Medicare Approved Facilities/Trials/Registries Long Term Oxygen Treatment Trial
Guidance for Medicare Approved Facilities/Trials/Registries on the National Heart, Lung, and Blood Institute (NHLBI), study titled Long Term Oxygen Treatment Trial administered by CMS.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: January 01, 2020
The National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), and the Centers for Medicare & Medicaid Services (CMS) launched the largest randomized clinical trial of the effectiveness and safety of long-term, home oxygen therapy for COPD (chronic obstructive pulmonary disease). The six-year, $28 million project will study patients with moderate disease.
NHLBI will administer and oversee the study, and Medicare will cover the costs of items and medical services that are generally available through that program to beneficiaries enrolled in the trial. NIH and CMS are agencies of the U.S. Department of Health and Human Services (HHS).
Patient recruitment for the Long-term Oxygen Treatment Trial (LOTT) began in late 2007. Participants are be 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.
Further details on the trial can be found on the Clinicaltrials.gov website
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