Coverage Policy Manual
Policy #: 2012014
Category: Laboratory
Initiated: April 2012
Last Review: April 2022
  Genetic Test: Asthma, HLA-DR and HLA-DQ Genotyping

Description:
In 2012, CPT released a series of codes to be used for HLA typing (81370-81383). HLA-DR and HLA-DQ genotyping may be billed with a combination of these codes. Prior to the release of these codes, a combination of the following molecular diagnostic codes may have been used: 83890,  83891, 83896, 83898, 88384,88385, 83900 and 83912.

Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
HLA-DR and HLA-DQ genotyping for the diagnosis and management of asthma or other allergic disorders does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, HLA-DR and HLA-DQ genotyping for the diagnosis and management of asthma or other allergic disorders is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
In their genome-wide association study (GWAS), Li and Colleagues found an association between HLA-DR and HLA-DQ and the severe or difficult to treat asthma patient (Li, 2010). The authors of this observational study report that their study will “stimulate more comprehensive research”; but no conclusions are drawn regarding the clinical utility of this testing.  
 
There is insufficient scientific evidence that this test improves health outcomes and is either not recommended by, or is not addressed in the following references.
 
EGAPP:
HLA-DR and HLA-DQ genotyping for the diagnosis and management of asthma or other allergic disorders has not been evaluated by EGAPP.
 
Gene Reviews:
HLA-DR and HLA-DQ genotyping for the diagnosis and management of asthma or other allergic disorders has not been evaluated by GeneReviews.
 
American College of Medical Genetics:
HLA-DR and HLA-DQ genotyping for the diagnosis and management of asthma or other allergic disorders has not been evaluated by the American College of Medical Genetics.
 
Hayes Inc Assessment:
Hayes Inc. Assessment does not address HLA-DR and HLA-DQ genotyping for the diagnosis and management of asthma or other allergic disorders.
 
2014 Update
 
A literature search conducted through March 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search was conducted using the MEDLINE database and the clinicaltrials.gov website.  There were no published studies assessing the clinical utility of HLA genotyping in the treatment or management of Asthma. Additionally, there were no ongoing clinical trials identified.
 
2016 Update
A literature search conducted through March  2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature review conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.   
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2018. No new literature was identified that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through March 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2022. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
81370HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA A, B, C, DRB1/3/4/5, and DQB1
81371HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA A, B, and DRB1 (eg, verification typing)
81372HLA Class I typing, low resolution (eg, antigen equivalents); complete (ie, HLA A, B, and C)
81373HLA Class I typing, low resolution (eg, antigen equivalents); one locus (eg, HLA A, B, or C), each
81374HLA Class I typing, low resolution (eg, antigen equivalents); one antigen equivalent (eg, B*27), each
81375HLA Class II typing, low resolution (eg, antigen equivalents); HLA DRB1/3/4/5 and DQB1
81376HLA Class II typing, low resolution (eg, antigen equivalents); one locus (eg, HLA DRB1, DRB3/4/5, DQB1, DQA1, DPB1, or DPA1), each
81377HLA Class II typing, low resolution (eg, antigen equivalents); one antigen equivalent, each
81378HLA Class I and II typing, high resolution (ie, alleles or allele groups), HLA A, B, C, and DRB1
81379HLA Class I typing, high resolution (ie, alleles or allele groups); complete (ie, HLA A, B, and C)
81380HLA Class I typing, high resolution (ie, alleles or allele groups); one locus (eg, HLA A, B, or C), each
81381HLA Class I typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, B*57:01P), each
81382HLA Class II typing, high resolution (ie, alleles or allele groups); one locus (eg, HLA DRB1, DRB3/4/5, DQB1, DQA1, DPB1, or DPA1), each
81383HLA Class II typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, HLA DQB1*06:02P), each

References: American College of Medical Genetics Practice Guidelines. Accessed at http://www.acmg.net//AM/Template.cfm?Section=Home3. Last accessed April 19, 2012.

Evaluation of Genomic Applications in Practice and Prevention. Accessed at http://www.egappreviews.org/. Last accessed April 19, 2012.

GeneReviews. Accessed at http://www.ncbi.nlm.nih.gov/books. Last accessed April 19, 2012.

Hayes Genetic Test Evaluation. Accessed at https://www.hayesinc.com/subscribers/subscriberHome.do. Last accessed April 19, 2012.

Knutsen AP, Vijay HM, Kumar V, et al.(2010) Mold-sensitivity in children with moderate-severe asthma is associated with HLA-DR and HLA-DQ. Allergy 2010;65: 1367-1375.

Li X, Howard TD, Zheng SL, et al.(2010) Genome-wide association study of asthma identifies RAD50-IL13 and HLA-DR/DQ regions. J Allergy Clin Immunol. 2010 February; 125(2): 328-335.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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