CMS Home Use of Oxygen in Approved Clinical Trials Form

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 240.2 and 310.1).

(This NCD was last reviewed April 2006)