CMS Decision Memo for Electrical Bioimpedance for Cardiac Output Monitoring (CAG-00001R)

August 7, 2003

This memorandum serves four purposes: (1) provides a brief description of hemodynamic monitoring; (2) describes various methods of hemodynamic monitoring, with an emphasis on thoracic electrical bioimpedance (TEB); (3) presents and analyzes the available scientific and clinical literature on TEB for certain patient populations for the purpose of determining whether the current national coverage policy should be modified; and (4) announces our intent to refine the current national coverage policy for cardiac-related indications, to leave the decision regarding coverage of TEB for the management of drug resistant hypertension to contractor discretion, and to noncover TEB for all other indications.

 

Managing Patients with Cardiac Disease

APPROVED

Based on our [CMS] review of the evidence as a whole, the previous coverage decision, and in light of the general absence of studies evaluating the impact of using TEB for managing patients with cardiac disease, we conclude that TEB continues to be reasonable and necessary for the following indications with minor modifications to meet the current literature and guidelines:

  • Differentiation of cardiogenic from pulmonary causes of acute dyspnea when physician 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;

  • Optimization of atrioventricular interval for patients with an atrioventricular sequential pacemaker when physician 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; and

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

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

  • Optimization of fluid management in patients with congestive heart failure when physician 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;

Hypertension

MAY BE APPROVED

Under our original national policy, coverage of TEB for the management of hypertension could have been inferred under the broad category of “suspected or known cardiovascular disease,” and therefore, discretionarily covered by some Medicare contractors if so interpreted. No evidence to support this use was presented in connection with the original coverage decision and it was not our intent to cover management of hypertension at that time. That hypertension was not covered in the earlier decision is supported by the fact that we have now been asked to make a specific coverage determination on TEB for this purpose. Because our intent in this regard may have been unclear in the original decision, any claims that were processed for this purpose under contractor discretion will not be re-examined.

The new evidence reviewed by CMS pertains only to patients with drug resistant hypertension. While the totality of the evidence is not sufficient to support a broad positive coverage determination for this use, it indicates that there may be situations in which TEB could be useful in monitoring of response to medication changes in treatment of drug resistant hypertension. Therefore,

  • CMS determines that the coverage and description of the specifics of the situation in which TEB is reasonable and necessary for the treatment of drug resistant hypertension is left to carrier discretion.

Drug resistant hypertension is defined as failure to achieve goal BP in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic.

  • CMS also determines that the evidence is inadequate to conclude that TEB is reasonable and necessary for the management of all other forms of hypertension, and therefore its use for all other forms of hypertension is non-covered.

Other Uses

NOT COVERED

CMS found no evidence to support removing the noncoverage restrictions listed in the current national coverage policy. Therefore, TEB continues to be non-covered when used for monitoring of patients with:

  • Proven or suspected disease involving severe regurgitation of the aorta;

  • Minute ventilation (MV) sensor function pacemakers, since the device may adversely affect the functioning of that type of pacemaker; or

  • During cardiac bypass surgery.

Due to an absence of evidence, all other uses of TEB not described in this memorandum are noncovered.

CMS Analysis

National Coverage Determinations (NCDs)

National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act §1869(f)(1)(B).


In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage.


Moreover, with limited exceptions, no payment may be made for any expenses incurred for items or services that are not “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” §1862(a)(1)(A).

 

Accuracy of TEB Relative to Other Tests of Hemodynamic Parameters

Deemed ACCURATE

CMS has thoroughly reviewed all available and relevant literature, including a comprehensive external technology assessment, in order to evaluate the accuracy of TEB. The data provided in these studies suggest that TEB derived hemodynamic measurements generally trend in the same direction as those measures obtained by other, usually invasive, diagnostic testing modalities.

Request to Expand Medicare Coverage to Include Management of Hypertension

MAY BE USEFUL for the Treatment of Drug Resistant Hypertension

The Taler et al. study is a relatively well-designed trial that suggests that TEB may be helpful in patients with drug resistant hypertension who are being treated by a hypertension specialist. The results at the end of 90 days demonstrated a statistically significant, although small, improvement in blood pressure in patients treated using TEB-derived data as compared to a control group treated without TEB.

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