J3385, Injection, velaglucerase alfa, 100 units
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Continuation of ERT requires documented positive clinical response, FDA-labeled dosing, and continuation up to 12 months.
- Initial authorization duration limited to 12 months.
Key Coverage Criteria
- Initial therapy for Type 1 Gaucher disease with Cerezyme, Elelyso, or VPRIV requires: (1) diagnosis of Type 1 Gaucher disease, (2) symptomatic disease, (3) dosing in accordance with FDA labeling, and (4) initial authorization for up to 12 months; continuation requires: (1) documented positive clinical response, (2) dosing in accordance with FDA labeling, and (3) continuation up to 12 months.
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
- Taliglucerase alfa (Elelyso) is covered for individuals ≥4 years with confirmed Type 1 Gaucher disease.
- Velaglucerase alpha (VPRIV) is covered for long-term ERT in individuals ≥4 years with Type 1 Gaucher disease.
- Vestronidase alfa-vjbk (Mepsevii) is covered for individuals with MPS VII (Sly syndrome).
- Agalsidase beta (Fabrazyme) is covered when the member is ≥2 years old and has a confirmed diagnosis of Fabry disease.
13 Active Policies
UHC-POL-intravenous-enzyme-replacement-therapy-gaucher-disease, Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
BCBSIL-RX501.067, Enzyme-Replacement Therapy for Lysosomal Storage Disorders
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
Related Codes
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