Article - Billing and Coding: Omalizumab (A52448)

CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE).Definitions:Moderate persistent asthmaModerate persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as:Daily symptomsDaily use of inhaled short-acting beta2-agonistSome limitation with normal activityExacerbations requiring oral systemic corticosterioids>2/yearNighttime symptoms greater than 1 time a week but not nightlyFEV1>60% but <80% predictedFEF1/FVC reduced 5%Severe persistent asthmaSevere persistent asthma is defined by the National Heart, Lung, and Blood Institute (NHLBI) as:Symptoms throughout the dayUse of inhaled short-acting beta2-agonist several times per dayExtremely limited normal activityExacerbations requiring oral systemic corticosterioids>2/yearNighttime symptoms often 7x/weekFEV1<60% predictedFEV1/FVC reduced >5%NHLBI normal ranges by age for FEV1/FVC8-19 years of age  85%;20-39 years of age  80%;40-59 years of age  75%;60-80 years of age  70%.The presence of one of these features of severity (moderate or severe) is sufficient to place a patient in that category. These clinical features are based on pre-treatment symptoms and measurements.Because of the chance of anaphylaxis with omalizumab, patients should receive omalizumab treatment in a doctor's office or clinic setting and be observed for an appropriate period of time after each treatment. Omalizumab should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.Omalizumab has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus.Utilization:Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.Omalizumab is covered when the drug is administered by a physician or incident to a physicians service in a clinic or office setting.Omalizumab is not covered if self-administered by the patient.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc. AHFS Drug Information. Bethesda, MD: 2007.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 06/15/2021.Lexi-Drugs Web site. http://online.lexi.com/lco/action/home. Accessed 06/15/2021.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 06/15/2021.Micromedex DrugDex Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 06/15/2021.U.S. Food and Drug Administration label approved 06/20/2003. Drugs@FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed 02/16/2022.United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.