Crysvita (Burosumab) Approval with UnitedHealthcare in New York: Complete Guide to Prior Authorization, Appeals, and Coverage
Answer Box: Getting Crysvita Covered by UnitedHealthcare in New York
UnitedHealthcare covers Crysvita (burosumab) for X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO) with prior authorization in New York. Key requirements include confirmed diagnosis via genetic testing or elevated FGF23, specialist prescribing, and documented clinical need. First step today: Contact your endocrinologist to submit prior authorization through the UnitedHealthcare provider portal with required lab values and genetic test results. If denied, New York's external appeal system provides binding independent review within 4 months of final denial.
Table of Contents
- Coverage Basics
- Prior Authorization Process
- Timing and Urgency
- Clinical Criteria Requirements
- Costs and Patient Support
- Common Denials and Appeals
- Annual Renewals
- Specialty Pharmacy Requirements
- New York Appeals Rights
- Troubleshooting Common Issues
Coverage Basics
Is Crysvita Covered by UnitedHealthcare?
Yes, UnitedHealthcare covers Crysvita for approved indications with prior authorization. Coverage applies to both commercial and Medicaid plans in New York for:
- X-linked hypophosphatemia (XLH) in adults and children ≥6 months
- Tumor-induced osteomalacia (TIO) with unresectable tumors
The medication requires specialty pharmacy dispensing and ongoing monitoring per UnitedHealthcare's medical policy.
Which UnitedHealthcare Plans Cover Crysvita?
Coverage extends across UnitedHealthcare plan types in New York:
- Commercial employer plans
- Individual marketplace plans
- Medicare Advantage plans
- Medicaid managed care plans
Note: Coverage criteria may vary slightly between plan types. Always verify your specific plan's requirements through the member portal or by calling the number on your insurance card.
Prior Authorization Process
Step-by-Step: Fastest Path to Approval
1. Gather Required Documentation (Patient/Clinic)
- Genetic test results showing PHEX gene mutation, OR
- Elevated serum FGF23 level (>30 pg/mL), OR
- Biochemical confirmation: serum phosphate <3.0 mg/dL, normal creatinine, serum 25(OH)D ≥16 ng/mL
- Prior treatment history with phosphate and vitamin D analogs
- Current clinical symptoms documentation
2. Specialist Consultation (Required)
- Must be prescribed by or in consultation with an endocrinologist or metabolic bone disease specialist
- Specialist provides clinical justification and monitoring plan
3. Submit Prior Authorization (Provider)
- Submit via UnitedHealthcare Provider Portal or OptumRx system
- Include all required documentation and lab values
- Expected timeline: 5-15 business days for standard review
4. Monitor Status (Patient/Provider)
- Check status through provider portal or member portal
- Contact OptumRx provider support at 888-397-8129 for questions
Timing and Urgency
Standard Review Timeline
- Initial determination: 5-15 business days
- Expedited review: 72 hours (for urgent medical needs)
- Appeal response: 30 days for standard, 72 hours for expedited
When to Request Expedited Review
Request expedited processing if:
- Patient has severe symptoms requiring immediate treatment
- Delay could seriously jeopardize health or ability to regain maximum function
- Standard timeline would cause significant deterioration
Tip: Document medical urgency clearly in the prior authorization request to qualify for expedited review.
Clinical Criteria Requirements
Coverage at a Glance
Requirement | What It Means | Where to Find It |
---|---|---|
Confirmed XLH/TIO diagnosis | Genetic testing or biochemical markers | Lab reports, genetic test results |
Specialist prescribing | Endocrinologist or metabolic bone specialist | Provider credentials |
Age requirement | ≥6 months old | Medical records |
Prior therapy documentation | Trial/failure of phosphate + vitamin D analogs | Treatment history |
Monitoring plan | Serum phosphorus tracking | Provider attestation |
Dosing compliance | FDA-approved weight-based dosing | Prescription details |
Required Laboratory Values
For XLH diagnosis confirmation:
- Fasting serum phosphate below normal range for age
- Serum FGF23 >30 pg/mL (if genetic testing unavailable)
- Normal or elevated alkaline phosphatase
- Serum 25(OH)D ≥16 ng/mL
- Normal serum creatinine for age
Ongoing monitoring requirements:
- Baseline and periodic serum phosphorus levels
- Evidence of clinical improvement on therapy
- Documentation that levels remain within target range
Costs and Patient Support
UnitedHealthcare Coverage
- Specialty tier copay/coinsurance applies (typically $50-$500+ per month depending on plan)
- Annual deductible may apply before coverage begins
- Out-of-pocket maximum caps total yearly costs
Manufacturer Support Programs
Ultragenyx UltraCare® Program offers:
- Copay assistance for commercially insured patients (may reduce costs to $0)
- Prior authorization support and appeals assistance
- Nurse support for treatment adherence
- Foundation referrals for underinsured patients
Note: Manufacturer copay cards cannot be used with government insurance (Medicare, Medicaid) due to federal regulations, but charitable foundations may provide support.
To enroll: Contact UltraCare® through your prescribing physician or the Crysvita healthcare professional website.
