TL;DR: Aetna, a CVS Health company, modified CPB 0932 covering burosumab-twza (Crysvita), effective January 15, 2026. Here's what billing teams need to know before submitting claims.
Aetna updated its burosumab-twza coverage policy under CPB 0932 Aetna system, tightening the medical necessity criteria for two covered indications: X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO). The primary billing code is HCPCS J0584 (injection, burosumab-twza 1 mg), and every claim requires precertification. If your team bills J0584 for Crysvita without a clean prior authorization on file, expect a claim denial.
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Burosumab-twza (Crysvita) — CPB 0932 |
| Policy Code | CPB 0932 |
| Change Type | Modified |
| Effective Date | January 15, 2026 |
| Impact Level | High |
| Specialties Affected | Endocrinology, Nephrology, Metabolic Bone Disease |
| Key Action | Verify PHEX gene testing results and lab values are documented before submitting precertification for J0584 |
Aetna Burosumab-twza (Crysvita) Coverage Criteria and Medical Necessity Requirements 2026
The Aetna Crysvita coverage policy under CPB 0932 covers burosumab-twza for two specific indications only. Everything else is experimental. The criteria are strict, and missing even one element will trigger a denial.
Prescriber requirement: Burosumab-twza must be prescribed by — or in consultation with — an endocrinologist, nephrologist, or a physician specializing in metabolic bone disorders. A primary care prescription alone won't pass precertification. Make sure the ordering provider's specialty is documented on every prior authorization request.
X-linked Hypophosphatemia (XLH)
To meet medical necessity for XLH, the member must satisfy all three of the following conditions:
First, the member must meet at least one genetic or lab criterion:
| # | Covered Indication |
|---|---|
| 1 | Genetic testing confirming a pathogenic variant in the PHEX gene in the member, or |
| 2 | Genetic testing confirming a pathogenic PHEX variant in a directly related family member with appropriate X-linked inheritance, or |
| 3 | FGF23 level above the upper limit of normal or abnormal for the assay |
Second, the member's baseline fasting serum phosphorus (CPT 84100) must be below the normal range for age.
Third, the member must have radiographic evidence of rickets or other bone disease attributed to XLH.
All three conditions are required. If you have genetic confirmation via CPT 81406 (molecular pathology, Level 7) but no radiographic evidence on file, you don't have a clean claim. Get the imaging documentation before you submit.
Tumor-Induced Osteomalacia (TIO)
TIO criteria are even more layered. The diagnosis must be confirmed by all three lab findings simultaneously:
| # | Covered Indication |
|---|---|
| 1 | FGF23 above the upper limit of normal or abnormal for the assay |
| 2 | Baseline fasting serum phosphorus (CPT 84100) below normal range for age |
| 3 | TmP/GFR (ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate) below normal range for age |
Beyond those labs, the member must have clinical signs or symptoms of TIO — bone pain, fractures, muscle weakness, limb deformity, craniofacial anomaly, or a localized mass. Document these in the chart explicitly.
The final TIO criterion is the one that trips up the most claims: the disease must be associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized. If the tumor has been identified and is surgically resectable, burosumab-twza is not covered. Your clinical team needs to document why resection or localization isn't feasible.
Prior Authorization and Site of Care
Precertification is required on every claim. Call (866) 752-7021 or fax (888) 267-3277. Aetna also applies its Site of Care Utilization Management Policy to burosumab-twza. That means the site where the subcutaneous injection (CPT 96372) is administered may affect reimbursement. Office-based infusion is typically preferred over hospital outpatient for specialty drug administration. Confirm the approved site of care during the prior authorization process — don't assume your current setting is approved.
Continuation of Therapy
Reauthorization is available for members currently receiving burosumab-twza who show benefit from therapy. Aetna defines benefit as disease improvement or stability — specifically: increased or normalized serum phosphate, improved bone and joint pain, fewer fractures, or improved skeletal deformities. Document these outcomes explicitly at each reauthorization. "Patient tolerating therapy" isn't enough.
Aetna Burosumab-twza Exclusions and Non-Covered Indications
Aetna's position is direct: all indications other than XLH and TIO are experimental, investigational, or unproven. That's a broad exclusion with real financial exposure.
Conditions like fibrous dysplasia (ICD-10 M85.0–M85.9) and tyrosinemia (E70.21) appear in the policy's code set, but they're listed as related codes — not covered indications. Billing J0584 for these diagnoses will result in a claim denial. If your practice treats patients with these conditions and a provider is exploring off-label burosumab-twza use, talk to your compliance officer before submitting any claims.
