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.
- Coverage determinations for off-label use require supporting peer-reviewed literature, specialty consultant advice as indicated, and reference to accepted standards of medical practice; documentation of these sources must be provided for review.
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.
- NGS covers leuprolide acetate (LHRH analog) as palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.
- A drug use is covered if it is an FDA-approved labeled indication or is a medically accepted off-label indication supported by one of the accepted compendia at the specified levels (AHFS-DI supportive; NCCN Category 1 or 2A; Micromedex DrugDex Class I/IIa/IIb or Clinical Pharmacology supportive; Lexi-Drugs Evidence Level A) or by articles or LCDs published by National Government Services (NGS).
16 Active Policies
A52448 — Billing and Coding: Omalizumab and biosimilar, OMLYCLO (omalizumab-igec)
J06
L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J06
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UHC-POL-xolair-omalizumab — Xolair (Omalizumab)
Related Codes
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