioz is billed exclusively through pharmacy benefits, not medical benefits. This distinction is crucial for proper claim submission and prior authorization routing.

Pharmacy Benefit Pathway:

  • Uses National Drug Codes (NDCs)
  • Processed through Cigna's pharmacy benefit manager (Express Scripts)
  • Requires pharmacy-specific prior authorization forms
  • No HCPCS J-codes exist for oral formulations

Key Billing Points:

  • Bill by total mL dispensed per fill for LQ formulation
  • Include patient weight on all prescriptions for dosing verification
  • Route through Part D processes for Medicare patients
  • Use NDC-based prior authorization, not medical benefit PA forms

ICD-10 Mapping and Documentation

Proper diagnosis coding is essential for medical necessity determination. Cigna requires specific ICD-10 codes depending on the indication.

Primary Diagnosis Codes:

  • G47.24 - Circadian rhythm sleep disorder, non-24-hour sleep-wake type
  • Q93.82 - Other microdeletions (for Smith-Magenis Syndrome)
  • G47.0 - Sleep disturbance (secondary code for SMS sleep issues)

Documentation Requirements: For Non-24-Hour Sleep-Wake Disorder, include:

  • Sleep diary showing irregular sleep-wake patterns
  • Actigraphy data demonstrating circadian misalignment
  • Failed light therapy attempts
  • Functional impairment documentation

For Smith-Magenis Syndrome, provide:

  • Genetic testing confirming 17p11.2 deletion or RAI1 mutation
  • Sleep specialist evaluation
  • Behavioral sleep interventions attempted
  • Weight documentation for pediatric dosing
Tip: Use specific language like "circadian entrainment failure" and "melatonin rhythm disruption" in clinical notes to support medical necessity.

Product Coding: NDC Numbers and Dosing Units

Primary NDC for Hetlioz LQ:

  • NDC: 69336-0317-53 (4 mg/mL oral suspension)
  • Available in 48 mL and 158 mL bottles
  • Manufacturer: Vanda Pharmaceuticals

Critical Dosing Conversions: The oral suspension concentration is 4 mg/mL. Common billing errors occur when assuming 1 mg = 1 mL.

Weight-Based Dosing Formula:

  • Patients ≤28 kg: 0.7 mg/kg once daily
  • Patients >28 kg: 20 mg (fixed dose) once daily

Example Calculation: For a 20 kg child:

  • Dose: 20 kg × 0.7 mg/kg = 14 mg
  • Volume: 14 mg ÷ 4 mg/mL = 3.5 mL per dose
  • Monthly supply: 3.5 mL × 30 days = 105 mL

Clean Prior Authorization Request

A successful PA request includes these components in order:

1. Patient Demographics and Insurance Information

  • Complete Cigna member ID and group number
  • Patient weight (essential for dosing calculations)
  • Prescribing physician NPI and contact information

2. Clinical Justification

Patient has confirmed [diagnosis] with documented:
- Failed trial of ramelteon (duration and reason for discontinuation)
- Failed trial of [preferred sleep medication per plan formulary]
- For SMS: Genetic testing confirming 17p11.2 deletion
- Sleep specialist consultation and recommendations

3. Prescription Details

  • Drug: Hetlioz LQ (tasimelteon) oral suspension
  • NDC: 69336-0317-53
  • Strength: 4 mg/mL
  • Dose: [calculated mg and mL] once daily, one hour before bedtime
  • Quantity: [monthly mL supply based on weight]
  • Days supply: 30

4. Supporting Documentation

  • Genetic test results (for SMS)
  • Sleep diary or actigraphy data
  • Prior therapy failure documentation
  • Medical necessity letter from specialist
From our advocates: We've seen PA approvals happen faster when the initial request includes a one-page summary highlighting the specific failed therapies and genetic confirmation upfront, rather than burying these details in lengthy clinical notes. This helps reviewers quickly identify that step therapy requirements have been met.

Common Billing Pitfalls

Pitfall Consequence Solution
Incorrect mg-to-mL conversion Quantity limit rejection Always use 4 mg/mL concentration factor
Missing patient weight PA denial for dosing verification Include weight on all prescriptions and PA forms
Wrong NDC for package size Claim rejection Verify NDC 69336-0317-53 with dispensing pharmacy
Using J-codes instead of NDC Wrong benefit category Use NDC for oral suspension billing through pharmacy benefit
Incomplete genetic documentation Medical necessity denial for SMS Attach complete genetic test results showing 17p11.2 deletion

Most Common Denial Reason: Insufficient documentation of step therapy completion. Ensure clear documentation of failed trials with ramelteon and at least one other preferred sleep medication.

