NEW COLUMN: Ask the Leadership with Raul J. Rosenthal, MD, FACS, FASMBS

| March 18, 2013

This column is dedicated to sharing the vast knowledge and opinions of the American Society for Metabolic and Bariatric Surgery leadership on relevant topics in the field of bariatric surgery.

This Month’s Interview: Ninh T. Nguyen, MD, FACS, Department of Surgery, University of California Irvine Medical Center, Orange, California; President-Elect, The American Society for Metabolic and Bariatric Surgery

This Month’s Topic: Complications and Reoperation Before Versus After the Centers for Medicare and Medicaid Services Policy of Restricting Coverage to Bariatric Centers of Excellence: Comments on the Michigan Study

A Message from Column Editor Raul J. Rosenthal, MD, FACS, FASMBS

Dear Readers of Bariatric Times:
Welcome to the first installment of our new column “Ask the Leadership,” in which I ask leaders within the American Society for Metabolic and Bariatric Surgery (ASMBS) questions that many of you may want to ask or believe should be asked. For our debut installment, I interview ASMBS President-Elect Dr. Ninh Nguyen. There is a perception amongst some bariatric surgeons that the concept of having an accredited center with team members who specialize in one disease process, such as obesity, is not beneficial to our patients. Their conclusions, recently published in the Journal of the American Medical Association (JAMA) are, in my opinion, incorrect and shortsighted. The outcomes of bariatric surgery are not measured only by complications, but more importantly in how well patients do in the long term. We know from our data that the likelihood of having complications or dying from bariatric procedures is extremely low. Surgeons are just one piece of a multidisciplinary team who deal with a lethal disease process that needs to be followed for life and might recur requiring further interventions.

Sincerely,
Raul J. Rosenthal, MD, FACS, FASMBS

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Bariatric Times. 2013;10(3):12–14.

Dr. Rosenthal: What are your intial thoughts on the study, “Bariatric surgery complications before vs after implementation of a national policy restricting coverage to centers of excellence,”[1] which was recently published in the Journal of the American Medical Association? What do you think are the limitations to this study and why are they important to note?

Dr. Nguyen: Initally, this study looks straight forward in that it found no statistical significant differences in outcome after initiation of the Centers for Medicare and Medicaid Services (CMS) policy; however, there are several limitations that would challenge the conclusion of this study. Two previous studies[2,3] examining outcomes before and after the Medicare National Coverage Determination (NCD) have suggested beneficial effects of the CMS policy restricting bariatric surgery to accredited bariatric centers (previously called Centers of Excellence [COE]). It seems to me that Dimick et al felt that these two studies lacked a control group and hence the studies were unable to isolate the effect of the CMS NCD from many other unrelated factors that may have improved bariatric outcome during the same time period. Dimick et al elected to use non-Medicare patients to control for other factors, such as increase in utilization of laparoscopic approach, that may have led to the observed time-trend improvement in outcomes that are independent of the CMS policy. This decision to use the non-Medicare patients as a control group to eliminate the impact of bariatric surgery accreditation is one of the major limitations of this study as by the time the CMS NCD took effect in 2006, the control group (non-Medicare patients) were already exposed to the COE process as bariatric accreditation nationwide was initiated in 2004 by the American Society for Metabolic and Bariatric Surgery (ASMBS) and in 2005 by the American College of Surgeons (ACS). Based on this assumption, the authors examined the model differences between Medicare and non-medicare patients and concluded that the CMS policy itself had no benefit, but failed to acknowledge that the CMS policy took effect approximately two years after initiation of COEs in the United States by the ASMBS for non-Medicare patients.

In Table 2 of the study, the authors found a significant reduction in complication rate after initiation of the medicare NCD for both Medicare beneficiaries and non-Medicare patients. However, it would be difficult to determine if initiation of the CMS NCD was truly responsible for the improved outcome. Another important factor that may have had an effect on the improved outcome is the development of and increase in utilization of the laparoscopic approach to bariatric surgery. The authors also did not find any difference in complication and reoperation rates between COE and non-COE centers; however, the year of their analysis was not specified. This is important as the COE process was not widely implemented prior to 2007 and any evaluation prior to that time would not have given an accurate depiction on the impact of the accreditation process. Additionally, this study evaluated complication and reoperation using administrative data that have been shown to be neither sensitive nor specific. Their definition for serious morbidity was vague and nonspecific. In this study, serious complication was defined as “any complication associated with a length of stay greater than four days.” This would mean that if a patient with protracted nausea and vomiting after sleeve gastrectomy stayed in the hospital for five days, that patient would be considered to have a serious complication. This definition can result in false positive findings and is less than desirable. The most reliable outcome parameters for administrative data are mortality, length of stay, and costs, but the authors elected not to analyze any of these parameters. There have also been several studies documenting improved outcome after initiation of COE accreditation. In particular, my colleagues and I analyzed the University HealthSystem Consortium database and found a significantly lower in-hospital mortality at accredited compared to non-accredited centers. The improved outcome at accredited centers was found to be related to the improved care in complex operations, such as Roux-en-Y gastric bypass (RYGB) and for complex patients with higher severity of illnesses.

Dr. Rosenthal: Can you comment on the fact that this study did not examine long-term outcomes? Do you think the conclusion might be different if long-term outcomes are examined?

