Noncoverage for Anodyne Therapy?

CMS proposes national non-coverage for infrared therapy devices July 26, due to insufficient evidence that the treatment is reasonable and necessary for beneficiaries with peripheral neuropathy, skin ulcers and related conditions. The agency cites poor quality, small sample size and "a significant placebo effect" in the available clinical studies. "Only when basic efficacy has been established can investigators determine through additional studies which populations, if any, might benefit from experimental light therapy," the agency writes. CMS generated the national coverage decision internally, in part due to an FDA warning letter concerning burns from the Anodyne Therapy device (1"The Gray Sheet" Feb. 6, 2006, p. 5). Comments on the proposed decision are due Aug. 25...