Posted 7/26/2013

Friday, 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 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 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. 

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”
Aetna Institutes
Aetna Institutes of Quality Bariatric Surgery Facilities Program Requirements (pdf)

Anthem Blue Cross and Blue Shield / Wellpoint
“Blue Distinction Centers for Bariatric Surgery”
Anthem Blue Cross and Blue Shield Centers of Excellence Blue Distinction Centers for Bariatric Surgery (pdf)

Cigna
“3 Star Quality Bariatric Centers”
Bariatric Centers of Excellence Cigna 3 Star Quality Bariatric Center Designation Criteria (pdf)

United Healthcare / Optum Health Coverage Summary – Obesity – Treatment of Obesity (pdf) Treatment Summary Bariatric Centers of Excellence Network (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)

Interval

Medicare, %

Non-Medicare, %

P value

30-Day

2.48

0.76

0.0090

90-Day

3.19

1.04

0.0041

1 -Year

3.90

1.45

0.0044

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,

Jaime Ponce, MD, FACS, FASMBS President, American Society for Metabolic and Bariatric Surgery

Harvey Grill, PhD President, The Obesity Society

Gerald Fried, MD President, The Society of  American Gastrointestinal Endoscopic Surgeons

David B. Hoyt, MD, FACS Executive Director, American College of Surgeons

David Bryman, D.O American Society of Bariatric Physicians