HCFA Seeks Long-Term Data From Trials; Health Plans Prefer The Opposite
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers designing clinical trials to support both premarket approval and reimbursement coverage for their devices need to demonstrate "long-term outcome measures," Grant Bagley, director of the Coverage and Analysis Group in the Health Care Financing Administration's Office of Clinical Standards and Quality, said at an Association for the Advancement of Medical Instrumentation meeting Oct. 9 in Baltimore.