Bariatric Surgery for the Treatment of Morbid Obesity

NAASO—The Obesity Society’s Response to the Centers for Medicare and Medicaid Services’ National Coverage Determination for Bariatric Surgery

NAASO – the Obesity Society generally supports the Centers for Medicare and Medicaid Services’ (CMS) National Coverage Determination (NCD) for Bariatric Surgery. This represents an important step that will positively affect the health and well-being of select Medicare recipients who suffer from extreme obesity.

Bariatric surgery clearly is the most effective treatment for persons with extreme obesity who have failed to lose weight using less intensive interventions. The steady growth in the number of surgeries performed each year reflects both the increasing rate of extreme obesity in the United States (now nearly 5% of adults), as well as an increase in the number of medical centers, hospitals, and surgeons now offering bariartric surgery.

We join our colleagues at the American Society for Bariatric Surgery (ASBS) in recommending that this NCD require that Medicare patients undergo bariatric surgery only at high quality surgical centers with appropriate credentialing and certification. We further believe that ASBS is well qualified to develop an accreditation program for Bariatric Surgery Centers of Excellence. To receive accreditation, ASBS requires that Centers perform at least 125 surgeries a year and that individual surgeons perform at least 50 operations yearly. These criteria are based on findings that mortality and morbidity rates decline as the number of surgeries performed yearly increases.

NAASO – The Obesity Society applauds CMS for requiring that bariatric surgery centers “have an integrated program for the care of the morbidly obese patient that provides: ancillary services such as specialized nursing care, dietary instruction, counseling support groups, exercise training, and psychogical assistance as needed.” Such multidisciplinary care is needed to ensure an optimal outcome for all individuals. With its recognition of the need for such services, it is critical that CMS authorize payment for each of the therapies listed, as well as for others that may be required.

We are concerned by the NCD’s limitation of bariatric surgery to only those Medicare recipients who are under 65 years of age. We agree with CMS that there has not been adequate study of the effects of baraitric surgery in older individuals. However, there is reason to believe that such intervention, when conducted by experienced (high-volume) surgeons is likely to be associated with a favorable outcome, as suggested by Sugerman and colleagues¹. Further evidence of the benefits of weight loss in older adults is provided by the Diabetes Prevention Program². Modest weight loss, achieved with diet and exercise, decreased the risk of developing type 2 diabetes by 71% in persons 60 years and older, as compared with only 44% in participants 25 to 44 years of age. A recent joint position statement on Obesity in Older Adults, issued by the American Society for Nutrition and NAASO – The Obesity Society, concluded that weight loss therapy improves physical function, quality of life, and medical complications of obesity in older adults.³

NAASO – The Obesity Society strongly supports CMS’s proposal to extend bariatric surgery to persons 65 years and older under the “Coverage with Evidence Development” (CED) option. This option provides an excellent means of providing surgery to appropriately selected individuals whose outcomes will be carefully evaluated. Completion, in this manner, of several hundred surgeries should begin to provide the data needed to make evidence-based practice decisions concerning individuals > 65 years. Failure to adopt the CED option would prevent older Medicare recipients from receiving potentially optimal care for their extreme obesity with its attendant health complications. There is minimal evidence to suggest that a 65-year old person, who receives optimal surgical intervention, is at greater risk of morbidity and mortality than a 64-year old. This is also true for individuals who undergo other surgical procedures that are currently covered by Medicare, such as orthopedic joint replacement and coronary revascularization. Thus, the 65-year age cut-off is arbitrary and potentially discriminatory. As our nation’s population continues to age, increasing numbers of persons who are 65 years or older will suffer from extreme obesity and its associated health complications. Thus, we believe that the potential benefits and risks of bariatric surgery must be examined in this population.

In summary, NAASO – The Obesity Society generally supports CMS’s National Coverage Determination for Bariatric Surgery. However, we urge CMS to use the CED option to extend bariatric surgery to persons 65 years and older who are treated at accredited institutions.

1. Sugerman HJ, DeMaria EJ, Kellum JM et al. Effects of bariatric surgery in older patients. Ann Surg 2004;240:243-247.

2. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention and metformin. N Engl J Med 2002;346:393-403.

3. Villareal DT, Apovian CM, Kushner RF, Klein S. Obesity in older adults: technical review and position statement of the American Society for Nutrition and NAASO, The Obesity Society. Am J Clin Nutr 2005;82:923-934

Submitted by: NAASO – The Obesity Society

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Donald Maynard MD Comment on the Biliopancreatic diversion with duodenal switch non-approval by the NCD

Thank you for your efforts to improve the quality of bariatric patient care and access to bariatric surgery through a National Coverage Determination (NCD)

I am concerned that the NCD as it is written specifically excludes the Biliopancreatic diversion with the duodenal switch (BPD/DS, both open and laparoscopic) for Medicare patients and their physicians who want and in many cases need this surgical option.

Long term studies of the Biliopancreatic diversion with duodenal switch procedure demonstrate superior effectiveness for maximal weight loss, the ability to maintain the weight loss and have a much less restrictive eating lifestyle. The BPD/DS has withstood appropriate scrutiny through peer review, scientific literature and the experience of the surgeons who perform it.

All Medicare patients and their physicians should be given the option to choose the surgical procedure that will afford them the best opportunity to achieve their weight management goals.

When discussing surgical weight loss options with patients, I encourage them to become as informed as possible with all American Society for Bariatric Surgery (ASBS) and American Medical Association (AMA) approved bariatric surgical procedures. I request that patients acquire this information by asking three basic questions:

1. Will the surgery do what it is intended to do over the short and long term?(1) Hess DS, et al demonstrated a 95.7% success rate at 10 years “…BPD/DS(duodenal switch) has the best long term weight loss of any procedure done today. It is the easiest to reverse or revise, has the fewest marginal ulcers (pts can take non steroidals eg aspirin to lower heart disease risk), cures the highest percentage of co-morbidities, and has the lowest rate of failure… the BPD/DS should be considered the new gold standard. Others should strive to match these results…” (2)(3)(5)(6)(7)

2. What problems does the surgery itself bring to the table?(7)“…LapDS (duodenal switch) is not associated with broad nutritional deficiencies. Annual laboratory studies, which are required following any type of bariatric operation, appear to be sufficient to identify unfavorable trends. In selected patients, additional iron and calcium supplementation are effective when indicated...”(2)(4)(6)

3. How close to a normal lifestyle will I get with the surgery?(5) A 10 year review of 701 patients who had the biliopancreatic diversion with duodenal switch reported “…duodenal switch is a safe and effective primary procedure for the treatment of morbid obesity. It has the advantage of allowing acceptable alimentation with a minimum of side effects while producing and maintaining significant weight loss. These results are achieved without developing significant dietary restrictions or clinical metabolic or nutritional complications…”(1)(2)(3)

(6)”…The duodenal switch provides excellent weight loss with preservation of good alimentation, even in the super obese. This is accomplished with acceptable operativemortality and minimal dietary limitations and metabolic sequelae. The results of the duodenalswitch that are reported in the literature should remove any inhibitions that exist about the use of this procedure as treatment for patients who have morbid obesity…” (1)(2)(3)

Based on the current scientific data provided and many studies not listed here, I recommend that non-approval of access to the biliopancreatic diversion with duodenal switch procedure (open and laparoscopic) be reconsidered and reversed.

1. Hess DS, Hess DW, Oakley RS: “Biliopancreatic diversion with duodenal switch: results beyond 10 years” Obes Surg 2005 Mar. 15(3) 408-16
2. Marceau P, Hould FS, Simard S, et al. Biliopancreatic diversion with duodenal switch” World J Surg 1998. 22: 947-954
3. Hess DS, Hess DW, “Biliopancreatic diversion with duodenal switch” Obesity Surg 1998. 8:267-282
4. Marceau P, Biron S., et al “ Biliopancreatic diversion with a new type of gastrectomy” Obesity Surg 1993. 3:29-35
5. Anthone G, Lord RV, DeMeester TR, Crooks PF “ The duodenal switch operation for the treatment of morbid obesity” Ann Surg 2003 Oct; 238 (4): 618-27
6. Anthone GJ, “the duodenal switch operation for morbid obesity” Surg Clin North Am. 2005 Aug;85 (4):819-33viii.
7. Rabkin RA, Rabkin JM, Metcalf B, Lazo M, et al “Nutritional markers following duodenal switch for morbid obesity” Obes Surg. 2004 Jan; 14(1): 84-90

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This new National Coverage Determination (NCD) for bariatric surgery is a major step forward in recognizing obesity as a disease and providing Medicare patients nationwide access to the only treatment for severe obesity that has proven long-term efficacy. Numerous studies have shown that high-volume, high quality centers can deliver outstanding long-term weight loss with gastric bypass and adjustable gastric banding with very low morbidity and mortality (<1%) (1-6).

I, and many other bariatric surgeons, who treat elderly patients (>65 years old) are concerned that the NCD as currently written will eliminate access to bariatric surgery for senior citizens. I am aware of no other surgery or therapy that becomes unsuitable, unsafe or ineffective upon acquiring 65 years of life. Medicare will cover procedures such as colectomy, coronary artery bypass, abdominal aortic aneurysm repair and gastrectomy in patients >65 years old. A recent study demonstrates national mortality rates for these procedures in the range of 5-10% (7). Although the recent Flum et al study noted a high (6.9%) 30-day mortality rate amongst this group of patients, the 30-day mortality rate was 1.1% in those centers where relatively large number of Medicare patients had undergone the surgery (8). Several centers have published mortality rates in this age group well below 1%(9,10). The practical solution would be to limit bariatric surgery for patients ¡Ý 65 years of age to centers with high volume and a proven track record. The ASBS Center of Excellence (COE) program could serve as a quality assessment tool for Medicare. The ASBS COE evaluates key programmatic factors such as surgeon credentials, volume, facility equipment, and outcome tracking that are determinants of good results. This program is already up and running with over 500 participating centers and over 900 surgeons. Over 50 centers have received full approval with site inspection. The ASBS COE is most suitable to serve as the vehicle for Coverage with Evidence Development (CED) that is currently being considered by Medicare. Patients ¡Ý 65 years of age should not be denied effective therapy, but rather, they should be assured that they are receiving care at a facility that has excellent results..

I also believe it is very important for CMS to support the two-stage approach for extremely high-risk patients. Patients with severe organ system impairment, cardiac disease, severe sleep apnea and high BMI (> 60) are at much higher risk of operative mortality because of their underlying disease yet bariatric surgery can be life preserving. Many young and older Medicare patients fit into this high risk category A sleeve gastrectomy is a much quicker, lower risk procedure enabling weight loss that will down-stage operative risk for the second stage gastric bypass. My own experience with this technique exceeds 100 high-risk patients with a mortality rate less than 1%. Several studies have confirmed efficacy of the two-stage approach in a select high-risk population (11, 12).

1)Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. Jama 2004; 292(14):1724-37.
2)Christou NV, Sampalis JS, Liberman M, et al. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg 2004; 240(3):416-23; discussion 423-4.
3)DeMaria EJ, Sugerman HJ, Kellum JM, et al. Results of 281 consecutive total laparoscopic Roux-en-Y gastric bypasses to treat morbid obesity. Ann Surg 2002; 235(5):640-5; discussion 645-7.
4)Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg 2000; 232(4):515-29.
5)Wittgrove AC, Clark GW. Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3-60 month follow-up. Obes Surg 2000; 10(3):233-9.
6)O'Brien PE, Dixon JB. Weight loss and early and late complications the international experience. Am J Surg 2002; 184(6B):42S-45S.
7)Goodney PP, Siewers AE, Stukel TA, et al. Is surgery getting safer? National trends in operative mortality. J Am Coll Surg 2002; 195(2):219-27.
8)Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908.
9)Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247.
10)Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R.Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392.
11)Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg 2003; 13:861-864.
12)Nguyen NT, Longoria M, Gelfand DV, Sabio A, Wilson SE. Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the super-obese with massively enlarged liver. Obes Surg 2005; 15:1077-1081.

Philip R Schauer, MD
President-Elect
American Society for Bariatric Surgery

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Bariatric Surgery is Safe and Effective in Patients Over 65

Submitted by the Massachusetts Morbid Obesity Study Group (UMass Memorial Health Center, Brigham & Women's Hospital, Beth Israel Hospital, Massachusetts General Hospital, New England Medical Center)

Background: Recently published reports have brought into question the safety and efficacy of bariatric surgery in the elderly population. As the lifespan of this population continues to increase, the potential health benefits derived from bariatric surgery are irrefutable. Based on data collected by the Massachusetts Morbid Obesity Study Group, patient age should not preclude bariatric surgery as an option for weight loss in the morbidly obese and surgery in this population is both safe and effective.

Methods: A review of all bariatric procedures performed at 5 major bariatric centers in Massachusetts between January 1, 2000 and December 1, 2005 was completed. Three centers perform bariatric surgery on patients aged 65 and older. Data from these 3 centers was included for this study.

Results: A total of 54 patients were 65 years of age or older at the time of surgery. Operations performed included Laparoscopic Roux-En-Y Gastric Bypass, Laparoscopic Adjustable Gastric Banding and Open Roux-En-Y Gastric Bypass. No mortalities are reported within 30 days of surgery. Furthermore, there are no mortalities in the 40 patients who are at least 1 year out from surgery.

Conclusion: Patients aged 65 years and older can safely undergo bariatric surgery with minimal morbidity. Furthermore, this population can experience similar weight loss and resolution of co-morbidities to that seen in younger patients undergoing the same procedure. Failure to offer bariatric surgery on the basis of patient age is neither evidence-based nor ethical.

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On behalf of Surgical Review Corporation (SRC), we support the favorable modifications proposed by the Centers for Medicare and Medicaid Services (CMS) in its National Coverage Determination (NCD) Manual, sections 40.5 and 100.1. This decision will benefit many patients.

The American Society for Bariatric Surgery (ASBS) realizes the seriousness of surgery for severe obesity and that it is extremely important for surgeons and medical centers to provide quality care. Unlike the past history of some subspecialty medical societies in the United States, the ASBS is not trying to “feather its nest” by lowering requirements for its membership to increase surgical volume. The ASBS, in its determination to provide outstanding quality care and to collect validated outcomes data, contracted with SRC to administer the Bariatric Surgery Centers of Excellence (BSCOE) program. A separate company was formed in order to assure credibility, eliminate bias and avoid potential conflicts of interest.

SRC was founded in November, 2003 as an independent not-for-profit corporation guided by industry stakeholders. It is governed by a board of directors with representation not only by prominent bariatric surgeons but also representatives from allied health (nurses, registered dieticians, psychologists), a health insurance plan (the CEO of Blue Cross/Blue Shield of North Carolina), malpractice insurance carrier (the CEO of Medical Mutual Insurance of North Carolina), industry (the president of the ASBS Corporate Council) and a consumer. Additional information about SRC is available on our website: www.surgicalreview.org. More than 500 hospitals and over 900 bariatric surgeons have applied to the ASBS BSCOE program. Over 120 site inspections have been completed for over 130 applicants for Full Approval. More than 60 centers have received ASBS BSCOE designation and more are announced weekly on the ASBS and SRC websites. A program for designation of freestanding, ambulatory surgery centers to perform bariatric surgery procedures that do not require stomach stapling or division of the gastrointestinal tract (e.g. laparoscopic adjustable gastric banding) has been developed. A strong, risk stratified national registry will be the cornerstone of the ASBS BSCOE program. SRC expects to accumulate over 50,000 patients per year in its database, where long-term outcomes (requirement for 75% follow-up at 5 years) are required.

We write specifically in response to the last paragraph of the NCD decision summary:

We are aware that the American College of Surgeons and the American Society for Bariatric Surgery have developed accrediting programs and are specifically asking for comments about their level of competence in performing this facility review.

The ASBS program is an excellent choice for the following reasons:

As a general surgeon and critical care surgeon on faculty at the University of Connecticut School of Medicine and the University of Connecticut Health Center, I was directed to become involved with obesity surgery five years ago. Initially skeptical, I was won over to the utility of obesity surgery in the management of morbid obesity by the literature and the testimonials of those involved initially and then by the results that my patients experienced. I agree with CMS that the evidence is adequate to conclude that gastric bypass and gastric banding are reasonable and necessary for Medicare beneficiaries. I do take exception to your conclusion that the evidence is not adequate for vertical banding gastroplasty. The evidence may not be as strong but it is so analogous to the lap band that its exclusion appears petty. Having said that, I have done very few of these through the years as a gastric bypass is more efficacious. I have no experience with the malabsorptive procedures, but they appear to also have a long track record of efficacy.

You specifically request comment on the population 65 years of age and older. I defer comment on this as I have too little experience with that age group and am personally reticent to apply a gastric bypass to individuals over 65 years of age. The role of the lap band in this population is equally unclear to me. That having been said there are a number of series now with individuals greater than 65 that have been reported including Harvey Sugerman’s group from MCV.

You also ask for comments in regard to bariatric surgery volume criteria for facilities and surgeons. Having developed my bariatric surgeryprogram and experience in the context of critical care, general surgery and faculty responsibilities, I was not able to give bariatric surgery more than fifty percent of my time. However, over three years I operated on 94 patients (averaging about 30/ year) The patients’ mean body mass index was 50. I had no mortality at 30 or 120 days, with one death at approximately 150 days from an apparent pulmonary embolus. Despite my critical care training, the group had only six ICU days in total for whole group. These were also the first bariatric surgery cases I had ever done, as this was not available to me in my training.

Having been a new “small operator” with high- quality expectations and outcomes, I have watched the volume-outcome literature very closely. Unfortunately this literature does not distinguish laparoscopic from open procedures. I think this lack of distinction is particularly important and has not received enough attention. In summary, I do not find any evidence in the literature to suggest that quality is improved after doing 21 open procedures per year. I developed the program at the University of Connecticut paralleling the CMS facility standards that you have published. In fact I believe that establishing the proper process in conjunction with adequate technical abilities are the keys to good outcomes from a good program.

The literature commonly sited to suggest a relationship between volume and outcome includes Nguyen’s paper from the Annals of Surgery 2004. This paper as well as that of Courcoulas (Surgery 2003) are both taken from the same period of time, 1999 – 2002 or 2001 respectively, a time when there has been tremendous growth in the bariatric surgery field and the addition of many new programs. Both generalize from this four or three-year period respectively to volume that surgeons perform per year. I think that, firstly, this is a fundamental flaw as there were a number of programs getting started in this four or three year period so that one is generalizing the outcomes from the start of a program to that of established low-volume surgeons or hospitals. Secondly, some vital data in regards to the patient population is missing because of the nature of administrative databases. However both papers show, and others have suggested from other data sources, that the low-volume surgeons and hospitals operated on patients who are sicker (even twice as sick) as those operated on by highest volume surgeons as defined by those databases. The absolute mortality rate difference between the groups was 0.9% and 1.3% respectively. Further, in his discussion Nguyen concedes that 62% of the low-volume institutions had a lower observed-to-expected in-hospital mortality ratio than expected (i.e., expected for the low volume group was 2.0, and 61% were less than 1. The expected observed-to-expected in- hospital 30 day mortality ratio for the largest volume groups was 0.6, again an indicator that the largest volume groups did not operate on the sickest patients.).

The time period with which these two papers is associated is particularly important when you consider the analysis of Flum and Dellinger in the JACS 2004. Their analysis of Washington State data in a multivariable logistic regression analysis suggested low/early surgical experience (defined as the first nineteen procedures performed lifetime), as well as an advanced Charlson co morbidity index were associated with increased 30-day mortalities. In fact that paper’s data goes on to suggest that after 81 lifetime cases the 30-day mortality rate falls to its lowest point.

In the oral presentations made in June 2005 at the ASBS (American Society of Bariatric Surgery) meeting in Orlando, Dr. Edward Livingston, Chief of Gastrointestinal Surgery at UT Southwest in Dallas began his talk on assessing volume- outcomes relationship by apologizing that he had found no relationship. (As an audience member I questioned whether or not those who perform less than twenty procedures per year, from his data, in fact may have had a higher complication rate/mortality rate. However the limitations of the environment prevented me from adequate analysis.) Additionally, the next paper was presented by Dr. Michael Murr with an examination of the Florida discharge databases. I was struck by the fact that surgeons in hospitals doing 21 to 50 cases per year had the shortest length of stay, lowest complication rate and a mortality rate of 0.3 compared to 0.2 for the largest volume surgeons in hospitals.

I am intrigued by the comparison between obesity surgery outcome-volume relationships and that found with Whipple operations and liver transplantations. My understanding is that in these two areas the volume considered adequate for good results are 12 and 20 cases per year respectively. While I submit that both of these operations (and the process surrounding liver transplantation) are more complicated than the gastric bypass, the caveat to that difficulty of technique is in whether or not the procedure is done laparoscopically or open. The learning curve for this procedure laparoscopically appears more than 50 cases and probably 75 or 100. Therefore one would anticipate a wide range of variance in outcomes reported based on whether the procedure was done laparoscopically or open, and where in the lifetime experience a surgeon resides at the time his data is being collected for reporting. (Again, the importance of mixing laparoscopic and open data is a very big issue, and confounds, if not negates, in my opinion, all the papers written on the volume-outcome relationship from administrative databases which can not differentiate between the operation techniques.)

At the last meeting of the ASBS (Orlando, 2005) there was significant concern voiced by surgeons who are more rurally based and have a significant interest in bariatric surgery. These surgeons have increasing pressure to do all kinds of general surgery because general surgeons are not being replaced in the rural areas as they retire. Therefore the workload of these surgeons demands that their time not be devoted entirely to obesity surgery. Their concern was that although they follow the process outlined by the ASBS’s Surgical Review Corporation (multidisciplinary approach with standardized process and operations in setting dedicated to care for the obese patient while tracking their results, etc.) that they will never qualify as a Center of Excellence in part because their volume is not adequate. In discussions with some of the leaders of the SRC, they admitted that the first reason for forming the SRC was out of fear that they would lose their livelihood in obesity surgery due to the inept work and therefore lousy outcomes of some inattentive, inexperienced and relatively uninterested surgeons throughout the country. Therefore they set to develop criteria for the SRC that would exclude those who do not do a fairly high volume of work in an elaborate atmosphere, recognizing they would probably sacrifice the practice of the small quality programs in so doing – but that this was preferable to not moving forward with some kind of quality initiative.

In July 2005, the Harvard programs sponsored a “Patient Safety in Obesity Surgery, Defining Best Practices” conference in which this issue was discussed. While I expected a debate between Dr. Walter Pories of the SRC and Dr. Thomas Russell of the ACS (American College of Surgery), the differences were much more striking between their positions and those articulated by Dr. David Flum and also Dr. Alan Hardy of the Betsy Lehman Center for Patient Safety and Reduction of Medical Errors. Both Drs. Flum and Hardy suggested, in different ways, a sharing of best practices and a general “raising of the tide so all the boats float higher”. This, with a national registry, would have been a different, and in my estimation more inclusive way to accomplish the same objective of increasing the quality of surgical practice.

Lastly, I would argue that if one is serious about the fact that this treatment for obesity is more than just about an operation (as John Kral has stated “behavioral surgery”) therefore requiring careful multidisciplinary follow-up and support, this operation should only be done by a local program – that is less than a two hour drive away. Patients on disability all around the country deserve access to this surgery. So, while I do not practice in rural America I find the concerns of the rural surgeon very valid.

For all these reasons, I would therefore request that CMS not limit its reimbursement for gastric bypasses to only those who perform high numbers of gastric bypasses or lap bands per year. As long as they continue to have a high volume requirement, I ask that the Surgical Review Corporations’ Center of Excellence designation not be a requirement for Medicare patients wishing to have this surgery.

Thank you for your solicitation of opinions and perspectives. Thank you also for the patience you have demonstrated in reading this letter. If I can be any help to you or your committee please do not hesitate to contact me.

Sincerely yours,

David Giles, MD.
Surgical Director of Clinical Weight Loss Center,
New Britain General Hospital, NB, CT

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Medicare:It is my sincere hope that someone is actually reading all these comments. I have been involved in bariatric surgery as Clinical Nurse/Program Director, for more than 10 years now. It is my privilege to work with dedicated surgeons in a multidisciplinary program. I follow surgical weight loss patients that go out over 20 years. I also follow our Open postop Duodenal Switch patients, numbering more than 400, going out 12 years. Our Lap DS patients now number 1030, with no mortality in the first 30 days. We have 129 patients that are sixty and over, with no mortality in the first 30 days. We have 20 patients 65 and over, as well with no mortality. Our oldest patient has been 72 years old, now two years postop and when he isn’t gardening, he might be out hunting. He no longer has diabetes or sleep apnea. What a joy it was to recently call these 20 postop 65 and plus patients to ask them to comment on this page. I hope they share with you the decrease in co-morbidities they had, decrease in medications, office visits and increase in quality of life. They can often be quoted as saying,” I got my life back.” What other surgery can so quickly cure so many diseases? I, like so many others, see the positive results of the Duodenal Switch every day of the week, every week of the year and have been for over 10 years. I review preop labs, of which we can see deficiencies preop. I review postop labs annually on our patients. We can see some vitamin deficiencies, yes, we will recommend a supplement at that time. We are observing calcium absorption; osteoporosis is an age related disease, but one we all must pay attention to. We can see fewer anemias with our DS patients than we do with our Roux-en-Y Gastric Bypass because we do not have gastritis. W e rarely see Vit B 12 deficiencies because the intrinsic factor is available in our normally functioning stomach. NSAID’s and aspirin can be taken to help relieve degenerative arthritis. The Duodenal Switch has proven itself with 3 long-term peer reviewed publications. (Hess, Biron, and Anthone) Weight maintenance at 10 years in all 3 studies is 75-85% excess weight. We hope to publish soon on our long-term patients as well. Insurance companies have unfairly picked on the DS. This surgery requires a skilled, dedicated surgeon and a committed bariatric team. We have one and I am proud to be a part of this team. Denying medical care is unethical. Patient’s choice of surgery should be between the surgeon and patient; not insurance companies.

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We have done a recent study that evaluated intermediate outcomes of bariatric surgery in 25 patients who underwent bariatric surgery at two university-affiliated programs in Florida. Not only weight loss in these patients was similar to that achieved in younger patients but there was significant resolution of obesity-related medical comorbidities (diabetes 100% resolution; sleep apnea 77% resolution; and hypertension 67% resolution …etc) and a significant reduction of medication use in these patients (from 9-4 medication/day)

We confirmed the safety of bariatric surgery in patients 65 years or older by reporting in- hospital mortality and morbidity of 231 patients who underwent gastric bypass in Florida from 1999- 2003. The in-hospital mortality of 1.3% is much less than the mortality of hip replacement or coronary artery bypass in Medicare patients.

As we do not operate on patients based on their birth certificates but rather on their performance status and medical burden of their disease; I urge to reconsider your decision and approve coverage of bariatric surgery in patients 65 years or older

Respectfully,

Michel M. Murr, MD, FACS
Director of Bariatric Surgery
University of South Florida Health Science Center
Tampa General Hospital PO Box 1289
Tampa, FL 33601

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Bariatric Partners, Inc
7401 Carmel Executive Park
Suite 200
Charlotte, NC 28226

December 23, 2005

CMSComments re National Coverage Decision – Obesity Surgery

Please note that an attachment has been sent to CAGinquiries@cms.hhs.gov which includes citations not able to be copied in this document.

This comment is on behalf of Bariatric Partners, Incorporated. Bariatric Partners, in partnership with physicians, develops and manages weight loss centers and programs focusing on surgical options available to the morbidly obese. These services offered through Bariatric Partners’ programs are comprehensive in nature and include evaluation of patients for the most appropriate weight loss solution, the surgical procedure, and post surgical support such as psychological, nutritional, and exercise counseling. I am Dr. John Morton, Director of Clinical Research for Bariatric Partners.

In general, we applaud CMS for recognizing the importance of weight loss surgery and support the National Coverage Decision to provide benefits for weight loss surgery for the morbidly obese. For the malabsorptive surgical procedures, we believe that your guidance is exactly correct. We concur that any site of service should be a center of excellence complying with appropriate accrediting body standards. However, the surgical procedures themselves are vastly different and consequently, require different standards. The restrictive surgery, Laparoscopic Adjustable Gastric Banding (LAGB) should be appreciated for its very different risk outcomes, complication rate, OR time and recovery time. The Center of Excellence concept for LAGB should be different than contemplated in the NCD. In fact, for those individuals under 65 years of age having Laparoscopic Adjustable Gastric Banding the most appropriate site of service may be an ambulatory surgery center or outpatient surgical setting that can arrange for support services and meet outpatient credentialing criteria developed by an appropriate entity. Our primary concern is that the NCD treats all the approved procedures the same way from a credentialing standpoint. However, these procedures while having the same weight loss outcome, are very different surgically and not only can, but should be performed in a site of service chosen by the surgeon based on the patient needs.

LAGB technology was first performed in the US in 1993. The initial work was almost exclusively performed in a hospital setting. As the acceptance and utilization of this procedure increased, the choice of setting evolved to the hospital outpatient surgical department. In the last 18 months, the experience of the surgeons, the evolution of the American Society of Bariatric Surgeon certification programs, and the continuing development of outpatient skills has allowed the movement of the LAGB into the free standing ASC. Physicians from Dalton, Georgia, state that after performing 787 procedures, “Most complications were minor and easily managed on an outpatient basis. Patient satisfaction was very high even in those experiencing complication. These results follow the trends established in the worldwide literature.”

The NCD lists 6 facility standards. We agree with the criterion that specifies surgeon credentialing and certification. We also agree that each individual providing support services and patient care should be qualified to provide or supervise services. Likewise we agree that an integrated program for the care of the morbidly obese must be provided. The fourth criterion in the NCD discusses the importance of written policies to address and document adverse outcomes. Again, we agree with the importance of documenting outcomes, developing any corrective actions and following up to reduce adverse outcomes. We agree with the informed consent process; and, you are very correct in requiring specialized equipment.

