By Counterforce Health Team in Xywav (Ca/Mg/K/Na oxybates) —

Do You Qualify for Xywav Coverage by UnitedHealthcare in New York? Decision Tree & Appeals Guide

Quick Answer: Getting Xywav Covered by UnitedHealthcare in New York

Eligibility: You likely qualify if you have narcolepsy (type 1 or 2) or idiopathic hypersomnia with documented sleep study results, are enrolled in the REMS program, and have tried required step therapy medications. Fastest path: Submit prior authorization through OptumRx with complete sleep study documentation, REMS enrollment proof, and step therapy records. Start today: Call UnitedHealthcare member services to confirm your plan's specific requirements and get the current PA forms. If denied, New York's external appeal process through DFS provides binding independent review within 30 days (72 hours for urgent cases).

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternatives and Exception Requests
  6. If Denied: Appeal Path Chooser
  7. New York External Appeals Process
  8. Common Denial Reasons & How to Fix Them
  9. Costs and Financial Assistance
  10. FAQ
  11. Sources & Further Reading

How to Use This Decision Tree

This guide helps you determine if you qualify for Xywav coverage under UnitedHealthcare in New York, what documentation you need, and how to appeal if denied. Work through each section in order—the decision tree will direct you to the most relevant next steps based on your specific situation.

Before you start, gather these documents:

  • Insurance card and member ID
  • Sleep study results (polysomnography and MSLT)
  • Complete medical records from your sleep specialist
  • List of previous sleep medications tried
  • Any prior authorization denial letters

Eligibility Triage: Do You Qualify?

Diagnosis Requirements

✅ Likely Eligible if you have:

  • Narcolepsy Type 1: Documented cataplexy OR mean sleep latency ≤8 minutes on MSLT with ≥2 sleep-onset REM periods (SOREMPs)
  • Narcolepsy Type 2: Mean sleep latency ≤8 minutes and <2 SOREMPs on MSLT
  • Idiopathic Hypersomnia: Daily excessive sleepiness ≥3 months, mean sleep latency ≤8 minutes, <2 SOREMPs, total 24-hour sleep ≥660 minutes (11 hours), and absence of cataplexy

⚠️ Possibly Eligible if you have:

  • Sleep study showing excessive sleepiness but missing some diagnostic criteria
  • Narcolepsy diagnosis without complete MSLT documentation
  • IH diagnosis but unclear total sleep time documentation

❌ Not Yet Eligible if you have:

  • No confirmed sleep disorder diagnosis
  • Haven't completed required sleep studies
  • Sleep apnea or other primary sleep disorders not yet treated

Additional Requirements Check

Requirement Status Action Needed
REMS Program Enrollment Required for all patients Enroll at XywavXyremREMS.com
Sleep Medicine Specialist Must prescribe or co-manage Find neurologist or sleep medicine physician
Step Therapy Completion Usually modafinil/armodafinil Document trials and outcomes
UnitedHealthcare Coverage Active member Verify benefits and formulary status

If "Likely Eligible": Document Checklist

Required Documentation for Prior Authorization

Sleep Study Documentation:

  • Complete polysomnography (PSG) report
  • Multiple Sleep Latency Test (MSLT) results showing mean sleep latency and SOREMP count
  • 24-hour sleep study or actigraphy data (for IH patients)
  • Sleep logs documenting sleep patterns over ≥7 days

Clinical Documentation:

  • Physician letter confirming diagnosis with ICD-10 codes (G47.419 for narcolepsy, G47.11/G47.12 for IH)
  • Epworth Sleepiness Scale (ESS) baseline scores
  • Documentation of cataplexy presence/absence
  • Medical necessity letter explaining why Xywav is appropriate

Step Therapy Documentation:

  • Records of modafinil or armodafinil trial (unless contraindicated)
  • Documentation of inadequate response, intolerance, or contraindications
  • For narcolepsy: may need trials of other agents per UnitedHealthcare's step therapy protocol

REMS Program Proof:

  • Confirmation of patient and prescriber enrollment
  • REMS program patient ID number
  • Completed risk evaluation forms

Submission Process

  1. Get current PA forms from UnitedHealthcare provider portal
  2. Submit complete package via OptumRx (verify current submission method)
  3. Follow up within 5-7 business days to confirm receipt
  4. Standard review timeline: 15 business days for non-urgent requests

If "Possibly Eligible": Tests to Request

Missing Diagnostic Elements

If sleep study is incomplete:

  • Request referral to accredited sleep center
  • Ensure both overnight PSG and next-day MSLT are scheduled
  • For IH diagnosis, specifically request 24-hour PSG or extended monitoring

If step therapy documentation is missing:

  • Work with prescriber to document previous medication trials
  • If no prior trials, discuss starting with required first-line agents
  • Document any contraindications to standard therapies

Timeline to reapply: Once you have complete documentation, typically 30-60 days depending on sleep study scheduling.

What to Track While Waiting

  • Keep detailed sleep diary with timing, duration, and quality ratings
  • Document any cataplexy episodes (frequency, triggers, duration)
  • Track current medication effects and side effects
  • Monitor Epworth Sleepiness Scale scores monthly

If "Not Yet": Alternatives and Exception Requests

Alternative Coverage Pathways

If primary diagnosis isn't established:

  • Consider coverage for diagnostic sleep studies first
  • Some plans cover stimulants while sleep evaluation is pending
  • Discuss bridge therapy options with your physician

Exception Request Strategy:

  • Gather peer-reviewed literature supporting off-label use (if applicable)
  • Document failed standard treatments comprehensively
  • Include letters from multiple specialists if available
  • Consider compassionate use programs while appealing
From our advocates: We've seen cases where patients initially denied for incomplete sleep studies were approved after submitting comprehensive 24-hour monitoring data. The key was working closely with the sleep center to ensure all ICSD-3 criteria were properly documented and submitted together as a complete package.

