ASMBS News and Update—September 2011

by Robin L. Blackstone, MD, FACS, FASMBS

Dr. Blackstone is President of the American Society for Metabolic and Bariatric Surgery and Medical Director, Scottsdale Healthcare Bariatric Center, Scottsdale, Arizona.

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

Important upcoming dates. September 23–24, 2011. American Society for Metabolic and Bariatric Surgery (ASMBS) Fall Education Event, Hyatt Regency, Chicago, Illinois. For more information, visit www.fall2011.asmbs.org
October 31, 2011. Abstract deadline for ASMBS Annual Meeting 2012.

Obesity still not declared a disease by the Centers for Medicare and Medicaid Services. Obesity is still not classified as a disease by the Center for Medicare and Medicaid Services (CMS). In 2004, CMS actually took obesity off of the list of “conditions,” allowing consideration of reimbursement for the treatment of obesity. In what has become one of the most important moments in our field, a Medicare committee met and evaluated the evidence supporting the treatment of obesity with surgery and the National Coverage Decision (NCD) was made effective February of 2006. The decision by Medicare established an important beachhead for access to care for patients with obesity. In 2009, CMS again examined the evidence and strengthened the NCD by adding type 2 diabetes mellitus (T2DM) as an indication for surgery. An additional part of the NCD was that it supported the ASMBS Bariatric Centers of Excellence program and the American College of Surgeons (ACS) Bariatric Surgery Network level 1 program as the chosen sites for performance of surgery.  While limiting the coverage to only these designated centers initially decreased access, within a few years access rebounded.

Why did Medicare cover the treatment of obesity? The final decision was about the data, but the impetus was, and is, financial. Data available from the Centers for Disease Control and Prevention (CDC) outline cost differences between a patient with obesity versus the patient without obesity.[1] According to the data, for each obese beneficiary, Medicare, Medicaid, and private insurers pay $1,723, $1,021, and $1,140, respecitively, more than they do for “normal-weight beneficiaries.

In 2010, Thorpe and Yang2 reported the impact of weight loss on lifetime medical care spending among Medicare beneficiaries.[2] They found that weight losses of 5, 10, and 15 percent are associated with substantial Medicare savings. For example, a 15-percent weight loss in the first year of Medicare enrollement among beneficiaries with Class II/III obesity confers a 15 percent lifetime Medicare savings of $60 million.

Medicare/Medicaid is suffering from adverse selection. The government provides coverage to a disproportionate share of the population with obesity in some estimates of more than 38 percent.[3] One strategy CMS could employ would be to support obesity as a disease, which would mean it would be covered within the Essential Health Benefit. With this one intervention, the government would spread the adverse selection bias among all insured patients in the United States. The ASMBS Leadership and Access Team is encouraging CMS to declare obesity as a disease and ensure coverage in the Essential Health Benefit.

The difficulty in estimating the number of bariatric procedures performed per year. One of the questions most often asked of the ASMBS is, “How many procedures were done last year?” followed by, “How many adjustable gastric bands versus gastric bypass procedures were done?” and, “What is the percent increase in the sleeve gastrectomy over last year?”

Unfortunately, these questions are more difficult to answer than you would think. First, there is no global source that gives both inpatient and outpatient cases. Often, cases performed in ambulatory centers are simply not captured even if all the correct Current Procedural Terminology (CPT) codes are defined. Attempts at surveys of our membership are often not well subscribed to and thus do not provide enough credible data. Finally, estimates from industry may reflect a bias. Last year, Bruce Wolfe, MD, appointed a task force, led by Anita Courcoulas, MD, MPH, FACS, an investigator from the Longitudinal Assessment of Bariatric Surgery to develop a methodology to estimate the numbers that could be repeated annually and published. The task force report should be available early 2012.

In the meantime, a report has emerged that shows bariatric surgery has plateaued in volume since 2004.[4] The new report from lead author Ninh Nguyen, MD, FACS, Secretary-Treasurer of the ASMBS, and his colleagues at University of California, Irvine, California, showed that using the National Inpatient Sample (NIS) data, the number of bariatric surgery peaked in 2004 at 63.9 procedures per 10,000 adults and decreased to 54.2 procedures in 2008. In-hospital mortality decreased from 0.21 percent in 2003 to 0.10 percent in 2008, and the percentage of procedures performed laparoscopically was 90.2 percent in 2008, up from 20.1 percent in 2003.

