Bariatric Surgery for the Treatment of Morbid Obesity - Facility Certification Requirement

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July 24, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
CMS/OCSQ/Coverage and Analysis Group
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, MD 21244

Cc:
Patrick Conway, M.D.
Director & CMS Chief Medical Officer
Acting Director, Center for Medicare & Medicaid Innovation
Email: Patrick.Conway@cms.hhs.gov

Marilyn Tavenner
Administrator
Centers for Medicare & Medicaid Services
200 Independence Avenue, S.W.
Washington, DC 20201

RE: Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3) issued on June 27, 2013

Dear Dr. Jacques:

On behalf of Johnson & Johnson’s Operating Companies, I am pleased to submit these comments and recommendations in response to the Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3) issued by the Centers for Medicare and Medicaid Services (CMS) on June 27, 2013. We are concerned with the removal of Facility Certification. We encourage CMS to continue the Facility Certification Requirement for bariatric surgeries.

Johnson & Johnson (J&J) is the world’s most comprehensive and broadly-based manufacturer of health care products for the consumer, pharmaceutical and medical devices and diagnostics markets. For 125 years, J&J Companies have supplied hospitals with a broad range of products and has led the way in innovation; from the first antiseptic bandages and sutures to the first drug-eluting stents. This comment specifically reflects the opinion of Ethicon, Inc. (“Ethicon”), a Johnson & Johnson company that provides instruments used in bariatric and metabolic surgery.

J&J and Ethicon have reviewed the Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3). J&J and Ethicon strongly encourage the continuation of the Facility Certification/Center of Excellence Requirement for Bariatric Surgery.

CENTER OF EXCELLENCE CERTIFICATION PROCESS IS OF GREAT VALUE TO PATIENTS

We consider Bariatric Surgery Facility Certification requirement to be an effective means to ensure that Medicare beneficiaries receive appropriate and high quality treatment and a valuable safeguard to minimize any associated complications. Since the advent of the certification process in 2004, enormous gains in patient safety and effectiveness have been achieved. We have not seen compelling evidence to discontinue what has become a patient safety success story. We are concerned the proposal to remove the Bariatric Surgery Facility Certification will place the highly vulnerable Medicare population at risk.

Facility Certification for bariatric surgery has been adopted by the medical professionals. For example, within the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) organized by The American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS), there are 725 Accredited Centers nation-wide. In fact, the ASMBS and the ACS bariatric surgery certification programs preceded the CMS 2006 NCD. Furthermore, the evidence for certification is embraced by major commercial payors. We have previously reviewed private payers’ policies in our letter dated February 22, 2013. Several major commercial payers have continued to support bariatric surgery facility certification. These payors include Aetna, Anthem Blue Cross and Blue Shield/Wellpoint, CIGNA, United Healthcare and others. Removal of the Bariatric Surgery Facility Certification puts CMS in the unique situation of being the only major insurer not providing Facility Certification for Bariatric Surgery. Therefore, we encourage CMS to continue the Facility Certification requirement for bariatric surgery.

LITTLE EVIDENCE SUPPORTING REMOVAL OF FACILITY CERTIFICATION

We suggest CMS conduct a complete review and analysis of the evidence before removing the Facility Certification. While concern regarding access has been raised, little evidence supports diminished access to care with substantial increases in Medicare bariatric surgery since the 2006 NCD.

Since our February 22, 2013 letter, there have been two new relevant publications that merit review. The 2011 Flum study which clearly demonstrates the value of accreditation specifically for Medicare beneficiaries whereby 90-day mortality fell 50% (1.5% to 0.7%), readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and costs fell 20% ($24,363 to $19,746) post-NCD.

In Nguyen’s recent Surgical Endoscopy study “Volume and Outcome relationship in Bariatric Surgery in the Laparoscopic Era,” based on 277,760 cases performed between 2006-2010 and 85% procedures performed at high volume centers (HVC, annual volume >50), he found accredited high volume centers have significantly lowered in-patient mortality while non-accredited high volume centers have worse mortality outcomes indicating that accreditation provides a benefit beyond volume.

In conclusion, bariatric surgery facility certification was established to improve outcomes for patients. Removing the facility certification process will not benefit patients. In all likelihood, it is possible that patient safety may be compromised by discontinuing the certification requirement for Medicare beneficiaries. Since the National Coverage Determination and the certification requirement have been put in place, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been maintained.

Ethicon and J&J appreciates the opportunity to submit our comments and recommendations to CMS. We had great collaborations with your staff in the past to ensure the accuracy and fairness of coverage decision. We look forward to continuing to do so.

Sincerely,

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I disagree with the proposed change to the NCD going away from the requirement of patients to go to accredited centers. I strongly believe this change will lead to the most vulnerable group of patients experiencing a higher rate of adverse outcomes. This is absolutely a patient safety issue. I have read the material submitted and I believe an area there is an important aspect that may not be fully understood. The Michigan Surgery Collaborative has made great strides in their community in oversight and communication of best practices. However, this is not likely able to be replicated in other communities. There is a very unique environment in Michigan where every single surgeon and facility is required to be a part of the collaborative. This is funded by commercial insurance and has made it possible to have oversight and influence over programs that were not actively participating in other accreditation formats. Essentially these programs were participating in a forum that was very strongly influenced by the current accreditation process with the ASMBS and the ACS. Therefore, to state the results of those surgeons and facilities accurately represent the results of other programs that do not participate with the current accreditation program is completely inaccurate. In other states there is not the ability to have oversight of facilities and surgeons adequately without an accreditation process. In many states the programs that do not participate in the current accreditation process lack the standardization of processes and evidence based protocols that provide consistency of outcomes. These processes have the most impact in high risk patients such as Medicare patients.

I do believe if the decision to stop requiring Medicare patients to use accredited centers goes forward we will see the unintended consequence of higher morbidity and mortality in the Medicare population within 3-5 years. At that point it may be very difficult to reverse course.

Since the implementation of the original 2006 National Coverage Determination for Bariatric Surgery, we have witnessed an American patient success story regarding patient safety in the bariatric surgery population.

Nguyen in a 2012 Journal of the American College of Surgeons (JACS) found significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758).

2011 Flum study which clearly demonstrates the value of accreditation specifically for Medicare beneficiaries whereby 90-day mortality fell 50% (1.5% to 0.7%), readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and costs fell 20% ($24,363 to $19,746) post-NCD

I strongly disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

Sincerely,

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I wholeheartedly support the continued requirement that a hospital be an accredited center of excellence in order to operate on Medicare patients. The consequence of this requirement has implications that extend beyond Bariatric surgery affecting a hospital’s preparedness to care for all overweight patients; a group increasing in numbers yearly. I have been performing bariatric surgery for 12 years. I continue to see patients that have had mismanaged complications from bariatric surgery sent to us from hospitals that are not certified. The protocols which we have instituted and the commitment of our hospital to bariatric surgery have cost our institution hundreds of thousands of dollars but have resulted in a hospital which can safely and compassionately care for patients exceeding 500 pounds. At shady Grove Adventist hospital the educational programs concerning compassionate care, recognizing and treating complications and ergonomics of patient movement have been so successful that they are now part of nursing orientation, yearly staff development days, and the online training modules which all nurses must pass to maintain employment. By request from the nursing department, we additionally offer classes preparing for the certified bariatric nurse test. The protocols are available at every nursing station, the emergency room and also radiology. The program has been so well received that the stroke clinical pathways and the orthopedic clinical pathways are now modeled after the bariatric program. I do not doubt, as some have suggested, that a moderate sized hospital with a commitment to bariatric surgery could achieve a reasonably low complication rate however I do not believe that we would see the across-the-nation commitment to outstanding bariatric patient care and bariatric staff education demonstrated at center of excellence hospitals without the Medicare requirement. Dedicated cardiac centers and pediatric hospitals have taught us the dramatic improvements in both medical outcomes and patient education which are attainable. Bariatric centers have now raised the bar by requiring 100% independent outcome data collection. We will soon be able to compare each center to national benchmarks and improve outcomes even further. Lastly, by requiring patients to fulfill Medicare criteria for having weight loss surgery, our Center of Excellence has assured a 100% approval of surgery by CMS thereby saving CMS the cost of prosecuting denials for weight loss surgery performed on Medicare beneficiaries that have not met the strict criteria.

I urge you to continue the requirement that Medicare patients be operated on in a center of excellence hospital. Thank you for your attention.

sincerely,

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I disagree with the CMS decision to drop the need to send Medicare/MediCal patients to a COE facility. We are a COE facility and we work closely with our surgeon's office in preparing patients for surgery, seeing them in the hospital and also following them postoperatively. Our surgeons are one of the few who take Medicare and/or MediCal patients in Northern California so we get patients from sometimes 150+ miles away. This group of patients often present with additonal barriers and challenges (financial, educational, lack resources and/or transportation) from other patients we serve because they are > 65, disabled and/or unemployed or underemployed. We often have a need to spend a considerable amount of time with them to be assured they have an opportunity to be as successful as our non Medicare/MediCal patients.

Why are there so few Bariatric surgeons taking Medicare/MediCal patients in California? I think the answer is simple. The reimbursement is not sufficient and as stated before these patients present with additional challenges which equates to more cost.

By not requiring patients go to a COE facility you have the potential of having possibly lesser skilled surgeons or hospitals taking care of a group of patients who inherantly have more social challenges and health issues then the non-Medicare/MediCal population. The lesser skill may just be due to less volume but it could be more than that.

Really the big question is "If this new Medicare ruling passes will there be an improved, same or lesser caliber of surgeon and/or hospital opening up their doors to the Medicare/MediCal population?" If the answer is improved or same and access to care for these patients increases then maybe it is a good decision. My gut feeling is that is not going to be the case and this group of patients is going to receive less preop and postop education and care which in turn is going to potentially make them less successful or worse be a disaster for them and to all of us who are going to have to pick up the pieces.

PS Why are there Centers of Distinction/COE facilities for many other specialties but Bariatrics is the one that may be dropped?

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I am conflicted with the CMS proposed decision memo to eliminate COE accredition. On one hand, evidence shows no significant difference in outcomes in a non-COE versus COE programs. Thus, we should not exclude surgeons who can perform bariatric surgery well and achieves good outcomes, but simply cannot meet the volume criteria to qualify as a COE. On the other hand, there appears to be sufficient data showing that quality of care and patient safety has improved significantly after the implementation of COE programs.

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Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Proposed Decision Memo: Bariatric Surgery for the Treatment of Morbid Obesity – Facility Certification Requirement (CAG-002850R3). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments

AHIP and our member health plans encourage the use of robust evidence-based research to ensure safe and effective treatments. After reviewing the evidence pertaining to outcomes from centers of excellence (COE) vs. non-COE facilities, our members believe that the evidence is sufficient to determine that there is added value to COE accreditation.

Patient Population and Risks

The patients for whom bariatric surgery is indicated are high risk patients, and Medicare members are at increased risk due to their advanced age and/or disability. Bariatric surgery has been considered a high-risk procedure associated with considerable post-op morbidity and peri-operative mortality for specific populations. The hospitals where the procedures are performed need to have bariatric beds, bariatric capabilities in their diagnostic departments, and nutritionists as well as experienced physicians on board. The certification requirements, particularly the requirement for higher volume of procedures, help ensure care is delivered by more experienced surgeons at better equipped facilities, reducing the likelihood of complications.

Limitations in Evidence

Many of the studies cited in the proposed decision memo do find a statistically significant improvement in outcomes for surgeries performed in COE facilities on initial analysis, however, when adjusted for a number of variables, the authors concluded that the net outcomes are no different between COE and non-COE facilities. Most of the authors of the studies cite significant gaps in data and other limitations. The vast majority of the studies referenced indicate that long-term outcomes were not considered. The studies are retrospective, and there are significant variations in how the studies analyzed the complex and changing variables during the study periods.

Expanding Guidelines and Requirements for Certification

Our members believe that CMS should focus its requirements on monitoring both capability (e.g., surgical volumes by facility and surgeon) as well as outcomes regarding the specific bariatric procedure to provide the highest level of benefit to the member. CMS could consider including benchmarking of readmission rates, complications, mortality, length of stay and rates of revisions as well as ensuring lifetime follow-up post procedure.

Current guidelines are broad-based and do not address the various procedure types that are available to Medicare members. Guidelines should be developed to address how a specific bariatric procedure type may best benefit a specific population and ultimately limit revisions, morbidity and mortality.

CMS should provide more robust criteria in regards to preparing the member for bariatric surgery to ensure success of the procedure and sustained weight loss. For some facilities, revisions are the most common bariatric procedure performed which indicates a failure of the original surgery. Guidelines should be developed to indicate when and if a revision is appropriate. Facilities that were excluded from the CMS network could have appeal rights if their application for CMS network inclusivity was rejected. Finally, CMS should set standards for patient eligibility for bariatric procedures based upon:

• Number of procedures allowed per lifetime
• Medical necessity for revision or conversion surgery
• Definition of complications of the original bariatric surgery
• The appropriateness of a member for bariatric surgery based upon weight (body mass index), co-morbidities, ability to participate in the pre-op and post-op programs essential to the success of a bariatric procedure (i.e., exclusion of patients with psychiatric conditions that would detract from participation in the program), and the ability to participate in a 6 month pre-operative physician-supervised weight management program.

In summary, our members believe that there is insufficient evidence at this time to support CMS’ proposal to remove the facility certification requirement for coverage of covered bariatric surgery procedures. We recommend a prospective evaluation of evidence with well-defined and consistent variables to establish more robust guidelines for facility certification and tracking of process and outcome measures, to improve safety and efficacy.

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I am writing to state that I strongly disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I am very much in favor on continued CMS Bariatric Facility Certification for the following reasons:

1. Patient safety is increased. Numerous publications including those by Encinosa in 2009, Nguyen in 2012, Kwon in 2012, Flum in 2011, Dimick in 2013 and Nguyen in 2013 have demonstrated a significant reduction in mortality in accredited centers.
2. Certification is aligned with other certification programs. Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population. This is a radical departure from previous CMS policy. Other interventional Nation Care Determinations all have a facility criteria requirement &/or certification. For example, Adult Liver Transplant, Artificial Hearts & Related Devices, Deep Brain Stimulation for Essential Tremor and Parkinson's Disease, Pancreas Transplants, Lung Volume Reduction Surgery, Pediatric Liver Transplantation, Transcatheter Aortic Valve Replacement and Transmyocardial Revascularization.
3. Medicare Patients are Sicker and have a higher risk of morbidity and mortality than the general bariatric surgery population. In a 2011 Archives of Surgery article by Nguyen et al, they found that Medicare status increased the risk of potentially fatal anastomotic leaks by 54%, a stronger risk factor than chronic lung disease or male gender. In a 2012 publication in SOARD, Gould et al, report that Medicare status significantly increased readmissions and ED visits.
4. Access to Quality Care is Increased. There are 725 Accredited Centers in the MBSAQIP program and with a new lower volume standard of 50 stapled bariatric cases/year, there are anticipated to be even further gains in centers and patient access.
5. Integrated Health is Supported. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines including surgery, internal medicine, registered dieticians, cardiology and mental health professionals. Without facility certification, nutritional/psychological evaluation services may not be provided or supported.
6. The Federal Budget Impact is Neutral. Costs of Certification are borne by Hospitals. Certification has decreased costs, per Flum, where readmissions decreased 25%, reoperations declined 33% and overall costs fell 20% post-NCD in 2006. Removal of facility certification will lead to increased complications and resultant costs.

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Thank you for the opportunity to contribute my opinion. I am a bariatric surgeon who is allowed by all major insurers to perform bariatric surgery, and is having great results, despite not being in a designated Center of Excellence facility. We are rigorous about the quality of our work. The only patients who cannot benefit from our services are those who are CMS beneficiaries (Medicare)

1. The COE experiment fulfilled its role as an experiment. It entailed a variable degree of access limitations that was thought of as a necessary disadvantage. The new data show that such a disadvantage in limiting access is not truly necessary.

2. Since the Medicare patient population is perceived to include a higher incidence of issues that can make bariatric surgery less successful or more risky, those issues have to be identified, rather than limiting access across the board. identifying those issues will serve all patients and may indeed specify a subpopulation of patients that should be treated in specialized centers.

3. Sleeve gastrectomy should be adopted by Medicare. Its effectiveness is comparable to gastric bypass with much less morbidity, and is far more effective (and more consistent in its effectiveness) than the adjustable gastric banding. I will not be surprised if data show that sleeve gastrectomy is more cost-effective, or at least as cost-effective as, gastric bypass and/or laparoscopic gastric banding. Private insurers have not shown the slightest regret since accepting it, and their business is for-profit.

Thank you again for the opportunity.

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July 26, 2013

Dear Dr. Jacques:

The Joint Commission appreciates the opportunity to provide comments on CMS’ Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3). Since its founding in 1951, The Joint Commission has been acknowledged as the leader in developing the highest standards for quality and safety in the delivery of health care, and evaluating organization performance based on these standards. Today, more than 20,000 health care organizations and programs in the United States use Joint Commission standards to guide how they administer care and continuously improve performance. The Joint Commission evaluates health care organizations across the continuum of care, including most of our Nation’s hospitals. The Joint Commission also accredits clinical laboratories, ambulatory care and office-based surgery facilities, and behavioral healthcare organizations, home care, hospice, and long term care organizations.

