Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

20.16

Version Number

Effective Date of this Version

11/24/2006

Implementation Date

1/16/2007

Benefit Category

Diagnostic Tests (other)

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

Thoracic electrical bioimpedance (TEB) devices, a form of plethysmography, monitor cardiac output by non-invasively measuring hemodynamic parameters, including: stroke volume, systemic vascular resistance, and thoracic fluid status. Under a previous coverage determination, effective for services performed on and after July 1, 1999, use of TEB was covered for the "noninvasive diagnosis or monitoring of hemodynamics in patients with suspected or known cardiovascular disease." In reconsidering this policy, the Centers for Medicare & Medicaid Services (CMS ) concluded that this use was neither sufficiently defined nor supported by available clinical literature to offer the guidance necessary for practitioners to determine when TEB would be covered for patient management. Therefore, CMS revised its coverage policy language in response to a request for reconsideration to offer more explicit guidance and clarity for coverage of TEB based on a complete and updated literature review.

Indications and Limitations of Coverage

B. Nationally Covered Indications

Effective for services performed on and after January 23, 2004, TEB is covered for the following uses:

1. Differentiation of cardiogenic from pulmonary causes of acute dyspnea when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.

2. Optimization of atrioventricular (A/V) interval for patients with A/V sequential cardiac pacemakers when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.

3. Monitoring of continuous inotropic therapy for patients with terminal congestive heart failure, when those patients have chosen to die with comfort at home, or for patients waiting at home for a heart transplant.

4. Evaluation for rejection in patients with a heart transplant as a predetermined alternative to a myocardial biopsy. Medical necessity must be documented should a biopsy be performed after TEB.

5. Optimization of fluid management in patients with congestive heart failure when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.

C. Nationally Non-Covered Indications

1. TEB is non-covered when used for patients:

With proven or suspected disease involving severe regurgitation of the aorta;
With minute ventilation (MV) sensor function pacemakers, since the device may adversely affect the functioning of that type of pacemaker;
During cardiac bypass surgery; or,
In the management of all forms of hypertension (with the exception of drug-resistant hypertension as outlined below).

2. All other uses of TEB not otherwise specified remain non-covered.

D. Other

Contractors have discretion to determine whether the use of TEB for the management of drug-resistant hypertension is reasonable and necessary. Drug resistant hypertension is defined as failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate 3-drug regimen that includes a diuretic. Effective November 24, 2006, after reconsideration of Medicare policy, CMS will continue current Medicare policy for TEB.

(This NCD last reviewed November 2006.)

Transmittal Number

Transmittal Link

http://www.cms.hhs.gov/transmittals/downloads/R63NCD.pdf

Revision History

08/1989 - Excluded from coverage. Effective date 08/25/1989. (TN 38)

04/1999 - Limited coverage for six uses. Contractors may cover additional uses when they believe there is sufficient evidence of medical effectiveness of such uses. Effective date 07/01/1999. (TN 109) (CR 827)

01/2004 - Offered more explicit guidance and clarification for coverage of TEB based on a complete and updated literature review. Effective date 01/23/2004. Implementation date 02/23/2004. (TN 6) (CR 2689)

12/2006 - Effective date: 11/24/2006. Implementation date: 01/16/2007. (TN 63) (CR5414)

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.