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Billing and Coding: Omalizumab and biosimilar, OMLYCLO® (omalizumab-igec)
A52448
National Government Services, Inc. (J06)
Effective: October 1, 2025
Updated: December 31, 2025
Policy Summary
Omalizumab (OMLYCLO®) is covered when administered in a clinic or office by a physician or incident-to a physician, with dose and frequency consistent with the FDA label or recognized compendia. Patients must be treated in a healthcare setting with documented pre-treatment clinical assessment (including spirometry for asthma) and observed post-injection by providers prepared to manage anaphylaxis; self-administration and use for acute bronchospasm/status asthmaticus are not covered.
Coverage Criteria Preview
Key requirements from the full policy
"Omalizumab is covered when administered by a physician or incident-to a physician’s service in a clinic or office setting."
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