Appeals Process in Michigan

Internal Appeals with Cigna

Timeline for Filing: 180 days from denial date Decision Timeline: 30 days (standard) or 72 hours (expedited)

How to File:

  1. Call Cigna member services at the number on your insurance card
  2. Request internal appeal forms
  3. Submit via member portal, mail, or fax as directed
  4. Include all supporting clinical documentation

External Review through Michigan DIFS

If your internal appeal is denied, Michigan offers robust external review rights.

Timeline for Filing: 127 days from final internal denial Decision Timeline: 60 days (standard) or 72 hours (expedited)

Filing Process:

  1. Complete the DIFS External Review Request form
  2. Submit online, email, fax, or mail
  3. For expedited review, include physician letter documenting urgency
  4. Call DIFS at 877-999-6442 for assistance

Required Documentation:

  • Copy of final internal denial letter
  • All medical records supporting your case
  • Physician statement of medical necessity
  • For expedited review: letter stating delay would harm patient health
Note: Michigan's 127-day filing window is longer than the federal 120-day standard, giving you extra time to prepare a thorough external appeal.

Cost-Saving Programs

HETLIOZSolutions Patient Support Program

  • Copay assistance for eligible commercial insurance patients
  • Free drug program for qualifying uninsured patients
  • Enrollment: 1-833-HETLIOZ (1-833-438-5469)

Typical Costs:

  • Hetlioz capsules: approximately $5,895 for 30×20-mg
  • Hetlioz LQ: approximately $24,678 for common bottle sizes
  • With insurance: varies by plan, typically $20-$50 copay after PA approval

Verification Steps

Before submitting your PA request, verify these details with Cigna:

  1. Call member services to confirm current PA requirements for your specific plan
  2. Check formulary status - Hetlioz may be on different tiers depending on your plan year
  3. Verify step therapy requirements - preferred alternatives may vary by plan
  4. Confirm specialty pharmacy - ensure Accredo is still the designated provider
  5. Review quantity limits - limits may differ for adult vs. pediatric formulations

Cigna Provider Resources:

  • Provider portal for PA submission
  • CoverMyMeds platform integration
  • ExpressPAth for electronic submissions

Pre-Submission Checklist

Patient Information:

  • Complete insurance card copy
  • Current weight documented
  • Prior authorization form signed by prescriber

Clinical Documentation:

  • Confirmed diagnosis with appropriate ICD-10 code
  • Genetic test results (for SMS patients)
  • Documentation of failed step therapy (ramelteon + preferred alternative)
  • Sleep specialist consultation notes
  • Medical necessity letter

Prescription Details:

  • Correct NDC: 69336-0317-53
  • Weight-based dose calculation in both mg and mL
  • "One hour before bedtime" timing specified
  • Accurate monthly quantity calculation

Submission Method:

  • Submitted through correct channel (provider portal/CoverMyMeds)
  • All required attachments included
  • Follow-up plan established for tracking approval status

When to Contact Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to draft targeted, evidence-backed rebuttals. If your Hetlioz prior authorization is denied, their platform can help identify the specific denial basis and create a point-by-point appeal aligned to Cigna's own coverage rules, potentially saving weeks in the appeals process.

The platform pulls relevant citations from FDA labeling, peer-reviewed studies, and specialty guidelines, weaving them into appeals with the required clinical facts and procedural requirements for Michigan's external review process.

FAQ

How long does Cigna prior authorization take for Hetlioz in Michigan? Standard PA decisions are made within 72 hours of receiving complete documentation. Expedited reviews for urgent medical needs are completed within 24 hours.

What if Hetlioz is not on my Cigna formulary? You can request a formulary exception through your physician. Cigna processes these requests within 72 hours (24 hours for expedited requests) when proper clinical justification is provided.

Can I request an expedited appeal in Michigan? Yes, both Cigna internal appeals and Michigan DIFS external reviews offer expedited processes (72 hours) when a physician certifies that delay would harm your health.

Does step therapy apply if I failed medications outside Michigan? Yes, documented failures from other states are typically accepted as long as the medications match Cigna's current step therapy requirements and proper documentation is provided.

What happens if my external review is approved? DIFS external review decisions are binding. If approved, Cigna must cover Hetlioz as directed and cannot re-deny for the same clinical circumstances.

Can I use an out-of-network specialist for my PA documentation? Yes, genetic testing and specialist evaluations from non-contracted providers are typically acceptable for medical necessity documentation, though you may bear out-of-pocket costs for the consultation.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice or a guarantee of coverage. Insurance policies vary, and you should verify current requirements with Cigna and consult your healthcare provider for medical decisions. For personalized assistance with appeals, consider consulting Counterforce Health or other patient advocacy services.

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