BLIS Article Obesity Surgery Aug 2012.pdf

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OBES SURG DOI 10.1007/s11695-012-0745-6

OTHER

The Results of a Surgical Complication Protection Program (BLIS, Inc.) for Private Pay Bariatric Patients in the U.S.: 2006–2011 Joseph E. Chebli & Regi Schindler

# Springer Science+Business Media, LLC 2012

Abstract Background Bariatric surgery is the most effective treatment for morbid obesity and associated medical co morbidities. There is currently minimal surgical treatment penetration of this widespread disease. BLIS has been able to improve the access to bariatric surgery for cash-pay patients by alleviating concern about the costs of postsurgical complications. Recently, there has become an ability to attract payor groups by offering a “bundled” payment which includes BLIS complication protection. Methods A total of 5,364 self-pay patients underwent laparoscopic adjustable gastric banding, laparoscopic vertical sleeve gastrectomy, or laparoscopic Roux-en-Y gastric bypass with BLIS complication insurance. Results Of the overall 5,364 patients, the 30-day mortality rate was 0.04 % and 1-year mortality rate was 0.06 %. The frequency of complications was 5.4 % in the gastric banding group, 6.5 % in the sleeve gastrectomy group, and 9.7 % in the gastric bypass group. Conclusions The results for mortality and complications in the BLIS data set compares very well with other large data sets in bariatric surgery. BLIS complication insurance improves the access to bariatric surgery in patients who self-pay. Keywords Obesity . Type 2 diabetes . Sleeve . Gastric bypass . Adjustable gastric band . Laparoscopy . Surgery

J. E. Chebli (*) Northwest Metabolic and Bariatric Surgery, Seattle, WA, USA e-mail: [email protected] R. Schindler BLIS, Inc., Portland, OR, USA e-mail: [email protected]

Background There are more than 22 million persons eligible for bariatric surgery in the USA according to the National Institute of Health criteria [1]. It is estimated that 220,000 weight loss surgeries were performed in 2008 [2]. This represents a minimal penetration (1 %) of an epidemic problem in American society. In 2007–2008, the prevalence of obesity was 32.2 % among adult men and 35.5 % among adult women [3]. There are many obstacles to bariatric surgery but it is certainly possible that the greatest barrier is access to bariatric surgery. BLIS provides complication insurance to cash-paying patients through BLIS surgeons. It has already allowed many patients to consider bariatric surgery who otherwise would have been reluctant to consider surgery for the fear of a financially devastating complication. Recently, BLIS has developed the ability to bundle this complication protection into one fixed price for surgery. The payor community has taken a particular interest in the ability of the BLIS surgeon to offer this type of “bundled” payment as it represents a true “outcomes”-based reimbursement model. The most recent global predictions by the International Diabetes Federation (IDF) suggest that there are 285 million people with diabetes worldwide. This number is set to escalate to 438 million by 2030 [4]. The IDF recently determined bariatric surgery to be an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies. The IDF also stated that surgery should be an accepted option in people who have type 2 diabetes and a body mass index (BMI) of 35 kg/m2 or more. A meta-analysis by Buchwald demonstrated that 78.1 % of patients demonstrated remission of diabetes following bariatric surgery [5]. Bariatric surgery has been demonstrated to lead to a decrease in mortality. In the Swedish Obese Subjects study, there was a 29 % all-cause mortality decrease [6]. In the study from Adams in Utah, the all-cause mortality decrease was 40 % [7].

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It is possible that there will be many more patients and payors looking to obtain better access to bariatric surgery in light of these benefits and determinations. The ability BLIS has developed to include protection from complicationrelated medical expense as part of the cost of surgery can help to shape a future that creates an environment for unrestricted access to bariatric surgery.

