Surgery for Diabetes

Steve Phurrough MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland, 21244

RE: Proposed Decision Memo for Surgery for Diabetes (CAG-00397N)

Dear Dr. Phurrough:

On behalf of the 74,000 Fellows of the American College of Surgeons (ACS), the more than 3,000 members of the American Society for Metabolic and Bariatric Surgery (ASMBS), and the 5,000 members of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), we appreciate the opportunity to submit this joint comment letter regarding the proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS).

In 2008, the Obesity Society published a White Paper, which states that obesity should be treated as a disease. Treating obesity as a disease would mean eliminating arbitrary boundaries and indications for surgery making treatment decisions for obese patients similar to the decision to offer any specific treatment regimen in any disease. The November 17 Proposed Decision Memo perpetuates the myth that somehow obesity treatment requires a different set of rules. In addition, it continues to reinforce the discriminatory and prejudicial treatment of obese patients by other national and state insurers and employers.

In regard to the three proposed decision memo statements, we have the following comments:

1) Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatric surgery in patients with type 2 diabetes with a BMI of >/=30kg/m2. We are concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, CMS even states in the conclusion section of the November 17 memo that: “We would ideally like to see an adequately powered Random Clinical Trial (multi-center if possible) with a control arm of medical treatment, with the ability to evaluate outcomes in subgroups of BMI above and below 35.” Therefore, we believe that CMS should utilize Medicare’s Coverage with Evidence Development (CED) process as opposed to finalizing a non- coverage policy for this specific population under the agency’s proposed new section 100.14 of Medicare’s NCD Manual. We believe that the potential benefits of surgical intervention for these patients are so great that CMS should seriously evaluate CED on this issue.^1-5 In addition, there are already tremendous data collection avenues available, which CMS could call on for this effort, such as: the ACS Bariatric Surgery Center Network Accreditation Program and the outcomes data housed in the College’s National Surgical Quality Improvement Program; the ASMBS Bariatric Surgery Center of Excellence Program; and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD™).

Medicare’s CED process is designed to collect additional patient data as part of the coverage process so as to generate more robust data on the utilization and impact of a particular service in question. Utilization of the CED process would enable Medicare to better document the appropriateness of bariatric surgery for this specific population and generate additional clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding bariatric surgery for diabetes.

2) A second and continuing concern revolves around how Medicare Administrative Contractors (MACs) will interpret the inclusion of type 2 diabetes as the only listed co-morbidity outlined under Section 100.1 of the Medicare Coverage Manual regarding bariatric surgery for treatment of morbid obesity. Morbidly obese patients are already facing significant roadblocks to accessing medical and surgical treatment for their disease. We fear that this recent action by CMS may further fortify, rather than breakdown, many of these obstacles. Unless specifically instructed otherwise, MACs may interpret type 2 diabetes as the only acceptable co-morbidity and continue to apply their own additional standards limiting care. For example, some MACs require Medicare beneficiaries to have uncontrolled type 2 diabetes in order to qualify as an acceptable candidate for bariatric surgery. CMS should issue specific instructions informing MACs that the diagnosis of type 2 diabetes in any morbidly obese individual is only one of many acceptable co-morbidities enumerated in the February 21, 2006 NCD, which allow for bariatric surgical treatment.

This would reinforce coverage for those with type 2 diabetes while ensuring that those with other co-morbidities maintain coverage as well. These co-morbidities include, but should not be limited to, hypertension; dyslipidemia; type 2 diabetes; coronary heart disease; stroke; gallbladder disease; osteoarthritis; sleep apnea; respiratory problems; and endometrial, breast, prostate, and colon cancers.

Again, the ACS, ASMBS and SAGES appreciate the opportunity to comment on this issue. If you have any questions regarding our comments, please contact either Elizabeth Hoy with ACS at 202-672- 1508 (ehoy@facs.org), Christopher Gallagher with ASMBS at 571-235-6475 (chris@potomaccurrents.com), or Sallie Matthews with SAGES at 310-437 0544 (sallie@sages.org).

Sincerely,

Thomas R. Russell, MD, FACS
Executive Director, ACS

Scott Shikora, MD, FACS
President, ASMBS

Mark A. Talamini, MD, FACS
President, SAGES

1. Dixon JB, O’Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008; 299(3):316-323.

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;240:416–423.

3. Parikh M, Duncombe J, Fielding GA. Laparoscopic adjustable gastric banding for patients with body mass index of Surg Obes Relat Dis. 2006;2(5):518-522.

4. Scopinaro N, Papadia F, Marinari G, et al. Long-term control of type 2 diabetes mellitus and the other major components of the metabolic syndrome after biliopancreatic diversion in patients with BMI < 35 kg/m2. Obes Surg 2007;17(2):185-192.

5. Cohen RV, Schiavon CA, Pinheiro JC, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with BMI 22-34: a report of 2 cases. Surg Obes Relat Dis 2007;3(2):195-197.

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Steven Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore, MD 21244

Re: Comment on Proposed Decision for Surgery for Diabetes (CAG-00397N)

Dear Dr. Phurrough:

Covidien firmly agrees with CMS that Bariatric surgery is a reasonable and necessary intervention for beneficiaries suffering from clinically severe obesity and diabetes. Despite this concordance, we have several areas of concern regarding the Proposed Decision. Diabetes is but one obesity-related co-morbidity We urge CMS to exercise caution in wording the final memo modifying NCD 100.1 (Bariatric Surgery for Treatment of Morbid Obesity) in specifying diabetes as a covered co-morbidity. It should be made very clear that the Medicare Administrative Contractors (MACs) should not use this Proposed Decision to further limit beneficiaries’ access to surgery as a treatment for other obesity-related co-morbidities, such as hypertension, dislipidemia, and sleep apnea, to name but a few.

Our analysis of MedPAR data has shown that after CMS issued NCD 100.1 the number of beneficiaries undergoing bariatric surgery actually decreased for the next quarter; reaching a nadir in Q2 2006. The number of procedures increased until Q2 2007 and has been in decline since. We attribute the first decline to the lack of designated Centers of Excellence as specified in and designated by NCD 100.1. The second decline is attributed to local medical directors requiring beneficiaries to undergo medically-supervised weight loss for a designated period, usually six months to a year. This weight loss stipulation was not in NCD 100.1 of February 2006 and has amounted to a profound limit on access to care for Medicare beneficiaries. Obesity is but one diabetes-related co-morbidity We further urge CMS to be cautious in overly-associating diabetes with obesity as in the Proposed Decision. Clustering of cardiometabolic risk factors shows that there are a considerable number of patients who exhibit significant risk factors for diabetes and cardiovascular disease who may benefit from surgery for diabetes who are not severely obese. Similarly, there are numbers of people who are severely obese who do not carry significant comorbidities . CMS is proposing to exclude both groups from coverage, perhaps correctly for the latter, whereas the former may be in need of further intervention.

CMS notes that the prevalence of diabetes in people with a BMI between 35 and 39.9 and above 40 kg/m2 is 14.9% and 25.6%, respectively. A more recent study examining National Health and Nutrition Examination Surveys (NHANES) data showed similar prevalence rates of 17% and 25%, respectively, but also a 14% prevalence rate for patients with diabetes with a BMI between 30 and 34.4 kg/m2. Examining the distribution of BMI in a population of patients with diabetes, it is clear that there are roughly the same numbers of patients with diabetes with a BMI between 30 and 34.4 kg/m2 as those with a BMI above 35 kg/m2. Additional data is needed Covidien agrees with CMS that more information is needed regarding surgery for diabetes in patients with BMIs less than 35 kg/m2. The data that CMS analyzed as well as data published since its analysis shows overwhelming support for surgery as a treatment for patients with diabetes across a wide BMI range. Indeed, no papers have been released to date that have indicated Bariatric surgery is inappropriate for treatment of obese patients with diabetes. In its analysis, CMS notes that few of the subjects in the studies “were over the age of 65 years“. While this is true of the studies, it is not necessarily germane to the age of the current Medicare beneficiaries undergoing bariatric surgery. Published reports show that the majority of CMS beneficiaries undergoing bariatric surgery are under the age of 65 , , with the most recent data showing an average age of 48 . A large study from 2006 showed the average age of beneficiaries to be 41 . An analysis performed in 2005 showed that 91% of beneficiaries undergoing bariatric surgery were under age 65 . Indeed, our MedPAR analysis shows similar results 75% of beneficiaries undergoing bariatric surgery are under age 65. CMS beneficiaries tend to be heavier, have more co-morbidities and to be older than the average bariatric surgery patient. Disabled CMS patients undergoing bariatric surgery also return to work more often when compared to a matched case non-surgically treated cohort . CMS should consider reviewing outcome data more as a matter of clinical severity rather than of age, in order to determine applicability to a typical CMS bariatric surgery population.

