DATE

XXXXXX, MD
Medical Policy Medical Director

XXXXX Health Plans

Dear Dr. XXXXXX:

I’m writing you today on behalf of the XXXX Chapter of the American Society of Metabolic and Bariatric Surgeons soliciting your support in coverage of Sleeve Gastrectomy, CPT 43775 -Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy), as a stand alone procedure for patients who meet the NIH Criteria for Bariatric Surgery.

ESTABLISH CREDIBILITY - Paragraph about author for example: I am the Medical Director for YYYYYYYYYY Weight Loss Program; specializes in minimally invasive surgery, number of total procedures done, number of sleeve procedures. [Reference experience with Sleeve Cases in his own practice.]

My clinical experience parallels the peer reviewed evidence for Sleeve Gastrectomy for weight loss, resolution of co-morbid conditions, safety and patient compliance.

Recently published papers – tworandomized controlled study[1],[2], a large registry[3] and two case series[4],[5] showexcess weight loss for sleeve gastrectomy at three years to be between 62% and 74%;which compares favorably to a randomized trial[6] and case matched studies[7] for Roux en Y gastric bypass and adjustable gastric banding as well as meta analyses for bariatric surgery[8],[9]. This sustained weight loss also leads to comparable resolution of obesity related comorbidities[10],[11],[12] in resolving or improving type 2 diabetes, hypertension, hyperlipidemia sleep apnea or degenerative joint disease/ joint pain by greater than 70% of the time after surgery. In addition to the references above, attached please find a table of comorbidities and references for sleeve gastrectomy.

In 1998, the National Institute of Health published a Clinical Guidelines Report outlining the patient selection criteria for a Bariatric Procedure. Patients with a BMI 35-39.9 with a co-morbid condition such as Diabetes, Hypertension, Sleep Apnea, or Hyperlipidemia, or patients with a BMI greater than 40, regardless of co-morbid conditions are candidates for weight loss surgery. These are the same criteria used currently in Aetna’s policy.

I am requesting that XXXXXremove Sleeve Gastrectomy from the Experimental Procedures list contained within the XXXXX Clinical Policy Bulletin and list it as a covered procedure since there is substantial peer reviewed literature showing the safety and efficacy of the procedures. Aetna should follow the same inclusion and exclusion criteria for patient selection as Roux-en-y Gastric Bypass, Laparoscopic Adjustable Silicone Banding, Biliopancreatic Diversion and Duodenal Switch Procedures.

I am available via telephone and welcome the opportunity to discuss this with you further.

Thank you,

SELECTED CASE STUDY LITERATURE

•18 Papers Published since November 2005 (the last citations included in the CMS NCD 100.1)

•Greater than 10 Patients

•BMI reported pre-op and at follow-up

Table 1 – Obesity related diseases and literature citing outcomes after sleeve gastrectomy.

Obesity Related Disease / Reference
Diabetes / 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18
Hypertension / 1, 2, 3, 5, 6, 7, 8, 9, 10, 14, 15, 16, 17
Dislipidemia / 1, 2, 3, 5, , 9, 10, 14, 15, 16, 17
Sleep Apnea / 2, 3, 5, 6, 8, 9, 14, 15, 16, 17
Joint disease / 2, 3, 5, 9, 16, 17,

