March 30, 2010

Doug Hadley, M.D.

Cigna

Dear Dr. Hadley,

I should like to write to you on behalf of the American Society for Metabolic Surgery (ASMBS) as it’s current president. My name is John Wilder Baker, MD. I am a practicing Bariatric and General Surgeon in Little Rock, Arkansas.

We understand that Cigna is currently reviewing the surgery for obesity policy 0051. The ASMBS urges you to consider adding laparoscopic sleeve gastrectomy (CPT code 43775) as a covered procedure. We believe that the recent peer reviewed medical literature shows it to be safe and efficacious I have attached a copy of the updated clinical position statement from ASMBS on sleeve gastrectomy. This updated statement supersedes the prior statement on sleeve gastrectomy and the joint AACE (American Association Clinical Endocrinology) TOS (The Obesity Society), ASMBS guidelines.

Since the last major review by CMS in early 2006, over 70 papers have been published on sleeve gastrectomy including two randomized controlled trials[1],[2] and 4 comparative studies[3],[4],[5],[6], and 1 systematic review[7]. The data now shows that sleeve gastrectomy is as safe as or safer than other covered bariatric procedures such as Roux en Y gastric bypass and adjustable gastric banding. The sleeve gastrectomy has weight loss that is comparable to other covered bariatric procedures. It also has an impact on resolution of obesity related diseases. In addition, the major professional societies involved in the management of obesity support sleeve gastrectomy including ASMBS, the American College of Surgeons (ACS), and The Society of American Gastrointestinal and Endoscopic Surgery (SAGES). These societies do not consider sleeve gastrectomy to be investigational.

Including sleeve gastrectomy as a treatment option for morbid obesity will not necessarily increase the risk to the patient population. A recent systematic review7and large registry[8]showed perioperative mortality rates of 0.19% and 0.36%, respectively.This is not substantially different from other mortality rates reported for other bariatric surgery procedures ranging from 0.30% in a national NIH sponsored registry[9]to 0.55% in a recent meta-analysis[10]. The sleeve gastrectomy does not appear to have an increase risk of reoperation, perioperative bleeding or gastric leakscompared to other bariatric procedures[11].

Published data clearly shows that sleeve gastrectomy is an effective weight loss procedure. It has better weight loss than Adjustable Gastric Banding and studies show that it reduces hunger, a positive for continued patient success.

Advantages include

  • No anastomoses
  • Continuity of gastrointestinal tract
  • Functional pylorus
  • Does not bypass duodenum
  • No implanted device
  • Follow up visits to adjust device not needed
  • Fewer interventions required

The ASMBS hopes that CIGNA, when writing a coverage policy, would consider sleeve gastrectomy as a primary bariatric procedure and not restrict this to patients with a high BMI as part of a two-stage procedure. The literature supports sleeve gastrectomy as a primary procedure for those patients who meet the current indications for treatment of class II (BMI 35) obesity or higher and related diseases.

In conclusion, we would like to point out that weight loss drives obesity related comorbidity resolution. Sleeve gastrectomy has better weight loss than adjustable gastric banding and fewer complications than Roux en Y gastric bypass or biliopancreatic diversion and duodenal switch. We respectfully request that CIGNA change the designation on Sleeve Gastrectomy to a medically necessary and covered procedure. Thank you for your time in reading our request. I would be glad to discuss further and can be reached at the number below.

Thank you,

John W. Baker. M.D., F.A.C.S., F.A.S.MB.S.

President, American Society for Metabolic and Bariatric Surgery

Cell: 501.247.4887

Office: 501.221.9175 ext 104

Additional Sleeve Gastrectomy References (Published since Brethauer7)

Abbatini, F., M. Rizzello, et al. (2009). "Long-term effects of laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding on type 2 diabetes." Surg Endosc.

Acholonu, E., E. McBean, et al. (2009). "Safety and short-term outcomes of laparoscopic sleeve gastrectomy as a revisional approach for failed laparoscopic adjustable gastric banding in the treatment of morbid obesity." Obes Surg 19(12): 1612-6.

Arias, E., P. R. Martinez, et al. (2009). "Mid-term follow-up after sleeve gastrectomy as a final approach for morbid obesity." Obes Surg 19(5): 544-8.

Armstrong, J. and S. P. O'Malley (2009). "Outcomes of sleeve gastrectomy for morbid obesity: A safe and effective procedure?" Int J Surg.

Breznikar, B. and D. Dinevski (2009). "Bariatric Surgery for Morbid Obesity: Pre-operative Assessment, Surgical Techniques and Post-operative Monitoring." J Int Med Res 37(5): 1632-45.

Bueter, M., A. Thalheimer, et al. (2009). "Reoperations after gastric banding: replacement or alternative procedures?" Surg Endosc 23(2): 334-40.

Chowbey, P. K., K. Dhawan, et al. (2009). "Laparoscopic Sleeve Gastrectomy: An Indian Experience-Surgical Technique and Early Results." Obes Surg.