Support Clinical Evidence CMS suggests that the evidence supports conducting a randomized controlled trial that has the ability to evaluate subgroups of patients regarding BMI and procedure. We agree, and even prior to this suggestion Covidien made the decision to support several multicenter clinical trials focused on one suggested subgroup (comparing the outcomes of patients undergoing gastric bypass and best medical management to patients only receiving best medical management in severely diabetic patients with BMIs between 30 and 34.9 kg/m2).

While we agree that further research is needed, we do not agree that the current information is inadequate to support surgery as a treatment for diabetes in clinically severe obese diabetic patients. Furthermore, issuing a non-coverage NCD for surgery for diabetes in obese patients may very well have a chilling effect on patient recruitment for such trials. We strongly urge CMS to consider coverage with evidence development as outlined in the 2006 guideline National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development. The current medical evidence is adequate to conclude that surgery for diabetes is reasonable and necessary under section 1862(a)(1)(A).Conclusion Covidien fully agrees that diabetes should be a covered co-morbidity defined in NCD Manual 100.1 (Bariatric Surgery for Treatment of Morbid Obesity). However, CMS should use caution in constructing the final rule so as not to further compromise beneficiaries’ access to what CMS has deemed a reasonable and necessary benefit.

We agree that more data are needed for lower BMI diabetic patients. CMS properly calls for a study to evaluate subgroups of patients regarding BMI and procedures. But CMS should also approve coverage with special conditions for surgery for diabetes in beneficiaries with a BMI between 30 and 34.9 kg/m2, using Coverage with Evidence Development to help collect the necessary data to evaluate which beneficiaries most benefit from which type of surgery.

Published studies show that the majority of beneficiaries undergoing bariatric surgery are under the age of 65. Thus, CMS should consider not only age, but associated co-morbidities, when reviewing the medical evidence in order to consider the applicability of outcomes to the general CMS beneficiary population.

Thank you for your attention to this important and timely issue

Michael Tarnoff, MD FACS
Chief Medical Officer
Covidien Surgical Devices

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Response to CMS regarding coverage for bariatric surgery for patients with type 2 diabetes and BMI 30-35 kg/m2

Phil Schauer MD, David Cummings MD, Francesco Rubino MD, Lee Kaplan MD

As principal organizers of the first International Conference on Gastrointestinal Surgery to Treat Type 2 Diabetes – or Diabetes Surgery Summit (DSS) – held in Rome, March 2007, we wish to respond to the recent determination by CMS regarding coverage for bariatric surgery in patients with type 2 diabetes mellitus (T2DM) and BMI < 35 kg/m2. Among other issues related to surgery to treat diabetes, this consensus conference did specifically address this issue, and we wish to communicate some of the recommendations included in the DSS Position Statement that will be published in a major medical journal in early 2009.

Because of increased worldwide use of conventional bariatric surgery and experimental gastrointestinal (GI) manipulations to treat T2DM, particularly in less obese patients, the DSS consensus conference was organized to determine, based on best scientific evidence, appropriate indications for this evolving practice of “diabetes surgery”. The 50 voting delegates included endocrinologists, gastroenterologists, diabetologists, surgeons, basic scientists, epidemiologists, and health economists. To minimize potential bias, delegates were weighted toward non-surgeons (58%) and university faculty (92%), without any industry employees. All proceedings were open to the public, and ~400 professionals with relevant expertise from 27 countries on 6 continents participated in discussions. The conference was endorsed by 21 diverse international scientific societies. Based on analysis of published evidence and newly reported data, position statements were crafted, and support for these was quantified using real-time audience-response technology. Viewpoints that achieved consensus are summarized in the DSS Position Statement that will be published very soon. The DSS also provided an opportunity to comprehensively review available evidence on GI surgery to treat diabetes, and a report of this appraisal will be published separately in the form of a review paper. Based on extensive review of the literature, we cannot agree with the conclusion of the CMS reviewers. In fact, although we concur that long-term data on efficacy and safety are not yet sufficient to advocate the use of GI surgery as a primary treatment of T2DM in non-obese patients, we should recognize the definitive evidence that a specific cut-off BMI at 35 kg/m2 is inadequate to predict either the efficacy of surgery or potential complications from it. In addition, when considering patients with T2DM, BMI per se is not an adequate predicting factor for the risk of developing diabetes-specific complications and mortality. Furthermore, BMI levels do not reflect equivalent risk profiles in males and females, nor in different ethnic groups. Consistent with these various lines of evidence, delegates at the DSS unanimously recognized that adopting the strictly BMI-based criteria used for bariatric surgery would be inadequate to select candidates for diabetes surgery, and that other parameters should be used.

Any consideration on whether to expand or restrict surgical indications in patients with diabetes should be done with full consideration of the reported dramatic reduction of all-cause mortality, and especially in diabetes-related deaths, after bariatric surgery (Adams et al and Sjostrom et al NEJM Aug 2007). This makes GI surgery an overall life-saving option in patients with T2DM. The evidence that some surgical operations engage anti-diabetes mechanisms that are independent of, and act in addition to weight loss justifies considering surgery as a specific diabetes intervention, rather than viewing diabetes remission merely as a collateral effect of weight-loss surgery.

Thus, there is no evidence, and indeed not even a single study or reasonable argument, to support a strict cut-off BMI at 35 kg/m2 as a criterion to define contraindications to surgical treatment of diabetes. Denying a surgical option to patients with poorly controlled diabetes and progressive deterioration of cardiovascular risk profile in the face of ineffective medical treatment would be unjustified and, in fact, discriminatory, since many ethnic groups – especially African Americans, Native Americans, and people of Asian decent – have severe metabolic disease at a lower BMI than do Caucasians. However, considering the scarcity of studies directly evaluating surgical treatment of diabetes as a primary therapy, we suggest that it would be inappropriate to advocate routine clinical use of GI surgery as a first-line treatment of diabetes regardless of BMI level. A reasonable approach would be to assess the risk/benefit profile of individual patients, and consider a surgical option in those with inadequately controlled T2DM and at high cardiovascular risk due to their metabolic status.

Besides the above medical reasons, it would also be questionable for a health care system to continue to cover a costly medical treatment when this has become evidently ineffective and to deny, a priori, the alternative of a surgical option, when the latter has a strong potential to substantially improve the disease and the patient’s survival. Regarding the opportunity to expand surgical indications in patients with T2DM, the DSS delegates adopted a cautious and conservative approach, yet they recognized the legitimacy of a surgical option as a non-primary alternative in mild-to-moderately obese patients (BMI 30-35 kg/m2) who are inadequately controlled by lifestyle and medications. We respectfully recommend that CMS adopt the consensus opinion of the DSS that bariatric surgery be considered an option for patients with BMI 30-35 kg/m2, with T2DM inadequately controlled by lifestyle and medications. A requirement to demonstrate evidence of the institution of T2DM treatment based on current ADA/EASD guidelines seems reasonable. If a patient is unable to achieve defined targets for glycemic control, blood pressure, and triglyceride levels under a reasonable medical treatment as assessed by a multidisciplinary team that includes a diabetes specialist, then conventional bariatric operations with acceptable risk profile (i.e. Roux-en-Y gastric bypass or adjustable gastric banding) could be considered an option and a covered benefit of CMS. Requiring evidence of compliance with ADA/EASD guidelines will ensure that overzealous use of surgery is avoided, and this may motivate practitioners to adhere intensely to the well-established, evidenced-based guidelines, thus avoiding surgery for most patients. Considering that the relative risks as well as efficacy for patients with T2DM and BMI > 35 kg/m2 are well documented and supported by an extensive literature, evidence thus far suggests that patients with BMI 30-35 kg/m2 should have a comparable risk-benefit profile for surgery. Given the well documented morbidity and mortality of uncontrolled T2DM sustained over many years, the relative risk and to lesser uncertainty of surgical outcomes in this population with BMI 30-35 kg/m2, seems warranted at this time.