For over six years, The Joint Commission has had two facility certification programs that CMS has required in National Coverage Decisions (NCDs) to ensure that Medicare beneficiaries are receiving safe and high quality care. In 2006, at the request of CMS, The Joint Commission developed a certification program for facilities seeking Medicare reimbursement for the implantation of ventricular assist devices (VADs) used for destination therapy (VAD-DT). In 2007, CMS modified the VAD-DT NCD to require facilities seeking Medicare reimbursement to be certified by The Joint Commission. We have certified 123 VAD-DT programs across the U.S. during the past six years. Also at the request of CMS, The Joint Commission developed a certification program for facilities that perform the complex and very rare procedure, lung volume reduction surgery (LVRS). We believe that these certification programs have been successful and have identified risks attendant to these procedures that otherwise would not have risen to the attention of the hospital. Thus we support continued CMS recognition of procedure-specific certification programs in certain areas, especially where clinical experts have valued and helped set such standards.

As a leader in healthcare quality and safety, The Joint Commission strongly supports the need for an external body, such as an accreditation organization, to certify compliance with a set of rigorous requirements that have been vetted and approved by experts in the field. Programs that offer bariatric surgery for the treatment of morbid obesity are complex and need an objective assessment of their systems and processes to ensure that they are safe, improve patient outcomes and advance quality assurance and performance improvement activities. Obesity is one of our nation’s greatest public health concerns and represents a tremendous economic burden for our health care system. Thus, at a time when our country is focusing efforts to prevent and reduce obesity, it would be inappropriate to put patients seeking bariatric surgery at risk. Especially, in light of the new study that found that non-accredited bariatric centers had an in-hospital mortality rate that was more than three times higher than accredited centers (0.22% vs. 0.06%, respectively) with similar volume.

There is substantial evidence of the positive impact that certification can have on the safety and effectiveness of bariatric surgery. Therefore, we strongly encourage CMS to reject the proposal to eliminate the bariatric surgery facility certification requirement.

If you have any questions, please do not hesitate to contact me at (202) 783-6655 or at mvanamringe@jointcommission.org.

Sincerely,

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I am a general and bariatric surgeon in Tampa, Florida. I practice exclusively in a hospital that is not a Center of Excellence for bariatric surgery. I am not in favor of Facility Certification Requirement in it's present form or draft form. The reason for my opposition is that there are not outcome measures for this "certification". In fact, numbers of procedures per year for the institution has been the measure that distinguishes those hospitals with, and those without, certification. The problem with requiring a certain "number" of procedures is that a new program like mine, or a program that has outstanding outcomes, but with a smaller number of procedures, is unable to provide the service to patients with Medicare or an insurance policy that requires "Center of Excellence". This prevents developing programs from growing. It becomes the scenario of "haves and have nots".

I think there may be a benefit to "Certification" for bariatric surgery programs. The crieria should focus on resources and outcomes. There must be a fair method for "developing" programs to become certified.

I suspect the Center of Excellence requirement in my community limits access to care for many patients in need.

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July 26, 2013

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

I would like to express my serious concern regarding the Centers for Medicare and Medicaid (CMS) June 27, 2013 Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-0025OR3). I disagree that the evidence is sufficient to conclude that there is no value to the requirement for certification for bariatric surgery.

Examination of the data is important. Studies show that major complication rates are similar between low volume surgeons and high volume surgeons and between accredited and non-accredited programs. However, major surgical complications are mostly a reflection of the intra-operative skill of the surgeon. The story of safety is best told in the context of mortality that best reflects the impact of the entire team, structure and process of care. This evidence does exist, in the study co-authored by Professor of Surgery from the University of Irvine, Ninh T. Nguyen, MD utilizing large numbers of patients from the National In-Patient sample. These data show a three fold difference in mortality between accredited and non-accredited centers.

The American Society for Metabolic and Bariatric Surgery and the American College of Surgeons established a joint accreditation and quality improvement program in April of 2012 (MBSAQIP). The 750+ MBSAQIP programs report to the joint national MBSAQIP data registry and the registry now contains over 200,000 patient cases. While the new unified program brought strengths from each of the previous programs both societies wanted to continue the effort to improve patient safety and effectiveness. Last summer a representative group of surgeons from both societies was appointed and after careful review of the existing standards and the current peer reviewed literature they moved forward to propose s new structure for accreditation. This new structure is inclusive and promotes access to patient care in their local environment by accrediting qualified programs after performing 25 cases as long as they had established a full support structure for the patient. Other critical changes involve increasing fidelity and long term capture of the data, accreditation for adolescent bariatric surgery and use of outcomes through collaborative committees to promote improvement.

This proposal then went through a public comment period where multiple stakeholders made comments that were then reexamined by a wider group of surgeons, integrated health partners and payers. The new standards will be available for the second public comment period shortly and will be implemented this year. The new structure of the program provides a planned pathway for new programs to become accredited and a structure for collaborations on the local, state and national level to occur. The combination of the improvements in the standards provides an environment where an improvement in surgical complications and patient experience of care will be greatly enhanced. The new program is an advancement on each societies first efforts and is informed by the experience of over 750 programs and integrated health staff and 1200 surgeons that are committed to providing care in a setting that meets the goals of a continuous learning environment.

It is essential that CMS continue to support accreditation through MBSAQIP. Without this support some surgeons and hospitals will treat surgical management of obesity the way they do other general surgery procedures that do not require long term care. Patients who suffer from obesity are vulnerable. Without better outcomes and value data publicly available it falls to the societies to support patient safety and offer resources for safe care.

The major surgical societies working in this field, ASMBS, ACS and SAGES as well as patient advocacy groups like the Obesity Action Coalition and the societies representing our partners in the management of obesity: the American Dietetic Association and The Obesity Society all support the MBSAQIP program accreditation. Why would CMS not chose to join that coalition? It makes no sense in an era when partnering of payers and providers of care is necessary to define value.

CMS has a chance to lead in the right direction. CMS should continue to support society based accreditation through MBSAQIP, 100% reporting of data to the national MBSAQIP data registry and use of the data to improve outcomes. The patient will be the winner.

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Louis Jacques, MD
Director, Coverage and Analysis Group
CMS/OCSQ/Coverage and Analysis Group
7500 Security Blvd.
Mailstop C1 -09-06
Baltimore, MD 21244

Re: CAG-00250R3 (National Coverage Analysis (NCA) for Bariatric Surgery for the Treatment of Morbid Obesity- Facility Certification Requirement)

Dear Dr. Jacques,

The American Society for Metabolic and Bariatric Surgery and American College of Surgeons along with all the undersigned professional societies have reviewed the Centers for Medicare and Medicaid Services (CMS) early-released June 27, 2013 Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3). As organizations committed to quality improvement and safety protections for our patients, we fully support the continuation of the Facility Certification Requirement established in 2006; and therefore, strongly oppose CMS’ decision to overturn current, established policy.

We are concerned that the Proposed Decision Memo to remove the Bariatric Surgery Facility Certification requirement is a radical departure from previous Bariatric Surgery quality initiatives, is contrary to general CMS Facility Certification efforts, and is based upon an incomplete review and analysis of the evidence. In addition, we believe the proposal to remove the Bariatric Surgery Facility Certification will place the highly vulnerable Medicare population at risk. We believe that the Proposed Decision Memo to remove Facility Certification is not compatible with CMS published standards of scientific integrity and relevance. While concern regarding access has been raised, little evidence supports diminished access to care with substantial increases in Medicare bariatric surgery since the 2006 NCD. Furthermore, within the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MSAQIP), there are 725 Accredited Centers nation-wide and, with a new lowered volume standard of 50 stapled bariatric cases annually, we anticipate even more accredited centers with the same demonstrated level of quality that beneficiaries and the Medicare program have come to rely upon. Finally, removal of the Bariatric Surgery Facility Certification puts CMS in the unique situation of being the only major insurer not providing Facility Certification for Bariatric Surgery.

We appreciate the opportunity to provide comments on this Proposed Decision memo. However, given the quality and safety implications for Medicare patients, we are concerned with the lack of communication between CMS and our organizations as the administrators of the accreditation programs most active in bariatric surgery. In this capacity, both ASMBS and ACS have a tremendous amount of data and experience that could help CMS better understand the value of accreditation for patients; yet, CMS has sought little counsel from our organizations, while using language in the Proposed Decision memo that seems to rely almost solely on information from a single source. Of note, we have polled out membership regarding bariatric surgery facility certification and have found that over 80% support continued facility certification. We ask you to carefully review the contents of this letter and come to the appropriate conclusion that Bariatric Surgery Facility Accreditation continue with a lowered volume standard.

Previous Evidence for Facility Accreditation

We have previously reviewed the evidence supporting Facility Accreditation in our letter dated February 22, 2013 (http://asmbs.org/2013/02/cms-responses-facility-accreditation/#CMS Response to Facility Accreditation). At the time of the February 2013 letter, there were seven studies in support of facility accreditation and two studies against facility accreditation. The first study offered against facility accreditation was the 2009 Archives of Surgery Livingston publication. It should be noted that the Livingston study utilized 2005 Nationwide Inpatient Sample data, which predates the 2006 NCD. The second article cited against facility certification was from Birkmeyer in a JAMA 2010 article. At the time of study, it should be noted that of the 25 hospitals participating in the Michigan Bariatric Surgery Collaborative (MBSC) 19 were Centers of Excellence. Participation in MBSC has virtually the same elements as the current accreditation process. In addition, in closer examination of the study, there is a question of how applicable these results are for Medicare patients. In the MBSC, the average BMI and Age was a modest 46 with a peak of 56 for both demographic measures. This MBSC population may not be generalizable to the Medicare population, which tends to be older and heavier (Yuan SOARD 2009).

New Evidence Regarding Facility Accreditation

Since our February 22, 2013 letter, there have been two new relevant publications that merit review. In the proposed June 27, 2013 decision memo, the 2013 JAMA Dimick article is given ample weight as demonstrating lack of support for facility accreditation. This article like the other articles utilize administrative, claims data. It is important to reference the 2011 Flum study which clearly demonstrates the value of accreditation specifically for Medicare beneficiaries whereby 90-day mortality fell 50% (1.5% to 0.7%), readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and costs fell 20% ($24,363 to $19,746) post-NCD.

JAMA Dimick 2013
As outlined in the Morton/Nguyen commentary (SOARD 2013), the Dimick study found the same improvement for the Medicare population with reductions in any complication (12.3% to 7.9%) and serious complications (7.5% to 3.4%) after the NCD, as did the Flum study. Not surprisingly, the comparison population (Non-Medicare) had the same improvement. Surprisingly, the authors do not utilize mortality as an outcome. What is stunning is that the improvements in outcomes between Medicare and Non-Medicare populations were not significantly different is noteworthy given the high comorbid condition of the Medicare population. The authors utilize a difference-in-differences analysis and make a flawed assumption that the control group wasn’t exposed to the policy change. By 2006, non-Medicare patients were already exposed to the accreditation process given the requirement by private payors for hospital accreditation and that accreditation by ACS and ASMBS preceded the CMS NCD. Health policy impact analysis is commonly performed by Joinpoint regression analysis not by the econometric difference-in differences techniques. Furthermore, the authors don’t account for migration to and from accredited status.

Another major limitation to the study is administrative data, which lack specificity and sensitivity for complication reporting, as well as the data source, which is only for 25% of the nation. The study notes robust improvements for bariatric surgery may be due to greater utilization of laparoscopy, increasing surgeon experience, and fellowship training. All of these drivers for improvement were accelerated by facility accreditation, which provides a vehicle for hospital resource prioritization. The authors’ main objection against accreditation is the issue of limiting access. This is unfounded. In their own study, access for bariatric surgery in Medicare beneficiaries actually did improve after the NCD. Operations in Medicare beneficiaries increased from 6,273 procedures pre-NCD to 15,854 post-NCD. The article also inaccurately asserts a minimal volume effect in bariatric surgery despite multiple studies confirming that volume improves outcomes including a study by the article’s senior author.

Surgical Endoscopy Nguyen 2013
Many of the studies, either for or against facility certification, cite the difficulty in determining if the benefit of Bariatric Surgery Facility Certification is due to Accreditation or to a Volume Standard, which is a component of Facility Certification. In the recent Surgical Endoscopy study, Nguyen addresses both the utility of facility accreditation and the volume threshold. In Nguyen’s study “Volume and Outcome relationship in Bariatric Surgery in the Laparoscopic Era,” he utilized 2006-2010 laparoscopic, stapled bariatric surgery data from the Nation-Wide Inpatient Sample (NIS). Of note, the Dimick study utilized State-Inpatient Databases, which are a component of the NIS. In the Nguyen study, he found 277,760 cases performed between 2006-2010 with 85% performed at high volume centers (HVC, annual volume >50). The mean number of annual laparoscopic stapled cases at HVC was 144+117 and at LVC 17+14. In-patient hospital mortality was 0.17% at LVC and 0.07% at HVC.

Within the HVC population alone, the in-hospital mortality at HVC non-accredited centers was 0.22% and at HVC accredited centers it was 0.06%. Once correcting for confounders with multivariate analysis, non-accredited centers had significantly higher mortality (odds ratio 3.6, 95% CI, 1.5, 8.3, p < 0.01) and lower serious morbidity (odds ratio 0.8, 95% CI, 0.7, 0.9, p < 0.01). Accredited high volume centers have significantly lowered in-patient mortality while non-accredited high volume centers have worse mortality outcomes indicating that accreditation provides a benefit beyond volume. While non-accredited, high volume centers have less serious morbidity; this is coupled with significantly higher mortality indicating a failure to rescue patients who have complications. Hallmarks of accreditation include culture of commitment, proven experience, ancillary staff and bariatric specific resources, which are critical for the rescue of these patients if they encounter complications.

In addition to safeguarding compromised patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported (Wadden & Sarwer, SOARD 2006).

CMS and Facility Certification

In addition to the new evidence to be reviewed, we believe that this proposed decision to remove Bariatric Surgery Facility Accreditation is a radical departure from previous CMS policy. The following interventional National Care Determinations all have facility criteria requirement and/or certification: Adult Liver Transplantation (260.1), Artificial Hearts and Related Devices (20.9), Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease (160.24), Pancreas Transplants (260.3), Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1), Pediatric Liver Transplantation (260.2), Transcatheter Aortic Valve Replacement (TAVR) (20.32), and Transmyocardial Revascularization (TMR) (20.6). Of note, some these NCD facility criteria requirement and/or certification have existed for over 20 years. While substantial gains have been made in bariatric surgery, quality and patient safety are enduring goals that best take place in the setting of Facility Certification. Facility Certification allows for the marshaling of needed resources from a hospital perspective such as data collection, which may not occur with Facility Certification.

As noted previously and below, the four main private payors have embraced and continue to support bariatric surgery facility accreditation as confirmed by ASMBS leadership (all accessed July 2013). Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population.

Aetna
“Institutes of Quality Bariatric Surgery Facilities”
http://www.aetna.com/healthcare-professionals/quality-measurement/institutes.html
http://www.aetna.com/healthcare-professionals/documents-forms/Bariatric_IOQ_Program_Requirements.pdf

Anthem Blue Cross and Blue Shield / Wellpoint
“Blue Distinction Centers for Bariatric Surgery”
http://www.anthem.com/wps/portal/ahpfooter?content_path=shared/noapplication/f0/s0/t0/pw_ad093285.htm&label=Centers%20for%20Excellence
http://www.anthem.com/shared/noapplication/f0/s0/t0/pw_ad093282.pdf?refer=ahpfooter

Cigna
“3 Star Quality Bariatric Centers”
http://www.cigna.com/healthcareprofessionals/resources-for-health-care-professionals/health-and-wellness-programs/certification-for-bariatric-surgery.html
http://www.cigna.com/assets/docs/health-care-professionals/3star_designation.pdf

United Healthcare / Optum Health
https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/UnitedHealthcare%20Medicare%20Coverage/Obesity_SH_Ovations.pdf
https://www.myoptumhealthcomplexmedical.com/gateway/public/bariatric/bariatric.jsp
https://www.myoptumhealthcomplexmedical.com/gateway/cmsrepository/DOCUMENT/1354747298296_121205_BRS_Internal_COE_MAP_md_w_UHC_brand_md.pdf

The Medicare population is at high risk

The Medicare population is specifically an at-risk population for obesity and its consequences. Eligibility for Medicare benefits include age >65 and disability including end-stage renal disease (ESRD). Numerous studies have detailed the impact of obesity leading to disability. In a 2008 Obesity Review article, Neovius and colleagues found that patients with a BMI>35 had a Three-Fold risk of being disabled. The same article highlighted the strong impact of bariatric surgery upon potential reversal of disability with a doubling of return to work for obese disabled patients who had surgical treatment for their obesity. Flegal in a 2010 JAMA article found a 12.1 % incidence of BMI>35 in the population age>60. Obesity has also been found to lead to increased waiting times for ESRD patients awaiting transplant leading to weight-related disparities in care for these Medicare patients in need (Segev, J Am Soc Nephrol, 2008).

The specific impact of Medicare status upon bariatric surgery outcomes is undeniable: Medicare patients have higher risk of morbidity and mortality than the general bariatric surgery population. In American Surgeon, Carbonell et al reported in 2005 that age greater than 60 years, Medicare or Medicaid-insured status, and surgery performed in nonteaching, large, urban-located hospitals with low case volumes is associated with longer LOS and higher charges. In another 2005 American Surgeon article, Poulose found that Medicare coverage compared to private insurance increased the risk of post-operative respiratory failure significantly (OR 2.2 [1.2-3.8], P < 0.05).

In a 2006 Archives of Surgery publication by Livingston, he found Medicare status unadjusted for age, gender, and comorbidities had an increased odds ratio for mortality of 4.31 and once adjusted 1.44. In a 2006 American Surgeon article by Nguyen, Nationwide Inpatient Sample patients similar to Medicare population (age>60) had more than twice the mortality rate as younger patients (0.7 vs. 0.3%). In a SOARD 2009 article, Yuan described an academic center’s operative experience pre-2006 NCD (1981-2006) for 3300 patients. As seen below, Medicare status increased mortality for 30, 90 and 1-year mortality rates in comparison to Non-Medicare patients.

