US · guidance
CMS Pub. 100-03, ch. 1, § 240.2.1
Home Use of Oxygen in Approved Clinical Trials (Effective March 20, 2006)
A. General
Oxygen is a colorless, odorless gas that comprises 21 percent of the atmospheric gases at sea level.
Historically, long term supplemental oxygen has been administered in higher than atmospheric
concentrations to patients with chronic hypoxemia, generally resulting from cardiac and/or pulmonary
disease. The need for supplemental oxygen is assessed by direct or indirect measurement of the partial
pressure of oxygen (conventionally expressed in millimeters of mercury, mmHg) and the oxygen saturation
of hemoglobin in arterial blood (expressed as a percent). Chronic oxygen therapy is generally administered
via nasal cannulae, face mask, or tracheostomy, from a stationary or portable oxygen tank or an oxygen
concentrator.
The medical literature documents health benefits as well as serious adverse events associated with
supplemental oxygen use. In this light, it is clear that the decision to initiate, continue, or discontinue the use
of supplemental oxygen should be guided by high quality scientific evidence.
B. Nationally Covered Indications
Effective for services performed on or after March 20, 2006 the home use of oxygen is covered for those
beneficiaries with arterial oxygen partial pressure measurements from 56 to 65 mmHg or oxygen saturation
at or above 89% who are enrolled subjects in clinical trials approved by the Centers for Medicare &
Medicaid Services and sponsored by the National Heart, Lung & Blood Institute (NHLBI).
C. Nationally Non-Covered Indications
N/A
D. Other
This policy does not alter Medicare coverage for items and service that may be covered or non-covered
according to the existing national coverage determination for the home use of oxygen provided outside the
context of approved clinical trials (National Coverage Determination Manual, section 240.2and 310.1).
(This NCD was last reviewed April 2006)
History
(Rev. 57, Issued: 05-26-06; Effective: 03-20-06; Implementation: 10-03-06)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
b4bb4ae6fbee64b212e25e2f654b546fba67cacbf82b74b8123ae9eac1d3f6a2
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