Phil Schauer MD
Professor of Surgery
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio

David Cummings MD
Associate Professor of Medicine
University of Washington
Seattle, Washington

Francesco Rubino MD
Associate Professor of Surgery
Weill Cornell Medical College
New York, New York
Lee Kaplan MD
Associate Professor of Medicine
Harvard Medical School
Boston Massachusetts

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I am one surgeon in a three surgeon bariatric surgical practice in Lafayette, Louisiana. Thanks to the decision made by CMS two years ago to allow RYGBP, LAGB, and BPD/DS to be done in a "center of excellence" setting, we have been able to provide a worderful service to the Medicare beneficiaries in our state. The majority of our patients, in addition to other obesity-related co-morbid conditions, have also had type 2 diabetes mellitus (T2DM). Over 90% of our patients with T2DM are now in complete remission from diabetes and off all medication. With normal blood glucose levels, these patients have freed themselves from the fear of such diabetic complications as coronary artery desease, arteriosclerotic peripheral vascular disease, chronic renal failure and dialysis, peripheral neuropathy, sexual dysfunction and blindness. Can any medical therapy make this claim? Many of our patients have normal blood glucose levels by the time they leave the hospital two or three days after surgery, and thus are also off all diabetes medications. This demonstrates the metabolic effect of the surgical procedure, well before any weight is lost. Is BMI 35 anything more than an arbitrary number? I think not. A person with a BMI of 34 will benefit from a bariatric surgical procedure in the same way as a patient whose BMI is 36. We see this every day in our cash pay patients, whose BMIs are as low as 30, but don''t qualify for insurance coverage because their BMIs are < 35. Professor Nicola Scopinaro from the University of Genoa in Italy has a pilot study, started in 2007, consisting of 26 patients with a mean age of 57, a mean BMI of 30.8 (range 27 to 34), and a mean duration of T2DM of 12.5 years(more than half on insulin therapy). All 26 were in complete remission by 8 months, with normal insulin sensitivity restored. None of these patients had excessive weight loss. None had significant nutritional complications. It may come as a surprise to North Americans, but Brazil is now the most advanced country in the world in the field of bariatric and metabolic surgery, possibly due to the relative freedom from government regulation in that country. Multiple series have been forthcoming from Brazil demonstrating the effectiveness of bariatric surgical procedures in overcoming T2DM in patients with BMIs ranging from 25 to 35. It is also well-recognized in the world bariatric surgery community that the metabolic syndrome, which includes T2DM, develops in Asian and Native American (and thus in Latin American populations) at a much lower BMI level than in European populations, due to a combination of genetics and a diet in which carbohyddrates (rice, corn, etc.) predominate. Multiple examples that these populations with BMI ranges from 25 to 35 respond to standard bariatric surgical procedures without excessive weight loss or other complications are coming from India, the Phillippines, Malaysia, China, Japan, Korea and the Latin American countries. Certainly it has not gone unnoticed that these non-European people also happen to be U.S. citizens and Medicare beneficiaries and that their numbers are steadily increasing in this country. Possibly the reason for claiming "inadequate evidence to conclude that bariatric procedures improve health outcomes in Medicare beneficiaries who have T2DM and BMI < 35" is the fear that the converse colclusion would "open Pandora''s Box" and overwhelm the system. Or, that beneficiaries that have LADA (Latent Autoimmune Diabetes in the Adult), a type of Adult type l diabetes which is much more prevalent in lower BMI patients, will be subjected to ineffective surgical procedures by overzealous surgeons. Or, that excessive weight loss will occur in those with lower BMIs. It has been our own experience in Louisiana that most practices, including many COE practices, try to avoid taking on Medicare patients because, in addition to low reimbursement, these patients are more difficult to treat than younger non-Medicare patients. (This is not the case in our COE practice) So, I don''t think the system will be overwhelmed. With respect to the LADA problem, a simple measurement of the C-peptide level will differentiate between LADA and true metabolic syndrome with T2DM. This measurement could be a requirement for any Medicare beneficiary being considered for surgical treatment of their diabetes and could be hinged to reimbursement. So far as excessive weight loss is concerned, this just does not seem to happen, even in very low BMI patients. As was done two years ago with Medicare beneficiaries in the >35 BMI range, I would urge CMS to "do the right thing for Medicare beneficiaries and include the BMI 30-35 in the coverage with evidence development(CED) process, utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation''s Bariatric Outcomes Longitudianl Data Base. In this way the United States health care system will not fall behind in the field of Bariatric and Metabolic Surgery.

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December 17, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed national coverage determination (NCD) on Surgery for Diabetes (CAG-00397N). America’s Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
We encourage CMS to ensure that all patients receive the most effective and appropriate treatments based on the latest scientific evidence. AHIP concurs with CMS that there is a lack of evidence to conclude that coverage should be provided for open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) to improve health outcomes in Medicare beneficiaries who have type 2 diabetes mellitus and a body mass index (BMI) ≥35.

Additionally, AHIP supports CMS’s proposed decision to provide coverage for those same procedures to Medicare beneficiaries with type 2 diabetes and a BMI ≥35. This proposed decision is in line with the current coverage criteria for the NCD 100.1 Bariatric Surgery for Treatment of Morbid Obesity where Medicare beneficiaries are eligible for coverage for RYGBP, LAGB, or BPD/DS if they have a body-mass index ≥35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity, as diabetes is a co-morbidity related to obesity. However, AHIP recommends that CMS revise their proposed coverage decision to add the same level of criteria for Surgery for Diabetes as is found within NCD 100.1, so that it would read:

“The evidence is adequate to conclude that open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) improve health outcomes in Medicare beneficiaries who have type 2 diabetes mellitus, a BMI ≥ to 35, and have been previously unsuccessful with medical treatment for obesity and/or diabetes. Thus, we are proposing that type 2 diabetes mellitus is a comorbid condition related to obesity as defined in NCD Manual 100.1 (Bariatric Surgery for Treatment of Morbid Obesity).”

However, our original concerns expressed in our June 2008 comment letter on this issue still exist and we continue to agree with the medical leadership of the American Diabetes Associationⁱ that questions remain about the safety and effectiveness of surgery for diabetes, especially regarding the risks and benefits over the longer term. AHIP concurs with CMS that it would be beneficial to further develop the evidence on these procedures with either an adequately powered randomized control trial, with a control arm of medical treatment, with the ability to evaluate outcomes in subgroups of BMI above and below 35, and comparative effectiveness studies that are able to draw conclusions about the safety and effectiveness of conventional bariatric surgeries such as RYGBP, LAGB, and BPD/DS.

As we have previously commented in our June 2008 letter, there are several key questions that must be addressed regarding future evidence on surgery for diabetes. Studies should concentrate on the following areas:

1. The early evidence has not clearly established which kind or kinds of surgery may provide a benefit. It appears that weight loss following bariatric surgery is not required for there to be a decrease in insulin requirements. Therefore, much remains to be learned about the pathophysiology underlying the impact of various types of gastric bypass and other similar surgeries on diabetes.

