Inside the Diagnostics Industry: Next-Gen-Based Tests Face Significant Reimbursement Hurdles
During the first quarter of 2013 all eyes have been focused on early coverage and pricing decisions for molecular tests during the gap-filling transition to the new molecular pathology (MoPath) Current Procedural Terminology (CPT) codes. Like most molecular tests, tests utilizing next-generation sequencing (NGS) technology face challenges in establishing positive reimbursement decisions from payers and proving clinical utility. But NGS-based tests face an even greater battle for reimbursement since testing volumes remain low and the technology does not yet have dedicated CPT codes, making the desired test transparency virtually impossible.The new MoPath codes are intended to bring greater transparency to laboratory coding for tests and allow payers to better track test utilization. But standardized evidence thresholds to prove clinical utility remain elusive, and test developers must pursue coverage and reimbursement conversations with each payer individually. “There is a great deal of uncertainty when it comes to reimbursement in part because of the deficit in education in molecular testing as a whole,” says Jerry Conway, vice president of reimbursement and payer strategy for Foundation Medicine (Cambridge, Mass.). “As the system of payment evolves to accommodate other molecular technologies that have been on the market longer and drive higher volumes of testing, […]
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