MedStar Health, Inc. POLICY AND PROCEDURE MANUAL POLICY NUMBER: PAY.122.MH REVISION DATE: N/A ANNUAL APPROVAL DATE: 03/13 PAGE NUMBER: 1 of 4 SUBJECT: Genetic Testing for Clopidogrel (Plavix) Metabolism INDEX TITLE: Medical Management ORIGINAL DATE: January 2013 This policy applies to the following lines of business: (Check those that apply.) COMMERCIAL MedStar Select ( X ) MedStar Medicare Choice ( X )
It is the policy of MedStar Health, Inc. to cover Genetic Testing for Clopidogrel (Plavix) metabolism when it is medically necessary as detailed in this policy and covered under the member’s specific benefit plan.
DEFINITIONS
The purpose of this policy is to identify indications for Genetic Testing for Clopidogrel (Plavix) metabolism.
This policy applies to various MedStar Health departments as indicated by the Benefit and Reimbursement Committee. These include but are not limited to Medical Management, Benefit Configuration and Claims Departments.
PROCEDURE A. Medical Description / Background
UPMC Health Plan and Evolent Health provide administrative functions and services
on behalf of MedStar Health, Inc. and its affiliates.
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POLICY NUMBER: PAY.122.MH REVISION DATE: N/A ANNUAL APPROVAL DATE: 03/13 PAGE NUMBER: 2 of 4
PLAVIX® /Clopidogrel Bisulfate, an anti-platelet agent, is commonly prescribed for patients with a history of recent myocardial infarction, stroke, or established peripheral arterial disease, acute coronary artery syndrome (ACS) as well as patients who are to be managed with percutaneous coronary intervention (PCI). CYP2C19 is one of the principal enzymes involved in the metabolism of the Clopidogrel (Plavix). The presence of CYP2C19*2, a gene variant, can cause poor metabolism of the drug which can lead to increased risk for adverse cardiovascular events. Genetic testing is available to identify a patient's CYP2C19 genotype (including the presence of gene variants) which can be used in determining the therapeutic strategy for treatment with Clopidogrel (Plavix). Examples of test names are: AccuType® CP, AccuType™ and Clopidogrel CYP2C19 genotyping.
B. Indications
Genetic testing for Clopidogrel (Plavix) metabolism is covered for persons who are being considered for the drug, before treatment begins, and have not been previously tested.
C. Limitations/Exclusions
Genotype test results are applied life-long, therefore, repeat genetic testing for Clopidogrel (Plavix) metabolism has no proven value.
D. Variations E. Quality Audit Quality Audit monitors policy compliance and/or billing accuracy at the request of the MedStar HealthTechnology Assessment Committee or the Benefits Reimbursement Committee. F. Records Retention Records Retention for documents, regardless of medium, are provided within the MedStar Health, Inc. Policy and Procedure CORP.028.MH Records Retention. G. References
1. Holmes DR, et al. (2010). ACCF/AHA Clopidogrel clinical alert: Approaches to the FDA
"Boxed Warning": A report of the American College of Cardiology Foundation Task Force on
UPMC Health Plan and Evolent Health provide administrative functions and services
on behalf of MedStar Health, Inc. and its affiliates.
Proprietary and Confidential Information of UPMC Health Plan 2013 UPM
POLICY NUMBER: PAY.122.MH REVISION DATE: N/A ANNUAL APPROVAL DATE: 03/13 PAGE NUMBER: 3 of 4
Clinical Expert Consensus Documents and the American Heart Association. Circulation, 122(5): 537–557
2. PubMed: Clopidogrel, 11/1/103. Mega JL, et al. (2010). Reduced-function CYP2C19 genotype and risk of adverse clinical
outcomes among patients treated with clopidogrel predominantly for PCI: A meta-analysis. JAMA, 304(16): 1821–1830
4. Paré G, et al. (2010). Effects of CYP2C19 genotype on outcomes of clopidogrel treatment.
New England Journal of Medicine, 363(18): 1704–1714
5. Michael Holmes, Pablo Perel et al: CYP2C19 Genotype, Clopidogrel Metabolism, Platelet
Function, and Cardiovascular Events A Systematic Review and Meta-Analysis, JAMA 2011;306(24):2704-2714
6. SA Scott, K Sankuhl, EE Gardner et al: Clinical Pharmacogenetics Implementation
Consortium Guidelines for Cytochrome P450-2C19 (CYP2C19) Genotype and Clopidogrel Therapy, Consortium of the National Institutes of Health’s Pharmacogenomics Research Network, Clinical Pharmacology & Therapeutics, 6/29/11
7. QUEST: AccuType™ CP testing for Clopidogrel CYP2C19 Genotype (*1, *2, *3, *4, *5),
8. QUEST: AccuType® CP: Clopidogrel Response Testing, 11/12
9. ACCF/AHA Clopidogrel Clinical Alert: Approaches to the FDA “Boxed Warning, Circulation
10. BCBC Technology Evaluation Center , Assessment Program, Volume 23, No. 1, May 2008
11. Dept of Health and Human Services, AHRQ: decode Clopidogrel, Technology Assessment,
12. Dept of Health and Human Services Technology Assessment (AHRQ) Update on Horizon
Genetic Tests Currently Available for Clinical Use in Cancers, 4/15/11
Disclaimer: MedStar Health, Inc. medical payment and prior authorization policies do not constitute medical advice and are not intended to govern or otherwise influence the practice of medicine. The policies constitute only the reimbursement and coverage guidelines of MedStar Health, Inc. and its affiliated managed care entities. Coverage for services varies for individual members in accordance with the terms and conditions of applicable Certificates of Coverage, Summary Plan Descriptions, or contracts with governing regulatory agencies. MedStar Health, Inc. reserves the right to review and update the medical payment and prior authorization guidelines in its sole discretion. Notice of such changes, if necessary,
UPMC Health Plan and Evolent Health provide administrative functions and services
on behalf of MedStar Health, Inc. and its affiliates.
Proprietary and Confidential Information of UPMC Health Plan 2013 UPM
POLICY NUMBER: PAY.122.MH REVISION DATE: N/A ANNUAL APPROVAL DATE: 03/13 PAGE NUMBER: 4 of 4
shall be provided in accordance with the terms and conditions of provider agreements and any applicable laws or regulations. These policies are the proprietary information of UPMC Health Plan. Any sale, copying, or dissemination of said policies is prohibited.
UPMC Health Plan and Evolent Health provide administrative functions and services
on behalf of MedStar Health, Inc. and its affiliates.
Proprietary and Confidential Information of UPMC Health Plan 2013 UPM
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MedStar Health, Inc. 
POLICY NUMBER: PAY.122.MH 
POLICY NUMBER: PAY.122.MH 
POLICY NUMBER: PAY.122.MH