2. The longer-term duration and degree of benefits and harms from surgery must be established. Short-term studies showing rapid decrease in patients’ need for insulin do not establish the intervention as a sustained “cure” for diabetes. Longer-term (3-5 years) controlled trials involving larger patient cohorts are needed to investigate fully the balance of net harms and benefits of surgery.

3. The generalizability of results to the Medicare population must be clarified. Since gastric bypass surgery has been shown to be riskier among elderly patients, studies of surgery for diabetes should include patients with comorbidities representative of the general Medicare population whenever possible.

4. Surgery should be compared to standard therapy for diabetes so that the decisions regarding surgery do not rely simply on case series without a contemporaneous true control group. There is a lack of specificity within current evidence about who would benefit most from these surgeries, including the level of severity or stage of type 2 diabetes of the patient. Only with comparison to standard therapy will it be possible to determine patient characteristics that might indicate which approach is best for different kinds of patients. Without understanding the pathophysiology that results in the elimination of diabetes in the short term observations, it is not prudent for patients to be covered for major surgery that may not be needed to achieve the same results

5. Any judgment of the impact on net health benefit of surgery for diabetes should include decision analytic modeling of the effects of lowered Hemoglobin A1c. It is likely that studies will not be able to measure the impact of any improvement in laboratory measures on actual patient outcomes of mortality or diabetes-related complications. But studies will be able to capture short-term risks of surgery. In order to compare any possible long-term benefits with the risks incurred, CMS should consider the results of decision analytic modeling studies as an important part of the evidence base for this intervention.

Surgery for diabetes is a novel intervention that could have potential to significantly impact the health options for patients within the Medicare system, but is currently lacking the required level of clinical evidence for coverage. If adopted, the intervention would also have a substantial impact on utilization of resources. The uncertainties about the safety and effectiveness of surgery for diabetes are substantial and AHIP urges CMS to move rapidly to create a robust, national approach to the evaluation of the evidence as it continues to develop.

Thank you for the opportunity to comment on this important issue.

Sincerely,

Carmella Bocchino
Executive Vice President, Clinical Affairs & Strategic Planning

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December 16, 2008

Steve Phurrough MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Phurrough:

On behalf of the Obesity Action Coalition (OAC), I am writing to respond to the Centers for Medicare & Medicaid Services (CMS) request for public comment on the agency’s proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008. We appreciate the Medicare program’s interest in this issue.

The OAC is a national non-profit organization representing nearly 12,000 members – the majority of which have been personally affected by obesity. Our membership includes adults who are overweight, obese, morbidly obese and those who have successfully addressed their obesity, parents of children who are affected by obesity as well as concerned members of the public. In addition, our membership also includes more than one thousand healthcare providers who care for those afflicted with the disease of obesity. Our strong belief is that obesity, like other diseases, must be both prevented and treated. Those either currently obese, or at risk for developing obesity, and are ready to make a change in their lives, should have expanded access to both prevention and treatment avenues.

The OAC viewed CMS’s February 2006 national coverage decision regarding bariatric surgery for the treatment of morbid obesity as a potential major milestone for ensuring access to surgical intervention for Medicare beneficiaries suffering from morbid obesity and the myriad of co-morbidities that accompany this disease. We applauded the agency for its thorough review of the literature regarding bariatric surgery as well as its flexibility during the public comment period to consider additional studies suggested by the medical community.

It appears that CMS has followed a similar rigorous approach to reviewing the data regarding the benefits of surgical intervention for non-morbidly obese individuals suffering from type two diabetes mellitus (T2DM). And although the OAC agrees with Medicare’s decision to not lower the minimum BMI requirements regarding diabetics seeking surgery until further efficacy and safety data are available, we urge CMS to be especially vigilant as new data become available in the coming months and years.

In fact, the potential for such procedures may be so great that CMS might wish to investigate utilizing its coverage with evidence development (CED) process utilizing the data collection services of existing Bariatric Surgery Centers of Excellence. We agree with Medicare’s CED process and that collecting additional patient data as part of the coverage process would generate more robust data on the utilization and impact of bariatric surgery on non-morbidly obese individuals suffering from T2DM. As a result, Medicare would be able to better document the appropriateness of bariatric surgery for this population and generate clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding bariatric surgery for diabetes.

One major concern of the OAC revolves around how Medicare Administrative Contractors (MACs) will interpret the inclusion of T2DM as the only listed co-morbidity outlined under Section 100.1 of the Medicare Coverage Manual regarding bariatric surgery for treatment of morbid obesity. We believe that such specificity in listing T2DM could further exacerbate access to care for the morbidly obese as MACs may choose to define covered co-morbidities as only those specifically enumerated by CMS within the Coverage Manual. CMS should include all the co-morbidities that can be alleviated or eliminated post bariatric surgery such as hypertension; dyslipidemia; T2DM; coronary heart disease; stroke; gallbladder disease; osteoarthritis; sleep apnea; respiratory problems; and endometrial, breast, prostate, and colon cancers.

As we outlined to CMS coverage staff this past summer, morbidly obese patients are already facing significant roadblocks to accessing medical and surgical treatment for their disease. We fear that this recent action by CMS may further fortify, rather than breakdown, many of these obstacles. The OAC is concerned that unless specifically instructed otherwise, many MACs may interpret T2DM as the only acceptable co-morbidity and continue to apply their own additional standards limiting care (for example, requiring uncontrolled T2DM to be an acceptable candidate). We urge the agency to issue specific instructions informing MACs that the diagnosis of T2DM in any morbidly obese individual is one of many acceptable co-morbidities enumerated in the February 21, 2006 NCD, which allow for bariatric surgical treatment.

Another obstacle to care, which we discussed during the aforementioned meeting with CMS, revolves around certain MACs and their medical weight management requirements prior to bariatric surgery. While the OAC strongly believes that medical weight management should be a Medicare-covered therapy for those affected by overweight/obesity, we feel that 6-18 month mandates required by some MACs are arbitrary and intended solely as a barrier to surgical care for Medicare beneficiaries. We believe it would be more appropriate for a 3-month requirement specifically designed to educate bariatric surgery patients on the nutrition, exercise and other lifestyle changes necessary to be successful long-term.

Medical weight loss management holds promise in helping overweight and obese individuals obtain modest weight-loss. While these individuals often do not achieve “ideal” body weight, even modest weight-loss offers profound benefit in improving quality of life and preventing or delaying the onset of many of the co-morbidities previously outlined. Therefore, Medicare should provide coverage for medical weight loss management for those Medicare patients that may benefit from it as well as for those who may not, but yet are mandated by Medicare to attempt this bridge crossing in order to qualify for bariatric surgery. As is the case with coverage for treatment surrounding other diseases such as diabetes and heart disease, Medicare should provide both access to, and coverage of, a wide range of treatment options for those affected by overweight/obesity.

Thank you for the opportunity to comment. Please do not hesitate to contact me via phone at 813-872-7835 or email at jnadglowski@obesityaction.org if I can provide any additional information.

