ASMBS News and Update—October 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.

ASMBS Mission Statement
The American Society for Metabolic and Bariatric Surgery was founded in 1983 to establish educational and support programs for surgeons and integrated health professionals. Our mission is to improve the care and treatment of people with obesity and related disease; to advance the science and understanding of metabolic surgery; to advocate for health care policy that ensures patient access to high-quality prevention and treatment of obesity. For more information, visit www. ASMBS.org. If you are interested in becoming a member or have questions about ASMBS, please contact Georgeann Mallory, the ASMBS Executive Director, via phone: (352)-331-4900 or e-mail: [email protected].

Important upcoming dates.
October 31, 2011. Abstract deadline for American Society for metabolic and Bariatric Surgery (ASMBS) Annual Meeting 2012.

The ASMBS strengthens the statement on laparoscopic greater curvature plication (LGCP) with or without banding. Last year, some outpatient surgery centers and surgeons in California queried the ASMBS about whether the laparoscopic greater curvature plication (LGCP) was an approved ASMBS procedure. ASMBS President Bruce Wolfe asked the Clinical Issues committee, led by Stacy Brethauer, to evaluate the literature base. The Clinical Issues committee then stated that the literature was insufficient to allow even a clinical position statement to be issued. The ASMBS Executive Committee decided at the Winter Retreat in February of 2011 to make a statement that the LGCP was investigational with insufficient data of safety or efficacy and should be performed under an institutional review board (IRB).

Recently, the issue was raised again as a question from a hospital bariatric committee on whether the LGCP plus adjustable gastric band (AGB) was specifically covered by the statement. An additional literature search was conducted on both the LGCP and the LGCP plus AGB. Again, the Clinical Issues committee found data insufficient to reach any conclusion except that these procedures should be considered. The Executive Council took up this additional question and has strengthened the original statement on the LGCP and the LGCP plus AGB to specifically state that both procedures are considered investigational and should be done only under an IRB. In the case of the LGCP plus AGB, there is only one article describing 26 patients with one-year follow up.

The ASMBS currently supports the following recommendations regarding gastric plicaton alone or in combination with adjustable gastric band placement for the treatment of obesity:

1.    Gastric plication procedures should be considered investigational at this time. This procedure should be performed under a study protocol with third party oversight (local or regional ethics committee, IRB, Data Monitoring and Safety Board, or equivalent authority) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.
2.    Reporting of short- and long-term safety and efficacy outcomes in the medical literature and scientific meetings is strongly encouraged. Data for these procedures should also be reported to a program’s Center of Excellence (COE) database.
3.    Any marketing or advertisement for this procedure should include a statement to the effect that this is an investigational procedure.
4.    The ASMBS supports research conducted under an IRB protocol as it pertains to investigational procedures and devices. Investigator meetings held to facilitate research are necessary and supported, as is the reporting of all data through the Bariatric Outcomes Longitudinal Database (BOLD), Bariatric National Surgical Quality Improvement Program (NSQIP), or a specific research database. The ASMBS does not support continuing medical educations (CME) courses on investigational procedures and devices held for bariatric surgeons for the purpose of use of investigational procedures outside an IRB research protocol.

Over the past 50 years, the field of bariatric surgery has investigated the treatment of obesity using the scientific method and peer-reviewed scrutiny. Through use of the scientific method, we have established credibility with our medical and surgical colleagues. This credibility is threatened when surgeons abandon this process to adopt new, unproven procedures for which the safety and efficacy data are unknown. It is not the case that the only good procedures are the ones we already have, but with the procedures we are currently doing, the data are strong and the risks and benefits are known in large groups of patients. In addition, for three of these procedures, sleeve gastrectomy, Roux-en-Y gastric bypass (RYGB), and biliopancreatic diversion with duodenal switch (BPD/DS), the mechanism of action of these procedures is tied to the change in biology of the patient with obesity. This means that these procedures are truly metabolic surgical procedures and do not primarily work through restriction or malabsorption.[1]

Medical legal and ethical issues are also present in this discussion. Legally offering unapproved procedures unsupported by the literature puts a surgeon at risk for litigation, should a complication occur, and may also create a situation where his or her malpractice carrier abandons coverage. The ethical issues are perhaps more important, especially if part of the motivation to perform these procedures is monetary (since they are not covered by insurance, patients pay cash for them). At the heart of both of these issues is the inability of a surgeon, in the situation where the peer-reviewed literature is insufficient, to adequately inform the patient of the risk or benefit of the operation.

