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CMS Proposes National Coverage For Microvolt T-Wave Alternan Testing

This article was originally published in The Gray Sheet

Executive Summary

Cambridge Heart (HeartWave II) appears to have prevailed in its quest to obtain national coverage for Microvolt T-Wave Alternan testing to evaluate patients at risk of sudden cardiac death, despite opposition from professional societies and the three major ICD firms

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Cambridge Heart Sees Strong Growth, Despite Blue Cross’ Negativity

The Blue Cross Blue Shield Association has reaffirmed its negative assessment of microvolt T-wave alternans testing to risk-stratify candidates for ICD therapy, despite accelerating market adoption that is driving sales growth for MTWA test maker Cambridge Heart

Medicare In Brief

MTWA covered: Cambridge Heart receives national coverage for its Heartwave II Microvolt T-Wave Alternans test March 21. The non-invasive test can identify patients who are unlikely to benefit from an implantable cardioverter defibrillator. ICD manufacturers, who argued against coverage during the public comment period, fear that the final decision represents an attempt by CMS to cut Medicare costs by reducing the ICD candidate population. The final coverage determination echoes CMS' Dec. 21 proposed decision, which requires use of Cambridge Heart's patented analytic spectral algorithm, but does not mandate MTWA testing for a patient to be eligible for an ICD (1"The Gray Sheet" Jan. 2, 2006, p. 6). Because General Electric's Marquette T-Wave Alternans device relies on a different algorithm than Cambridge Heart's, CMS says that all local carriers covering GE's device must halt coverage until the firm applies for an NCD...

Medicare In Brief

MTWA covered: Cambridge Heart receives national coverage for its Heartwave II Microvolt T-Wave Alternans test March 21. The non-invasive test can identify patients who are unlikely to benefit from an implantable cardioverter defibrillator. ICD manufacturers, who argued against coverage during the public comment period, fear that the final decision represents an attempt by CMS to cut Medicare costs by reducing the ICD candidate population. The final coverage determination echoes CMS' Dec. 21 proposed decision, which requires use of Cambridge Heart's patented analytic spectral algorithm, but does not mandate MTWA testing for a patient to be eligible for an ICD (1"The Gray Sheet" Jan. 2, 2006, p. 6). Because General Electric's Marquette T-Wave Alternans device relies on a different algorithm than Cambridge Heart's, CMS says that all local carriers covering GE's device must halt coverage until the firm applies for an NCD...

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