Mortality rates at 30 days, 90 days, and 1 year (Yuan, SOARD 2009)

In a 2011 Archives of Surgery publication, Nguyen et al found that Medicare status increased the risk of potentially fatal anastomotic leaks by 54%, a stronger risk factor than chronic lung disease or male gender. In a 2012 SOARD paper by Gould et al, Medicare status significantly increased readmissions and ED visits.

In a 2008 Annals of Surgery article by Perry et al, morbidly obese Medicare patients who underwent bariatric surgery had increased survival rates over the 2 years of this study when compared with a similar morbidly obese nonsurgical group (P < 0.001). For patients under the age of 65, this survival advantage started at 6 months postoperatively and for patients over age 65, at 11 months. These clear survival benefits for the Medicare population would be extinguished if surgeries are performed at non-accredited centers which have higher mortality rates even if they are high volume centers as noted in the 2013 Nguyen Surgical Endoscopy paper.

There are approximately 15,000 Medicare bariatric surgery performed annually. If we extrapolate the impact of loss of Medicare Facility Certification upon operative mortality, there will be an additional 240 deaths annually based on the mortality at Accredited High Volume Centers (0.06%) and Non-Accredited High Volume Centers (0.22%) as stated in the 2013 Nguyen Surgical Endoscopy paper.

Access

In the proposed Decision Memo, the issue of access to care for Medicare bariatric surgery patients has been raised. Every study since implementation of Facility Certification has demonstrated an increase in access. In the 2013 Dimick JAMA article, operations in Medicare beneficiaries increased from 6,273 procedures pre-NCD to 15,854 post-NCD. In the 2011 Flum Annals of Surgery article, Medicare bariatric surgery operation in the two years prior to the NCD increased from 17,127 to 29, 903 for the two years after the NCD. Of note, since implementation of the unified MBSAQIP program, there are now 725 centers available nation-wide for Medicare beneficiaries. An additional benefit to the unified MBSAQIP program is the ability to coordinate care on a national level. If the CMS Coverage Group has specific documented examples of lack of access, ASMBS and MBSAQIP is fully equipped and willing to address any access issue. As Adams noted in JAMA 2000, selective referral to appropriate centers can save lives and does not add undue burden upon the patient, particularly when there are more than 700 accredited bariatric surgery centers nationwide. We are all of the belief that all bariatric patients should all have access to quality care.

MBSAQIP Quality Standards are now available for public review. Of note, a key component to the new Quality Standards is the Facility Volume Requirement, which has been lowered from an annual 125 total to 50-stapled bariatric cases. Hospital volume does have an effect in bariatric surgery with the beneficial effect at 50 annual hospital stapled cases as confirmed by the Nguyen 2013 Surgical Endoscopy study. All of the eight studies supporting accreditation support provide evidence for hospital volume as part of the accreditation process. In addition, there are multiple studies confirming that volume should be a cornerstone of the certification process including the systematic review by Zevin in Annals of Surgery 2012. Additional studies supporting volume in bariatric surgery include the 2010 JAMA Birkmeyer study as well as the following: Courcoulas, Surgery 2003; Liu, American Surgeon 2003; Flum, JACS 2004; Nguyen, Annals of Surgery 2004; Smith, SOARD 2010; Flum, JAMA 2005; Weller, JACS 2007; Murr, Annals of Surgery 2007; Parker, Surgical Endoscopy 2007; Kelles, Obesity Surgery 2009; Birkmeyer, JAMA 2010.

Conclusion

Bariatric patient safety, cost and effectiveness have been vastly improved without decrease in access as a direct result of the 2006 Medicare National Coverage Determination for Bariatric Surgery. Overwhelmingly, bariatric surgeons support continued facility certification as noted in in an internal survey of the American Society of Metabolic and Bariatric Surgeons membership and the previous CMS public comments even after removing any perceived form letters.

It also should be noted that facility accreditation programs of the ASMBS and ACS were not established for nor intended to be research projects to determine the efficacy of certification. To abandon an existing, successful policy for which there is limited new evidence against facility certification is premature and places vulnerable Medicare patients at risk. Careful review of the evidence particularly the new 2013 literature support facility accreditation. Given the current state of the evidence, we strongly suggest that facility certification continue.

We believe that it is critical that bariatric programs look at meaningful measures with high-quality, standardized, valid data on clinically, impactful outcomes. Quality improvement is an iterative process that must continue to develop and move forward to enable innovation, evaluation of efforts around the country, and rapid-cycle learning and disseminating evidence about what works (Arch Surg 2009; http://www.ahrq.gov/workingforquality/nqs/principles.htm. Accessed July 2013). These concepts are supported by all undersigned and also align with the National Quality Strategy. Without accreditation, there is simply no validation for the success of such programs. CMS has also recognized the value and importance of accreditation, as seen in the support of the Joint Commission Hospital Accreditation program. Removing the accreditation requirement could result in a fragmented system with disconnected information and standards, which will reduce the sharing of best practices and consistent high-quality care for the obese population.

In keeping with the CMS Coverage with Evidence requirements, MBSAQIP has developed the bariatric surgery data registry and is committed to its maintenance and active use in quality improvement. Our first national collaborative will be an initiative to reduce 30-day readmissions, a quality initiative that CMS has embraced. In developing its program, MBSAQIP has worked with multiple stakeholders including manufacturers, health care providers and facilities, professional societies, foundations, and health plans.

Since the CMS NCD supporting accreditation, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened. Without accreditation, long-term data collection will be impaired and quality improvement efforts will be severely impeded. In any analysis, it is apparent that accreditation has caused no harm and the preponderance of the evidence indicates that facility certification has lead to improved outcomes. Removing the facility certification process will not benefit patients and a real question arises as to who would actually benefit if the facility accreditation process were removed. We can safely say that the Medicare patient will not benefit from loss of accreditation and may be harmed. Accreditation has worked to date and we question why we should gamble with patient lives now. Quality improvement and patient safety are enduring efforts, which can best be accomplished by the bariatric surgery facility accreditation. We appreciate the opportunity to review the many benefits of Bariatric Surgery Facility Certification and strongly urge you to continue this valuable initiative for your beneficiaries.

Sincerely,

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I believe that we have already been in a time and place when there was no facility certification. No standardization was being done within a single institution. Outcomes and complications were horific and the introduction of the COE for Medicare allowed for patients that in general are higher risk whether older age or disabled to go to places where the surgeons have experience in bariatric surgery and treating complications.

I feel this decision is not based on the previous history of the early 2000's and will reintroduce more complications and poor outcomes for the patients.

I believe access is an issue but I do not feel this should be changed in order to compromise care and send patients to centers with less experience.

There are center s that are dedidcated to this field and do provide the same care as COE centers but how will this be regulated and maintained. I do not think thet we should go backwards to go forwards.

The ACS has multilevels for accredidation and this should serve for people to get adequate access if a program is dedicated to the bariatric field.

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July 26, 2013

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

On behalf of the nearly 50,000 members of the Obesity Action Coalition (OAC), I would like to express our deep concern regarding the Centers for Medicare & Medicaid Services (CMS) June 27, 2013 Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3). The Memo states that CMS believes “the evidence is sufficient to conclude that continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries.” We strongly disagree with such a statement and urge significant caution around basing such an important decision on very limited and mixed evidence.

The 2006 bariatric surgery center facility requirements that the agency now proposes to eliminate broadly include procedure volume requirements for surgeon and facility, as well as establishment and maintenance of an integrated program for the care of Medicare patients affected by severe obesity.

The OAC acknowledges that procedure volume requirements likely should be lowered to allow more facilities to participate as a qualified certified facility. Such an approach is already encompassed in the new MBSAQIP being jointly developed by the American Society for Metabolic and Bariatric Surgery and the American College of Surgeons – the two scientific organizations that were deemed acceptable for Medicare COE certification under the February 2006 NCD. However, we worry that the agency, in focusing on the volume requirements, is overlooking the critical benefits of certification associated with maintaining a solid integrated program – one that is specifically tailored to the long term needs of those affected by the disease of severe obesity.

For example, the 2006 NCD states that bariatric surgery Centers of Excellence (COE) “must have ancillary services such as specialized nursing care, dietary instruction, counseling, support groups, exercise training, and psychological assistance, as needed; and a multidisciplinary bariatric surgery team with written descriptions of the responsibilities of each member of the team.” Furthermore, this team “must be comprised of individuals with the appropriate qualifications, training and experience in the relevant areas of bariatric surgery, rehabilitation, critical care anesthesia, and nutrition counseling for those affected by morbid obesity and post-bariatric surgery patients.” Finally, Medicare COEs “must have sufficient operating room tables, equipment, instruments and supplies specifically designed or appropriate for bariatric surgery; a recovery room capable of providing critical care to patients affected by obesity; and an intensive care unit with similar capabilities.”

We strongly believe that Medicare patients continue to need access to the appropriate treatment tools and clinical environment necessary, as detailed above, to receive both safe and effective treatment for the disease of obesity and severe obesity and that an elimination of certification will likely allow facilities providing bariatric surgery to either open without such services and/or we could see facilities eliminate such services.

Validating the above, we would direct CMS to the latest scientific studies that demonstrate the clear benefits for patient care surrounding accreditation. For example, a new study co-authored by Ninh T. Nguyen, MD, FACS, vice-chair of the department of surgery at UC Irvine School of Medicine, found non-accredited bariatric surgery centers had an in-hospital mortality rate that was more than three times higher than accredited centers (0.22% vs. 0.06%, respectively) with similar volume. These findings suggest that the standards required for accreditation provide important pre-operative and post-operative life-saving safeguards for patients – particularly for those at high risk for surgical and obesity-related complications.

Improved access to bariatric surgery is one of the main reasons cited driving this policy change. However, we were surprised to see no analysis included in the coverage decision on whether or not access to bariatric surgery, because of facility certification, is a problem. While we acknowledge that the OAC initially received complaints from Medicare recipients unable to identify a certified facility in their area; we are happy to report that we have not received any such complaints in years following the maturity of the ASMBS and ACS COE certification programs. However, we do receive complaints from Medicare recipients surrounding Medicare Contractor decisions related to the vague medical weight management requirements included in the NCD, gastric sleeve coverage or difficulty in securing a revision procedure. In fact, we would argue that the lack of clarity around both the medical weight management issue and lack of guidelines on revision procedures are the primary barriers to bariatric surgery among Medicare recipients affected by severe obesity, not facility certification.

The OAC believes that CMS must reject its proposal to eliminate the bariatric surgery facility certification requirement. We stand by our original comment on this issue urging CMS to maintain certification, but work with both ASMBS and ACS to develop a dynamic certification program – adapting to the latest scientific advancements in bariatric surgery and care coordination. This would allow an increase in the number of legitimate hospital-based bariatric surgery programs. Elimination of bariatric surgery facility certification is clearly at odds with previous CMS policy supporting patient safety and measures that promote improved outcomes. Please do not jeopardize the substantial progress that has been made in bariatric surgical outcomes by eliminating Medicare’s requirements for facility and personnel resources. Such a decision could have deadly consequences for thousands of future Medicare patients.

Sincerely,

Joseph Nadglowski, Jr
President/CEO

Pamela R. Davis, RN, CBN
Chairman of the Board

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

Nguyen in a 2012 Journal of the American College of Surgeons (JACS) found significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758).

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I strongly disagree with the decision to eliminate the need for facility certification for bariatric surgery. The ASMBS and ACS have made great strides in improving the safety and efficacy of bariatric surgery through the center of excellence programs they have developed. Their actions have pushed hospitals to provide the infrastucture for this improvement in the quality of bariatric care. Some hospitals and surgeons may claim they have done the same without certification but it is my understanding that most of them have adopted the "requirements" for center of excellence designation without attaching the name.

I have certainly seen a trend toward support of bariatrics driven by the certification process in my facility and in other facilities. Removing this requirement for certification will lead to hospitals directing dollars, equipment, etc. to other areas of the hospital at the expense of the bariatric population.

This certification process focuses hospitals on the needs of a population that tends to be sicker, have more physical limitations, and carry more risk of perioperative problems. Facility certification helps increase safety/quality and is in line with similar certifications (such as trauma care) championed by the ACS.

Please don't take a step backward and remove the framework for quality care of an ever increasing patient population.

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July 26, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
CMS/OCSQ/Coverage and Analysis Group
7500 Security Blvd. Mailstop C1 -09-06
Baltimore, MD 21244

Re: CAG-00250R3 (National Coverage Analysis (NCA) for Bariatric Surgery for the Treatment of Morbid Obesity - Facility Certification Requirement)

Dear Dr. Jacques:

The Academy of Nutrition and Dietetics (the “Academy”) is pleased to comment on the proposed decision memorandum regarding the NCA for Bariatric Surgery for the Treatment of Morbid Obesity - Facility Certification Requirement issued June 27, 2013. The Academy is the world’s largest organization of food and nutrition professionals, with more than 75,000 members comprised of registered dietitian nutritionists (RDNs), registered dietitians (RDs), dietetic technicians, registered (DTRs), and advanced-degree nutritionists. Every day we work with Americans in all walks of life—from prenatal care through old age—providing nutrition care and conducting nutrition research. We are committed to improving the nation’s health and work treat individuals with obesity, including significant counseling before and after they undergo bariatric surgery.

The Academy associates itself with the comments submitted by (1) the American Society for Metabolic and Bariatric Surgery and American College of Surgeons (“ASMBS/ACS comments”) and (2) the American Association of Clinical Endocrinologists (“AACE comments”). On the bases detailed therein, we do not support the proposal to discontinue the certification requirement for bariatric facilities, referred to as the center of excellence (COE) program.

The Academy believes that there is insufficient quality data to conclude that the COE requirement for bariatric surgery centers should be eliminated. Given this lack of compelling data and the absence of any consensus in the literature, we believe it is prudent to maintain the status quo for the COE program, which has helped evolve comprehensive programs for bariatric surgical care and has contributed to decreasing rates of mortality and morbidity. Facility certification directly involves the well-being of our patients referred for bariatric surgery; patient safety is the primary concern underlying the Academy’s opposition to the proposed decision memorandum. The Academy urges CMS to consider the specific concerns detailed in the ASMBS/ACE comments and the ACE comments. A decision of such import and consequence should be based on a firm and conclusive body of evidence that does not yet exist.

The Academy appreciates the opportunity to comment on the proposed decision memorandum and we hope you will look towards the Academy and our members’ expertise as you promulgate additional regulations related to patient safety and bariatric surgery. Please contact either Jeanne Blankenship at 202-775-8277 ext. 1730 or by email at jblankenship@eatright.org or Pepin Tuma at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely,

Jeanne Blankenship, MS RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics

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I have been involved with bariatric surgery for 37 years, and have seen bariatric surgery on patients with no structured program and those that are done in bariatric surgery COE. It's comparing night and day. Medicare patients are usually sicker and they best be done in centers with experienced bariatric surgeons and supporting staff, to achieve a safe and successful surgery. COE equates to experience and good results. I believe it is short sighted in eliminating the COE status for CMS patients. I'm sure it will come back to haunt you for this poor judgement.

Sincerely,

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I strongly support continued CMS accreditation of bariatric surgery facilities. Since the implementation of the accreditation programs by the American College of Surgeons and the American Society of Bariatric Surgery, complications and mortality rates following bariatric surgery have been significantly reduced in both the Medicare and non-Medicare populations. This fact is not disputed, even in those publications which have attempted to discredit the certification process.

A major flaw in these publications was the failure to account for programs that had applied for certification, are in provisional status with the ASMBS, or had been granted Level 2 status by the ACS. These programs are included in the control, non-COE, groups in these studies. The vast majority of facilities in the United States committed to a successful bariatric program have applied for certification. In submitting an application, the programs have confirmed that they have implemented the structures and processes believed by the certifying bodies to produce optimal outcomes in bariatric surgery. Having served on the program review committee of the ASMBS program since 2005, served as committee chair since 2009, and as co-chair of the verification committee of the new joint MBSAQIP program, I have reviewed the applications of the majority of applicant programs. Case volume remains the primary factor keeping the majority of “non-COE” programs from being certified. This speaks against the current volume standard of 125 cases per year, not the certification process itself.

This point is reinforced by the recent publication by Nguyen in Surgical Endoscopy (2013). Comparing accredited to non-accredited high volume facilities, mortality was significantly lower in the accredited centers. A high volume center that has elected to not become certified demonstrates an unwillingness to commit to the structures and processes that produce optimal outcomes.

The Dimick 2013 publication compared outcomes in Medicare to non-Medicare bariatric surgery patients. Improvements in outcomes since the implementation of the accreditation programs were demonstrated in both populations. As the majority of patients in accredited programs are non-Medicare, improvements should be expected in both groups. The secondary analysis comparing COE and non-COE again fails to account for the provisionally approved and level 2 programs in the non-COE group.

Finally, the Birkmeyer 2010 publication compared outcomes amongst the Michigan Bariatric Surgery Cooperative participating programs with regards to volume and COE status. Dr. Birkmeyer helped form the MBSC and Drs. Birkmeyer, Birkmeyer, and Dimick play a vital role in its direction. The MBSC, through its rigorous data collection and quality improvement programs, is a COE program of the highest order, though not recognized as such by CMS. Again, it is not the letter of certification that improves outcomes, but the implementation of structures and processes, data collection, and quality improvement.

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I am a bariatric surgeon in private practice for 13 years, and I fully support ongoing facility certification for bariatric surgery.

Although I agree that there is not clear evidence that certification of centers per se has improved outcomes, there is also not clear evidence that removing the certification requirement will benefit patients, and there is a risk that outcomes will deteriorate without center certification.

There is very clear evidence for a volume outcome relationship in complex bariatric procedures such as the gastric bypass, as we showed in our analysis from data from the NIH-funded LABS consortium (Smith et al, SOARD). Removing the facility volume requirement will therefore likely result in increased complications.

