Biodesix today commended the Centers for Medicare & Medicaid Services (CMS) for publishing preliminary 2018 rates for clinical diagnostic laboratory tests, including Biodesix’s VeriStrat® test. The CMS has announced that rates will be finalized in November 2017, following a public comment period, and that the new rates are scheduled to become effective on January 1, 2018.
“This is a clear and welcome signal to the industry that CMS is committed to the system envisioned by Congress in the Protecting Access to Medicare Act of 2014, or PAMA,” said Biodesix CEO David Brunel. “Biodesix appreciates that CMS remains committed to modernizing the CLFS rate development process detailed in PAMA since it provides stability to the market while ensuring Medicare beneficiaries access to innovative diagnostics including the VeriStrat test. Further, the additional reporting flexibility earlier this year and robust transparency offered last week are notable reinforcements of CMS’s support for the new market-based payment model. Biodesix appreciates CMS’s openness throughout the PAMA rate setting process. We look forward to continued partnership with CMS as it finalizes the PAMA rates, and as we begin a new CLFS payment system in January.”
Biodesix’s VeriStrat test is a predictive and prognostic blood-based proteomic test for patients with advanced non-small cell lung cancer. The test is used to assess disease aggressiveness by characterizing host response to the tumor, classifying patients as either VeriStrat-Good or VeriStrat-Poor. VeriStrat test results are available to ordering physicians within 72 hours.
Biodesix® is a molecular diagnostics company advancing the development of innovative blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic blood tests, including the GeneStrat™ and VeriStrat® tests that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of precision medicine, Biodesix is developing new blood tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.