Coverage Policies

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Current policies effective through April 30, 2024.

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QualChoice reserves the right to alter, amend, change or supplement medical policies as needed. QualChoice reviews and authorizes services and substances. CPT and HCPCS codes are listed as a convenience and any absent, new or changed codes do not alter the intent of the policy.


Effective Date: 11/01/2018 Title: Crysvita
Revision Date: 12/01/2020 Document: BI582:00
CPT Code(s): J0584
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Crysvita (burosumab-twza) requires prior authorization.

2)    Crysvita is used to treat a rare form of hypophosphatemia and tumor-induced osteomalacia.

Medical Statement

Crysvita (burosumab-twza) is considered medically necessary for patients who:

1)    Are 6 months of age or older AND

2)    Have a diagnosis of X-linked hypophosphatemia (XLH),which is also known as X-linked dominant hypophosphatemic rickets or X-linked vitamin D-resistant rickets) AND

3)    Patient will discontinue any oral phosphate or active vitamin D analog supplementation at least one week prior to starting therapy with Crysvita AND

4)    Prescriber agrees to measure serum phosphorous level monthly for the first three (3) months of therapy and periodically throughout therapy, holding the dose if level above 5mg/dL AND

5)    Fasting serum phosphorous is not within or above the normal range for age at start of therapy AND

6)    Patient does not have severe renal impairment or end stage renal disease (ESRD), defined as eGFR < 30mL/min/1.73m2.


Crysvita is also considered medically necessary for members meeting the following criteria:

1)    Diagnosis of Tumor-Induced Osteomalacia (TIO) with confirmed serum FGF23 levels; AND

2)    Age > 2 years; AND

3)    Failure of a > 3 consecutive month trial or oral phosphate and vitamin D replacement therapy, unless contraindicated or clinically significant adverse effects are experienced; AND

4)    Current (within the last 30 days) serum phosphorus levels are one of the following (a or b):

a.    Below the reference range for age and gender (use laboratory-specific reference ranges if available), and member has not received oral phosphate or vitamin D replacement therapy;

b.    In normal range, but member remains symptomatic (e.g., osteomalacia, muscle weakness, fatigue, bone pain, fractures) despite currently receiving oral phosphate and/or vitamin D replacement therapy;

5)    Documentation confirms the causative tumor(s) is/are not amenable to surgical excision or resection;

6)    Crysvita is not prescribed concurrently with oral phosphate or vitamin D replacement therapy


Reauthorization Criteria:

1)    Patient must have diagnosis of X-linked hypophosphatemia or tumor-induced osteomalacia AND

2)    Prescriber agrees to measure serum phosphorous throughout therapy and hold the dose if level above 5mg/dL AND

3)    Patient does not have severe renal impairment or end stage renal disease (ESRD), defined as eGFR < 30mL/min/1.73m2.


1)    Crysvita Prescribing Information. Ultragenyx Pharmaceutical Inc. Novato, CA.August 2020.

2)    Clinical Pharmacology. Accessed online October 2021.




1)    Effective 10-01-2019: Added HCPC J0584 to policy.

2)    Effective 12/01/2020: Updated age range to 6 months or older for hypophosphatemia.

3)    Effective 12/01/2021: added coverage criteria for tumor-induced osteomalacia.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.