Comments on the Centers for Medicare and Medicaid Services’ Proposed Decision on the Centers of Excellence (COE)/Accreditation Requirement for Medicare Patients: Hoping They Reconsider

Dear Colleagues:

I am starting this editorial with mixed feelings. I am happy and excited that the American Medical Association (AMA) has finally recognized obesity as a disease process. This milestone in healthcare should be seen as a major victory to all of us that are working in the bariatric field and have been battling this deadly disease process for decades. I hope that as a result of this, it will not be so easy for insurance carriers to simply decline coverage to those who are desperately seeking medical and surgical treatment of their obesity disease.

In contrast to the good news from AMA, I became saddened, angry, and worried by the news delivered by the Centers for Medicare and Medicaid Services (CMS). CMS anticipated that they might stop requiring their patients to go to facilities that have achieved the designation of Centers of Excellence (COE) and to accredited surgeons for bariatric surgery. This decision was triggered by Dr. John Birkmeyer, who requested that CMS reopen the National Coverage Decision (NCD) for bariatric surgery based on a study performed by the Michigan Collaborative Study Group. This manuscript published in the Journal of the American Medical Association (JAMA) in 2011[1] reviewed and compared the outcomes of bariatric procedures performed in COE and non-COE-designated centers. The study examines complications from 15,200 bariatric cases performed by 62 surgeons in 25 hospitals and concludes that while volume is inversely related to the incidence of complications, there is no significant difference in outcomes at 30 days when comparing centers with or without designation of COE.

I question the paper’s conclusions and wonder how is it possible for CMS to make such a drastic and far-reaching decision based on the results of this one study. In the JAMA article, the average age of the patients was 47 years and not 65, the average age of most Medicare patients. It is well known that a significant number of complications after bariatric surgery occur later than 30 days past surgery, and therefore those later but critical complications were not captured in this study analysis. After reviewing 1,200 gastric bypasses performed by my team at the Cleveland Clinic Florida, anastomotic stricture was the most common complication, occurring in 6.6 percent of our patients and presented, on average, on postoperative Day 52.[2] Why is it that CMS does not value the impact of complications that might ensue after 30 days? In addition, 17 out of the 25 hospitals that participated in Birkenmeyer’s study were COEs; the remaining eight hospitals did not have the designation of COE but were collecting and reporting data, which, in association with an accredited/certified bariatric surgeon, gives them, to some degree, important components of a COE, and likely reflects an institution with means and structure closer to a COE than a rural or even urban facility that does not have the funding and/or critical components that make a COE a COE.

Why do we always have to be so worried when the NCD is opened for public comment? Is it possible that CMS ignores the far-reaching benefits of institutions that invest heavily in having dedicated healthcare professionals taking care of patients with a specific disease process? Are complications the only variable that matters when it comes to the value of an accredited surgeon? What will the position of CMS be if, in the coming years, we show in a follow-up study that a significant number of these patients that were operated on by a non-certified surgeon and/or in a non-COE-designated center failed to lose weight, never had resolution of comorbidities, and/or needed a reoperation because the non-accredited center or surgeon did not follow up on his or her patient, performed the wrong procedure, or used a poor technique? Who will follow up on nutritional requirements and identify psychological problems, such as depression or addiction, if not a team of critical multidisciplinary integrated healthcare professionals that are an essential and required component of a COE? Why go backwards and dismantle our teams? If not proven beneficial to CMS, the establishment of COE certainly does not harm our patients.

For the last decade, CMS has been requesting long-term data. Is it possible that suddenly a study with a 30-day follow-up and outcomes measuring one single variable can be the trigger to disregard more than 10 years of excellence in healthcare delivered by the American Society for Metabolic and Bariatric Surgery (ASMBS) and American College of Surgeons (ACS)? If data collection and external audit had an impact maintaining the quality of outcomes in the Dimick et al study, how will Medicare achieve that end result? In other words, who will pay for the database, data collection, and audit? I am not only saddened about CMS’s decision, but I am also disappointed and extremely worried for our patients’ well-being and the resulting potential effect on standard of care for future patients because of it.