LGCP or LGCP plus AGB may yet prove to be a valuable procedure to add to our arsenal of surgical procedures used in the treatment of morbid obesity. The adoption of the procedure outside a research protocol under an IRB is premature.

Steve Jobs in a conversation with Steven Lohr in the early 1990s commented about the start ups that were focused on an “exit strategy” of selling their companies. “It’s such a small ambition and sad really,” Mr. Jobs said. “They should want to build something, something that lasts.”[2]

The ASMBS launches new website. The ASMBS Communications Committee (Chair Dr. Kevin Reavis) and the ASMBS Information Technology staff have created a new user friendly, dynamic website to better serve our members and the public. The new site is easier to navigate and engages the user who is looking for information from the society. Eventually, the site will incorporate a public portal and access to care coverage maps that will help patients find our ASMBS members. In addition, there is a more robust social networking site.

Stay tuned for the BMI (Bariatric Movies and Images) section where you will be able to post your best videos and have your peers rank them.

We will continuously update the website as we strive to improve on this resource. The ongoing objective remains to enhance communication between the ASMBS and its members, potential members, and the public through this web portal.
Please go to www.asmbs.org to visit the new site.

Medicare reopens National Coverage Determination to consider adding sleeve gastrectomy as a covered procedure. The Centers for Medicare and Medicaid Services (CMS) has opened the National Coverage Determination (NCD) on bariatric surgery to consider the narrow question of whether the sleeve gastrectomy should be added to the covered procedures for Medicare patients.

In 2004, CMS decided that obesity was not a “condition” but did not go so far as to declare obesity a disease. This opened the door for coverage of bariatric procedures for obesity (conditions are not covered under CMS). Then CMS moved forward with a public review of the data on bariatric surgery framed around a number of questions. The leadership of the ASMBS testified at that meeting and the Medicare Coverage Advisory Committee  (MCAC) voted to endorse providing bariatric surgery through the ASMBS bariatric surgery COE program and the American College of Surgeons (ACS) Bariatric Surgery Center Network (BSCN) program. In 2009, the NCD was reopened by CMS for the specific reason to include type 2 diabetes mellitus (T2DM) as an indication for surgery.

The leadership of ASMBS approached CMS in October 2010 to discuss adding the sleeve gastrectomy procedure to the list of covered procedures since the NCD covers BPD/DS of which the sleeve is a component, but CMS declined. The data on sleeve were sent to CMS. Since then, the data have been strengthened and the Society is poised to meet the call for public comment with a strong evidence-based letter authored by Access to Care Committee Chair John Morton, data from BOLD and Debbie Winegar, Vice President of Research at Surgical Review Corporation (SRC), and comments from organizations that are part of the obesity coalition from around the country, including the Michigan Bariatric Surgery Collaborative the the Obesity Action Coalition (OAC). The comment period is open through October 30, 2011. Comments should be data driven.

To view the full announcement, please visit https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=258&fromdb=true

Instructions for submitting public comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage.

The ASMBS and ACS enter a new period of collaboration on quality in bariatric surgery. Bruce Wolfe, ASMBS Past President of ASMBS; Robin Blackstone, MD, ASMBS President; Jaime Ponce, MD, ASMBS President Elect; and Ninh Nguyen, MD, ASMBS Secretary Treasurer, met with representatives of the ACS led by David Hoyt, MD, Executive Director; Cliff Ko, MD; and Matt Hutter, MD, in Chicago on September 22, 2011. During the two-hour meeting, we examined the history of the two programs and how they came to evolve. We discussed the ASMBS vision for the future of the ASMBS BSCOE as well as the vision of the college for its overall quality program through NSQIP. This frank and open discussion allowed the two societies to find common ground to begin working together on joint projects like Facility Credentialing in Bariatric Surgery.

