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US · guidance

CMS Pub. 100-03, ch. 1, § 240.2.1

Home Use of Oxygen in Approved Clinical Trials (Effective March 20, 2006)

activein force · 2026-08-25 – presentas-observed

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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