However, outpatient facilities will not be able to comply with several requirements, such as intensive care units and, because of the current statutory and regulatory scheme, in house staff to supply medical consults and ancillary services. These two criteria alone create a de facto situation in which no freestanding ASC and many outpatient surgery centers could be considered as appropriate sites of service. An outpatient setting can and should be certified as a COE, but does not need to have an ICU. Likewise, an outpatient facility can and should arrange for the medical and ancillary support services. The following narrative supports that position and expands on those remarks.

First, the recommendation that an institution have an ICU in order to become certified as a Center of Excellence:

As you are aware, there are two types of bariatric surgery: malabsorptive and restrictive surgery. The malabsorptive surgical techniques are indeed associated with a higher incidence of adverse surgical outcomes. These malabsorptive types of surgery include the Roux-en-Y gastric bypass and bilio-pancreatic diversion procedures (which are done laparoscopically by some surgeons). The laparoscopic adjustable gastric banding (LAGB) is the restrictive type of surgery in which an adjustable silicone band is inserted and subsequently adjusted over time. The LAGB is clearly different in that it does not require the division of any portion of the alimentary tract and is more straight-forward as depicted below. The LAGB is not associated with the same types of complications. The literature indicates the following: “complications occur in a very small per cent of the cases;” LAGB is “very safe and effective;” LAGB is “safe and standardized;” LAGB has “an acceptably low complication rate.” LAGB has “revolutionized surgical treatment” of morbid obesity with “rare early post-operative complications.”

GASTRIC BYPASS LAP-BAND

Risks of LAGBThe risks inherent in operating on the morbidly obese are mitigated in LAGB by adherence to strict patient selection guidelines. Patients with pre-existing cardiac disease and sleep apnea requiring CPAP are eliminated. Typically, patients with a BMI of >50 are eliminated.

In addition, the largest meta-analysis to date comparing bariatric procedures found that adjustable gastric banding had the lowest complication rate of all procedures.

See footnote for reference for table .

Indeed, the perforation/leak rate is not materially different from the same rate of complication rate seen in colonoscopy. A procedure commonly performed in ASCs.

“The Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) in a systematic review of the work literature of LAGB found an early mortality rate of 0.05% or 1:2000, which is 1/10 the mortality of Roux-en-Y gastric banding and 1/6 the mortality of vertical banded gastroplasty.“ The literature reports very few perioperative complications. The predominant post-operative complication is pouch dilation. Pouch dilation is corrected post operatively and poses no immediate threat to the patient.

While the gastric bypass procedure is associated with a steep learning curve, the lap banding procedure is not associated with a steep learning curve given the inherent anatomic differences between procedures. Another factor that limits the learning curve for the lap band is the requirement by the manufacturer (Inamed) that all surgeons must complete a standardized hands-on course and have advanced laparoscopic experience and proctoring for their initial experience. This responsible approach selects motivated, experienced, and capable surgeons to perform the Lap Band which is very different from the gastric bypass procedure that has no certifying criteria. Medical malpractice providers insist that ASCs credential physicians in such a way that allows only those physicians who have performed a significant number of LAGB procedures to become privileged to perform these procedures in an ASC. The literature indicates that the complication rate drops dramatically to nearly non existence after the physician has performed at least 100 procedures. ASCs would certainly have to follow this guideline.

Indeed, the laparoscopic gastric bypass has a steep learning curve. Few surgeons are attempting this procedure today. We are currently recommending that the restrictive procedure, laparoscopic adjustable gastric banding, be performed in ASCs but not laparoscopic gastric bypass. These two surgeries are significantly different with very different complication rates. We do not believe at this time that laparoscopic gastric bypass should be considered appropriate in a freestanding ambulatory surgery center.

Precedence has clearly been established on the outcomes of LAGB performed in freestanding ASCs. Drs. Watkins, et al report their experience with 400 consecutive patients in an outpatient surgery center. From Nov 2002 to Aug 2004, prospective data were collected on 400 consecutive LAGB patients and evaluated retrospectively.
RESULTS: There were 354 (88.5%) females and 46 males (11.5%), with mean age 43.6 years and mean BMI 46.2 kg/m2. For outpatients (freestanding ambulatory surgery center), mean OR time was 55.4 min in 208 patients (52%), compared to mean inpatient OR time of 70.5 min in 192 patients. Inpatients had a higher BMI (48.2 +/- 9.3 SD) than outpatients (43.9 +/- 5.7 SD) (P<0.0001). Complications occurred in 35 patients (8.8%). Average 1-year percent excess weight loss (%EWL) in 138 patients was 48.2%. Patients who had < or =50 kg initial excess weight (n=37, 27%) had a significantly higher %EWL (55.2%) at 1 year than patients who had >50 kg initial excess weight (P=0.0011).
CONCLUSIONS: LAGB has been safe and effective thus far for the surgical treatment of morbid obesity, and can be performed as an outpatient in select patients.

While other freestanding ASCs are performing these procedures, several with web sites document this experience. Among these freestanding ASCs, AIGB (www.aigb.com) in Texas has 4 free standing centers. One of which has performed 3,000 procedures

With regard to your specific request for comment on the selection of accrediting bodies, we believe that some competition is important to the integrity of these agencies. Therefore, we support a choice in accrediting bodies and do not believe that one program is remarkably different from the other at this point. Both the American College of Surgeons and the American Society of Bariatric Surgeons are competent to perform facility review. We would recommend, however, that CMS follow a program similar to the deemed status provision for Medicare Certification. Certainly, the accrediting body must meet minimum standards as set by CMS to continue in this capacity.

Morbid obesity poses a serious and growing health problem with significant human and monetary costs. This NCD recognizes that surgical correction is instrumental in alleviating this problem and its costly co-morbidities. In order to reduce the costs of this procedure safe, alternate sites of service need to be available. As the NCD is written, neither freestanding ambulatory surgery centers nor small HOPDs would be eligible to perform LAGB on Medicare patients. We believe it is important that the differences in these procedures be recognized and that while complying with necessary credentialing requirements, that the site of service designations should be broad enough to allow physician discretion.

Bariatric Partners appreciates your considered review of our comments and your deliberation to assure any NCD reflects the clinical differences in the procedures and that the qualifying criteria and reimbursement guidelines allow outpatient facilities to become certified as Centers of Excellence for Bariatric surgery.

Sincerely,

John Morton, MD
Director of Clinical Research

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We would like to submit several comments to the Center for Medicare and Medicaid Services (CMS) on the proposed coverage decision for bariatric surgery. Our practice consists of three fellowship-trained surgeons performing bariatric surgery at Legacy Hospitals in Portland, Oregon, with Laparoscopic Roux-en-Y Gastric Bypass, Laparoscopic Adjustable Gastric Banding and Laparoscopic Biliopancreatic Diversion being the most commonly performed procedures in our practice.

Overall, we agree with the conclusion by CMS that open and laparoscopic Roux-en-Y gastric bypass (RYGBP) and laparoscopic adjustable gastric banding (LAGB) are reasonable and necessary for Medicare beneficiaries who are under 65 years of age, have a body-mass index (BMI) ¡Ý 35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. We also support the conclusion that approved bariatric surgery procedures for Medicare beneficiaries are reasonable and necessary if the facility performing the procedure meets CMS facility standards. We disagree with the statement in the Proposed Decision Memorandum that a medical treatment trial of 6 to 12 months is 'reasonable' prior to bariatric surgery. Little data supports the efficacy of medical treatment for 6 to 12 months trial prior to bariatric surgery. We feel that this decision is best left to the individual patient, surgeon, and multidisciplinary team involved with the bariatric evaluation.

CMS requests comments on the potential to expand coverage under the Coverage with Evidence Development (CED) option. Although there is a paucity of data on bariatric surgery in patients who are 65 years of age or older, we feel strongly that coverage should be expanded to this population under CED. Medicare beneficiaries who are 65 years of age or older represent a distinct group that may benefit the most from bariatric surgery. The increasing prevalence of obese elderly presents an immediate challenge to the healthcare delivery system in the United States (1-2); the prevalence is estimated to increase by 5.4% between 2000 and 2010, which averages to about 630,000 new Medicare-eligible obese elderly each year (2).The obese elderly have a higher total medical expense, inpatient care expense, and prescription medicine expense compared to normal weight elderly (3) and Medicare bears a large proportion (> 40%) of aggregate medical spending attributable to overweight and obesity (4).

The high early mortality rate in elderly patients undergoing bariatric surgery in Flum's recent study (5) is concerning; however, mortality rate after procedures performed by high volume surgeons is less than those performed by low volume surgeons and is actually comparable to the rate seen in younger patients when treated by high volume surgeons. Recently, we presented our own experience with 40 elderly patients (Age ¡Ý 60) (6). In the Age ¡Ý 65 subgroup, 14 patients underwent bariatric surgery (12 LAGB; 2 RYGBP) with zero early or late mortality. For LRYGB, excess weight loss (EWL) is 72% at 1 year. For LAGB, EWL is 37% at 1 year and 46% at 2 years of follow-up. Other surgeons have reported similar success in the elderly through this public comment section. In the absence of any other effective long-term treatment for morbid obesity, we feel that there is enough evidence that bariatric surgery procedures for Medicare beneficiaries who are 65 years of age or older are reasonable and necessary, provided that surgeon volume criteria and CMS facility standards are met. We support the revision of the noncoverage of the age 65 and older population with the application of CED, as this option would be an ideal approach. This would provide expanded coverage to a deserving population and would permit clinical trials and/or prospective cohort studies that compare surgery with non-surgical management in this population.

Finally, CMS requests public comment on bariatric surgery volume criteria for facilities and surgeons and appropriate entities to apply facility standards. Currently, insufficient data exists to define specific volume criteria for surgeons/hospitals. As for an appropriate entity, the Surgical Review Corporation (SRC) is an independent, not-for-profit entity under contract with the American Society for Bariatric Surgery to administer the Bariatric Surgery Centers of Excellence initiative. The SRC has the support of many bariatric surgeons. We feel that the SRC would be the best organization to apply facility standards and to define surgeon volume criteria.

Thank you for allowing us to comment on the proposed modifications of the National Coverage Determination Manual

Sincerely,

Emma J. Patterson, M.D., FACS, FRCSC
Dennis Hong, M.D., FRCSC
Jay C. Jan, M.D.

(1) Health, United States, 2004; Table 69.
(2) Arterburn, J et al. The coming epidemic of obesity in elderly Americans. Am Geriatr Soc 2004; 52: 1907-1912.
(3) Rhoads, J.A. Overweight and obese elderly and near elderly in the United States, 2002. MEPS-AHRQ Statistical Brief #68, 2005.
(4) Finkelstein, E.A. et al. National medical spending attributable to overweight and obesity: How much, and who's paying?, Health Affairs Web Exclusive, May 14, 2003.
(5) Flum D.R. et al. Early mortality among medicare beneficiaries undergoing bariatric procedures. JAMA 2005; 294: 1903-1908.
(6) Jan J et al. Safety of laparoscopic gastric bypass and laparoscopic adjustable gastric banding in older patients. Presented at the 22nd Annual Meeting of the American Society for Bariatric Surgery 2005, Orlando, FL (Plenary Session).

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It is a dreadful mistake to withold duodenal switch from the population under 65. Long term success in weight loss maintenance is better with duodenal switch than with RNY, with better quality of life and the ability to eat fairly normally without dumping or vomiting. The Lap Band ends up being more costly because of adjustments and causes problems with erosion, and also results in less weight loss.

It is a dreadful mistake to withhold weight loss surgery from the over 65 population across the board. It is far simpler to provide extra protein in the form of protein drinks, and supplementation, than to try to move 300 -500 pound people around. Think of the workmen's comp claims you can avoid by allowing Medicare recipients to lose weight and regain mobility.

You are dooming obese Medicare recipients to poor quality of life and an early death, which, though it may be of benefit to your bottom line, is really bad for the patients and society in general.

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I have worked in the field of bariatric surgery for the past ten years. In conjunction with experienced and dedicated bariatric surgeons and hospitals, we developed bariatric surgery centers in many Midwest and Southeast metropolitan areas, including Chicago, Cleveland, Indianapolis, Louisville KY, and Nashville TN. These centers continue to operate today and are standard-bearers in their area for quality care and commmitment to patient success for a lifetime after surgery.

In recent years, I have been disappointed by the field of bariatric surgery. Before 2000, the field was really dedicated to patient well-being. It was populated by surgeons who were empathetic to the morbidly obese, and who were committed to helping them, knowing that surgery was just a tool and that the real success indicators for surgical patiets would be the education before and after surgery,and the patient's commitment to their aftercare.

Commercialism and profits entered in the 21st century, and the field took a "wrong turn" into just being focused on increasing surgeries. Surgeons who never before had any interest in the morbidly obese attended short training sessions, were schooled in how to get insurance approval, and were willing to operate on just about anyone.

The events in bariatric surgery remind me of a similar demise in the alcoholism and psych industry of the late 80's and early 90's. Profiteers came in then, too, and transformed a needed and medically viable industry into just a way to increase revenues.

While I believe bariatric surgery will always be a necessary TOOL that should be available for the morbidly obese, I would urge and encourage Medicare to adopt some preliminary requirements for education and patient selection BEFORE any patient is approved for bariatric surgery under new guidelines.

Patients should be required to fully participate in a predetermined and established pre-operative bariatric lifestyle course that includes nutrition, fitness, and behavioral elements for at least six months prior to surgery. Monitors, documentation, and reporting mechanisms should be established so that patient compliance with instructions, nutritional choices, and other lifstyle factors necessary for success after surgery can be assessed. If a patient can't comply with instructions, and attend every session scheduled for them BEFORE surgery, why would anyone expect that they will be compliant AFTER surgery?

The taxpayers of this country will support treatment for morbid obesity when other GOOD and well-directed methods of weight management have failed. Please don't listen to the cries of bariatric surgeons who say there is a 97% failure rate with non-surgical diets. Today, they are right, but until recently there has been NO FOCUS on developing a program that will work to help patients LOSE WEIGHT and KEEP IT OFF, leading to improved health.

There are good programs out there, with clinical studies from places such as Johns Hopkins University, that show morbid obesity for some can be overcome if the patient is compliant and given the proper tools.

Please do not subject the taxpayers of this country to arbitrary bariatric surgery simply because a patient has a BMI of 40 or above. You need a good case management program, a good pre-surgery program, and outcomes. Simply giving everyone the tool of surgery WITHOUT giving them the other tools they need to be successful, will ultimately fail AND simply lead to more cost.

IF I can be of service in your efforts, or if you would like more information on patient compliance methods we have recently employed to test the likelihood of patient success, let me know. They are illuminating and support my opinions here.

After ten years in the field, I support bariatric surgery, but have come to learn the absolute necessity of at least six months standardized education and compliance through another program to help patients be successful.

Thanks for your time and your efforts in reviewing this most important health issue.

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What happens to those with a Nissen fundiplication- RNY and Lapband are not going to be options for them. They will need a biliopancreatic diversion/duodenal switch, BPD/DS (duodenal switch)as an option to benefit from surgery. The BPD/DS has been long proven to be the most effective surgery in regards to % of excess weight lost and long term success. Dr. Hess, Dr. Husted, Dr. Spaw, Dr. Smith, Dr. Maynard, Dr. Gonzales, Dr. Rabkin and many other Doctors across the county have 1,000 s of patients between them that have found the BPD/DS the most beneficial surgery for thier physical and mental needs. This surgery is proven- it should be covered by Medicare.

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CMS is to be commended for the extraordinary effort made to evaluate the appropriate role of bariatric surgery as treatment for morbid obesity in the Medicare population. We concur with the conclusion that gastric bypass and laparascopic adjustable banding (LAGB) are indicated as primary intervention for Medicare beneficiaries with comorbidity and associated with morbid obesity and associated comorbidity. The issue of Medicare beneficiaries greater than 65 years of age requires additional comment and consideration. Of the increased morbidity and mortality risk among such Medicare beneficiaries is clearly reported by Flum et al. (Ref. 1). As noted in the accompanying editorial however, the fact that given population has a higher complication or mortality rate does not necessarily mean that the intervention is contraindicated for the entire population as the vast majority of patients, who in this case undergo bariatric surgery, may derive a substantial benefit from such procedures. In addition, it is reasonable to predict that the morbidity and mortality rates in this over 65 population undergoing bariatric surgery will improve in the immediate future. This prediction is based on the following consideration:

1) Identification of the increased operative risk for patients greater than 65 years of age may stimulate surgeons to more critically evaluate operative risk in prospective candidates, thereby restricting operation to patients who appear to have satisfactory preoperative risk. A greater attention to preoperative preparation regarding associated comorbidities may also be stimulated. In the longer term, establishment of databases to provide greater information regarding identification of risk factors will allow more precise identification of patients with increased risk. Limitation of operative intervention of patients with lesser preoperative risk will obviously improve outcomes.

2) Concentration of operative intervention at centers with established processes and high volume. The Flum data clearly indicates that concentration of operative procedures at high volume centers reduces complications. Complications may be reduced further by establishment of detailed protocols and procedures for quality assurance, such as the programs established by the Surgical Review Corporation at the American Society of Bariatric Surgery and the American College of Surgeons.

3) Greater application of LAGB to these higher risk patients. The operative mortality is consistently shown to be lower for LAGB than for a gastric bypass. In the past however, the application for LAGB has been infrequently utilized due to the more relatively recent availability of FDA approval of the LAGB.

4) Due to the fact that Medicare provides healthcare reimbursement for nearly all persons 65 years and older in the United States, some modification of the Medicare policy will be necessary if clinical research in this sizeable population is to continue. Some plan therefore, whereby those patients whose evaluation and outcomes are entered into a prospective database which can be analyzed and subsequently used for appropriate decision making regarding Medicare policy is strongly recommended. As suggested by Dr. Walter Pories, approval for Medicare beneficiaries greater than 65 years of age at surgical centers designated as Centers of Excellence by the Surgical Review Corporation or by the American College of Surgeons would be reasonable and appropriate. The same rationale could be provided for limited approval for the duodenal switch procedure for Medicare beneficiaries. The advocates of this procedure are many, even though presently available data does not fully justify widespread application of this procedure. We recommend modification of the exclusion of open adjustable gastric banding. There should be no disincentive to converting any laparoscopic operation to open for whatever reason. The open approach to gastric banding may be indicated and safer in selected patients who qualify for bariatric surgery who have known or presumed extensive intestinal adhesions, a large ventral hernia or other contraindication to a laparoscopic approach. Gastric banding may be preferred in such patients.

Sincerely,

Bruce M. Wolfe
Clifford Deveney
Robert O’Rourke
Robert G. Martindale

References

1. Flum DR, Salem L, Brockel Elrod J, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA. 2005; 294:1903-1908.

2. Wolfe BM, Morton JM. Weighing in on bariatric surgery. JAMA. 2005;294:1960 1963

3. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724-1737.

4. Jan JC, Hong D, Pereira N, Patterson EJ. Laparoscopic adjustable gastric banding versus laparoscopic gastric bypass for morbid obesity: a single-institution comparison study of early results. J. Gastrointest Surg. 2005; 9(1): 42-43.

5. Myers, MA. Presented at the annual Clinical Congress, American College of Surgeons. October 2005. Data summarized in Surgery News Dec 2005, p25.

6. Kumbhani, D. Presented at the annual Clinical Congress, American College of Surgeons. October 2005.

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Thank you for the opportunity to provide comments on the proposed decision for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R). I am the Chief Medical Officer of EnteroMedics Inc., a company dedicated to developing novel medical devices to treat obesity. Our purpose with this communication is to express our support for the thoughtful and thorough approach that you are taking with this proposal. We all share the challenge of addressing the individual and public health issues presented by the obesity epidemic and its consequences. We therefore would like to offer our thoughts on your proposal.

I would like to commend the Centers for Medicare and Medicaid Services (CMS) for their thoughtfulness and efforts in attempting to improve healthcare access in the United States by addressing the weight loss surgery options for morbidly obese Americans through its recent National Coverage Decision (NCD). Having read the decision summary, I recognize that the decision making process was not an easy one and therefore appreciate this opportunity to make a public comment. I would specifically like to address the issue of expanding coverage under the Coverage with Evidence Development (CED) option.

Every physician faced with a morbidly obese patient must assess the risk:benefit ratio of any treatment option being considered, even if that treatment option is “no intervention”. A bariatric surgeon has numerous treatment options within his/her armamentarium, and only after careful evaluation of a patient and thorough discussions with the patient, can a proper assessment be made. No one particular option is appropriate for all patients. Sometimes if the surgical risk is high, a procedure with a lower mortality risk is the intervention of choice. For other patients, a planned “staged” procedure is more appropriate. The art of medicine as it pertains to bariatric surgery is in knowing how to identify which treatment option best fits each individual patient in any given situation.

In 1991, the National Institutes of Health (NIH) Consensus Development Conference on “Gastrointestinal Surgery for Severe Obesity” stated that the Vertical Banded Gastroplasty and the Gastric Bypass were the dominating procedures in the United States at that time. Although there are now minimal access techniques for performing general and bariatric surgery, gastric restrictive procedures and gastric bypass procedures still dominate the field. More malabsorptive procedures, popularized in Europe since the 1980’s, have also been performed very successfully in this country, adding to the treatment options available to morbidly obese patients.

I am very concerned by the proposed exclusions being considered by CMS.

It is my firm belief that chronologic age and physiologic age of a patient do not correlate 100%. Although a patient will often appear physiologically older than his/her stated chronologic age, there are certainly situations where the opposite also holds true. I request that the committee reconsider its position on creating an artificial exclusion criterium bases on this arbitrary value of 65 years.

The decision to exclude Vertical Banded Gastroplasty (VBG), both “open” and laparoscopic, as well as “open” adjustable gastric banding, is very troublesome. This would limit “restrictive” treatment options to laparoscopic adjustable gastric banding (LAGB) only. The VBG has a very long history with an established track record. The LAGB has been in use in the USA for only 4 years, with very mixed results. This is a very bad decision.

Biliopancreatic Diversion with or without Duodenal Switch, performed by any access technique, whether as one procedure or as a planned two stage procedure, offers patients an additional treatment option too valuable to exclude. Although not necessarily the best choice for most patients, many surgeons and patients feel the higher success in weight reduction and resolution of comorbid conditions, earns this procedure a secure position in the arsenal of treatment options. Again, excluding this valuable tool will be a disservice to the morbidly obese patient.

In summary, I feel your committee is doing very important and much needed work. I hope your policy decisions open up broader avenues for access to proper medical care to the morbidly obese American patient population. Please don’t shut down our treatment options. Our patients need us now, more than ever, to keep an open mind about advances in medical care, including surgical options.

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Dear Doctor Phurrough: As a bariatric surgeon in NC I have performed 1000 bariatric procedures over the last 5 years and have had the priviledge of observing the profound improvements in comorbidities and lifestyle that resulted from these surgeries. Some of the most dramatic improvements have been in the over 60 age group, including a number of patients over 65. To limit their access based on age alone is not only unjust but unrealistic as our average lifespan continues to lengthen. These decisions should be based on physiologic age, risk/benefit, and careful consideration of focused data, ideally from bariatric centers of excellence.
Sincerely,
Roc W. Bauman,MD,FACS
Concord,NC

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Regarding the question of Medicare funding forbariatric procedures, published research hasrepeatedly shown that there is great benefit forthose individuals in need of this service. Thedecision as to whether or not a surgical procedureis well advised for a particular individual shouldbe left up to the individual and his or hersurgeon. The question of Medicare funding islarger than this. Many private insurance carriers’official medical policies are influenced by, ifnot based on, Medicare policy. Exclusion byMedicare may well be used as rationale for thespecific exclusion of these procedures by manycarriers to the population at large. This wouldnot be in the public’s best interest.

I would like to address the question of thespecific exclusion of the procedure generallyreferred to as Duodenal Switch (DS). I will showthat the DS procedure is safer and less prone tocomplications than the “allowed” procedure, theRNY/GB. There have been several variants of thisprocedure as it has evolved and as a result thereare more than one descriptive term used for thisprocedure. For clarity in this paper I will usethe term Gastric Reduction/Duodenal Switch (GR/DSor DS). This has been shown in peer-reviewedpublished literature to be the most effective andthe less prone to long term complications. It isthe most effective in terms of total weight lossand the long term maintenance of weight loss. Itis also the least likely to create unnaturalmetabolic conditions which in turn create theprobability of side effects requiring medicalintervention. I will attempt to explain thesedifferences in lay terms as I attempt to compareand contrast the two most effective procedures.

There are several very significant differencesbetween these two bariatric procedures. Thesedifferences have to do with the way the food isprocessed in the digestive tract. The RNY/GB isprimarily restrictive and slightly malabsorptivewhereas the DS is primarily malabsorptive butsomewhat restrictive. The primary reason the DShas so few complications as compared to the GB hasto do with the unnatural digestive physiology theGB creates. Digestive physiology in the DS patientis much closer to normal

In the GB the stomach is divided is such a way asto limit its capacity to about 1 oz. and aphysiologically abnormal connection is made to thesmall intestine by dividing the intestine andre-routing it up to the small stomach pouch. Thesection of small intestine which is attached tothe stomach pouch is lined with cells adapted tothe normally alkaline environment of the smallintestine. Because of the special adaptation ofthese cells they do not well tolerate the acidicenvironment they now are forced to endure. Thisover time can cause ulcerations (in 12%) andscarring which causes the opening to becomenarrowed, a condition called stenosis (alsooccurring in 12% of patients). Both of theseconditions may require medical intervention.Because there is no functioning pylorus (the valveat the lower end of the normal stomach where itjoins the small intestine) the patient is prone toa several unpleasant side effects. These sideeffects are not only are painful and inconvenient,but can be medically dangerous as well (extremelylow blood sugar, for example). In all thepatients with the RNY/GB there is an overallreported rate of complications relating to thisconnection (plugging of the stomach pouch 47%, 68%report vomiting, and fully 76% develop dumpingsyndrome). The majority of GB patients areintolerant of red meat. I feel that these sideeffects contribute to weight gain. Because ofthese side effects and the fact that they cannottolerate what most would consider a satisfyingdiet, some GB patients eat soft foods comprising ahigh calorie diet which is easy to process throughthe small stomach pouch. There is yet anotherabnormal aspect to the GB procedure which createspotentially problematic alteration to the normaldigestive physiology.

The reconnection of the small intestine with theRNY/GB eliminates the passage of the food throughthe proximal duodenum (the beginning of thenatural small intestine). This is very significantand important to explain. The proximal duodenum iswhere the process of chelation occurs. Chelationis how minerals are combined with specificproteins (manufactured by the body for thispurpose) so they can be selectively absorbed. Simply put no chelation, no absorption. No mineralabsorption leads to a number of conditions thatcan be very serious. In contrast to the RNY /GB,in the DS procedure the stomach is reduced in sizeto about 4-6 oz., or the size of a banana. Thisallows a more normal sized meal. The pylorus ismaintained completely. In this way the proceduremaintains the normal function of food passingthrough the stomach into the first part of theduodenum, thus there is no dumping syndrome. Other functions of normal digestive physiology aremaintained. Stomach acid is neutralized as itshould be as it enters the small intestine,avoiding the stomal complications of ulcerationsand stenosis. Chelation occurs so minerals areabsorbed more normally. Because the patient has amuch more normal digestive function in terms ofthe digestive processing in the more normalstomach, the food also has a much greater exposureto intrinsic factor. This is a substance secretedby specialized cells in the stomach lining and isvital to vitamin B12 absorption. DS patient alsoneeds to use vitamin and mineral supplementationas does the GB patient but to a somewhat lesserextent.

The GB patient must be very careful about vitaminsupplementation or suffer the potential for veryserious consequences such as osteoporosis, irondeficiency anemia or anemia due to vitamin B12deficiency, to name a few. The DS patient has nearnormal digestive function is this respect. Thesevitamin and mineral issues are seldom seen in a DSpatient eating a healthy diet and using reasonablecare in their supplementation.

The GB must have food pass through an unnaturalconnection which is prone to chronic problems. TheDS patient has normal anatomy in this respect.

The GB patient has the probability of a ratherrestricted diet. The DS patient has a much morenormal diet.

Medicare should be VERY careful about how theliterature relating to the GR/DS is reviewed. Ithas been the experience of many people who havewanted the DS and had it denied by their insurancecompanies that the literature cited in theirinsurance companies’ policies cite data reportedin papers describing the biliopancreatic diversion(BPD) or Scopinaro procedure, an older procedurefrom which the GR/DS significantly differs, injustifying their policies excluding the GR/DS. This “confusion” possibly relates to the fact thatthe GR/DS was developed as a solution to themetabolic sequelae that plagued the BPD, and thuswas misleadingly named (apparently out of respectfor the pioneering Dr. Scopinaro, who is stillactive in the field of bariatric surgery). Itrust that Medicare can review the literature withthis understanding and make this distinctioneasily and without guile.

In conclusion, it seem obvious that the DS patienthas a more normal lifestyle and diet while at thesame time maintaining greater weight loss with amuch smaller chance of bothersome or serious sideeffects. Medicare wants to exclude which procedure?

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Thank you for your efforts to improve access to weight-loss surgery through a National Coverage Decision. As a Registered Dietitian dealing with bariatric patients I see how bariatric surgery can improve patient’s quality of life on a daily basis.

The bariatric program in our facility has provided bariatric surgery to over 1300 patients since 2001. We collect data confidentially on all of our bariatric surgery patients. Recently we reviewed our data for outcomes specific to our patients 65 years of age and older. I was not surprised by our findings. In our elderly patients with an average age of 68.5, our complication rates are low. The only complications found were hernia at 1% and anastamotic stricture at 1%. Our excess weight loss in this population is above the national average at 73% at 3 years, as is the follow-up rate of 75%. Taking this data into consideration, I do not believe limiting access to bariatric surgery because of age is rational.

I would support Medicare Coverage with an Evidence Determination program with the conditions that surgeons be appropriately experienced and that mortality and complication data be collected to evaluate the potential of a future expansion of coverage.

Finally, I am concerned that comprehensive long- term follow-up care was not discussed in the NCD. Despite support and referrals from physicians, coverage of services provided by a Registered Dietitian has yet to be covered by Medicare. Obesity research of surgical and non- surgical programs finds that long-term follow-up care is essential to patient’s success with weight management.

