Mr. Chairman, my name is Morgan Downey and I am the Executive Director of the American Obesity Association. It is a pleasure to appear before you today and address the serious and complex issues of obesity and the Medicare program. For the record the American Obesity Association is supported by several major companies including Amgen, Hoffman-LaRoche, Knoll Pharmaceuticals and Weight-Watchers. and dues from professional and lay members. To the best of my knowledge, no supporter has a specific coverage issue before the Medicare Coverage Advisory Committee.

At the outset, I would like to put our current and foreseeable situation on the record. Over half of the United States population is overweight and about one quarter is obese (measured as a Body Mass Index of over 25 and over 30 respectively.) According to 1991 data the percentages of the Medicare population with a BMI = 27.8 for males and >27.3 for females ranges from 23.8% for white males to 48.7% for black females (National Institutes of Health, Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults, 1998, p. 130-131). As you know, obesity is a major and independent risk factor for major conditions, including Type II diabetes, hypertension, heart disease, stroke, several cancers, arthritis, end stage renal disease, gallbladder disease and sleep apena to name a few of the 30 or so conditions where associations have been found.

We know that obesity is increasing in the population at an alarming rate. Jeffrey P. Koplan, director of the Centers for Disease and Control and Prevention, has likened its spread to that seen in infectious diseases. According to a recent article in JAMA between 1991 and 1998, the prevalence of obesity (BMI=30) among persons age 60 to 69 increased 44.9%. The prevalence among persons =70 increased 28.6% (Mokdad, AH, The Spread of the Obesity Epidemic in the United States, 1991-1998, JAMA, 282;16;1519. October 27, 1999).

We also know that obesity is a major generator of health care costs. According to a study the American Obesity Association commissioned from the Lewin Group last year, the direct health care costs of obesity exceeded $100 billion dollars in 1999. This figure does not include indirect costs or the costs spent on treating obesity itself. It was not without substantial justification that obesity is now one of the Nation's ten Leading Health Indicators as announced a few weeks ago by the Surgeon General.

We can see therefore that more and more Americans are becoming obese which will dramatically increase their risks for diseases which Medicare will pay for. These people will come into the Medicare program both as they age and also as they become eligible for disability under Social Security procedures. The standards for evaluation of obesity under Social Security are currently undergoing some changes but we expect that the current number of 137,000 persons receiving Social Security disability income support in the amount of about $77 million per month will continue to increase . As you know, after two years on Social Security disability, these individuals start receiving health care coverage under the Medicare program.

Our interests today are two-fold. First, we propose that the Committee consider when evaluating new medical products be they laboratory tests, diagnostic procedures, preventive intervention or treatment that a quarter or more of the Medicare population is overweight. Recent reports have indicated, for example, that women who are obese may receive PAP smears and mammograms less frequently than their non-obese peers, that the resolution in mammograms is poor for obese women and that obese persons may be excluded from bone marrow transplantation without medical justification. Questions which the Committee should ask of proponents of new technology might inlcude "Were the studies in support of the new procedure conducted in a representative sample of the covered population by weight?" and "Can Medicare beneficiaries who are obese access the new technology?"

Second, we propose that the Committee begin the process of clarifying Medicare coverage of obesity. Medicare national coverage determinations on obesity are inconsistent. ¶35-26 of the Coverage Manual states explicitly, " Obesity itself cannot be considered an illness. The immediate cause is a caloric intake which is persistently higher than caloric output. Program payment may not be made for treatment of obesity alone since this treatment is not reasonable and necessary for the diagnosis and treatment of an illness or injury. However, although obesity is not in itself an illness, it may be caused by illnesses…In addition, obesity can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension. Therefore, services in connection with the treatment of obesity as covered services when such services are an integral and necessary part of the course of treatment for one of these illnesses."

Yet, obesity surgery is covered in ¶ 35-40 if medically appropriate and necessary to correct an illness caused or aggravated by obesity. Clearly, these two paragraphs are inconsistent. If obesity cannot be considered an illness, the surgery to correct it cannot be covered by Medicare. On the other hand, if reduction of weight can improve an illness or a condition, what possible justification exists for covering solely the most drastic and life-threatening intervention when other effective and less risky and costly treatments are available?

Clearly, ¶ 35-26 of the Coverage Manual is wrong and should be considered an embarrassment to the Health Care Financing Administration. "Illness " is synonymous with "disease". Virtually every medical and scientific definition has a definition like Steadman's Medical Dictionary,

Disease "1…an interruption, cessation, or disorder of body functions, systems, or organs. 2. A Disease entity, characterized usually by at least two of the se criteria: a recognized etiologic agent (or agents); an identifiable groups of signs and symptoms; consistent anatomical alterations."

Clearly obesity meets all three of these components.

Any analysis of the definitions of illness, injury or disorder will demonstrate that obesity is considered an illness by the vast weight of modern scientific and medical understanding. Therefore, we would like to suggest three issues for your consideration.

First, given the increase in the overall Medicare population which is obese, and the improvements in medical technology, we want to be sure that such all such advances are available to the obese Medicare population. Therefore, the AOA suggests that all future subjects for Medicare coverage determinations, be evaluated with this population in mind.

Second, we suggest that the Committee establish a subcommittee or working group to revise the current incorrect coverage manual ¶ 35-26. Several excellent guidelines for the treatment of adult obesity exist including one developed by the American Obesity Association, one by the American Academy of Clinical Endocrinology and an excellent product from the National Institutes of Health. A review of the later will reveal that numerous randomizied clinical trials and other high quality scientific studies are available which can meet this Committee's proposed standards for the determination of coverage decisions.

The American Obesity Association would be pleased to provide whatever assistance or help in such an undertaking.

Thank you.