L50.1 — Idiopathic urticaria
ICD-10-CM
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
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.
- All documentation must be maintained in the patient's medical record and made available to the contractor upon request; every page must be legible and include appropriate patient identification (e.g., complete name, dates of service).
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.
- Allergy testing is covered when the medical record documents a history indicating the possible presence of allergy and the clinician selected a minimal number of tests/antigens based on patient-specific history and physician examination.
- Allergy testing is covered when the medical record documents the test(s) used, the interpretation(s), and objective measurement of reaction size (wheal and erythema in mm) or a standardized in vivo grading system.
13 Active Policies
L36402 — Allergy Testing
J05
A57473 — Billing and Coding: Allergy Testing
J05
L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J06
A52448 — Billing and Coding: Omalizumab and biosimilar, OMLYCLO (omalizumab-igec)
J06
A57531
Related Codes
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