The ASMBS Executive Council, based on recommendations from the Quality and Standards Committee, approved moving forward to define a composite outcomes measure as a way for ASMBS BSCOE programs to measure themselves and their performance against their peers. In addition, planning for creation of the ASMBS National Bariatric Quality Improvement Program (ASMBS NBQIP) to complement the ASMBS BSCOE program  is being explored with guidance from Nancy and John Birkmeyer who have been instrumental in establishing the Michigan Bariatric Surgery Collaborative (MBSC). The ASMBS Quality and Standards Committee currently have support for its work from expert researchers in quality from ASMBS, ACS, and MBSC. This assembly of talent will be able to provide thoughtful and informed guidance of our BSCOE program.

Update on Institute of Medicine report on the Essential Health Benefit. The major gap in coverage of bariatric surgery is in the small employer market (10–499 employees). The Health Insurance Exchanges are being set up to help these small employers afford quality healthcare by pooling the risk of many small employers together. The Institute of Medicine (IOM) was tasked with producing a document to guide the Health and Human Services (HHS) develop what will constitute the Essential Health Benefit (EHB).

One reason that small employers in the field of bariatric surgery have not been able to get a benefit is that the group is not large enough to offset the risk of having one person who is obese and needs surgery (with the accompanying expense). The ASMBS has been working very hard to insert the “evidence-based treatment of obesity” in the EHB. Unfortunately, the IOM report did not address obesity specifically. The ASMBS Access to Care committee and our partners will be meeting in early October 2011 to plan a strategy going forward. We still have hopes that recognition of the major role obesity and related diseases are playing in the cost of healthcare will motivate Secretary Sibelius to include the evidence-based treatment of obesity in the EHB (due out January 1, 2012).

Chris Gallagher from Potomac Currents, who represents the ASMBS in Washington, DC, has summarized the IOM recommendations for the development of the EHB. The following lists the recommendations:

IOM criteria to guide content of the aggregate EHB package. In the aggregate the EHB must do the following:
•    Be affordable for consumers, employers, and tax- payers
•    Maximize the number of people with insurance coverage
•    Protect the most vulnerable by addressing the particular needs of those patients and populations
•    Encourage better care practices by promoting the right care to the right patient in the right setting at the right time
•    Advance stewardship of resources by focusing on high value services and reducing use of low value services (value is defined as outcomes relative to cost)
•    Address the medical concerns of greatest importance to enrollees in EHB-related plans, as identified through a public deliberative process
•    Protect against the greatest financial risks due to catastrophic events or illnesses.
Criteria to guide EHB content on specific components. The individual service, device, drug for the EHB must do the following:
•    Be safe—expected benefits should be greater than expected harms
•    Be medically effective and supported by a sufficient evidence base, or in the absence of evidence on effectiveness, a credible standard of care is used
•    Demonstrate meaningful improvement in outcomes over current effective services/treatments
•    Be a medical service, not serving primarily a social or educational function
•    Be cost effective, so that the health gain for individual and population health is sufficient to justify the additional cost to taxpayers and consumers

Caveats.
•    Failure to meet any of the criteria should result in exclusion or significant limits on coverage.
•    Each component would still be subject to the criteria for assembling the aggregate EHB package.
•    Inclusion does not mean that it is appropriate for every person to receive every component.

Criteria to guide methods for defining and updating the EHB. Methods for defining, updating, and prioritizing must be the following:
•    Transparent. The rationale for all decisions about benefits, benefit design, and changes is made publicly available.
•    Participatory. Current and future enrollees have a role in helping define the priorities for coverage.
•    Equitable and consistent. Enrollees should feel confident that benefits will be developed and administered fairly.
•    Sensitive to value. To be accountable to taxpayers and plan members, the covered service must provide a meaningful health benefit.
•    Responsive to new information. EHB will change over time as new scientific information becomes available.
•    Attentive to stewardship. For judicious use of pooled resources, budgetary constraints are necessary to keep the EHB affordable.
•    Encouraging to innovation. The EHB should allow for innovation in covered services, service delivery, medical management, and new payment models to improve value.
•    Data driven. An evaluation of the care included in the EHB is based on objective clinical evidence and actuarial reviews.

ASMBS industry advertising policy and committee announced.
by Jaime Ponce, MD, FASMBS, ASMBS President Elect

The ASMBS Executive Council authorized the formation of this committee to examine any submitted advertising for the journal Surgery for Obesity and Related Diseases (SOARD) and for our annual meetings. Editors of other journals covering topics in baritric surgery who have an ad they feel may be in error can also use the committee as needed for third-party review of any particular ad if they feel there may be bias in internal review. The following advertising policy was developed by the ASMBS Corporate Council and unanimously approved by the Executive Council.