Sincerely,
Joseph Nadglowski, Jr.
President/CEO
Obesity Action Coalition

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VIA Electronic Mail submission to: CAGinquiries@cms.hhs.gov

Stephen Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group

Marcel E. Salive, M.D., M.P.H.
Director, Division of Medical and Surgical Services

Ross Brechner, M.D., M.S. (Stat.), M.P.H.
Lead Medical Officer, Division of Items and Devices

Arthur A. Meltzer, Ph.D.
Lead Analyst, Division of Medical and Surgical Services

Center for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: National Coverage Analysis for Surgery for Diabetes (CAG-0397N): Request for public comments on Proposed Decision Memo

Dear Drs. Phurrough, Salive, Brechner, and Meltzer:

On behalf of Allergan, Inc., the manufacturer of the LAP-BAND® Adjustable Gastric Banding System (“LAP-BAND”), we are pleased to submit comments on the Proposed Decision Memo for the above-captioned National Coverage Analysis (NCA). We support the Center for Medicare & Medicaid Services’s (CMS’s) determination that the evidence is adequate to conclude that laparoscopic adjustable gastric banding (LAGB), open and laparoscopic Roux-en-Y gastric bypass (RYGBP), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) improve health outcomes in Medicare beneficiaries with type 2 diabetes mellitus (T2DM) and body mass index (BMI) >35 kg/m2, and we appreciate CMS’s proposal to specify in the revised National Coverage Determination 100.1 “Bariatric Surgery for Treatment of Morbid Obesity” that T2DM is a co-morbidity for the purposes of that NCD. For the Final Decision Memorandum and NCD, we recommend that CMS further specify that beneficiaries with T2DM are eligible for coverage of LAGB, RYGBP, and BPD/DS without requiring that T2DM be treated with insulin or that the beneficiary have a history of being poorly controlled or refractory to medical therapy. Coverage of LAGB, RYGBP, BPD/DS in Medicare Beneficiaries with T2DM and BMI >35 kg/m2.In the Proposed Decision Memo, CMS reviewed findings from 30 published studies to reach the conclusion that the evidence is adequate to conclude that LAGB, RYGBP, and BPD/DS improve health outcomes in Medicare beneficiaries with T2DM and BMI >35 kg/m2. We agree with this conclusion; there is a very robust evidence base showing that these bariatric surgical procedures can have a substantial beneficial impact in patients with T2DM. This assessment is also consistent with the evidence summary we submitted with our comments upon the opening of the NCD. Based upon this evidence review and coverage determination, we appreciate CMS’s proposal to revise NCD 100.1 to specify that T2DM is considered a co-morbidity for the purposes of that NCD, which requires that there be at least one co-morbidity related to obesity for the bariatric surgical procedures to be covered under Medicare. We appreciate CMS’s proposal to clarify this in NCD 100.1, and we recommend that CMS include the proposed language in the final, revised NCD.

In addition to specifying that T2DM is recognized as a co-morbidity for the purposes of coverage of the bariatric surgical procedures in patients with BMI >35 kg/m2, we would recommend that CMS further clarify and instruct the Medicare Administrative Contractors and other entities bound by the NCD that Medicare beneficiaries with T2DM and BMI >35 kg/m2 are eligible for coverage of these bariatric surgical procedures (as long as they meet all other criteria for coverage) without requiring that the beneficiary be treated with insulin or have a history of being poorly controlled or refractory to medical therapy.In the evidence base reviewed by CMS for the Proposed Decision Memo, several studies indicated that the bariatric surgical procedures improve glycemic control not only in patients diagnosed with T2DM, but also in patients with impaired glucose tolerance: (Long [1994], Pories [1992], Pories [1995], and Wikremesekera [2005]). In addition, where predictors of improvement in diabetes mellitus-related outcomes were analyzed specifically, it was clear that outcomes were better among patients with shorter duration of diabetes mellitus and with less severe metabolic dysfunction than among patients whose diabetes mellitus was poorly controlled. As presented in the Proposed Decision Memo:

Schauer (2003) found that “[p]atients with the shortest duration (< 5 years), the mildest form of T2DM (diet controlled), and the greatest weight loss after surgery were most likely to achieve complete resolution of T2DM.”

Torquati (2005) showed that “[o]n univariate analysis, preoperative variables associated with resolution of T2DM were waist circumference [smaller], HbA1C , and absence of insulin treatment.

Dixon (2002) reported: “Risk factors for remission of diabetes was predicted by logistic regression to be greater weight loss and a shorter history of diabetes.”

Ponce (2004) reported that “Patients in whom diabetes was improved but not resolved had lower %EWL than did those whose diabetes went into remission (27.0% at 1 year and 26.5% at 2 years). Patients with the shortest duration of diabetes (&< 5 years) and better weight loss after surgery achieved higher resolution rates.”

Therefore, we would propose that CMS include the following language in the final, revised NCD 100.1:

“Open and laparoscopic Roux-en-Y gastric bypass (RYGBP), open and laparoscopic Biliopancreatic Diversion with Duodenal Switch (BPD/DS), and laparoscopic adjustable gastric banding (LAGB) are covered for Medicare beneficiaries who have a body-mass index >35, have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. These procedures are only covered when performed at facilities that are: (1) certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery as a Bariatric Surgery Center of Excellence (program standards and requirements in effect on February 15, 2006).Type 2 diabetes is a co-morbidity for purposes of this NCD. Medicare beneficiaries with Type 2 diabetes and BMI >35 kg/m2 who meet all other criteria for coverage shall be eligible for coverage of RYGBP, BPD/DS or LAGB without requiring that the beneficiary be treated with insulin, have a history of being poorly controlled or refractory to medical therapy for the treatment of diabetes mellitus.”(Italicized language is revised language proposed by CMS in the Proposed Decision Memo. Italicized and bolded language is revised language we are recommending.)

* * * *

We are pleased to have the opportunity to submit comments in response to Proposed Decision Memo for this NCA. Please contact Alan Ackerman, Ph.D., Master Medical Scientific Liaison, at 970.396.5945 or mailto:ackerman_alan@allergan.com if you have any questions or comments about this letter or our recommendations.

Sincerely yours,
/s/
Steven James, M.D.
Vice President, Medical Affairs
Allergan, Inc.

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December 16,2008

Dear Dr. Phurrough:

On behalf of Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, I am pleased to submit comments on the Proposed Decision Memo for Surgery for Diabetes that was issued by CMS on November 17, 2008. Ethicon Endo-Surgery, Inc. manufactures and distributes minimally invasive surgery products used for open and laparoscopic gastric bypass and laparoscopic adjustable gastric banding.

Acknowledge ongoing clinical studies on treating diabetes with bariatric surgery
EES is aware of current ongoing clinical trials that will provide evidence on the safety and efficacy of bariatric surgery in Medicare Beneficiaries with Type 2 diabetes with a BMI of ≥ 30kg/m2. However, the language in the proposed decision memo leaves little room for the inclusion of these ongoing, as well as future clinical studies. We recommend that CMS use language in the NCD that acknowledges that current and future trials may offer evidence that will significantly impact this NCD and leave the door open to further clarification at the time data from these trials are available.

Clearly identify Type 2 Diabetes as one of several significant comorbidities that qualifies a beneficiary for bariatric surgery
EES is also concerned about how Medicare Administrative Contractors (MACs) will interpret the inclusion of Type 2 Diabetes as the only listed co-morbidity outlined under Section 100.1 of the Medicare Coverage Manual on bariatric surgery for treatment ofmorbid obesity.

Unless specifically instructed otherwise, many MACs may interpret Type 2 Diabetes as the only acceptable co-morbidity requirement for bariatric surgery and apply their own additional requirements limiting care. For example, some MACs require Medicare beneficiaries to have uncontrolled Type 2 Diabetes in order to qualify as an appropriate candidate for bariatric surgery. CMS should issue specific instructions that the diagnosis of Type 2 Diabetes in any obese individual with a BMI ≥ 35 qualifies a beneficiary for bariatric surgery, and is only one of several appropriate co-morbidities enumerated in the February 21, 2006 NCD, which allow for bariatric surgical treatment. This would reinforce coverage for those with Type 2 Diabetes while ensuring that those beneficiaries with other obesity-related comorbidities maintain coverage as well.

Specify that preoperative weight loss is not a requirement prior to bariatric surgery
Many MACs are applying their own additional requirements, including a requirement for preoperative weight loss prior to surgery, to Section 100.1 of the Medicare Coverage Manual on bariatric surgery for treatment of morbid obesity. Many of the presurgical requirements imposed by the MACs have no evidence to support them and are perceived by Medicare beneficiaries and providers as a way for MACs to limit care. We encourage CMS to specify that preoperative weight loss is not a requirement prior to bariatric surgery and clearly articulate the requirements beneficiaries must meet to qualify for bariatric surgery.

Thank you for the opportunity to comment on the potential NCD topics. Please feel free to contact me at 513-337-3201 if you require additional information.

Sincerely,

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December 15, 2008

To Whom It May Concern:
The Centers for Medicare and Medicaid Services

RE: CMS national coverage decision regarding surgery for diabetes.

