By Counterforce Health Team in Crysvita (burosumab) —

How to Get Crysvita (Burosumab) Covered by UnitedHealthcare in California: Complete Prior Authorization Guide with ICD-10 and Appeals

Answer Box: Getting Crysvita Covered by UnitedHealthcare in California

Crysvita (burosumab) requires prior authorization from UnitedHealthcare OptumRx. Submit PA requests through the UnitedHealthcare Provider Portal with genetic testing (PHEX mutation or elevated FGF23), documented failure of oral phosphate/calcitriol therapy, and endocrinologist involvement. If denied, file an internal appeal within 180 days, then request California's Independent Medical Review (IMR) through DMHC for a binding external review. IMR success rates for specialty drugs range from 35-73% in California. First step today: Confirm your UnitedHealthcare plan is DMHC-regulated and gather genetic testing results and prior therapy documentation.

Table of Contents

  1. Coverage Requirements Overview
  2. Prior Authorization Process
  3. ICD-10 Codes and Documentation
  4. HCPCS Coding and Billing
  5. Common Denial Reasons and Solutions
  6. Appeals Process in California
  7. Cost Assistance Options
  8. FAQ

Coverage Requirements Overview

UnitedHealthcare requires prior authorization for Crysvita (burosumab) through their OptumRx pharmacy benefit management system. The medication is typically covered under the medical benefit rather than pharmacy benefit, given its subcutaneous administration by healthcare providers.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all strengths UHC PA Requirements
Age Requirements ≥6 months (XLH), ≥2 years (TIO) FDA labeling
Diagnosis Codes E83.31 (XLH), E83.39 (TIO) ICD-10 manual
HCPCS Code J0584 (1 mg = 1 unit) CMS fee schedule
Specialist Required Endocrinologist preferred Payer policies
Appeals Deadline 180 days (internal), 6 months (IMR) DMHC regulations

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documentation (Patient/Clinic)
    • Genetic testing results showing PHEX mutation or elevated FGF23 levels
    • Laboratory values: low serum phosphorus, normal calcium/PTH
    • Documentation of failed oral phosphate and calcitriol therapy
    • Timeline: 1-2 weeks to collect
  2. Submit PA Request (Prescriber)
  3. Include Medical Necessity Letter (Prescriber)
    • Confirm diagnosis (X-linked hypophosphatemia or tumor-induced osteomalacia)
    • Document prior therapy failures and contraindications
    • Cite FDA labeling and clinical guidelines
    • Timeline: 1-3 business days for letter preparation
  4. PA Review Process (UnitedHealthcare)
    • Standard review: 15 business days
    • Expedited review: 72 hours (for urgent cases)
    • Timeline: 3-15 business days for decision
  5. Appeal if Denied (Patient/Prescriber)
    • Internal appeal: 180 days from denial date
    • Submit via portal or mail with additional evidence
    • Timeline: 30 days for standard, 72 hours for urgent
  6. Request IMR if Internal Appeal Denied (Patient)
    • File with California DMHC within 6 months
    • Online at healthhelp.ca.gov or call 888-466-2219
    • Timeline: 45 days standard, 7 days expedited
  7. Implementation (All parties)
    • UnitedHealthcare must authorize within 5 business days of favorable IMR
    • Coordinate with specialty pharmacy for drug acquisition
    • Timeline: 5-10 business days for treatment initiation
Tip: Request expedited review if the patient has progressive skeletal deformities or fractures. Use the script: "Urgent Crysvita PA due to worsening skeletal manifestations requiring immediate treatment."

ICD-10 Codes and Documentation

Primary Diagnosis Codes

X-linked Hypophosphatemia (XLH):

  • E83.31 - Familial hypophosphatemia (most specific)
  • E83.3 - Disorders of phosphorus metabolism and phosphatases (broader)

Tumor-Induced Osteomalacia (TIO):

  • E83.39 - Other disorders of phosphorus metabolism
  • M83.89 - Other adult osteomalacia (supportive)

Documentation Requirements for Accurate Coding

For XLH (E83.31):

  • Genetic testing showing PHEX gene mutation (Xp22.1)
  • Family history of X-linked inheritance pattern
  • Childhood onset rickets/osteomalacia
  • Characteristic features: bowed legs, short stature, dental abscesses
  • Laboratory confirmation: low serum phosphate, elevated FGF23, normal vitamin D

For TIO (E83.39):

  • Adult-onset osteomalacia with bone pain/fractures
  • Tumor identification or clinical suspicion when tumor cannot be located
  • FGF23-mediated hypophosphatemia
  • Failed response to tumor resection (if applicable)
Clinical Note: Include radiographic evidence (rickets, bowing deformities, pseudofractures) and genetic testing results to support specific coding over general phosphorus metabolism disorders.

