By Counterforce Health Team in Crysvita (burosumab) —

How to Get Crysvita (Burosumab) Covered by Humana in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Crysvita (Burosumab) Covered by Humana in New York

Crysvita (burosumab) requires prior authorization from Humana Medicare Advantage plans. To get approval: (1) Confirm your diagnosis of X-linked hypophosphatemia (XLH) with low serum phosphorus (<2.5-3.0 mg/dL) and PHEX gene testing, (2) Document failure or contraindication to oral phosphate plus calcitriol therapy, and (3) Submit via Humana's provider portal with a detailed medical necessity letter. Standard decisions take up to 72 hours. If denied, you have 65 days to file an internal appeal, then can pursue external review through New York's Department of Financial Services within 4 months.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Coding & Billing Information
  5. Documentation Requirements
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: What to Expect
  9. Common Denial Reasons & How to Fix Them
  10. Appeals Process in New York
  11. Costs & Financial Assistance
  12. Quick Reference Checklist

Who Should Use This Guide

This guide is designed for patients with X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO) who need Crysvita (burosumab) coverage through Humana Medicare Advantage plans in New York. You'll also find this helpful if you're a caregiver, healthcare provider, or patient advocate navigating the prior authorization process.

Expected outcome: With proper documentation and submission, most medically appropriate Crysvita requests are approved. Humana Medicare Advantage has a relatively low denial rate (~3.5% in 2023), but specialty medications like Crysvita require thorough documentation to meet clinical criteria.

Member & Plan Basics

Coverage Requirements

  • Active Humana Medicare Advantage enrollment in New York
  • Part B coverage (Crysvita is typically covered under Medicare Part B as an outpatient injectable)
  • Prior authorization required for all Crysvita prescriptions through Humana Clinical Pharmacy Review

Plan Type Considerations

Humana offers various Medicare Advantage plans in New York. Your specific plan's formulary and prior authorization requirements can be verified using Humana's Prior Authorization Search Tool by entering "Crysvita" or the HCPCS code J0584.

Note: Private fee-for-service plans may only require notification rather than prior authorization. Check your specific plan documents.

Clinical Criteria for Approval

FDA-Approved Indications

Crysvita (burosumab) is approved for:

  1. X-linked hypophosphatemia (XLH) in adults and pediatric patients ≥6 months of age
  2. FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) when the tumor cannot be localized or completely resected, in adults and pediatric patients ≥2 years of age

Key Diagnostic Requirements

Requirement XLH Criteria TIO Criteria
Serum Phosphorus Persistently low (<2.5-3.0 mg/dL, fasting) Low serum phosphorus with renal phosphate wasting
Genetic Testing PHEX gene mutation (preferred but not always required) Not applicable
FGF23 Levels Elevated or inappropriately normal Elevated
Imaging Evidence of rickets/osteomalacia Tumor identification attempts
Age Requirements ≥6 months ≥2 years

Prior Therapy Requirements

Before approving Crysvita, most payers require documentation of:

  • Failed conventional therapy: Oral phosphate supplements plus active vitamin D analogs (calcitriol, paricalcitol)
  • Contraindications or intolerance to conventional therapy
  • Inadequate response after appropriate trial period (typically 3-6 months)
Important: Discontinue oral phosphate and active vitamin D supplements one week before starting Crysvita, per FDA labeling.

Coding & Billing Information

HCPCS/J-Code

  • Primary code: J0584 (Injection, burosumab-twza, 10 mg)

ICD-10 Diagnosis Codes

  • XLH: E83.31 (Familial hypophosphatemia)
  • TIO: M83.89 (Other adult osteomalacia)

Billing Units

  • XLH pediatric: 90 units every 14 days
  • XLH adult: 90 units every 28 days
  • TIO: 180 units every 14 days

Dosing Guidelines

  • Pediatric (≥10 kg): 0.8 mg/kg (max 90 mg) every 2 weeks
  • Adult XLH: 0.5-1 mg/kg (max 90 mg) every 2-4 weeks
  • Adult TIO: 0.5-1 mg/kg (max 180 mg) every 2 weeks

Documentation Requirements

Medical Necessity Letter Components

Your prescribing physician should include these elements in the medical necessity letter:

Patient Information:

  • Complete diagnosis with ICD-10 codes
  • Age, weight, and relevant medical history
  • Current symptoms and functional limitations

Clinical Justification:

  • Laboratory results confirming hypophosphatemia
  • Genetic testing results (PHEX mutation for XLH)
  • Imaging studies showing rickets/osteomalacia
  • Documentation of renal phosphate wasting (TmP/GFR <2.2 mg/dL)

Prior Treatment History:

  • Specific phosphate supplements tried (doses, duration)
  • Active vitamin D analogs used (calcitriol, paricalcitol)
  • Reasons for failure, inadequate response, or contraindications
  • Any adverse effects experienced

Treatment Plan:

  • Proposed Crysvita dosing schedule
  • Monitoring plan (serum phosphorus every 4 weeks initially)
  • Treatment goals and expected outcomes

Required Attachments

  • Recent laboratory results (serum phosphorus, PTH, FGF23, vitamin D levels)
  • Genetic testing report (for XLH)
  • Relevant imaging studies
  • Previous prescription records showing conventional therapy trials
  • Specialist consultation notes (endocrinologist, metabolic bone specialist)

Submission Process

How to Submit

  1. Provider Portal: provider.humana.com (preferred method)
  2. Fax: Check current fax number on your plan's prior authorization form
  3. Phone: Provider services number on member ID card

Timeline Expectations

  • Standard review: Up to 72 hours with prescriber supporting statement
  • Expedited review: Available for urgent medical needs (contact plan directly)
  • Electronic submissions: Humana targets 95% of decisions within 1 business day by January 2026
Tip: Submit requests promptly after the initial evaluation visit. Delays can result in patient responsibility for full medication cost if started before approval.