Thanks again for your efforts to expand the treatment of morbid obesity. Sincerely,

Mari Kadow, RD, LD
St. Joseph’s Area Health Services
600 Pleasant Ave.
Park Rapids, MN 56470

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As Coordinator of the Surgical Weight Loss Program at St. Joseph Regional Health Center in Bryan, Texas, I am submitting a comment regarding CAG-00250R: the proposed modification to the NCD manual sections on bariatric surgery for the treatment of morbid obesity.

Your review of current literature repeatedly notes that there is inadequate research available on the results of bariatric surgery in the elderly, yet you propose to discontinue coverage for this population. In this era of evidence-based medicine, this decision seems particularly difficult to understand. Rather than discontinue these procedures for patients 65 and older, it would seem more logical to continue these surgeries by qualified, experienced surgeons with rigorous controls and every attempt to track outcomes data. Indeed, you cite a study done at the University of Pittsburgh in 2003, “Diagnosis and Treatment of Obesity in the Elderly” which recommends just that: future research to analyze effects of surgery in the elderly.

Further, your literature search yielded 213 papers, but only 27 were considered acceptable to be used in guiding your decision. Obviously, more carefully documented and controlled research is necessary before the CMS can make a fair and reasonable decision in this matter.

The research of Medicare data done by Dr. David Flum was recently discussed in a JAMA Institute for Healthcare Improvement “Author in the Room” conference call. While Dr. Flum showed a higher mortality rate in older patients, the mean age of the patients in his study was 47.7 years. Further, the implications that can be drawn from his study are hampered by several factors: gastric banding was not included, co-morbidities of the patients were unknown, pre-op education and post-op compliance were data was unavailable. Dr. Flum’s study showed that surgery is more risky for older persons – this is not new information. He also showed that surgery is riskier when performed by inexperienced surgeons. Again, this is not new information. Dr. Flum also admitted that there was no attempt to compare mortality rates from surgery to mortality rates from continued obesity.

Older patients know that they have a greater risk when undergoing any surgical procedure. They also know the risks and diminished quality of life from the co-morbidities associated with being morbidly obese. They should be allowed to decide for themselves which risk they wish to take. Discrimination against the elderly is illegal. It should be illegal to discriminate against the morbidly obese. If you decide to exclude coverage for elderly morbidly obese patients, you will be practicing discrimination. I strongly urge you to continue Medicare coverage for bariatric surgery for all persons, regardless of age.

My final comment addresses the suggestion that only psychiatrists should be allowed to perform pre-operative evaluations of patients considering bariatric surgery. Again, I strongly disagree. Our program utilizes several extremely competent psychologists who are well qualified to assess the mental preparedness of patients considering surgery. Further, if a prospective patient already has an established relationship with a psychologist, that individual is the more competent person to make that determination than an unknown psychiatrist.

Thank you for reviewing this opinion.

Cathy King
Surgical Weight Loss Program Coordinator
St. Joseph Regional Health Center
2810 Franciscan Drive
Bryan, TX 77802

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Medtronic, Inc. welcomes the opportunity to respond to the Centers for Medicare & Medicaid Services’ (CMS’) request for public comment on the National Coverage Analysis (NCA) for Bariatric Surgery for the Treatment of Morbid Obesity. Medtronic is the world’s leading medical technology company, providing lifelong solutions for individuals with chronic diseases and enhancing the lives of Medicare beneficiaries.

In reviewing the proposed NCA, Medtronic was pleased to see CMS’ intention to expand beneficiary access for the treatment of obesity to include open and laparoscopic Roux-en-Y gastric bypass (RYGBP) and laparoscopic adjustable gastric banding (LAGB). We also support CMS’ decision to allow beneficiaries access to important innovations in treatments for obesity as they become available in the future.

CMS has requested public comment on the facility criteria, specifically whether the Agency should include more definitive bariatric surgery volume criteria for facilities and surgeons. Based on the current evidence for bariatric surgery, we believe that the facility criteria that CMS has preliminarily developed are reasonable to help ensure that beneficiaries receive quality care before, during and after surgery.

In addition, Medtronic agrees with CMS’ determination that these standards are best applied by organizations experienced in the accreditation process. If the accrediting organization’s criteria minimally include CMS’ standards, we believe this should then serve as qualification for a Medicare center of excellence. The accreditation process is lengthy and costly for facilities and physicians, and this would retain flexibility while ensuring quality care.

We remain concerned by proposed language in the draft NCA limiting access to these procedures and technologies to beneficiaries over age 65. While we understand CMS’ concern regarding the surgical risks for this population, the Flum study results showed similar rates of mortality in the >65 and < 65 population when the surgeries were performed in higher volume facilities. This study also demonstrated that there was an increase in mortality rates when the surgeries were performed in lower volume centers. We believe that the bariatric surgery volume criteria for facilities and surgeons performing these procedures should be sufficient to ensure beneficiary safety and provide optimal clinical benefit, and we encourage CMS to provide coverage for these procedures in the aged Medicare population if performed in certified and approved facilities.

As you know, Medtronic plans to bring an innovative treatment for obesity to market in the near future. We look forward to continually working with CMS to assure that Medicare beneficiaries have access to clinically effective therapies.

Sincerely,

Kathleen Dunham
Senior Reimbursement Manager
Medtronic

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To whom it may concern,

We are very concerned and disappointed that CMS would consider limiting or eliminating the bariatric surgery benefit for patients over sixty-five. I understand the concerns regarding safety, efficacy and cost. I will elaborate on our recent experience with this population in an effort expel some of these concerns.

Our group began placing Laparoscopic Adjustable Gastric Bands in September of 2004. To Date we have placed 15 of our 110 Lap-Bands in patients over 65 years of age and covered by Medicare, and another 12 Lap-bands in those patients over 55.

The first concern of course is safety. We have had no deaths in our cohort. 12 of the fifteen patients were discharged on the first post-operative morning. Two patients stayed longer than 23 hours. The first had a concomitant hiatal hernia repair and experienced nausea the morning following surgery and was discharged without complication the following day. The second patient was wheel chair bound, and bordering on home oxygen. She became very disoriented on the post-operative narcotics and stayed an extra day for pulmonary evaluation and pain control. The final patient was a late day case, requiring overnight ventilation. She was extubated the following morning and discharged on the second post-operative day.

The cost of Lap-Band placement is about one half to two thirds of an uncomplicated gastric bypass. This does not take into account the inevitable complication of gastric bypass that can be quite costly. Many cost analyses have shown that Bariatric surgery meets the standard of $50000/per life year saved set by the dialysis benefit. This can only be truer for Gastric banding where initial cost is much lower.

Finally, there is efficacy. Our excess BMI loss at 1, 3, and 6 months is 16, 25, 32% respectively. Nearly all patients who are 6 months out have had objective improvement in comorbidities with decreased medications and improvement in weight related medical conditions. Many are losing significant weight for the first times in there lives. All patients note the subjective finding of increased energy and mobility. One patient is now ambulating out of her wheel chair with ease. Our two patients who are one year out have lost 56% and 25% of excess BMI. The latter is off her diabetic medications out of her wheel chair and has had trouble with follow up because her husband has had to have two surgeries (back and eye) and she could not make it to her appointments. However, she couldn’t be happier and sings the praises of her band. Both of these patients had sought gastric bypass in other location and been refused because of age and medical problems.

These data highlight the remarkable safety and efficacy of lap-band in the over 65 Medicare population. In many cases Lap Band is the only hope for significant weight loss and with it improvement in medical conditions and quality of life.

Sincerely,

Matthew Brengman MD FACS
Gregory Schroder MD FACS

Bariatric Division,Richmond Surgical Group

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As the director of a bariatric center that recently received full approval from the surgical review corporation/ ASBS as a center of excellence in bariatric surgery I believe that I have reasonable insight and first-hand knowledge on this topic.

The 1991 Consensus statement from the NIH together with the 1998 "Evidence Document" on Overweight and Obesity in the United States, form the basis for the clear justification of a surgical approach to obesity.

The rise in popularity of the surgery over the past decade combined with the recent focus on "patient safety" across the country led to the development of a national "Center of Excellence" designation initiative by the American Society of Bariatric Surgery through a separate entity known as the Surgical Review Corportation.

Over the past 2 years this has resulted in over 400 centers applying for and reaching preliminary approval status and ongoing site visits leading to "full approval" for a much smaller number of programs.

Separately, the American College of Surgeons has set up a similar but not associated program for COE designation. The concept of COE has clearly been embraced by the bariatric community and I do not believe needs to be recreated by CMS.

A comprehensive, multidisciplinary approach to the total care of the morbidly obese patient has been accepted as the "best practice" model for bariatric surgery. CMS appears to understand this concept. ASBS/SAGES/ACS all have established baseline guidelines for patient selection for bariatric surgery.

The key to selection is careful, complete risk assessment and, where possible, modification of risk. The work from Flum et al. was compelling and important, however, we must not allow a single set of data to dictate policy without corroboration.

Our program has several suggestions:

1. We agree that patients over 65 should be considered "high risk."
2. That these patients be subjected to a standardized "degree of risk" stratification scheme.
3. A select subgroup be considered, at least, for Laparoscopic Adjustable Gastric Banding on a national protocol basis.
4. We recommend that CMS utilize the one of the current "center of excellence" initiatives available (ASBS/SRC or ACS) and not add yet another credentialling program to select appropriate surgeons and facilities to provide care for beneficiaries.Specific and comprehensive criteria for both surgeons and facilities exist within the context of these current center of excellence designation entities and provide what, I believe, CMS is looking for to ensure the safety of its beneficiaries.

Respectfully,

Jeffrey M. Nicastro, MD, FACS
Director of Bariatric Surgery
Staten Island University Hosptial
Staten Island, NY
ASBS/SRC Center of Excellence

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I am curious as to know why something that has been proven to help people is going to be unavailable. Is it not true that everyone deserves access to medical procedures? Why would the government choose to deny people the right to life, liberty, and the pursuit of happiness by denying this procedure? People could lose their lives by not having this available, they risk their health not ever being better, and happiness comes with self content, which the decision to remove this surgery from the approved list, would remove contentment as well. If giving people the best option medically speaking is not good enough, think of the money that will be saved by curing the underlying cause of potentially life long medical costs. I ask that you listen to those who pay into the system and give them the option that is best for them.

One more question, is it okay to be fat if you are old? That does not even make any sense. I would like to know the brilliant person who was elected to think that one up!

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I suggests that your organization reconsider the decision for denial of coverage for the two-stage procedure. Despite my extensive experience in laparoscopic bariatric surgery, there are a group of patient who I would considered as high- surgical risks and would benefit from this approach. For example, we have found that large males with central obesity are prime candidate for the two-stage operation as these patients have been shown to have higher morbidity and mortality. A major technical hurdle in laparoscopic gastric bypass is mobilization of the angle of his to create the gastric pouch. Large males tend to have large amount of omentum in this region and a large left lobe of the liver that can obscure visualization of this region. We have previously described a two-stage procedure for such a patient. The first stage consist of creating Roux-en-Y gastric bypass with a large gastric pouch. The second stage consists of a sleeve gastrectomy of the gastric pouch at an interval of 4-6 months after the 1st- stage procedure. The two-stage procedure may reduces morbidity and mortality associated with the high risk patients.

Ninh Nguyen, MD

Nguyen NT, Longoria M, Gelfand DV, Sabio A, Wilson SE. Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the super-obese with massively enlarged liver. Obes Surg 2005; 15:1077-1081.

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GI Dynamics, a privately held, venture-backed company that is developing innovative products for the treatment of obesity and its complications, welcomes the opportunity to provide comments on the proposed Medicare coverage policy for Bariatric Surgery for Treatment of Morbid Obesity.

Morbid obesity is an important and often medically intractable health problem, one for which current therapeutic options are clearly less than satisfactory. Many individuals for whom obesity constitutes a significant and imminent health risk are unable to reduce their weight through behavioral, dietary or pharmacological means. For such individuals, bariatric surgery may currently be the last and best option, but its benefits are accompanied by substantial morbidity and mortality risk.

GI Dynamics’ lead product, currently under development and in the early stages of clinical testing, is an endoscopically-delivered, implantable (and removable) device for the treatment of morbid obesity. It has the potential to provide the benefit of clinically significant weight reduction without the risks attendant upon current surgical approaches. If successful, our product – and/or other products currently under development elsewhere – may provide a safe and clinically effective therapy that renders most bariatric surgeries unnecessary.

We look forward to sharing details about our product, its capabilities, and our clinical plan with CMS in the not-too-distant future. However, in the absence of safe and effective non-surgical interventions supported by clinical data, patients must have access to the best available treatment options for morbid obesity. CMS is to be commended for its efforts, as reflected in the National Coverage Analysis and proposed National Coverage Policy, to identify those bariatric surgical methods that provide the highest likelihood of meaningful benefit coupled with an acceptable level of risk.

In light of all available clinical evidence, the proposed coverage policy is appropriately conservative in terms of the surgical approaches covered as well as the facility requirements specified. CMS has properly recognized that the benefits of bariatric surgery have been convincingly demonstrated for only a limited set of surgical approaches, and that even then those benefits can only be reasonably assured in experienced centers that provide comprehensive and multidisciplinary support for morbidly obese patients. The detailed facility requirements that are proposed – requirements equivalent to those applied by Medicare for heart and other organ transplant centers - are appropriately responsive to the high level of risk associated with all forms of bariatric surgery.

The Informed Consent requirements specified in the proposed facility standards, including the disclosure of national and facility-specific morbidity and mortality data, are critically important to the protection of potential bariatric surgery patients. It is not obvious, however, how these data will be maintained and kept current in the apparent absence of required participation in a national bariatric surgery registry. We believe that overall monitoring of trends in the safety of these procedures is important for quality assurance and patient protection. Maintenance of a national registry, and the implementation of quality performance standards that must be maintained by “qualified” facilities, should be a mandated task for whichever professional association CMS selects to administer facility participation standards.

Finally, GI Dynamics strongly supports the use of Coverage with Evidence Development (CED) as a mechanism to extend coverage of bariatric surgery to beneficiaries age 65 and above. CMS is correct in concluding that the available evidence is insufficient to serve as the basis for a well-founded coverage decision for beneficiaries who qualify for Medicare coverage on account of age. CED is the best mechanism for providing access to bariatric surgery for beneficiaries most in need while at the same time collecting the data necessary for a more definitive coverage determination.

Thank you again for the opportunity to provide these comments.

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Sirs:

I thank you for the National Coverage Decision for bariatric surgery for Medicare recipients. In 2001, fourteen percent of the Medicare beneficiaries were younger than 65. The baby boomers are approaching the elgible age quickly. Coverage should be considered for the group 65 and older as well. The Medicare Payment Advisory committee report to Congress March, 2005 outlines the increased cost our society faces due to obesity.From the Report" Lifestyle and health care spending Changes in personal behavior affect U.S. health care spending both for Medicare and other populations. The prevalence of obesity—which is thought to be associated with our more sedentary lifestyle and high-caloric diet—has doubled since 1980 to about 30 percent of the adult population today. One recent study calculated that obesity’s rising prevalence and higher per capita spending on obese people accounted for a sizable portion of the growth in real per capita spending between 1987 and 2001 (Thorpe et al. 2004a). For the U.S. population age 65 and older, projections suggest that the prevalence of obesity will grow from 29 percent in 2000 to 36 percent by 2010 (Arterburn et al. 2004). Obesity in the elderly is associated with an increased risk of diabetes mellitus, cardiovascular disease, hypertension, stroke, lipid abnormalities, osteoarthritis, and some cancers. Other recent research finds that obesity during young adulthood and middle age is significantly associated with higher Medicare spending later in life (Daviglus et al. 2004)."Arterburn's paper suggests that 36% Medicare eligible population will be obese in 2010. The CDC data released this month shows that 40% of our Medicare elgible population is obese. The costs of treating the comorbidities from the obesity is going to significantly increase the costs of the Medicare program overall in addtion to the Medicare prescription Drug program.

The VA system has recognized the costs savings from Bariatric surgery as well. The costs were recouped in the first two years of their program. Going forward the costs to care for the veterans who underwent surgery dropped from $10,000 per year to $2,000.

Bariatric surgery should be an option for over 65 age group as well for the potential improved quality of life. Better control of Diabetes mellitus, elimination of urinary stress incontinence and obstructive sleep apnea (OSA) are some of the improvements patients report.

The coverage determination for Laparoscopic adustable band should include open approach. there will be patients in whom a n endoscopic approach will not be posssible or will need to be converted to an open approach.

Biliopancreatic diversion and Duodenal switch should be considered for the severe class III obesity(BMI > 60). The regional coverage determination for Bariatric surgery for Regions VI and 1 Rhode Island includes this at least on a casae by case basis, see insert "Documentation Requirements: Chart notes from the patient's primary care physician providing documentation of the BMIand any co-morbid conditions.
Utilization Guidelines:
Sources of Information and Basis for Decision:
1. Blue Cross and Blue Shield of North Dakota Corporate Medical Policy.
2. CMS Manual System Pub 100-03, Medicare National CoverageDeterminations Manual, Transmittal 23, CR 3502, October 1, 2004.
3. CMS Manual System Pub 100-03, Medicare National CoverageDeterminations Manual, Chapter 1, Part 2, sections 100.1, 100.8, and 100.11.
Advisory Committee Notes:
The Arkansas consortium combined policy was presented in January 2005 and acceptedin AR, LA, MO, NM, OK and RI."This policy does not reflect the sole opinion of the contractor or Contractor MedicalDirector. Although the final decision rests with the contractor, this policy was developed incooperation with advisory groups, which includes representatives from general surgeryand bariatric surgery."
Start Date of Comment Period: 01/01/2005
End Date of Comment Period: 02/28/2005
Start Date of Notice Period: 03/31/2005
Revision History:Page 3 of 3 Medicare Part B Local Coverage Determination: SURGICAL TREATMENT OF MORBID OBESITY
6/15/2005
http://www.arkmedicare.com/provider/medpolb/ac05003.asp

Thorpe, K. E., C. S. Florence, D. H. Howard, et al. 2004a. The impact of obesity on rising medical spending. Health Affairs Web Exclusives (October 20): W4-480–W4-486.

Daviglus, M. L., K. Liu, L. L. Yan, et al. 2004. Relation of body mass index in young adulthood and middle age to Medicare expenditures in older age. Journal of the American Medical

Arterburn, D. E., P. K. Crane, and S. D. Sullivan. 2004. The coming epidemic of obesity in elderly Americans. Journal of the American Geriatric Society 52, no. 11 (November): 1907–1912.Association 292, no. 22 (December 8): 2743–2749.

Thank you for considering this additional information.

Sincerely,

John W. Baker, MD, FACS

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This letter is in regard to the proposed Medicare rule regarding denial of payment for bariatric surgical procedures in patients 65 years and older.

Within our program, we have performed over 1300 Roux-en-Y gastric bypasses in the last five years. Among that group, there have been 18 patients in the age 65-74 range. The analysis of this patient group shows a low rate of complications and no mortalities. The excess of body weight loss averaged 73%. Among this older population reversal of comorbid conditions such as type 2 diabetes mellitus and sleep apnea, as well as the quality of life index, are as good or better than their younger counterparts.

In view of these outcomes, it is very clear that bariatric surgical procedures in appropriately selected patients 65 years and older are highly beneficial and medically appropriate. Our own data is also supported by several reports in the surgical literature showing similarly good results in patients 65 years and older.

It is our strong opinion that the Medicare population would be best served by changing the proposed Medicare rule to allow payment for bariatric surgical procedures in the patients 65 years and older who otherwise meet standard criteria for bariatric surgery.

If you have any questions, please feel free to contact us.

Sincerely,

Daniel A. P. Smith, M.D., F.A.C.S.
Chief of Surgery, Dakota Clinic – Park Rapids
Assistant Professor, Department of Surgery,
University of North Dakota

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I have written and presented numerous articles demonstrating the safety and efficacy of the Duodenal Switch (DS) procedure as a treatment option for patients with morbid obesity. Having performed this procedure (DS) over 1400 times with a mortality rate below 1% and a morbidity rate lower than reported for Roux en-Y Gastric Bypass I am wondering how CMS can state the data is "inadequate" to support its use. I was also the first surgeon to report on the use of the "sleeve gastrectomy" as a definitive or staged procedure for high risk patients with morbid obesity. Since our publication, there has been numerous other authors documenting the benefits of this approach. Please provide me with the rational/data to support your particular decisions concerning these two procedures. Thank You, Gary Anthone, MD

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Thank you for your efforts to improve access to weight-loss surgery through a National Coverage Decision. In Northern Minnesota, I see daily how bariatric surgery can improve patient’s quality of life.

Our program has provided bariatric surgery to over 1300 patients since 2001. We collect data confidentially on all of our bariatric surgery patients. Recently we reviewed our data for outcomes specific to our patients 65 years of age and older. I was not surprised by our findings. In our elderly patients with an average age of 68.5, our complication rates are low. The only complications found were hernia at 1% and anastamotic stricture at 1%. Our excess weight loss in this population is above the national average at 73% at 3 years, as is the follow-up rate of 75%. I do not believe limiting access to bariatric surgery because of age is rational.

I would support Medicare Coverage with a Evidence Determination (CED) program with the conditions that surgeons be appropriately experienced (granted status as a American Society of Bariatric Surgeons’ Centers of Excellence Program) and that mortality and complication data be collected to evaluate the potential of a future expansion of coverage.

Thanks again. I commend your to efforts to expand the treatment of morbid obesity.

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I appreciate the careful and deliberate way that Medicare has approached this difficult topic. I completely agree with their coverage decision regarding the treatment of Medicare patients for the indication of Morbid Obesity under the age of 65 but would like to provide additional evidence on the group of patients 65 and over.

Scottsdale Bariatric Center represents a group of three surgeons, two internal medicine physicians practicing as Bariatricians, two psychologists with a specialization in the treatment of eating disorders and mutliple allied health, nursing and clinical staff who are intimately involved in provding daily care to the morbid obese patient. We evaluate and provide both medical and surgical management to over 1000 patients per year. I had an opportunity to address the MCAC board last November regarding some of our data and can provide an update at this time which combines data from our group and the Geisinger clinic in Pennsylvania led by Dr. Chistopher Still. This data forms the basis for a paper that is being submitted on this issue. Both programs are designated as a Center of Excellence by the American Society of Bariatric Surgeons.

A total of 153 Medicare patients were enrolled in the study. Patients 18-61 (N=91) and patients 62 and older (N=62) were compared. The patients were treated using primarily laparoscopoic gastric bypass or laparoscopic banding. The older group of patients was more likely to choose the band (19.7% vs 3.3%)The Excess Weight Loss for the younger Medicare patients was 72% and for the older patients was 54%. Both groups significantly lowered their HA1C levels. There were no deaths in either group and fewer readmissions in the older group. The risk of serious adverse events was 0.7% in the younger group and 1.7% in the older group.

Our study clearly demonstrates that operating in an older group of Medicare patients is safe and effective when offered in the setting of an ASBS Center of Excellence. In addition, it shows that operating on Medicare pateints older than 62 does not significantly differ in outcomes from the group under 62.

I would to comment on two additonal aspects of the NCD:

Although we offer intense medical therapy for morbid obesity few if any patients can lose more than 10% of their excess weight. While we support a request of the patient to lose this amount of weight as a way of making their surgery somewhat safer, we do not support including an arbitrary medical weight loss period prior to seeking surgery.

All patients should be preauthorized for a procedure unless performed in an ASBS Center of Excellence. The American College of Surgeons program does not have high enough standards at Level II and the economic burdens of participating in NSQIP are to high for most hospital systems/centers to afford.

Thank you for allowing comment on the National Coverage decision. Please contact me at ***-***- **** if I can provide any additional information.

Sincerely,

Robin Blackstone, MD,FACS

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While I applaud the medicare coverage decision in so many ways, I must speak out against two exclusions that have been included in the final document with which I strongly disagree.
1. Bariatric surgery in patients over the age of 65- Age discrimination in this field is an unfounded concept based primarily on studies from large administrative databases (such as Flum, et al. JAMA 2005) which provide insufficient clinical data to characterize the patient population other than ‘age’. Selected older patients can clearly undergo safe bariatric surgery with low risk profiles- discriminating against an entire subset of the population based upon data that does not include simple and powerful risk-stratifying variables like body mass index (Flum, et al. JAMA 2005) is unreasonable. In fact, numerous clinically-rich reviews do not support such a conclusion in the older patient. In my role as Program Chairman of the American Society for Bariatric Surgery I have seen approximately 12 to 15 studies submitted to that organization over the past 3 years demonstrating outstanding clinical outcomes for bariatric surgery in patients over the age of 65- time in the program has prevented the vast majority of these works from being presented at the meeting plus they are in the category of ‘confirmatory’ work supporting the conclusions of our group’s previously-published work (1).
2. Staging of surgical procedures. Controversy in bariatric surgery primarily focuses on risk, particularly mortality risk. This has been an area of research interest for me for the past five or so years and I have published several studies dealing with this topic (2.3). Recent work (to be presented at ASBS 2006) has allowed delineation of a risk scoring system which indicates the highest-risk subgroup of the bariatric surgery population to have a mortality risk in the range of 5 percent- defining the optimal target population for risk reduction strategies as one might easily classify such a high mortality as ‘prohibitive risk’. Risk reduction strategies are essential for management of this patient population and to increase the public’s trust in the concept of surgical treatment it must above all be a safe choice. One particularly valuable strategy for risk reduction in my opinion is staging of procedures. It is common surgical practice to stage procedures in seriously ill patients – e.g. staged resection of the colon for critical patients with malignant obstruction or perforated diverticulitis. Staging options are often chosen because of extreme technical difficulty during the surgical procedure- clearly Medicare should not be in a position to mandate single stage completion of a complex GI procedure when the operating surgeon is not comfortable that doing so is safe! This approach clearly oversteps the boundaries of a ‘payer’s” role in surgical decision-making. Since the major rationale for staging of procedures is based up patient safety in the setting of technical obstacles to safe performance of a complex GI operation, it seems clear to me that they must be allowed and compensated. Surprisingly such “first stage” procedures (e.g. ‘sleeve’ gastreectomy) appear to have some durability in terms of weight loss which remains to be completely understood. However durable weight loss is not their primary role in the armamentarium of weight loss surgery and should not be considered the major focus for a discussion of their contribution to the field. It is expected that all patients who undergo a first stage procedure will ultimately require a second stage be performed- the net result of the two stage approach appears to be a dramatic reduction in surgical risk for the highest risk patients in terms of both co-morbidity and technical obstacles (e.g. massive hepatomegaly) which make a single stage procedure unsafe.

In summary, medicare’s national coverage decision is a step in the right direction but should be additionally modified to include coverage for patients over age 65 in bariatric centers that meet the requirements for certification by the Surgical Review Corporation and under no circumstances can medicare limit the surgeon’s arsenal in combating this disease by disallowing staging of surgical procedures- the payer should never attempt to micromanage surgical decision-making and I can easily predict mortalities occurring across our country should surgeons feel that a single stage procedure must be completed at all costs. The other alternative- ie that the sickest patients (those at highest risk and logical candidates for staged procedures) be deprived of the only potential cure- is also reprehensible.

Respectfully submitted,
Eric J. DeMaria, MD
Duke University

References
1. Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247.
2. Fernandez, AZ, DeMaria, EJ, Tichansky, DS, Kellum, JM, Wolfe, LG, Meador, J, Sugerman, HJ. Multivariate Analysis of Risk Factors for Death Following Gastric Bypass for Treatment of Morbid Obesity. Ann Surg 2004; 239(5): 698-702
3. Jamal, MK, DeMaria, EJ, Carmody, BJ, et al. The impact of major co-morbidities on mortality and complications after gatric bypass. Surgery for Obesity and Related Disorders, 2005 (in press)

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To The Centers for Medicare and Medicaid Services:

I am writing this comment in response to The Centers for Medicare and Medicaid Services’ proposal of a coverage decision that would negatively impact potential weight-loss surgery patients. The decision, I understand, would eliminate Medicare and Medicaid coverage entirely for the Duodenal Switch procedure, and also eliminate coverage of weight loss surgery for people over the age of 65, among other things. I am extremely concerned about this proposal in limitation of coverage for a health condition that has such an enormous impact on so many members of our society.

According to the American Obesity Association (“AOA”), Approximately 127 million adults in the U.S. are overweight, 60 million obese, and 9 million severely obese. Currently, 64.5 percent of U.S. adults, age 20 years and older, are overweight and 30.5 percent are obese. Severe obesity prevalence is now 4.7 percent, up from 2.9 percent reported in the 1988 - 1994 National Health and Nutrition Examination Survey (NHANES) by the Centers for Disease Control and Prevention (CDC).

Also according to the AOA, health and social impacts from obesity include: (1) increased risk of illness from about 30 serious medical conditions, (2) increases in deaths from all-causes, (3) earlier onset of obesity-related diseases, such as type 2 diabetes, (4) higher risk for impaired mobility, (5) social stigmatization and discrimination in employment and academic situations.

The AOA has also found that overweight and obesity increases steadily with age for both men and women. In the last decade, all adult age groups in both genders have experienced an increase in overweight and obesity. At a minimum, half of all age groups are overweight and at least 20 percent obese. The age group with the highest prevalence of overweight and obesity among men is 65 to 74 years, and among women, 55 to 64 years. Obviously, those individuals that are overweight when they enter the Medicare-supported age group are not likely to have less of a problem with overweight as they increase in age.

Bariatric surgery (weight loss surgery, or “WLS”) has improved the quality of life of countless individuals already, and decreased their comorbidities, making it possible for Medicare, Medicaid and their private insurance companies, to pay less, in the long run, for their medical care. If Medicare and Medicaid pay for weight loss surgery, it will result in many thousands of dollars less, per individual, in payment for conditions that are comorbidities of obesity.

Furthermore, if Medicare and Medicaid rule against covering weight loss surgeries, the private insurers will undoubtedly follow their lead, meaning a result in hundreds of thousands of dollars more in Medicare payments later, for obesity comorbidities in individuals that were denied WLS by their private insurers when they were younger and not at that time available for Medicare coverage. This constitutes a ripple-effect that I do not believe that Medicare and Medicaid can afford to ignore.

