CMS not convinced by BioZ data
This article was originally published in The Gray Sheet
Executive Summary
CMS Nov. 20 finalizes its proposed decision not to expand national coverage of CardioDynamics' BioZ transthoracic electrical bioimpedance test to guide treatment of drug-resistant hypertension. "The absence of a direct link from the intervention to the reported outcome is at the core of our reservations about the CONTROL trial," upon which the firm based its request, CMS writes. The agency provides guidelines as to what a more convincing trial might look like, including longer follow-up and tighter protocols. CardioDynamics says it will develop another hypertension study (1"The Gray Sheet" Sept. 4, 2006, p. 17)...