HCPCS Coding and Billing

Primary Billing Code

J0584 - Injection, burosumab-twza, 1 mg

  • Each unit = 1 mg of burosumab
  • Typically billed under medical benefit (Medicare Part B model)
  • Prior authorization required by most payers

Dosing and Billing Units

Indication Standard Dose Maximum Dose Billing Units (J0584)
Pediatric XLH 0.8 mg/kg Q2 weeks 90 mg Q2 weeks Up to 90 units Q14 days
Adult XLH 0.5-1 mg/kg Q2-4 weeks 90 mg Q4 weeks Up to 90 units Q28 days
Adult TIO 0.5-1 mg/kg Q2 weeks 180 mg Q2 weeks Up to 180 units Q14 days

Site of Care and Administration

  • Outpatient infusion center or specialty clinic
  • Subcutaneous injection by healthcare provider
  • Cannot be self-administered at home
  • Coordinate with specialty pharmacy for drug acquisition

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting targeted appeals with the right clinical evidence and payer-specific documentation.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Lack of genetic confirmation Submit PHEX mutation results or elevated FGF23 levels Genetic testing report, laboratory values
Insufficient prior therapy documentation Provide detailed trial history with dates, doses, outcomes Pharmacy records, physician notes documenting failures
Missing specialist involvement Obtain endocrinologist consultation and prescription Specialist referral, consultation notes
Age criteria not met Verify patient meets minimum age requirements Birth certificate, medical records
Concurrent contraindicated therapy Document discontinuation of oral phosphate/active vitamin D Medication reconciliation, prescriber attestation
Lack of monitoring plan Submit serum phosphorus monitoring protocol Laboratory schedule, follow-up plan

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements:

  • Confirmed diagnosis with genetic testing or biochemical markers
  • Documentation of prior therapy failures (oral phosphate, calcitriol)
  • Contraindications to standard therapy
  • Expected clinical outcomes and monitoring plan
  • Citations to FDA labeling and clinical guidelines

Key Supporting Evidence:

Appeals Process in California

Level 1: Internal UnitedHealthcare Appeal

Timeline: File within 180 days of denial Response time: 30 days standard, 72 hours urgent How to file:

  • Online: UnitedHealthcare member portal
  • Phone: Member services number on insurance card
  • Mail: Address provided in denial letter

Required documents:

  • Original denial letter
  • Medical records supporting medical necessity
  • Physician letter explaining why treatment is needed
  • Any additional clinical evidence

Level 2: California Independent Medical Review (IMR)

California's IMR process provides binding external review for UnitedHealthcare denials. Success rates for specialty drug appeals range from 35-73% based on available data.

Eligibility: DMHC-regulated UnitedHealthcare plans (most HMOs and managed care plans) Timeline: File within 6 months of internal appeal denial Cost: Free to patients Response time: 45 days standard, 7 days expedited

How to file IMR:

  1. Online: healthhelp.ca.gov (fastest method)
  2. Phone: 888-466-2219 (24/7 for urgent cases)
  3. Mail: DMHC Help Center, 980 9th Street, Suite 500, Sacramento, CA 95814

Required for IMR:

  • Completed internal appeal with UnitedHealthcare
  • Medical records and physician support
  • Proof of medical necessity
  • Documentation that treatment is not experimental/investigational
Success Strategy: Include peer-reviewed studies demonstrating Crysvita's efficacy for your specific condition and evidence that standard therapies have failed or are contraindicated.

Scripts for Patients

Calling UnitedHealthcare for PA Status: "I'm calling to check the status of a prior authorization request for Crysvita, submitted by Dr. [Name] on [Date]. My member ID is [Number]. Can you tell me if any additional information is needed and when I can expect a decision?"

Requesting Expedited Review: "My condition is worsening with progressive bone deformities. I need an expedited review of my Crysvita prior authorization. What documentation do you need from my doctor to process this as urgent?"

Cost Assistance Options

Manufacturer Support

Kyowa Kirin Patient Support Program

Foundation Grants

  • Patient Access Network (PAN) Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs

  • California's Medicaid (Medi-Cal) coverage
  • Covered California marketplace plans
  • State pharmaceutical assistance programs

FAQ

How long does UnitedHealthcare prior authorization take in California? Standard PA review takes up to 15 business days. Expedited review for urgent cases is completed within 72 hours. Submit requests through the provider portal for fastest processing.

What if Crysvita is not on UnitedHealthcare's formulary? Non-formulary medications can still be covered through the prior authorization process with medical necessity documentation. Focus on demonstrating that formulary alternatives have failed or are contraindicated.

Can I request an expedited appeal in California? Yes, both UnitedHealthcare internal appeals and DMHC IMR can be expedited for urgent medical situations. Document progressive symptoms or time-sensitive treatment needs.

Does step therapy apply if I've tried treatments outside California? Prior therapy documentation from other states is typically accepted. Provide pharmacy records and physician notes documenting failed trials regardless of where they occurred.

What happens if my IMR is approved? UnitedHealthcare must authorize the treatment within 5 business days and pay for any services already received. The decision is binding and cannot be appealed by the insurance company.

How much does Crysvita cost without insurance? Cash prices range from approximately $4,000-$40,000+ per vial depending on strength (10-60 mg). Annual costs vary significantly based on weight-based dosing requirements.

Can I get Crysvita at any pharmacy? Crysvita is typically dispensed through specialty pharmacies and administered at outpatient infusion centers or specialty clinics, not retail pharmacies.

What if UnitedHealthcare requires step therapy? Document failed trials of oral phosphate and calcitriol (active vitamin D) therapy. Include specific dates, doses, duration, and reasons for discontinuation (lack of efficacy or intolerance).

This guide provides general information about insurance coverage and appeals processes. It is not medical advice. For personalized guidance on your specific situation, consult with your healthcare provider and contact California's DMHC Help Center at 888-466-2219.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create evidence-backed rebuttals tailored to each payer's specific requirements. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and improve approval rates for critical medications.

Sources & Further Reading

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