Electrical Bioimpedance for Cardiac Output Monitoring

CMS NCA document | source_status=Closed | review_type=1st Recon | public_comment_open=False | document_id=CAG-00001R

Based on our 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; 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. 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.