The only potentially plausible argument to remove center accreditation would be if there were an issue with access to local care for some patients not residing near an accredited center. Given there are hundreds of accredited centers all over the country, I do not believe this is a valid argument.

The question of the value of bariatric surgery center accreditation was raised by surgeons from Michigan, where they have a unique quality program that is well-funded by an insurance company. They did not find that center accreditation correlated with improved outcomes. However, they do require each institution do 40 procedures per year in order to participate, so they are essentially all similar to accredited centers (with the new lower volume criteria).

The rest of the states do not have access to this type of fully funded quality program. Our newly revised national quality program, which is a partnership between the ASMBS and the ACS, is the best program that we have nationally in order to monitor and improve quality in our field.

Over the last 13 years in practice I have observed vast improvements in bariatric surgery outcomes, which are due to many factors including laparoscopic surgery, better ICU care, better patient education, and likely many of the processes and protocols for standardization that are part of the facility accreditation process.

I urge CMS to reconsider this preliminary decision to eliminate the facility accreditation requirement.

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I disagree with the plan to allow Medicare patients to have surgery at non Center of Excellence facilities. As a surgeon who has practiced bariatric surgery for 22 years and who has seen the development and implementaion of the COE at two hospital, I can attest to the improvements in care that come with preparing and maintaining COE status. There is NO question that the hospital administration is more responsive to the needs of the bariatric patient when COE designation is at stake. Likewise physicians step their game when certification is at stake.

Please maintain certification requirements for the sake of patient safety.

Charles Callery, MD, FACS

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Thank you for taking the time to read our comments.

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CMS continues with its stupid decisions that lead healthcare in the wrong direction. there is reasonable data to suggest that Medicare patients undergoing bariatric surgery have a death rate that is 4 times higher than non-Medicare patients.

The decision to allow medicare bariatric surgery in non COE facilities defies common sense. it basically allows the highest risk patients to have surgery in the least qualified facilities.

there is also ample evidence that "centralization" of health care results in more cost efficient care...protocols and repetition make higher volume hospitals better at certain operations. again, it defies common sense to allow high risk Medicare patients to go any hospital which might be able to perform a bariatric surgery.

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As a Certified Bariatric Nurse, as the program director of a comprehensive, high-volume MBS-AQIP [PHI Redacted], I would like to express my profound concern over the Centers for Medicare & Medicaid Services (CMS) June 27, 2013 Proposed Decision Memo on Facility Certification for Bariatric Surgery for the Treatment of Morbid Obesity (Facility Certification Requirement CAG-00250R3). The Memo states that CMS believes “the evidence is sufficient to conclude that continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries.” I disagree with this conclusion and urge CMS to evaluate all of the factors contributing to both the short-term and long-term success after surgery and to not focus their attention on one narrow study.

In 2006, CMS set specific criteria in the NCD detailing, “Centers of Excellence (COE) “must have ancillary services such as specialized nursing care, dietary instruction, counseling, support groups, exercise training, and psychological assistance, as needed; and a multidisciplinary bariatric surgery team with written descriptions of the responsibilities of each member of the team.” Furthermore, this team “must be comprised of individuals with the appropriate qualifications, training and experience in the relevant areas of bariatric surgery, rehabilitation, critical care anesthesia, and nutrition counseling for those affected by morbid obesity and post-bariatric surgery patients.”

I’ve worked as a nurse for the last 20 years. To in any way, remove the “specialization” of bariatric surgery and return it to the equivalent of a procedure such as a cholecystectomy or colectomy where the patient sees only the surgeon once before surgery and once after surgery at which point their care is “complete” would set the strides in both improved mortality and morbidity back tremendously. The multi-disciplinary approach provided to bariatric surgery patients which includes in-depth dietary and nutritional counseling, exercise counseling, behavior modification and psychological support in its current state as embraced by payors beyond CMS has driven all programs to provide, or strive to provide this level of care as they seek designation as a Center of Excellence. The primary obstacle to facilities achieving this designation has been the volume requirements. As such, I implore CMS to consider revising only the volume requirement. Please don’t jeopardize the substantial progress that has been made in bariatric surgical outcomes by throwing out Medicare’s requirements for facility and personnel resources.

A recent study co-authored by Ninh T. Nguyen, MD, FACS, vice-chair of the department of surgery at UC Irvine School of Medicine, found non-accredited bariatric centers had an in-hospital mortality rate that was more than three times higher than accredited centers (0.22% vs. 0.06%, respectively) with similar volume. These findings suggest that the standards required for accreditation provide important pre-operative and post-operative life-saving safeguards for patients – particularly to those at high risk for complications.

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I am a health economist, assistant professor of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health, and faculty associate at the University of Michigan. Together with surgeon colleagues, I have been researching the intended and unintended consequences of the 2006 National Coverage Decision for bariatric surgery. Our research suggests that Medicare patients would benefit from the proposed discontinuation of the Facility Certification Requirement for bariatric surgery.

The proposed decision memo highlights known limitations of the current bariatric surgery Centers of Excellence (COE program), namely that patient outcomes at COEs are not significantly better than outcomes at non-COE hospitals. Our forthcoming work raises additional concerns about the facility certification requirement. In particular, we find that this policy has adversely impacted access to surgery among minority patients and distorted choice of procedure type.

1- Disparities: As prior work has demonstrated, minorities account for a disproportionate share of obesity, but are underrepresented among bariatric surgery recipients. The Medicare NCD went into effect during a period of growth in use of surgery by minority patients. After the NCD, this trend continued for non-minority patients, while minorities began accounting for a declining share of Medicare patients. Using rigorous econometric difference-in-difference methods, we estimate that the NCD was associated with a 20% reduction in the proportion of minority Medicare bariatric surgery patients in the first 3 years of the facility certification requirement. Hospitals chosen by minority Medicare patients prior to the NCD were less likely to become Centers of Excellence by 2010. Since bariatric surgery requires multiple pre and post-operative visits for appropriate care, loss of access to preferred hospitals may have deterred minority patients from pursuing surgical treatment.

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I was shocked to read the proposed CMS decision to not require ASMBS SRC standardiation for the Medicare patient. First and foremost, prior to having this standard in place, the death rate following bariatric surgery surged. This was the initiative to instigate a standard in the first place. To take the data from the Michigan consortium and then to determine that they did not have a standard of care and qualification process, is ludicrous. Clearly over $2,000,000 dollars from Blue Cross Blue Shield funded this Program. Although the ASMBS SRC standard was not designated, there were designations. The medicare bariatric patient is the patient at the greatest risk for surgery. Today with standardization, the death rate has fallen following bariatric to 1 in 500 nationally. Here at Unity Hospital, we have a 1 in 3844 rate. We provide a very high standard of care.

To put that patient at risk by not demaning the highest level of care to ensure a positive outcome, is not just a poor business decision, it is medically negligent. I urge you to reconsider this recommendation.

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In years past Bariatric Surgery was considered "cosmetic" to many. It is not cosmetic. Bariatric surgery is a treatment for obesity, a real disease. In the past (prior to COE's)you would hear stories of negative outcomes, i.e. mortalities, complications, etc... Since the implementation of Centers of Excellence we have had hospitals step up to the plate to put the resources into integrated programs to make the program(s) complete and safer for patients seeking this surgical tratment for weightloss. Hospitals resources are generally not put out there unless it is required. The patients have access to Quality Care with COE's. The Medicare patient population tends to be sicker and COE's work hard to make sure they have the best outcomes possible.There was a study specific for Medicare patients (20111 Flum) which clearly shows the 90 day mortality rate fell by 50% (1.5%-0.7%),readmissions decreased by 25%(19.9%-15.4%), reoperations declined 33%(3.2%-2.1%) and cost fell 20% (20,363.00 to 19,746.00)post NCD.

There are several studies that showed reductions in complications.

Overall the integrated programs with utilizations of a leader such as a Coordinator or Director who is a Certified Bariatric Nurse or equivelent to lead the program, implement and maintain support group meetings, offer pre-operative education that goes above and beyond requirements, staff education, and pathways have made a difference in the outcomes of patients, from the surgery itself to the success long term. Support for this patient population both pre and post op has made a diference in outcomes. COE Hospitals who really care about Quality do not allow a surgeon without proper training to perform Bariatric Surgery.

Privare Insurance companies see value in their own certified Bariaric Programs. This makes sense to have one major Certification process for facilities.

Hospitals have Bariatric chairs in the waiting rooms, registration areas, etc... COE Hospitals spend money on the proper equipment necessary for safe patient care.

I disagree with the CMS Bariatric Facility Certification proposed decison memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

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As a facility who has been doing bariatric surgery for over 30 years, with the implementation of certification requirements, it has pushed weight loss surgery programs to excel to a higher level and invest more into the care of patients. It would be concerning if certification was abandoned and patients were brought to surgery and left without the necessary support system to help them succeed with this life change. I support certification that monitors the outcomes, support and education of patients before and after surgery. Unfortunately, alone the surgery does not guarantee success. I also believe a surgeon needs to be very experienced to help maintain the positive outcomes that have been preserved by our bariatric surgeons.

Thank you for your consideration in helping to keep our patients safe who are in need of this life changing surgery.

Alicia Allen
Registered Dietitian

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue for the following reasons:

As CEO & President of Colquitt Regional Medical Center in Moultrie, Georgia, I wish to applaud your proposal in eliminating the certificate of excellence designation for facilities providing bariatric surgical services.
In Moultrie-Colquitt County, we are a sole community 99-bed hospital with an overall payor mix of about 50% Medicare patients in a population of approximate 46,000.
The current requirement for COE for Medicare patients have limited our services to patients in need. We are a county where 13% of our population is 65 years or older and 30% of the adults suffer from obesity.

Our bariatric center provides services of medical and surgical options. We have counseled, and provided lap-band services for many patients with successful outcomes. Due to the fact that we are not a designated center of excellence facility, patients are turned away only because our facility does not produce the volume of surgical bariatric cases required for COE status. The closest COE facility to our area is over 100 miles away and just not convenient for patients. This designation only causes the patient to suffer.

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I believe Bariatric Surgery Facility Certification is important, and should continue. I believe the American Society for Metabolic and Bariatric Surgery, along with the American College of Surgeons, are best entrusted to design a logical certification system. Such a system needs to have real-time, risk-adjusted outcomes reporting, and eventually such data should be publicly available. Transparency is an important element of public trust.

Joshua B. Alley, MD FACS
Director of Metabolic and Bariatric Surgery
Guthrie Weight Loss Center
Guthrie Clinic

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I am writing to express my opinion about the requirement for a COE facility for bariatric services. As a bariatric nurse [PHI Redacted] I do not feel it is necessary or beneficial for pts to be required to have their procedures at a COE facility. Our program is small(which hinders us from obtaining a COE certification) However I would put our program up against any COE program. We see our Pts frequently, follow them closely. They can come to our clinic as often as they like to weigh and be counseled by our staff. Not always just for adjustments, mostly for teaching and monitoring which may be the most important part of bariatric sevices.

[PHI Redacted] We are constantly sending potential pts away only because of the COE reqirement. We need the surgery to be as convient for the pt as possible for it to be a success. We want and need to get many people to a healthier wieght. Obesity is now a recognized disease and is an epidemic.

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July 22, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-8010

RE: Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity-Facility Requirement (CAG-00250R3)

Dear Dr. Jacques:

The American Association of Nurse Anesthetists (AANA) welcomes the opportunity to comment on the proposed decision memo for Bariatric Surgery for the Treatment of Morbid Obesity-Facility Requirement (CAG-00250R3). The AANA supports the highest level of care for all patients. Regardless of whether Medicare retains or removes its certification requirement for bariatric facilities, the AANA continues to support eliminating accreditation program requirements that impede Certified Registered Nurse Anesthetists (CRNA) from providing care in bariatric surgical facilities, such as by requiring anesthesiologist or physician supervision of CRNAs.

Background of the AANA and CRNAs

The AANA is the professional association for CRNAs and student nurse anesthetists, and AANA membership includes more than 45,000 CRNAs and student nurse anesthetists representing over 90 percent of the nurse anesthetists in the United States. CRNAs are advanced practice registered nurses (APRNs) who personally administer more than 34 million anesthetics to patients each year in the United States, according to the 2012 AANA Practice Profile Survey. Nurse anesthetists have provided anesthesia in the United States for 150 years, and high-quality, cost-effective CRNA services continue to be in high demand. CRNAs are Medicare Part B providers and since 1989, have billed Medicare directly for 100 percent of the physician fee schedule amount for services.

CRNA services include providing a pre-anesthesia patient assessment, obtaining informed consent for anesthesia administration, developing a plan for anesthesia administration, administering the anesthetic, monitoring and interpreting the patient's vital signs, and managing the patient throughout the surgery. CRNAs also provide acute and chronic pain management services. CRNAs provide anesthesia for a wide variety of surgical cases and in some states are the sole anesthesia providers in nearly 100 percent of rural hospitals, affording these medical facilities obstetrical, surgical, trauma stabilization, and pain management capabilities. According to a May/June 2010 study published in the journal of Nursing Economic$, CRNAs acting as the sole anesthesia provider are the most cost-effective model for anesthesia delivery, and there is no measurable difference in the quality of care between CRNAs and other anesthesia providers or by anesthesia delivery model.[1] Furthermore, an August 2010 study published in Health Affairs shows no differences in patient outcomes when anesthesia services are provided by CRNAs, physicians, or CRNAs supervised by physicians.[2]

According to a 2007 Government Accountability Office (GAO) study, CRNAs are the principal anesthesia provider where there are more Medicare beneficiaries and where the gap between Medicare and private pay is less.[3] Nurse anesthesia predominates in Veterans Hospitals and in the U.S. Armed Forces. CRNAs work in every setting in which anesthesia is delivered including hospital surgical suites and obstetrical delivery rooms, ambulatory surgical centers (ASCs), pain management facilities, and the offices of dentists, podiatrists, and all types of specialty surgeons.

AANA Supports Eliminating Any Accreditation Program Mandate for Anesthesiologist Provision of Care or Supervision of CRNAs, which is Costly and Unnecessary to Patient Safety

AANA supports ensuring the highest quality of patient care. Regardless of whether CMS retains or removes its requirement for certification of bariatric surgery facilities, the AANA supports eliminating certification requirements that impair full use of CRNA services, such as by requiring anesthesiologist provision or supervision of anesthesia care in bariatric facilities. No evidence links such a costly mandate to improvements in patient safety or access to care.

In our Feb. 22, 2013, comments on the National Coverage Analysis for Bariatric Surgery for the Treatment of Morbid Obesity,[4] the AANA expressed concerns about the merged American College of Surgeons (ACS) and American Society for Metabolic and Bariatric Surgery (ASMBS) accreditation program’s proposal to require that an anesthesiologist provide anesthesia services or supervise CRNA-delivered anesthesia services. That requirement is also present in the ACS Level 1 accreditation standards and the ASMBS outpatient accreditation standards, which are currently being implemented until the standards for the unified program are finalized. Notably, in contrast, the current ASMBS hospital accreditation standard does not require that an anesthesiologist participate in, or supervise, anesthesia services when CRNAs deliver anesthesia care, nor does it require physician supervision of CRNAs. If the unified program finalizes standards that include the restrictive anesthesiologist requirement, current ASMBS-accredited hospitals that provide anesthesia services exclusively by CRNAs would be disqualified from accreditation and face severe hardships, including possible program closure or increased costs resulting from a mandate to hire anesthesiologists.

The AANA supports improvements in patient care that are grounded in evidence of positive patient outcomes. The AANA strongly opposes the anesthesiologist requirements in the proposed unified standards, the current ACS standards, and the ASMBS outpatient standards as no evidence supports a mandate for anesthesiologist or physician supervision of CRNA services. Numerous studies find no difference in the quality of care provided by CRNAs or anesthesiologists, dismissing any justification for an anesthesiologist supervision mandate in bariatric surgery centers. Furthermore, the anesthesiologist requirement is more burdensome than current CMS requirements, state law, and other accrediting bodies’ standards, without benefit of quality improvement or cost efficiency. In fact, the anesthesiologist requirement increases burdens in a manner counter to efforts by the Administration and CMS to reduce regulatory burden. The requirement to hire anesthesiologists stifles innovation in the healthcare system by dictating a costly and unnecessary anesthesia staffing model. To the extent that the merged bariatric accreditation program continues to include a restrictive CRNA requirement (e.g., requiring anesthesiologist or physician supervision of CRNAs), the AANA supports eliminating that requirement from bariatric facility certification.

We thank you for the opportunity to comment on this proposed decision memo. Should you have any questions regarding these matters, please feel free to contact the AANA Senior Director of Federal Government Affairs, Frank Purcell, at 202.484.8400, fpurcell@aanadc.com.

Sincerely,

Janice J. Izlar, CRNA, DNAP
AANA President

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To Whom It May Concern:

I disagree wholeheartedly with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I bwlieve CMS Bariatric Facility Certification should continue, and these are some of the most significant reasons:

I am happy to elaborate on any or all of these points, however please understand that the proposed changes are NOT good for patient safety in any arena, public or private.

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To Whom It May Concern:

I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove facility certification. Facility certification is valuable and should be continued. At no increased cost to the federal budget, this program has, and should continue, to increase patient safety, improve access to quality care, promote the concepts of integrated health, and continue to remain aligned with other certification programs. Today, we live in a world of standards and the guidelines for facility certification in the bariatric surgery CMS system serve a useful purpose, which is logical, and provides for reasonable standards.

Thank you.

