ASMBS News and Update—November 2011

November 2011

by Robin L. Blackstone, MD, FACS, FASMBS

Dr. Blackstone is President of the American Society for Metabolic and Bariatric Surgery and Medical Director, Scottsdale Healthcare Bariatric Center, Scottsdale, Arizona.

Important news. The American Society for Metabolic and Bariatric Surgery (ASMBS) responded with a strong letter to the Centers for Medicare and Medicaid Services (CMS) about the coverage of sleeve gastrectomy within the National Coverage Determination on Bariatric Surgery. In preparing that response the society updated the Laparoscopic Sleeve Gastrectomy position statement.
For the full details please go to bit.ly/ASMBSPositionStatements

Health Care Services Corporation removes mandatory preoperative weight loss requirement
By Christopher Joyce, MD, FACS, FASMBS
Health Care Services Corporation (HCSC), the parent company of BlueCross BlueShield (BCBS) of Illinois, Texas, Oklahoma, and New Mexico has eliminated the mandatory six-month weight loss requirement prior to bariatric surgery. Multiple meetings and correspondence between the ASMBS members and Medical Policy representatives of HCSC resulted in this improved access to care for patients suffering from obesity.

Access to care became more onerous when HCSC increased the preoperative requirement from 3 to 6 months on March 15, 2011. That led to a meeting between the officers of the Illinois State Chapter of ASMBS, Drs. Christopher Joyce and Rami Lutfi, and BCBS of Illinois, at which time clinical data were provided and reviewed. The Chairman of the Insurance Committee, Dr. Jaime Ponce, the Chairman of the Access to Care Committee, Dr. John Morton, and the Chairman of the State Chapters Committee, Dr. Lloyd Stegemann provided valuable assistance and guidance. In addition, the draft of the ASMBS Position Statement on Preoperative Supervised Weight Loss Requirement was instrumental in preparation for the meeting. Through Dr. Stegemann, similar efforts were applied in Texas between its State Chapter and BCBS of Texas.

After months of correspondence between the state chapters’ leadership and BCBS followed by an objective internal review of the medical evidence by the medical policy makers, HCSC came to the conclusion that the preoperative weight loss requirement should be removed. This news was revealed at a meeting in Chicago between the President of ASMBS, Dr. Robin Blackstone, the President of the Illinois Chapter of ASMBS, Dr. Joyce, and the Director of Medical Management of BCBS of Illinois, Dr. Rose Ann Madarang, on September 21, 2011. This important step toward better access to care for our patients was accomplished through advocacy and teamwork by ASMBS leadership and a willingness of HCSC to evaluate the medical evidence objectively.

ASMBS participates in the United States Food and Drug Administration hearing on medical devices by Bipand Chand, Chair of Emerging Technology and Procedures Committee. The Device Development in Obesity and Metabolic Disease (DDOMD) meeting, October 16 to 18, 2011, Washington, DC, was hosted by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), the Dartmouth Device Development/GI (3Dgi) at Dartmouth Medical School, and the Obesity, Metabolism and Nutrition Institute (OMNI) at Massachusetts General Hospital (MGH). The focus of the meeting was on best practices in clinical trial design and efficacy and safety assessment of medical devices for the treatment of obesity and metabolic disorders. The organizers included Herbert Lerner, MD (FDA); Richard Rothstein, MD (MGH); and Lee M. Kaplan, MD, PhD (Dartmouth).

Over 130 individuals were actively involved in the meeting, including over 30 members from the United States Food and Drug Administration (FDA), 50 representatives from industry, 30 clinicians and scientists, and several other stakeholders. ASMBS representatives included our president Dr. Robin Blackstone and Dr. Bipan Chand, ASMBS Emerging Technology and Procedures Committee Chair. The format of DDOMD consisted of lectures and panel discussions addressing several key topics, including an overview of the epidemic of obesity and associated metabolic diseases. The predominant theme of the meeting was optimization of clinical trial design for devices in the obesity field.

