Diverse Stakeholders Form Molecular Diagnostics Coalition

A diverse group of stakeholders across health care industries and patient advocacy organizations has formed a new coalition to advocate for transparency and input in the discussion about Medicare payment for molecular diagnostic testing. The Coalition to Strengthen the Future of Molecular Diagnostics (CSFMD) was formed with the objective of informing policymakers and CMS about the value of genetic testing and the impact timely and accurate diagnosis have on treatment decisions and patient outcomes. Under a new policy by which Medicare Administrative Contractors (MACs) determine prices for new molecular pathology codes, CMS on May 9 posted interim prices for the remainder of 2013. Those prices effectively cut payment rates for many critical tests by an average of 20 percent and as high as 80 percent in some cases from 2012 levels. Compounding the drop in Medicare reimbursement is the fact that many diagnostic tests are not being covered by MACs outside of the normal coverage decision process, and many clinical labs that have been performing these tests since January 2013 are discovering they will not be paid at all. The confluence of these actions are threatening the business viability of molecular labs across the country, as well triggering uncertainty for R&D investors and pharmaceutical companies manufacturing targeted therapies, according to the coalition.