The Alliance submitted a letter to CMS' Coverage and Analysis Group Director inquiring why the Agency has not addressed the reconsideration request submitted in July 2021 regarding Local Coverage Determination L33797 (Oxygen and Oxygen Equipment), which had established Medicare coverage criteria for topical oxygen therapy (TOT) in the treatment of diabetic foot ulcers (DFUs). The American Diabetes Association published a clinical compendia stating that the “evidence supporting TOT’s efficacy in healing chronic DFUs can no longer be disputed” and supported the inclusion of TOT in clinical practice guidelines for chronic DFUs, the Alliance reminded CMS. "The continued [18 month] delay of not moving forward with the reconsideration request for TOT increases the risk of negative health outcomes for some of the most at-risk Medicare patients."

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