Specialty Pharmacy Coordination

Preferred Pharmacy Networks

Crysvita is typically dispensed through specialty pharmacies. Common options include:

  • Humana's preferred specialty pharmacy partners
  • Manufacturer support through Kyowa Kirin Cares program
  • Hospital-based specialty pharmacies

Transfer Process

  1. Verify coverage approval before initiating pharmacy transfer
  2. Coordinate with specialty pharmacy for home delivery or clinic administration
  3. Confirm NDC numbers match approved formulation
  4. Schedule administration if clinic-based injection required

After Submission: What to Expect

Tracking Your Request

  • Confirmation numbers: Record all reference numbers provided
  • Status checks: Monitor through provider portal or member services
  • Documentation: Keep copies of all submitted materials

Decision Timeline

Review Type Decision Time Next Steps if Approved
Standard 72 hours Specialty pharmacy coordination
Expedited 24-72 hours Immediate pharmacy contact
Complex cases Up to 14 days Additional documentation may be requested

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Missing genetic confirmation Submit PHEX gene testing results; if unavailable, provide detailed family history and clinical criteria documentation
Insufficient prior therapy documentation Provide prescription records, pharmacy fill history, and physician notes documenting specific trials and outcomes
Age criteria not met Verify patient age meets FDA labeling (≥6 months for XLH, ≥2 years for TIO)
Concurrent phosphate/vitamin D use Document discontinuation plan and timing per FDA requirements
Incomplete tumor workup (TIO) Provide imaging studies and specialist consultation confirming unresectable/non-localizable tumor

Appeals Process in New York

Internal Appeals (Humana)

Timeline: 65 days from denial notice to file appeal

Process:

  1. Submit appeal through Humana member portal
  2. Include additional clinical documentation
  3. Request peer-to-peer review with medical director
  4. Standard decision time: 30 days (expedited available for urgent needs)

External Review (New York State)

If Humana's internal appeal is unsuccessful, New York residents can pursue external review through the Department of Financial Services (DFS).

Key Features:

  • Timeline: 4 months from final adverse determination to file
  • Cost: Up to $25 (waived for financial hardship or Medicaid)
  • Decision time: 30 days standard, 72 hours expedited
  • Binding decision: Insurer must comply with favorable external review decisions

How to File:

  1. Complete internal appeal process first
  2. Submit external appeal form to DFS
  3. Include all medical documentation and denial letters
  4. Request expedited review if urgent medical need
New York Advantage: The state's external appeal program has successfully overturned many insurance denials for specialty medications, particularly when strong clinical evidence supports medical necessity.

Additional Resources

  • Community Health Advocates: Free assistance at 888-614-5400
  • New York Consumer Assistance Program: Help with insurance appeals and rights

Costs & Financial Assistance

Medicare Part D Out-of-Pocket Protection

Starting in 2025, Medicare Part D has a $2,000 annual out-of-pocket cap, providing significant protection for high-cost medications like Crysvita.

Manufacturer Support

Kyowa Kirin Cares offers:

  • Patient assistance programs for eligible uninsured/underinsured patients
  • Copay assistance for commercially insured patients
  • Care coordination services

Cost Considerations

Crysvita wholesale acquisition cost (2024):

  • 10 mg/mL vial: $4,451.45
  • 20 mg/mL vial: $8,902.91
  • 30 mg/mL vial: $13,354.36

Total treatment cost depends on patient weight and dosing frequency.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients needing specialty medications like Crysvita. Our platform analyzes denial letters, identifies specific coverage criteria, and drafts evidence-backed appeals that speak directly to payer requirements. We help patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and reduce the time spent on administrative barriers to care.

Quick Reference Checklist

Before You Start

  • Confirm active Humana Medicare Advantage coverage
  • Verify Crysvita requires prior authorization for your specific plan
  • Gather insurance card and member ID information

Clinical Documentation

  • Confirmed XLH or TIO diagnosis with appropriate ICD-10 codes
  • Low serum phosphorus levels (<2.5-3.0 mg/dL, fasting)
  • PHEX genetic testing (for XLH) or tumor workup (for TIO)
  • Documentation of failed conventional therapy (phosphate + vitamin D)
  • Current laboratory results and imaging studies

Submission Requirements

  • Complete prior authorization form
  • Medical necessity letter from prescribing physician
  • All required attachments and supporting documentation
  • Correct HCPCS code (J0584) and diagnosis codes
  • Specialty pharmacy coordination plan

After Submission

  • Record confirmation numbers and reference information
  • Schedule follow-up to check approval status
  • Prepare appeal documentation if needed
  • Coordinate with specialty pharmacy once approved

Frequently Asked Questions

How long does Humana prior authorization take for Crysvita in New York? Standard decisions are made within 72 hours when a prescriber's supporting statement is included. Expedited reviews are available for urgent medical needs.

What if Crysvita is not on Humana's formulary? You can request a formulary exception through Humana's standard process. Include a detailed medical necessity letter explaining why covered alternatives are not appropriate.

Can I request an expedited appeal in New York? Yes, both Humana internal appeals and New York State external reviews offer expedited processes for urgent medical needs. Contact the plan directly to request expedited review.

Does step therapy apply if I've tried conventional treatment outside New York? Yes, prior therapy documentation from any location is typically accepted. Provide complete prescription records and physician notes documenting trials and outcomes.

What happens if my external appeal is successful? If New York's external reviewer overturns the denial, Humana must cover the treatment and may need to refund your appeal filing fee.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with your insurance plan and consult with your healthcare provider for medical decisions. For personalized assistance with your specific situation, consider contacting Counterforce Health or a qualified patient advocate.

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