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Medicare proposes decision NOT to pay for genetic testing for warfarin (Coumadin) dosing

Marie B. Walker
July, 2009

Two years ago, ClotCare examined the issue of genetic testing for warfarin (Coumadin) dosing and concluded that:

...genetic testing for warfarin dosing may hold promise, but its time has not yet arrived. Clearly, more research is needed in this area, and solid clinical data demonstrating a clear benefit of such testing should be required before such testing is recommended on a routine basis.

Recently, Medicare issued a proposed decision that seems to agree. The complete text of the proposed decision is available on Medicare's website at cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=224. An excerpt from the decision is below:

CMS believes that the available evidence does not demonstrate that pharmacogenomic testing to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries. Therefore, we are proposing that pharmacogenomic testing 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 suggests that Coverage with Evidence Development (CED) under §1862(a)(1)(E) of the Social Security Act is appropriate. Thus, we are proposing the following decision:

Pharmacogenomic testing to predict warfarin responsiveness is covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin and only then in the context of a prospective, randomized, controlled clinical study...

Read more at cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=224.

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Monday, October 23, 2017