I seriously hope that you will reconsider your proposed change in coverage, and I will be sending e-mail copies of this correspondence to President George W. Bush, Senators Dianne Feinstein and Barbara Boxer, and Representative David Dreier.

Very sincerely,

Martha Bryan

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I am here to support the Duodenal Switch surgery for people who are morbidly obesity(BMI above 40) and super morbidly obese (BMI 50 and above). I also support this for people who are over the age of 65 if the physician determines that the duodenal Switch is the appropriate surgery.

The Duodenal Switch is the newest developing generation of weight loss surgery.

It seems to me like denying people on medicare access to this surgery is a form of discrimination to those who are economically disadvantaged. It says to medicare recipeints "because you are among the people in the nation that are disabled and are on Medicare you do not deserve to have the lastest, and most progressive surgery." Not investigational because it's been used for over 10 years.

Many years ago the medical community believed that bleeding a person could cure them of any problem. My grandmother had a shallow hip socket and that was the treatment of her day. Today that would be considered barbaric.

To severe part of the stomach and make an artificial opening to connect the "pouch" to the intestinal tract seems barbaric to me. The Duodenal Switch leaves intact the operations of the stomach so that it emptys naturally. It is reduced in size to control the amount of food eaten just as the Roux-en-y does. The intestinal portion of the duodenal switch is very similar to the Roux-en-y.

I know what I'm saying I have not documented but what I'm saying is from the heart. Also, please don't deny both those that are under 65 or those over 65 (a blant form of agism)the Duodenal Switch when it is medically necessary.

I sincerely thank you for reading and considering my plea.

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Comments of Inamed Corporation to CMS on Proposed Bariatric Surgery NCD

Inamed Corporation (“Inamed”) would like to thank the CMS staff for their diligent and hard work in developing this Proposed National Coverage Determination on Bariatric Surgery. This is a significant step forward in creating a homogeneous policy for all Medicare Beneficiaries. We would like to offer the following comments relative to the Proposed NCD.

1. Inamed is opposed to limiting access to bariatric surgery solely to beneficiaries under the age of 65. Many other forms of treatment that have comparable or increased risk of morbidity are provided to beneficiaries over 65 (certain forms of chemotherapy, implanted cardiac stimulators, etc.). We do agree that there are risks associated with surgery and would be supportive of coverage for the over 65 population in centers with high quality programs. We would support limiting the over 65 population’s access to surgery to those bariatric programs that can demonstrate standards such as those outlined in the NCD, or who are accredited as Centers of Excellence by accrediting bodies such as the Surgical Review Corporation or the American College of Surgeons, or similar bodies that may accredit bariatric surgery programs in the future.

2. Inamed believes that it is vital for CMS to include a list of comorbid conditions as was offered in the original NCD request to CMS. Failure to define which comorbid conditions would be recognized, and leaving it to the local intermediaries to determine what constitutes a comorbid condition, leaves open the potential for inconsistent coverage as exists today for bariatric surgery. Using the list submitted as the basis for coverage creates a comprehensive baseline for coverage and then would allow local intermediaries to expand the list as additional data becomes available.

3. Open Adjustable Gastric Banding should be included as a recognized procedure. This type of procedure may be necessary as a conversion procedure from a Laparoscopic Adjustable Gastric Banding procedure in certain clinical circumstances, such as Hepatomeglia where the liver is so large that it cannot be retracted laparoscopically. This procedure while rare (<1%) nevertheless should be recognized. Failure to do so penalizes the facility and surgeon through non-payment of submitted claims because of clinical circumstances that are forced on them.

In addition to Open AGB, CMS should recognize laparoscopic or open BPD with or without DS as a covered procedure. We believe that the choice of the surgical procedure that is most appropriate should be a decision left to the surgeon and the patient. With proper screening, demonstrated skill and standards and the appropriate post operative care and follow-up all the surgical procedures have acceptable risks and outcomes.

4. Inamed requests that CMS include in the NCD recognition of the necessity for pre-surgical evaluation and post operative follow-up care beyond the 90 day global period for all bariatric procedures. We also request that follow up care be recognized in whatever instructions are ultimately sent to intermediaries. A recent article demonstrates that the success of certain procedures, such as the LAP-BAND procedure, are related to regular follow-up visits and the requirement to individualize the adjustment of the band to maximize the restrictive effect on patients. Shen, et. al, Impact of patient Follow-up Weight Loss after Bariatric Surgery, 14 Obesity Surgery 514-19 (2004).

5. The proposed NCD discusses the need for beneficiaries to have undergone some form of previous weight loss attempt. We urge CMS to simply require that surgeon documentation of a previous attempt in the patient records be sufficient. Any requirement that a beneficiary go through a medically supervised weight loss program immediately prior to surgery simply puts the person at risk for increased mortality with no medical benefit. This has been documented by the CA State Department of Managed Health Care which determined that there is no medical evidence to require a period of weight loss prior to surgery. CA Department of Managed Health Care, Review of Weight Loss Prior To Bariatric Surgery. We are forwarding a copy of this document to CMS under separate cover.

In closing we again thank CMS and its staff for their fine work in addressing the issue of access to surgical intervention, which is the only proven treatment for morbid obesity. We believe that all Medicare beneficiaries that are appropriately screened, have reasonable expectations and receive high quality care from a facility with the appropriate multi-disciplinary services will benefit from these procedures. At the same time, we believe that the NCD’s emphasis on quality and experience, to be achieved through meeting the high standards proposed, will ultimately result in the resolution of the outcomes issues raised by CMS.

On behalf of Inamed I thank you for the opportunity to submit these remarks on this important topic.

Sincerely yours,

Jim Garver
Director of Reimbursement

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Bariatric Surgery is so important to our future. It has literally changed the lives of millions of obese people. Whether someone is 45 or 66 we all have our lives to live and if we are sick "morbid obesity" we deserve the same chance someone has that has an medical problem. We are all living longer and when we are sick we should be able to rely on our health care system to get the help we need. Please reconsider helping people older than 65 in obtaining the medical attention they need for morbid obesity.

Robin Wolff

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Dear Decision Maker
To limit surgery for those who is Morbidly obese regardless of their age is sending a message to people that their health is less important than the amount of money it takes. Persons who are morbidly obese are probably taking a large number of medications. I have seen persons who were diabetics or have high blood pressure, have the surgery and were off of these medications in a matter of months thats saves Medicare/Medicaid thousands of dollars alone. If Medicare limits this surgery, it will only cost the organization more money in keeping people on medications and other medical issues will probably surface.

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Comments to CMS on Proposed Bariatric Surgery NCD

Inamed Corporation (“Inamed”) would like to thank the CMS staff for their diligent and hard work in developing this Proposed National Coverage Determination on Bariatric Surgery. This is a significant step forward in creating a homogeneous policy for all Medicare Beneficiaries. We would like to offer the following comments relative to the Proposed NCD.

1. Inamed is opposed to limiting access to bariatric surgery solely to beneficiaries under the age of 65. Many other forms of treatment that have comparable or increased risk of morbidity are provided to beneficiaries over 65 (certain forms of chemotherapy, implanted cardiac stimulators, etc.). We do agree that there are risks associated with surgery and would be supportive of coverage for the over 65 population in centers with high quality programs. We would support limiting the over 65 population’s access to surgery to those bariatric programs that can demonstrate standards such as those outlined in the NCD, or who are accredited as Centers of Excellence by accrediting bodies such as the Surgical Review Corporation or the American College of Surgeons, or similar bodies that may accredit bariatric surgery programs in the future.

2. Inamed believes that it is vital for CMS to include a list of comorbid conditions as was offered in the original NCD request to CMS. Failure to define which comorbid conditions would be recognized, and leaving it to the local intermediaries to determine what constitutes a comorbid condition, leaves open the potential for inconsistent coverage as exists today for bariatric surgery. Using the list submitted as the basis for coverage creates a comprehensive baseline for coverage and then would allow local intermediaries to expand the list as additional data becomes available.

3. Open Adjustable Gastric Banding should be included as a recognized procedure. This type of procedure may be necessary as a conversion procedure from a Laparoscopic Adjustable Gastric Banding procedure in certain clinical circumstances, such as Hepatomeglia where the liver is so large that it cannot be retracted laparoscopically. This procedure while rare (<1%) nevertheless should be recognized. Failure to do so penalizes the facility and surgeon through non-payment of submitted claims because of clinical circumstances that are forced on them.

In addition to Open AGB, CMS should recognize laparoscopic or open BPD with or without DS as a covered procedure. We believe that the choice of the surgical procedure that is most appropriate should be a decision left to the surgeon and the patient. With proper screening, demonstrated skill and standards and the appropriate post operative care and follow-up all the surgical procedures have acceptable risks and outcomes.

4. Inamed requests that CMS include in the NCD recognition of the necessity for pre-surgical evaluation and post operative follow-up care beyond the 90 day global period for all bariatric procedures. We also request that follow up care be recognized in whatever instructions are ultimately sent to intermediaries. A recent article demonstrates that the success of certain procedures, such as the LAP-BAND procedure, are related to regular follow-up visits and the requirement to individualize the adjustment of the band to maximize the restrictive effect on patients. Shen, et. al, Impact of patient Follow-up Weight Loss after Bariatric Surgery, 14 Obesity Surgery 514-19 (2004).

5. The proposed NCD discusses the need for beneficiaries to have undergone some form of previous weight loss attempt. We urge CMS to simply require that surgeon documentation of a previous attempt in the patient records be sufficient. Any requirement that a beneficiary go through a medically supervised weight loss program immediately prior to surgery simply puts the person at risk for increased mortality with no medical benefit. This has been documented by the CA State Department of Managed Health Care which determined that there is no medical evidence to require a period of weight loss prior to surgery. CA Department of Managed Health Care, Review of Weight Loss Prior To Bariatric Surgery. We are forwarding a copy of this document to CMS under separate cover.

In closing we again thank CMS and its staff for their fine work in addressing the issue of access to surgical intervention, which is the only proven treatment for morbid obesity. We believe that all Medicare beneficiaries that are appropriately screened, have reasonable expectations and receive high quality care from a facility with the appropriate multi-disciplinary services will benefit from these procedures. At the same time, we believe that the NCD’s emphasis on quality and experience, to be achieved through meeting the high standards proposed, will ultimately result in the resolution of the outcomes issues raised by CMS.

On behalf of Inamed I thank you for the opportunity to submit these remarks on this important topic.

Sincerely yours,

Jim Garver
Director of Reimbursement

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Upon the request of the American Society for Bariatric Surgery (ASBS), the Center for Medicare and Medicaid Services (CMS) recently released a National Coverage Determination (NCD) for the provision of bariatric surgery for Medicare and Medicaid patients.

US Bariatric (USB) agrees with CMS that Medicare patients should undergo their surgery at high quality surgical centers. These Institutions would be Centers where: 1) 125 or more procedures are performed annually, 2) each surgeon performs ¡Ý 50 procedures/year and has done ¡Ý 125 procedures in their past, and 3) the procedures and facilities are designed to provide optimal care.

Several studies support these volume requirements, Ref. 1,2. Such volume requirements have also benefited many patients especially those undergoing transplantation and coronary artery bypass grafts.

We believe that bariatric surgery for Medicare and Medicaid patients should be provided at bariatric surgical Centers of Excellence (COE) as designated by the ASBS and the Surgical Review Corporation (SRC). Presently 49 COE have been approved and are posted on the SRC website: http://www.surgicalreview.org .

We strongly support and agree with Dr. Flum's concluding statement, Ref. 3 that bariatric surgery performed in patients 65 years old or greater should only be performed at institutions designated by the SRC as Centers of Excellence.

Although Dr. Flum et al, Ref. 3 reported a high (6.9%) 30-day mortality rate amongst this group of patients, the 30-day mortality rate was only 1.1% in those centers where a relatively large number of Medicare patients had undergone the surgery.

This is consistent with two other studies (19 patients ¡Ý 65 years of age in the study by Sugerman et al.) with a very low mortality in patients ¡Ý 65 years of age, Ref. 4,5.

Our own data at USB (consisting of 77 ¡Ý 65 years), documents no mortality at 30 or 90 days. One patient died at 10 months as the result of a gastrointestinal bleed from ingestion of Non-Steroidal Anti-Inflammatory Drugs (NSAID's) leading to a 1.8 % mortality rate for patients 65 years old and older.

We also agree with the ASBS statement that patients 65 and older have the option to undergo elective coronary artery bypass, joint replacement, peripheral vascular surgery with equivalent morbidity and mortality and that it is discriminatory to block access to bariatric surgery for this age group.

The obese patients in Dr. Flum's study had open gastric surgeries. Safe transition from open gastric surgeries to the laparoscopic (Lap) procedures requires additional training and expertise to provide expert and safe care for obese patients.

With the advent of Lap bariatric surgery, complications such as incisional hernia and intestinal obstruction secondary to adhesions are no longer causes of readmissions post-operatively.

Thus the increasing morbidity and readmissions after open gastric bypass, reported by Zingmond et al. Ref. 6, are no longer evident with the advent of Lap gastric surgeries.

With additional modifications of the Lap gastric bypass surgery, internal herniation, which was initially the cause for readmissions post-procedure, have also been nearly eliminated.

We, therefore, think it is important for CMS to factor these additional training expenses and expertise in the surgical fee structure to provide and facilitate safe, expert and comprehensive care of the bariatric surgical patients during and after surgery.

It is important that the requirement for medical management of obesity be for a 6-month period at some time in the past and that it not be mandated to be within the year preceding surgery. Coverage by CMS for such medical management of obesity would also be needed for patients prior to surgery.

Finally, we strongly support the requirement for ancillary care services of bariatric surgery patients and believe that it will be important for Medicare to cover these services (e.g. dietary management, physician visits, psychotherapeutic visits, exercise training, etc.) beyond the 90-day post-operative period as a means of significantly improving the health of this morbidly obese patient population while mitigating the negative effects of obesity and its co-morbidities.

Robert T. Marema, M.D.
Bariatric Surgeon, Director & Founder of US Bariatric

Cynthia Buffington, Ph.D.
Director of Research
US Bariatric

Michael A. Perez, M.D.
Bariatric Surgeon
US Bariatric

Keith Kim, M.D.
Bariatric Surgeon
US Bariatric

RoseMarie Toussaint, M.D.
Bariatric Surgeon
US Bariatric

References:

1. Courcoulas A, Schuchert M, Gatti G, Luketich J. The relationship between surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery 2003; 134:613-621.

2. Nguyen NT, Paya M, Stevens CM, Mavandadi S, Zainabadi K, Wilson SE. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg 2004; 240:586-593.

3. Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908.

4. Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247.

5. Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R. Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1: 389-392.

6. Zingmond, DS, McGory, ML, Ko, CY, Hospitalization Before and After Gastric Bypass Surgery, JAMA 2005; 294:1918-1924.

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We commend CMS on reaching a national coverage decision regarding bariatric surgical coverage for its beneficiaries. As a long time supplier of instrumentation to the bariatric surgery community, we agree with the decision to provide coverage for open and laparoscopic Roux-en-Y gastric bypass (RYGBP) and laparoscopic adjustable gastric banding (LAGB) for Medicare beneficiaries who are under 65 years of age, have a body-mass index (BMI) > 35, have at least one co-morbidity related to obesity, and have been unsuccessful in achieving weight loss with medical treatment for obesity.

We also believe that the evidence supports coverage for vertical band gastroplasty (VBG) in this population. Several meta analyses have indicated that VBG is equivalent or in some cases more effective than gastric banding (Buchwald et al JAMA 2004;292:1724-1737, AHRQ Publication No. 04-E028-2 July 2004, Maggard et al, Ann Intern Med. 2005;142:547-559). In the recently published Swedish Obesity Study (SOS), the authors showed that VBG was more effective in achieving weight loss than banding when measuring BMI change at 10 years, 12.8 kg/m2 vs. 16.0 kg/m2, respectively, p < 0.05 Engl J Med 2004;351:2683-93).

The AHRQ and Maggard meta-analyses identify biliopancreatic diversion with duodenal switch as a procedure that results in greater weight loss than gastric bypass. For many of the most severely obese patients, coverage of a switch procedure is warranted. In addition, the Medicare Coverage Advisory Committee convened November 4, 2004 was relatively, but not statistically, more confident that biliopancreatic diversion with or without duodenal switch would produce a clinically important net health benefit in the treatment of obese patients with one or more co-morbidities than they were for adjustable banding.

It should be noted that patient involvement is essential to success of any procedure; therefore stipulating which procedure is performed may be detrimental in obtaining optimal results.

We believe that in regarding bariatric surgery for beneficiaries over 65, the decision should be left to the patient and provider as to whether the patient is appropriate for surgery. This informed decision is in the purview of the people involved. However, if Medicare continues in its determination that coverage for beneficiaries in patients over 65 years of age for open and laparoscopic Roux-en-Y gastric bypass (RYGBP) and laparoscopic adjustable gastric banding (LAGB) is not appropriate, we then endorse using Coverage with Evidence Development (CED) programs to provide coverage for these procedures. In addition, coverage for the following procedures should also be covered under similar CED criteria and protocols:
a. open vertical banded gastroplasty,
b. laparoscopic vertical banded gastroplasty,
c. open sleeve gastrectomy,
d. laparoscopic sleeve gastrectomy,
e. open adjustable gastric banding,
f. open biliopancreatic diversion with or without duodenal switch, and
g. laparoscopic biliopancreatic diversion with or without duodenal switch.

A general bariatric surgery CED protocol should be developed for beneficiaries undergoing bariatric surgery not covered under this NCD where a surgical intervention for morbid obesity is sought. The data collection is similar enough for the bariatric procedures named above to be covered under one CED, rather than establishing separate protocols for each procedure.

We support that the facilities performing the procedures meet the suggested CMS facility standards. We strongly support the bariatric surgeons’ efforts at establishing credentialing criteria that will provide the highest level of patient outcomes. As in other surgical procedures, it has been established that improved patient outcomes are directly related to surgical volume (Courcoulas Surgery 2003; 134:613-621, Flum et al J Am Coll Surg 2004;199:543–551, Nguyen et al Ann Surg 2004; 240:586-593, Flum et al JAMA 2005; 294:1903- 1908). CMS should therefore choose credentialing criteria that has minimum standards of 50 and 125 procedures per year for surgeons and facilities, respectively.

Data should be collected from the participating facilities under the credentialing body; and the aggregate data should be shared allowing the participants to compare their outcomes to the population as a whole. These data would also be collected and analyzed to support the CED protocol.

It may be confusing for beneficiaries to understand different levels of credentialing and they may not easily discern one level from the other. Facilities and providers may take advantage of this confusion and not indicate their level of experience or credentialing. It would be more appropriate to have one credentialing standard, ensuring a high level of experience in the bariatric program.

Thank you for the opportunity to comment on this draft National Coverage Determination.

William Denman, MD
Medical Director
Vice President, Medical Affairs
Tyco Healthcare LP

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CMS should continue to focus on outcomes following bariatric surgery, including taking into account high-risk patients which will skew the outcomes, as well as considering that many "complications" are actually secondary to their extensive medical comorbidities, not the surgery itself.

Small volume centers, such as those in rural America, should be allowed to continue offering bariatric surgery for 2 very important reasons:

1. patients who have to travel long distances (more than an hour or so by car) for bariatric surgery are more likely to be unable to reach a bariatric surgeon if post-op complications arise, thus greatly increasing their individual morbidity and mortality;

2. lifetime annual follow-up is the key to long term success, and patients who have to travel long distances are less likely to stay with their annual follow-up. Solid, year-long formal bariatric surgery fellowship training is probably the most important factor for insuring excellent surgical outcomes, more so than initial volumes.

We're all familiar with the disasters that can occur in that learning curve of the first 100 gastric bypasses. Outcomes data will support this policy.Finally, CMS should follow the same national guidelines for patient qualifications for bariatric surgery that most private insurers, and societies such as the ASBS and ACS endorse. Specifically, require no medical comorbidities for patients with a BMI of 40 or more.Thank you for your consideration.

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Weight loss surgery is not a cosmetic procedure. It is a treatment for severe obesity. The procedure itself, as well as the lifestyle adjustments that must be made afterward, are not easy and should not be undertaken lightly. But for someone who has been severely obese and unable to lose weight by non-surgical means, it is a life-saving procedure. It can also be a money-saving procedure, as many patients are able to stop taking medications or seeing specialists for conditions such as diabetes, high blood pressure, bad joints, high cholesterol, heart conditions - the list goes on and on. While I believe the criteria should be kept rather strict to prevent people from entering into the decision lightly or turning surgery into the next fad diet, I believe it would be a terrible mistake to deny coverage for surgical treatment of morbid obesity. Please consider carefully the negative impact this decision could have on a population that already have so many strikes against them.

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The American Obesity Association (AOA) is pleased to comment on the proposed National Coverage Decision on Bariatric Surgery for Morbid Obesity. We strongly agree with the decision to expand coverage for the non-elderly Medicare beneficiaries who are disabled. We also strongly support coverage of services when provided in a Center of Excellence established by the American Society for Bariatric Surgery and the Surgical Review Corporation (hereinafter ASBS/SCR). However, we strongly object to excluding elderly Medicare beneficiaries from these important procedures.

1. CMS states: “We are specifically interested in comments on the potential to cover the 65 and older population under CED (Coverage with Evidence Option.)
Comment:
Obesity is a major driver of poor health in the elderly population. According to Medicare statistics, several of the major health conditions of this population are directly attributable to obesity. These include hypertension, type 2 diabetes, stroke, some cancers, urinary incontinence, heart disease and arthritis, particularly osteoarthritis of the knee and hip.

According to a meta-analysis, cited in the Proposed Decision Memorandum (p.20), bariatric surgery is effective in eliminating or resolving many of these conditions. (1) The Medicare Coverage Advisory Committee concluded after a day of hearing the evidence that, “even though the evidence in the over 65 population was sparse, the results of bariatric surgery in obese patients with one or more co-morbidities could be generalized to the older Medicare population. (Proposed Decision Memorandum p. 15.) CMS overruled this conclusion on the basis of one study by Dr. David Flum. However, in comments received by CMS, Dr. Flum suggests coverage of these procedures when performed by experienced surgeons and those who can demonstrate an appropriate track record of outcomes in high-risk patients. (Comment filed 11/23/05).

Other studies support inclusion of bariatric surgery for the elderly population. Mann and colleagues, using NHANES data, conclude that obesity is an independent risk factor or coronary heart disease (CHD) mortality, even after controlling for traditional CHD risk factors and that obesity should be aggressively treated. (2) Groessl and colleagues report that obese older adults have a lower health related quality of life than those who are overweight or of normal weight. They conclude that the lower Quality of Well-Being scores associated with obesity translate into millions of Quality- Adjusted Life Years (QALYs) lost each year. (3) Blaum et al have found obesity to be significantly associated with the frailty syndrome in older women. (4)

The recent supplement to Health Affairs, “Health and Costs of the Future Elderly,” (Collection 2005, Vol.24, Supp.2) provides several new studies, funded by CMS attesting to the devastating effects of obesity on the elderly and the high costs incurred by the obesity elderly population. Dana P. Goldman writes, “The health of the elderly has been improving in important ways since the early 1980s. However, the rising prevalence of diseases such as obesity and diabetes among the young and the increases in disability suggest that future cohorts entering Medicare may be less healthy.” (5) Goeffrey F. Joyce and colleagues report that, “having diabetes at age sixty-five lowers life-expectancy by 3.1 years. Diabetes also increases health care costs by $1,930 per year and $13,032 cumulatively.” (6)

Darius N. Lakdawalla et al. found, “Obese elderly people live about as long as their nonobese peers, but they experience a poorer quality of life and face higher medical spending. Obesity in one seventy-year-old costs Medicare about $36,000 in expected present value and it costs other payers about $3,000. Therefore, we estimated that preventing obesity in one person is worth at least $39,000 in gross value to society, in 2004 dollars. That is, if such an outcome could be achieved at a cost under $39,000, it would improve welfare… The obese can expect 4.0 disability-free life years- the lowest of any group. The underweight are next at 5.8 disability-free years. The overweight live for 6.6 disability-free years, while the normal-weight group lives without disability for an average of 6.8 years. Obese seventy-year olds can expect to spend 40 percent more time in disability than their normal weight counterparts. The obese also spend about 40% more time in the two most disabled states (at least three ADLs or institutionalized) than any other group. They will be in one of these two states for an average of 4.7 years, while the next most disabled group, the underweight, spends just 3.3 years in these states on average… over their remaining lifetimes, the obese are the most costly. From age seventy, an obese person can expect to spend $230,000 on health care in present-value terms, $143,000 of which is borne by Medicare. This is the highest spending level for any group and is statistically different from all other groups. The total burden on Medicare is more than 20 percent higher than for the next closest group (the overweight)….Obese people suffer from diabetes for 41% of their life years, while normal-weight people suffer for just 17 percent of their life years. The gradient in hypertension is also quite large…Obese seventy- year-olds can expect to face 2.8 years of ADL, disability, two years of which will be involve moderate to severe levels of disability (three or more ADL limitations or institutionalization)… The U.S. Centers for Disease Control and Prevention has suggested that a year of life spent with an ADL limitation is about half as valuable as a year of healthy life. Therefore, the cost of 2.8 additional disabled life years is similar to losing 1.4 years of life. Since a year of life to an elderly person is easily worth more than $28,000, the cost of disability must be larger than $39,000….Ultimately, the impact of obesity treatment on medical costs and health outcomes depends on the extent to which obesity is the primary driver of health differences between the obese and the nonobese. If the relationship is causal, preventing or curing obesity in one person will restore that person to the spending level of someone of normal weight. More clinical and epidemiological research is needed to establish the precise extent of causality, but existing evidence points toward a causal relationship. In clinical trial and observational studies, weight loss is considered related to improvements in health. The fact that these improvements occur for a variety of weight-loss mechanisms suggests that weight loss itself improves health, instead of the possibility that a particular feature of a weight-loss device (for example, a particular chemical byproduct of pharmaceutical therapy), is responsible for health improvement”. (7)

Finally, S. Jay Olshansky concludes, “The bottom lime message in all of the research on the health effects is consistent: Not only does obesity increase the risk of death for most people at most ages, it consistently leads to a much higher level of disability and disease at all ages.” (8)

In conclusion, the MCAC panel found that the studies in younger populations were able to be generalized to the elderly population. The one study cited by CMS in opposition to this conclusion is not agreed to by the author of this study. Bariatric surgery has been shown to extend life and improve quality of life. Obesity is the elderly is a major and growing health problem in terms of disability and quality of life. Therefore, obese elderly Medicare beneficiaries should have access to these procedures on an equal basis with non-elderly Medicare beneficiaries in approved Centers of Excellence.

2. CMS is “also asking for public comment on the facility criteria to include the potential to establish more definitive bariatric surgery volume criteria for facilities and surgeons.” Comment:

The AOA strongly supports the ASBS/SCR processes for determination of Centers of Excellence for the provision of bariatric surgery for the Medicare population. The ASBS/SCR standards were developed by respected specialists in the surgical treatment of morbid obesity who have a history of working with this population and advancing quality improvements in bariatric surgery. They have invited AOA comments all along the developmental process. Their standards are grounded in both the published literature and practical clinical experience of the ASBS membership. The ASBS/SCR program requires significantly higher volumes of surgeries than that developed by the American College of Surgeons and is based on a rich database of outcomes. AOA concludes that the ASBS/SCR process is the one most likely to significantly improve patient care.

3. Finally, we would like to comment on the proposed coverage language that eligible beneficiaries “have been previously unsuccessful with medical treatment for obesity.” We believe that this language is too open to interpretation in different regions of the country. We suggest more particular language, such as “have been previously unsuccessful with medical treatment for obesity of at least six month duration.”

In conclusion, AOA supports the proposed NCD with the recommendation of making these valuable procedures available to the elderly population at ASBS/SCR credentialed facilities. Thank you for this opportunity to share our views.

Morgan Downey
Executive Director

Footnotes:
1. Buchwald H, Avidor, Y, Braunwald E, et al, Bariatric Surgery: a systematic review and meta-analysis; JAMA, 2004;292:1724-1737.
2. Mann DM, Lee J, Liao Y, Independent effect and population impact of obesity on fatal coronary heart disease in adults. Prev Med. 2005 Nov. 15.
3. Groessl, EJ, Kaplan RM, Barrett-Connor E, Body Mass Index and quality of well-being in a community of older adults. Am J Prev Med. 2004 Feb; 26(2):126-9.
4. Blaum CS, Xue QL, Michelon E, et al. The association between obesity and the frailty syndrome in older women: The Women’s Health and Aging Studies. J Am Geriatr Soc 2005 Jun;53 (6):927-34.
5. Goldman DP, Shang B, Bhattacharya J, et al, Consequences of Health Trends and Medical Innovation for the Future Elderly, Health Affairs, Sept. 26, 2005; 24, Supp. 2:W5-R5-17.
6. Joyce GF, Keeler, EB, Shang B, et al, The Lifetime Burden of Chronic Disease Among the Elderly. Health Affairs, Sept. 26, 2005; 24, Supp. 2:W5-R18-29.
7. Lakdawalla DN, Goldman DP, Shang, B, The Health and Cost Consequences of Obesity Among the Future Elderly, Health Affairs, Sept. 26,2005; 24, Supp. 2:W5-R30-41.
8. Olshansky SJ, Perspective: Projecting the Future of U.S. Health and Longevity. Health Affairs, Sept. 26, 2005; 24, Supp. 2:W5-R86-89.

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My name is Dale Jenkins and I am the CEO of Medical Mutual Insurance Company of North Carolina. We provide professional liability insurance for over 8500 physicians in NC, VA and GA. At the request of Dr. Walter Pories, I am also a member of the Board of Directors of SRC.

I believe that bariatric surgery can be a true life changing and life saving event for many people. The effectiveness of this surgery is well documented. However, we all know that not every obese individual is an ideal candidate, and considerable judgement is required in order to determine who should receive this surgery. Also, the surgery is complex, and there must always be an adequately trained team of professionals to support individuals that undergo this surgery.

