FDA MAY PROVIDE ASSISTANCE TO HCFA IN MAKING MEDICARE DEVICE COVERAGE DECISIONS; FDA EVALUATING HCFA HOME-USE DEVICE DATA FOR DESIGNING CLINICAL STUDIES
This article was originally published in The Gray Sheet
Executive Summary
An FDA role in device Medicare coverage decisions made by the Health Care Financing Administration is being explored by the two agencies. FDA's Center for Devices and Radiological Health and HCFA's Bureau of Policy & Development have held preliminary talks over the past several weeks to discuss ways in which device data received by CDRH might be helpful to HCFA in making coverage decisions.