Does Q5154 require prior authorization?

No, Q5154 does not require prior authorization (high confidence). Covered without prior authorization.

What is the Medicare reimbursement rate for Q5154?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`Q5154`, Injection, omalizumab-igec (omlyclo), biosimilar, 5 mg

HCPCS/CPT

Prior Authorization

No Prior Auth Required

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.

Provider requests to add an off-label use must be submitted in writing with supporting data consisting of either at least two Phase III trials demonstrating safety and effectiveness, or if no Phase III evidence exists, at least two large Phase II trials from different centers or other overwhelming Phase II evidence for rare diseases.

Trials cited must be published in national or international peer-reviewed journals (editorial committees comprised of physicians); abstracts and non-peer-reviewed or in-house publications are not acceptable.

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).

3 Active Policies

NGS-J6-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

A52448, Billing and Coding: Omalizumab and biosimilar, OMLYCLO (omalizumab-igec)

NGS-JK-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

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Q5154, Injection, omalizumab-igec (omlyclo), biosimilar, 5 mg