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Molecular Dx Coalition Seeks to Prod CMS to Restore Test Pricing During Review

NEW YORK (GenomeWeb News) – Clinical lab organizations and a number of companies that develop and make molecular diagnostics have banded together to create a group to press for better government reimbursement while the US Centers for Medicare and Medicaid Services works to restructure its pricing plans.

The Coalition to Strengthen the Future of Molecular Diagnostics said last week that it has launched because CMS has been paying lower reimbursement rates while it conducts a review of its process for pricing these tests.

Before 2013, CMS used a method called code stacking, in which each step or process used to perform a test is reimbursed, but the centers have engaged a different method, called gap-fill, to price these tests while it conducts its review.

The gap-fill pricing method has led to cuts in payment rates of around 20 percent for many tests, and a reduction of as much as 80 percent for some tests, compared with 2012 levels.

"This drastic plummet in reimbursement will have a dangerous ripple effect felt throughout the country," Richard Ding, CEO of coalition member BioTheranostics, said in a statement.

"This is a critical time to demonstrate the value molecular diagnostic testing adds to the healthcare system overall and help CMS to understand the role of this science in a patient's course of care from diagnosis to treatment," added Alan Mertz, president of American Clinical Laboratory Association.

"Molecular diagnostic testing has transformed the way cancer and many other life-threatening conditions are treated, therefore the cost and value of that contribution must be factored into Medicare pricing for these services," Mertz noted.

The coalition said it supports the CMS goal of enhanced transparency and a more efficient pricing method, but it is not happy about the interim pricing or the process by which this method was settled upon. The members are asking CMS to provide relief from the new reimbursement rates from some tests and that it use a "data-driven pricing process that will allow for more transparency and participation from various industries and interest groups."

The group's members include a number of large and small molecular diagnostic firms, pharmaceutical companies, as well as the ACLA and the Lung Cancer Alliance.