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Comments for CardioDynamics NCD

This article was originally published in The Gray Sheet

Executive Summary

Firm finds physician support in the majority of more than 200 comments submitted during the initial comment period, ended March 30, on expanded national coverage for its BioZ impedance cardiography technology. CardioDynamics is seeking coverage for the test's management of all patients with hypertension (1"The Gray Sheet" March 6, 2006, In Brief). The firm notes that results of its CONTROL trial supporting this indication have been published since CMS opened the decision. Robert Streimer, deputy director at CMS' Office of Clinical Standards & Quality until 2004, claims the original limited coverage decision for the technology was pushed through by former California congressman Randy "Duke" Cunningham and recommends either totally withdrawing coverage for BioZ or reducing the product's payment. CMS' proposed coverage decision is due Aug. 28...

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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...

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Firm hopes CMS will expand coverage of its thoratic electrical bioimpedance (TEB) devices for the management of all patients with hypertension. Coverage for the management of drug-resistant hypertension, defined by non-response to three or more medications, is at the discretion of local contractors, while other forms of hypertension are non-covered. CardioDynamics cites recent data from its multi-centered, randomized CONTROL trial as evidence that its BioZ impedance cardiography technology leads to greater reduction in blood pressure than standard care (1"The Gray Sheet" July 4, 2005, p. 15). An initial comment period on the decision ends March 30, with a proposed decision due by Aug. 28...

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