I believe that SRC serves a very valuable role for the public. This organization has stepped forward and developed what I consider the "gold standard" of credentialing bariatric surgeons and the facilities where bariatric surgery is performed. The organization has spent considerable time in developing the criteria for determing what constitutes a qualified surgeon and facility. Their guidelines have been developed after hundreds of hours of debate between the most skilled bariatric surgeons. Also importantly, it has included information supplied by health and professional liability insurers, as well as patients. Having witnessed much of this process, I can personally attest to it's thoroughness and completeness.

As you may know, there is considerable variability across the country regarding the availability of professional liability insurance for bariatric surgeons. At Medical Mutual, we will insure these physicians if they have been credentialed by SRC. We have worked closely with SRC to develop underwriting guidelines that we believe appropriate. As a result, we do indeed believe that we are promoting quality healthcare.

Bariatric surgery clearly has a place in medicine, but it needs to be performed by highly qualified surgeons in an appropriate facility that can support the entire health care needs of the obese. SRC has emerged as the clear leader in helping the public determine who can perform this surgery and where it should be done. I heartily endorse the SRC program, and believe it to be essential in our health care delivery system.

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After reading many negative comments directed at obese individuals, or at Medicare for considering W.L.S. I feel something needs to be stated. Most individuals seeking W.L.S. have spent lifetimes trapped in tortured bodies educating themselves in weight loss. Most have tried multiple avenues of weight loss and showed more self discipline than many healthy weight people. Our problem is we have been unsuccessful in overcoming our affliction. W.L.S. is in most cases a life saving last resort for these misfortunate tortured individuals. Uneducated individuals posting a negative response to Medicare helping individuals afflicted with this problem (In most cases from childhood) only displays ignorance openly for the whole world to see. I find the only other explanation for their negative comments is they may be part of an Obesity hate group as Hainus as any other hate group in the world. I feel their negative comments should be considered corrupt, uninformed and invalid. Without any malice I find it unfortunate for these uninformed and misguided individuals and their families if they are not seeking education on the subject, or psychiatric

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Im not sure who made this decision........it's bad enough to survive being normal, with health issues and being over weight many people could not get a chance to be HEALTHY or HAPPY without insurances. Why would you do this? This make no sense at all your telling us were a obese country and you want to take that chance away. Many of us would never get a chance of being NORMAL, that may not sound much to you and the government but to us little people....means EVERYHTING!!! Please re-think your decision, many lives are at stake, DOESN'T THAT MEAN ANYHTING AT ALL?DEANA CAIN

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MEDICARE POLICY OBESITY

I am taking this opportunity to comment on the National Coverage Decision (NCD) on bariatric surgery for Medicare patients. Although I respect Medicare for confronting this difficult issue, I was particularly disturbed by Medicare’s denial of bariatric surgery for “retirees,” those patients age 65 and/or over. As a bariatric surgeon I remain cynical regarding Medicare’s motivations and those of other third party payers regarding their willingness to consider the patients’ perspective in the decision to pursue bariatric surgery. It is my belief that essentially all coverage decisions made by such third party payers are focused on cost containment rather than the health and wellbeing of their subscribers. There have been several recent publications on the topic of bariatric surgery for Medicare patients. One of the most recent and likely most controversial was the article published by Flum, et al in JAMA. I am sure that those involved with Medicare’s NCD were aware of those results prior to release of their coverage decision. Although there is no reason to dispute the data in Flum’s report, these results are markedly different than those of other published reports of bariatric surgery in Medicare patients. Two other recent articles published in peer reviewed journals (cited below) show tremendous health-related benefit and a markedly lower morbidity and mortality rate vs Flum’s report.

I asked my office staff to compile a list of Medicare patients who had bariatric surgery through our practice during the past 3 years, January 2003 through November 2005. This review included 46 patients age 65 or older. Among this group we had NO mortality. Moreover, the early complication rate was under 10% and the improvement in quality of life was truly dramatic. In fact, this population may benefit the most in terms of quality of life improvement since all of these elderly patients have at least one (usually many) comorbidites and are on NUMEROUS medications for control of these comorbidites. Therefore, there is every reason to believe that there would be SUBSTANTIAL COST SAVINGS in performing bariatric surgery in Medicare patients over age 65. This reason alone should prompt Medicare to reconsider its decision to deny surgery to this group of patients. Note also that late mortality (during the past 3 years) in our group of 46 bariatric surgical patients over age 65 has been zero!

These excellent results also support the concept of “Centers of Excellence” as recently established by the American Society for Bariatric Surgery in conjunction with the Surgical Review Corporation. Note that we are a Center of Excellence. The disparity in our results along with those of Sugerman and Quebbemann in comparison with the results published in Flum’s recent JAMA paper clearly support the concept of high volume, high quality Centers of Excellence for Bariatric Surgery.

I have asked many of these patients to enter their own comments regarding your decision to deny access for bariatric surgery in Medicare patients age 65 and older. Hopefully, you will get an earful!

In summary, I believe you are doing a tremendous disservice to Medicare as both a cost- conscious entity and its humane goals in denial of access to bariatric surgery in patients over age 65. Although I am not yet 65 I am a dues paying member of the AARP. Certainly, I plan to get them involved if you do not reverse this component of your November 23, 2005 NCD. It’s a travesty!

Sincerely,Robert E. Brolin, M.D.

Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908.

Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247.

Quebbemann B, Engstrom D, Siegfried T, Garner K, Dalla R. Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392.

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On behalf of Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, we wish to submit our comments to the Center for Medicare and Medicaid Services (CMS) on the proposed coverage decision for bariatric surgery for morbid obesity that was issued on Wednesday, November 23, 2005. Ethicon Endo-Surgery, Inc. manufactures and distributes minimally invasive surgery products used for open and laparoscopic gastric bypass. Overall we support Medicare’s assessment of bariatric surgery and offer the following suggestions:

MEDICARE BENEFICIARIES UNDER 65 YEARS OF AGE.
We agree with CMS’s review of the clinical evidence to conclude that open and laparoscopic Roux-en-y gastric bypass and laparoscopic adjustable gastric banding (LAGB) are reasonable and necessary for Medicare beneficiaries who are under 65 years of age, have a body mass index (BMI) > 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. There are numerous studies that show the benefits of bariatric surgery to the general population, such as the study by Buchwald et al in their Meta- Analysis (JAMA. 2004; 292:1724-1737).

PREVIOUSLY UNSUCCESFUL MEDICAL TREATMENT
The proposed coverage decision memorandum mentions that morbidly obese patients who are previously unsuccessful with medical treatment for obesity are appropriate candidates for bariatric surgery. CMS suggests that 6 to 12 months for medical treatment is reasonable prior to bariatric surgery (CMS Decision Memorandum, page 20). We recommend that CMS defer the decision on the duration and type of unsuccessful medical treatment for obesity to the provider and his/her patient. Clearly the ability of a morbidly obese patient to participate in a medical treatment program is determined by the extent of the patient’s co-morbid condition/s, their BMI and the duration of their morbid obesity.

FACILITIES PERFORMING BARIATRIC SURGERY PROCEDURES MEET CMS FACILITY STANDARDS
We support CMS’s requirement that facilities performing bariatric surgery procedures meet CMS facility standards. We also recommend that CMS establish appropriate minimum volume standards for facilities and surgeons performing bariatric surgery. For example, facilities should be expected to perform in excess of 100 to 125 bariatric surgery cases per year and surgeons more than 50 cases per year to achieve lower adverse outcomes. The evidence for facility and surgeon volumes, such as the recent Flum article (JAMA, 2005; 294:1903-1908), the Courcoulas article (Surgery 2003; 134:613-23) and the Nguyen article (Ann Surg 2004; 240:586-594) clearly indicate that high volume providers have better outcomes including lower mortality and complication rates.

Finally, the learning curve for laparoscopic gastric bypass should also be addressed by CMS. The evidence suggests that the learning curve for this procedure may be in excess of 100 cases or more. (Flum, JACS 2004; 199:543-55; Nguyen, Ann Surg 2004; 240: 586-594; and Shikora, Arch Surg 2005; 140:362-367.)

MEDICARE BENEFICIARIES UNDER 65 YEARS OF AGE
We wish to comment on CMS’s decision to not cover Medicare beneficiaries that are over 65 years of age, based on the limited clinical trial data in the older population and the significant surgical risk to the older patient. We respectfully recommend that Medicare consider revising their coverage decision for the over 65 years of age Medicare patient from a ‘no coverage’ decision to ‘coverage with evidence development’ (CED). Since the data for the over 65-age Medicare beneficiary is limited, Medicare should consider encouraging the collection of evidence through a registry.

CMS has set a precedent for a registry under CED when in January 2005 CMS announced it would expand Medicare coverage of implantable cardioverter defibrillators (ICD) and require providers to submit data to an ICD registry as a criterion of coverage. The agency should use the same approach to collect bariatric surgery data to answer important clinical questions about which patients over 65 benefits most from bariatric surgery.

The rationale to permit coverage with evidence development in the over 65 population is supported by a recent government report of baby boomers approaching Medicare having a high incidence of obesity. Two in five Americans aged 55-64 are obese, according to Health, United States, 2005, the government's annual report to the President and Congress on the health of all Americans. The report was prepared by the Centers for Disease Control and Prevention's (CDC) National Center for Health Statistics from data gathered by state and federal health agencies and through ongoing national surveys.

The report features an in-depth look at the 55-64 age group, which includes the oldest of the baby boomers. In 2011, the oldest of the boomers will be eligible for Medicare, and by 2014, the ranks of Americans ages 55-64 will swell to 40 million. The report foreshadows the potential increased financial and health burden of obesity on the Medicare program as many baby boomers who are obese approach Medicare age. "Controlling obesity is crucial for health, and particularly for baby boomers as they grow older," said HHS Secretary Mike Leavitt. "It's time to act against both conditions so more Americans can live longer, healthier lives." The full CDC press release summarizing the study and a link to the report can be found at the following website: http://www.cdc.gov/od/oc/media/pressrel/r051208.htm.

We think that CMS has a unique opportunity to employ its CED option to gather the evidence needed to determine if bariatric surgery can effectively improve the health of the over 65 beneficiary while reducing the health care costs for the Medicare population.

Again, we thank CMS for the opportunity to comment on the proposed new coverage policy for bariatric surgery. Please feel free to contact Henry Alder at ***-***-**** if you require additional information.

Sincerely,
Henry Alder
Director, Reimbursement & Healthcare Economics
Ethicon Endo-Surgery, Inc.

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Why is age the criteria?

The suitability of a procedure for an individual should be determined by a certified physician or a group of physicians after taking all the facts and data about each patient into consideration.

Age is not the proper factor for this determination. The condition of the patient surely must be the only real consideration

Why would a patient be less fit for this surgery one day after their 65th birthday than they were the day before it? Their ability to have a good longterm outcome should be evaluated by a physician or a team of physicians who are considering the medical data for one individual.

As many of the surgeons who have commented on this proposal have observed, the CMS would better serve their patients by setting up centers of excellence for weight loss surgery in order to improve the skill sets of the surgeons who are certified to perform weight loss surgeries. It is the skill of the surgeon that determines to a great degree the outcome of these procedures rather than the age of the patient.

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Since 1991 I have worked with the Duodenal Switch procedure. Previously working with gastric bypass patients and VBG's I was very leary of this 'new' procedure. What I soon realized was how wonderful the DS was for the patient. It did then and continues to this day to provide a normal quality of life for this particular group who have not only lost weight and kept it off but have been able to enjoy life without severe restriction and without severe deficiencies. We have had the pleasure of working with ages from 16-70 and are following 88% of our patients to this day. They are monitored very closely and the overall majority have been very proactive by working with the new support group members.When I speak about the DS I know very well the majority of DS surgeons and know their interest in not only about just doing any procedure but they take pride in doing what they know is best for the patient. The DS does afford each individual such a normal life that it would be an injustice to discontinue this wonderful procedure. We would hope that serious consideration would be given to continue this surgery that has saved thousands of lives. In our patient calendar for 2006 the total weight loss for all patients included is 21,771 lbs. This is just an example of our patient population not including those from all over the United States who have had the priviledge of having the DS.As far as the age range it is sad to think that Medicare will deny access to those over the age of 65 when for many people that is when life just begins. In our practice we would never consider such discrimination.I would like to think that Medicare will strongly reconsider this action.

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Medicare should not exclude BPD/DS for the treatment of morbid obesity since it has been done in hundreds of patients over more than a decade with good results. Many of us who are experts believe it is, in fact, the procedure of choice for the "super obese"-those who are most in need of surgical weight loss for life-saving reasons since it is both safer to do in these large patients, and more effective. No operation is perfect, but do not take away the safest and best option for these, most needy patients!

Furthermore, Medicare can not exclude patients over age 65 from being covered for bariatric surgery. It has been shown in good surgical reports that this is effective surgery in this age-group. Since when do we offer surgery to the American population for good reasons, and then discriminate against people over 65 on the basis of age only? That would be a gross injustice!

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Thank you for your efforts to improve access to weight-loss surgery through a National Coverage Decision. As coordinator of a comprehensive weight management program at a community hospital in Northern Minnesota, I see daily how bariatric surgery can improve patient’s quality of life.

Our program has provided bariatric surgery to over 1300 patients since 2001. We collect data confidentially on all of our bariatric surgery patients. Recently we reviewed our data for outcomes specific to our patients 65 years of age and older. I was not surprised by our findings. In our elderly patients with an average age of 68.5, our complication rates are low. The only complications found were hernia at 1% and anastamotic stricture at 1%. Our excess weight loss in this population is above the national average at 73% at 3 years, as is the follow-up rate of 75%. Taking this data into consideration, I do not believe limiting access to bariatric surgery because of age is rational.

I would support Medicare Coverage with a Evidence Determination (CED) program with the conditions that surgeons be appropriately experienced (granted status as a American Society of Bariatric Surgeons’ Centers of Excellence Program) and that mortality and complication data be collected to evaluate the potential of a future expansion of coverage.

I was also concerned that comprehensive long- term follow-up care was not discussed in the NCD. Coverage of services provided by a Registered Dietitian has yet to be covered by Medicare, despite support and on-going referrals from physicians. Obesity research of surgical and non-surgical programs finds that long-term follow-up care is essential to patient’s success with weight management.

Thanks again. I commend your to efforts to expand the treatment of morbid obesity.

Leah Walters, RD, LD, CDE
St. Joseph’s Area Health Services
600 Pleasant Ave.
Park Rapids, MN 56470

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Dear Sirs,
I was disheartened by your decision re 65 yrs and older patients not being approved for gastric bypass surgery. I have been performing open gastric bypasses for 20 yrs now. I ahve two practices—one at Mass General Hospital and the second in a community hospital just north of Boston. It is here that over the past 6 years I have operated on over 120 patients that were 65 yrs of age or older and have not had one death. the morbidity rate remains similar the the younger population. The severity of illness does not get preferential treatment and referred into my MGH practice. I would very much like to review the data with you prior to your final decisions.
Sincerely,
Sheldon Randall M.D.

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Dear Sir,

I too, wish to weigh in on this decision. I am a bariatric surgeon who has performed over 1500 gastric bypasses in my 14 year career. Included in those cases were 25 patients 65 years and older (65-77). I analyzed their results and found that the complication rates, mortality, weight loss, and outcomes were no different for the older patients as compared to younger patients.

There are currently no restrictions for age when it applies to cancer, open heart, or orthopedic procedures even though the literature demonstrates higher complication rates. Unfortunately, there is currently little literature as it applies to bariatric surgery for older patients.

Allowing high quality, high volume bariatric centers to perform surgery on older patients will enable us to generate that data.

I therefore strongly encourage you to approve coverage for bariatric surgery for patients older than 65 years for evidence development

Thank you for giving me the opportunity to respond

Scott Shikora, MD, FACS
Chief of Bariatric Surgery
Tufts-New England Medical Center
Boston

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In my poinion as a health care proffessional the Gatric Banding prceedure should be covered,and NOT the Gartric BYPASS, this proceedure id a lot less invasive as bypass and requires less time in the hospital and infact can be performed as an outpt proceedure.The recovery time is cut by 70% and the pt is able to go back to work within 5-6days,The effect on people with Diabetes has been extreemly helpfulin terms of the weight loss,mand in the long run costs a lot less than treating the long term complications from the Diabetes,that the gvernment ends up paying for anyway.

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To whom It May Concern,

If infact the Weight Loss Surgery is excluded their will be much higher medical cost for medicare in the future because of diabetes, heart attack, and all the other alements that go along with being obese. Socail Security will be pushed to more of a limit, with the amount of people that will be filing disablity in the future for the cause of morbid obesity. In the long run the exclusion of Weightloss Surgery will bare a much higher cost in the future than the cost medicare is paying right now in the coverage of this surgery. Would you rather have a hundred people asking for this surgery, and returning to a healthy and productive life where they are capable of working and adding to the Social Securoty fund or one hundred folks filing for disabliltyand paying out $600 to $1000 a month per person in the future because these folks can not even get out of bed and cannot get or keep a job because they are obese? What makes more sense to you?

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I am the program coordinator for a Surgical Weight Loss Center in TN. In 1.5 years, we have performed 65 cases, which includes 9 (nine) Medicare patients. Two of our Medicare patients were >age 65 (ages 66 & 72) with severe diabetes (A1Cs were 13 & 11.2 respectively). Both patients had successful laparoscopic RNY gastric bypass, both were off insulin by discharge from the hospital. The 66 year old stopped all diabetic medications at six weeks postop., the 72 year old stopped all diabetic medications by 8 weeks postop. Our Medicare patients who were under age 65 were all performed laparoscopically with improvement/resolution of the following co-morbidities: diabetes, sleep apnea, hypertension, and osteoarthritis by their three month follow up appointment. I am very happy that CMS has decided to continue to cover bariatric surgery, but saddened that they have attached an age limit. At the 2005 ASBS conference, we learned that there should be NO UPPER AGE LIMIT, the patient, PCP & surgeon should collectively discuss and decide do the benefits of surgery outweigh the risks of surgery for each individual patient. When CMS decided to remove the phrase "obesity is not a disease", they said it was because they do not define disease states, why then do they feel it is appropriate for them to universally eliminate a group of patients from having the option of surgery. Age discrimination comes to mind.

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On behalf of the Obesity Action Coalition (OAC), I would like to take this opportunity to thank the Centers for Medicare and Medicaid Services (CMS) for their efforts in reviewing the scientific-evidence validating bariatric surgery as an effective treatment of morbid obesity and proposing rules that would expand access to bariatric surgery. The OAC strongly supports the coverage of weight-loss surgery as studies show the surgical treatment of morbid obesity decreases mortality, improves or resolves obesity-related illnesses and improves quality of life.

As background, the OAC is a non-profit organization dedicated to bringing a patient voice to the obesity crisis in the United States. The OAC encourages patients to educate themselves about obesity, its complications and treatments. We believe that educated patients are best able to make decisions about their healthcare, and therefore are able to be healthier and happier. The OAC encourages patients and their families to support one another, as there is no one better to share the social, emotional, physical and medical impact of obesity than people who have been personally affected. The OAC empowers patients to become proactive advocates for change by helping to eliminate the negative stigma associated with obesity and working to ensure that obesity is treated as a national disease.

The OAC would like to raise the following concerns regarding National Coverage Decision (NCD):

Medicare Recipients 65 and Older

In the NCD, CMS specifically cites data from a recent study by David Flum, MD, which illustrates an elevated risk for older patents as their reason for non-coverage of those 65 an older. However, Dr. Flum points out in his study, and in his own comments to CMS, that the risks of weight-loss surgery among those 65 and older were similar to younger patients when performed by experienced surgeons. As such, the OAC is requesting that Medicare cover surgery for those more than 65 years of age under Medicare’s Coverage with Evidence Determination (CED) program, with the conditions that surgeons be appropriately experienced (granted status as an American Society of Bariatric Surgeons’ Centers of Excellence Program or similarly developed future programs) and that mortality and complication data be collected to evaluate the potential of a future expansion of coverage.

Previous Unsuccessful Medical Treatment

The NCD mentions a requirement of previous unsuccessful medical treatment of obesity but does not apply specific definitions or requirements. As there is no clinical evidence that such programs improve the outcomes of weight-loss surgery and as requirements can vary widely between Medicare intermediaries, the OAC requests that Medicare adopt a policy of three to six months of medically supervised (physician, allied health professional or commercial agency) weight-loss during the past five years but not necessarily within one year of surgery.

Bileopancreatic Diversion with Duodenal Switch (BPD/DS)

Although not as common as gastric bypass and laparoscopic adjustable banding procedures, BPD/DS may be the preferred surgery type for some patients. The OAC believes that a patient and their surgeon are best able to make the appropriate decision regarding their surgery options. As such, the OAC is also requesting that Medicare’s CED program be utilized to allow for coverage of BPD/DS under similar circumstances to the 65 and older population – a requirement for appropriately experienced surgeons and data collection for comparative studies to other types of weight-loss surgery.

Payment of Follow-up Visits

As part of the OAC’s belief that comprehensive long-term follow-up care is required to be a successful weight-loss surgery patient, the OAC is concerned that follow-up physician and healthcare professional visits are not discussed in the NCD. Such visits could include follow-up consultations with a surgeon and/or dietitian and in the case of laparoscopic adjustable banding patients, required fills to assure their band is working effectively. The OAC requests Medicare adopt policies to allow for coverage of medically necessary follow-up care.

Obesity is a disease. It is not simply a condition caused by overeating. As such, patients, with guidance from healthcare professionals, should have access to appropriate medical care to treat the disease. Bariatric surgery is the most successful option for treating morbid obesity currently available and too often, appropriate candidates are denied access to this life-changing and life-saving treatment. The OAC believes that the proposed new rules for bariatric surgery, with the adjustments suggested above, will guarantee appropriate candidates have access to high-quality, safe and effective treatment of their obesity.

Thank you for the opportunity to comment. If you have any questions, please do not hesitate to contact the OAC at (800) 717-3117.

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As a member of the bariatric surgery team at St. Joseph’s Hospital in Bryan Texas, I am submitting a comment regarding CAG-00250R: the proposed modification to the NCD manual sections on bariatric surgery for the treatment of morbid obesity. The specific concern is with the statement “Each institution will have staff and readily available consultations in cardiology, pulmonology, rehabilitation, and psychiatry who have prior experiences with bariatric surgery patients.”

The inclusion of psychiatrists but not psychologists on the multidisciplinary bariatric team is not consistent with the widely accepted practice to utilize psychologists on bariatric surgery teams. Virtually all bariatric surgery programs require a psychological evaluation prior to the surgery. The American Society for Bariatric Surgery (ASBS) recommends pre-surgery psychological evaluations and has an excellent document concerning this issue (www.asbs.org). Evaluations typically include an interview and psychological testing to assess multiple areas including behavioral, cognitive, emotional, developmental, and motivational factors, as well as current stressors and expectations of the long-term dietary and exercise requirements. ASBS recommends psychological testing in addition to an interview. Test results provide additional data to an interview such as the presence and degree of a wide range of psychopathologies, objective information that a patient does not disclose in an interview, and research data that will generate knowledge about predictors of post-surgery adjustment and adherence.

As recognized by ASBA, only psychological and behavioral measures that meet standards established by the American Psychological Association should be used. These standards include the use of tests that meet psychometric criteria of reliability and validity, and appropriate test selection for surgery candidates. ASBS addresses the qualifications that a behavioral health examiner must have to perform their function on the bariatric team. They recommend that the clinician have a license in a profession that authorizes them to perform psychological evaluations, form diagnoses, and provide psychotherapy. Performing psychological evaluations is the primary reason why psychologists must be a member of the bariatric consultation team because only psychologists are trained in psychometric theory, tests and measurement, and test interpretation.

The role of psychologists in post-surgery treatment is also critical. Many patients need individual or group therapy that uses cognitive-behavioral treatment techniques, relapse prevention techniques, and coping skills to manage the significant changes brought on by large weight loss. Psychotherapy is effective in sustaining adherence to dietary and exercise requirements for long-term weight management. While these therapy skills are not the unique repertoire of psychologists, psychologists are highly skilled in these techniques. The primary service of psychiatrists, medication management, is not a frequently needed service for these patients. In fact, many bariatric surgery patients are able to stop taking anti-depressant and anti-anxiety medications after the surgery and subsequent weight loss.

It is critical that the final NCD document avoiding any wording that could be interpreted to exclude a particular profession from providing the behavioral health services. The recommendation is not that psychiatry be excluded, rather it is to assure that psychologists are recognized as members of the multidisciplinary consultation team because of the critical components of psychological evaluations and behavioral compliance.

Finally, many of the private insurance companies that cover bariatric surgery require patients to have a psychological evaluation prior to approval for surgery. In fact, some require that this be one of the first evaluations because it is very inexpensive relative to other pre-surgery medical evaluations. CMS should consider requiring psychological evaluations on all surgery candidates in order to eliminate the patients who are at high risk for noncompliance. Psychological evaluations can significantly reduce the expense and risk of performing surgery on patients who are not likely to sustain long term weight reduction. This goal of identifying failures prior to performing surgery is central to the objective of the CMS proposal to modify coverage of bariatric surgery for the treatment of morbid obesity.

Respectfully,
Margaret P. Norris, Ph.D.
Psychologist
Texas License #24743

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December 18, 2005

Morbid and super morbid obesity is a seriousdisease and very difficult to treat. Presentlyonly surgery has a significant long termsatisfactory result on this medical condition. There are several types of surgical procedures andall have some complications. The morbid obesepatient has serious comorbidities, such asdiabetes, hypertension, arthritis, cardiacdiseases as well as difficulty in their normaldaily activities.

I have performed bariatric surgery for 26years. The last 15 years I have performed mostlythe Biliopancreatic Bypass with a Duodenal Switch(BPD/DS) which is one of the more successfulprocedures. The decision to not allow the BPD/DSfor Medicare Medicaid patients is not justified. There have been in excess of 12,000 of these casesperformed in the United States and this should beconsidered satisfactory for Medicare/Medicaidpatients.

On November 4, 2004; I presented before aMedicare Coverage Committee for the USA FederalGovernment at Baltimore, Maryland. Mypresentation was the only one with significantlong term results. In October of l982 I had agroup of 182 patients which were all ten years toseventeen years post-surgery. Their averageexcess weight loss at ten years was 76% with 92%follow-up; the average successful percent of thatgroup individually was 94%. All patients below50% excess weight loss were consideredunsatisfactory. No other bariatric surgeryprocedure has matched this record.Of our 1400 patients with the PBD/DS the deathrate was 0. 58% and most of these were in thesuper obese. Our leak rate was less than onepercent. Revision of the procedure is between 3and 5%. Reversal of the procedure is ½ of 1% andperformed only for patients who would have amalignancy or some other problem complicatingtheir medical condition.

The advantages of this procedure are thepatient can eat a regular diet. It is easilyreversible if needed by changing part of the smallbowel. They do need to take vitamins and mineralsand have follow up care with their physician whichis a requirement of other types of bariatricsurgery also.

Thank you.
Respectfully,
Douglas S. Hess, M.D.

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In my opinion this surgery should NOT be discontinued. It gives people the chance at a better life. Anyone that has never been obese does not know and has no conception what it is like. Not everyone can just bang lose weight or there would be no obesity in this day and age. Why should the age be an issue? Just because a person is over the age of 65 does not make them any less of a person that needs help. When in fact it would help in the length of their life along with the quality of life. Insurance companies are only looking at the bottom line which is the almighty dollar! They do not think of all the medicine, obesity related conditions that result in costing them MORE money than the surgery itself over the years. They also try to use the excuse that it is risky and dangerous WELL so is being obese. The conditions that the surgery benefits the patient far out weighs any risk involved. I think that if Medicare stops paying for the surgery it would be a devistation to the world. Other insurance companies would follow suit even more than already deny it. The amount of money that would result by being denied the surgery would esculate. PLEASE DO NOT DO THIS TO US!!!!!

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Good idea to restrict medicare coverage for bariatric surgery for those over 65. I think it should be restricted for those over 50... as the mortality rate from this surgery for older people by some studies is 40 percent. And especially since it has been shown that fat people who exercise are at no higher risk for morbidity than normal weight people who exercise.

A recent study found that for people of age 65 to lose weight even by healthier ways than bariatric surgery, is so risky as to be generally not advisable.

The nuns study found that people who gained weight after 65 had virtually no risk of dementia, people who stayed the same had a 10 percent risk and people who LOST weight after the age of 65, had a 35 percent greater risk of dementia.

Finally, Dr Rudy Leibel in his speech up on the NIH site, called bariatric surgery a "draconian solution" because of all the health problems which can follow the inability to digest most vitamins.

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To deny bariatric surgery to severely obese patients simply because they are over 65 is NOT appropriate. We have a number of patients that have exceptionally well and we have not had complications in patients over 65. Bariatric surgeons and programs(Ones that you identify as appropriate via a centers of excellence)have the good judgement to consider the whole patient including the impact of comorbidities on morbidity and mortality. We have refused some older patients on that basis. I would support specific criteria regarding cardiopulmonary situation that would deem selected patients not to be candidates for surgery.

I think there are a number of problems with the recent medicare study and to respond by denying lifesaving surgery is NOT an appropriate response to this data. This decision is based on questionable data. We have taken responsibility in bariatric surgery societies to collect our data and are amassing better data all the time. Please consider mandatory entry into a comprehensive database through ASBS and or IFSO.

There is no other effective treatment for morbid obesity than obesity surgery. I am not aware of any other surgical procedure that has had this ridiculous age cutoff imposed on it. Should we deny ALL surgery to patients over the age of 65? You cannot tell me that data on hip replacement, knee replacement, spine surgery, lung surgery, vascular surgery, cardiac surgery would not have similar data on obese patients over the age of 65.

The cost benefits of bariatric surgery is UNDENIABLE. As a taxpayer alone, acceptable risk patients should get benefits for weight loss surgery. The human toll on the morbidly obese individual with an age greater than 65 and their families is uncalculable.