In a separate report, Edward Livingston, MD,[5] used the 2006 National Hospital Discharge Survey (NHDS), the NIS, and the Survey of Ambulatory Surgery and found that the number of primary procedures, including outpatient bands, was 112,999 cases in 2006 with 91,289 inpatient cases. Nguyen et al[4] estimated 92,147 in 2006; remarkably similar to Dr. Livingston’s estimate. Both studies show a peak in procedures in 2004.

The major event that occurred between 2004 and subsequent years is that insurance policies dropped bariatric surgery coverage as a standard benefit included within the general surgery procedures. This change in insurance coverage, which was completed by January 2005, was most dramatically seen in Florida. Although many have cited the economy as the reason for the decline in numbers of cases, this first effort by insurance companies to control what they viewed as uncontrolled and uncontrollable use of surgery to treat a disorder that was a cosmetic problem was the real cause of the decline as these numbers show.

The bottom line is that according to the National Health and Nutrition Examination Survey 2010,[6] patients affected by severe obesity (BMI >40kg/m2) equal 5.7 percent of the population of 312,163,474 people in the United States. That means 17,793,318 patients are affected; however, only 0.7 percent of these patients are receiving this life-saving treatment. The continuing battle to gain universal and standard coverage through the Essential Health Benefit is important to open access of these life-saving treatments to patients.

Prevention of osteoporosis—is your program doing enough? In 2008, the ASMBS Integrated Health team published guidelines for nutritional supplementation of the post-bariatric patient.[7] This was followed by the publication of guidelines for nutritional management of the post-bariatric patient.[8] Both publications discuss the management of calcium and vitamin D in the bariatric patient undergoing a malabsorptive procedure in regards to their risk for osteoporosis and fracture. At a recent meeting, some new data was presented that indicate that the risk of bone loss and fracture in the patient after gastric bypass may be higher.

A 2011 study[9] not yet published by the Mayo Clinic, Rochester, Minnesota, compared fracture rates in 277 patients undergoing bariatric surgery with local age- and sex-matched fracture rates. The surgeries occurred between 1985 and 2004, and 94 percent were gastric bypasses. The retrospective chart study found 138 fractures in 82 patients since the surgery, with a standardized incidence ratio of 2.1 for any fracture and 1.9 for fractures of the hip, spine, wrist, or arm after bariatric surgery.

Additional studies for gastric bypass exist. One study[9] of 15 patients reported an eight-percent decrease in total hipbone mineral density within nine months. Femoral neck bone density decreased by nine percent within one year of gastric bypass in a separate study of 23 patients.[10] A third study[11] of 42 patients reported a seven-percent decrease in spine bone density and a 10-percent decrease in total hipbone density a year after gastric bypass.

The most recent prospective study[12] of 59 women three years after GBP concluded that Menopausal women and women with greater lean body mass loss were at a higher risk for osteopenia, but that fracture risk in this short follow up period was low. All of these studies are small in numbers of patients and short in terms of follow up and in addition rely on bone scanning that may have some technical limitations in interpretation.

Mechanism of bone loss after gastric bypass. Whether you lose weight by dieting or surgery, any voluntary or involuntary weight loss will result in some bone loss and increase fracture risk. This may be accelerated when coupled with a procedure that changes the absorption of calcium.  Other contributions to bone loss may be the body’s signals about decreased skeletal loading with weight loss, and changes in fat-secreted hormones.

Patients with adjustable gastric band may not have risk associated with changes in absorption but they are eating far less food and will have bone loss with weight loss.

Vitamin D deficiency can be a problem for patients with obesity before and after bariatric surgery.

Prior to surgery. Check serum 25-hydroxyvitamin D (25[OH] D) levels and prescribe preoperative treatment to augment vitamin D in patients with low levels. Make sure you have documented consent of the patient on the vitamin deficiencies and subsequent problems, such as calcium and vitamin D deficiency. Use of second-generation consent forms will help provide clear information about these issues.

