Pathway for Endorsement for New Procedures

Obesity has been recognized as a disease by the American Medical Association since 2013. Metabolic and bariatric surgery is a proven, effective, and enduring treatment for patients living with this disease. Bariatric and metabolic surgery strives to provide the most innovative therapies for patients with obesity, and as new treatments and procedures emerge, the American Society for Metabolic and Bariatric Surgery must lead the way in developing, evaluating, and implementing innovative solutions for this chronic disease. This pathway provides a formal process for endorsing and sanctioning new procedures by the ASMBS.

Problem

A review of historical ASMBS policy for the approval of new obesity treatment procedures reveals that there was no standardized pathway. Previously approved procedures or devices were granted approval by ASMBS leadership through expert review only. However, our specialty may have procedures that have become obsolete or new procedures that emerge, which may be rapidly adopted without ASMBS endorsement.

Process

1. Application by an ASMBS Member Sponsor in active practice for a new procedure or removal of an endorsed procedure. Multiple ASMBS Member Co-Sponsors are allowed and encouraged.
2. Primary Board Executive Committee (BEC) Review: Majority Approval Required to Next Stage. This review will be inclusive, primarily to ensure the plausibility of the new procedure before undertaking a full review.
3. Application Presented to Board of Directors by ASMBS Member Sponsor and 1 Co-Sponsor and Pro and Con Advocates.
4. Board of Directors Review and Open Vote: A Majority Approval Is Required to Proceed to the Next Stage.
5. ASMBS Member Comment on New Procedure Application with BEC and Board of Directors Majority Approval.
6. Final Board Vote: Majority Approval Required for final affirmation
7. Outcome of approval sent to major insurers and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program once the application is endorsed.

Application Form

The following information is provided to assist in your application preparations.

Apply Online Today

1. Name(s) of ASMBS Sponsor and Co-Sponsor
2. Indicate if this is a New or Extinct Procedure. There may be procedures that are no longer viable, and these may be removed from the endorsed list.
3. Indicate if this Procedure Requires a Device. If so, Indicate if the Required Device FDA-approved with documentation to support.
4. Indicate if the Procedure is Novel or Similar to Established Procedure. If similar to established procedure, describe how the new procedure differs from current established procedure.
5. Disclose any Conflictsof Interest. Such as if you or your co-sponsors have a financial relationship with the new device or procedure, including but not limited to consulting, ownership, proctoring, etc? If so, what is the relationship?
6. Provide publications with evidence grades utilizing established evidence scales such as those offered by The University of Oxford Centre for Evidence-Based Medicine.
7. If the Procedure is new/novel, provide support of:
   A) Is this a new procedure or a modification of an existing procedure?
   B) Based on current knowledge, does the new procedure or modification of an existing procedure potentially have a different risk/benefit profile than an existing procedure?
   C) Does it add a new mechanism to an existing procedure?
   D) Does it have a new name or names that should be standardized as part of the endorsement process?

New Procedure Endorsement

A new procedure performed before endorsement must be conducted under an IRB and entered into MBSAQIP.

For a new procedure to be endorsed by ASMBS, reviewers will address the following questions:

1. Is this a new procedure or a modification of an existing procedure?
2. Based on current knowledge, does the new procedure or modification of an existing procedure potentially have a different risk/benefit profile than an existing procedure?
3. Does it add a new mechanism to an existing procedure?
4. Does it have a new name or names that should be standardized as part of the endorsement process?

While the reviewers will determine the level of evidence required for endorsement on a case-by-case basis, the suggested quantity and quality of evidence that warrant consideration could include one or both of the following:

Medium-term follow-up should include weight loss, comorbidity outcomes, and early and late complication rates as defined by the Standards in Outcome Reporting in SOARD.