BioZ Coverage Expansion Effort Requires Another Study, Firm Says
This article was originally published in The Gray Sheet
Executive Summary
CardioDynamics will develop an additional trial of its BioZ impedance cardiography (ICG) test for managing drug-resistant hypertension patients following CMS' proposed rejection of expanded Medicare coverage for the procedure
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CMS not convinced by BioZ data
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)...
CMS not convinced by BioZ data
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)...
CMS plans not to expand BioZ coverage
CMS proposes Aug. 24 to leave coverage of transthoracic electrical bioimpedance (TEB) treatment for drug-resistant hypertension at the discretion of local contractors. Although a majority of the 214 comments made during the initial 30-day public comment period supported CardioDynamics' request that coverage for its BioZ TEB system be expanded to all patients with hypertension, CMS argues that no new scientific evidence was submitted (1"The Gray Sheet" April 10, 2006, In Brief). CardioDynamics cited a study in the June 6 Journal of the American College of Cardiology showing the near-term heart failure predictive power of its BioZ impedance cardiography technology (2"The Gray Sheet" June 12, 2006, In Brief). Comments on the proposal are due Sept. 23, with a final decision expected in November...