BG Medicine said this week that the Centers for Medicare and Medicaid Services have assigned a payment rate for the company's BGM Galectin-3 test under a new analyte-specific Current Procedural Terminology code that will go into effect Jan. 1, 2013.
The company added that CMS declined BG Medicine's request for a higher payment rate under this new code and will instead crosswalk the payment rate to the CPT code under which the test is currently paid.
In a statement, BG Medicine president and CEO Eric Bouvier said that despite the CMS decision, the company plans to continue pursuit of the higher reimbursement rate next year. "We will pursue an increased Medicare reimbursement rate for this test for 2014 that, we believe, will more appropriately reflect the value of this important diagnostic test," he said.
The company sells the BGM Galectin-3 test for use in monitoring patients with chronic heart failure. A manual version of that test has received US Food & Drug Administration 510(k) approval and a CE mark from the EU, and in July the company filed a 510(k) application for an automated version of the test to be run on Abbott Laboratories' Architect platform (PM 7/27/2012).
The company is also pursuing wider applications for the test. In May, BG announced that it had obtained a CE mark and filed a 510(k) submission for an expanded use of the Galectin-3 test that could be used for predicting risk of heart failure in the general adult population (PM 5/17/2012). According to Bouvier, this additional use would significantly expand the market for the test – taking it from around 20 million patients in the US and Europe to roughly 200 million.
Recent data from the National Heart, Lung and Blood Institute's Framingham Heart Study, however, has called into question the test's usefulness with regard to this expanded indication (PM 9/7/2012).