Elazary, R., D. Hazzan, et al. (2009). "Feasibility of sleeve gastrectomy as a revision operation for failed silastic ring vertical gastroplasty." Obes Surg 19(5): 645-9.

Foletto, M., L. Prevedello, et al. (2009). "Sleeve gastrectomy as revisional procedure for failed gastric banding or gastroplasty." Surg Obes Relat Dis.

Frezza, E. E. and M. S. Wachtel (2009). "The economic impact of morbid obesity." Surg Endosc 23(4): 677-9.

Genco, A., M. Cipriano, et al. (2009). "Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study." Surg Endosc 23(8): 1849-53.

Iannelli, A., A. S. Schneck, et al. (2009). "Laparoscopic sleeve gastrectomy as revisional procedure for failed gastric banding and vertical banded gastroplasty." Obes Surg 19(9): 1216-20.

Jacobs, M., W. Bisland, et al. (2009). "Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results." Surg Endosc.

Kakoulidis, T. P., A. Karringer, et al. (2009). "Initial results with sleeve gastrectomy for patients with class I obesity (BMI 30-35 kg/m2)." Surg Obes Relat Dis 5(4): 425-8.

Kasama, K., N. Tagaya, et al. (2009). "Laparoscopic Sleeve Gastrectomy with Duodenojejunal Bypass: Technique and Preliminary Results." Obes Surg.

Kiriakopoulos, A., C. Varounis, et al. (2009). "Laparoscopic sleeve gastrectomy in morbidly obese patients. Technique and short term results." Hormones (Athens) 8(2): 138-43.

Lakdawala, M. A., A. Bhasker, et al. (2009). "Comparison Between the Results of Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass in the Indian Population: A Retrospective 1 Year Study." Obes Surg.

Lewis, C. E., A. Dhanasopon, et al. (2009). "Early experience with laparoscopic sleeve gastrectomy as a single-stage bariatric procedure." Am Surg 75(10): 945-9.

Menenakos, E., M. S. K, et al. (2009). "Laparoscopic Sleeve Gastrectomy Performed with Intent to Treat Morbid Obesity: A Prospective Single-Center Study of 261 Patients with a Median Follow-up of 1 Year." Obes Surg.

Merchant, A. M., M. W. Cook, et al. (2009). "Comparison between laparoscopic paraesophageal hernia repair with sleeve gastrectomy and paraesophageal hernia repair alone in morbidly obese patients." Am Surg 75(7): 620-5.

Miguel, G. P., J. L. Azevedo, et al. (2009). "Glucose homeostasis and weight loss in morbidly obese patients undergoing banded sleeve gastrectomy: a prospective clinical study." Clinics (Sao Paulo) 64(11): 1093-8.

Peterli, R., B. Wolnerhanssen, et al. (2009). "Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial." Ann Surg 250(2): 234-41.

Rosenthal, R., X. Li, et al. (2009). "Effect of sleeve gastrectomy on patients with diabetes mellitus." Surg Obes Relat Dis 5(4): 429-34.

Sabbagh, C., P. Verhaeghe, et al. (2009). "Two-Year Results on Morbidity, Weight Loss and Quality of Life of Sleeve Gastrectomy as First Procedure, Sleeve Gastrectomy After Failure of Gastric Banding and Gastric Banding." Obes Surg

Shah, P. S., J. S. Todkar, et al. (2009). "Effectiveness of laparoscopic sleeve gastrectomy on glycemic control in obese Indians with type 2 diabetes mellitus." Surg Obes Relat Dis.

Todkar, J. S., S. S. Shah, et al. (2009). "Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus." Surg Obes Relat Dis.

[1]Himpens et al. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg. 2006; 16:1450–6.

[2]Karamanakos et al. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg. 2008; 247:401–7.

[3]Vidal et al. Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects. Obes Surg. 2008; 18:1077– 82.

[4]Lee et al. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007; 21:1810–6.

[5]Strain et al. Comparison of weight loss and body composition changes with four surgical procedures. Surg Obes Relat Dis. 2009 Sep-Oct; 5(5):582-7. Epub 2009 Apr 14.

[6]Wong et al. Laparoscopic bariatric surgery: a five-year review. Hong Kong Med J. 2009 Apr; 15(2):100-9.

[7]Brethauer et al. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis.. 2009; 5:469-475.

[8]Sanchez-Santos et al. Short- and Mid-term Outcomes of Sleeve Gastrectomy for Morbid Obesity: The Experience of the Spanish National Registry, Obes Surg 2009;19 :1203–1210

[9]Longitudinal Assessment of Bariatric Surgery (LABS) Consortium et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54.

[10]Buckwald et al. Bariatric surgery, a systematic review and meta-analysis. JAMA. 2004; 292:1724-1737.

[11]Maggard M, et al, Meta-Analysis: Surgical Treatment of Obesity. Ann Intern Med. 2005; 142:547-559.