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Dear Dr. Jaques:

The American Association of Clinical Endocrinologists (AACE) appreciates the opportunity to provide comment regarding the proposal by CMS to eliminate the designation for bariatric surgery “Centers of Excellence” (COE) [Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity - Facility Certification Requirement (CAG-00250R3)]. CMS proposes to remove the COE certification requirement based evidence indicating that continuing the requirement for certification of bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries.

The American Association of Clinical Endocrinologists (AACE) represents over 6,000 endocrinologists in the United States and abroad. AACE is the largest association of clinical endocrinologists in the world. The majority of AACE members are certified in Endocrinology and Metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity. AACE members are committed to providing the highest quality of care to the patients they serve.

AACE physicians require effective and safe interventions for treating patients with obesity. In fact, AACE has recently published a complications-centric approach for management of this disease as component of its overall Comprehensive Diabetes Treatment Algorithm. Bariatric surgery is an essential treatment option, particularly for patients who have not achieved therapeutic targets with lifestyle modification and/or weight loss medications. It is in the interest of our patients to have access to bariatric surgery when indicated under conditions that maximize patient outcomes and safety. It is in this context that we provide comment regarding the COE requirement.

AACE does not support the proposal, and contends that continuation of the COE requirement is in the best interest of patients with obesity. The 2006 CMS National Coverage Determination indicates that bariatric surgery should be performed in facilities conducting 125 bariatric surgery cases per year (and 50 cases per year for each surgeon); by experienced and credentialed providers; in programs with comprehensive pre- and post-operative care; as part of an integrated program that includes nutrition counseling, support groups, exercise training, and psychological assistance as needed. AACE sees high value in these requirements, and is concerned about potential harm if bariatric surgery programs are not required to maintain a critical patient volume and comprehensive care programs. A high level of compelling evidence is required if incentives for maintaining high-quality comprehensive programs are to be dismantled; otherwise, patient safety and clinical outcomes may be compromised.

The CMS proposal is in response to supporting data submitted by the requestor, and it in on the basis of scientific data that we oppose the proposal. First, it has been widely established that mortality and operative morbidity are minimized when procedures are conducted by experienced surgeons who maintain a high caseload on an ongoing basis. This is true of bariatric and non-bariatric procedures and represents, in part, the rationale for the COE designation in the first place. Another point to consider is that the CMS COE requirement has improved bariatric surgery outcomes in the US, both at COE and non-COE centers, as non-COE strive to satisfy COE requirements and model their care programs accordingly. It is a concern that the elimination of COE requirements may lead to a diminution in the quality of care particularly at the non-COE. Furthermore, the evidence marshaled to support the elimination of the COE requirement has multiple shortcomings as follows:

1. All studies are retrospective including the 3 articles submitted by the requestor (Livingston 2009, Birkmeyer 2010, Dimick 2013) and the articles identified through the CMS literature search (Kwon 2012, Kohn 2010, Nguyen 2010, Flum 2011, Nguyen 2012). The retrospective surveys involve various patient medical record databases and non-scientifically selected sample populations with uncertain relevance to the general patient population. This retrospective design is inferior to prospective randomized trials.

2. The studies are confined to in-hospital mortality and complications. Longer-term complications were not considered, and this is a major shortcoming. The COE designation is designed to assure comprehensive post-operative care to minimize longer-term complications, which are not addressed in these studies.

3. Information about the BMI and specific types of bariatric procedures being performed is lacking in most studies. The fact that outcomes and complications were not stratified by BMI and type of procedure markedly weakens the data regarding conclusions on the value of the COE designation.

4. The use of hospital databases (e.g., UHC) will not capture complications or deaths occurring during subsequent admissions to other hospitals or health care systems.

5. Many of the authors recognize another limitation that coding of complications may be inaccurate because post-operative adverse events can be subjectively defined.

6. The procedures being performed may not reflect current preferences for bariatric surgery options. For example, in Flum 2011, 61% of surgeries were ‘open’ and not performed by laparoscopy. In Birkmeyer 2010, a very high proportion of patients underwent lap band procedures, which are being performed with decreasing frequency, and patients needing revisional surgery and duodenal switch were excluded.

7. Finally, the data in several papers support the COE requirement for a critical number of cases per year. In Livingston 2009, logistic regression modeling of the combined data from COE and non-COE hospitals confirmed that procedure volume was inversely related to complication rates, and “bariatric procedures conducted at hospitals performing fewer than 125 cases per year would appear to have an 18% greater likelihood of being associated with complications”! Nguyen 2012 reported “Non-accredited centers are associated with a 3.5-fold increase in observed in-hospital mortality risk (95% CI 1.5 to 8.0) compared with accredited centers (p = 0.003)"; the "calculated risk-adjusted in-hospital mortality was 0.045% at accredited centers and 0.175% at non-accredited centers."

On balance, AACE does not feel that there is sufficient quality of data to warrant the conclusion that the COE requirement for bariatric surgery centers should be eliminated. We believe it is prudent to maintain the status quo unless there are compelling data to dispense with a COE program that has helped evolve comprehensive programs for bariatric surgical care and contribute to decreasing rates of mortality and morbidity. This is a complex yet critically important issue that directly involves the well-being of our patients who are referred for bariatric surgery, and it is entirely in the interest of patient safety that we answer this request for commentary. Again, we believe that such an important decision should be based on a firm and conclusive body of evidence that is currently lacking.

Sincerely,

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Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services

RE: Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity - Facility Certification Requirement (CAG-00250R3)

Dear Dr. Jaques:

The American Association of Clinical Endocrinologists (AACE) appreciates the opportunity to provide comment regarding the proposal by CMS to eliminate the designation for bariatric surgery “Centers of Excellence” (COE) [Proposed Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity - Facility Certification Requirement (CAG-00250R3)]. CMS proposes to remove the COE certification requirement based evidence indicating that continuing the requirement for certification of bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries.

The American Association of Clinical Endocrinologists (AACE) represents over 6,000 endocrinologists in the United States and abroad. AACE is the largest association of clinical endocrinologists in the world. The majority of AACE members are certified in Endocrinology and Metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity. AACE members are committed to providing the highest quality of care to the patients they serve.

AACE physicians require effective and safe interventions for treating patients with obesity. In fact, AACE has recently published a complications-centric approach for management of this disease as component of its overall Comprehensive Diabetes Treatment Algorithm. Bariatric surgery is an essential treatment option, particularly for patients who have not achieved therapeutic targets with lifestyle modification and/or weight loss medications. It is in the interest of our patients to have access to bariatric surgery when indicated under conditions that maximize patient outcomes and safety. It is in this context that we provide comment regarding the COE requirement.

AACE does not support the proposal, and contends that continuation of the COE requirement is in the best interest of patients with obesity. The 2006 CMS National Coverage Determination indicates that bariatric surgery should be performed in facilities conducting 125 bariatric surgery cases per year (and 50 cases per year for each surgeon); by experienced and credentialed providers; in programs with comprehensive pre- and post-operative care; as part of an integrated program that includes nutrition counseling, support groups, exercise training, and psychological assistance as needed. AACE sees high value in these requirements, and is concerned about potential harm if bariatric surgery programs are not required to maintain a critical patient volume and comprehensive care programs. A high level of compelling evidence is required if incentives for maintaining high-quality comprehensive programs are to be dismantled; otherwise, patient safety and clinical outcomes may be compromised.

The CMS proposal is in response to supporting data submitted by the requestor, and it in on the basis of scientific data that we oppose the proposal. First, it has been widely established that mortality and operative morbidity are minimized when procedures are conducted by experienced surgeons who maintain a high caseload on an ongoing basis. This is true of bariatric and nonbariatric procedures and represents, in part, the rationale for the COE designation in the first place. Another point to consider is that the CMS COE requirement has improved bariatric surgery outcomes in the US, both at COE and non-COE centers, as non-COE strive to satisfy COE requirements and model their care programs accordingly. It is a concern that the elimination of COE requirements may lead to a diminution in the quality of care particularly at the non-COE. Furthermore, the evidence marshaled to support the elimination of the COE requirement has multiple shortcomings as follows:

1. All studies are retrospective including the 3 articles submitted by the requestor (Livingston 2009, Birkmeyer 2010, Dimick 2013) and the articles identified through the CMS literature search (Kwon 2012, Kohn 2010, Nguyen 2010, Flum 2011, Nguyen 2012). The retrospective surveys involve various patient medical record databases and non-scientifically selected sample populations with uncertain relevance to the general patient population. This retrospective design is inferior to prospective randomized trials.

2. The studies are confined to in-hospital mortality and complications. Longer-term complications were not considered, and this is a major shortcoming. The COE designation is designed to assure comprehensive post-operative care to minimize longer-term complications, which are not addressed in these studies.

3. Information about the BMI and specific types of bariatric procedures being performed is lacking in most studies. The fact that outcomes and complications were not stratified by BMI and type of procedure markedly weakens the data regarding conclusions on the value of the COE designation.

4. The use of hospital databases (e.g., UHC) will not capture complications or deaths occurring during subsequent admissions to other hospitals or health care systems.

5. Many of the authors recognize another limitation that coding of complications may be inaccurate because post-operative adverse events can be subjectively defined.

6. The procedures being performed may not reflect current preferences for bariatric surgery options. For example, in Flum 2011, 61% of surgeries were ‘open’ and not performed by laparoscopy. In Birkmeyer 2010, a very high proportion of patients underwent lap band procedures, which are being performed with decreasing frequency, and patients needing revisional surgery and duodenal switch were excluded.

7. Finally, the data in several papers support the COE requirement for a critical number of cases per year. In Livingston 2009, logistic regression modeling of the combined data from COE and non-COE hospitals confirmed that procedure volume was inversely related to complication rates, and “bariatric procedures conducted at hospitals performing fewer than 125 cases per year would appear to have an 18% greater likelihood of being associated with complications”! Nguyen 2012 reported “Non-accredited centers are associated with a 3.5-fold increase in observed in-hospital mortality risk (95% CI 1.5 to 8.0) compared with accredited centers (p = 0.003)"; the "calculated risk-adjusted in-hospital mortality was 0.045% at accredited centers and 0.175% at nonaccredited centers."

On balance, AACE does not feel that there is sufficient quality of data to warrant the conclusion that the COE requirement for bariatric surgery centers should be eliminated. We believe it is prudent to maintain the status quo unless there are compelling data to dispense with a COE program that has helped evolve comprehensive programs for bariatric surgical care and contribute to decreasing rates of mortality and morbidity. This is a complex yet critically important issue that directly involves the well-being of our patients who are referred for bariatric surgery, and it is entirely in the interest of patient safety that we answer this request for commentary. Again, we believe that such an important decision should be based on a firm and conclusive body of evidence that is currently lacking.

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Dear Centers for Medicare and Medicaid Services:

As a bariatric surgeon of 13 years and one of the first to commit to the concept of a full and dedicated program for the bariatric patient in North Carolina, I’ve seen the consequences of itinerant surgeons, dabbling surgeons, and programs without the commitment and/or the facility to provide the services that these extraordinary patients require. The fallout is poor technical performance, poor outcome, weight regain, complication, readmission, extra dollars spent, and more morbidity in many cases than existed pre-operatively.

The Center of Excellence Concept arose from a standardization of medical delivery. It has been successful. No longer do I receive the number of transfers of surgeries gone wrong in remote areas of the state. No longer is the general public uninformed about the risks and benefits of bariatric surgery as the education afforded by these centers of excellence has increased awareness to the level of true informed consent.

The statistics offered by the Michigan consortium imply that any facility or surgeon is capable of duplicating the results heretofore observed by CMS Certification Centers when the consortium by definition had guidelines much like those of the CMS –designated programs.

I urge you to reconsider your reversal of the Center of Excellence requirement on behalf of the morbidly obese population in North Carolina and the American taxpayer.

Respectfully,

Below please find a compilation of data generated by our organization regarding the achievements enjoyed by the establishment of CMS designated centers:
Patient Safety is Increased
Since the implementation of the original 2006 National Coverage Determination for Bariatric Surgery, we have witnessed an American patient success story regarding patient safety in the bariatric surgery population.

Encinosa from the Agency for Healthcare Research and Quality detailed in a 2009 Medical Care article the steep decline in complications following the NCD including large reductions in patient, 30-day and 180-day complications respectively, 37%, 24%, and 21%.

Specific to the Medicare population, Nguyen in a 2010 Archives of Surgery article noted a 33% reduction in mortality in Medicare beneficiaries following the NCD resulting in an overall bariatric surgery mortality rate 0.2%.

Nguyen in a 2012 Journal of the American College of Surgeons (JACS) found significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758).

Kwon in a 2012 Surgery for Obesity and Related Diseases publication showed the value of accreditation using the national MarketScan Commercial Claims and Encounter Database (2003–2009). In this study, the accredited centers had significant reductions in inpatient mortality (.3% to .1%; P =. 02), 90-day reoperations (.8% to .5%; P=. 006), complications (36.4% to 27.6%; P<. 001), and readmissions (10.8% to 8.8%; P <. 001).

2011 Flum study which clearly demonstrates the value of accreditation specifically for Medicare beneficiarieswhereby 90-day mortality fell 50% (1.5% to 0.7%), readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and costs fell 20% ($24,363 to $19,746) post-NCD

2013 Dimick study found the significant improvement for the Medicare population with reductions in any complication (12.3% to 7.9%) and serious complications (7.5% to 3.4%) after the NCD. What is stunning is that the improvements in outcomes between Medicare and non-Medicare populations were not significantly different; this is noteworthy given the high comorbid condition of the Medicare population.

2013 Nguyen Surgical Endoscopy study found within the High Volume Center population alone, the in-hospital mortality at HVC non-accredited centers was 0.22% and at HVC accredited centers it was 0.06%. Once correcting for confounders with multivariate analysis, non-accredited centers had significantly higher mortality (odds ratio 3.6, 95% CI, 1.5, 8.3, p < 0.01) and lower serious morbidity (odds ratio 0.8, 95% CI, 0.7, 0.9, p < 0.01). Accredited high volume centers have significantly lowered in-patient mortality while non-accredited high volume centers have worse mortality outcomes indicating that accreditation provides a benefit beyond volume. While non-accredited, high volume centers have less serious morbidity; this is coupled with significantly higher mortality indicating a failure to rescue patients who have complications. Hallmarks of accreditation include culture of commitment, ancillary staff and bariatric specific resources, which are critical for the rescue of these patients if they encounter complications.

Is Aligned with other Certification Programs
Four main private payors have embraced and continue to support bariatric surgery facility accreditation (Anthem, Aetna, Cigna, United: all accessed July 2013). Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population.

The proposed decision to remove Bariatric Surgery Facility Accreditation is a radical departure from previous CMS policy. The following interventional National Care Determinations all have a facility criteria requirement and/or certification: Adult Liver Transplantation (260.1), Artificial Hearts and Related Devices (20.9), Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease (160.24), Pancreas Transplants (260.3), Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1), Pediatric Liver Transplantation (260.2), Transcatheter Aortic Valve Replacement (TAVR) (20.32), and Transmyocardial Revascularization (TMR) (20.6).

Medicare Patients are Sicker
The specific impact of Medicare status upon bariatric surgery outcomes is undeniable: Medicare patients have higher risk of morbidity and mortality than the general bariatric surgery population.

2005 American Surgeon article, Poulose found that Medicare coverage compared to private insurance increased the risk of post-operative respiratory failure significantly (OR 2.2 [1.2-3.8], P < 0.05).

2006 Archives of Surgery publication by Livingston, he found Medicare status unadjusted for age, gender, and comorbidities had an increased odds ratio for mortality of 4.31 and once adjusted 1.44.

2006 American Surgeon article by Nguyen, Nationwide Inpatient Sample patients similar to Medicare population (age>60) had more than twice the mortality rate as younger patients (0.7 vs. 0.3%).

2011 Archives of Surgery publication, Nguyen et al found that Medicare status increased the risk of potentially fatal anastomotic leaks by 54%, a stronger risk factor than chronic lung disease or male gender.

2012 SOARD paper by Gould et al, Medicare status significantly increased readmissions and ED visits.

2008 Annals of Surgery article by Perry et al, morbidly obese Medicare patients who underwent bariatric surgery had increased survival rates over the 2 years of this study when compared with a similar morbidly obese nonsurgical group (P < 0.001). For patients under the age of 65, this survival advantage started at 6 months postoperatively and for patients over age 65, at 11 months. These clear survival benefits for the Medicare population would be extinguished if surgeries are performed at non-accredited centers which have higher mortality rates even if they are high volume centers as noted in the 2013 Nguyen Surgical Endoscopy paper.

There are approximately 15,000 Medicare bariatric surgery performed annually. If we extrapolate the impact of loss of Medicare Facility Certification upon operative mortality, there will be an additional 240 deaths annually based on the mortality at Accredited High Volume Centers (0.06%) and Non-Accredited High Volume Centers (0.22%) as stated in the 2013 Nguyen Surgical Endoscopy paper.

Access to Quality Care is Increased
Within the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), there are 725 Accredited Centers nation-wide and, with a new lowered volume standard of 50 stapled bariatric cases annually, there are anticipated even further gains in centers and access. In the 2013 Dimick JAMA article, operations in Medicare beneficiaries increased from 6,273 procedures pre-NCD to 15,854 post-NCD. In the 2011 Flum Annals of Surgeryarticle, Medicare bariatric surgery operation in the two years prior to the NCD increased from 17,127 to 29, 903 for the two years after the NCD.

Integrated Health is Supported
In addition to safeguarding compromised patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported (Wadden & Sarwer,SOARD 2006).

Bariatric Surgery Facility Certification is Federal Budget Neutral
Costs of Certification are borne by Hospitals. Certification has decreased costs, per Flum, where readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and overall costs fell 20% ($24,363 to $19,746) post-NCD. Removal of facility certification will lead to increased complications and resultant costs.

