NEW YORK (GenomeWeb News) – The Centers for Medicare and Medicaid Services said this week that it would not pay for genetic tests to help guide warfarin dosing for Medicare recipients, noting in a proposed decision memo that "available evidence does not demonstrate that pharmacogenomic testing to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries."
Instead, CMS proposed a so-called "coverage with evidence development" strategy, in which it would pay for PGx-based warfarin dosing only for Medicare beneficiaries who are part of a prospectively designed, randomized-controlled trial showing pharmacogenomics-guided dosing strategies improve health outcomes over standard dosing methods.
CMS is soliciting comments on this proposal until June 3.
Under the CMS proposal, coverage for Medicare beneficiaries will be granted only when a prospective, randomized trial finds that PGx-guided warfarin dosing compared to standard methods lessens the frequency and severity of hemorrhage and thromboembolism, or reduces mortality. In order to receive payment, studies must adhere to "appropriate standards of scientific integrity," and relate to the Medicare population, according to the standards laid out by CMS.
In August 2007, the FDA updated the label for warfarin to note that people with variations of the genes CYP2C9 and VKORC1 may respond adversely to the drug. The agency did not require physicians to genetically test their patients, however, noting that additional outcomes studies would be necessary.
Despite the update, most national insurers have decided to not cover genetic tests for warfarin dosing, maintaining that there is insufficient evidence confirming the clinical utility of the technology.
At least one large, national insurer, Aetna, told GenomeWeb Daily News sister publication Pharmacogenomics Reporter this week that it does not currently cover PGx testing for warfarin and suggested that CMS' CED proposal will not inspire any policy changes in the near term.
"Aetna currently does not cover diagnostic genetic tests for warfarin because the clinical value of this type of genetic testing has not been established," an Aetna spokesperson said. "Aetna would not currently cover them in a clinical trial setting either."
A more comprehensive version of this article is available on Pharmacogenomics Reporter.