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National Coverage Analysis (NCA) Tracking Sheet for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R)

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Morbid obesity is recognized as a significant health risk associated with physical problems that may increase morbidity and mortality among the Medicare population.   According to the U.S. Preventive Services Task Force, “obesity is a risk factor for major causes of death, including cardiovascular disease, numerous types of cancer, and diabetes, and is linked with markedly diminished life expectancy.” The surgical management of morbid obesity, bariatric surgery, is a treatment that may result in dramatic weight loss.  Several different surgical procedures have been used for people with morbid obesity, including biliopancreatic diversion, Roux-en-Y gastric bypass, and gastric banding. 

The CMS policy on obesity can be found in Section 40.5 of the NCD Manual:   “Obesity may be caused by medical conditions such as hypothyroidism, Cushing's disease, and hypothalamic lesions, or can aggravate a number of cardiac and respiratory diseases as well as diabetes and hypertension. Services in connection with the treatment of obesity are covered when such services are an integral and necessary part of a course of treatment for one of these medical conditions. However, program payment may not be made for treatment of obesity unrelated to such a medical condition since treatment in this context has not been determined to be reasonable and necessary.”

Currently Section 100.1 of the National Coverage Determination (NCD) Manual states: Gastric bypass surgery which is a variation of the gastrojejunostomy, is performed for patients with extreme obesity.   Gastric bypass surgery for extreme obesity is covered under the program if (1) it is medically appropriate for the individual to have such surgery; and (2) the surgery is to correct an illness which caused the obesity or was aggravated by the obesity.

Intestinal Bypass Surgery (NCD Manual Section 100.8) and Gastric Balloon for Treatment of Obesity (NCD Manual Section 100.11 are not covered by Medicare since the safety of these procedures for the treatment of obesity has not been demonstrated.

A Medicare Coverage Advisory Committee discussing bariatric surgery meeting was held November 4, 2004.   The summary, transcript and supporting documents can be found at https://www.cms.hhs.gov/mcd/viewmcac.asp?where=index&mid=26.

CMS has received a request to review the evidence for coverage of the following surgical procedures;   Roux-en-Y Gastric Bypass (open and laparoscopic); Adjustable Gastric Banding (open or laparoscopic); and Biliopancreatic Diversion (with or without duodenal switch, both open and laparoscopic; Vertical Banded Gastroplasty (open or laparoscopic).    
Incident to a physician's professional Service
Inpatient Hospital Services
Physicians' Services
Requestor Name(s):  Harvey J. Sugerman, MD, FACS, American Society for Bariatric Surgery; American Obesity Association; Ethicon Endo-Surgery Inc. (a Johnson & Johnson company); INAMED Corp.; US Surgical, a division of Tyco Healthcare Group LP; Transneuronix Corp
Requestor Letter(s):  View Letter
Formal Request Accepted and Review Initiated:  05/24/2005
Expected NCA Completion Date:  02/22/2006
Public Comment Period:  05/24/2005 - 06/24/2005
Proposed Decision Memo Released:  11/23/2005
Proposed Decision Memo Public Comment Period: 11/23/2005 - 12/23/2005 
Decision Memo Released:  02/21/2006
Comments for this NCA::  View Public Comments
Lead Analyst(s): 
  • Kate Tillman, RN, MA
  • Susan Harrison, MPP
Lead Medical Officer(s): 
  • Ross Brechner, MD, MS(Stat.), MPH
May 24, 2005 CMS opens this reconsideration for review of the coverage of bariatric surgery. CMS is requesting public comment on the following issues, as well as any others of concern to the public:
  • Is the evidence adequate for evaluating health outcomes of the bariatric surgery procedures listed in the request?
  • Should CMS define the list of comorbid conditions that qualify a patient for bariatric surgery?
  • Should CMS adopt criteria for facilities or surgeons who deliver these procedures?
  • Is there a need for routine data collection on the delivery or outcomes of bariatric surgery?
After considering the public comments and reviewing relevant evidence, we will release a proposed decision memorandum.

Instructions for submitting public comments can be found at https://www.cms.hhs.gov/coverage/8h.asp
November 23, 2005

CMS posts a proposed decision memorandum to modify sections 40.5 and 100.1 of the National Coverage Determination (NCD) Manual. CMS is requesting public comment on:

1) the proposed coverage;

2) the potential for expanding the proposed coverage for those age 65 and over under the “Coverage with Evidence Development (CED )” option;

3) the facility guidelines to include the potential of expanding those guidelines to include bariatric surgery volume criteria for both facilities and surgeons.

 

After considering public comment, we will release a final decision memorandum. Instructions for submitting public comments can be found here.
February 21, 2006 The final decision memorandum  is now posted.
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