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Dear CMS Official

I am writing to express my concern about the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I support Facility Certification and request CMS to continue the existing facility certification and Center of Excellence.

I am a Professor of Surgery, Physiology and Molecular Pharmacology at the University of South Florida. I have practiced bariatric and gastrointestinal surgery since 1995 and have published more than 120 peer reviewed manuscripts in obesity, bariatric surgery and related topics. I also established a fellowship training program in obesity management and bariatric surgery since 2003 and I have trained 20 surgeons in laparoscopic bariatric surgery. I also served in various leadership positions in the ASMBS including the Research and Patient Access Committees for 8 years and the Executive Council for 2 years. Currently, I am an Associate Editor of the premier bariatric journal, Surgery for Obesity and Related Disorders that has an impact factor of 4.1. I am writing from critical vantage points because of first-hand knowledge in bariatrics, patient care, administrative and quality management.

I lead a team of researchers and published our findings in the Annals of Surgery (impact factor 8.1) which can be found through pubmed (A state-wide review of contemporary outcomes of gastric bypass in Florida: does provider volume impact outcomes? Murr MM, Martin T, Haines K, Torrella T, Dragotti R, Kandil A, Gallagher SF, Harmsen S. Ann Surg. 2007 May;245(5):699-706). We researched the outcomes of >19,000 patients who underwent bariatric surgery in Florida; we found a reverse relationship between adverse outcomes and the caseload of surgeons and hospitals. These important findings represent a critical view of the surgical landscape in Florida where more than 103 surgeons did bariatric surgery during the time of the study; that landscape has not changed much. There are many more surgeons in non-accredited facilities who would take bariatric surgery without adequate training or appropriate facilities and infra-structure.

I can attest to these facts because I am the President of the Florida Chapter of the ASMBS and has practiced in Florida in the same facility since 1998. I am confident in stating that the proposed decision memo mounts to ‘deregulation’ without a safety net for patients.

I strongly support CMS Bariatric Surgery Facility Certification because:

I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

CMC Bariatric Facility Certification has provided several benefits including

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I am a Professor of Psychology in the Departments of Psychiatry and Surgery at the Perelman School of Medicine at the University of Pennsylvania. Our bariatric program is one of the highest volume programs in the country. Since 1998, I have conducted the preoperative psychological evaluations of our patients and, since 2001, I have had an active program of research (funded by grants from the National Institutes of Health) on the psychosocial and behavioral aspects of bariatric surgery.

As I have watched the field of bariatric surgery evolve over the past 15 years, there is no question that facility certification is critical to ensure the highest quality of patient care. The certification process insures that the multidisciplinary care necessary to appropriate preoperative preparation and postoperative success is delivered by bariatric programs. While it is difficult to quantify the impact of these services via traditional research methods, those of us who work in the field have no doubt that the inclusion of multidisciplinary care, as required by facility certification requirements, helps us best prepare patients for surgery and work with them postoperatively to achieve the most optimal of outcomes.

Elimination of the certification process would open the door to hospitals and surgeons providing bariatric surgery without these critical resources. Hospitals and surgeons would be likely to do this in an effort to increase revenues. Unfortunately, quality of care would inevitably suffer and postoperative outcomes would be negatively impacted.

For these reasons, I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove the requirement of facility certification. I strongly support the continuation of CMS Bariatric Facility Certification.

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I firmly believe that removing the requirement is a serious mistake. When I performed my first laparoscopic bariatric operation 15 years ago, we lacked significant support from our institution. It rapidly became evident that institutional support was critical to the success of a quality bariatric surgery program. It was only when the center of excellence programs were created that institutional support of the bariatric surgery programs became a requirement. As a result, the center of excellence programs Forced many institutions to provide the logistical and material support to the batiatric surgery programs. Removing such a requirement with turn the clock back more than a decade! Many programs would no longer receive the financial support needed by their institutions. As a result, many patients will suffer due the decreasing quality of the programs available. I strongly recommend that this policy not be reversed.

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue. I have been in the field of bariatrics since 2004. I have seen firsthand major positive changes since the development and implementation of the accreditation and facility certification program. First and foremost, patient safety has improved. There have been numerous publications that validate lower complication rates and readmissions. At the same time, it has increased access to quality care and lowered costs. Accreditation holds facilities to higher standards of care and the ancillary support for long term success, which not only is beneficial for the patient, but also financially it drives down the healthcare costs due to resolution of comorbid conditions. With the accreditation data collection, we can continue to analyze the data and improve the quality of care and enhance patient outcomes.

In addition to safeguarding compromised patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported (Wadden & Sarwer,SOARD 2006).

I strongly advise you consider all of these mentioned variables and resend the decision to eliminate the facility certification.

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Support CMS Bariatric Surgery Facility Certification!

Since the CMS NCD supporting accreditation, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened. Without accreditation, long-term data collection will be impaired and quality improvement efforts will be severely impeded. CMS Facility Certification has worked since 2006. Let’s continue our progress.

We Support CMS Bariatric Surgery Facility Certification Because:
Patient Safety is Increased
Is Aligned with other Certification Programs
Medicare patients are Sicker
Access to Quality Care is Increased
Integrated Health is Supported
Federal Budget Impact is Neutral

Patient Safety is Increased
Since the implementation of the original 2006 National Coverage Determination for Bariatric Surgery, we have witnessed an American patient success story regarding patient safety in the bariatric surgery population.

Encinosa from the Agency for Healthcare Research and Quality detailed in a 2009 Medical Care article the steep decline in complications following the NCD including large reductions in patient, 30-day and 180-day complications respectively, 37%, 24%, and 21%.

Specific to the Medicare population, Nguyen in a 2010 Archives of Surgery article noted a 33% reduction in mortality in Medicare beneficiaries following the NCD resulting in an overall bariatric surgery mortality rate 0.2%.

Nguyen in a 2012 Journal of the American College of Surgeons (JACS) found significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758).

Kwon in a 2012 Surgery for Obesity and Related Diseases publication showed the value of accreditation using the national MarketScan Commercial Claims and Encounter Database (2003–2009). In this study, the accredited centers had significant reductions in inpatient mortality (.3% to .1%; P =. 02), 90-day reoperations (.8% to .5%; P=. 006), complications (36.4% to 27.6%; P<. 001), and readmissions (10.8% to 8.8%; P <. 001).

2011 Flum study which clearly demonstrates the value of accreditation specifically for Medicare beneficiarieswhereby 90-day mortality fell 50% (1.5% to 0.7%), readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and costs fell 20% ($24,363 to $19,746) post-NCD

2013 Dimick study found the significant improvement for the Medicare population with reductions in any complication (12.3% to 7.9%) and serious complications (7.5% to 3.4%) after the NCD. What is stunning is that the improvements in outcomes between Medicare and non-Medicare populations were not significantly different; this is noteworthy given the high comorbid condition of the Medicare population.

2013 Nguyen Surgical Endoscopy study found within the High Volume Center population alone, the in-hospital mortality at HVC non-accredited centers was 0.22% and at HVC accredited centers it was 0.06%. Once correcting for confounders with multivariate analysis, non-accredited centers had significantly higher mortality (odds ratio 3.6, 95% CI, 1.5, 8.3, p < 0.01) and lower serious morbidity (odds ratio 0.8, 95% CI, 0.7, 0.9, p < 0.01). Accredited high volume centers have significantly lowered in-patient mortality while non-accredited high volume centers have worse mortality outcomes indicating that accreditation provides a benefit beyond volume. While non-accredited, high volume centers have less serious morbidity; this is coupled with significantly higher mortality indicating a failure to rescue patients who have complications. Hallmarks of accreditation include culture of commitment, ancillary staff and bariatric specific resources, which are critical for the rescue of these patients if they encounter complications.

Is Aligned with other Certification Programs
Four main private payors have embraced and continue to support bariatric surgery facility accreditation (Anthem, Aetna, Cigna, United: all accessed July 2013). Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population.

The proposed decision to remove Bariatric Surgery Facility Accreditation is a radical departure from previous CMS policy. The following interventional National Care Determinations all have a facility criteria requirement and/or certification: Adult Liver Transplantation (260.1), Artificial Hearts and Related Devices (20.9), Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease (160.24), Pancreas Transplants (260.3), Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1), Pediatric Liver Transplantation (260.2), Transcatheter Aortic Valve Replacement (TAVR) (20.32), and Transmyocardial Revascularization (TMR) (20.6).

Medicare Patients are Sicker
The specific impact of Medicare status upon bariatric surgery outcomes is undeniable: Medicare patients have higher risk of morbidity and mortality than the general bariatric surgery population.

2005 American Surgeon article, Poulose found that Medicare coverage compared to private insurance increased the risk of post-operative respiratory failure significantly (OR 2.2 [1.2-3.8], P < 0.05).

2006 Archives of Surgery publication by Livingston, he found Medicare status unadjusted for age, gender, and comorbidities had an increased odds ratio for mortality of 4.31 and once adjusted 1.44.

2006 American Surgeon article by Nguyen, Nationwide Inpatient Sample patients similar to Medicare population (age>60) had more than twice the mortality rate as younger patients (0.7 vs. 0.3%).

2011 Archives of Surgery publication, Nguyen et al found that Medicare status increased the risk of potentially fatal anastomotic leaks by 54%, a stronger risk factor than chronic lung disease or male gender.

2012 SOARD paper by Gould et al, Medicare status significantly increased readmissions and ED visits.

2008 Annals of Surgery article by Perry et al, morbidly obese Medicare patients who underwent bariatric surgery had increased survival rates over the 2 years of this study when compared with a similar morbidly obese nonsurgical group (P < 0.001). For patients under the age of 65, this survival advantage started at 6 months postoperatively and for patients over age 65, at 11 months. These clear survival benefits for the Medicare population would be extinguished if surgeries are performed at non-accredited centers which have higher mortality rates even if they are high volume centers as noted in the 2013 Nguyen Surgical Endoscopy paper.

There are approximately 15,000 Medicare bariatric surgery performed annually. If we extrapolate the impact of loss of Medicare Facility Certification upon operative mortality, there will be an additional 240 deaths annually based on the mortality at Accredited High Volume Centers (0.06%) and Non-Accredited High Volume Centers (0.22%) as stated in the 2013 Nguyen Surgical Endoscopy paper.

Access to Quality Care is Increased
Within the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), there are 725 Accredited Centers nation-wide and, with a new lowered volume standard of 50 stapled bariatric cases annually, there are anticipated even further gains in centers and access. In the 2013 Dimick JAMA article, operations in Medicare beneficiaries increased from 6,273 procedures pre-NCD to 15,854 post-NCD. In the 2011 Flum Annals of Surgeryarticle, Medicare bariatric surgery operation in the two years prior to the NCD increased from 17,127 to 29, 903 for the two years after the NCD.

Integrated Health is Supported
In addition to safeguarding compromised patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported (Wadden & Sarwer,SOARD 2006).

Bariatric Surgery Facility Certification is Federal Budget Neutral
Costs of Certification are borne by Hospitals. Certification has decreased costs, per Flum, where readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and overall costs fell 20% ($24,363 to $19,746) post-NCD. Removal of facility certification will lead to increased complications and resultant costs.

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To whom it may concern,

The decision to continue Bariatric Surgery Center of Excellence is necessary in promotion of measurable outcomes, decrease mortality, improved obesity management, and increased quality of life. Our bariatric program has worked for fifteen years to overcome a stigma regarding the mortality rate with bariatric surgery. The medical physicians of our area were trained during the pioneering of bariatric surgery with high mortality and complication rates. The negative impact has just now started to move in a positive direction. We still have physicians who have heard of the ileojejunal bypass surgery complications and refuse to send those in need to our program.

The Bariatric surgery has been proven to manage the disease of obesity and reduce co-morbidities such as diabetes, hypertension, and obstructive sleep apnea. The impact to weight loss management is remarkable but life-long management is what Center of Excellence programs provide to your population. Obesity must be managed by a multidisciplinary team to be effective. Patients lose weight but healthy lifestyles must be promoted to maintain future weight maintenance. Our team includes surgeons, nurses, psychologists, dietitians, pharmacists, and exercise specialists to follow patients preoperatively as well as post operatively to ensure successful healthy lifestyle transformations. The surgery is a tool for change but the education pre and post operatively is necessary. The psychology piece to obesity is ever evolving and mental and behavioral health must be managed to ensure quality of life.
I sincerely request recognition of the team effort by Center of Excellence programs around the nation developing new trends in obesity prevention. Healthy lifestyles are taught not something naturally inherited. Please consider promoting the Center of Excellences to your CMS populations.

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I Support CMS Bariatric Surgery Facility Certification!

Bariatric surgery is a specialty and ordinary general surgeons should not casually do these operations. It is much more that just procedures. These patients need the insight, knowledge and expertise of surgeons dedicated to bariatric surgical care.

The literature supports the centers of excellence as a way to identify surgeons and centers that have dedicated themselves to doing bariatric surgery practice according to certain parameters and quality assurance.

Since the CMS NCD supporting accreditation, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened. Without accreditation, long-term data collection will be impaired and quality improvement efforts will be severely impeded. CMS Facility Certification has worked since 2006. Let’s continue our progress.

I Support CMS Bariatric Surgery Facility Certification Because:
Patient Safety is Increased
Is Aligned with other Certification Programs
Medicare patients are Sicker
Access to Quality Care is Increased
Integrated Health is Supported
Federal Budget Impact is Neutral

Patient Safety is Increased
Since the implementation of the original 2006 National Coverage Determination for Bariatric Surgery, we have witnessed an American patient success story regarding patient safety in the bariatric surgery population.

Encinosa from the Agency for Healthcare Research and Quality detailed in a 2009 Medical Care article the steep decline in complications following the NCD including large reductions in patient, 30-day and 180-day complications respectively, 37%, 24%, and 21%.

Specific to the Medicare population, Nguyen in a 2010 Archives of Surgery article noted a 33% reduction in mortality in Medicare beneficiaries following the NCD resulting in an overall bariatric surgery mortality rate 0.2%.

Nguyen in a 2012 Journal of the American College of Surgeons (JACS) found significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758).

Kwon in a 2012 Surgery for Obesity and Related Diseases publication showed the value of accreditation using the national MarketScan Commercial Claims and Encounter Database (2003–2009). In this study, the accredited centers had significant reductions in inpatient mortality (.3% to .1%; P =. 02), 90-day reoperations (.8% to .5%; P=. 006), complications (36.4% to 27.6%; P<. 001), and readmissions (10.8% to 8.8%; P <. 001).

2011 Flum study which clearly demonstrates the value of accreditation specifically for Medicare beneficiarieswhereby 90-day mortality fell 50% (1.5% to 0.7%), readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and costs fell 20% ($24,363 to $19,746) post-NCD

2013 Dimick study found the significant improvement for the Medicare population with reductions in any complication (12.3% to 7.9%) and serious complications (7.5% to 3.4%) after the NCD. What is stunning is that the improvements in outcomes between Medicare and non-Medicare populations were not significantly different; this is noteworthy given the high comorbid condition of the Medicare population.

2013 Nguyen Surgical Endoscopy study found within the High Volume Center population alone, the in-hospital mortality at HVC non-accredited centers was 0.22% and at HVC accredited centers it was 0.06%. Once correcting for confounders with multivariate analysis, non-accredited centers had significantly higher mortality (odds ratio 3.6, 95% CI, 1.5, 8.3, p < 0.01) and lower serious morbidity (odds ratio 0.8, 95% CI, 0.7, 0.9, p < 0.01). Accredited high volume centers have significantly lowered in-patient mortality while non-accredited high volume centers have worse mortality outcomes indicating that accreditation provides a benefit beyond volume. While non-accredited, high volume centers have less serious morbidity; this is coupled with significantly higher mortality indicating a failure to rescue patients who have complications. Hallmarks of accreditation include culture of commitment, ancillary staff and bariatric specific resources, which are critical for the rescue of these patients if they encounter complications.

Is Aligned with other Certification Programs
Four main private payors have embraced and continue to support bariatric surgery facility accreditation (Anthem, Aetna, Cigna, United: all accessed July 2013). Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population.

The proposed decision to remove Bariatric Surgery Facility Accreditation is a radical departure from previous CMS policy. The following interventional National Care Determinations all have a facility criteria requirement and/or certification: Adult Liver Transplantation (260.1), Artificial Hearts and Related Devices (20.9), Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease (160.24), Pancreas Transplants (260.3), Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1), Pediatric Liver Transplantation (260.2), Transcatheter Aortic Valve Replacement (TAVR) (20.32), and Transmyocardial Revascularization (TMR) (20.6).

Medicare Patients are Sicker
The specific impact of Medicare status upon bariatric surgery outcomes is undeniable: Medicare patients have higher risk of morbidity and mortality than the general bariatric surgery population.

2005 American Surgeon article, Poulose found that Medicare coverage compared to private insurance increased the risk of post-operative respiratory failure significantly (OR 2.2 [1.2-3.8], P < 0.05).

2006 Archives of Surgery publication by Livingston, he found Medicare status unadjusted for age, gender, and comorbidities had an increased odds ratio for mortality of 4.31 and once adjusted 1.44.

2006 American Surgeon article by Nguyen, Nationwide Inpatient Sample patients similar to Medicare population (age>60) had more than twice the mortality rate as younger patients (0.7 vs. 0.3%).

2011 Archives of Surgery publication, Nguyen et al found that Medicare status increased the risk of potentially fatal anastomotic leaks by 54%, a stronger risk factor than chronic lung disease or male gender.

2012 SOARD paper by Gould et al, Medicare status significantly increased readmissions and ED visits.

2008 Annals of Surgery article by Perry et al, morbidly obese Medicare patients who underwent bariatric surgery had increased survival rates over the 2 years of this study when compared with a similar morbidly obese nonsurgical group (P < 0.001). For patients under the age of 65, this survival advantage started at 6 months postoperatively and for patients over age 65, at 11 months. These clear survival benefits for the Medicare population would be extinguished if surgeries are performed at non-accredited centers which have higher mortality rates even if they are high volume centers as noted in the 2013 Nguyen Surgical Endoscopy paper.

