2009-08-13
The Centers for Medicare
& Medicaid Services (CMS) posted a decision memo noting that the available
evidence does not demonstrate that pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict
warfarin responsiveness improves health outcomes in Medicare beneficiaries. CMS
has determined that pharmacogenomic testing of CYP2C9 or VKORC1
alleles to predict warfarin responsiveness is not reasonable and necessary, but
the available evidence supports that Coverage With Evidence Development
is appropriate.
The final decision is that 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;
- 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 specific standards.
In September 2008, ASH
submitted comments to CMS on this issue. There was significant uncertainty
regarding this new and emerging technology and ASH did not support the use of
pharmacogenomic testing to guide initial dosing or ongoing treatment of
warfarin, but was supportive of the use of pharmacogenomic testing for warfarin
responsiveness in the context of randomized prospective clinical trials to
establish the efficacy and safety of this approach. The CMS final decision is consistent with the
ASH letter.
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