National Coverage Analysis (NCA) Tracking Sheet

Electrical Bioimpedance for Cardiac Output Monitoring

CAG-00001R2

Issue

The Centers for Medicare & Medicaid Services is reviewing its national coverage decision regarding Electrical Bioimpedance for Cardiac Output Monitoring, also known as impedance cardiography and thoracic electrical bioimpedance (TEB).  TEB is a diagnostic method that non-invasively measures cardiac output.

In 1999, the Centers for Medicare & Medicaid Services (CMS) issued a national coverage decision (Coverage Issues Manual 50-54) for TEB for six indications.  In 2003 CMS issued a reconsidered NCD (NCD Manual 20.16) that expanded coverage to include treatment of drug-resistant hypertension, defined as failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic.

CardioDynamics, a manufacturer of TEB technology, has submitted a formal written request for another reconsideration of the 2003 reconsidered NCD to expand coverage for TEB in the treatment of hypertension, based on new evidence that was not available at the time of the first reconsideration.  Our decision may take the form of continuing the current policy, noncoverage, limiting coverage, or expanding coverage.  In the interim, the current coverage policy remains in force until a new policy decision, if any, is finalized based on our reconsideration.  A new policy would be prospective and would not call into question the legitimacy of the claims paid for under the old policy.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
CardioDynamics View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/28/2006
Expected NCA Completion Date
11/21/2006
Public Comment Period
02/28/2006 - 03/30/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
08/24/2006
Proposed Decision Memo Public Comment Period
08/24/2006 - 09/23/2006
Decision Memo Released
11/20/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Francina C. Spencer
Michael Lyman, RN, MPH
Lead Medical Officers
Madeline Ulrich, MD, MS

Medicare Benefit Category Determination Date

Actions Taken

February 28, 2006

CMS formally accepts the request for reconsideration and extension of coverage and opens a 30 day public comment period.

April 6, 2006

August 24, 2006

CMS posts the proposed decision memorandum  and invites public comments. The 30 day public comment period begins.

Instructions on submitting public comments can be found at: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

October 2, 2006

November 20, 2006

CMS posts the final decision memorandum.