Heart Rhythm Society, Doctors Oppose National Coverage Of GE’s MTWA Test
This article was originally published in The Gray Sheet
Executive Summary
GE Healthcare and Cambridge Heart are squaring off over rival methods of microvolt T-wave alternans testing
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Medicare Coverage News In Brief
GE T-Wave doesn't measure up: Cambridge Heart's HearTwave II microvolt T-wave alternans test would remain the only such test covered by Medicare under a Feb. 14 CMS proposal. GE Healthcare had requested that the agency expand its 2006 policy to cover the firm's Marquette MTWA test, also used to risk stratify patients who might need implantable defibrillators but with a different calculation method than HearTwave (1"The Gray Sheet" Sept. 24, 2007, p. 21); CMS says the evidence for Marquette's method is limited and not yet convincing. Perhaps more significantly, the agency notes that before finalizing its decision it will review recently reported data from the Medtronic-sponsored MASTER 1 trial, which CMS says casts doubt on the general usefulness of MTWA testing. The study could cause the agency to reassess whether MTWA, regardless of method, should be covered at all. Comments on the proposal are due March 15, and CMS will make a final decision by May 14
Medicare Coverage News In Brief
GE T-Wave doesn't measure up: Cambridge Heart's HearTwave II microvolt T-wave alternans test would remain the only such test covered by Medicare under a Feb. 14 CMS proposal. GE Healthcare had requested that the agency expand its 2006 policy to cover the firm's Marquette MTWA test, also used to risk stratify patients who might need implantable defibrillators but with a different calculation method than HearTwave (1"The Gray Sheet" Sept. 24, 2007, p. 21); CMS says the evidence for Marquette's method is limited and not yet convincing. Perhaps more significantly, the agency notes that before finalizing its decision it will review recently reported data from the Medtronic-sponsored MASTER 1 trial, which CMS says casts doubt on the general usefulness of MTWA testing. The study could cause the agency to reassess whether MTWA, regardless of method, should be covered at all. Comments on the proposal are due March 15, and CMS will make a final decision by May 14
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...