New list of ASMBS endorsed procedures

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DianaCox

Bad Cop
Joined
Dec 30, 2013
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Location
San Jose
Basically, anything goes :mad:
ASMBS Endorsed Procedures and Devices for Metabolic and Bariatric Treatment
Surgical Procedures, Devices and ApproachesPrimary Case
Adjustable Gastric BandingNo IRB
Sleeve GastrectomyNo IRB
Roux-en-Y Gastric BypassNo IRB
BPD/Duodenal SwitchNo IRB
AspireAssist®No IRB
Intragastric balloonsNo IRB
Vagal nerve blocking therapy (vBloc®)No IRB
Vertical Banded GastroplastyNo IRB
Bariatric Reoperative ProceduresN/A
Open procedures as deemed appropriateNo IRB
Single Anastomosis Duodenal Switch Procedures (SADI, SADI-S, SIPS, Loop DS)IRB or IRB Exemption Required
Single Anastomosis Gastric Bypass (Mini-Loop Gastric Bypass)IRB or IRB Exemption Required
Endoluminal/Endoscopic Sleeve GastroplastyIRB or IRB Exemption Required
Gastric plication

 
I guess insurance wants to pay for diabetes, obesity related illnesses and injuries. Oh, and lots of drugs.
 
So, am I understanding correctly they've basically said SADI-SIPS-LOOPS and MGP are NOT standard of care and require additional approval in order to be performed at MBSAQIP-Accredited centers? If so, I agree, I think that appropriately reflects the need for additional due diligence for experimental procedures.
 
Diana, can you dumb this down for me? Does this mean DS is NOT covered without appeal and approval? And SADI and the others ARE covered?
 
“MBSAQIP-Accredited centers must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures that are not endorsed by the ASMBS. The IRB approval must be for performing the procedures, and not solely for data collection of outcomes from these procedures. In the event that an IRB determines a study protocol unnecessary for a primary procedure that is not endorsed by the ASMBS, a letter of exemption from the IRB is required to demonstrate compliance with MBSAQIP standards. Procedures and devices used for re-operative purposes do not require IRB approval or IRB exemption. However, the ASMBS recommends conforming to the endorsed procedure list when selecting procedures and devices for re-operative purposes whenever possible:”

I think this means that the ones that say no IRB, the ASMBS-accredited centers (which are ASMBS-invented rules that the DS surgeons scoffed at as driven by insurance companies to cut off access to their smaller practices) don’t need approval to perform the standard procedures (including VBG! and Crapband! And Aspire and gastric balloon - UGH!), but the last 4 do require approval.
 

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