The Centers for Medicare & Medicaid Services (CMS) May 4 proposed that pharmacogenomic testing to predict how a beneficiary responds to an anticoagulant drug will not be covered by Medicare, unless the beneficiary is enrolled in a clinical trial that meets specific guidelines.

In the proposed decision memo, CMS said it believes that testing to predict responsiveness to warfarin is not “reasonable and necessary,” and does not improve the health outcomes of beneficiaries.

However, CMS said the available evidence on the effectiveness of the pharmacogenomic testing suggested that coverage with evidence development (CED) would be appropriate. CMS said the testing would only be covered if the beneficiary were a candidate for anticoagulation therapy with the drug warfarin in the context of a randomized clinical trial.

CMS said it is soliciting public comments on the proposed decision. The agency did not specify a deadline for comments.

CMS said in the notice the use of pharmacogenomic testing would be used to predict a patient's response to warfarin before the initiation of the drug. The agency said it would be a once-in-a-lifetime test, absent any reason to believe that the patient's personal genetic characteristics would change over time.

Warfarin is a self-administered oral blood thinner, and affects vitamin K dependent clotting factors. It has a trade name of Coumadin, but also is marketed by various manufacturers under different names.

There has been only one instance when CMS expanded Medicare coverage following data collection under CED. That occurred in April, when CMS expanded coverage of positron emission tomography (PET) scans for certain cancer treatments.

In the CMS document, the agency noted that several laboratory test manufacturers offer Food and Drug Administration-cleared kits suitable for testing for VKORC1 and CYP2C9 gene variants associated with warfarin metabolism. One such test is from Nanosphere Inc., and received FDA market clearance in 2007.

The Proposed Decision Memo for Pharmacogenomic Testing for Warfarin Response can be found at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=224 .