There are approximately 15,000 Medicare bariatric surgery performed annually. If we extrapolate the impact of loss of Medicare Facility Certification upon operative mortality, there will be an additional 240 deaths annually based on the mortality at Accredited High Volume Centers (0.06%) and Non-Accredited High Volume Centers (0.22%) as stated in the 2013 Nguyen Surgical Endoscopy paper.

Access to Quality Care is Increased
Within the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), there are 725 Accredited Centers nation-wide and, with a new lowered volume standard of 50 stapled bariatric cases annually, there are anticipated even further gains in centers and access. In the 2013 Dimick JAMA article, operations in Medicare beneficiaries increased from 6,273 procedures pre-NCD to 15,854 post-NCD. In the 2011 Flum Annals of Surgeryarticle, Medicare bariatric surgery operation in the two years prior to the NCD increased from 17,127 to 29, 903 for the two years after the NCD.

Integrated Health is Supported
In addition to safeguarding compromised patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported (Wadden & Sarwer,SOARD 2006).

Bariatric Surgery Facility Certification is Federal Budget Neutral
Costs of Certification are borne by Hospitals. Certification has decreased costs, per Flum, where readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and overall costs fell 20% ($24,363 to $19,746) post-NCD. Removal of facility certification will lead to increased complications and resultant costs.

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I work in Honolulu Hawaii with an HMO that recently got certified by the ACS/ASMBC COE/MBSAQIP for both Inpatient and Outpatient.

On behalf of our program, we support CMS Bariatric Surgery Facility Certification because it made us better. In preparation we reviewed ourselves like we otherwise never would have. We made changes prior to the submission and site visit. We didn’t shoot for a score, we wanted to be excellent in every category.

I'll leave it to other respondents to cite the literature proving improved outcomes, safety, cost and accountability.

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This comment is written in strong support of continuing the accreditation requirement for CMS beneficiaries undergoing bariatric surgery.

CMS has stated that the evidence is sufficient to conclude that continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries. The current evidence simply does not support that conclusion. In fact, it is clear from the evidence that removing the requirement for certification for bariatric surgery facilities will degrade the health outcomes for Medicare beneficiaries. Specifically, mortality rates will increase if there is no accreditation requirement and any surgeon, regardless of training or program support, is allowed to perform these complex operations on the older, sicker Medicare patient population.

The papers cited by CMS to support their conclusion are flawed in their methodology and lack of generalizable clinical outcome data (particularly the lack of mortality data in the most recent citation). The fact that these papers conclude that COE status did not show better outcomes compared to some non-COE centers should not be interpreted to mean that COE status has had no positive effect on bariatric surgery outcomes over the last seven years:

-Eliminating very low volume, inadequately trained surgeons from the bariatric surgery marketplace has saved lives.
-Establishing robust multidisciplinary programs around well-trained bariatric surgeons has improved outcomes and access.
-Performing bariatric surgery in centers of excellence has resulted in lower mortality due to the recognition of complications and rescue of patients who have complications after bariatric surgery.

Additionally:
-The proposed volume requirement for the new MBSAQIP program of 50 stapled cases will allow more centers to obtain accreditation and will increase access further without compromising patient safety.
-The institutional support for multi-disciplinary bariatric teams and resources to care for the obese patient has been instrumental in improving patient care and this should not be compromised by removing accreditation requirements.

I strongly urge that the NCD be reconsidered to continue facility accreditation. To continue on the positive trajectory we are currently on, the field of bariatric surgery must maintain high standards, require data reporting to evaluate our outcomes, and support the multidisciplinary approach that has served us well over the last 7 years.

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I Support CMS Bariatric Surgery Facility Certification Because:

Patient Safety
Since the implementation of the original 2006 National Coverage Determination for Bariatric Surgery, we have witnessed an American patient success story regarding patient safety in the bariatric surgery population.

Encinosa from the Agency for Healthcare Research and Quality detailed in a 2009 Medical Care article the steep decline in complications following the NCD including large reductions in patient, 30-day and 180-day complications respectively, 37%, 24%, and 21%.

Specific to the Medicare population, Nguyen in a 2010 Archives of Surgery article noted a 33% reduction in mortality in Medicare beneficiaries following the NCD resulting in an overall bariatric surgery mortality rate 0.2%.

Nguyen in a 2012 Journal of the American College of Surgeons (JACS) found significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758).

Kwon in a 2012 Surgery for Obesity and Related Diseases publication showed the value of accreditation using the national MarketScan Commercial Claims and Encounter Database (2003–2009). In this study, the accredited centers had significant reductions in inpatient mortality (.3% to .1%; P =. 02), 90-day reoperations (.8% to .5%; P=. 006), complications (36.4% to 27.6%; P<. 001), and readmissions (10.8% to 8.8%; P <. 001).

2011 Flum study which clearly demonstrates the value of accreditation specifically for Medicare beneficiaries whereby 90-day mortality fell 50% (1.5% to 0.7%), readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and costs fell 20% ($24,363 to $19,746) post-NCD

2013 Dimick study found the significant improvement for the Medicare population with reductions in any complication (12.3% to 7.9%) and serious complications (7.5% to 3.4%) after the NCD. What is stunning is that the improvements in outcomes between Medicare and non-Medicare populations were not significantly different; this is noteworthy given the high comorbid condition of the Medicare population.

2013 Nguyen Surgical Endoscopy study found within the High Volume Center population alone, the in-hospital mortality at HVC non-accredited centers was 0.22% and at HVC accredited centers it was 0.06%. Once correcting for confounders with multivariate analysis, non-accredited centers had significantly higher mortality (odds ratio 3.6, 95% CI, 1.5, 8.3, p < 0.01) and lower serious morbidity (odds ratio 0.8, 95% CI, 0.7, 0.9, p < 0.01). Accredited high volume centers have significantly lowered in-patient mortality while non-accredited high volume centers have worse mortality outcomes indicating that accreditation provides a benefit beyond volume. While non-accredited, high volume centers have less serious morbidity; this is coupled with significantly higher mortality indicating a failure to rescue patients who have complications. Hallmarks of accreditation include culture of commitment, ancillary staff and bariatric specific resources, which are critical for the rescue of these patients if they encounter complications.

Certification
Four main private payors have embraced and continue to support bariatric surgery facility accreditation (Anthem, Aetna, Cigna, United: all accessed July 2013). Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population.

The proposed decision to remove Bariatric Surgery Facility Accreditation is a radical departure from previous CMS policy. The following interventional National Care Determinations all have a facility criteria requirement and/or certification: Adult Liver Transplantation (260.1), Artificial Hearts and Related Devices (20.9), Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease (160.24), Pancreas Transplants (260.3), Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1), Pediatric Liver Transplantation (260.2), Transcatheter Aortic Valve Replacement (TAVR) (20.32), and Transmyocardial Revascularization (TMR) (20.6).

Medicare Patients are Sicker
The specific impact of Medicare status upon bariatric surgery outcomes is undeniable: Medicare patients have higher risk of morbidity and mortality than the general bariatric surgery population .

2005 American Surgeon article, Poulose found that Medicare coverage compared to private insurance increased the risk of post-operative respiratory failure significantly (OR 2.2 [1.2-3.8], P < 0.05).

2006 Archives of Surgery publication by Livingston, he found Medicare status unadjusted for age, gender, and comorbidities had an increased odds ratio for mortality of 4.31 and once adjusted 1.44.

2006 American Surgeon article by Nguyen, Nationwide Inpatient Sample patients similar to Medicare population (age>60) had more than twice the mortality rate as younger patients (0.7 vs. 0.3%).

2011 Archives of Surgery publication, Nguyen et al found that Medicare status increased the risk of potentially fatal anastomotic leaks by 54%, a stronger risk factor than chronic lung disease or male gender.

2012 SOARD paper by Gould et al, Medicare status significantly increased readmissions and ED visits.

2008 Annals of Surgery article by Perry et al, morbidly obese Medicare patients who underwent bariatric surgery had increased survival rates over the 2 years of this study when compared with a similar morbidly obese nonsurgical group (P < 0.001). For patients under the age of 65, this survival advantage started at 6 months postoperatively and for patients over age 65, at 11 months. These clear survival benefits for the Medicare population would be extinguished if surgeries are performed at non-accredited centers which have higher mortality rates even if they are high volume centers as noted in the 2013 Nguyen Surgical Endoscopy paper.

There are approximately 15,000 Medicare bariatric surgery performed annually. If we extrapolate the impact of loss of Medicare Facility Certification upon operative mortality, there will be an additional 240 deaths annually based on the mortality at Accredited High Volume Centers (0.06%) and Non-Accredited High Volume Centers (0.22%) as stated in the 2013 Nguyen Surgical Endoscopy paper.

Access
Within the unified Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), there are 725 Accredited Centers nation-wide and, with a new lowered volume standard of 50 stapled bariatric cases annually, there are anticipated even further gains in centers and access. In the 2013 Dimick JAMA article, operations in Medicare beneficiaries increased from 6,273 procedures pre-NCD to 15,854 post-NCD. In the 2011 Flum Annals of Surgery article, Medicare bariatric surgery operation in the two years prior to the NCD increased from 17,127 to 29, 903 for the two years after the NCD.

Integrated Health
In addition to safeguarding compromised patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported (Wadden & Sarwer, SOARD 2006).

Bariatric Surgery Facility Certification is Federal Budget Neutral
Costs of Certification are borne by Hospitals. Certification has decreased costs, per Flum, where readmissions decreased 25% (19.9% to 15.4%), reoperations declined 33% (3.2% to 2.1%) and overall costs fell 20% ($24,363 to $19,746) post-NCD. Removal of facility certification will lead to increased complications and resultant costs.

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In his public comment, Dr. Harvey Sugerman, a senior ASMBS leader, suggests that Justin Dimick and I were financially motivated in requesting that CMS reconsider the COE requirements, a serious but unfair accusation. As stated, we are co-founders of ArborMetrix, a database software company that provides support to the Michigan Bariatric Surgical Collaborative on a pro bono basis. The company has had no other involvement in the field of bariatric surgery and has no financial interest in the outcome of this COE debate.

Dr. Sugerman's comment is somewhat disingenuous to the extent that ACS/ASMBS collects millions in fees in administering the current bariatric COE program, a much more obvious financial conflict.

Regardless, the most important issue in this debate is the lack of evidence that the COE program has improved the safety and outcomes of bariatric surgery.

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Since the CMS NCD supporting accreditation, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened. Without accreditation, long-term data collection will be impaired and quality improvement efforts will be severely impeded. CMS Facility Certification has worked since 2006. Let’s continue our progress.

I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

Since the CMS NCD supporting accreditation, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened. Without accreditation, long-term data collection will be impaired and quality improvement efforts will be severely impeded. CMS Facility Certification has worked since 2006, and I Support CMS Bariatric Surgery Facility Certification because:

I am in total support of dropping COE criteria for Medicare coverage. It has been an overall, even if well intended, burden for the clinical care of my patients. We now know that there is, if anything, evidence against COE as a tool or designation is counterproductive (JAMA - Michigan Bariatric Collaborative). In light of this, I urge the discontinuation of requirement of COE for bariatric surgery in Medicare patients

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I'm in complete agreement with CMS's decision.

I'm an ASMBS member and have still thought that requirements for an expensive and unnecessary certification were burdensome to many facilities. Although our facility has currently undergone all requirements to be certified by the ASMBS, we have never thought it should be a necessary REQUIREMENT by CMS and was just limiting access to care to Medicare and Medicaid patients who often had to travel 150miles to a certified center. We have always practiced excellent bariatric care and our quality numbers will show that.

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.
I Support CMS Bariatric Surgery Facility Certification Because:

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Strongly feel that retracting credentialing efforts will severely impact quality and safety efforts established as a grassroots effort by Bariatric Surgeons nationwide.

How can any medical or surgical group look be encouraged to improve the outcomes, create the data and transparency so desparately needed by our patients and our evolving health care system if our efforts will be so roundly defeated as seeming to "limit" access by the same federal govt who are demanding accountability and quality.

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. The improvements in the quality and safety of bariatric surgery at our facility and in other certified hospitals in our state has been dramatic, and we believe are directly attributed to the accountability requirements integral to the accreditation process. In addition, the quality processes put in place by certification has led to outcome measurement, teamwork, system-based management that has additionally improved safety, quality and in turn, outcomes - in many other areas of surgery as well! It would be a huge mistake, and a serious step backwards, if this unfortunate decision is not reversed.

As a result, our institution strongly desires CMS Bariatric Facility Certification to continue.

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

I believe that the facility certification has improved care. It has provided a blueprint for clinical success at our program. I do not believe it impacts access to care, as there is no shortage of accredited centers in our region (NYC). however the certification requirements have improved the process of delivery of bariatric surgical care. I fear that removing the certification will set us back several years because there will be no generally accepted standard for high-quality bariatric surgical care. If you look at other surgical subspecialties that do not have such rigorous standards, the mortality/morbidity have not improved as significantly as they have in bariatric surgery. Although it has been shown that high-quality care can be delivered without certification, this may not be generalizable across the country at every hospital trying to perform bariatric surgery.

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Every 3-4 weeks I see a patient who needs a bariatric procedure. Life continues to carry a great burden for thes unfortunates who genetically cannot carry the extra 50 lbs without the inevitable hio and knee pain, decreased activity, more weight, diabetes and hypertention. Typically, in my practice, available work is physical more than mental. Next is disability and more weight. Bariatric surgery for these patients simply never gets done in the seemingly distant city of Houston where Medicare coverage is available.

I have worked with Dr Urmil Shukla for 16 years. His training and abilities are way beyond the norm for General Surgery. He has the back up of Anesthesi, Hospitalists internists, Pulmonary, Nephrology , and Cardiology for ontoward problems likely to occur with these patients. Dr. Shukla is an accomplished vascular interventionalist and surgeon with a young pardner coming next month to handle IVC Filters if needed. Our Bariatric program is new and initially succesful, but only for non-Medicare patients, who perhaps need the local service the most.

I do not do this type of surgery and likely never will (age 72), but my patients need it. At Huntsville Memorial Hospital we now have a safe place to do it, and from the cost appoach, not having a urban MSA rating, we do it cheaper for you, the taxpayers, and the patient.

Please pay us to do bariatric surgery locally without the volume requirement designed to keep surgery in the big medical centers, no longer necessary after a procedure has passed muster as effective and plenty of surgeons are now trained to do it

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I am against not requiring Medicare/Medicaid patients to use a COE facility. I am a bariartic nurse practitioner at Baylor University in Dallas and we are COE. I have been at this facility for 3 years and although most of our patients are Medicare and have complex problems, we have not had one single death. This is compared to other facilities in Dallas that are not certified and have experienced deaths.

We have a higher set of standards both preoperatively and postoperatively and because of that our lenghth of stay is shorter with less complications. There has been research that shows that the complications are 12% less in a COE facility and that readmissions drop by 25%.

I think that CMS needs to reexamine the data and continue to support that their patients go to a COE facility that have done many cases and have proven skilled surgeons.

Sincerely,

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.
Without accreditation, long-term data collection will be impaired and quality improvement efforts will be severely impeded. This Certification increases patient safety. Specific to the Medicare population, Nguyen in a 2010 Archives of Surgery article noted a 33% reduction in mortality in Medicare beneficiaries following the NCD resulting in an overall bariatric surgery mortality rate 0.2%. Also from Nguyen in a 2012 Journal of the American College of Surgeons (JACS) found significant reduction in mortality in accredited centers (0.06% vs. 0.21%). Compared with nonaccredited centers, bariatric surgery performed at accredited centers was also associated with shorter length of stay (mean difference 0.3 days) and lower cost (mean difference, $3,758).

Four main private payors have embraced and continue to support bariatric surgery facility accreditation (Anthem, Aetna, Cigna, United: all accessed July 2013). Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population.

In addition to safeguarding compromised patients, the accreditation process has also contributed to enhancing bariatric surgery effectiveness. A key component of facility accreditation includes appropriate patient selection whereby key personnel provide essential service to the accredited bariatric center. The preoperative evaluation of the patient seeking bariatric surgery involves multiple professional disciplines, including surgery, internal medicine, registered dieticians, cardiology and mental health professionals (Mechanic SOARD 2008). Without the facility certification requirement, nutritional/psychological evaluation services may not be provided or supported (Wadden & Sarwer, SOARD 2006). This would be a huge mistake for patient care and long-term outcomes.

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I disagree with the CMS proposed decision memo to remove Bariatric Facility Certification. Currently, all centers with the ASMBS/ACS Center of Excellence certification have gone through extensive approval processes which are set in place, most importantly, to improve overall patient safety. Medicare patients are a much more sick population than privately insured patients and typically have higher BMI's. It's imperative that a facility can accommodate morbidly obese patients from the time they walk in the door until discharge to ensure patient safety. From furniture in the front lobby to hospital beds, stretchers, wheelchairs, OR tables, floor mounted toilets, proper fitting gowns, etc are all needed to ensure safety and make the patient comfortable. These things aren't required at a facility that doesn't currently have a Center of Excellence certification.

Operating on patients with a very extensive health history should only be done at facilities that are experienced in caring for sicker patients. Facilities that haven't currently been operating on Medicare patients don't have the experience to manage the pre, peri and post op care that is needed with this patient population.

