Report: US Reimbursement System Hinders Diagnostics Development

Some innovative diagnostic tests may never make it to market in the U.S. unless changes are made to the country’s reimbursement system, the Biotechnology Industry Organization (BIO) says. Obtaining coverage, appropriate coding and value-based payment for novel diagnostics is proving to be difficult because the current reimbursement system was designed to support relatively simple tests, which formed the basis of the traditional diagnostics industry, according to a new report commissioned by BIO.
International Medical Device Regulatory Monitor