Billing and Coding: Omalizumab

This 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 asthma_ **  
  
**Moderate persistent asthma is defined by the National Heart, Lung, and Blood
Institute (NHLBI) as: **  
**

  * Daily symptoms
  * Daily use of inhaled short-acting beta 2-agonist
  * Some limitation with normal activity
  * Exacerbations requiring oral systemic corticosterioids _ > _ 2/year
  * Nighttime symptoms greater than 1 time a week but not nightly
  * FEV 1 >60% but <80% predicted
  * FEF 1/FVC reduced 5%

_Severe persistent asthma_  
  
Severe persistent asthma is defined by the National Heart, Lung, and Blood
Institute (NHLBI) as:

  * Symptoms throughout the day
  * Use of inhaled short-acting beta 2-agonist several times per day
  * Extremely limited normal activity
  * Exacerbations requiring oral systemic corticosterioids _ > _ 2/year
  * Nighttime symptoms often 7x/week
  * FEV 1 <60% predicted
  * FEV 1/FVC reduced >5%

  
NHLBI normal ranges by age for FEV 1/FVC

  * 8-19 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 physician's 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.