Noncoverage for Anodyne Therapy?
This article was originally published in The Gray Sheet
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...
You may also be interested in...
CMS' internally-generated national coverage request for infrared therapy devices uncharacteristically refers to a recent FDA warning letter to manufacturer Anodyne Therapy
Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.
AstraZeneca's research head admits that the half dose approach was a lucky mistake - but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.