Methods An IRB exemption for this study was obtained by Western Institutional Review Board on May 14, 2012. BLIS, Inc. is a private corporation headquartered in Portland, Oregon which was co-founded by Art Richards and Regi Schindler in 2005. BLIS, an acronym for “Bundled Loan and Indemnity Solutions” grew out of a request by the American Society of Bariatric Surgery and then president, Neil Hutcher. At that time, the ASBS was struggling with the effects of a growing cash pay bariatric surgery market. If a cash-pay patient experienced a known complication of surgery which required additional medical care, the associated medical bills were problematic. BLIS developed an entirely new type of insurance that insures surgeons, not patients or hospitals, from the cost of complication-related medical care. Billing BLIS, and not the cash-pay patient, for the complication-related medical care is a far more attractive scenario and designed by BLIS to help increase access to surgery. By removing concern about this risk, (the “indemnity” portion of “BLIS”) and by having an effective credit solution available to patients in order to help pay for the primary procedure, (the “loan” portion of “BLIS”) BLIS hopes to help their client, the surgeon, perform more cases. To date, the BLIS model has been very effective with over 5,000 surgical cases having been covered by BLIS since the first case in December of 2006. To date, BLIS has approved 300 surgeons. This group of surgeons covers 43 US states. The individual patient template for a laparoscopic Rouxen-Y gastric bypass is demonstrated in Table 1. Table 1 Individual patient template for a laparoscopic RYGB

Coverage applies only to three primary bariatric procedures which are: laparoscopic Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), and the laparoscopic vertical sleeve gastrectomy (VSG). Revisions are not eligible. However, it should be noted that BLIS pays for a revision if it is the result of a covered complication from the index procedure. Generally, the BLIS surgeon has agreed to report all of their cash pay cases that meet the prior agreement with BLIS as they are scheduled for surgery; however, some exceptions apply. For example, the surgeon can elect to opt out of the mandatory case reporting for the gastric banding procedure and make it optional for the patient. If they choose, this route then they agree to limit the patient population to an agreed age, BMI, and co-morbid limitations.

Results The data set encompasses the following procedures: LAGB, RYGB, and VSG between December 2006 and December 2011. There were two patients (one VSG, one RYGB) who experienced a 30-day death and one more patient with a death between 31 and 365 days in the series (RYGB, day95). Overall 30-day mortality is 0.04 % and 1-year mortality is 0.06 %. The overall cases are presented in Table 2. The individual procedures, incidence of complications, and general category of complication are presented in Table 3. Complication events listed by the date of occurrence and by procedure are detailed in Table 4.

Discussion Our results compared favorably with the Bariatric Outcomes Longitudinal Database (BOLD) [8] and the Longitudinal Assessment of Bariatric Surgery (LABS) [9]. In the BOLD data set, the 30-day mortality was 0.89 % and the overall mortality was 0.135 %. The percentage of patients

BLISCare complication protection matrix; RYGB Protection package

Protection period

Cardiopulmonary and thromboembolic

A B C D E F G

90 days 90 days 90 days 90 days 6 months 12 months 18 months

X

Bleeding, infection, leak and perforation

Obstruction

Stenosis

X X X X

X X X

X X

OBES SURG Table 2 Total BLIS-covered cases by surgical procedure type Procedure

Cases

Complications

VSG LAGB RYGB Total

2,489 1,863 892 5,364

161 102 87 358

Frequency (%) 6.47 5.48 9.75 6.67

In order that BLIS can pay for a complication related medical bill, the case must be first be promptly reported so that protection is in place at the time of surgery. Should a complication event occur, it must be promptly reported to BLIS so that the medical bills can be paid. As a result, the BLIS dataset represents a highly accurate, representative, and unbiased view of the complication risks associated with BLIS-covered procedures.

VSG vertical sleeve gastrectomy, LAGB laparoscopic adjustable gastric banding, RYGB Roux-en-Y gastric bypass

experiencing at least one complication was 4.62 % for LAGB, 10.84 % for the VSG and 14.87 % for the RYGB. In the BLIS data set, the frequencies of complications are 5.4 % for LAGB, 6.5 % for the VSG, and 9.7 % for the RYGB. In the LABS database, the 30-day mortality among patients who underwent RYGB or LAGB was 0.3 %.