References for Table 1

Reference # / Citations
1 / Breznikar B,Dinevski D. Bariatric surgery for morbid obesity: pre-operative assessment, surgical techniques and post-operative monitoring. J Int Med Res.2009 Sep-Oct;37(5):1632-45.
2 / Cottam D, Qureshi FG, Mattar SG, Sharma S, Holover S, Bonanomi G, Ramanathan R, Schauer P. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc. 2006 Jun;20(6):859-63. Epub 2006 Apr 22.
3 / Genco A,Cipriano M,Materia A,Bacci V,Maselli R,Musmeci L,Lorenzo M,Basso N. Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study. Surg Endosc.2009 Aug;23(8):1849-53. Epub 2009 Jan 24.
4 / Jacobs M,Bisland W,Gomez E,Plasencia G,Mederos R,Celaya C,Fogel R. Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results. Surg Endosc.2009 Aug 19. [Epub ahead of print]
5 / Kakoulidis TP,Karringer A,Gloaguen T,Arvidsson D. Initial results with sleeve gastrectomy for patients with class I obesity (BMI 30-35 kg/m2). Surg Obes Relat Dis.2009 Jul-Aug;5(4):425-8. Epub 2008 Sep 26.
6 / Kasalicky M,Michalsky D,Housova J,Haluzik M,Housa D,Haluzikova D,Fried M. Laparoscopic sleeve gastrectomy without an over-sewing of the staple line. Obes Surg.2008 Oct;18(10):1257-62. Epub 2008 Jul 23.
7 / Lakdawala MA,Bhasker A,Mulchandani D,Goel S,Jain S. 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.2010 Jan;20(1):1-6. Epub 2009 Oct 3.
8 / Menenakos E,M Stamou K,Albanopoulos K,Papailiou J,Theodorou D,Leandros E. 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.2009 Jul 28. [Epub ahead of print]
9 / Moon Han S,Kim WW,Oh JH. Results of laparoscopic sleeve gastrectomy (LSG) at 1 year in morbidly obese Korean patients. Obes Surg.2005 Nov-Dec;15(10):1469-75.
10 / Ou Yang O,Loi K,Liew V,Talbot M,Jorgensen J. Staged laparoscopic sleeve gastrectomy followed by Roux-en-Y gastric bypass for morbidly obese patients: a risk reduction strategy. Obes Surg.2008 Dec;18(12):1575-80. Epub 2008 May 28.
11 / Rosenthal R,Li X,Samuel S,Martinez P,Zheng C. Effect of sleeve gastrectomy on patients with diabetes mellitus. Surg Obes Relat Dis.2009 Jul-Aug;5(4):429-34. Epub 2008 Nov 18.
12 / Sánchez-Santos R,Masdevall C,Baltasar A,Martínez-Blázquez C,García Ruiz de Gordejuela A,Ponsi E,Sánchez-Pernaute A,Vesperinas G,Del Castillo D,Bombuy E,Durán-Escribano C,Ortega L,Ruiz de Adana JC,Baltar J,Maruri I,García-Blázquez E,Torres A. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg.2009 Sep;19(9):1203-10. Epub 2009 Jul 2.
13 / Shah PS,Todkar JS,Shah SS. Effectiveness of laparoscopic sleeve gastrectomy on glycemic control in obese Indians with type 2 diabetes mellitus. Surg Obes Relat Dis.2009 Jul 10. [Epub ahead of print]
14 / Silecchia G,Boru C,Pecchia A,Rizzello M,Casella G,Leonetti F,Basso N. Effectiveness of laparoscopic sleeve gastrectomy (first stage of biliopancreatic diversion with duodenal switch) on co-morbidities in super-obese high-risk patients. Obes Surg.2006 Sep;16(9):1138-44.
15 / Tagaya N,Kasama K,Kikkawa R,Kanahira E,Umezawa A,Oshiro T,Negishi Y,Kurokawa Y,Nakazato T,Kubota K. Experience with laparoscopic sleeve gastrectomy for morbid versus super morbid obesity. Obes Surg.2009 Oct;19(10):1371-6. Epub 2008 Dec 9.
16 / Todkar JS,Shah SS,Shah PS,Gangwani J. Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus. Surg Obes Relat Dis.2009 Jul 10. [Epub ahead of print]
17 / Weiner RA,Weiner S,Pomhoff I,Jacobi C,Makarewicz W,Weigand G. Laparoscopic sleeve gastrectomy--influence of sleeve size and resected gastric volume. Obes Surg.2007 Oct;17(10):1297-305.
18 / Miguel GP, Azevedo JL, Gicovate Neto C, Moreira CL, Viana EC, Carvalho PS. Glucose homeostasis and weight loss in morbidly obese patients undergoing banded sleeve gastrectomy: a prospective clinical study.Clinics (Sao Paulo). 2009;64(11):1093-8.

[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]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

[4]Armstrong, and O'MalleyOutcomes of sleeve gastrectomy for morbid obesity: A safe and effective procedure? Int J Surg. 2009 Nov 24. [Epub ahead of print]

[5]Todkaret al. Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus. Surg Obes Relat Dis.2009 Jul 10. [Epub ahead of print]

[6]Angrisani et al. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial, Surg Obes Rel Dis 2007;3:127-133

[7]Christou et al. Five-year outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Ygastric bypass in a comprehensive bariatric surgery program in Canada, Can J Surg, Vol. 52, No. 6, December 2009 E249-258

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

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

[10] Abbatini et al. Long-term effects of laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding on type 2 diabetes. Surg Endosc.2009.

[11]Brethauer et al Systematic review of sleeve gastrectomy as staging and primary bariatric procedure SOARD 2009;5;469-475

[12]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