Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesEndocrinologyCommunity-Care Burosumab (Crysvita) Coverage | Ope…
    Ask Trek AI about this page
    CurrentCommunity-CarePolicy N/A

    Burosumab (Crysvita) medical benefit coverage — X-linked hypophosphatemia and tumor-induced osteomalacia

    Customize your policy alerts

    Sign up for all Community-Care policy alerts

    Know when Community-Care releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Defines medical necessity criteria, authorization periods, quantity limits, and coding for burosumab (Crysvita) for X-linked hypophosphatemia and tumor-induced osteomalacia for Community-Care members and providers.

    Policy Summary
    PayerCommunity-Care
    PolicyBurosumab (Crysvita) medical benefit coverage — X-linked hypophosphatemia and tumor-induced osteomalacia
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateN/A
    Last ReviewAug 1, 2024
    Next Review DateAug 1, 2024
    Key ActionSubmit prior authorization with required documentation including diagnosis, specialist involvement, age, baseline and follow-up serum phosphorus, and prior treatment history.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3Covered indications
    ≥6mo/≥2yMin age (pediatric/TIO)
    J0584

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    HCPCS
    1 yrContinuation period

    Coverage Criteria for Burosumab (Crysvita)

    inv-01: Initial Therapy — Pediatric XLH

    Covered when ALL of the following are met

    Pediatric XLH initial: (i) Diagnosis of X-linked hypophosphatemia; (ii) Prescribed by, or in consultation with, an endocrinologist, nephrologist, or medical geneticist; (iii) ≥ 6 months old; (iv) Open epiphyses; (v) Serum phosphorus is below the normal range for age; (vi) No known severe renal impairment or end stage renal disease; (vii) Discontinuation of oral phosphate and active vitamin D analogs ≥ 1 week prior to initiation.

    inv-02: Initial Therapy — Adult XLH

    Covered when ALL of the following are met

    Adult XLH initial: (i) Diagnosis of X-linked hypophosphatemia; (ii) Prescribed by, or in consultation with, an endocrinologist, nephrologist, or medical geneticist; (iii) Serum phosphorus is below the normal range for age despite use of oral phosphate and vitamin D analog use; (iv) No known severe renal impairment or end stage renal disease; (v) Patient has experienced bone or joint pain, muscle weakness, poor stamina, or fractures secondary to X-linked hypophosphatemia; (vi) Discontinuation of oral phosphate and active vitamin D analogs ≥ 1 week prior to initiation of burosumab (Crysvita).

    inv-03: Initial Therapy — Tumor-Induced Osteomalacia

    Covered when ALL of the following are met

    TIO initial: (i) Diagnosis of both: (1) FGF23-related hypophosphatemia; (2) Tumor-induced osteomalacia; (ii) Prescribed by, or in consultation with, an oncologist, orthopedist, or a specialist in bone metabolic disorders; (iii) Phosphaturic mesenchymal tumor cannot be curatively resected or localized; (iv) ≥ 2 years old.

    inv-04: Continuation Therapy — Pediatric XLH

    Covered when ALL of the following are met

    Pediatric XLH continuation: (i) Diagnosis of X-linked hypophosphatemia; (ii) Documentation of positive response to burosumab (Crysvita); (iii) Open epiphyses.

    inv-05: Continuation Therapy — Adult XLH

    Covered when ALL of the following are met

    Adult XLH continuation: (i) Diagnosis of X-linked hypophosphatemia; (ii) Improvement in serum phosphorus levels; (iii) Documentation of symptomatic improvement in bone or joint pain, muscle weakness, stamina, or fracture frequency and healing time.

    inv-06: Continuation Therapy — Tumor-Induced Osteomalacia

    Covered when ALL of the following are met

    TIO continuation: (i) Diagnosis of both: (1) FGF23-related hypophosphatemia; (2) Tumor-induced osteomalacia; (ii) Improvement of serum phosphorus levels; (iii) Documentation of symptomatic improvement in pain, total fractures healing after starting therapy, or a decrease in osteoid volume or bone volume from baseline.

    Known severe renal impairment or end stage renal disease (ESRD) is listed as a contraindication to initiation of burosumab for X-linked hypophosphatemia and therefore is not eligible for coverage under initial approval criteria.

    Therapy with burosumab may be considered not medically necessary when the member’s serum phosphorus is within the normal range for age, when required specialist prescribing or consultation is not documented, when the member does not meet the stated age criteria for the indication, or when required documentation of treatment response or prerequisite management (for example discontinuation of oral phosphate and active vitamin D analogs where specified) is not provided.

