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National Coverage Determination (NCD)

Home Use of Oxygen in Approved Clinical Trials

240.2.1

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Tracking Information

Publication Number
100-3
Manual Section Number
240.2.1
Manual Section Title
Home Use of Oxygen in Approved Clinical Trials
Version Number
1
Effective Date of this Version
03/20/2006
Ending Effective Date of this Version
Implementation Date
10/03/2006
Implementation QR Modifier Date

Description Information

Benefit Category
Durable Medical Equipment


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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.
Indications and Limitations of Coverage

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)
Cross Reference

CED page
Claims Processing Instructions

Transmittal Information

Transmittal Number
57
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R57NCD.pdf
Revision History

05/2006 - CMS will cover the home use of oxygen in clinical trials identified by CMS and sponsored by the National Heart, Lung, & Blood Institute.  Effective date: 03/20/2006. Implementation date: 10/03/2006. (TN 57) (CR4389)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Home Use of Oxygen in Approved Clinical Trials 1 03/20/2006 - N/A You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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