While some members might welcome the CMS decision, with the thought that assembling, funding, and supporting a team of healthcare experts, as well as spending time and money to collect data and follow-up with patients, might have been a burden to surgeons and hospitals, the majority of us think otherwise. In the last 10 years, we members of ASMBS and ACS have invested a tremendous amount of dollars, time, and effort to gain recognition by insurance carriers and peers and, more importantly, to improve patient outcomes. I am certain that you all share hopes that we continue our path and strong collaboration with ACS setting up the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) program to maximize patients’ safety, follow-up, and success when it comes to bariatric surgery. I look forward to the strong response from our society’s leaders, and I am hoping that CMS will reconsider its decision.

I have heard some say, “Medicare patients represent only five percent of our volume.” My take on this is different. When it comes to medical care for our loved ones, it is not quantity that matters but quality. Those who worked so hard all their lives or are unfortunately disabled are probably the most fragile ones and deserving of world-class care. We should strongly support COE designation and surgeons’ accreditation. Bariatric surgery is a team approach. You can’t whistle a symphony; you need an orchestra to play it.

In this issue of BT, we present a new column titled “Let’s Get Real” with Dr. Walter J. Pories, ASMBS past president and father of metabolic surgery. This month, Dr. Pories discusses “return on investment,” which might sound like a strange topic, unrelated to caring for our loved ones. As sad as it might sound, return on investment in healthcare is a reality. Thank you, Walter, for your leadership, insights, and inspiration in the world of bariatric and metabolic surgery. We welcome your thoughts and artwork to our journal.

For those of you who have patients and relatives in need of state-of-the-art bariatric care in the southern part of the country, I urge you to consider UT Southwestern Medical Center in Dallas, Texas. Dr. Michal Lee, Director of Metabolic & Bariatric Surgery, describes the center in this month’s Bariatric Center Spotlight.

Also in this issue, we highlight an interview with Drs. Kashyap and Schauer who review the results of medical and surgical treatment of diabetes as well as long-term follow up results of the STAMPEDE (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently) substudy.[3]
Vivus Pharmaceuticals has unfortunately seen a disappointing launch of their weight loss drug Qsymia with significant losses in their stock values. We are indeed many years away from finding a reliable and efficacious medical treatment of severe obesity.

In this month’s installments of “Surgical Pearls: Techniques in Bariatric Surgery” and “Checklists in Bariatric Surgery,” two columns that I am privileged to co-edit, we present the readers with a standard laparoscopic approach to place a gastrostomy as well as a step-by-step management of a patient with gastric remnant distension after Roux-en-Y gastric bypass (RYGB).

We also present an interview with Dr. Daniel Jones, coauthor of the recently published Clinical Practice Guidelines[4] endorsed by The Obesity Society (TOS), ASMBS, American Association of Clinical Endocrinologists (AACE), ACS, and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), among other leading societies. As mentioned by Dr. Jones in his interview, this was a huge undertaking and we should commend those who authored this paper for their efforts and contribution to our field. Regarding putting in a drain after a gastric bypass, my answer is yes, I love those. The only time I regretted drains was when I did not put them in. I would like to thank Dr. Daniel Jones for his interview and hope that you enjoy reading this issue of BT.

Sincerely,

Raul J. Rosenthal, MD, FACS
Editor, Bariatric Times

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.    Koppman JS, Poggi L, Szomstein S, Ukleja A, Botoman A, Rosenthal R. Esophageal motility disorders in the morbidly obese population. Surg Endosc. 2007;21(5):761–764. Epub 2007 Feb 7.
3.    Kashyap SR, Bhatt DL, Wolski K, et al. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Feb 25. [Epub ahead of print]
4.    Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient-2013 update: cosponsored by american association of clinical endocrinologists, the obesity society, and american society for metabolic and bariatric surgery. Endocr Pract. 2013;19(2):337–372.

Tags: Dr. Raul Rosenthal

Category: Editorial Message, Past Articles