I do both gastric bypass and Lap Band. The lap band is effective and 10 times safer than the gastric bypass. It is as good option for patients over 65 with significant comorbidity.

I could go on and on, but please do not take away the only hope some people have to avoid misery and slow death. It is like refusing all cardiac surgery or all dialysis on patients over age 65. It is overt age discrimination.

Thank you for your time.

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AS I understand it, Medicare will not cover theopen vertical banded gastroplasty, (also known bymany as the "Fobi Pouch"). It is an unfortunatechoice not to cover this procedure as statisticshave shown that the Fobi Pouch is one of the mostsuccessful surgeries, with the lowest rate ofrecidivism (weight regain), and a lower thanaverage morbidity and mortality rate. Because ofthe post surgical vitamin regimin, Fobi patientstend to be some of the healthiest of weight losssurgery patients over years of follow-up.

The Roux-en-Y surgery, which you will cover, hasone of the highest levels of regain for patients.This is terrible. Yes, it takes the patient out ofthe morbid obisity category for a short time, butmany regain weight, and this is extremelydebilitationg, both physically and mentally to thepatient, and would not create any kind of savingson behalf of Medicare. Many patients who have theRNY and then regain, will again need to be onblood pressure, diabetes, and cholesterol meds, aswell as treatment for arthritis, sleep apnea etc.Wouldn't it make more sense financially to fundthe Vertical Banded Gastroplasty (Fobi Pouch) andhave the weight issue and its comorbidities becomehistory for both the patient and Medicare? Thecost of the surgeries are about the same, so thedecision to exclude it makes no sense. Please takethe time to reconsider this procedure.

Thank you.

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I believe based on previous experience that severely obese patients over 65 years of age who meet NIH consensus criteria for bariatric surgery deserve the only opportunity to cure or control their comorbidities. Since it is well established that medical management fails in atleast 97% of patients, age should not be a restriction. Age is not a restriction for other serious forms of surgery.

The ASBS and ACoS has established registry programs which are recently implimented and should provide excellent standards for the safe implementation and folloewup of surgery for those individuals who qualify, whether over 65 or under 65.
Bruce E. Duke, III,MD FACS

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This approach seems very age discriminatory to me. Each patient, no matter what their age, should be treated on a case by case basis and not automatically eliminated from consideration strictly because of age. I do not believe that there is enough conclusive evidence to arbitrarily eliminate an entire population from receiving a surgical procedure that has proven to improve overall health and eliminate numerous health problems related to morbid obesity. I would like to see data used from the Surgical Review Committee which oversees the American Society of Bariatric Surgeons' Centers of Excellence program. Thank you.

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To deny bariatric surgery to severely obese patients simply because they are over 65 is unfair. First, there is no other effective treatment for morbid obesity. Second, we do not have such rules for other operations. Third and most importantly, the decision is based upon very limited data.

Instead, a better approach would be to approve bariatric surgery for patients over 65 provided that each patient is entered into the bariatric surgery registry of the Surgical Review Corporation (SRC). SRC is an independent, not-for- profit entity under contract by the American Society of Bariatric Surgery to administer its Bariatric Surgery Centers of Excellence program. The SRC registry currently includes almost 50,000 patients that were treated in over 130 Bariatric Surgery Centers of Excellence. This approach would enable the CMS to use registry data to reach future decisions with much greater confidence.

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My opinion counts and you must know upfront that I am angry....

There is no way that anyone - medical profession or government of our people - no one is even listening to the true experiences of even the most 'successful' WLS patients.

Most of the after-surgery patients are not relating their honest experiences out of shame upon themselves, that they have not done what they needed to do to have a successful surgery.

They are prematurely aging! They are in pain. They are infected. They are malnourished beyond belief. They are vomiting and their bowels trouble them indefinitely. They are house-bound. Maybe not all, but entirely too many.

People are suffering from were left to accept and care for their bodies naturally.

People must be accepted at the size and weight they are.

And they must be taught to move in ways their bodies will find confortable in order to gain flexibility, regardless of their size.

People must be taught to eat healthy. And that does not mean some gimick 1500 calories or less near starvation plan. No one can manage their health on that for a degree of time. Not unless they are born that way. WAKE UP!

These surgeries are using our people as test animals and this is a shame. All people must hear that this is wrong!

The government has no business pushing this on people in the guise of saving lives. Oh my god!

But who even listens?

Are you?

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Your decisions regarding bariatric surgery are short sighted and very negligent. The treatment of these patients to reduce their weight is beneficial not only to the patient but to the entire healthcare system. The cost of treating these people long term for Diabetes, Hypertension, Heart Disease and any number of other diseases far out reaches the cost of this surgical treatment. It not only decreases the stress on an already over taxed health care system it returns these people to strong productive lives. Please reconsider this decision.
Elizabeth Smith

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To deny bariatric surgery to severely obese patients simply because they are over 65 is unfair. First, there is no other effective treatment for morbid obesity. Second, we do not have such rules for other operations. Third and most importantly, the decision is based upon very limited data.

Instead, a better approach would be to approve bariatric surgery for patients over 65 provided that each patient is entered into the bariatric surgery registry of the Surgical Review Corporation (SRC). SRC is an independent, not-for-profit entity under contract by the American Society of Bariatric Surgery to administer its Bariatric Surgery Centers of Excellence program. The SRC registry currently includes almost 50,000 patients that were treated in over 130 Bariatric Surgery Centers of Excellence. This approach would enable the CMS to use registry data to reach future decisions with much greater confidence.

Walter J. Pories, MD, FACS

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Today the subject is Weightloss Surgery and age 65... and tomorrow what will it be? What procedures, treatments or medications will we look to deny? And what parameters will we use? Too old, too young, too poor, too uneducated, too white, too black...

It is NOT for the "almighty Medicare & Insurance Deities" to decide whose life is valuable and whose life is not worth their year-end profits.

Let the doctors be doctors and decide if this is the right treatment to improve, or even save, one's life -

A reminder, one day, even those who callously run Medicare and Insurance companies will grow up... at least chronologically. May you be treated with the same concerns that you have treated others.

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Patients ¡Ý 65 have the option to undergo elective coronary artery bypass, joint replacement, peripheral vascular surgery with equivalent morbidity and mortality; it is discriminatory to block access to bariatric surgery for this age group.
Courcoulas A, Schuchert M, Gatti G, Luketich J. The relationship between surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery 2003; 134:613-621.
Nguyen NT, Paya M, Stevens CM, Mavandadi S, Zainabadi K, Wilson SE. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg 2004; 240:586-593.
Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908.
Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247. Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R.
Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392.
Marceau P, Hould FS, Simard S, et al. Biliopancreatic diversion with duodenal switch. World J Surg 1998; 22:947-954.
Hess DS, Hess DW. Biliopancreatic diversion with a duodenal switch. Obes Surg 1998; 8:267-282 Kral JG, Thung SN, Biron S, et al. Effects of surgical treatment of the metabolic syndrome on liver fibrosis and cirrhosis. Surgery 2004; 135:48-58.
Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg 2003; 13:861-864.
Nguyen NT, Longoria M, Gelfand DV, Sabio A, Wilson SE. Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the super-obese with massively enlarged liver. Obes Surg 2005; 15:1077-1081.

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I congratulate CMS for making the decision to cover bariatric surgery specifically Gastric Bypass and Adjustable Gastric Banding for the morbidly obese. I am concerned about the decision to exclude this treatment for patients age 65 and over. While I agree that there is limited data on outcomes in this group of patients the data that is available documents good weight loss outcomes. In fact we recently presented our data on this and I am sending a copy of that presentation under seperate cover. In short weight loss with gastric bypass was equivalent and superior after banding as compared to younger patients. Several other authors have reported similarly good results in the elderly population ( Sugerman et. al. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247. and Quebbemann et. al. Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392. among others).In our series of 45 patients there was no mortality. This of course raises the issue of mortality as recently described by Flum et. al. (Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908.) that relative risk of mortality in the medicare population age over 65 is 3 times that of younger patients. A significant criticism of that study is that the baseline mortality is 2-3 times that seen in centers with significant experience where 0.3-0.5% is the current mortality rate. In fact the outcomes in the most experienced centers was not dramatically different for older patients. As the life expectancy is increasing patients aged 65 can expect to live 20 years or more and even if increased survival cannot be documented, the improved quality of life with significant weight loss is undeniable and no less significant than with other procedures covered in this age group such as hernia repair, joint replacement or palliative treatment for incurable cancer.Given the relative paucity of data I would strongly suggest CED with limitation to centers with significant experience. It is my bias, and there is significant evidence in younger patients, that adjustable banding is a lower risk procedure I would prefer to see both bypass and banding included in such a plan. I do think that cosideration be given to an upper age limit in the initial phases (perhaps age 75) and that this only be expanded if the safety I expect will be shown for this group as compared to younger patients is documented. I also would advocate for collection of quality of life data as well as comorbidity outcomes in addition to weight loss, mortality and cost. Similar to the trial on lung volume reduction, I expect that centers that focus on the care of obese patients with significant volume will have better outcomes. This effect has been shown for bariatric surgery in several studies (Courcoulas et. al. The relationship between surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery 2003; 134:613-621. and Nguyen et al. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg 2004; 240:586-593.) The above plan would offer treatment while allowing for a long term decision to be made that is based on solid evidence that otherwise would not be available outside a large muticenter study.

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I would like to make several comments regarding the proposed changes for Medicare coverage for bariatric procedures. Apparently, it is proposedthat patients 65 years of age or older should not be covered for bariatric procedures because of an increased risk cited by a recent study by David Flum in JAMA. It should be evident that the study by Flum is flawed by the fact that there was no appropriate control group. It is likely, in fact, that the patients who did have a bariatric procedure had better longer term survival with the procedure than without it. It should be evident that older patients have increased risk factors, and their death rates would be expected overall to be higher. I have done a gastric bypass on 13 patients over the age of 65 with a 30 day mortality of 0% and a one year mortality of 0%. Certainly, selected patients for this procedure will receive great benefit, and it would be a tragedy to not provide services to those who desperately need it. In addition to survival issues, quality of life is an important consideration inasmuch as virtually everyone who has a gastric bypass will have an improved quality of life. It may well be that provision of such services by inexperienced surgeons would result in an inferior outcome.

I would also like to comment on the requirement for previous unsuccessful medical treatment for obesity. Inasmuch as medical reatment for obesity is almost uniformly unsuccessful, this requirement is actually deleterious since it may prevent some patients from having the surgery during a more ideal time period. Medical treatment for obesity, at least at the present time, only presents a hurdle to providing appropriate surgical treatment, and it is an unnecessary utilization of healthcare dollars.

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I have performed over 1800 Roux-En-Y gastric bypass surgeries. Many of which were Medicare patients. Our patients over and under the age of 65 have done very well. Our mortality rate on Medicare patients is 0% (no deaths) Bariatric surgery can provide patients with an opportunity for improved quality of life, as well as,increase their longevity. Bariatric surgery offers many patients suffering from Hypertension, Diabetes, Sleep Apnea, Heart Disease, etc. an opportunity to be free from these diseases and free from the bondage and expense of multiple medications to control these diseases.

The 65 year old and older Medicare population is typically at a greater risk due to age and co-morbidities, HOWEVER, they can undergo the surgery with excellent outcomes.

Consider continuing coverage of the 65 and older population by requiring Medicare patients have surgery by an ASBS Center of Excellence, by requiring specific qualifications of the surgeon and staff, and by including volume criteria for surgeons.

Bariatric surgery is a team approach. Approved facilities should have a multi-disciplinary team available to provide Medicare patients the best possible outcome following Bariatric Surgery.

I am willing to provide any outcomes data you wish to review regarding the Medicare cases we have perfromed. Our data supports that Bariatric Surgery is beneficial to the Medicare population of all ages.

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When it is medically necessary for an individual to undergo bariatric surgery, it is only logical that he or she should have the option to undergo the research-based effective procedure that best fits the individual needs of the person. The biliopancreatic diversion/duodenal switch is a procedure that is comparable to the gastric bypass, but fundamentally different in that it utilizes less restriction and more malabsorption. Both of these are utilized in gastric bypass. For some patients, massive food consumption is not the main reason for their weight and related health problems, but simply inherited metabolic anatomy. The DS uses so much more than restriction to help individuals loose weight. The BPD/DS also contributes to a higher quality of life than gastric bypass as patients are able to return to a eating regimin that typical healthy individuals use, rather than highly restrictive for anyone. The risks for both procedures are both minimal with proper follow up care and comparable. BPD/DS has a higher success rate than other bariatric procedures with a higher percentage of excess body weight lost and less regain. Please consider giving bariatric patients the option of choosing the procedure that best fits their needs. I forsee, with more exposure, that the BPD/DS will be the procedure of choice for bariatric patients and widely accepted and recognized. Please do not succomb to the bias prejudice against individuals with obesity that is still accepted in our society today. It is a legitimate medical disease which patients do not choose. Please treat these patients with the respect and good health care as any cancer patient you may serve. Thank you for your time.

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Why should any version of this surgery be based upon a person's age? Why not base it upon whether or not they meet the criteria for the procedure, what co-morbidities they have, what are their surgical risks and what is the value of having the procedure? Most people in their 70's are acting and looking like people used to do in their 50's. Over the years the RYN gastric bypass seems to have become thegold standard, but the upcoming research tends to show that other procedures, such as the duocenal switch may be as effective, if not more so. Many people are traveling to other countries and paying out-of-pocket to have these done becasue most third party payers here are not covering them. Most people cannot afford this, though. Discrimination against the morbidly obese is still very much acceptable. Should Medicare and other insurers not pay for surgery , chemo or other treatment for smokers who get lung disease? Is obesity just due to overeating, as many people think? Does Medicare only want to use this as a way of saving money? There are a lot more questions to answer, and meanwhile people are dying due to risks associated with morbid obesity. Yes, people can die from the surgery-from ANY surgery-but more lives are being saved than lost, with a decreased number of health risks from those who have the surgery. And paying only for those under 65 who are disabled-talk about discrimination?

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I am a bariatric surgeon at the University of Chicago. I have two comments regarding the Medicare coverage proposal for bariatric surgery. The first is that the duodenal switch does have a role in the surgical treatment of the super obese. In numerous single center studies and in our institutions experience, the weight loss is superior to that of RYGB or Lap-band for this subset of patients. It is our surgery of choice for the super-obese. The ongoing NIH-sponsored Longitudinal Assessment of Bariatric Surgery study will further clarify this, therefore, until this study is completed, I think it would be a mistake to deny coverage, as this would drastically decrease the number of patients having duodenal switches and underpower the study. Second, the proposed 6 to 12-month trial at medical weight loss is unnecessary. The data on the ineffectiveness of medical weight loss is solid with a >95% failure rate, so even if a patient is temporarily successful, they will not be able to achieve nor sustain weight loss sufficient for resolution of co-morbidities. The private insurance carriers have used this criteria only as a method of denying coverage and biding their time, not in the best interest of their subscribers.

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I am a practicing bariaric surgeon and a professor of surgery at the University of Chicago. I have been practicing bariatric surgery for 15 year and take care of very high risk patients in an urban setting. Numerous studies have shown that the patients that need bariatric surgery the most (i.e the highest weight, most medical problems) are the least likely to undergo an operation. This group of high risk, high weight patients exert the highest finacial burden to the system as a result of their weight. The average BMI of our patients is 56, corresponding to a weight of approximately 350 lbs. Without the availability of two stage procedures and the duodenal switch for patients in the high risk high weight category, most medicare and medicaid patients (which also fit into the high weight high risk category- see Flum JAMA 2006) will receive either a lap band or a roux en Y bypass. This will result in a very high failure rate approaching 40%. There is no rational basis for this restriction and it will not be cost-effective. The currently proposed limitations will result in the following outcome, an outcome that any behavioral economist would predict: Most surgeons will view medicaid/medicare patients as potentially high risk, and as such will opt for performing quick lap band (it takes an experienced surgeon 30-45 minutes to pop one in). More lap bands than ever will be placed in these patients driven by pure economics, a surgeon can put in as many as 10 per day. The failure rate in patients with a BMI of 50 or greater will be at least 50% for a lap band. This irrational approach will ultimately cost the system more than doing the right operation at the start.

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Thank you for the opportunity to respond to the Medicare proposal for obesity surgery. My employment history has been in the health care field as a registered nurse with experience in areas of critical care, triage, home health, insurance evaluation, utilization management, smoking cessation and currently disease management. My following comments are not quick judgments but rather observations of the typical patient in our health care system. Numerous chronic disease processes begin with obesity and evolve into costly longterm comorbidities. Our population would be better served through education on diet, exercise and responsible health habits. We sould eliminate reinforcement for lack of discipline and poor lifestyle choices. This would instill accountability and relieve taxpayers of an unnecessary and unfair burden. Perhaps rewarding ones that make good choices would produce better outcomes. Productive citizens should not be obligated and burdened financially by those that fail to care for themselves.

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This is an exceptionally positive move for the participants who utilize Medicare/Medicaid services/coverage. The health risks and/or comorbilities brought on by obesity steal an enjoyable life from the patient. At the same time treatements for those same comorbities cost taxpayers millions of dollars each year.

The availability of Bariatic Surgery as a treatment for Morbid Obesity will allow patient and doctor to make plausible health decisions, which could remedy or reduce injurious comorbilities (ie, diabetes, hypertension, etc). Successful bariatric surgery reduces the associated medical costs for managing those dieases. In addition it opens up potential opportunties for lives to be lived rather than sustained. Those Medicare/Medicaid covered persons who do decide to undergo bariatric surgery will be given an avenue of hope at the very least. Aftercare is most important, so it is reassuring this aspect was included in the approval of Centers of Excellence criteria.

Additionally, it is awesome to see the government including both the gastric bypass as well as the adjustable band as surgical methods. From the research I have done, both of these surgeries have shown high rates of long-term positive outcomes. Because private insurance carriers tend to follow the Medicare/Medicaid guidelines, hopefully there will be a swift turn from straight denials to a more pro-patient viewpoint.

Well done...

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As a health professinal working in after care providing nutrition programs for bariatric surgical patients, I strongly support access to weight loss surgery procedures for qualified individuals over the age of 65. In patients who are carefull selected for surgery, and who are cared for by qualified health professionals, age should not be a primary criteria. Older patients should be able to have excellent outcomes with improved health and quality of life with bariatric surgery. Equally important would be supporting the long-term nutritional needs of these patients. One of the things that makes the difference between patients who are successful after surgery versus those who are not is maintaining nutritional status. Gastric Bypass, Adjustable Gastric Banding (Lap-Band), and other procedures all create nutritional risks. As older individuals are more likely to develop deficiencies in general, to cover the procedure, but not provide reimbursement for the nutrients patients need to stay healthy does not make sense. Nonetheless, bariatric surgery is currently the most successful treatment available for the treatment of morbid obesity. Patients of any age deserve coverage for these procedures until there are better options available to them. Thus far in medical history, diets and drug have not provided these results in a satisfactory manner.

Sincerely,

Dr. Jacqueline Jacques
Chief Science Officer
Catalina Lifesciences, LLC

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I agree with the age limit of 65 for bariatric surgery, but I would suggest an increase in the limit upon recommendation of the surgeon and the primary care physician or internal medicine specialist for specific individuals.

I am pleased to hear that coverage is being considered for weight management programs. I would recommend coverage for comprehensive, hospital based programs staffed with health professionals, including registered dietitians. These types of programs have been shown to increase the skills of participants for long-term lifestyle changes. Very low-calorie and low-calorie diet programs are increasingly providing good results and long-term maintenance for patients.

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Dear Members of the NCD-Medicare.
I am a fellowship trained Bariatric Surgeon. I perform primarily Bariatric Surgery. This includes Lap RYGBP, Lap Bands and sleeve gastrectomies in the super obese which later get converted to Lap RYGBP. I have several significant concerns.

1) 5% of our practice involves Florida patients who are > 65 years of age. Denial of access to bariatric surgery I feel is a significant disservice to many patients. Our complication rate for > 1000 patients is <2% with no deaths. I understand the data presented in the Flum et al paper, however, with experienced surgeons performing in dedicated Centers of Excellence, denial is not an option.
Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908.
Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247.
Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R.Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392.

2)There is a role for staged procedures. I have several individuals who have BMIs > 70 with chronic MRSA skin infections. Their medications alone are costing Medicare > $500/Mo. These individuals are candidates for a sleeve gastrectomy which after one year should be converted to a RYGBP. This really is their only option. Perhaps you should identify surgeons who can safely perform these procedures and allow them to perform them.

3) The 3 separate 6 month MD monitored diet is absolutely ludicrous. Many of our patients are 63, wheel chair bound and will certainly fail any an all diets. By the time they are thru their diet they are either > 65 or even more heavy and sicker than before, making them an even greater risk. I personally believe that after your BMI > 50, your odds of ever successfully completing any diet approaches zero. Your MD directed diet should only be 3 months, or not required if their weight has been well documented for 3 years. Mandating a failed diet within one year prior to surgery is a blanket statement that just doesn't hold water.The NCD panel needs to get proactive, look at and select surgeons who do good work and don't scam the system. If someone doesn't do > 50 cases in a year or has done <100 cases, they have no business performing bariatrics. They need to go get more training.

All major insurance companies follow your guidelines. You need to get productive and formuate stipulations. It is not well trained surgeons like myself who are hurting your patients, but the dablers in the country. I assure you, Blue Cross, United, Aetna, etc will follow suit with your guidelines. They should be strick, but reasonable. However, you are looking at the wrong data. You shouldn't be looking to pigeon hole patients, but more importantly pigeon holing doctors and hospitals that perform. Don't limit patients, limit doctors. That way you are assured that the best quality job will be performed in the safest manner. It is impossible to stipulate every detail of every patient. You can however, identify the key characteristics of the surgeons. You need to work closely with the leaders of the ASBS and the guidelines of the SRC. Those are the centers dedicated to getting patients healthy. I hope you make your decisions wisely.

Sincerely,

Jeffrey L. Lord MD FACS
Director of Bariatrics
Sacred Heart Institute for Surgical Weight Loss
5151 N. 9th Ave, Suite G 27
Pensacola, Florida 32504

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To whom it may concern. I write to you in support of bariatric procedures from which you apparently plan to withdraw support and payment. Also, though I don't generally believe that politics has the right to control science, that you have added payment for a procedure that is not ready to be advanced.

First, open vs laparoscopic procedures is a surgeon's choice based on the circumstances in an individual patient. Because the operation should be the same, there should be no basic superiority of one over the other.

Primarily I write in support of biliopancreatic diversion with duodenal switch. This operation has many advantages ove gastric bypass. Even though a patient has greater capacity to eat, which insures better long term compliance, the weight loss is greater than gastric bypass by a small but significant percentage. Where as gastric bypass is notorious for dumping syndrome and dangerous marginal ulcers, duodenal switch is not associated with these problems. In addition, in gastric bypass, the bypassed stomach can never be seen again by any ordinary method. With duodenal switch, the stomach is abailable for surviellance by all conventional methods. In addition, almost every gastric bypass patient becomes vitamin B 12 defficient, where as this is quite rare in duodenal switch patients.

In summary, biliopancreatic diversion is superior in every way to gastric bypass. I am a surgeon who performs both procedures. In general, my duodenal switch patients have superior results and are happier with their lifestiles. I am just beginning to collect data in the hope of publishing the differences between the results of the two operations. If you withdraw payment, this will curtail the gathering of this information. Please do not withdraw payment for biliopancreatic diversion with duodenal switch.

I also believe vertical banded gastroplasty still has a small place in the treatment of morbid obesity, which I feel is one of the worst diseases in modern American society.Sincerely,Wm.S. Peters D.O., FACS

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I am a bariatric surgeon and I would like to commend Medicare for its decision to endorse baraitric surgical coverage for its patients. There are some particulars with which I take exception however. I feel that the American Society of Bariatric Surgery has done an outstanding job at attemting to ensure the quality of baraitric operations being done in this country through their Centers of Excellence program. Myself, my practice and my hospital went through the process and I firmly believe that in preparing for the designation we became a better program (and I had believed that we were already pretty good!) Their process made us better. Several studies have been published (Surgery 2003; 134:613-621 and Ann Surg 2004; 240:586-593) recently which have shown that higher volumes or more experienced facilities and surgeons lead to better results. The ASBS Centers of Excellence make minimum volume limits one of their many important requirements for designation. I think that support for the ASBS initiative should be given by Medicare. I also believe that any requirements for recent dietary failure within the time period preceding surgery is also misguided. We're not talking about patients who are looking to "shave off" a few pounds. These are morbidly obese people who by definition are at least 100# over ideal body weight. Most patients didn't get that way 1 month before they went to see their surgeon, they've been obese for many years. Dietary intervention (with or without exercise) DOESN'T work in these patients. That's been proven. By making preoperative roadblocks with fruitless interventions that show no efficacy whatsoever we are merely denying the appropriate treatment for no proven scientific reason. Please remove all preoperative dietary requirements. They are unproven and make no postive contribution. They only serve to delay a very effective treatment for a far-reaching disease.Lastly I feel denying coverage for patients based on age is wrong. Why will someone 64n years of age, with severe arthritis, sleep apnea and hypertension derive a greater benefit from this surgery than a similar patient who's 66 years of age? Maybe the patient will not have prolonged life but will their quality be improved? You bet! Recent studies by Drs. Sugerman, et al. (Ann Surg 2004; 240:243-247) and Quebbemann, et al. (Surg Obes Relat Dis 2005; 1:389-392) have shown that surgery in the morbidly obese elderly "is safe and effective." Life expectancy is decreasing in this country because obesity is increasing. Medicare is the single largest health care provider in this country. If Medicare starts denying proven, effective care to patients based on non-medically founded issues, then all insurance carriers will follow suit and at the end of the day American citizens will suffer. Thank you for your time, and again I applaud Medicare's decision to support bariatric surgery, but I feel there's still some room for improvement. Sincerely, Keith Zuccala, MD, FACS.

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You would not deny treatment for breast cancer, colon cancer or pancreatic cancer to elderly patients. Some of this illness have treatments that are with debatably marginal outcomes. The obesity treatment has been proven to be beneficial and in long term cost effective, I think it is a great injustice to deny percentage of our population effective treatment solely based on age criteria. What ever happen to no descrimination based on age/race/religion etc motto. What sort of example are you setting for private healthcare industy and when are we going to start seeing this arbitrary denials for other life altering treatments, such as knee and hip replacements

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I believe this is a very important surgery and really needs to continue. These people are on medication for all sorts of others complications and by having the surgery their chance of being taken off the medications are very high. The surgery would be much easier and cheaper than continuing all of the medications for the entire life of a person. Also, these people may be able to return to the work force which therefore, would lower the unemployment/ disability rate.. Please keep this surgery going VERY IMPORTANT!!

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I JUST DO NOT UNDERSTAND THE LOGIC OF TAKING AWAY THIS BENIFIT/WHICH IS A TOOL. DO THE INSURARNCE COMPANY RELIZE HOW MUCH MONEY THIS SURGERY WOULD SAVE THEM IN THE LONG RUN? MORBID OBESITY IS A SICKNESS/BELEIVE ME I WOULD NOT WISH THIS SICKNESS ON ANYONE.YOU WILL TAKE CARE OF A SICKNESS SUCH AS ACHOLOL/OR DRUGS TO BE COVERED, BUT NOT COVER SURGERY FOR MORBID OBESITY! PLEASE DON'T STOP HELPING THE PEOPLE THAT NEED THE HELP NO MATTER WHAT AGE THEY ARE. I THINK THAT SHOULD BE LEFT UP TO THE DR'S. SOME PEOPLE DON'T QUALIFY FOR SURGERY AT AGE 30 EACH PERSON IS DIFFERENT, NO MATTER AGE.

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It is amazingly shortsighted to think of the elimination of Medicare and Medicaid coverage for the Duodenal Switch procedure, and also elimination of coverage of weight loss surgery for people over the age of 65, among other things. Given the tremendous amount of other health related costs associated with morbid obesity, it seems crucial for surgeries such as these to be covered in order to avoid further costs that occur due to the medical effects of obesity. Although this decision doesn't effect me directly (since I have private insurance and am well under 65 years of age), this issue will cost us taxpayers millions in the long run! Please rethink your stance on this issue!

Sincerely,
Brandy Prather-Payne

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Virginia Commonwealth University would like to submit it's data in patients over the age of 65. We have performed bariatric surgery in 26 patients with ages ranging from 65 to 74 years. There have been no 30, or 90 day or in-hospital deaths in these 26 pts done over 7 years. The mean percentage of excess weight lost was 50%and this was maintained for 3 yr. There was: 40% resolution of hypertension at 1 yr, 60% resolution of diabetes, 92% resolution of stress urinary incontinence, 100% resolution of heartburn, 50% resolution of arthritis. These patients have shown marked improvement in their quality of life with morbidity and mortality similar to those of their younger counterparts. They should not be denied these improvements in their lives because of arbitrary age requirements.

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I am a ABS certified general surgeon practicing in the Huntsville, Alabama area for over 10 years. I have been performing laparoscopic roux- en-y gastric bypasses since 1998 within a comprehensive surgical weight loss program. I have performed over 1500 cases.

In my experience, there is no significant difference in age as related to outcomes. This point is made by the authors of the recent JAMA article by Dr. Flum. My experience is limited in less than 2% of my patients are over 60. However, I have found that a risk assessment identifies most high risk patients that can be advised of their high risk status and perhaps offerred a less invasive procedure if at all. My 90 day mortality rate is less than 0.2%. I have no patients who have died following bariatric surgery that are over 60.

The article published in JAMA 2005 actually discusses the low risk of open bariatric surgery in high volume centers performed by experienced bariatric surgeons. My experience confirms this finding using the laparoscopic approach.

I recommend for CMS to offer coverage for roux- en-y gastric bypass to be performed by experienced bariatric surgeons. The increased difficulty in performing the laparoscopic approach would increase the RVU. Therefore, an increased reimbursement for the laparoscopic roux-en-y gastric bypass based on RVU should be adopted.

As laparoscopic cholecystectomy has become the standard of care, laparoscopic gastric bypass will eventually follow. The benefits of laparoscopic bariatric surgery performed by an experienced laparoscopic bariatric surgeon has been extensively published.

