Industry officials, including leadership at the Advanced Medical Technology Association, are calling on FDA and CMS to improve coordination to prevent mixed messaging as part of the competitive bidding process, with FDA recently acknowledging divergent focuses from the two agencies, according to informed industry sources. The disconnect — with CMS and health reformers focusing on lowest prices of products, and FDA stressing more support services — leads to planning confusion for manufacturers of sophisticated therapy products for the home, sources said.
Manufacturers don’t know whether to develop lowest cost products to win CMS competitions or to strive to meet FDA standards for product support.