CSHCN 2009 > Physician > Benefits, Limitations, and Authorization Requirements

29.2.24.17 Omalizumab

Omalizumab (procedure codes J2357) is a benefit of the CSHCN Services Program when medically necessary for the treatment of clients 12 years of age or older with severe asthma and must be prior authorized. Clients younger than 12 years of age may be considered for authorization in exceptional circumstances. Procedure code J2357 must be used to request prior authorization and the exact dosage must be indicated.

Doses and dosing frequency are determined by body weight and by serum IgE level (IU/ml) measured before the start of the treatment.

Authorization of omalizumab is based on the following medical necessity criteria:

•Diagnosis of asthma

•12 years of age or older

•Documentation of positive skin test or RAST to a perennial (not seasonal) aeroallergen within the past 36 months

•Total IgE level greater than 30 IU/ml but less than 700 IU/ml within the past 12 months

•Documentation of appropriate dose of inhaled steroid prescribed approximately 660 micrograms per day of fluticasone [adult] or comparable dose of other inhaled steroid)

•Documentation of patient compliance with inhaled steroid regimen

•Clinical evidence of inadequate asthma control. This evidence may include:

•Dependence on continuous systemic steroid, maximal inhaled steroid regimen with frequent systemic steroid pulses.

•Significantly declining pulmonary function test or frequent hospitalizations for severe asthma exacerbations in the face of adequate maximal standard therapy and client has to have been on daily therapy for persistent asthma for at least 1 year, with daily use of beta agonist.

•A pulmonary function test (performed in the last year) must demonstrate a forced expiratory volume (FEV) 1.0 less than 80 percent of predicted in conjunction with FEV 1.0/FVC ratio < 0.7 of pulmonary function test; and test results demonstrating on the same test a 12 percent or greater post bronchodilator improvement of FEV 1.0

Providers may submit documentation that the client is unable to perform the pulmonary function test in lieu of test results. Provider must document that the client is not currently smoking, pregnant, intending pregnancy, or breast feeding.

Omalizumab approvals are for intervals of 3 months at a time. Clients must be fully compliant with their omalizumab regime in order to qualify for any additional authorizations. The provider must submit a statement documenting full compliance with the requests for each renewal in order to qualify for any additional authorizations. After 9 continuous months of authorizations, the provider must submit documentation of satisfactory clinical response to omalizumab in order to qualify for additional authorizations.

Prior authorization requests following lapses in treatment is considered on an individual basis with provider documentation.

Providers may not bill separately for an office visit if the only reason for the visit was the omalizumab injection.

Refer to: Appendix B, "CSHCN Services Program Prior Authorization Request for Omalizumab," on page B-57.