Advertisement policy. The ASMBS welcomes advertising in its publications and at its educational events as an important means to keep the bariatric surgical community informed of products and services for bariatric and metabolic surgery. Such advertising must be factual, dignified, tasteful, and intended to provide useful product and service information. These standards apply to all product-specific promotional material submitted to ASMBS programs. Advertisements must not be deceptive or misleading. All claims must be supported by data and meaningful in terms of performance and other benefits. ASMBS reserves the right to request additional supporting information as needed.

Advertisements should include footnotes where testing methodology and statistical analysis are easily identified. References from surgical and scientific literature are acceptable, provided the facts cited are truthful, fair, accurate, and represent fairly the body of literature regarding the claim. Internal data (quoted as “data on file”) has to be clearly documented as an internal study that has not been published or peer reviewed.

ASMBS Advertising Committee members: Chair President Elect Jaime Ponce, MD; Co-Chair Kevin Reavis, MD (Chair of the Communications Committee); Marc Bessler, MD (at large member of ASMBS Executive Council); and ad hoc member Debbie Winegar (can be asked to participate if the question concerns an ad containing BOLD data).

ASMBS announces bariatric surgery fellowship training certificate program. On September 15, 2011, ASMBS President Robin Blackstone, MD, and Bariatric Surgery Training Committee Chair, Samer Mattar, MD, announced the 2011 Fellowship Certificate Program. The program serves to acknowledge surgeons who have completed their training in an accredited fellowship program and who have met the educational and training requirements needed to practice safe and effective bariatric surgery (according to fellowship training standards established by the ASMBS). The objective is for these certificates to add value to surgeons beginning their careers in the field by emphasizing their ability to adequately perform metabolic and bariatric surgery. This process has been endorsed by the ASMBS Executive Council.

The program is currently open for applicants who graduated from their fellowship program in 2010 and 2011. To access the Core Curriculum and ASMBS Fellowship Training Guidelines and to view a list of certificate recipients please visit http://s3.amazonaws.com/publicASMBS/GuidelinesStatements/Guidelines/Core%20Curriculum%20for%20ASMBS%20Fellowship%20Training%20sac.pdf

The application deadline for the 2011/2012 Fellowship class is November 1, 2011. Please contact [email protected] for additional information.

Bariatric surgery complications now recognized with new International Classification of Diseases-9 Codes.
By Tina Napora, CPC, ASMBS Insurance Committee

Effective on October 1, 2011, specific new International Classification of Diseases (ICD)-9 codes covering complications will be in the 2012 ICD-9 reference book. Bariatric procedures for weight loss have become increasingly common in recent years and so has the incidence of surgical complications. The National Center for Health Statistics (NCHS) proposed a new category of codes to report complications of infection or device malfunction with bariatric surgery. These codes will be located in the 2011 ICD-9-CM for Hospitals. Volumes 1, 2, and 3. Professional Edition (part 3, volume 1, chapter 9, Diseases of the Digestive System).[3] Prior to this new code set, complications of bariatric surgery were reported with ill-defined codes in the 2010 ICD-9-CM (part 3, volume 1, chapter 17: Injury and Poisoning. Complications of Surgical and Medical Care, Not Elsewhere Classified). Too often, we received claim denials from payors stating the diagnostic code billed is not appropriate for the procedure code reported. With these new codes, billing departments across the country can provide a diagnosis that is more precise in reporting and get your claims for complications paid correctly the first time.

Examples of the new codes include the following: 1) 539.01—infection due to gastric band procedure, 2) 539.09—other complication of gastric band procedure, 3) 539.81—infection due to other bariatric procedure, and 4) 538.89—other complications of other bariatric procedures

References
1.    Bueter M, le Roux CW. Int J Obes (Lond). 2011;35 Suppl 3:S35–39.
2.    Lohr S. The Power of Taking the Big Chance. The New York Times. October 8, 2011.
3.    Buck CJ. 2011 ICD-9-CM for Hospitals. Volumes 1, 2, and 3. Professional Edition. St. Louis, Missouri: Elsevier Saunders; 2011.

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Category: ASMBS News and Update, Past Articles