As 10 surgeons who have seen type 2 diabetes resolve after Bariatric surgery, we are troubled by Medicare’s decision to not cover Bariatric surgery for non-morbidly obese Medicare beneficiaries with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS).

Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of Bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. We are concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, we believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing its coverage with evidence development (CED) process – utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD).

Medicare’s CED process is designed to collect additional patient data as part of the coverage process so as to generate more robust data on the utilization and impact of a particular service in question. Utilization of the CED process would enable Medicare to better document the appropriateness of Bariatric surgery for this specific population and generate additional clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding Bariatric surgery for diabetes.

A second, and continuing concern, revolves around how Medicare Administrative Contractors (MACs) will interpret the inclusion of type 2 diabetes as the only listed co-morbidity outlined under Section 100.1 of the Medicare Coverage manual regarding Bariatric surgery for treatment of morbid obesity. Morbidly obese patients are already facing significant roadblocks to accession medical and surgical treatment for their disease. We fear that this recent action by CMS may further fortify, rather than breakdown, many of these obstacles.

Unless specifically instructed otherwise, many MACs may interpret type 2 diabetes as the only acceptable co-morbidity and continue to apply their own additional standards limiting care. For example, some MACs require Medicare beneficiaries to have uncontrolled type 2 diabetes in order to qualify as an acceptable candidate for Bariatric surgery. CMS should issue specific instructions – informing MACs that the diagnosis of type 2 diabetes in any morbidly obese individual is only one of many acceptable co-morbidities which are enumerated in the February 21, 2006 NCDD and which allow for Bariatric surgical treatment. This would reinforce coverage for those with type 2 diabetes while ensuring that those with other co-morbidities maintain coverage as well.

Type 2 diabetes is a costly disease – in terms of both medical expenses and patient suffering. For all the reasons above, I urge CMS to rescind this proposed Decision Memo in its current form and utilize the CED process to gather the needed evidence regarding the impact of Bariatric surgery on this specific population.

Sincerely,
Stephen S. Clark, M.D., FACS, FASMBS

Tim L. Faulkenberry, M.D., FACS, FASMBS
ASMBS Bariatric Surgery Center of Excellence Surgeon

Mark R. Sherrod, M.D., FACS, FASMBS
ASMBS Bariatric Surgery Center of Excellence Surgeon

Nancy G. Marquez, M.D., FACS, FASMBS
ASMBS Bariatric Surgery Center of Excellence Surgeon

Paula S. Oliver, M.D., FACS, FASMBS

Patrick C. Dillawn, M.D., FACS, FASMBS
ASMBS Bariatric Surgery Center of Excellence Surgeon

Steven M. Fass, M.D., FACS, FASMBS
ASMBS Bariatric Surgery Center of Excellence Surgeon

Bridget Brady, M.D., FACS

Mario A. Longoria, M.D., FASMBS

Jinnie A. Bruce, M.D., FACS

Southwest Bariatric Surgeons, PLLC
8701 Shoal Creek Blvd., Ste. 201
Austin, TX 78757
Ph: (512) 334-1885
Fax: (512) 334-1890

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As a member of the healthcare team that provides treatment to those suffering from obesity, I am troubled by Medicare’s decision to not cover bariatric surgery for non-morbidly obese Medicare beneficiaries with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS). Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, I believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing its coverage with evidence development (CED) process utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD™). I continue to me amazed at the lack of education which results in the the failure to provide desperately needed healthcare to the people of this country.

Kerry Kole, D.O.

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As a bariatric surgeon providing treatment to those suffering from obesity, I am troubled by Medicare’s decision to not cover bariatric surgery for Medicare beneficiaries with BMI < 35 with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS). Currently there are ongoing clinical trials that will clarify the efficacy and safety of bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, I believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing its coverage with evidence development (CED) process - utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD™).

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As a member of the healthcare team that provides treatment to those suffering from obesity, I am troubled by Medicare’s decision to not cover bariatric surgery for non-morbidly obese Medicare beneficiaries with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS). Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, I believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing itscoverage with evidence development (CED) process utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD™). Medicare’s CED process is designed to collect additional patient data as part of the coverage process so as to generate more robust data on the utilization and impact of a particular service in question. Utilization of the CED process would enable Medicare to better document the appropriateness of bariatric surgery for this specific population and generate additional clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding bariatric surgery for diabetes. A second, and continuing concern, revolves around how Medicare Administrative Contractors (MACs) will interpret the inclusion of type 2 diabetes as the only listed co-morbidity outlined under Section 100.1 of the Medicare Coverage Manual regarding bariatric surgery for treatment of morbid obesity. Morbidly obese patients are already facing significant roadblocks to accessing medical and surgical treatment for their disease. We fear that this recent action by CMS may further fortify, rather than breakdown, many of these obstacles. Unless specifically instructed otherwise, many MACs may interpret type 2 diabetes as the only acceptable co-morbidity and continue to apply their own additional standards limiting care. For example, some MACs require Medicare beneficiaries to have uncontrolled type 2 diabetes in order to qualify as an acceptable candidate for bariatric surgery. CMS should issue specific instructions informing MACs that the diagnosis of type 2 diabetes in any morbidly obese individual is only one of many acceptable co-morbidities enumerated in the February 21, 2006 NCD, which allow for bariatric surgical treatment. This would reinforce coverage for those with type 2 diabetes while ensuring that those with other co- morbidities maintain coverage as well. Thank you for your time and consideration.

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I would like to express my disappointment with CMS decision not to cover bariatric surgery for patients with a BMI over 30 and Type II Diabetes. As a surgeon who does many of these procedures I am seeing this procedure as a cure for diabetes with people normalizing without any further need for medication. I therefore feel this is denying these patients a chance for a cure of there disease. I understand that there is a provision that at least allows for this to be covered while it is being studied further and ask that you consider allowing this to occur.

Also I am concerned about how other insurance companies will view this and use this decision to restrict coverage of other patients. Already they will only cover patients with a BMI between 35 and 40 if they have poorly controlled DM II. Again I think this is unreasonable and unethical when we have a therapy that cures over 70% of the patients affected by this devastating disease. What is the rationale for denying these patients a chance for a cure.

I thank you for your consideration in this matter.

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As a member of the healthcare team that provides treatment to those suffering from obesity, I am troubled by Medicare’s decision to not cover bariatric surgery for non-morbidly obese Medicare beneficiaries with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS). Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, I believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing its coverage with evidence development (CED) process utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD™). Thank you for your consideration of my comments.
Allen F. Browne, M.D., FAAP, FACS
Associate Professor of Clinical Surgery
Ohio State University
Staff Pediatric Surgeon
Nationwide Childrens Hospital
700 Children’s Dr – ED382
Columbus, Ohio 43205
Phone – 614-722-3901
Fax – 614-722-3903
E-mail – allen.browne@nationwidechildrens.org

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Included below are comments on behalf of The Endocrine Society. A formal letter attachment will be sent to CAGinquiries@cms.hhs.gov.

Thank you,

Holly Whelan

December 12, 2008

Kerry N. Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

RE: CAG-00397N – Proposed Decision Memo for Surgery for Diabetes

Dear Mr. Weems:

The Endocrine Society (Society) appreciates the opportunity to provide comments on the Centers for Medicare & Medicaid Services'' (CMS) proposed national coverage determination on bariatric surgery for individuals with type 2 diabetes (CAG-00379N). Founded in 1916, the Society represents over 14,000 physicians and scientists engaged in the treatment and research of endocrine disorders, such as obesity, diabetes, hypertension, osteoporosis, infertility, and thyroid disease.

