Studies Examine Home Oxygen Therapy

SANTA MONICA, Calif.–A new study indicates that home oxygen use
could save thousands of lives among patients with COPD.

According to the study, conducted by non-profit research
organization Rand Corp., obstructive lung diseases, including
asthma and chronic obstructive pulmonary disease, affect an
estimated 12 to 50 million Americans, but patients with these
diseases receive only about half of the recommended medical
care.

For example, only 32 percent of COPD patients with baseline
hypoxia received home oxygen, the study stated, estimating that
increasing the number could prevent 27,000 to 57,000 deaths
annually. COPD is the fourth leading cause of death in the U.S.

The study, published in the November issue of the medical
journal Chest, also found that patients with asthma
received about 67 percent of the care recommended for routine
management of their illness, but only 48 percent of the care
recommended when their condition worsened.

Meanwhile, the government is launching its own study of home
oxygen therapy for COPD. The six-year, $28 million project–the
largest randomized clinical trial of the subject–will be conducted
by the National Heart, Lung and Blood Institute, one of the
National Institutes of Health, and CMS.

During the trial, researchers at 14 clinical centers across the
country will study approximately 3,500 patients with moderate COPD
to determine whether supplemental oxygen will help them lead longer
and better quality lives. The results will be used to determine
whether to extend Medicare coverage of home oxygen treatment for
those with moderate COPD. CMS currently covers home oxygen therapy
only for COPD patients with a severe form of the disease.

“COPD is a devastating, highly disabling disease. The prospect
that home oxygen therapy could lessen the disability of COPD and
perhaps even prolong life when given earlier during the course of
the disease is enticing, but we need more information to determine
the risks and benefits,” said NHLBI Director Elizabeth Nabel.

About 12 million adults in the country have been diagnosed with
COPD, and approximately one million of those receive supplemental
oxygen treatment. Another 12 million Americans are believed to be
undiagnosed.

NHLBI and CMS previously collaborated on a landmark study that
determined which patients with severe COPD are most likely to
benefit from or suffer complications from lung volume reduction
surgery. Findings from the National Emphysema Treatment Trial were
reported in May 2003, and Medicare subsequently began coverage of
the procedure based on the results.

Patient recruitment for the Long-term Oxygen Treatment Trial is
expected to begin in late 2007. Participants will be randomly
selected to receive or not to receive supplemental oxygen for 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 study
period.

In March, Medicare announced that it would extend coverage of
home oxygen treatment to Medicare-eligible patients enrolled in the
study who would not otherwise be covered.

“Medicare is committed to ensure that beneficiaries have access
to the most appropriate treatments based on the best available
science,” said CMS Chief Clinical Officer Barry Straube. “The
results of this study will improve our understanding of the effects
of oxygen treatment in a broader group of COPD patients and will
help guide our policy decisions.”