J2357, Injection, omalizumab, 5 mg
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
- Medical records must document the clinical indication and justification for omalizumab, including pre-treatment symptoms and objective spirometry (FEV1 and FEV1/FVC) consistent with moderate or severe persistent asthma when used for asthma.
- Claims must document that administration occurred in a clinic or office by a physician or incident-to a physician and include evidence of post-administration observation and readiness to manage anaphylaxis.
- Dose and frequency used must be supported by the FDA label or a recognized compendium citation in the medical record for covered uses or off-label compendia-supported uses.
- Clinical documentation demonstrating the therapy is effective for the relevant diagnosis.
Key Coverage Criteria
- Omalizumab is covered when administered by a physician or incident-to a physician’s service in a clinic or office setting.
- Dose and frequency of omalizumab must follow the FDA-approved label or recognized compendia for the indicated or off-label use.
- Use for patients with moderate or severe persistent asthma as defined by NHLBI clinical features and pre-treatment spirometry (FEV1 and FEV1/FVC thresholds by age) is the clinical context described in the policy.
- Patients should receive omalizumab in a healthcare setting and be observed for an appropriate period after each treatment; administration must be by providers prepared to recognize and manage anaphylaxis.
- 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.
- Coverage, exclusions, and any dollar caps or limitations are determined by the member's benefit plan, summary plan description, or contract; members and providers must consult that plan to determine coverage.
16 Active Policies
A52448, Billing and Coding: Omalizumab and biosimilar, OMLYCLO (omalizumab-igec)
J6
NGS-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
JK
RX501.058, Omalizumab
BCBSIL-RX501.058, Omalizumab
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
Related Codes
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