If Denied: Appeal Path Chooser

UnitedHealthcare Internal Appeals

First Level Internal Appeal:

  • Timeline: Must file within 180 days of denial
  • Process: Submit via member portal or mail to address on denial letter
  • Required: Copy of denial letter, medical records, physician letter of medical necessity
  • Decision timeframe: 30 days (72 hours for urgent requests)

Peer-to-Peer Review:

  • Request physician-to-physician discussion
  • Your prescriber speaks directly with UnitedHealthcare medical director
  • Often resolves coverage without formal appeal
  • Can be requested before or during appeal process

When Internal Appeals Fail

If UnitedHealthcare upholds the denial after internal review, you have powerful options in New York.

New York External Appeals Process

New York offers one of the nation's strongest external appeal processes through the Department of Financial Services (DFS), providing independent medical review that's binding on insurers.

Eligibility and Timeline

Who can file:

  • Patients: Within 4 months of final internal denial
  • Providers: Within 60 days of final internal denial

Types of denials eligible:

  • Medical necessity determinations
  • Experimental/investigational treatment denials
  • Coverage disputes for specialty medications

Filing Process

  1. Complete the New York State External Appeal Application
  2. Submit by fax: 800-332-2729 or mail to DFS, Box 177, Albany, NY 12210
  3. For urgent cases: Also call 888-990-3991 after faxing
  4. Include: Denial letters, medical records, physician attestation (if required)

Decision timeline:

  • Standard appeals: 30 days
  • Expedited appeals: 72 hours (24 hours for urgent drug denials)

Cost and Outcomes

  • Filing fee: Up to $25 (waived for financial hardship or Medicaid)
  • Fee refunded if appeal is successful
  • Decision is binding on UnitedHealthcare
  • Success rates vary, but New York's process is considered patient-friendly

Get help filing: Community Health Advocates provides free assistance at 888-614-5400.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not enrolled in REMS" Complete enrollment before resubmission REMS confirmation number and patient ID
"Step therapy not met" Document previous trials or contraindications Pharmacy records, physician notes on failures/intolerances
"Insufficient sleep study data" Submit complete PSG and MSLT reports Full sleep center reports with ICSD-3 criteria documentation
"Not medically necessary" Provide detailed clinical justification Medical necessity letter, peer-reviewed literature, treatment goals
"Quantity limits exceeded" Request exception with clinical rationale Dosing justification, safety monitoring plan, treatment response data

Costs and Financial Assistance

Insurance Coverage Optimization

Xywav typically costs over $100,000 annually without insurance. UnitedHealthcare coverage varies by plan:

  • Commercial plans: Usually covered with prior authorization
  • Medicare Advantage: May require additional documentation
  • Medicaid managed care: State-specific coverage policies apply

Financial Assistance Programs

JazzCares Patient Support:

  • Copay assistance for commercially insured patients
  • Free drug program for qualifying uninsured patients
  • Prior authorization support services
  • Visit JazzCares.com or call 1-800-XYWAV-HELP

Additional Resources:

  • Patient Advocate Foundation: 800-532-5274
  • NeedyMeds database of assistance programs
  • State pharmaceutical assistance programs (EPIC for seniors in NY)

When working with insurance coverage challenges, platforms like Counterforce Health specialize in turning denials into evidence-backed appeals by analyzing denial letters, plan policies, and clinical documentation to create targeted rebuttals that align with each payer's specific requirements.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Xywav? Standard review takes up to 15 business days. Urgent requests (when delay could jeopardize health) are reviewed within 72 hours. Submit complete documentation to avoid delays.

What if Xywav isn't on my plan's formulary? Non-formulary medications can still be covered through medical exception requests. You'll need strong clinical justification and documentation of why formulary alternatives aren't appropriate.

Can I get expedited coverage if I'm currently taking Xyrem? Yes, if switching from Xyrem to Xywav for medical reasons (like sodium restriction), document the clinical need for lower sodium content and request expedited review.

Does step therapy apply if I tried medications outside of New York? Yes, medication trials from other states count toward step therapy requirements. Ensure your physician documents these previous treatments in your PA request.

What happens if my appeal is denied? After exhausting UnitedHealthcare's internal appeals, you can file an external appeal with New York DFS. This provides independent medical review that's binding on the insurer.

How do I prove medical necessity for idiopathic hypersomnia? Document daily excessive sleepiness ≥3 months, absence of cataplexy, sleep study results meeting ICSD-3 criteria, and total sleep time ≥11 hours per day via sleep logs or actigraphy.

Sources & Further Reading

For complex prior authorization challenges, Counterforce Health helps patients and clinicians navigate insurance denials by creating evidence-backed appeals that address each payer's specific coverage criteria and procedural requirements.

Disclaimer: This information is for educational purposes only and doesn't constitute medical or legal advice. Coverage policies vary by specific plan and may change. Always consult your healthcare provider about treatment decisions and verify current requirements with UnitedHealthcare and New York state agencies.

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