The keynote speaker, Boris D. Lushniak, MD, MPH, Deputy Surgeon General of the United States, spoke of multiple measures taking place at the national level addressing the obesity epidemic and focused on several preventive measures currently in place and upcoming. The meeting continued with several case presentations of previous device trials with their outcomes. Discussion on appropriate inclusion and exclusion criteria for future trials and some of the pitfalls of current trial designs were discussed. Emphasis was placed on future trial designs by focusing on multiple outcome targets including weight loss and comorbidity improvement with direct relationship to risk of therapy and risk of withholding therapy. A significant part of the meeting was tying outcomes to risk, assessing device risks, and developing appropriate and graded outcomes when developing weight loss device trials. Lee Kaplan, MD, introduced and proposed a stratification system that took into account the risk of the device and the expected outcome of the therapy. An expert panel, including Drs. Chand and Ginsberg, Chairs of the ASMBS/ASGE Task Force on Endoluminal Bariatric Therapy (EBT), discussed the White Paper on EBT and strategies to take into account when evaluating such therapies and their primary intent in relationship to risk/benefit.
The second day focused on device development strategies and regulatory considerations. Several talks given by FDA members focused on similarities of devices and differences in regard to drug development, combination therapies, and regulatory considerations in device development. The meeting concluded with talks from members of industry, payors, and clinicians focusing on each of their perspectives on the development and incorporation of such devices in the treatment of obesity and related illnesses.

Dr. Herbert Lerner outlined the current steps industry should anticipate when creating trial designs for new devices and how members of the FDA evaluate devices and the methodology of such trials. Key to moving forward for all parties is an environment of transparency. Steps in place include developing a document by the FDA that can give guidance to industry, physicians, and other involved parties on how to best develop device trials in regard to risk and benefit. This document will be available later this year and will build on the foundation of the White Paper on EBTs and the proposed stratification system by Dr. Kaplan. An expert panel (FDA will assign members) will convene in early next quarter to further refine the appropriate device design and outcome measures.

Developing the ASMBS Coverage Map—Requesting help from all bariatric and insurance coordinators.
By Wayne English, Co-Chair ASMBS Access to Care Committee
The ASMBS is developing a comprehensive map of the United States that will provide the leadership with useful insurance information about coverage for bariatric surgery. The coverage map will be used to identify where insurance coverage and provider deficiencies exist, thus allowing the ASMBS leadership to focus their efforts and develop strategies to correct the disparity within these regions of the country. The map will also be available as a general reference for the ASMBS membership, where information can be obtained regarding bariatric surgery insurance coverage, preauthorizations, mandates, and restrictions by payors and state.

Additional information available on the coverage map will include the following:
•    state employee coverage data
•    nongovernmental employee coverage data
•    Medicaid coverage data
•    procedure density data per state and region (obtained from Bariatric Outcomes Longitudinal Database [BOLD])
•    Centers for Disease Control and Prevention (CDC) obesity trend maps
•    Center of Excellence (COE) density data per state
•    sleeve gastrectomy coverage data by state
•    data from all procedures using emerging technology and currently not covered by insurance
•    state chapter information
•    individual bariatric surgery practice and hospital information.

Maps and information from each state and practice will become more detailed as users negotiate the website.

To look at the coverage maps and help with the project please go to maps.asmbs.org

What’s at stake in doing investigational procedures outside of institutional review board/study circumstances? The national conversation about how and when we should be offering new procedures is ongoing. Recently the ASMBS Executive Council published a statement on Laparoscopic Greater Curve Plication (LGCP) and LGCP with a band. The full statement is available on the ASMBS website: bit.ly/ASMBSPolicyStatements. In addition to this publication, additional work is being done to address this within the ASMBS structure of bylaws under the ethics section led by Robert Brolin, Chair of the ASMBS Ethics Committee. Dr. Marc Bessler, Councilman at Large on the Executive Council of ASMBS, is leading a task force to develop a process and methodology that would allow new procedures to be investigated through a central institutional review board (IRB) process with capture of the data in the ASMBS Bariatric Surgery Center of Excellence (BSCOE) database. His taskforce will establish a framework for new procedures/devices seeking status as an ASMBS approved procedure.