Existing CMS policy on bariatric surgery (NCD Manual Section 100.1) states that surgical procedures aimed at treating massive obesity (open and laparoscopic Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and open and laparoscopic biliopancreatic diversion with duodenal switch) are reasonable and necessary for individuals with BMI > 35 and at least one co-morbid condition. The new CMS proposal set forth under CAG-00397N specifies that, for purposes of this provision, Type II Diabetes Mellitus (DM) will be considered an acceptable co-morbidity for determining medical reasonableness and necessity. This policy modification was based on an extensive analysis, detailed in CAG-00379N, with the conclusion that bariatric surgery improves health outcomes in individuals with Type II DM and BMI > 35. The Society supports this recommendation.

However, the Society has major concerns with the non-coverage recommendation in CAG-00379N that bariatric surgery is not medically reasonable and necessary for patients with Type II DM and BMI < 35. In particular, the Society believes that there is an insufficient quantity of evidence to determine whether or not bariatric surgery for such patients will lead to improved health outcomes, and that a formal national non-coverage determination for this group is premature at this time. In this regard, CMS’ own analysis in CAG-00379N points out that there have been very few patients reported in the literature with Type II DM, BMI < 35, and age over 65 (the Medicare population) who have had bariatric surgery.

CMS also indicates that an adequately powered randomized controlled study would be needed to establish the usefulness of bariatric surgery in this population, a statement with which the Society agrees. A national non-coverage determination at this time regarding bariatric surgery for Type II DM patients with BMI < 35 would carry enormous influence in the medical community and might well impair the ability to recruit for and to conduct the study that CMS recommends. In addition, private payers will likely follow the CMS lead by denying coverage, even though the CMS decision was really only an expression of a paucity of data on this issue in the Medicare population. The net result of such actions is that a potentially useful procedure for patients with Type II DM might be precluded from consideration not because of evidence of ineffectiveness but rather because of absence of sufficient evidence one way or the other.

Instead, the Society suggests an alternate approach whereby CMS consider issuing a national coverage determination establishing medical necessity and reasonableness for bariatric surgery performed on patients with Type 2 DM and a BMI >35 while at the same time not making any formal conclusion in the NCD about patients with Type II DM and BMI < 35. In that situation, existing CMS policies would apply to the latter group, and CMS could reevaluate the question of medical reasonableness and necessity at a time point in the future when adequate data were available to make an informed decision about health outcomes after bariatric surgery in Type II DM patients with BMI < 35. The Society feels that the enormous negative impact of a formal national non-coverage decision for the latter group is not warranted at this time, and that it is very likely that substantial additional information from research studies should be available to CMS within a relatively short period of time to enable a more precise determination of health outcomes and of medical necessity.

Thank you for the opportunity to comment on this issue. If you need further assistance, please don’t hesitate to contact Stephanie Kutler, Associate Director of Government and Professional Affairs at 301-941-0254 or skutler@endo-society.org.

Sincerely,

Robert M. Carey, MD, MACP
President
The Endocrine Society

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As a surgeon and member of a healthcare team that provides treatment to those suffering from obesity, I amtroubled by Medicare’s decision to not cover bariatric surgery for obese Medicarebeneficiaries with type 2 diabetes with a BMI Of less than 35, as outlined in the recently proposed Decision Memo for Surgery forDiabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services(CMS).Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatricsurgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned thatthe exclusive language in the proposed decision memo will leave little room for the inclusion of theseongoing, as well as future clinical trials. CMS should support language that acknowledges thatthese trials will significantly impact the discussion. Decisions can be made when data from these trials are available. In fact, I believe that the benefits of surgicalintervention for this specific population may be so great that CMS should investigate utilizing itscoverage with evidence development (CED) process utilizing the data collection services of existingBariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric OutcomesLongitudinal Database (BOLD™).

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As a member of the healthcare team that provides treatment to those suffering from obesity, I am troubled by Medicare’s decision to not cover bariatric surgery for non-morbidly obese Medicare beneficiaries with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS). Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, I believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing its coverage with evidence development (CED) process - utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD™). Medicare’s CED process is designed to collect additional patient data as part of the coverage process so as to generate more robust data on the utilization and impact of a particular service in question. Utilization of the CED process would enable Medicare to better document the appropriateness of bariatric surgery for this specific population and generate additional clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding bariatric surgery for diabetes. A second, and continuing concern, revolves around how Medicare Administrative Contractors (MACs) will interpret the inclusion of type 2 diabetes as the only listed co-morbidity outlined under Section 100.1 of the Medicare Coverage Manual regarding bariatric surgery for treatment of morbid obesity. Morbidly obese patients are already facing significant roadblocks to accessing medical and surgical treatment for their disease. We fear that this recent action by CMS may further fortify, rather than breakdown, many of these obstacles. Unless specifically instructed otherwise, many MACs may interpret type 2 diabetes as the only acceptable co-morbidity and continue to apply their own additional standards limiting care. For example, some MACs require Medicare beneficiaries to have uncontrolled type 2 diabetes in order to qualify as an acceptable candidate for bariatric surgery. CMS should issue specific instructions informing MACs that the diagnosis of type 2 diabetes in any morbidly obese individual is only one of many acceptable co-morbidities enumerated in the February 21, 2006 NCD, which allow for bariatric surgical treatment. This would reinforce coverage for those with type 2 diabetes while ensuring that those with other co-morbidities maintain coverage as well. Thank you for the opportunity, Sincerely Amjad Ali, MD

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Arthur Meltzer, Ph.D.
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21224
Re: Surgery for Diabetes CAG-00397N

Dear Dr. Meltzer,

As a designated Bariatric Center of Excellence, Gundersen Lutheran is concerned about the proposed rule revising Section 1862(a)(1)(A) of the Social Security Act to limit coverage for bariatric surgery patients with diabetes. As one of the nation’s best performing bariatric surgery programs in the country, our outcomes data adds to the evidence demonstrating how a successful bariatric surgery program can reduce healthcare costs of obese patients with diabetes.

After completing 700 surgeries with a zero fatality rate, Gundersen Lutheran has some of the best bariatric outcomes in the country. Gundersen Lutheran’s Bariatric Surgery team uses a type of minimally invasive obesity surgery called Laparoscopic Roux-en-Y gastric bypass (LRYGB).

Gundersen Lutheran’s physician researchers found that gastric bypass surgery patients have considerably better control of their Type 2 diabetes three years after gastric bypass surgery. We found that 82% of post-surgery patients no longer had Type II diabetes. The remaining patients experienced significant long-term improvement of their blood sugar levels. Nearly 60 percent more post-surgery patients were no longer using oral blood sugar medications or insulin than obese patients who were treated conventionally. The amount of money spent on medications for obese patients was reduced by 39 percent two years after surgery at Gundersen Lutheran. We are working to collect data regarding outpatient care savings, as well.

Gundersen Lutheran recommends that gastric bypass surgery be recognized by CMS as a primary treatment option for appropriate patients with Type 2 diabetes. The proposed rule’s restrictions in bariatric coverage limit the medical community’s ability to provide patient-centered, high quality, evidence-based care. The proposed rule will limit patient access to one of the most effective medical approaches to eliminating Type 2 diabetes and the costs associated with obesity’s co-morbidities.

Results from the 2003-2004 National Health and Nutrition Examination Survey (NHANES) show that an estimated 66 percent of U.S. adults are either overweight or obese with a BMI of 25 or higher. A person with a BMI of 25-35 experiences an average of three to four years of life lost.

According to the CDC, 23.7 million Americans have diabetes; with almost a third going undiagnosed and only 6% being classified as Type 1. In 2006, the nation spent $22.9 billion directly treating diabetes. Total direct and indirect costs of diabetes in the U.S. for 2007 were $218 billion. Although research is limited, initial studies indicate that gastric bypass surgery can improve patient health and lower healthcare costs by reducing costly obesity-related health conditions in patients with BMI’s lower than 35. Therefore, we recommend that the current guidelines for treatment be kept in place until a cost-benefit analysis for bariatric surgery in this patient population can occur. We are confident that the results will demonstrate a positive financial impact for the Centers for Medicaid and Medicare Services and healthcare costs nationally.

