LCD Reference Article Billing and Coding Article

Billing and Coding: Omalizumab

A52448

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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General Information

Source Article ID
N/A
Article ID
A52448
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Omalizumab
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
03/10/2022
Revision Ending Date
N/A
Retirement Date
N/A
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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

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Article Guidance

Article Text

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.

Response To Comments

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

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Group 1 Codes
Code Description
J2357 INJECTION, OMALIZUMAB, 5 MG
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CPT/HCPCS Modifiers

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(16 Codes)
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Group 1 Codes
Code Description
J33.0 Polyp of nasal cavity
J45.40 Moderate persistent asthma, uncomplicated
J45.41 Moderate persistent asthma with (acute) exacerbation
J45.42 Moderate persistent asthma with status asthmaticus
J45.50 Severe persistent asthma, uncomplicated
J45.51 Severe persistent asthma with (acute) exacerbation
J45.52 Severe persistent asthma with status asthmaticus
L50.1 Idiopathic urticaria
L50.6 Contact urticaria
L50.8 Other urticaria
L50.9 Urticaria, unspecified
T78.40XA Allergy, unspecified, initial encounter
T78.40XD Allergy, unspecified, subsequent encounter
T78.40XS Allergy, unspecified, sequela
Z91.010 Allergy to peanuts
Z91.040 Latex allergy status
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description
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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description
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Other Coding Information

Group 1

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
03/10/2022 R5

Based on provider comment, the following outdated information has been removed: Omalizumab is used as a maintenance drug to reduce the number of exacerbations in patients (12 years of age or above) with moderate to severe persistent asthma. Please refer to the FDA label.

07/01/2021 R4

Based on an FDA update, ICD-10 code J33.0 has been added effective for dates of service on or after 11/30/2020.

11/07/2019 R3

This article was converted to the new Billing and Coding Article format and the brand name, Xolair® has been removed. The Article Text section has been revised to remove the indications which can be found on the FDA Web site and in the approved compendia. The “Sources of Information” has been revised to “FDA and Compendia Review.” Sources of information other than the FDA and compendia have been moved to a PDF file attached to LCD L33394. The Bill type codes have been removed from this article. Guidance on these codes is available in the Bill type code section.

10/01/2015 R2 ICD-10-CM codes J45.41, J45.42, J45.51 and J45.52 have been added effective 10/01/2015. ICD-10-CM codes J45.20, J45.30 and J45.998 are being removed from the article as they are not appropriately used to describe moderate to severe persistent asthma and were included in error on transition to ICD-10-CM. Effective with claims received on or after 02/15/2016, these ICD-10 codes will no longer be covered.
10/01/2015 R1 The place of service guidelines for the Part B MAC have been removed. ICD-10-CM codes T78.40XD and T78.40XS have been added to the Group 1: Codes in the Covered ICD-10 Codes section. The dosing information has been removed and replaced with the following Utilization guideline: 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.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
03/04/2022 03/10/2022 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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