Dr. Nguyen: To date, all of the studies comparing COE to non-COE centers and time-trend effect of Medicare NCD have only examined perioperative outcome, so we do not know if the COE process might make a difference in longer term measures.

However, the accreditation standards strongly emphasize the need for long-term follow up and capturing of data on weight loss, long-term complications, and changes in comorbidities after bariatric surgery. These data will provide invaluable information for us to analyze long-term efficacy of bariatric surgery.

Dr. Rosenthal: Do you agree with the authors’ conclusion that restricting Medicare coverage to COEs may be reducing access to the procedure?

Dr. Nguyen: No, my colleagues and I do not agree that the CMS NCD has reduced access to bariatric care for the Medicare beneficiaries. This statement was not even supported by the authors’ own study in which they found an average of 2,988 Medicare patients undergoing bariatric surgery per year prior to the NCD (6,723 patients over a period of 27 months), which increased to 4,327 patients undergoing bariatric surgery per year after the NCD (15,854 patients over a period of 44 months). This increase would suggest that there was improved access and better care (as seen by a reduction in complication rate after the NCD) for the Medicare beneficiaries rather than restricting access. Additionally, using the nationwide Medicare data, Flum et al[2] examined the bariatric procedure rate per 100,000 patients before and after the Medicare NCD and found that there was a precipitous drop in the rate from 21.9 to 17.8 procedures per 100,000 patients, but the rate rebounded to baseline at 23.8 procedures per 100,000 patients in 2007 and increased higher than baseline at 29.1 procedures per 100,000 patients in 20084 The study by Flum et al[2] supports the fact that the Medicare NCD may in fact not only improve outcomes for Medicare beneficiaries, but do so without limiting access. Another concern Dimick et al stated was the need for Medicare beneficiaries to travel to accredited centers. It is important to note that there are more than 750 accredited centers nationwide, represented in all states. Additionally, the new joint ASMBS/ACS Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBS AQIP) will facilitate even more centers around the nation and the issue of traveling for care will be minimized.

Dr. Rosenthal: What are your thoughts on the ASMBS/ACS MBS AQIP?

Dr. Nguyen: The ACS and ASMBS program is multifaceted to promote the highest standards of quality for the bariatric surgery patient by holding hospitals and personnel accountable. In March 2012, the ACS and ASMBS signed a memorandum of understanding to begin the unification of their respective accreditation programs to form the MBS AQIP. At this time, both accreditation programs aligned their data reporting criteria to require 100-percent capture of all bariatric cases in a single, longitudinal outcomes database under a single set of national standards, which streamlines data collection and creates national benchmarks. This is the only nationwide outcomes database dedicated to bariatric surgery. The development of new standards that are supported by contemporary literature is underway and we are excited to obtain support of our program by CMS and payers.

Dr. Rosenthal: To your knowledge, what are the ASMBS and ACS positions regarding this study?

Dr. Nguyen: Both societies continue to support the accreditation process and believe that it has successfully created consistent care and standards across accredited facilities. The program requirements established a culture of safety by ensuring that facilities commit to resources to best serve special needs for patients with obesity, including patient education, appropriate equipment, and specialty trained surgeon and staff. Accreditation also allows centers to gain negotiating leverage within the program’s affiliated hospitals to obtain needed resources, such as integrated health support (e.g, dieticians and psychologists) toward improving patient outcomes.

In preparation for the release of their study, the Michigan group also requested that Medicare open a national coverage analysis to determine the need for facility certification. The ASMBS and ACS and many of their members have written comments to CMS stating their continued support for the accreditation process. Both societies are greatly concerned by the Michigan’s recommendation as removal of accreditation would halt efforts that promote the highest standard of care. Specifically, removal of the requirement might result in the following: 1) elimination of the ability to track outcomes for quality improvement in a centralized database with over 750 hospitals currently participating nationwide; 2) reimbursement for bariatric procedures without regard to the standards that should be monitored to meet the unique needs of bariatric patients; and 3) elimination of needed resources that facilitate strategic and focused quality improvement critical to addressing the national obesity epidemic. This nation is in need of more, rather than less, support for evaluating and improving care for the diverse population of patients with obesity.

Dr. Rosenthal: Dr. Nguyen, thank you for taking the time to speak with me on this important issue.

References
1.    Dimick JB, Nicholas LH, Ryan AM, Thumma JR, Birkmeyer JD. Bariatric surgery complications before vs after implementation of a national policy restricting coverage to centers of excellence. JAMA. 2013;309(8):792–799.
2.    Flum DR, Kwon S, MacLeod K, et al. Bariatric Obesity Outcome Modeling Collaborative. The use, safety and cost of bariatric surgery before and after Medicare’s national coverage decision. Ann Surg. 2011; 254(6):860–865.
3.    Nguyen NT, Hohmann S, Slone J, Varela E, Smith BR, Hoyt D. Improved bariatric surgery outcomes for Medicare beneficiaries after implementation of the medicare national coverage determination. Arch Surg. 2010;145(1):72–78.
4.    Nguyen NT, Nguyen B, Nguyen VQ, Ziogas A, Hohmann S, Stamos MJ. Outcomes of bariatric surgery performed at accredited vs nonaccredited centers. J Am Coll Surg. 2012;215(4):467–474.

Funding: No funding was provided in the preparation of this manuscript.

Financial disclosures: The author reports no conflicts of interest relevant to the content of this article.

Category: Ask the Leadership, Past Articles

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