Home Use of Oxygen

Working in Pulmonary Rehabilitation has shown me that patients recieve many benefits from proper use of supplemental oxygen therapy. Many patients who may have saturations at 89% at rest and even with some activity do much better with supplemental oxygen they are less SOB and thier anxiety level is diminished this allows then to increase activity and that in turn allows them to live a life that is more comfortable,allowing them perform more normaly thier tasks of daily living. With increase activity comes increase health and well being.

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Re: NCA Tracking Sheet for Home Use of Oxygen (CAG-00296N)

Oxygen is a colorless, odorless gas that comprises 20.9% percent of the atmospheric gases. Oxygen was first isolated by Joseph Priestly in 1774, when he obtained the gas from heating red mercuric oxide. Oxygen was first used in medical applications in 1885 for the treatment of bacterial pneumonia. In the 1970s, the National Heart, Lung & Blood Institute (NHLBI) organized a major conference (commonly referred to as the Sugarloaf Conference) to evaluate the scientific basis of respiratory care practices, including the use of oxygen. This conference led to the Nocturnal Oxygen Therapy Trial (NOTT), which is one of the landmark clinical research projects establishing the role of supplemental oxygen in the management of chronic hypoxemia in patients with chronic lung disease.

There are two major randomized, controlled clinical trials, performed independently on two continents that validate the role of long-term oxygen therapy in the management of chronic hypoxemia: the British Medical Research Council (BMRC) clinical trial and the NOTT study. Both are multi-center trials that examined the use of oxygen in patients with severe but stable chronic hypoxemia, as established by an arterial blood oxygen level (PaO2) of less than 55 mmHg.

The BMRC study (n=87) compared the use of 15 hours of oxygen per day in the study patients to a control group that did not receive oxygen. Survival in the oxygen treatment group after 5 years was significantly longer than for those in the control group.

The better known United States-based NOTT study (n=203) compared survival of patients treated with nocturnal oxygen therapy (NOT) or continuous oxygen therapy (COT). Survival of COT (actual mean = 17.7 hours) patients was significantly longer then NOT patients (mean = 11.8 hours). The 12-month survival rate of the COT group was 20.6%, versus 11.9% in the NOT group; and the 24-month survival rate of the COT group was 40.8%, versus 22.4% in the NOT group.

A subset of the NOTT patients (n=36) included those with PaO2 values of 56-59 mmHg and co-morbid conditions, including cor pulmonale and polycythemia (identical to the CMS Group II classification). In a published paper revisiting the NOTT study, Petty and Bliss segmented and analyzed additional NOTT data, including the survival of the Group II patients. The results demonstrated a survival trend among the Group II patients consistent with that of the Group I patients. This evidence supports the use of long-term oxygen therapy (LTOT) in Group II patients and has become the establish standard of care in the United States and elsewhere. In his detailed paper reviewing the effects of LTOT on mortality and morbidity, Criner notes that “patients with a PaO2 of 55-59 with signs of tissue hypoxemia (i.e., cor pulmonale, polycythemia, impaired cognition) should also be considered for LTOT.” The scientific foundation of LTOT used in chronic hypoxemia is largely established in the NOTT study, the BMRC study, and smaller subsequent studies. Since the publication of the NOTT study, the use of LTOT in patients defined by the Centers for Medicare and Medicaid Services (CMS) as Group I and Group II has become the established standard of care in the United States. Prolonged survival associated with LTOT use in Group I and Group II patients is the foundation of this recognized and accepted standard of care. Controlled studies withholding oxygen in patients with demonstrated chronic hypoxemia, including those with PaO2s of 56-59 mmHg, are considered unethical and would likely fail to meet the scrutiny of any institutional review board. As a result, there have been few, if any, studies to date challenging the results of the NOTT and BMRC trials.

Inogen urges CMS to maintain coverage of the Group II patients to ensure appropriate beneficiary access to home oxygen therapy until quality, randomized control studies are available to contradict the findings of the NOTT study and change the standard of care. In addition, we strongly support the expansion of the Group II coverage to include patients with PaO2 of up to 65 mmHg, in particular those enrolled in clinical studies as suggested in the tracking sheet.

Sincerely,

Joseph Lewarski, BS, RRT, FAARC
Vice President of Clinical Affairs
Inogen, Inc.
Goleta, CA

1. Petty TL. “Historical highlights of long-term oxygen therapy”. Respir Care 2000 45(1):29-36
2. Pierce AK, Saltzman HA. “Conference on the scientific basis of respiratory therapy”. Am Rev Respir Dis 1974;110(6 pt 2):1-3
3. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med 1980; 93:391.
4. Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet 1981; 1:681.
5. Petty TL, Bliss PL. “Ambulatory oxygen therapy, exercise and survival with advance chronic obstructive pulmonary disease (The Nocturnal Oxygen Therapy Trial revisited)”. Respir Care 2000;45(2):204-211
6. Criner GJ. “Effects of long-term oxygen therapy on mortality and morbidity”. Respir Care 2000;45(1):105-118

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After reviweing the case information provided, I have concluded that the studies I could find to review had 1 constant flaw. Overnight oximetry was not performed on a consistent basis to evaluate these borderline patients. I believe if LTOT response would have been measured in this matter, a greater reduction in mortality would be noticed and a larger response to the therapy would have been noted. Another variable not noted was the improved kidney function that comes with LTOT for patients who have secondary kidney failure due to chronic hypoxemia

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I practice medicine exclusively at home as a geriatric rehabilitation specialist. Some suggestions:

1. Hemoglobulin should be in the equation for oxygen necessity criteria
2. Due to the high cost and high profit margins in the number of companies in the "respiratory business, strict criteria for continued use are encouraged
3. Review of research needs to look at the person who "gets hooked" on oxygen even though sats are ok
4. Criteria for oxygen saturation decrease (again with hemoglobin as a covariant) during excercise should be established not the single criterion that exists
5. Some people may need intermittent oxygen ( patients with pulmonary edema that might flash in the middle of the night, angina/ impending MI patients) who do not fit the desaturation criteria. We need some criteria for a two hour supply of standby O2, maybe at cost structure. I carry some in my car and have used it a couple of times. There should have been o2 in the home but desaturation criteria could not be reached (CHF decompensation, sudden respiratory decompensation in COPD where previous sats had been normal)

I am glad you are looking at this. As a full time practicing home care physician, I see some waste, especially with long term use, when the O2 is no longer needed, and the lack of use for people with potential intermittend need who do not pass existing criteria for home use.

tfk

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I have not researched the net health benefits of home oxygen therapy in the population you are considering covering, however as an Internist in general practice I have had mann patients who do not currently meet the Medicare guidelines for home oxygen therapy who on their own have purchased home oxygen and their quality of life has significantly improved as a result. I would strongly recommend expanding the coverage for home oxygen therapy to include the patients you are considering. These patients often suffer from debilitating shortness of breath and markedly limited activities that in my experience have significantly improved with oxygen use. Spencer I Rozin, MD FACP

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The initial Medical medical coverage policies included a paragraph for consideration of "other clinical indications" in addition to the testing data. As testing data qualifications were tightened, the original language supporting consideration of these other clinical indications was lost.As a practicing respiratory therapist for almost 40 years, I believe that there are certain patients who would benefit from supplemental oxygen in the home who have not yet demonstrated an aterial P02 below 59. Certain other diagnostic and clinical data should be allowed for consideration for coverage for home oxygen in addition to these arbitrary blood gas values.These tests may include spirometry, etc.

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