Conclusion Obesity is an epidemic problem in the USA and around the globe. Currently, there are many difficulties for patients with Table 4 BLIS complication events by type of procedure and by days following surgery BLIS complication event detail by period

Table 3 Summary of BLIS-covered complication events by type of procedure and type of complication event Procedure

No. of complications

RYGB (n0892) Bleeding Cardiopulmonary GI Bleeding Infection Leak Obstruction Perforation Stenosis Thromboembolic LAGB (n01,863)

87 15 5 3 7 10 15 2 27 3 102

Band erosion Band slip Bleeding Cardiopulmonary Infection Obstruction Perforation Port site problem VSG (n02,489) Bleeding Cardiopulmonary Infection Leak Perforation Stenosis Thromboembolic Total (n05,244)

2 31 6 6 12 3 2 40 161 29 23 28 23 2 47 9 350

No. of days post-surgery Procedure

30

60

90

180

365

540

Total

9.7 1.68 0.56 0.34 0.78 1.12 1.68 0.22 3.03 0.34 5.4

RYGB—total Bleeding Cardiopulmonary GI bleeding Infection Leak Obstruction Perforation Stenosis Thromboembolic LAGB—total

4 3

17 3

44 6 4 3 5 7 6 1 11 1 16

14 2

6 1 1

2

87 15 5 3 7 10 15 2 27 3 102

0.11 1.66 0.32 0.32 0.64 0.16 0.11 2.15 6.5 1.17 0.92 1.12 0.92 0.08 1.89 0.36 6.7

Band erosion Band slip Bleeding Cardiopulmonary Infection Obstruction Perforation Port site problem VSG—total Bleeding Cardiopulmonary Infection Leak Perforation Stenosis Thromboembolic Total all procedures

Frequency (%)

RYGB Roux-en-Y gastric bypass, LAGB laparoscopic adjustable gastric banding, VSG vertical sleeve gastrectomy

1 2 4 1

2

1 1

33 5 7 10 4 5 2 39

6 1 2

1 1

28 2 4 5 3 1 12 1 47

1 2 3 2 5 1 2 73 17 11 11 14 1 14 5 133

1 1 3 7 7 4

1 1 1 3

3 24

2 1 1 24

51

1 7 2 1 3

18 1 2 2

10 22 5 1 2 2 11 1 52

2

1 27 2

2 55

2 31 6 6 12 3 2 40 161 29 23 28 23 2 47 9 350

RYGB Roux-en-Y gastric bypass, LAGB laparoscopic adjustable gastric banding, VSG vertical sleeve gastrectomy

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severe obesity in terms of access to bariatric surgery. BLIS improves the access to bariatric surgery for patients suffering from obesity and debilitating co-morbid diseases such as type 2 diabetes. The overall results compare very favorably with other larger data sets with regard to overall mortality and complications.

Disclosures Dr. Chebli is the chairman of the medical review board for BLIS, Inc. (uncompensated position) and a minority shareholder. Mr. Schindler is the chief executive officer for BLIS, Inc. and a majority shareholder.

References 1. Martin M, Beekley A, Kjorstad R, et al. Socioeconomic disparities in eligibility and access to bariatric surgery: a national populationbased analysis. Surg Obes Relat Dis. 2010;6:8–15.

2. American Society for Metabolic and Bariatric Surgery (2009) Fact sheet: metabolic and bariatric surgery. www.asbs.org/Newsite07/ media/asbs_presskit.htm. Accessed January 28, 2009 3. Flegal KM, Carroll MD, Ogden CL, et al. Prevalence and trends in obesity among US adults, 1999–2008. JAMA. 2010;303:235–41. 4. Dixon JB, Zimmet P, Alberti KG, et al. Bariatric surgery: an IDF statement for obese type 2 diabetes. Surg Obes Relat Dis. 2011;7:433–47. 5. Buchwald H, Estok R, Fahrbach K, et al. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009;122:248–56. 6. Sjostrom L, Narbo K, Sjostrom CD, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007;357:741–52. 7. Adams TD, Gress RE, Smith, et al. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007;357:753–61. 8. DeMaria EJ, Pate V, Warthen M, et al. Baseline data from American society for metabolic and bariatric surgery-designated bariatric surgery centers of excellence using the bariatric outcomes longitudinal database. Surg Obes Relat Dis. 2010;6:347–55. 9. Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445–54.