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I feel Medicare is doing a diservice to those who are morbidly obese and diets haven't helped. This surgery has helped many people live more quality of life and experience better health, in the long run costing Medicare a lot less then otherwise the complications of the morbidly obese have. So many of us could tell you stories of how diet after diet has failed only to find we gain more opounds when we relax finding we can't stay on a cardboard diet or the manyh other types out their. Please reconsider your decision of banning this surgery. In the long run less will be spent then what would be for the unfortunate people who struggle with morbid obesity. Thank you for listening to my opinion.

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You people at CMS are idiots! You cite one article by Dr. Flum about early mortality and neglect to acknowledge that LATE mortality is lowered (See another article by Dr Flum-Impact of gastric bypass operation on survival:A population based analysis. Journal of Am Coll of Surgeons 2004; 199:543-551). Has anything else OTHER than surgery combined with lifestyle change ever worked to help obese patients lose (and keep off) the excess weight? You want to eliminate surgery for patients over 65. In my medical practice, the UNDER 65 medicare are the least compliant medicare patients I have stop covering and subsidizing them!!!

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1) Outcome and not number of cases alone should be the factor to recognize and grant privilages for bariatric surgery. Beyond a critical point, systems can underperform due to exhaustion. Pushing for numbers will dilute resources and compromise quality.

2) Physiologic age and reserve should prevail over the strict arbitrary age of 65 years old.

3) Leaving 65 years or older out is excluding a main body of beneficiaries for which the system is responsible for. Sounds inconsistent and segregatory against the elder.

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I am writing to urge consideration of coverage for bariatric surgery to all Medicare beneficiaries regardless of age. There is ample data that while the risk may be higher, the benefit is equally great for these patients suffering from the chronic disease of Morbid Obesity. Our own research from the Lahey Clinic in Mass., presented at the Society of American Gastrointestinal and Endoscopic Surgeons Scientific Meeting in 2002 demonstrated equal improvements in health with no increase in morbidity or mortality. I strongly disagree with Sec'y McClelland's assertion that the 'best treatment is a nurtitious diet and exercise' in fact, the NIH consensus panel in 1991 declared that diet and exercise and medical treatment was ineffective for the treatment of morbid obesity. They further stated that Surgery was the only treatment proven to be effective long term. Their selection criteria did not include an age cut off. To deny coverage to Medicare beneficiaries over age 65 would be tantamount to age discrimination in denying them the only treatment proven to be effective. The health benefits obtained thru bariatric surgery can dramatically improve not only the quality of life for these patients, but also significantly decrease the cost of their ongoing care thru reduction or resolution of their obesity related conditions including diabetes, hypertension, sleep apnea, incontinence, etc. We do not deny joint replacement to these patients, but are we prepared to deny the treatment that might allow many of these patients to actually get the joint replacement that they need for their arthritis?I applaud the committee for recognizing the benefits of the surgery for patients debilitated by morbid obesity, and strongly urge the committee to consider expanding the national coverage recommendations to include all the patients that may benefit from this valuable intervention.

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In the July/August 2005 issue of Surgery For Obesity and Related Diseases, a report on a retrospective series of 27 patients >65 years undergoing bariatric surgery (lap band or gastric bypass) concluded that the operations are safe and gained significant benefit in terms of weight loss. The study shows progress over prior studies in that we have validation in the >65 yr age group. Given that this age group has increased risk of dying due to co-morbidities, we do need to increase awareness that bariatric surgery is safe and effective with experienced surgeons and facilities. This review is only a small glimpse however, of the safety and efficacy of the procedure. I believe that more data is needed before the federal government advocates this procedure for that population.

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BARIATRIC SURGERY FOR THE TREATMENT OF MORBID OBESITY: I am the Medical Director for Bariatric Surgery At Kaiser Permanente Northern California, South San Francisco. I have testified before MCAS at the last public hearings on bariatric surgery in 2004. I would like to add my comments as a primary care physician and subspecialist in severe obesity and bariatric surgery in an HMO setting.

1. AS my previous comments have stated, what is critical is that a responsible multidisciplinary team evaluate and ameliorate the many comorbidities of severe obesity as expeditiously and thorougly as rationally possible prior to elective surgery on this high risk group. We do not believe that simple age limitations is the real concern. It is a question of quality of evaluation and preoperative treatment. I would strongly support a 67 year old patient with type two diabetes in control to have a RNY or Lap band at an ASBS approved Center of Excellence. I would also strongly not support a 55 year old who and serious heart disease uncontroled and or diabetes out of control to get the same surgery. And if any patient was applying to get a surgery in a non-COE facility where the surgeons ( as in the Flum article) did not perform a required number of procedures/year, I would disallow it.(1- 5)

2. The Flum article points out the flaws of providing bariatric surgery to very sick individuals (the marjority of medicare recipients are SSI - ie often the sickest of the sick). Also Flums article exposes the pitfalls of inferiorly trained and practiced surgeons offerrig the surgery. (6) It is clear that the experience of others in California and elsewhere do NOT echo these statistics.

3. At Kaiser Permanente South San Francisco, we perform nearly 400 surgeries/year. Our statistics are perhaps the best in the nation. A recent abstract has been offerred to the ASBS for consideration with first author Robert LI. (7) In this evaluation he describes our experience with "carefully selected" patients over 65. Our experience is stellar. Well motivated and well medically selected and psychologically sound patients over the age of 65 are extremely successful. DO NOT PUT A BLANKET AGE RESTRICTION ON YOUR CRITERIA.

3. Kaiser data shows that with surgery we can decrease, four years post op, hgA1c to 5.8. This alone should tell you that the surgery should be promoted to all well selected and preoperatively managed patients. (8)

4. In regards to diet and exercise, the national statistics on obesity show that diet and exercise have not worked well on at least a major subset of the population. At KP SSF we assess in our multidisciplinary team the diet, exercise, psychological ( including eating disorders ), lifestye-other,and exhaustive medical comorbidities. If one looks one can assuredly find diet failure in all these patients. One can find emotional triggers. One can find significant psychological and medical disabilities. The real question is whether a bariatric service assesses these and begins to resolve all these issues before surgery, and then has a thorough plan for continuing to work on these comorbidities post operatively.

Severe obesity is not a surgical disease. It is a disease of a healthy stomach. The disease involves all the other parameters above. Smart and effective treatments are developed to utlize what I call the onion approach. Before surgery you begin peeling away the layers of the onion. If you do not begin before surgery, you will never have developed the language necessary to address these issues after surgery. And it has become clear to those of us who work in the discipline that these issues resurface for a significant number of patients in the post operative period. Once a patient has the surgery ( ie the tool of hope that there can be a better life), then it is CRITICAL that the rest of the layers of disease continue to be addressed by the health care team in order to maximize the benefits of the surgery.

1. Courcoulas A, Schuchert M, Gatti G, Luketich J. The relationship between surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery 2003; 134:613-621.
2. Nguyen NT, Paya M, Stevens CM, Mavandadi S, Zainabadi K, Wilson SE. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg 2004; 240:586-593.
3. Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247.
4. Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R. Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392.
5. Kral JG, Thung SN, Biron S, et al. Effects of surgical treatment of the metabolic syndrome on liver fibrosis and cirrhosis. Surgery 2004; 135:48-58.
6. Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908.
7. Li,R et al, Kaiser Perm abstract submitted to ASBS
8. Sidney, Stiles, Kaiser Permanente Outcomes Data in preparation for submission, 200-2004.

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As a bariatric nurse coordinator for almost 12 years, I have had the intense personal and professional satisfaction of seeing the lives of literally thousands of patients saved and improved by bariatric surgery. Our research article, Effects of Bariatric Surgery in Older Patients (Sugerman et al), presented data on 80 patients between the ages of 60 and 74 years old. These data clearly showed immense medical benefit from bariatric surgery in older patients, inlcuding (but certainly not limited to): resolution of hypertension (80% pre op incidence reduced to 52% at 1 year post op), diabetes (49% incidence pre op reduced to 17% at 1 year post op)and degenerative joint and back disease (reduced from 49% pre op to 44% 1 yr post op). Weight loss showed BMI reduction from 49 to 35 at 1 year post operatively.Additionally, 30 day mortality for primary bariatric surgery was 0%, even though older patients presented with more pre operative co-morbidities than younger patients.After years of feeling trapped in their unhealthy bodies, years of trying and failing every diet known to mankind, and a lifetime of ridicule, older patients have been offered a way to escape the imprisonment of obesity through bariatric surgery.I implore you to continue to allow bariatric surgery be an option for those over 65 years old. In the hands of an experienced bariatric surgery team, obesity surgery is and should be considered an acceptable option for older patients. They should not be robbed of freedom from the perils of obesity.

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I have been an executive secretary for a bariatric surgeon for the last six years. I have seen many more successful surgeries than unsucessful ones. As with any kind of surgery, there are pros and cons for which the patient must decide, and the pros for this surgery are numerous, such as decreasing the use of medications and prolonging ones life. However, I do feel there needs to be more specific criteria for the process of being approved for bariatric surgery, especially in the area of behavioral evaluation. I feel this area is lacking in guidance for the psychologist/psychiatrist who is evaluating the obese patient. While an obese person may obviously need the surgery, it doesn't always mean they are appropriate for it.It is this person who ultimately has the complications and fails to use the surgery as a tool to help them, and it is only a tool. I feel the person doing the behavioral evaluation are afraid to be the one to say "no, you're not ready for this" because they don't have specific guidelines in front of them. For certain psychological disorders, this surgery is inappropriate. In this case, more people need to be directed toward the nutrition track which needs to have more coverage from an insurance standpoint. However, we can't deny the patient who clearly meets the criteria.

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Opening up Bariatric surgery for Medicare ccoverage for patients under 65 presents a real dilemma. One cannot sign onto Medicare until age 65 except for special circumstances, so who are you really covering.?? How are you going to reimburse Medicare HMO's that have to do this surgery which can result in some very difficult, long term, costly complications.???

By Medicare forcing the issue on Bariatric surgery, the pressure on Insurance companies to offer Bariatric surgery will be very high. This could force states to mandate coverage for Bariatric Surgery. That will further increase the upward spiral on Insurance premiums. This would not be good for the economy or the individual.

I would ask the committee to seriously discuss all the adverse consequences of your decision and not just medical consequences. I also think in doing this, you are going to say to patients that you can just have surgery when you get too big. The emphasis should be on Medicare using those dollars to invest in furthering Obesity research to come up with solutions that are applicable to most people. Other wise you are going to create an industry of Bariatric surgery that will explode and more unqualified surgeons will be getting into action.

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PacifiCare applauds the effort that CMS has undertaken preparing the above mentioned National Coverage Determination regarding Bariatric Surgery for Morbid Obesity in Medicare Beneficiaries. We still however, continue to have some reservations as to its breadth of coverage, as well as certain deficiencies in its criteria for participating centers.

In the current draft NCD, CMS proposes “coverage for Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding are reasonable and necessary for Medicare beneficiaries who are under 65 years of age, have a body-mass-index (BMI) >/= 35, have at least one co-morbidity, and have been previously unsuccessful with medical treatment for obesity.” In its July 2004 review, RAND (Shekele PG, etal., Pharmacological and Surgical Treatment of Obesity. AHRQ Publication 04-E028-2) concludes that, “Surgical treatment is more effective than nonsurgical treatment for weight loss and the control of some comorbidities in patients with a body mass index of 40 kg/m2 or greater. More data are needed to confirm or refute the relative efficacy of surgery for less severely obese persons.” “ For patients with BMI between 35 and 40, we do not regard the existing published data as conclusive, because the data are derived from case series without a concurrent comparison group.” PacifiCare proposes that based on the RAND conclusions, that the NCD be restricted to beneficiaries under 65 years of age, with a BMI over 40 kg/m2.

Also, RAND does not specifically address the population over age 65, but your own in-depth review clearly reveals the paucity of data available for such an evidence based review. Furthermore, the recent October 19, 2005 issue of JAMA, (Flum DR, etal., Early Mortality Among Medicare Beneficiaries Undergoing Bariatric Surgical Procedure, JAMA, 2005; 294; 1903-1908.) highlights a “considerably higher all-cause mortality (p< .001)” in this population versus those under age 65 at 30 days, 90 days, and one year. Dr. Flum concludes, “Patients aged 65 years or older had a substantially higher risk of death within the early postoperative period than younger patients.” Based upon your extensive literature review, and Dr. Flum’s recent article, PacifiCare cannot support bariatric surgery for this specific population.

In our initial response to CMS in June, PacifiCare strongly encouraged the adoption of risk-adjusted outcomes data, very much like the Scientific Registry for Transplant Recipients (SRTR), for use in reviewing participating centers. The current NCD only calls for informing patients of “30 day mortality and other relevant outcomes measures.” We feel this is inadequate to fully inform beneficiaries of long term (90 day, 1 year and 3 year) outcomes, as well as being inadequate to address specific complication rates, and long-term weight loss and re-admission rates. We must again reiterate our concerns that these additional outcome measurements be added to all CMS certified bariatric surgery facilities.

For CMS to adopt an NCD that is not fully supported by evidence based reviews, and does not fully inform the beneficiary of potential short comings of their providers, does not support the mandate of promoting both high quality, and cost effective health services for all Medicare beneficiaries.

I look forward to our further discussions of this important health issue.

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This is a slap in the face of those who truly need help. If you are willing to cover rehab for drug/alcohol abuse and assist with quitting smoking why are you not willing to help those who are addicted or abuse food. THis is a politically correct double standard that needs to be halted. If you are an alcoholic/druggie/smoker you can for the most part just avoid the things that caused you to start down that road. But for the obese, you cannot just stop eating. This is a daily battle that no one understands, unless you are there. DO NOT halt the funding, if you do the private insurance companies will also.Just think of how much money you will be saving by spending the $20-30k on a WLS - compare that to the expense of diabetic treatment, heart problems, transportation items (carts, special vans, etc) pretty soon the $20-30k is starting to look like a cheap investment. Support the needy in our society!!!!!!

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Year
Total Obesity Procedures 2001
431 2002
864 2003
1,603 2004
1,957
65y and older 1 8 13 25
Percent 65y and older 0.23 0.93 0.81
1.28
Mortality all ages 2 2 0 2
MEDICARE FFS 29 38
68 86
MEDICARE MANAGED CARE 2
1 6
8

As you can see, we are dealing with a very small proportion of patients in the over 65yo age range (less than 1% in 2001-2003 and1.28% in 2004). Furthermore, overall in-hospital mortality has also been under 0.5% statewide. These mortalities were not predominant in the higher age brackets.

This data attests to the fact that patients of advanced age are chosen to undergo weight loss procedures only in very select circumstances when surgical risk is outweighed by potential benefits. The proposed restriction policy would remove individualized physician consideration of a patient’s medical best interests. This restrictive policy would disallow the chance for a morbidly obese but relatively healthy 66 year old patient with 4 grandchildren to undergo a procedure that could dramatically improve his or her quality of life by reducing debilitating arthritis, diabetes, sleep apnea, and other major illnesses.

An additional problem with the wordage of the proposal is lack of mention regarding coverage for patients with BMIs of >/= 40 who are free of comorbidities. Based on the 1991 NIH consensus statement, weight-related medical necessity can be defined as BMIs of 35 or more with coexistent weight related comorbidity AND patients with BMI of 40 with or without related illnesses. Your proposal neglects to include this population of patients. BMI >/= 40 carries significant future health risk that exceed the operative risks and therefore coverage needs to be maintained for this population of patients.

I hope this information is helpful in your policy review. If I can be of further assistance please feel free to contact me.

Sincerely,

Jonathan Aranow, M.D., F.A.C.S.

Chairman, American College of Surgeons (CT Chapter), Committee for Bariatric Surgery
Representative CT-ACS, CT Medicare Advisory Committee
Director, Center for Weight Loss Surgery, Middlesex Hospital, Middletown CT

400 Saybrook Rd.
Suite 110
Middletown, CT 06457

860-347-9167
860-347-1630 (fax)
To Whom it May Concern,

I am arguing against the proposed medicare restriction of bariatric procedures to patients over 65 years of age. While I am sure my colleagues have provided you with extensive literature to contest this view, I would like to also provide you with our statewide data here in Connecticut (collected by the Connecticut Hospital Association).

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I am a registered dietitian and I have been working with bariatric patients for almost 3 years now. Our program has close to 1900 bariatric patients. I have the chance to witness daily, the positive change bariatric surgery can have in the life of a morbidly obese person. Daily, I see people transform not only physically but mentally and spiritually. People that are given a second chance in life.

I have been a dietitian for 11 years and not until I started working with this patient population, did I understand the struggles faced by the morbidly obese. The simple things we take for granted, like fitting in a booth or being able to have good hygiene, are a real struggle for these people. And the discrimination they deal with daily.

A year ago, I had an experience with one of our patients, that I will never forget. She was wheelchair bound and weighed well over 400 lbs. Several years back, she had a horrible accident and lost one of her arms.When I was trying to wheel her in from the waiting room to weigh her, the wide wheelchair would not fit through the door. I proceeded to reassure her that she did not need to be weighed, but she wanted to see her weight since most scales do not accommodate up to 600 lbs., as our office scale does. I locked the wheelchair in place and she grabbed the door and door frame to pull herself up. As she strained herself she had an accident - she had a bowel movement.

This was a grown women, who had just had a bowel movement at the waiting area of a doctor's office. I could not imagine the embarrassment she must have felt. I have never felt so bad in my life. I kept on apologizing and was angry at myself for not knowing better.After I weighed her, I took her to the bathroom to clean herself up. The walk to the bathroom, which was just a few feet, make her as out of breath as if she had just ran several miles. I left her in the bathroom and several minutes later realized that once again, I was not thinking. I left this poor woman in the bathroom by herself. A patient her size can usually not reach behind themselves to have adequate hygiene. This poor woman also had only one arm.

Once I realized what I had done, I knocked on the door and offered to help, but she said she was ok. The poor lady sat through the nutrition consult for almost 2 1/2 hours, without having properly cleaned herself. I kept on apologizing and telling her that I was not thinking. And she was sweet enough to tell me not to worry, this happened to her all the time. This was one of the things she dealt with regularly due to her morbid obesity.

Later, I also found out that this woman was the sole caretaker of her elderly sick parents - both bedridden. She cooked for them, bathed them, dressed them. She told me she loved her parents and loved the life they gave her and she has always lived her life being very positive and happy.

I don't think anyone should ever have to feel as this poor woman did that day. These types of experiences should not be an usual part of someone's daily life. This patient is the perfect example of someone who can benefit so much from bariatric surgery. Bariatric surgery has given so many a second chance in life and I hope this will not be taken away from so many others that can benefit the same way.

Thank you for listening.

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I AM QUITE CONCERNED WITH THE DECISION THAT MEDICARE HAS REACHED IN REGARDS TO:

1. BLOCK ACCESS TO PATIENTS 65 Y.O AND OVER;
2. BLOCING ACCESS TO THE TWO-STAGE PROCEDURE.

AT OUR PRACTICE, WE HAVE BEEN PERFORMING WEIGHT LOSS SURGERY SINCE 2002. THE MAJORITY OF OUR PATIENTS ARE YOUNGER THAN 65 Y.O, HOWEVER OUR OLDER PATIENT THAT ARE 65 Y.O AND OVER (OUR OLDEST PT. WAS 67 Y.O) HAVE HAD WEIGHT LOSS SURGERY WITH SAFE AND HEALTHY OUTCOMES. THESE PATIENTS WERE ABLE TO RESUME A BETTER QUALITY OF LIFE WITHOUT THE NEED FOR CERTAIN MEDICATIONS SUCH AS DM, HTN, ABLE TO AMBULATE WITHOUT ASSISTANCE OF A WALKER OR A WHEELCHAIR. TO DENY THESE PATIENTS ACCESS TO PROPER HEALTHCARE AND TO DISCRIMINATE PATIENTS ACCORDING TO AGE IS A CRIME. IN OUR OPINION, EACH PATIENT REGARDLESS OF AGE, NEEDS TO BE CAREFULLY ASSESED AND EVALUATED BEFORE WEIGHT LOSS SURGERY. EACH PATIENT NEEDS TO UNDERGO EXTENSIVE TESTING TO DETERMINE WHETER THAT PERSON IS QUALIFIED TO UNDERGO SURGERY. IN EVERY PATIENT THE BENEFITS NEED TO OUTWEIGH THE RISKS THAT ARE INVOLVED WITH THESE PROCEDURES.

2. AT OUR PRACTICE, WE TAILOR THE SURGICAL PROCEDURES TO ACCOMODATE THE PATIENTS NEEDS. WE HAVE ROUTINELY PERFORMED WTHE LAPAROSCOPIC SLEEVE GASTRECTOMY AS PART OF A TWO-STAGE PROCEDURE FOR HIGH RISK PATIENTS. OUR RESULTS WITH LAP SLEEVE GASTRECTOMY HAVE BEEN EXCELLENT. IN OUR SERIES, THE AVERAGE WEIGHT LOSS FOR THESE PATIENTS IS AS FOLLOWING: 3 MONTHS POST OP:50 LBS, 6 MONTHS POST OP: 90-100LBS, 1 YEAR POST OP: 150-165 LBS. THE NEED FOR A CONVERSION TO A SECOND PROCEDURE IS CAREFULLY ASSESSED. THE RESULTS IN OUR PATIENTS HAVE BEEN GREAT. WE HAVE NOTED CONTINUED WEIGHT LOSS EVEN AFTER 1.5 YEARS WITHOUT THE NEED TO CONVERT TO A SECOND PROCEDURE. LAP SLEEVE GASTRECTOMY IS A PURELY RESTRICTIVE PROCEDURE AND MOST PHYSIOLOGICAL. THERE IS A NEED TO FURTHER INVESTIGATE THIS PROCEDURE AS A POSSIBLE PRIMARY PROCEDURE FOR THE TREATMENT OF MORBID OBESITY.

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I feel very strongly that limiting the age a person can be for a gastric bypass surgery goes against all common sense and rights of the people. What will be next, that persons over a certain age should not be allowed to have surgeries for cancer or heart bypass and on and on? The facts that gastric bypass surgery can improve health and lengthen the life are only two of many reasons it should be approved no matter what the age of a person. The doctor is the one to decide if the person it a candidate for any surgery and not the government.I feel the type of surgery to be performed should be decided by the patient and the doctor.I am 66 years old with 5 children, 15 grand children and 8 great grandchildren. I want to be around for a while longer to enjoy my family and I want to do it in good health. Please consider this action carefully as you will be robbing many people of a longer, healthier life if this action is passed. Thank you

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Sirs, As a surgeon actively participating in the care of morbidly obese patients, I am pleased that you are working to engage this topic in a careful and scientific way.

I request that you give additional consideration to the non-coverage position proposed for beneficiaries of age greater than 65 years. The medical literature demonstrates that Weight Loss surgery can be a safe and effective option for people older than 65 years, especially if the surgery is performed in a high-volume center by a high-volume surgeon.

I would support extension of the surgeon/center volume requirements to the entire medicare population - the medical literature and my own experience support the idea that surgeons and centers who concentrate on bariatric surgery are able to achieve better outcomes, including better safety.

Thank you,
John Pilcher, MD
San Antonio

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Bariatric surgeries in their many varieties (but most specifically, the BPD/DS - by far the most successful surgery for establishing and maintainint a normal body mass index) are and will be saving the medical industry MILLIONS - if not billions - of dollars in the treatment of obesity-related illnesses. Treatment of the comorbidities of obesity such as diabetes, insulin resistance, sleep apnea, hypertention, high cholesterol, heart disease, vascular conditions, congestive heart failure, polycystic ovary syndrome, and infertility (only to name a small FEW) is essentially ELIMINATED once a patient is able to achieve and maintain a normal and healthy BMI with the assistance of weight loss surgery. The initial cost of the surgery should be considered a deductible paid to ensure the HEALTH of your patients (so that they, in the long run, will save you money by using fewer of your resources to treat their long-term obesity related comorbidities). It's a win-win situation - your patients get their health, you keep more money in the long run. Consider yourselves blessed to have the chance to continue to pay for these life-saving surgeries.

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I think the approach CMS is taking on this coverage isssue is in the right direction. I would advise that CMS engage the american society of bariatric surgery as a facility and surgeon quality approval organization, including credentialling. I agree w/ the use of CED but would like to see a shorter trial period vs. historically long adoption periods, particularly given the standing history of bariatric surgery and the data available.

Lastly, I would adhore that CMS provide the necessary level of reimbursement for this costly procedure and use outcome measurements as a way to further reward organizations/surgeons for continuing good outcomes and best practices.

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I feel it is unfair for insurance companies to dictate what surgery someone should have. There are many downfalls to the RNY and the band. For some people, especially morbidly obese people the BPD/DS is their last resort. It has the highest weight loss percentage and when people follow the guidelines for living with the BPD/DS they have longer, healthier lives. It cures most diabetes and other comorbitities and I don't understand why it isn't realized that this saves the insurance companies MUCH money over time. People who are morbidly obese live on medications and Doctor's visits. Please review your decision and give so many people the chance of life!

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Dr. Anthone of Nebraska, Dr. Peter Crookes of California, Dr. McConnell of Oregon, Dr. Gagner of New York, and many other surgeons (50 or more) in the United States that perform the Duodenal Switch MUST be contacted BEFORE such a decision to EXCLUDE THEIR SPECIALTIES are withdrawn from Medicare coverage.

Have these surgeons been contacted? Are they aware of this heinous crime against the super morbidly obese? (Not being able to received their treatment/surgery of choice?)

Obesity is a DISEASE. Not unlike CANCER. It is a METABOLIC, HORMONAL-based disease, and should be treated with CARE - the people who have this DISEASE should be treated with CARE and the UTMOST RESPECT. I don't believe Medicare is able to gauge the outcomes of the BPD/DS procedure against the lap band or RNY adequately.

I would like to call for a reconsideration - INCLUDE THE BPD/DS FOR SUPER SUPER MORBIDLY OBESE PEOPLE (PEOPLE OVER 350 POUNDS). IT IS OUR ONLY HOPE!!!!!

Thank you,
Anne Stein

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I welcome the new NCD. I have the following concerns.Coverage for those 65 and over I know of many patients who are older than 65 and have done very well with weight loss surgery. I believe in experienced hands, people older than 65 have very good results with weight loss surgery. It is a fact that morbid obesity in patients older than 65, like other age groups does not have any other effective treatment. Denying weight loss surgery to those patients is akin to death sentence as they have no other option. Therefore I strongly suggest that CMS restore weight loss surgery authorizations for people older than 65.

Two-stage procedures for high risk patients Some patients are too high risk for a one stage weight loss surgery and by staging the operation, the risks of surgery can be brought down significantly. Therefore two stage procedures should be allowed for certain extremely high risk situations.BPD/DS There is plenty of data showing the efficacy of BPD/DS procedures and low risk of complications. Therefore patients should be allowed to have these procedures as treatment for morbid obesity.

Coverage for adjustable band procedures that need to be converted to the open approach.

No mandate for failed diet within the year preceding surgery

None of the studies have shown that non surgical means of weight loss are effective in morbidly obese patients. Therefore patients should not be subjected to the torture of another weight loss attempt that is likely to work in only 2-5 percent of the patients.

Coverage for long-term care beyond the 90-day postoperative period

Patients care beyond the 90 day period after surgery is very important to prevent any complications and treat them promptly. Therefore patients should be covered for their care beyond the 90 day period.

Here are some of the articles to support my arguments.

Courcoulas A, Schuchert M, Gatti G, Luketich J. The relationship between surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery 2003; 134:613-621. Nguyen NT, Paya M, Stevens CM, Mavandadi S, Zainabadi K, Wilson SE. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg 2004; 240:586-593. Flum DR, Salem L, Elrod JAB, Dellinger EP, Cheadle A, Chan L. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA 2005; 294:1903-1908. Sugerman HJ, DeMaria EJ, Kellum JM, Sugerman EL, Meador JG, Wolfe LG. Effects of bariatric surgery in older patients. Ann Surg 2004; 240:243-247. Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R.Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392. Marceau P, Hould FS, Simard S, et al. Biliopancreatic diversion with duodenal switch. World J Surg 1998; 22:947-954. Hess DS, Hess DW. Biliopancreatic diversion with a duodenal switch. Obes Surg 1998; 8:267-282 Kral JG, Thung SN, Biron S, et al. Effects of surgical treatment of the metabolic syndrome on liver fibrosis and cirrhosis. Surgery 2004; 135:48-58. Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg 2003; 13:861-864. Nguyen NT, Longoria M, Gelfand DV, Sabio A, Wilson SE. Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the super-obese with massively enlarged liver. Obes Surg 2005; 15:1077-1081.

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I am very upset with your decision with the BPD/DS surgery. This surgery is one of the best out there. If you do your research properly you would see that this is the best surgery to go for. It has the best success rates. This would eliminate any further costs down the road as well. Sometimes I wonder about you people. You'll pay thousands of dollars for 3 to 5 surgeries for the same thing but when you can pay once for something and be done you take that away. INSANE! I think you need to go back and look at your decision, do the proper research and then allow the BPD/DS surgery to be allowed. The government is supposed to help people; not ruin them. Please take this into serious consideration!!!!!

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While I agree to limit bariatric surgery to those under 65, I am quite concerned about patients being evaluated pre-operatively by only psychiatrists. These patients are highly motivated to have surgery, if not too highly motivated. None of them freely admit to eating disorder-type behaviors or other problems that could jeapordize their preoperative psychological evaluation recommendations. Only psychologists are trained in the administration and interpretaion of various tests and measures that can get past this very dangerous possibility. Furthermore, psychologists are much more thoroughly trained for conducting objective measures of treatment response and outcome in terms of the major psychological aspects of obesity. Thank you.

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As I understand it bariatric pre-surgery psychiatric evaluations are going to be required by "staff and consultants in psychiatry," which does not include psychologists. Psychologists are extremely qualified to conducted these evaluations and it would do a dis-service to Medicare beneficiaries to be denied access to their expertise. Psychologists who conducted these evaluations are quite skilled in performing evidenced-based evaluations and incorporating multi-faceted data such as is required in psychosocial/psychiatric evaluations. I strongly urge you to consider including psychologists in the guidelines for professionals qualified to perform these evaluations. Thank you.