    Coding and Age Limits

    Applicable HCPCS CodesHCPCSCovered
    J0584Injection, burosumab-twza 1 mg
    Minimum age for pediatric initiation
    Minimum age — pediatric XLH>= 6 months
    Minimum age — tumor-induced osteomalacia>= 2 years
    Context — indication-specificAge requirements apply to initiation of burosumab (Crysvita) per indication

    Provider Actions and Authorization Requirements

    Prior Authorization

    Prior authorization required for burosumab (Crysvita)

    Prior authorization is required for burosumab (Crysvita); requests must meet the initial approval criteria for the applicable indication, including diagnosis, prescribing specialist or documented consultation, age limits, laboratory and treatment prerequisites, and submission of required documentation. Continuation approvals require documented clinical or laboratory improvement per the continuation criteria.

    • Applicable HCPCS code: J0584
    Step Therapy

    Step therapy / prior treatment requirements

    Step therapy requirements differ by age: adults with XLH must have persistent low serum phosphorus despite use of oral phosphate and vitamin D analogs prior to initiation; pediatric patients are not required to trial these agents but must discontinue oral phosphate and active vitamin D analogs ≥ 1 week prior to initiation.

    • Adult XLH: serum phosphorus below age-normal range despite oral phosphate and vitamin D analog use

    Background

    X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia are disorders mediated by excess fibroblast growth factor 23 (FGF23) that cause hypophosphatemia and related skeletal manifestations. Burosumab (Crysvita) is a targeted anti‑FGF23 therapy; this policy defines the medical necessity criteria for initiation and continuation including diagnosis, required specialist involvement, age limits, biochemical evidence of low serum phosphorus, and documentation of clinical or laboratory response.

    Definitions

    Open epiphyses
    Open epiphyses definitionPresence of unfused growth plates; required for pediatric XLH initiation and continuation.
    Role in criteriaRequired finding for initial approval and continuation in pediatric X-linked hypophosphatemia
    DocumentationProvider must document open epiphyses in required documentation for authorization
    FGF23-related hypophosphatemia
    DefinitionHypophosphatemia driven by excess fibroblast growth factor 23 (FGF23)
    Diagnostic requirementRequired component of the diagnosis for tumor-induced osteomalacia
    Use in policy
    Policy Summary
    PayerCommunity-Care
    PolicyBurosumab (Crysvita) medical benefit coverage — X-linked hypophosphatemia and tumor-induced osteomalacia
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateN/A
    Last ReviewAug 1, 2024
    Next Review DateAug 1, 2024
    Key ActionSubmit prior authorization with required documentation including diagnosis, specialist involvement, age, baseline and follow-up serum phosphorus, and prior treatment history.
    SourceLink
    On This Page
    Coverage Criteria for Burosumab (Crysvita)Coding and Age LimitsProvider Actions and Authorization RequirementsBackgroundDefinitions
  1. Pediatric XLH: discontinuation of oral phosphate and active vitamin D analogs ≥ 1 week prior to initiation
    2. Documentation Required

    Documentation required for authorization

    Required documentation to support authorization includes the specific diagnosis (X-linked hypophosphatemia or tumor-induced osteomalacia), evidence of prescribing by or consultation with the specified specialist, patient age, open epiphyses for pediatrics, baseline and follow-up serum phosphorus values, prior use and discontinuation of oral phosphate and active vitamin D when applicable, documentation of clinical or laboratory improvement for continuation, and patient weight for quantity determination.

    • Diagnosis: XLH or FGF23-related tumor-induced osteomalacia
    • Prescribing specialist or documented consultation (endocrinologist, nephrologist, medical geneticist for XLH; oncologist, orthopedist, or bone metabolic disorder specialist for TIO)
    • Patient age and open epiphyses (pediatric)
    • Baseline and follow-up serum phosphorus values
    • Prior use and discontinuation of oral phosphate and active vitamin D (when applicable)
    • Documentation of symptomatic or laboratory improvement for continuation
    • Patient weight (required for quantity determination)
    Denial Risk

    Triggers for denial

    Denial risks include failure to document required age limits, the specific diagnosis (XLH or tumor-induced osteomalacia), appropriate specialist prescribing or consultation, serum phosphorus below the normal range for age when required, discontinuation of oral phosphate and active vitamin D analogs ≥ 1 week prior to initiation where specified, or evidence of known severe renal impairment or end stage renal disease.

    • Missing or unsupported diagnosis (XLH or FGF23-related tumor-induced osteomalacia)
    • No documentation of specialist prescriber or consultation
    • Age outside specified limits (≥ 6 months for pediatric XLH; ≥ 2 years for TIO)
    • Serum phosphorus not below the normal range for age when required
    • No documentation of discontinuation of oral phosphate/active vitamin D ≥ 1 week prior to initiation (where required)
    • Known severe renal impairment or end stage renal disease listed as contraindication
    Policy requires documentation of FGF23-related hypophosphatemia plus tumor-induced osteomalacia for initial approval