So why is there all of this attention at this time? In the long history of bariatric surgery, there have been groups of scientists who have carefully brought new procedures forward and studied them adequately to ensure safety and efficacy; however, there has always been an undercurrent of bariatric surgery that is entrepreneurial and experimental. This less scientific approach is part of the reason that bariatric surgeons have received little respect among their peers both among the surgical field and with medical colleagues. Surgeons have invented new procedures and, without scientific testing, began to offer it to patients without having adequate consent. We continue to battle the echoes of this in bariatric surgery. In 2011, our profession exists in a crucible of public opinion with constant digital scrutiny. In this day and age, when a billboard goes up advertising weight loss surgery along the California highway and high-profile deaths are made public, the calls come in from news organizations around the country asking that the society be held accountable.

Slowly over the last 10 years, and with a herculean effort on behalf of some of our best scientists, funding from the National Institutes of Health (NIH) and others has allowed us to carefully and prospectively study the procedures we perform. Basic scientofic research and careful study in animal models has brought understanding of the way in which the metabolic procedures we perform address the central biological defects of obesity. Through the scientific process, we have offered our medical colleagues a coherent and cogent argument for the use of bariatric surgery and gained credibility in our field. All of this is threatened when we go back to an old paradigm of experimentation.

Please join me and the leadership of the society in making a conscious decision to provide experimental procedures ONLY within the context of IRB guidance and adequate consent. Participate in working toward a system of careful study of any new procedures, by joining the group of surgeons who will study these procedures under IRB oversight and with accurate data collection.

Take an ethical stand with the leadership on this issue. Together we can continue to add credibility in our field of medicine while testing new procedures and devices for safety and efficacy. That is a win-win situation for surgeons and the patients we treat. We have come so far—let’s not allow that gain to be put at risk.

Institute of Medicine workshop on cancer recurrence and obesity. In October 2011, Past ASMBS President Dr. Bruce Wolfe and President Dr. Robin Blackstone attended a novel workshop in Washington, DC, on cancer recurrence and obesity. One in three Americans will develop cancer in their lifetime and of these, 15 percent will have a recurrence of cancer.[1] The workshop examined to what extent the recurrences are due to obesity. The mechanisms of how obesity drives cancer were examined in detail highlighting some intense and important discoveries about the biology of obesity. Dr. Wolfe reported the results of three studies in the surgical literature that demonstrate a decrease in cancer after gastric bypass (Table 1). Dr. Wadden gave an overview of the results of medical weight loss and the long-term benefits of behavioral weight loss that persist even in the face of weight regain (i.e., Legacy Effect). The slide presentation made by Dr. Wolfe can be found on the ASMBS website at bit.ly/ASMBSInfoInterest. ASMBS Program Chair Dr. Ninh Nguyen has placed a special forum on the topic of obesity and cancer on the agenda for the ASMBS Annual Meeting in June 2012. This is an area that is fertile for research efforts funded by the National Cancer Institute.