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"Each institution will have staff and readily available consultants in cardiology, pulmonology, rehabilitation and psychiatry who have prior experience with bariatric surgery patients."

I believe that the "psychiatry" requirement should instead be a requirement for consultants in behavioral health who have prior experience with bariatric surgery patients.

By restricting the consultant field to psychiatry instead of all the behavioral health professions, the proposal specifically eliminates psychologists, whose empirical testing of patients prior to surgery provides objective, empirical data on which to base decisions about a patient's ability to comply with the demands of surgery and post-surgical behavior change.

Clinical psychologists are recognized independent Medicare providers whose contributions to the field of evaluation of potential bariatric surgery extensive and should not be excluded by omission.

Ref: Obes Surg. 2003 Dec;13(6):926-31. Bariatric surgery and bariatric psychology: general overview and the Dutch approach.

Van Hout GC, Leibbrandt AJ, Jakimowicz JJ, Smulders JF, Schoon EJ, Van Spreeuwel JP, Van Heck GL.

See also: NATIONAL INSTITUTES OF HEALTH NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES WORKING GROUP ON BARIATRIC SURGERY May 8-9, 2002 Executive Summary

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To Whom It May Concern;
We created a bariatric program and began performing bariatric procedures in June 2001. Our experience with clients over the age of 65 has been excellent. It would be unfortunate if treatment for morbid obesity was denied to clients over the age of 65 based on one research paper. The JAMA article you refer to does not represent data from an ASBS Bariatric Surgery Center of Excellence (COE). An ASBS COE represents surgeons who maintain high volumes, out standing surgical outcomes and close follow-up. When this level of care is provided, laparoscopic bariatric surgery is safe and effective compared to the higher risk of untreated morbid obesity. Please refer to our published paper in the July issue of the Wisconsin Medical Journal http://www.wisconsinmedicalsociety.org.

Sincerely,
David J. Engstrand MD
Manfred C. Chiang MD
James W. Burhop MD
Bobby Wu MD
Megan O’Driscoll, RN
Bariatric Institute of Wisconsin
ASBS Bariatric Surgery Center of Excellence
22370 Bluemound Road Suite 102
Waukesha, WI 53186
262-522-8300
www.bariatricwi.com

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As a dedicated laparoscopic bariatric surgeon, I have provided surgical intervention for patients with morbid obesity to achieve weight loss, over the past 4 years. During this time, I have provided service to 15 patients over the age of 65, and to over 100 Medicare/Medicaid beneficiaries of all ages. We are proud of our record of ZERO mortalities during this time, as well as successful weight reduction (>65% of excess weight) in >75% of patients, with no patient failing to lose < 50% of excess weight, and dramatic improvement in comorbidities, including 85% cure rate of diabetes, and 75% cure, and 20% improvement, rate in high blood pressure. Laparoscopic sleeve gastroplasty is a valuable adjunct procedure for certain patients with extremely high Body Mass Index or massive hepatomegaly, or both, for whom initial bypass may be high-risk, but in a second stage provides a high likelihood of successful completion laparoscopically, with short stay, safe recovery, and dramatic weight loss. Currently the medical community of the U.S. has no alternative for weight loss for patients over the age of 65, and until a medical solution that provides reliable results comparable to surgery arises, it seems entirely unfair to patients to arbitrarily draw a line at age 65 barring patients from life-saving, life-improving, and life-extending surgery. Concerns regarding risks of morbidity/mortality from these procedures are not misguided, and I continue to urge patients to seek out surgical options at center that 1)perform at least 150 procedures per year, 2)offer more than one surgical option, so patients can maximize their options, and 3)have a demonstrated record of efficacy in line with, or better than, nationally-published averages. I would urge CMS to allow us to continue to provide this benefit to patients who meet appropriate screening criteria, to allow surgical intervention for >age 65, with consideration for two-stage laparoscopic procedures on an individual basis where BMI or massive hepatomegaly is a factor in the surgical decision. I would further encourage CMS to support providing this benefit preferentially at centers with a demonstrated high volume and level of excellence to safely intervene on behalf of Medicare/Medicaid beneficiaries. Your consideration is greatly appreciated.

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Dear Dr. McClellan:

This letter is in response to the Medicare news release about coverage for bariatric surgery procedures.

For the past 30 years I have been involved with the medical management of morbidly obese patients before and after bariatric surgery. It is very clear that this radical approach is effective and rational only in a small percentage of patients with grade IV & III obesity. Even in these categories patients should be excluded if they have a history of poor medical follow through or co-morbidities that make the surgical risk unacceptably high. Examples would be ventilator dependency, recent cardiac ischemic injury or a high risk of pulmonary embolism.

In February 2004 at the Clinical Nutrition week the opening speaker was Dr. Henry Buchwald, Professor of Surgery from the University of Minnesota. He gave an excellent presentation on the outcome of bariatric surgery in his large program. In closing he mentioned the reluctance of several insurance companies to cover this potentially very beneficial procedure. To many members of his audience the obvious answer was insurance companies must be seeing poorer overall outcome as described by Dr. Flum.

I think Medicare and other 3rd party payers would do all of us a tremendous service if they developed criteria for which sites can safely do this surgery, just as they have for organ transplant procedures. It is very difficult for the American College of Surgery to police this issue – and yet policing is urgently needed, especially with the complex laparoscopic procedures where there is a steep learning curve.

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WOW.... I am so disappointed! Some of these comments are obviously coming from uneducated and uninformed individuals. How can anybody want to deny a person the opportunity to improve the quality of there live and have the chance to see there children and grandchildren grow? I am an exercise physiologist and have never had a weight issue, but for those who struggle with morbid obesity day in and day out, my heart aches for you. Why not allow an individual to make an informed decision? I have worked with many moridly obese patients surgically and non-surgically. One thing I can say for post-op patients is they have a new zest for life. Sure, there are risks and complications as with any surgical procedure not to mention this is a higher risk population in general. Give these patients more credit! They research the heck out of the possibilities and understand there is always a possibility of death, although the percentage is very low. This is by far, NOT and I reiterate NOT the easy way out or a quick fix! This is truly a lifelong behavioral committment one is making when they choose surgery as an option. When a person can't volunteer with their child at school b/c there aren't any chairs large enough for them to sit, and their child cries and wants to know why? What do you tell them? The emotional side of this disease for many is unbearable not to mention the medical conditions which are fully exacerbated by morbid obesity. Surgery for morbid obesity truly has the potential to give back life to those who desperately want it and have tried all means of losing excess weight. The NIH states less than 4% of morbidly obese patients can lose excess weight long-term with non-surgical methods. What kind of hope is that for a patient? We'd all like to think we can beat the odds, but truly less than 4% is going to. Would anybody want to gamble with those odds?..... I am not suggesting that surgery is the answer for every morbidly obese person. What I am saying is, surgery may be the only hope a person has for a chance to live a happier life! Obviously, the pre-screening process needs to be done thoroughly and the education needs to be extensive for every single patient.

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I am a bariatric/general surgeon. I completed a fellowship in laparoscopy and bariatrics and performed 170 Lap RYGB in my fellowship. However, in my first year of practice I have done
less than 50 cases.

I am opposed to the following CMS criteria:

1) Volume criteria. There are many fellowship trained bariatric surgeons who are well trained in the procedure, however, it can take several years to establish a moderate-high volume program. Limiting coverage to surgeons with more than 50 cases/year discriminates against yuonger surgeons who are establishing bariatric programs.

2. 2 stage procedure: This is done in high risk patients and although it involves 2 procedures, it has an overall lower risk (i.e shorter LOS,less morbidity and mortality). Forcing surgeons to offer only one stage procedures on high risk medicare patients is wrong and compromises their safety.

3. Open adjustable gastric banding: If a patient is approved for lap banding and needs to be converted is it covered? If not, this would be unprecendented. What other procedure is not covered if the surgeon has to convert for the patient's safety?

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I am a bariatric surgeon who has performed over 1000 bariatric surgeries. I have done dozens of gastric bypasses on people 65 years or older. Because of Medicare's poor reimbursement, I do not perform these surgeries for profit. I do it because it helps these people. My results in patients over 65 have been excellent, with very low complications and no mortalities. It is unfortunate that CMS wants to discontinue coverage for these patients based on ONE study(Flum et. al.). Other studies such as those by McSwain et. al (Mayo Clinic) and Sugarman et. al. have been very positive. If CMS would rather let these patients stay morbidly obese and pay for diabetes medications, antihypertensives, CPAP, dialysis, coronary artery bypasses with sternal wound infections and leg wound dehiscense, venous stasis ulcers, Scooters, decubitus ulcers, tracheostomies, colostomies, peri-rectal abscesses, skin infections, knee replacements, hip replacements; GO AHEAD.

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Cardiac 'centers of excellence' offers cardiac patients both medical and surgical therapy solutions. Bariatric 'centers of excellence' offer only surgical solutions. Should it come as any surprise that every patient who enters a bariatric 'center of excellence' has surgery?

This one solution fits all approach is not a solution at all. What we are telling overweight patients is that we will offer them care only if they reach 100 pounds of excessive weight and develop comorbid conditions. Is this the message we want the overweight (64% of Americans) poplulation to hear?

In 2001 the FDA approved the LapBand, let's look at the 5 year outcome data next year to determine if appropriate follow up care is offered. The numbers won't lie, I expect to see disappointing outcome data due to inadequate long-term care. Why is the outcome data some much better in the Australian data? They offer long-term follow up care, which is not being offered to American patients. Bariatric surgery is not a cure for obesity, this is not a disease of the stomach.

Bariatric surgery when used in conjunction with a comprehensive long-term postoperative care program represents the best therapy available today. Bariatric surgery should be restricted to those centers where long-term follow up care is offered and documented.

I recommend that before you spend thousands of dollars per patient and millions of dollars per year on surgical procedures with questionable long-term outcomes you consider requiring long-term outcome data from each and every center that intends to do business with CMS.

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There clearly should be coverage for medicare patients less than 65 years old. These often are patients that are disabled due to their obesity and often can be gainfully employed after weight loss surgery. This expanded tax base should be an incentive to offer coverage.

Making morbidly obese patients prove once again that they cannot control their weight problem before they can undergo definitive treatment with weight loss surgery is needlessly delaying their treatment. Non-surgical weight loss programs even when supervised by physicians simply do not work in the morbidly obese population. Wasting time and money to prove failure before surgery is inefficient. Therefore one year or six month diets should not be a prerequisite for coverage for bariatric surgery.

Lastly, although bariatric surgery in patients over 65 years of age does carry higher morbidity and mortality than for younger patients, the benefits are worth it. The risks/benefits ratio is in favor of bariatric surgery when compared to medical management. Resolution of diabetes, dyslipedimia, sleep apnea and hypertension have been well documented in older patients undergoing bariatric surgery (1).

We do not deny transplants, joint replacement surgery or cardiac surgery arbitrarily to older patients because their risks are higher than younger patients. Coverage should be available and risk/benefit decisions should be individualized. Not all older morbidly obese patients should have bariatric surgery, but not all should have a blanket denial.

Centers of Excellence as determined by the ASBS, the American College of Surgeons, or Medicare should be able to provide this life saving procedure to appropriate older patiens.

1) Sosa JL, Pombo H, Pallavicini H, et al. Laparosocopic gastric bypass beyond age 60. Obes Surg 2004; 14:1398-1401.

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California Medicare Part B (NHIC) revised its Bariatric Surgery LCD in 2005. We did not consider restrictions over age 65 because (a) most beneficiaries were under 65 and (b) we were unaware of much precedent for cutting off services by age (e.g. implantable cardiac defibrillators over 80,etc) as evidence becomes more thin. We felt that higher risks in older patients should raise the bar for very careful consideration of risks/benefits but it is difficult to regulate every nuance of such patient/provider decisions. For example, Medicare patients may receive toxic chemotherapy with high risks and uncertain (probabilistic) benefit and the same logic may apply to bariatric surgery in terms of high risks and high perceived net benefits when successful. We initially required "prior medical treatment" which failed, as the new NCD now proposes, but concurred with comments that there was little definitive data in controlled studies that this was an impactful factor in outcome. in the absence of such controlled clear studies poorly defined "prior medical treatment" was a red herring, delay, and unjustified expense (that is, not reasonable and necessary for care). It seemed incongruous to require an unproven treatment that was noncovered. In terms of site-based certification, as a carrier we did not have authority to create that. However, we and our commenters recognized the general concern that a mere surgical fee alone (with a 90 day global period) which was regulated by our LCD could fall well short of a comprehensive team management approach of this disorder.

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I think this is a very short sighted decision. The benefits of obesity care in the over 65 aged population have been documented in the literature by Quebbemann et al. and are known to me personally through experiences in my own practice. There is NO QUESTION that obesity treatment RADICALLY changes medical issues for this group and improves quality of life. I can understand the decision of private- for profit- insureres denying coverage based on greed. How can medicare ignore the data? It has been shown that the cost savingsafter obesity surgery are recouped in approximately 3 years. The other insurers ignore this hoping the insureds will change plans or companies in that time. What's medicare's excuse? Sure seems like a waste of the taxpayer's money whether the medicare based prescription plan is in place or not. This issues needs to be reconsidered. sincerely, Nicholas A Bertha DO,FACS, Florham Park,NJ

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As the senior author on the only published paper regarding patients greater than 65 undergoing bariatric surgery, I would like to offer my insight.

We established that in expert hands (fellowship trained surgeons, or surgeons who have performed a significant number of operations) that the morbidity and mortality of bariatric surgery is no different in patients greater than 65 relative to the younger patients. The study by Dr Flum includes many surgeons whose experience is less than adequate. I do disagree then limitations placed such that procedures on medicare patients be performed by surgeons that have an established record of excellence.

To limit bariatric surgery to patients younger than 65 is not a viable solution to those elderly patients whose lives can be so changed by massive weight loss.

Personally, I believe that all bariatric surgery should be limited by those surgeons who have either demonstrated acceptable complication rates, or who have demontrated advanced training through 1-year bariatric surgery fellowships.

Medicare should punish the surgeons, not the patients for complication rates.

Furthermore, I have well established the overwhelmingly poor results of the Lap-Band procedure in the elderly patients. The gastric bypass, when performed correctly, has the best outcome in regard to quality of life, change in medications, change in medical conditions and overall health.

Please see the article below for more information.

Quebbemann B, Engstrom D, Siegfried T, Garner K, Dallal R. Bariatric surgery in patients older than 65 years is safe and effective. Surg Obes Relat Dis 2005; 1:389-392.

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Based on Department of Labor Statistics on Consumer Expenditures in 2001, the annual average cost of being obese was over $15,000 per patient. Medication costs, out of pocket health care expenses, and co-pays for medication are about half of this figure. If we expect that patients will require surgical procedures for the co-morbid conditions of obesity including gastroesophageal reflux disease, arthritis with need for total joint replacement, urinary incontinence and others all of which Medicare will pay for then it makes good economic sense in the long run to provide for a procedure that will remove the need for subsequent surgical procedures. With a cure rate of over 66% within one year of surgery for type II diabetes and cures of a large number of other conditions such as hypertension, hypercholesterolemia, hypertriglyceridemia, gastroesophageal reflux disease, sleep apnea and asthma, the cost savings from getting patients off medication is also astounding. I have personally had patients who have had annual medication bills running as high as $10,000.

Regarding the performance of bariatric surgery in patients under the age of 65 only, I have two observations. One observation is that Medicare patients who are under the age of 65 are frequently disabled because of their weight and co-morbid illnesses and are arguably at much higher risk for surgery than are patients over the age of 65 who meet criteria for bariatric surgery but are relatively healthy. Most studies that separate patients by age and stratify risk by co-morbid illnesses for specific operations find that, once adjusted for other risk factors, age alone is not a risk factor for operation. Furthermore, those patients who are most at risk and most disabled are frequently those that would be expected to benefit the most from bariatric operations. My other observation is that the lap-band system makes surgery more reasonable for the truly high risk patients. The overall risk of morbidity and mortality for the lap-band operation is about one-tenth that of gastric bypass. Therefore, it would seem to me that the lap-band system should be offered to all beneficiaries. As an ASBS member and a Fellow of the American College of Surgeons, I support the performance of bariatric surgery by surgeons who are experienced in these procedures and in centers where such operations can be done safely. We have many accrediting bodies breathing down our necks at all levels. I support the ASBS Centers of Excellence program primarily. However, I think that ASBS or ACS accreditation should be sufficient for accreditation of a center and its surgeons. Doing both programs is expensive and redundant; doing another accreditation program is also redundant.

I think that it is important that CMS realizes what a benefit bariatric surgery can be to a large number of Medicare beneficiaries. It is also important for CMS to realize what a problem obesity is in the United States and how expensive the treatment of this disease can be. Approximately $238 billion is expended annually for the treatment of obese patients and about half of this comes from government resources. The NIH Consensus Conference of 1991 made the statement that surgical treatment of obesity was the only way to achieve long lasting control of this disease and that surgery was indicated in patients who had been unable to sustain weight loss by dieting and who had a BMI over 40 or a BMI of > 35 with at least one obesity related disease (such as diabetes, hypertension, GERD, etc.). Long term cost savings would be enormous for the government and for private payors as well.

Finally, CMS needs to be careful in how it reimburses for bariatric surgery. Almost all of the private insurance companies pay based on Medicare reimbursement rates. Malpractice coverage for bariatric surgery can be very expensive I paid $162,000 for coverage last year and this is not the highest premium I know about. My office overhead continues to increase annually. It will soon be impossible to find general surgeons who are willing to train to do bariatric surgery and come into private practice to care for these patients. This is based on economic concerns: the average educational debt of a graduating medical student is over $100,000 (American Association of Medical Colleges website) and reimbursements are too low all around to attract talent into this area. The are approximately 15 Million morbidly obese patients in the U.S.; the number of surgeons we have cannot take care of them all even if we all operated night and day. Medicare reimbursement for operations I do now in 2005 is about one third (accounting for inflation) of what it was when I first came into practice in 1988. We can't stay in business doing operations for this sort of reimbursement, that is why my partner opted out of Medicare completely several months ago. We're better off just doing the few Medicare beneficiaries who can pay cash and getting rid of all the bureaucratic hassles and oversight that come with being Medicare providers. If Medicare comes out with a reasonable fee schedule for bariatric surgery and starts paying us [at least] the cost of doing business for doing business as general surgeons, we will be willing to study the options and sign up again within two years. Otherwise Medicaid appears to be the next payor which we will eliminate from our list. Private payors we'll deal with on a case-by-case basis, but, remember, the fees that Medicare sets will determine how the private payors will reimburse as well.

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As a Registered Dietitian, I am very disappointed that Medicare is even considering approving bariatric surgery for pt. under 65. The health risks associated with the surgery are tremendous, not to mention the procedure is extremenly expensive. I counsel pt. everyday on how to lose wt. I have people that have lost over 100 pounds and significantly improved their health and have been able to eliminate serveral of the medications they were on. I give them the tools and the support and guidance and the pt. can do it once they set their mind on losing wt. Too many people want the quick fix and I don't appreciate the government giving it to them. With the proper guidance Americans can lose wt. without costly and dangerous life changing surgery. Where is Medicare's support for Medical Nutrition Therapy? Having patients work one-on-one with a Registered Dietitians is a much better use of the tax payers money. Dietitians can customize meals, exercise routines, and behavior modification for the obese individuals of this country. here is the legislative proposals to increase Medical Nutrition Therapy benefits? I would be glad to answer any questions you have with regards to how dietitians can help with the obesity epidemic not bariatric surgery. Thank you for your time.

Susan Delagrange, RD,CD

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The credentialing guidelines suggested to approve centers and surgeons to perform bariatric surgery are very well established by the ASBS-SRC Centers of Excellence and Medicare should use this as their accrediting body. The SRC is well underway, establishing centers of excellence, with more than 1000 applicants, site vists, and a well established review committee of well-recognized bariatric surgeons. Creating a different body, will just duplicate work, expenses, and paperwork for everybody.

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I speak only for myself. I have been involved with bariatric surgery for the last 5 years. I have seen many patients over the age of 65 present with unrealistic expectations and poor outcomes. While a few may benefit from Gastric Bypass the majority have no significant benefit and they are all at increased risk of mortality. I agree with the age-limited coverage as a broad representation of overall poor physical status as a patient.I also agree with the limitation on BPD and DS. We have had too many GI cripples and too many complications from outside surgery. The patients who sign up for BPD don't realize they may end up a quadriplegic from their deficiencies.

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This new National Coverage Determination (NCD) is a major improvement for the care of the morbidly obese Medicare patient. Prior to this, the availability of the surgery varied from region to region and the provider could not be assured of reimbursement until after the procedure was performed and the charges submitted.

The American Society for Bariatric Surgery (ASBS),who requested this NCD, agrees with CMS thatMedicare patients should undergo their surgery athigh quality surgical centers with appropriatecenter and surgeon volumes. This should requireeach Center to perform ≥ 125 cases annually whereeach surgeon performs ≥ 50 procedures/year and hasdone ≥ 125 procedures in their past and where theprocedures and facilities are designed to provideoptimal care. Several studies support these volumerequirements (1,2). Any numbers less than thisrisks inadequate care and increased mortality inthe high-risk, disabled Medicare population. Webelieve that this will be best provided at abariatric surgery Center of Excellence (COE) asdesignated by the ASBS. There are currently over510 Centers with 904 surgeons who have applied for“Provisional Approval” as a COE to the SurgicalReview Corporation (SRC) on contract to the ASBS;166 Centers with 331 surgeons have paid and 132centers with 305 surgeons have completed theirapplications for “Full Approval”. Site inspectionshave been completed for 110 centers; 49 COE havebeen approved and are posted on the SRC website:www.surgicalreview.org and more are being addedeach week.

We are concerned that the NCD as currently writtenblocks access for the surgery to those ≥ 65 yearsof age. Although the recent Flum et al study (3)noted a high (6.9%) 30-day mortality rate amongstthis group of patients, the 30-day mortality ratewas 1.1% in those centers where relatively largenumber of Medicare patients had undergone thesurgery. This is consistent with two studies (19patients ≥ 65 years of age in the study bySugerman et al.) with a very low mortality inpatients ≥ 65 years of age.(4,5) Since only about200 bariatric surgical procedures are performedannually in this age-group in the entire UnitedStates with only a few procedures (1 to 5)performed at each center, a practical solutionwould be to limit the surgery to ASBS COEs whichrequire significant surgical volumes and aretherefore likely to provide the improved mortalitynoted in Flum et al’s study. These Centers arerequired as a component of their approval statusto submit outcomes data annually which will bevalidated with a site inspections every 3 years.The data for those ≥ 65 could then be assessed onan annual basis to provide Coverage with EvidenceDevelopment (CED). There are currently 50,000patients in this Surgical Review Corporation datapool.

Patients ≥ 65 should be given the option ofchoosing surgery with a thorough preoperativerisk:benefit discussion in a validated Center ofExcellence. Had this not been available, patientssuch as Robert Stratiff, who presented to theMedicare Coverage Advisory Committee (MCAC) inNovember, 2004 and who were incapacitated by theirsevere obesity, would not have the been able toreceive the benefits of bariatric surgery. Mr.Stratiff had his surgery when he was 69 years old.He had been a US Army jet and helicopter pilotand had become severely disabled in his retirementfrom morbid obesity complicated by sleep apnea,venous stasis and severe joint disease. He is now73, no longer obese, without sleep apnea or venousstasis disease, has had knee replacement surgery,and is walking several miles daily with arehabilitated life. Patients ≥ 65 have the optionto undergo elective coronary artery bypass, jointreplacement, peripheral vascular surgery withequivalent morbidity and mortality; it isdiscriminatory to block access to bariatricsurgery for this age group.

We also suggest that non-approval of access tothe biliopancreatic diversion with duodenal switch(BPD/DS) procedure (using an open or laparoscopicapproach) should be reconsidered. This procedurehas also had strongly supportive single casesseries.(6-8) It would be better to develop a CEDfor the BPD/DS comparing this operation in arandomized, controlled study (RCT) to a standardor long-limb gastric bypass in superobese (BMI ≥50 kg/m2) patients to determine if it, in fact,produces a greater weight loss than the gastricbypass with equivalent risk which is morelong-lasting, as its proponents contend or at theleast to allow it at Centers of Excellencededicated to this operation and collect data onthe procedure.

The option of open adjustable banding should beallowed for ‘as needed’ conversions to the openfrom the laparoscopic approach, such as forbleeding from an avulsed short gastric artery,inadequate laparoscopic visualization, etc.

We believe it is very important for CMS to supportthe two-stage approach for extremely high-riskpatients as are often found within the Medicarepopulation, many of whom are severely disabled asa consequence of their morbid obesity, with thePickwickian syndrome, severe venous stasis diseaseor congestive heart failure. This entails a“sleeve gastrectomy” (9,10) which can be performedrather quickly using a laparoscopic technique andwhich can be followed by the more definitiveprocedure (gastric bypass or BPD/DS) afterpatients have lost significant amounts of weightand their surgical risk is significantly reduced.

It is important that the requirement for medicalmanagement of obesity be for a 6 month period atsome time in the past and it not be mandated to bewithin the year preceding surgery. There are nodata to support such a mandate; in fact, in arecent paper patients for whom this was requiredhad no better weight loss than those for whom itwas not required and there was a greater rate ofpatient drop-out for surgery.(11)

Finally, we support the requirement for ancillaryservices for the care of bariatric surgerypatients and believe it will be important forMedicare to cover these services (e.g. dietarymanagement, physician visits, exercise training,etc.) beyond the 90-day post-operative period.

1. Courcoulas A, Schuchert M, Gatti G, Luketich J.The relationship between surgeon and hospitalvolume to outcome after gastric bypass surgery inPennsylvania: a 3-year summary. Surgery 2003;134:613-621.
2. Nguyen NT, Paya M, Stevens CM, Mavandadi S,Zainabadi K, Wilson SE. The relationship betweenhospital volume and outcome in bariatric surgeryat academic medical centers. Ann Surg 2004;240:586-593.
3. Flum DR, Salem L, Elrod JAB, Dellinger EP,Cheadle A, Chan L. Early mortality among Medicarebeneficiaries undergoing bariatric surgicalprocedures. JAMA 2005; 294:1903-1908.
4. Sugerman HJ, DeMaria EJ, Kellum JM, SugermanEL, Meador JG, Wolfe LG. Effects of bariatricsurgery in older patients. Ann Surg 2004; 240:243-247.
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11. Jamal MK, DeMaria EJ, Johnson JM, et al.Insurance mandated pre-operative dietarycounseling does not improve outcome and increasesdrop-out rates in patients considering gastricbypass surgery for morbid obesity. Surg Obes RelatDis 2006 (in press).

Harvey J. Sugerman, MD
Immediate Past President
American Society for Bariatric Surgery

Neil Hutcher, MD
President
American Society for Bariatric Surgery

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First, I feel that the criteria that a patient needs to meet in order to be covered for bariatric surgery under Medicare should be stricter, especially for the elderly. Surgical risks increase with age, and surgery such as bariatric surgery should only be performed on extreme cases.

Specifically, based on my experience as an actuarial health consultant and co-author of a research report regarding the costs and benefits of obesity and bariatric surgery, I feel that a person should have a BMI of at least 40, and be at least 100 pounds overweight. The related co-morbidity needs to be serious (i.e. hypertension), and they should have attempted at least 2 weight loss programs supervised by a physician prior to applying for bariatric surgery.

CMS should make clearer what exactly will be covered relating to bariatric surgery. For instance, will initial meetings with surgeons be covered? Follow-up meetings? What if nutritional supplements are needed post-surgery? What about abdominoplasty surgery post-surgery to remove excess skin and fat folds?

Additionally, CMS should be aware that the jury is still out on the long-term implications of the surgery. For instance, do overall total medical costs decline for bariatric surgery patients in the years following bariatric surgery? CMS should take a good, hard look at this question.

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I do not believe this surgery benefit should be allowed under Medicare to anyone unless they are physically unable to diet and exercise. Morbid obesity is a personal responsibility, and should not be paid for by taxpayers.

However, senior citizens eligible for Medicare should NOT be denied bariatric surgery coverage just because of their age. This is discriminatory to people over 65 years of age. Although the risks may be higher to some in this age group, the surgery should not be denied to all. This is a decision the attending physician should make.

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I am not morbidly obese, nor am I elderly...yet. But I object to the idea of denying bariatric coverage to anyone based solely on their age. If they are at immediate risk of death during surgery due to known medical issues, it is the patient and physician's call whether to operate. Just because someone might die within a year does not seem a valid reason for denial. It seems to me that for the morbidly obese a bariatric procedure is a life-saving, life-extending surgery, regardless of age. If there were other viable options bariatric surgery wouldn't be so popular, or necessary. But, as we have seen historically, simply telling people to "Eat less, eat right, and exercise more" is not working anymore than Nancy Reagan's "Just Say No" campaign worked against drug abuse. I urge you to reconsider the current proposal. Thank you.

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Our study in JAMA reporting mortality rates in Medicare beneficiaries was cited in CMS' decision to not cover bariatric surgery in patients 65 and older. That study also revealed that surgeons with higher levels of experience were able to provide similar outcomes in young and older Medicare beneficiaries. Given that the increased risk of the procedure among older patients seems to be the reason for the NCD it only seems appropriate that these procedures are covered in older patients when that risk is lowered by directing care to experienced surgeons.

I suggest CMS cover the procedures among patients 65 and older when those procedures are performed by more experienced surgeons and those who can demonstrate an appropriate track record of outcomes in higher risk patients.

The American Society of Bariatric Surgeons and the American College of Surgeons have been developing guidelines and standards to help CMS and other payers and purchasers of healthcare determine which centers and surgeons are qualified in this manner.

In my opinion CMS will best assure the public's safety and access to appropriate procedures by using the ACS and ASBS initiatives to help guide the delivery of bariatric surgical care to all patients-including those at highest risk of adverse outcomes.

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