Make sure you have a plan for postoperative supplementation. The following are our current recommendations for supplementation recommended to patients after all weight loss procedures:
•    Multivitamin (must contain 20 nutrients and at least 18mg of iron per serving)—two servings per day
•    Calcium citrate with vitamin D—1,500mg per day
•    Vitamin D3 supplementation of 800 to 2,000 IU per day of vitamin D3 can be met as part of the calcium supplementation
•    B50-Complex— one serving per day
•    Sublingual B12 (gastric bypass only)—1,000mcg per week.

Postoperative surveillance for osteoporosis. Postoperative surveillance is similar to previous recommendations. Check the following labs every six months for two years and then annually: calcium, albumin, phosphate, creatinine, 24(OH) D, and parathyroid hormone.

If the parathyroid hormone level is high, but the 25(OH) D level is low, treat with additional vitamin D supplementation. If the parathyroid hormone level is high and the 25(OH) D level is ideal, check the patient’s 24-hour urinary calcium, and if that is low, increase calcium intake.

All patients should be encouraged to get 60 to 80mg of protein daily and exercise daily.
DEXA scans. Suggested at baseline (if the patient can fit into the scanner, especially if post menopausal to document status of bone) and every one to two years after surgery.

It is critical that the surgeon and the program have a coherent and clear plan of communication and consent with the patient undergoing a bariatric procedure regarding the need for postoperative supplementation of minerals and vitamins and the prevention of osteoporosis. Preferably this is reviewed both in writing and verbally (documented in the medical record) with an indication of patient understanding (e.g., true/false test or signed second generation consent form).

ASMBS Bariatric Surgeon Compensation Survey. About 18 months ago, I transitioned from almost 20 years of being in private practice to becoming a hospital employee. As I began to look into the transition, I found little help available outside of some generous consultations from colleagues I knew who had undergone a similar transition. When putting together the new course for ASMBS on Coding and Reimbursement, which will be featured at the ASMBS Fall Event in Chicago, ASMBS recruited an expert in this field, Bruce Maller, CEO BMS Consulting, Inc. His first talk on this issue featured at the ASMBS annual meeting June 2011 was met with tremendous interest.

A recent letter from ASMBS, member Teresa LaMasters, MD, FACS, brought up the important issue that compensation surveys regarding hospital-employed surgeons were very sparse, with the most recent Medical Group Management Association (MGMA) survey including only a small sample of 26 surgeons. She also stated that 50 percent of surgeons are currently employed. Based on Dr. LaMasters request that ASMBS develop more information, we began working with Toms Augustin, MD, MPH, a MIS fellow with Ann Rogers, MD, the Director at the Penn State Surgical Weight Loss Program, Hershey, Pennsylvania; and Bruce Maller on the development of a bariatric surgery compensation survey to send to all ASMBS members October 2011.

The confidential survey questions are being developed now. The following are suggestions to be formatted and included:

1.    What is monetary compensation?
2.    Is the monetary compensation (salary) based on relative value units (RVUs)?
3.    What is the compensation per RVU and how is it determined?
4.    What does the compensation include (e.g., retirement, medical, life insurance, and disability, continuing medical education)?
5.    What is the total compensation package?
6.    How many RVUs or collections correlates with that salary?
7.    Define compensation by specific regions of the country
8.    What percentage of the surgeon’s practice is dedicated to bariatric surgery and not general surgery? (>20%, 21–50%, 51–80%, >80%)
9.    What type of practice (e.g., Solo private, group private, university, solo hospital, group hospital, multispecialty group)?
10.    Years in practice (total, and at this location)
11.    Years of bariatric experience
12.    Volume of bariatric procedures per year and total experience
13. Fellowship training: Yes or No

If you have any suggestions for questions for survey, please send them to [email protected].

