Medicare In Brief
This article was originally published in The Gray Sheet
Executive Summary
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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GE wants on the T-wave
CMS accepts GE Healthcare's request Aug. 17 to consider national coverage of its Marquette modified moving average (MMA) microvolt T-wave alternans test. MTWA tests are used to risk stratify patients for cardioverter defibrillator implants. Based on lack of evidence, a March 2006 CMS coverage decision excludes the MMA method - cleared for risk stratification in 2003 - and only covers Cambridge Heart's HearTwave II test, which uses a proprietary spectral analysis algorithm (1"The Gray Sheet" March 27, 2006, p. 18). GE says studies published in 2007 show MMA's equivalence to the spectral method. CMS is accepting initial comments on the reconsideration until Sept. 17 and will issue a proposed decision by Feb. 17...
GE wants on the T-wave
CMS accepts GE Healthcare's request Aug. 17 to consider national coverage of its Marquette modified moving average (MMA) microvolt T-wave alternans test. MTWA tests are used to risk stratify patients for cardioverter defibrillator implants. Based on lack of evidence, a March 2006 CMS coverage decision excludes the MMA method - cleared for risk stratification in 2003 - and only covers Cambridge Heart's HearTwave II test, which uses a proprietary spectral analysis algorithm (1"The Gray Sheet" March 27, 2006, p. 18). GE says studies published in 2007 show MMA's equivalence to the spectral method. CMS is accepting initial comments on the reconsideration until Sept. 17 and will issue a proposed decision by Feb. 17...
T-Wave Alternans ICD Screening May Gain Traction With St. Jude Pact
St. Jude Medical's endorsement of microvolt t-wave alternans testing under a co-marketing agreement with test maker Cambridge Heart will help accelerate adoption of the technology, which guides appropriate defibrillator patient selection, both companies say