National Coverage Analysis (NCA) Tracking Sheet

Surgery for Diabetes

CAG-00397N

Issue

Various bariatric surgery procedures, including gastric bypass surgery, have been reported to “cure diabetes”, possibly by increasing insulin production or altering metabolism in other ways, in patients who are overweight (as contrasted with obese or morbidly obese) or even of normal body-mass index. The evidence for improved health outcomes is scant, however, and leaders of the American Diabetes Association and academic institutions have urged caution in attributing a benefit to such procedures in the absence of convincing scientific data.

Although CMS has a specific national coverage policy for bariatric surgery, we do not restrict surgery for diabetes alone. Therefore surgery for diabetes may be covered at contractor discretion.

This national coverage analysis (NCA) will assess the nature of the scientific evidence supporting surgery for the treatment of diabetes and whether a NCD is warranted.

National Coverage Determinations

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Internal Request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
05/19/2008
Expected NCA Completion Date
02/15/2009
Public Comment Period
05/19/2008 - 06/18/2008
Proposed Decision Memo Due Date
Proposed Decision Memo Released
11/17/2008
Proposed Decision Memo Public Comment Period
11/17/2008 - 12/17/2008
Decision Memo Released
02/12/2009
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Arthur A. Meltzer, Ph.D.
Lead Medical Officers
Ross Brechner, MD, MS(Stat.), MPH

Medicare Benefit Category Determination Date

Actions Taken

May 19, 2008

CMS initiates this national coverage analysis for the use of gastric bypass and other types of surgery for diabetes. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.

CMS is requesting public comment on the health benefit outcomes of Surgery for Diabetes in the Medicare population.

CMS considers all public comments, and is particularly interested in comments regarding clinical studies and other scientific information about the technology under review and the short and long term outcomes. We are especially interested as to the types of studies needed if the evidence is determined to be premature for coverage.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

May 29, 2008

NCD 100.1 currently addresses coverage of certain types of bariatric surgery for morbidly obese persons having one or more comorbidities, including diabetes, associated with obesity. This NCA is not addressing any changes to that NCD. The purpose of this NCA is to assess the evidence for the ability of various gastric and intestinal bypass procedures to improve diabetes status among obese, overweight, and non-overweight diabetics regardless of that procedure's coverage under the bariatric surgery NCD.

November 17, 2008

Proposed decision memorandum posted and second 30-day public comment period begins.

CMS invites public comments on this proposed decision memorandum. CMS requests comments that include relevant new evidence about clinical studies and other scientific information for this procedure under review. We consider all public comments and maintain an interest in short and long-term health benefit outcomes in the Medicare population.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html. To submit a comment, we strongly urge the use of the orange "Comment" button at the top of the page. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

February 12, 2009