Medical Oxygen Requirements

Medical oxygen is prescribed by physicians for patients with medical conditions, such as emphysema, lung cancer, chronic obstructive pulmonary disease or congestive heart failure. Medical oxygen may be administered through a free-standing tank or via a portable oxygen container which may be carried or wheeled along by the patient. The use, prescription and dispensing of medical oxygen must meet the provisions of federal laws and regulations.

FDA Regulations

• The U.S. Food and Drug Administration (FDA) enacted regulations regarding medical oxygen in Section 503(b)(4) of the Food, Drug and Cosmetic Act, 21 CFR Sections 201(b)(1) and 211.130. In 1996, following a citizen petition, the FDA amended this law to require medical oxygen be labeled for emergency use only. Additionally, the FDA requires that medical oxygen labels indicate that the oxygen may only be administered by trained personnel and for reasons of resuscitation or oxygen deficiency. In all other medical situations, dispensing oxygen without a prescription is prohibited by federal law.

Oxygen Qualifying Guidelines

• The majority of patients who receive oxygen are on Medicare which sets qualifying guidelines for medical coverage. These standards are also used by most private health insurance companies in determining medical necessity and insurance coverage for oxygen therapy. To qualify for oxygen therapy under Medicare guidelines, a patient's oxygen saturation level must be 88 percent or lower. Patients may also qualify for three months of oxygen treatment with an oximetry testing of 89 percent and will qualify for lifetime coverage if they re-test at 88 percent within three months. The type of medical device used to administer oxygen varies according to the required liter flow of oxygen. Oxygen is typically administered via a concentrator which converts room air to concentrated oxygen. Patients requiring up to two liters per minute (LPM) of oxygen can use a portable pulse oxygen concentrator which is carried around in a backpack; patients requiring a higher liter flow will need to use a plug-in concentrator which is not portable. To do errands or for doctors' appointments, these patients typically use E-tanks, which are cylinders that are wheeled around on a cart.

Storage Requirements

• The National Fire Protection Association established requirements for health care facilities regarding the storage of medical gas, including oxygen. These requirements are outlined in NFPA 99, Standard for Health Care Facilities. Under these guidelines, oxygen stored outside must be in an enclosed area under lock and key. The outdoors storage unit must be at least 25 feet from the facility's nearest window. Smoking, heating elements and open flames must be kept away from the oxygen storage area.