Global bariatric healthcare statement is published by the ASMBS. Many surgeons in the United States are faced with the emergency care of patients who have sought their primary bariatric procedure outside the United States, a phenomenon often referred to as “medical tourism.” This industry is expected to exceed $21 billion dollars by 2011 with the cost of care discounted 40 to 80 percent. In response to this growing concern for AMSBS members, the Clinical Issues Committee with the International Committee, Chaired by Raul Rosenthal, proposed the following statement, which can be found at bit.ly/ASMBSPositionStatements, that has been approved by the Executive Council. The major summary points are as follows:
1.    Based on the unique characteristics of the bariatric patient, the potential for major early and late complications after bariatric procedures, the specific follow-up requirements for different bariatric procedures, and the nature of treating the chronic disease of obesity, extensive travel to undergo bariatric surgery should be discouraged unless appropriate follow up and continuity of care are arranged and transfer of medical information is adequate.
2.    The ASMBS opposes mandatory referral across international borders or long distances by insurance companies for patients requesting bariatric surgery if a high-quality bariatric program is available locally.
3.    The ASMBS opposes the creation of financial incentives or disincentives by insurance companies or employers that limit patients’ choices of bariatric surgery location or surgical options and, in effect, make medical tourism the only financially viable option for patients.
4.    The ASMBS recognizes the right of individuals to pursue medical care at the facility of their choice. Should they choose to undergo bariatric surgery as part of a medical tourism package or pursue bariatric surgery at a facility a long distance from their home, the following guidelines are recommended:
• Patients should undergo procedures at an accredited Joint Commission International (JCI) institution or preferably a bariatric center of excellence.
• Patients should investigate the surgeon’s credentials to ensure that the surgeon is board eligible or board certified by a national board or credentialing body. Individual surgeon outcomes for the desired procedure should be made available as part of the informed consent process whenever possible.
• Patients and their providers should ensure that follow-up care, including the management of short- and long-term complications, are covered by the insurance payer or purchased as a supplemental program prior to traveling abroad.
• Surgical providers should ensure that all medical records and documentation are provided and returned with the patient to their local area. This includes the type of band placed and any adjustments performed in the case of laparoscopic adjustable gastric banding, as well as any postoperative imaging performed.
• Prior to undergoing surgery, patients should establish a plan for postoperative followup with a qualified local bariatric surgery program to monitor for nutritional deficiencies and long-term complications, and to provide ongoing medical, psychological, and dietary supervision.
• Patients should recognize that prolonged traveling after bariatric surgery might increase the risk of deep venous thrombosis (DVT), pulmonary embolism (PE), and other perioperative complications.
• Patients should recognize that there are risks of contracting infectious diseases while traveling abroad that are unique to different endemic regions.
• Patients should recognize that travel over long distances in a short period of time for bariatric surgery may limit appropriate preoperative education and counseling regarding the risks, benefits, and alternatives for bariatric operations. This also significantly limits the bariatric surgery program’s ability to medically optimize the patient prior to surgery.
• Patients should understand that compensation for complications might be difficult or impossible to obtain;
• Patients should understand that legal redress for medical errors for procedures performed across international boundaries is difficult.
5.    When a patient who has had a bariatric procedure at a distant facility presents with an emergent life-threatening postoperative complication, the local bariatric surgeon on call should provide appropriate care to the patient consistent with the established standard of care and in keeping with previous published statement by the ASMBS.[2] This care should be provided without risk of litigation for complications or long-term sequelae resulting from the initial procedure performed abroad. Routine or nonemergent care for patients who have had bariatric surgery elsewhere should be provided at the discretion of the local bariatric surgeon.

To view the full position statements please go to the ASMBS website: bit.ly/ASMBSPositionStatements.

Teaching the biology of obesity and the mechanism of action of behavioral, pharmaceutical and surgical weight loss. Over a week in October 2011, I was engaged in teaching the first ever “obesity week” to second-year medical students in the University of Arizona School of Medicine Phoenix program. Fifty students were led through a complex curriculum that culminated with a session of five medical and surgical weight loss patients in a question-and-answer session. The next week, students came to our clinic to see patient operating room cases or see patients in the clinic in a “Capstone” project. Students also participated in a spin class with the instructor at 5:30am on Wednesday mornings.  At the beginning of the week, we had about three-fourths of the class participating, but as word spread about the relevance of the topics, more and more students started to come to class. On Friday morning, the patient session was standing room only.

The message was clear. I wanted these students at this formative time in their careers to see patients’ weight and risk for obesity-related disease clearly.  For instance, when a patient comes to the clinic with a headache, but his or her body mass index (BMI) is 50kg/m2, I wanted the students to ask themselves if this was a simple headache or perhaps a result of hypertension, pseudotumor cerebrii, or other causes that were weight related rather than simply a migraine.

I would encourage everyone who is teaching to strive to implement this type of training in obesity for students. Two-thirds of our students’ patients will be overweight or obese. Exposure at this early stage in their careers will have a major impact. The course was included in the section on endocrine and gastrointestinal tract. The syllabus can be viewed at the ASMBS website: bit.ly/ASMBSInfoInterest

References
1.    Parry C, Kent EE, Mariotto AB, et al. Cancer survivors: a booming population. Cancer Epidemiol Biomarkers Prev. 2011;20(10):1996–2005.
2.    Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery. American Society for Metabolic and Bariatric Surgery position statement on emergency care of patients with complications related to bariatric surgery. Surg Obes Relat Dis. 2010;6(2):115–117.

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Category: ASMBS News and Update, Past Articles