I am available to meet with you to provide additional information and expertise as CMS evaluates the value of bariatric surgery treatment for patients with Type 2 diabetes. Please do not hesitate to call me at the contact information listed.

Sincerely,

Dr. Shanu Kothari, M.D. FACS
Director of Minimally Invasive Bariatric Surgery
Gundersen Lutheran Medical Center
900 South Avenue
La Crosse, WI 54601
Mail Stop C05-001
608-775-5187
snkothar@gundluth.org

1. National Health and Nutrition Examination Survey. Centers for Disease Control. Department of Health and Human Services. Overweight and Obesity. Retrieved on December 3, 2008 from: http://www.cdc.gov/nccdphp/dnpa/obesity/faq.htm
2. Fontaine, K.R. et al. Years of Life Lost Due to Obesity. JAMA. 8 January 2003. 289:187-93.
3. 2007 National Diabetes Fact Sheet. Centers for Disease Control. National Center for Chronic Disease Prevention and Health Promotion. Department of Health and Human Services. Retrieved on December 3, 2008 from http://www.cdc.gov/Diabetes/pubs/estimates07.htm
4. Johnson, L. Study: Cost of Diabetes $218B. Associated Press. Extracted from the USA Today Online. 18 November 2008. Retrieved on December 3, 2008 from http://www.usatoday.com/news/health/2008-11-18-diabetes-cost_N.htm
5. State of Diabetes Complications in America. American Association of Endocrinologists. Extracted from Bio-Medicine.org. 10 April 2007.
6. Johnson, L. Study: Cost of Diabetes $218B. Associated Press. Extracted from the USA Today Online. 18 November 2008. Retrieved on December 3, 2008 from http://www.usatoday.com/news/health/2008-11-18-diabetes-cost_N.htm

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As a member of the healthcare team that provides treatment to those suffering from obesity, I amtroubled by Medicare’s decision to not cover bariatric surgery for non-morbidly obese Medicarebeneficiaries with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services(CMS).

Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges thatthese trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, I believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing its coverage with evidence development (CED) process utilizing the data collection services of existingBariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric OutcomesLongitudinal Database (BOLD™).

Medicare’s CED process is designed to collect additional patient data as part of the coverage process so as to generate more robust data on the utilization and impact of a particular service in question. Utilization of the CED process would enable Medicare to better document the appropriateness of bariatric surgery for this specific population and generate additional clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding bariatric surgery for diabetes.

A second, and continuing concern, revolves around how Medicare Administrative Contractors (MACs)will interpret the inclusion of type 2 diabetes as the only listed co-morbidity outlined under Section100.1 of the Medicare Coverage Manual regarding bariatric surgery for treatment of morbid obesity.

Morbidly obese patients are already facing significant roadblocks to accessing medical and surgical treatment for their disease. We fear that this recent action by CMS may further fortify, rather than breakdown, many of these obstacles.Unless specifically instructed otherwise, many MACs may interpret type 2 diabetes as the onlyacceptable co-morbidity and continue to apply their own additional standards limiting care. Forexample, some MACs require Medicare beneficiaries to have uncontrolled type 2 diabetes in order toqualify as an acceptable candidate for bariatric surgery. CMS should issue specific instructions informing MACs that the diagnosis of type 2 diabetes in any morbidly obese individual is only one of many acceptable co-morbidities enumerated in the February 21, 2006 NCD, which allow for bariatric surgical treatment. This would reinforce coverage for those with type 2 diabetes while ensuring that those with other co-morbidities maintain coverage as well.

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I am currently a bariatric surgeon practicing in Des Moines Iowa and I was very concerned about the recent CMS ruling. I strongly feel this will improperly limit access to life saving surgery for a large group of people and has implications to do the same for other patients with private insurance that tend to follow the lead of Medicare.

As a member of the healthcare team that provides treatment to those suffering from obesity, I am troubled by Medicare’s decision to not cover bariatric surgery for non-morbidly obese Medicare beneficiaries with type 2 diabetes as outlined in the recently proposed Decision Memo for Surgery for Diabetes (CAG-00397N) issued on November 17, 2008, by the Centers for Medicare & Medicaid Services (CMS).

Currently there are ongoing clinical trials that will shortly clarify the efficacy and safety of bariatric surgery in Medicare Beneficiaries with type 2 diabetes with a BMI of >/=30kg/m2. I am concerned that the exclusive language in the proposed decision memo will leave little room for the inclusion of these ongoing, as well as future clinical trials. CMS should instead support language that acknowledges that these trials may significantly impact the discussion and leave the door open to further clarification at the time data from these trials are available. In fact, I believe that the potential benefits of surgical intervention for this specific population may be so great that CMS should investigate utilizing its coverage with evidence development (CED) process utilizing the data collection services of existing Bariatric Surgery Centers of Excellence and the Surgical Review Corporation’s Bariatric Outcomes Longitudinal Database (BOLD™). Medicare’s CED process is designed to collect additional patient data as part of the coverage process so as to generate more robust data on the utilization and impact of a particular service in question. Utilization of the CED process would enable Medicare to better document the appropriateness of bariatric surgery for this specific population and generate additional clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding bariatric surgery for diabetes.

A second, and continuing concern, revolves around how Medicare Administrative Contractors (MACs) will interpret the inclusion of type 2 diabetes as the only listed co-morbidity outlined under Section 100.1 of the Medicare Coverage Manual regarding bariatric surgery for treatment of morbid obesity. Morbidly obese patients are already facing significant roadblocks to accessing medical and surgical treatment for their disease. We fear that this recent action by CMS may further fortify, rather than breakdown, many of these obstacles. Unless specifically instructed otherwise, many MACs may interpret type 2 diabetes as the only acceptable co-morbidity and continue to apply their own additional standards limiting care. For example, some MACs require Medicare beneficiaries to have uncontrolled type 2 diabetes in order to qualify as an acceptable candidate for bariatric surgery. CMS should issue specific instructions - informing MACs that the diagnosis of type 2 diabetes in any morbidly obese individual is only one of many acceptable co-morbidities enumerated in the February 21, 2006 NCD, which allow for bariatric surgical treatment. This would reinforce coverage for those with type 2 diabetes while ensuring that those with other co-morbidities maintain coverage as well.

Specifics of November 18, 2008 CMS Proposed Decision Memo regarding Surgery for Diabetes

1) The evidence is not adequate to conclude that open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) improve health outcomes in Medicare beneficiaries who have type 2 diabetes mellitus (T2DM) and a body-mass index (BMI) <35. Therefore, we are proposing that these procedures are not reasonable and necessary for patients with type 2 diabetes and BMI < 35 under section 1862(a)(1)(A) of the Social Security Act.

2) The evidence is adequate to conclude that open and laparoscopic Roux-en-Y gastric bypass (RYGBP), laparoscopic adjustable gastric banding (LAGB), and open and laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) improve health outcomes in Medicare beneficiaries who have T2DM and a BMI > to 35. Thus, we are proposing that type 2 diabetes mellitus is a comorbid condition related to obesity as defined in NCD Manual 100.1 (Bariatric Surgery for Treatment of Morbid Obesity).

3) This decision proposes no changes to National Coverage Determination (NCD) Manual section 100.8 (Intestinal Bypass Surgery) and section 100.11 (Gastric Balloon for Treatment of Obesity). Treatments for obesity alone remain non-covered, as does use of the open or laparoscopic sleeve gastrectomy procedure regardless of the patient''s BMI or comorbidity status

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I read the press release regarding MEDICARE PROPOSES REVISED COVERAGE POLICY FOR BARIATRIC SURGERY AS A DIABETES TREATMENT. Regarding the statement "While recent medical reports claimed that bariatric surgery may be helpful for these patients, CMS did not find convincing medical evidence that bariatric surgery improved health outcomes for non-morbidly obese individuals". I disagree with this statement. [PHI Redacted] I believe this is one of the best things that CMS has ever done...offer preventative surgery to those who otherwise would have no hope! Congratulations CMS...decision well made!

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