My name is Dr. Josef Fischer and I am testifying of behalf of the 66,000 surgeons who are members of the American College of Surgeons. I am the Mallinckrodt Professor of Surgery at Harvard Medical School and chair of the department of surgery at the Beth Israel Deaconess Medical Center in Boston, Massachusetts. Although I no longer perform bariatric surgery, four surgeons on the staff at my hospital do perform these procedures in a program that features extensive preoperative medical therapy and evaluates long-term postoperative outcomes.
I am also the College's representative to the Blue Cross and Blue Shield Association Medical Advisory Panel that examines whether treatments are effective and, hence, should be recommended for use. Typically, technical assessments are performed by an independent staff and are reviewed by the Medical Advisory Panel of the Technology Evaluation Center. As you doubtless know, the Blue Cross and Blue Shield Association released a technical assessment of bariatric surgery in September 2003.
The College has long been an advocate for bariatric surgery and firmly believes that bariatric surgery should continue to be covered by Medicare. The evidence shows that bariatric surgery is a reasonable solution for many patients who have failed on non-surgical weight loss regimens. The studies are clear that patients experience a greater weight loss over a longer term than those undergoing medical management. They also have a reduction in comorbidities associated with being morbidly obese.
Questions posed to the MCAC
To turn to the questions posed to the Medicare Coverage Advisory Committee (MCAC), the College believes there is strong evidence in the literature to answer with certainty the questions about surgery in relation to medical management of obesity. Data from the Swedish Obese Subjects (SOS) that is cited in the Blue Cross Blue Shield Association technical assessment shows a 16.3 percent decrease in total body weight for those undergoing bariatric surgery six years postoperatively. This is compared to a 0.8 percent increase in weight over the same period with non-surgical treatment. The technical evaluation that the Centers for Medicare & Medicaid Services (CMS) commissioned from the RAND Corporation suggests that there is greater sustained weight loss in very obese individuals—those with a body mass index (BMI) greater than or equal to 40—than those with a BMI between 35 and 40.
According to the SOS, the incidence of metabolic syndrome, or comorbidities of hypertension, diabetes, hyperlipidemia, and sleep apnea, is improved, although at differing amounts and rates depending on when measurements are made. Diabetes and hypertension deserve special mention, although for different reasons. Data from the SOS study shows a large reduction in diabetes over a 5.5-year mean follow-up. On the other hand, it appears as though the incidence and severity of hypertension post-operatively is dependent on how long patients are followed. Data from the SOS also suggest that the incidence of hypertension drops, but then by six years post-operatively hypertension rises for some reason, virtually to preoperative levels, suggesting that other factors are important as well. Later studies based on the SOS data, released after the technical assessments were done, do show some decrease in hypertension.
I could continue with the positive aspects of bariatric surgery but will instead at this time turn to some of the remaining questions in the literature. It is not yet possible to answer some of the crucial questions regarding the aged population. According to the technical assessment on treatment of obesity among the elderly, there are remaining questions about the benefit of reducing obesity in this population. The all-cause risk of mortality associated with obesity diminishes with age. Because there are age-related differences in underlying physiology in general and fat distribution in particular, one should be cautious in generalizing the findings in the younger population to the elderly (above 70 years of age).
Even if one assumes that it is reasonable to perform bariatric surgery in the elderly, there are few studies of surgical morbidity or mortality in the aged. A recent article, published in August 2004 in the "Annals of Surgery", reported on the results of 80 patients age 60 and over who had undergone bariatric surgery. The weight loss and reduction in comorbidities, while not as great as reported for a younger population, were clinically significant. There were some late deaths that were not, as nearly as we can tell, attributed to the surgery.
The College supports continued coverage of bariatric surgery and also supports long-term data collection and outcomes assessment for various procedures, consistent with our overall mission of quality improvement and patient safety.
Importance of long-term follow-up
In September 2000, the College published the attached statement of "Recommendations for facilities performing bariatric surgery," which addresses issues such as professional staff, the operating room and hospital facilities. The statement made it very clear that the success of bariatric surgery is dependent on four things:
- Having an experienced bariatric surgeon as the head of an interdisciplinary team throughout the pre- and postoperative period. The bariatric surgeon continues to follow the patient and to call on members of the team as needed for a very long period—years or perhaps the rest of the patient's life.
- Having a good team experienced in caring for the obese patient in the hospital. This includes anesthesiologists, critical care staff, registered nurses, and other hospital personnel.
- Having an interdisciplinary staff to provide care and counseling throughout an extended preoperative period and a long postoperative period. Preoperative psychiatric screening and pre- and postoperative nutritional counseling are the most important but not the only services that we believe must be made available.
- Having the full range of equipment appropriate for the bariatric patient in the operating room and hospital facilities. This includes such things as the special operating instruments, operating room tables, radiology and other diagnostic equipment, hospital beds, commodes, wheelchairs and chairs.
The College believes that Medicare coverage for the long-term follow-up of the patient, including for the medically necessary counseling and screening, is essential. At the present time, coverage varies from carrier to carrier, and perhaps even with the same carrier from time to time.
Conclusion
In brief, the College supports programs for what has become an epidemic of great public health concern to the nation—morbid obesity. It urges CMS to continue to collect data on outcomes for various bariatric procedures. Finally, CMS must take steps necessary to cover pre- and postoperative care, especially preoperative psychiatric screening and pre- and postoperative nutritional counseling.
Online November 8, 2004