The United States Department of Health and Human Services demonstrates the Standard Summary of Benefits and Coverage based on a policy excluding obesity treatment and bariatric surgery. One of the goals of the Patient Protection and Affordable Care Act (PPACA) is to standardize the way that specific benefits in the plan are conveyed to the public. The National Association of Insurance Commissioners (NAIC) was charged with assembling a group to develop a standard form and glossary of terms and instructions. The ASMBS Access to Care Committee, led by John Morton, MD, and members of the Obesity Care Continuum, The Obesity Society (TOS), American Diatectic Association (ADA), Obesity Action Coalition (OAC), and the ASMBS, representing more than 100,000 patients has been tracking this work carefully to make sure that no language adverse to bariatric surgery and obesity treatment was included.

Unfortunately and inexplicably, the final document came out with the form filled out using a policy that excludes both obesity treatment and bariatric surgery. The NAIC and the coalition met three times in order to try and find out what process had ensued between the final draft and the public document where the change was made. The final document also included pregnancy as an excluded benefit, but somehow that was corrected. Although the NAIC claimed to have communicated our concerns to HHS, we were very discouraged to find that the final public document came out with the exclusion for the treatment of obesity and bariatric surgery intact.

To view the document, visit http://s3.amazonaws.com/publicASMBS/top5/september2011/0911%20Potomac%20Current.pdf

Bariatric surgery is covered by 40 percent of small employers (i.e., 10 to 499 employees) and 70 percent of companies with over 20,000 employees, it is also covered in 47 state Medicaid policies and by 44 state employee health plans and by Medicare. Clearly the decision by HHS to release this particular policy is not representative of the country.
The ASMBS Access Team knows we will not prevail in every battle, but for HHS to contribute to the stigma of obesity by singling out the treatment of this one disease in their example is unfortunate and not consistent with the leadership we hope Secretary Sibelius and HHS will show in the Essential Health Benefit.

References
1.    Centers for Disease Control and Prevention. Overweiight and obesity. http://www.cdc.gov/obesity/index.htmlAccessed 9/8/11.
2.    K Thorpe, Yang Z. Impact of weight loss on lifetime medical spending among obese medicare beneficiaries. American Public Health Association. 2010. http://apha.confex.com/apha
/138am/webprogram/Paper233943.html. Accessed 9/8/11.
3.    Livingston EH, Ko CY. Socioeconomic characteristics of the population eligible for obesity surgery. Surgery. 2004;135(3):288–296.
4.    Nguyen NT, Masoomi H, Magno CP, et al. Trends in use of bariatric surgery, 2003–2008. J Am Coll Surg. 2011; 213(2): 261–266.
5.    Livingston EH. The incidence of bariatric surgery has plateaued in the U.S. Am J Surg. 2010;200(3):378–385.
6.    Ogden CL, Carroll MD. NCHS Health E-Stat. Prevalence of overweight, obesity, and extreme obesity among adults: United States, trends 1960–1962 through 2007–2008. http://www.cdc.gov/nchs/data/
hestat/obesity_adult_07_08/obesity_adult_07_08.htm. Accessed 9/8/11.
7.    Aills L, Blankenship J, Buffington C, Furtado M, Parrott J. ASMBS Allied Health Nutritional Guidelines for the Surgical Weight Loss Patient. Surg Obes Relat Dis. 2008;4(5 Suppl):S73-108.
8.    Heber D, Greenway FL, Kaplan LM, et al. Endocrine and nutritional management of the post-bariatric surgery patient: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95:4823–4843.
9.    Coates PS, Fernstrom JD, Fernstrom MH, et al. Gastric bypass surgery for morbid obesity leads to an increase in bone turnover and a decrease in bone mass. J Clin Endocrinol Metab. 2004;89(3):1061–1065.
10.    Fleischer J, Stein EM, Bessler M, et al. The decline in hip bone density after gastric bypass surgery is associated with extent of weight loss. J Clin Endocrinol Metab. 2008; 93:3735–3740.
11.    Carrasco F, Ruz M, Rojas P, et al. Changes in bone mineral density, body composition and adiponectin levels in morbidly obese patients after bariatric surgery. Obes Surg. 2009; 19(1):41–46.
12.    Vilarrasa N, San José P, García I, et al. Evaluation of bone mineral density loss in morbidly obese women after gastric bypass: 3-year follow-pp. Obes Surg. 2011;21:465–472.

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