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Medicare Coverage News In Brief

This article was originally published in The Gray Sheet

Executive Summary

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

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Inconsistent disclosures in stent studies: Authors did not disclose any financial ties to industry in 83% of scientific articles on coronary stents in 2006, according to a survey of 746 articles in 135 journals published by researchers at the Duke Clinical Research Institute. According to the survey results, appearing in the May issue of PlosOne, only 6% of the 2,985 authors credited in the surveyed articles disclosed a relationship in an article, and of the 75 authors who disclosed at least one financial relationship, only 2 (3%) disclosed that relationship in every article they wrote. Sixteen authors (26 articles total) disclosed a financial relationship in one article but declared they had no financial interests in another article. The survey is the first to examine the consistency of authors' disclosures in biomedical literature, Kevin Weinfurt, et al, say. "It could be argued that an inconsistent system of disclosure is more harmful than no disclosure at all," the author's argue. "The current approach creates the impression rather than the reality of transparency and may encourage underestimation of the impact of conflictions of interest on the integrity of medical science.

Research In Brief

Inconsistent disclosures in stent studies: Authors did not disclose any financial ties to industry in 83% of scientific articles on coronary stents in 2006, according to a survey of 746 articles in 135 journals published by researchers at the Duke Clinical Research Institute. According to the survey results, appearing in the May issue of PlosOne, only 6% of the 2,985 authors credited in the surveyed articles disclosed a relationship in an article, and of the 75 authors who disclosed at least one financial relationship, only 2 (3%) disclosed that relationship in every article they wrote. Sixteen authors (26 articles total) disclosed a financial relationship in one article but declared they had no financial interests in another article. The survey is the first to examine the consistency of authors' disclosures in biomedical literature, Kevin Weinfurt, et al, say. "It could be argued that an inconsistent system of disclosure is more harmful than no disclosure at all," the author's argue. "The current approach creates the impression rather than the reality of transparency and may encourage underestimation of the impact of conflictions of interest on the integrity of medical science.

Competitors Push New Data In Coverage Battle For T-Wave Alternans Tests

Industry and physician stakeholders say CMS missed a key study in considering its coverage policy for noninvasive tests that help assess a patient's need for an implantable defibrillator. Competing test makers have different views on how the new data should be interpreted

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