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Being a bariatric Surgeon in a rural site has many challenges to overcome and maintaining continuity of care as well as reasonable access to care is no exception. Many patients that are evaluated by our bariatric program are required to ultimately have their procedure at a COE due to current regulations. Patients are having to travel 5-6 hours to reach a facility that have COE certification. The relationship our office has with several COE facilities is excellent and we have always had great communication but ultimately after their procedure continuity of care is compromised. Having patients follow up locally sometimes is difficult let alone with a surgeon in another part of the state. Without the rapport built by having the continuity of care then logically follow up is compromised and ultimately an effective weight loss goal is not achieved.

Having said that I do not disagree with accreditation of sites as this maintains and improves quality of care. I wholeheartedly agree with COE accreditation and encourage all centers to continue to strive for perfection.

Patient's should have the choice to undergo surgery at a COE accredited site or a site pursuing COE accreditation, not a requirement of the accreditation for surgery to be allowed.

Thank you for your time and attention,

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

• Patient Safety is Increased
• Is Aligned with other Certification Programs
• Medicare patients are Sicker
• Access to Quality Care is Increased
• Integrated Health is Supported
• Federal Budget Impact is Neutral

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" In the proposed decision to remove certification requirements for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R3) is a proposal in the third paragraph of the Decision Summary that states:

"Lastly, we propose to change the title to better reflect the scope of the NCD and to make it clear in the manual that under the existing policy the local Medicare Administrative Contractors have the authority to make coverage decisions for any bariatric procedures not specifically identified as covered or non-covered by an NCD".

Presently, the procedure code used for conducting an adjustment of a gastric band is CPT 43999. This code is an unspecified surgical procedure code. Therefore, the proposal set forth would make coverage of gastric band adjustment, which is necessary for the ongoing treatment of morbidly obese patient with a gastric band, dependent on local Medicare Administrative Contractor coverage decision.

As the adjustment of the gastric band is required in the ongoing treatment of the morbidly obese patient with a gastric band it is proposed that the adjustment of a gastric band be included in the revised National Coverage Determination (NCD) Manual as a covered bariatric surgical procedure and that this should also be reflected in the NCD Manual and in changes to section 100.1 of the NCD Manual. "

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I support CMS Bariatric Surgery Facility Certification!

Since the CMS NCD supporting accreditation, lives have been saved, complications have been prevented, readmissions have been averted, cost has been lowered and access has been broadened. Without accreditation, long-term data collection will be impaired and quality improvement efforts will be severely impeded. CMS Facility Certification has worked since 2006. Let’s continue our progress.

• Patient Safety is Increased
• Is Aligned with other Certification Programs
• Medicare patients are Sicker
• Access to Quality Care is Increased
• Integrated Health is Supported
• Federal Budget Impact is Neutral

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The arguments that favor the repeal are likely most fervently presented in the article published in JAMA in February of this year. Unfortuntely, this article fails to account for one of the most important variables that impacts outcomes: BMI. If one looks at the data, there is an increase in all known characteristics associated with an increase risk of complication. There are more males. There are more patients with hypertension. The average age rose to 55 years of age. Finally, the BMI is not even addressed. What can be seen, is that the patients did get sicker following the decision. Risk adjustment was attempted. However, the complexity of model that includes these four common risks together was not apparently considered. Therefore, this article is inadequate to prove or disprove the effect. What it does prove is that patients receiving bariatric surgery at the Centers of Excellence are sicker than they were prior to the policy. Moreover, the risks associated with their surgeries have not changed. Therefore, it could also be argued that in fact the surgeries are much safer now than they were prior to the policy regarding the Centers of Excellence.

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Dear CMS,

I am writing to support the CMS policy requiring accreditation of bariatric surgical centers. The evidence supporting a requirement for bariatric surgical center certification has been delineated in detail by Drs. Ponce, Nguyen, Morton and Blackstone of the American Society for Metabolic and Bariatric Surgery. This response has been prepared with input from many critical reviewers and is well-supported by the cited literature. The present combined effort of the American College of Surgeons and the ASMBS to upgrade and improve the accreditation criteria and process should not be undermined at this critical time. The inability of a single state program to demonstrate improved outcomes by certification cannot be interpreted as indicating there is not a benefit to such certification in all other states that do not have similar quality programs. The proposed suspension of the CMS requirement for certification must be rejected.

Sincerely,

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I wholeheartedly support the CMS LIFTING OF COE CERTIFICATION.

All of the examples of benefits of COE are the result of surgeons hard work, NOT the COE process, or certification.

COE designation has not benefited my practice at all, and has actually caused me to have to spend more money to be eligible for continued certification. The COE process is nothing more than a scheme to keep the leadership in power over the membership. It's like a serfdom; the masses (surgeons) work and pay taxes (fees and other costs) while the king (ASMBS leadership) enjoys the spoils and the worship of the peasants. OFF WITH THEIR HEADS!!

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

I Support CMS Bariatric Surgery Facility Certification for the following reasons:

• Patient safety is increased
• Is aligned with other Certification Programs
• Medicare patients are sicker
• Access to quality care is increased
• Integrated health is supported
• Federal budget impact is neutral

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To whom it may concern,

I am a fellowship trained bariatric surgeon who serves in a rural community in western Missouri. Our center performs around 50 bariatric cases a year with excellent results. The nearest center of excellence is one hour away. Many Medicare patients are not able to drive an hour away for this life saving service. The literature is fairly clear that the COE programs do not improve outcomes. I STRONGLY AGREE WITH THE PROPOSAL TO ELIMINATE THE REQUIREMENT FOR COE STATUS FOR MEDICARE PATIENTS TO RECIEVE BARIATRIC SURGERY. It serves no purpose and is limiting access to this life saving therapy.

Thanks,

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue to ensure quality care is given to all patients consistently. Designation proves that the facility and surgeon are committed to providing exceptional and safe pre-operative, operative and post-operative care. Our Program and I are committed to providing the education needed at all levels to staff who care for this high acuity group of patients, as well as dedicating the time and financial backing to ensure our patients receive exceptional care by having equipment for treatment and post-operative care. I truly feel it’s important to have surgeons, facilities and staff that are committed to providing the best and safest care possible to patients and having this designation ensures that programs do provide this care.

Thank you,

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

I feel that by having a certification system, it allows for increased patient safety. Without any reference, you will see that over time, quality of care will be reduced.

Medicare patients are usually sicker, which requires a surgeon, facility and team with experience to better and positive outcomes.

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue.

• Patient Safety is Increased
• Is Aligned with other Certification Programs
• Medicare patients are Sicker
• Access to Quality Care is Increased
• Integrated Health is Supported
• Federal Budget Impact is Neutral

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I disagree with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue. The reasons I support the facility certification are;

• Patient Safety is Increased
• Is Aligned with other Certification Programs
• Medicare patients are Sicker
• Access to Quality Care is Increased
• Integrated Health is Supported
• Federal Budget Impact is Neutral

I believe there is enough published evidence to support it.
Thank you,

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Bariatric Bridge disagrees with the CMS Bariatric Facility Certification proposed decision memo to remove Facility Certification. I want CMS Bariatric Facility Certification to continue. We are heavily involved in patient support, patient access to healthcare and good outcomes with bariatrics. CMS decision is a step back in fighting obesity. The nation as a whole is suffering and the Facility Certification program was the right step in moving forward. Four main private payors have embraced and continue to support bariatric surgery facility accreditation (Anthem, Aetna, Cigna, United: all accessed July 2013). Removal of bariatric surgery facility certification would place CMS in the unique situation of being the only major payor not to have Facility Certification for Bariatric Surgery for a highly vulnerable population. We Support CMS Bariatric Surgery Facility Certification Because:

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Jyme H. Shafer, MD, MPH
Director, Division of Medical and Surgical Services
CMS/OCSQ/Coverage and Analysis Group
7500 Security Blvd, Mailstop C1-09-06
Baltimore, MD 21244

re: Bariatric NCD

I have learned to my great disappointment that CMS is considering dropping the requirement for accredited centers for the bariatric NCD. In my opinion, this is a huge mistake. Furthermore, I have concerns regarding how this change was requested.

I am a bariatric surgeon and work in two facilities and both are accredited Bariatric Surgery COE centers. Have been practicing for more than 14 years and have seen the trends of issues. Before the concept of “Bariatric Surgery Center of Excellence (BSCOE)” we did had on one side an exponential growth of bariatric procedures after 1999-2000 (Davis MM, Slish K, Chao C, Cabana MD. National trends in bariatric surgery, 1996-2002. Arch Surg. 2006 Jan;141(1):71-4) and along with that came the problems of having new surgeons and new centers treating severely obese patients that in many instances, were lacking of the expertise and specific resources. Beyond what is published, there were many instances of lack of equipment, wall-mounted toilets accidents secondary to patient’s excess weight overload, lack of obesity sensitivity with small gowns, discriminatory comments, etc., and most of all, the lack of resources in many hospitals. The BSCOE implementation even before CMS recognized the concept, allowed many hospitals to dedicate resources, staff and budget to meet the needed requirements. Medicare patients are well known to have higher medical risk (Flum DR, Salem L, Elrod JA, et al. Early mortality among Medicare beneficiaries undergoing bariatric surgical procedures. JAMA. 2005;294:1903–1908) and I cannot imagine what will happen if these patients will go to any center that may not have the expertise or resources. Flum has illustrated this already (Ann Surg 2011;254:860–865). The only 3 publications available that do not support accreditation (Livingston and Birkmeyer papers), made assumptions that the patients treated in non-COE facilities had less structure or process of care. But this is not necessarily the case, as many facilities have adopted the “culture” of BSCOE and the only thing that might be lacking was the 125 cases per year volume. Thanks to the data collection embraced by the COE concept, it has been documented that the volume threshold might be less than the original number (http://asmbs.org/2013/03/cms-response-volume-march-2013/), and many centers that were included in the published literature before as non-COE centers, could be COE centers under a new criteria with lower accepted and documented volume.

There is NO EVIDENCE to support the elimination of Accreditation, as we have not studied the consequences in Medicare patients, since all of them have had care in COE centers since 2006. But we do have evidence of lower mortality since the implementation of COE’s in both, accredited and non-accredited centers. Meaning that the “culture” and way of doing things in bariatric surgery has required special structure and process in place, data collection, and dedication. More centers will be able to offer the services safer with a combined effort from the ASMBS and the ACS. Private payers will continue to require some kind of accreditation for their patients and the only patients that may suffer will be the ones that need the most expertise: the Medicare patients.

I respectfully suggest that CMS reconsider the proposed decision until we have scientific evidence to support it. High-risk Medicare patients need expertise, structure, process, data collection with quality improvement and Accreditation is the vehicle to provide this. It will be a mistake to remove a requirement that is working and later find out that without accreditation, many Medicare patients will suffer increase complications or deaths. For patient safety and further evaluation, please consider keeping the Accreditation requirement for Medicare patients and evaluate the evidence showing lower case volume quoted above.

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As a bariatric surgeon and an author on one of the few publications examining the role of accreditation in bariatric surgery, I disagree with the proposed decision to remove the requirement for facility certification. Our study examining the outcome of accredited compared to non-accredited centers showed more than a 3-fold lower mortality within accredited centers. Understanding the limitations that the analysis was performed within academic centers, it is important to acknowledge that our data suggest that accreditation does improve the health outcomes by lowering the mortality associated with bariatric surgery. Therefore, I would caution that you should reconsider your decision as it can potentially impact the lives of Medicare benficiaries. Using the NIS database, our group recently presented data at SAGES which showed that centers performing >50 stapling cases/yr (bypass or sleeve) have lower mortality than centers performing < 50 stapling cases/yr (0.07% vs 0.17%, respectively). When we examined specifically the centers that perform high volume, stapling cases (>50 cases per year) and stratified according to accreditation, we found 90% of centers were accredited compared to 10% non-accredited centers. Accedited center have a 0.06% in-hospital mortality and non-accredited centers have a 0.22% mortality which is similar to that of low volume centers (0.17%). Despite having relatively high volume of stapling cases, high volume, non-accredited centers have mortality similar to that of low volume centers. This study suggests that accreditation may have an independent effect in improving health outcomes beyond that of volume alone. Our paper is in press for Surg Endosc. I can send you the entire paper if you are interested in reviewing it. I believe that this latest publication provide sufficient data for continuation of the facility certification unless you have conclusive evidence to conclude otherwise.

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Having been intimately involved as part of the physician/industry group who originally advocated for the creation of the NCD in 2005/2006 I am adamantly opposed to the language in the decision memo to no longer require certification of bariatric surgery facilities. While both employed with a company that offered a product used in the treatment of the morbidly obese, [PHI Redacted] I had the luxury of knowing who the best surgeons were and which facilities to go to. The average Medicare beneficiary does not have that luxury and in part relies on such things as certifications to help guide them in their choice as to which surgeons and facilities to go to. To no longer require that a facility be certified by Medicare removes one such resource in educating potential surgery patients who are Medicare beneficiaries as to which facilities provide high quality care both pre-op and post-op.
[PHI Redacted] I can personally attest to the fact that after care is just as, if not more, critical than the surgery itself. And aftercare programs are/were part of the overall requirement to receive certification by either the ASMBS or College of Surgeons. As such Medicare should continue to reflect those requirements as well by continuing to require bariatric surgery facilities be certified by CMS as well to protect Medicare beneficiaries from unregulated programs who may not have the quality of care to sustain the outcomes currently being reported.

To remove this requirement places Medicare beneficiaries at risk should they no longer at least have the knowledge that the program they are going to has met CMS requirements as opposed to lower quality programs that would not necessarily meet CMS standards, and would no longer disclose that fact.

Bariatric Surgery unfortunately remains a controversial choice and the bariatric community has worked hard to improve standards, part of which were demonstrated to CMS when it first issued the NCD. To remove the certification requirement would remove an incentive for programs to invest in necessary infrastructure, and I don't mean the equipment but more importantly the support and aftercare programs, to assure high quality care to beneficiaries who make the decision to avail themselves of this option.

I urge CMS to remove from the proposed decision the following language;

The Centers for Medicare & Medicaid Services (CMS) proposes that the evidence is sufficient to conclude that continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries. Therefore, CMS proposes to remove this certification requirement.

Just because the evidence has demonstrated that outcomes would not continue to improve is insufficient evidence in itself to suggest that removal of the certification requirement would sustain the outcomes currently being experienced. Rather the opposite holds true in that there is insufficient evidence to support removal of the requirement at this time and I would urge CMS to remove the language from the decision memo.

Other than holding a minimal number of shares of Allergan stock as a former employee I have no other financial disclosures or interests as I am no longer employed by any company involved in either bariatric surgery or the weight loss industry.

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As part of a recent project I studied bariatric surgery and how Medicare's 2006 NCD affected the rate of bariatric surgeries among the non-Medicare population to quantify the spillover effect of a Medicare reimbursement or coverage policy. My research, using HCUP NIS data, found that there was considerable spillover onto the non-Medicare population, so any improvements in Medicare beneficiaries' outcomes could also be seen among non-Medicare patients.

I did not compare quality outcomes, but I did evaluate rates of surgeries and both the Medicare and non-Medicare populations saw a significant decrease because of the NCD. Specifically, I found that the timing of the decrease and the magnitude of the decrease was similar for both the Medicare and the non-Medicare population. If low-volume providers (who were not accredited as centers of excellence) quit performing bariatric surgeries for the Medicare population, it is likely they also quit performing them for the non-Medicare population, so any positive effect from a decrease in low-volume providers would likely be similar between both populations.

I'm not advocating for or against the proposed decision, but instead point out only that the NCD has impacted both the Medicare and the non-Medicare population in a similar fashion, meaning that the non-Medicare population is not an ideal comparison group to evaluate the effect on the Medicare population.

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Dear Sirs:

I agree with this decision 100%. Patients have the ability to choose to have surgery with an institution in which they trust to deliver the best care for them. While I am a member of the ASMBS, and I believe that patients deserve the best quality care, the credentialling has been out of reach for my program due to the volume requirment. I have had to turn away Medicare patients who have used our facility (BayCare Health System) and trust us with their care for every other medical need. Why should bariatrics be any different? Our facility provides top notch, compassionate, care to our bariatric population as we do for all of our patients. As the bariatric program manager [PHI Redacted], I am passionate about this! We have everything in place that larger, credetialled programs have, but we have been shy on volume. To make matters worse, turning away Medicare patients, which Florida is full of, has caused us to remain in a catch 22!! Please, do not reconsider this decision as it is most definitely in the best interest of the consumer who should have the freedom to choose who they want to care for them. Thanks so much Michele Barnett, RN, BSN, CBN

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As a bariatric surgeon I support this policy change. I operate out of several hospitals; some are "COE" and some are not. Excellence does not come from filling out paperwork and paying money for certification. These requirements are silly and restrict access to care. Bariatric surgery is no different from any other kind of surgery; Medicare does not require gallbladder surgery to be done at a COE, and it shouldn't have any special certification requirements for bariatric surgery.

Congratulations on recognizing a program that doesn't work and getting rid of it.

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As a bariatric surgeon, and ASMBS member, in the Petersburg, VA area, I applaud the CMS proposal to remove the COE requirement for Medicare patients. I see a number of patients in the rural community who have a lack of access to a wide variety of medical care. This previous requirement essentially discriminated against rural patients without easy access to metropolitan COE bariatric programs.

I feel that as an ASMBS, board certified, fellowship trained bariatric surgeon, patient outcomes should be no different than in a large, academic, or COE facility. I'm happy that the CMS review also found the data to corroborate my clinical findings.

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I applaud this decision and feel that it is consistent with the best interest of my patients. I have a few high risk medicare patients that will be ready for surgery this fall. I've been very concerned about them since they would need to be done at the COE in my hospital system, 45 minutes away.

This decision will allow me to schedule them at my home institution where I can round on them several times per day and they can be seen by their regular cardiologist and other specialists.

This decision will allow me to provide better care for the medicare beneficiaries under my care.

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