The policy does not provide a grandfather clause for members who were previously approved under older criteria. Every reauthorization is evaluated against current criteria.
Coverage Indications at a Glance
| Indication | Status | Key Codes | Notes |
|---|---|---|---|
| X-linked Hypophosphatemia (XLH) | Covered | J0584, E83.31, CPT 81406, CPT 84100 | PHEX gene testing or FGF23 + low phosphorus + radiographic evidence required; prior auth required |
| Tumor-Induced Osteomalacia (TIO) | Covered | J0584, M83.8, CPT 84100 | FGF23 + low phosphorus + low TmP/GFR + clinical symptoms + unresectable tumor required; prior auth required |
| Fibrous Dysplasia | Not Covered | M85.0–M85.9 | Listed as related codes only; no covered indication |
| Tyrosinemia | Not Covered | E70.21 | Listed as related code only; no covered indication |
| All other indications | Experimental / Not Covered | — | Aetna considers all other indications experimental, investigational, or unproven |
Aetna Burosumab-twza Billing Guidelines and Action Items 2026
These are the steps your billing team should take before January 15, 2026.
| # | Action Item |
|---|---|
| 1 | Audit active J0584 prior authorizations now. Pull every open Crysvita auth and confirm each one documents either PHEX genetic testing results, FGF23 levels, or both. Claims missing that documentation will fail under the updated criteria. |
| 2 | Confirm CPT 81406 results are in the chart before precert submission. If your patient's auth rests on genetic testing, the pathogenic PHEX variant must be confirmed. CPT 81406 is the molecular pathology code for that level of analysis. If results are pending, don't submit precert until they're back. |
| 3 | Pull CPT 84100 lab values for every active patient. Baseline fasting serum phosphorus below normal range for age is required for both XLH and TIO. Make sure the value is documented and dated. A value from two years ago may not satisfy Aetna's reviewers. |
| 4 | Document TmP/GFR explicitly for TIO cases. This is the lab value most likely to be missing from charts. TIO coverage requires all three lab criteria simultaneously. If TmP/GFR isn't in the record, the auth will fail regardless of FGF23 or phosphorus results. |
| 5 | Verify the administering site is covered under Aetna's Site of Care policy. Aetna applies utilization management to the site where CPT 96372 (subcutaneous injection) is performed. Confirm the approved site during the prior authorization process. A mismatch between the authorized site and the billed site is a clean path to a claim denial. |
| 6 | Update your reauthorization documentation templates. Reauth submissions need quantified outcomes: serum phosphate levels, pain scores, fracture history, skeletal imaging changes. Generic "stable on therapy" language doesn't meet the continuation criteria. Work with your clinical team to build outcome documentation into the reauth workflow before the effective date of January 15, 2026. |
| 7 | Flag off-label requests for compliance review. If a provider orders burosumab-twza for fibrous dysplasia, cutaneous-skeletal hypophosphatemia, or any indication outside XLH or TIO, flag that request before precert. Submitting J0584 against M85.x codes is a denial — and potentially a billing compliance issue. Loop in your compliance officer before the claim goes out. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Burosumab-twza (Crysvita) Under CPB 0932
Primary Covered HCPCS Code
| Code | Type | Description |
|---|---|---|
| J0584 | HCPCS | Injection, burosumab-twza 1 mg |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| E83.31 | Familial hypophosphatemia — primary ICD-10 for X-linked hypophosphatemia (XLH) |
| M83.8 | Other adult osteomalacia — primary ICD-10 for tumor-induced osteomalacia (TIO) |
| E83.39 | Other disorders of phosphorus metabolism (includes cutaneous-skeletal hypophosphatemia syndrome) |
| E70.21 | Tyrosinemia |
| M85.0 | Fibrous dysplasia (monostotic) |
| M85.1 | Fibrous dysplasia (monostotic) |
| M85.2 | Fibrous dysplasia (monostotic) |
| M85.3 | Fibrous dysplasia (monostotic) |
| M85.4 | Fibrous dysplasia (monostotic) |
| M85.5 | Fibrous dysplasia (monostotic) |
| M85.6 | Fibrous dysplasia (monostotic) |
| M85.7 | Fibrous dysplasia (monostotic) |
| M85.8 | Fibrous dysplasia (monostotic) |
| M85.9 | Fibrous dysplasia (monostotic) |
A note on the fibrous dysplasia codes: M85.0 through M85.9 appear in the policy's code set, but Aetna does not cover burosumab-twza for fibrous dysplasia. These codes are listed as related codes only. Do not use them as primary diagnosis codes on J0584 claims.
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