CMS believes that the available evidence does not demonstrate that pharmacogenomic testing of CYP2C9 or VKORC1alleles to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries. Therefore, we have determined that pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness is not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act. However, we do believe the available evidence supports that Coverage with Evidence Development (CED) under §1862(a)(1)(E) of the Social Security Act is appropriate. Thus, we are making the following decision.
Pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness is covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin who:
- have not been previously tested for CYP2C9 or VKORC1 alleles; and
- have received fewer than five days of warfarin in the anticoagulation regimen for which the testing is ordered; and
- are enrolled in a prospective, randomized, controlled clinical study when that study meets the standards specified in the decision memorandum (DM).
The clinical study must answer one or more aspects of the questions stated in the decision memorandum. The criteria that CMS will use to evaluate study protocols submitted by investigators is in an appendix to the DM.
Study Title: Genetics Informatics Trial (GIFT) of Warfarin to Prevent DVT
Sponsor: Washington University School of Medicine
Clinicaltrials.gov Number: NCT01006733
CMS Approval Date: 12/16/2009
Study Title: Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Sponsor: Iverson Genetic Diagnostics, Inc.
Clinicaltrials.gov Number: NCT01305148
CMS Approval Date: 06/17/2010