Common Denials and Appeals
Top Denial Reasons and Solutions
Denial Reason | How to Overturn |
---|---|
Insufficient diagnostic confirmation | Submit genetic test results or complete biochemical panel (phosphate, FGF23, vitamin D, creatinine) |
Missing specialist involvement | Obtain consultation letter from endocrinologist or metabolic bone specialist |
Lack of prior therapy documentation | Provide records showing trial/failure of phosphate + vitamin D analogs, or contraindication documentation |
Inadequate monitoring plan | Submit provider attestation for serum phosphorus monitoring schedule |
Dosing concerns | Verify weight-based dosing aligns with FDA labeling and manufacturer guidelines |
UnitedHealthcare Internal Appeals Process
Level 1 Internal Appeal:
- Timeline: File within 180 days of denial
- Decision: 30 days (72 hours if expedited)
- How to file: UnitedHealthcare member portal, phone, or written request
Level 2 Internal Appeal:
- Timeline: File within 60 days of Level 1 denial
- Decision: 30 days (72 hours if expedited)
- Peer-to-peer option: Request physician-to-physician review
Annual Renewals
Reauthorization Timeline
Crysvita requires annual reauthorization (every 12 months) with UnitedHealthcare. Submit renewal requests 30-60 days before expiration to prevent treatment gaps.
Required Documentation for Renewal
- Clinical improvement evidence: Increased serum phosphate levels, reduced bone pain, fewer fractures, improved mobility
- Ongoing specialist oversight: Updated consultation notes
- Adherence confirmation: Treatment compliance documentation
- Current lab values: Recent serum phosphorus and related markers
- Continued medical necessity: Absence of contraindications
Tip: Start preparing renewal documentation 2-3 months early to ensure all required elements are available.
Specialty Pharmacy Requirements
Why Specialty Pharmacy is Required
UnitedHealthcare requires Crysvita dispensing through their specialty pharmacy network because:
- Complex handling and storage requirements
- Patient education and injection training needs
- Adherence monitoring and support
- Coordination with prior authorization and appeals
What to Expect
- Direct delivery to your home or clinic
- Nurse support for injection technique and side effect monitoring
- Refill coordination with your prescribing physician
- Insurance verification and copay assistance enrollment
Your specialty pharmacy will contact you directly once prior authorization is approved.
New York Appeals Rights
External Appeal Through NY Department of Financial Services
If UnitedHealthcare denies coverage after internal appeals, New York residents have the right to independent external review through the Department of Financial Services (DFS).
Key Features:
- Timeline: File within 4 months of final internal denial
- Decision: 30 days standard, 72 hours expedited
- Cost: $25 fee (refunded if you win; waived for Medicaid/hardship)
- Binding decision: Insurer must comply with favorable decisions
How to File:
- Complete DFS External Appeal Application
- Include denial letters, medical records, and supporting documentation
- Submit online, by mail, or fax to DFS
DFS External Appeals Database: Search previous decisions involving Crysvita and rare disease drugs at the Community Health Advocates database to find supportive precedents and medical literature.
Getting Help with Appeals
Community Health Advocates provides free assistance to New York residents:
- Phone: 888-614-5400
- Services: Appeal filing help, insurance counseling, rights explanation
- Eligibility: All New Yorkers, regardless of insurance type
Troubleshooting Common Issues
Portal Problems
- Can't access provider portal: Contact UnitedHealthcare provider services at 888-397-8129
- Missing forms: Download current forms from the UHC provider website
- Status unclear: Call OptumRx directly using the number on your denial letter
Documentation Issues
- Missing genetic test: Work with your specialist to order PHEX gene sequencing if not previously done
- Incomplete lab work: Ensure fasting serum phosphate, FGF23, and vitamin D levels are current
- Prior therapy records: Contact previous providers for treatment history documentation
Communication Scripts
Patient Phone Script for UnitedHealthcare: "I'm calling about prior authorization for Crysvita (burosumab) for X-linked hypophosphatemia. My member ID is [number]. Can you tell me the current status and any missing requirements?"
Clinic Staff Script for Peer-to-Peer: "I'm requesting a peer-to-peer review for Crysvita (burosumab) denial. The patient has confirmed XLH with [genetic/biochemical evidence] and has failed standard therapy. When can we schedule the physician-to-physician call?"
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-backed, targeted rebuttals. Our platform analyzes denial letters and plan policies to craft point-by-point appeals that address specific payer criteria, pulling the right medical literature and clinical documentation to support coverage requests. For complex cases like Crysvita approvals, having expert support can make the difference between denial and approval.
FAQ: Common Questions About Crysvita Coverage
Q: How long does UnitedHealthcare prior authorization take in New York? A: Standard prior authorization typically takes 5-15 business days. Expedited requests (for urgent medical needs) are decided within 72 hours.
Q: What if Crysvita is not on my formulary? A: Even if not listed, UnitedHealthcare may cover Crysvita through medical exception or prior authorization. Work with your specialist to document medical necessity.
Q: Can I request expedited appeal in New York? A: Yes, both UnitedHealthcare internal appeals and New York DFS external appeals offer expedited review for urgent medical situations.
Q: Does step therapy apply if I failed treatments outside New York? A: Treatment history from any location counts toward step therapy requirements. Provide documentation of prior failures regardless of where they occurred.
Q: What happens if I move within New York during treatment? A: Coverage typically continues if you remain with UnitedHealthcare. Notify your insurer and specialty pharmacy of address changes to ensure uninterrupted delivery.
Q: Can my doctor appeal on my behalf? A: Yes, providers can file appeals on patients' behalf. For New York DFS external appeals, providers have 60 days (vs. 4 months for patients) to file.
Sources & Further Reading
- UnitedHealthcare Crysvita Medical Policy
- New York DFS External Appeal Process
- Community Health Advocates - Free Insurance Help
- Crysvita Healthcare Professional Resources
- UnitedHealthcare Provider Portal
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider about treatment decisions and verify current coverage details with your insurance company. For personalized assistance with insurance appeals and coverage issues, consider contacting Counterforce Health or Community Health Advocates at 888-614-5400.
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