The NCD for the Home Use of Oxygen, released by CMS in March 2006, concludes that that there is insufficient evidence to identify the optimal daily use and long-term duration of long-term oxygen therapy for Medicare beneficiaries. Consequently, CMS had determined that additional clinical research is appropriate under Coverage with Evidence Development (CED). The NCD specifies that the home use of oxygen is covered for Medicare beneficiaries who have arterial oxygen partial pressures measurements from 56 to 65 mmHg or oxygen saturation at or above 89% when they are enrolled in clinical trials approved by CMS and sponsored by the National Heart, Lung, & Blood Institute (NHLBI), one of the National Institutes of Health (NIH).
The NHLBI and CMS have launched the largest randomized clinical trial of the effectiveness and safety of long-term home oxygen therapy for chronic obstructive pulmonary disease (COPD). Patient recruitment for the Long-term Oxygen Treatment Trial (LOTT) began in late 2007. Patients are randomly selected to receive or not to receive supplemental oxygen for approximately three years. All participants will be periodically monitored; those who are not initially selected to receive oxygen will be prescribed oxygen if their blood oxygen levels worsen during the trial.
Study Title: Long-term Oxygen Treatment Trial (LOTT)
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Number: NCT00692198
CMS Approval Date: 3/20/2006