CurrentBlue Cross Blue Shield - IowaPolicy 02.01.56

Miscellaneous Bariatric Procedures

Describes Wellmark/Blue Cross Blue Shield - Iowa policy on investigational status of specified bariatric surgical and minimally invasive procedures for treatment of obesity, summarizes evidence, regulatory context, and notes that prior approval is not applicable within this document (but other gastric restrictive procedures require prior approval per authorization table). This part lists procedures considered investigational and provides clinical rationale and evidence summaries.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMiscellaneous Bariatric Procedures

Policy CodePolicy 02.01.56

Change TypeRevised (May 2024)Annual Review (June 2025)

Effective DateDecember 2015

Next Review Date

Key ActionBenefit determinations are based on the applicable contract language in effect at time services rendered; verify individual member benefits and contract exclusions before proceeding.

SourceLink

POLICY UPDATE CHANGES

Policy revised May 2024; review date June 2025.

Policy history shows iterative annual reviews and revisions (most recently June 2025: Annual Review; Policy Renewed).

Policy shows successive annual reviews and revisions with the latest entries in June 2025 (Annual Review; Policy Renewed).

18+Procedures listed as investigational

LowOverall evidence quality summary

MultipleRCTs and systematic reviews cited

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ManyReferences cited

8Procedure / HCPCS codes listed

Coverage Summary

Scope: This Wellmark/Blue Cross Blue Shield - Iowa policy (02.01.56) addresses surgical and minimally invasive bariatric procedures for the treatment of obesity and defines the coverage stance for specified procedures. The policy states that a list of surgical and minimally invasive bariatric procedures are considered investigational for treatment of obesity because the evidence is insufficient to determine an improvement in net health outcome.

Overview: The policy applies to procedures performed in inpatient and outpatient settings and summarizes evidence, regulatory context, and procedural coding. It notes that prior approval is not applicable for this investigational policy (with the exception that some gastric restrictive procedures require prior approval per the Wellmark Authorization Table), and that procedures designated as investigational are considered not proven to improve net health outcome and therefore are not covered unless contract language provides otherwise.

Thresholds and device duration

BMI categories (overweight/obesity classes)Overweight 25.0-29.9; Class 1 obesity 30-34.9; Class 2 obesity 35-39.9; Class 3 obesity >=40

Device labeled BMI indications (examples)Obalon: BMI 30-40; Orbera: BMI 30-40; AspireAssist: BMI 35-55 and age >22

Intragastric balloon maximum placement time6 months (device-specific)

TransPyloric Shuttle (TPS) treatment durationUp to 12 months

Investigational / Not Medically Necessary Procedures

Procedure and Service Codes

Listed CPT codes (procedures referenced in supplemental material)CPT

43290	Esophagogastroduodenoscopy, flexible, transoral; with deployment of intragastric bariatric balloon.
43291	Esophagogastroduodenoscopy, flexible, transoral; with removal of intragastric bariatric balloon(s).
43659	Unlisted, laparoscopic, stomach.
43842	Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty.
43843	Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty.
43889	Gastric restrictive procedure, transoral, endoscopic sleeve gastroplasty (ESG), including argon plasma coagulation, when performed.
43999	Unlisted, stomach.
44799	Unlisted procedure small intestine.

Listed CPT codes (procedures described in document)CPT

43291	Esophagogastroduodenoscopy, flexible, transoral; with removal of intragastric bariatric balloon(s).
43659	Unlisted, laparoscopic, stomach.
43842	Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty.
43843	Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty.
43889	Gastric restrictive procedure, transoral, endoscopic sleeve gastroplasty (ESG), including argon plasma coagulation, when performed.
43999	Unlisted, stomach.
44799	Unlisted procedure small intestine.

HCPCS / C-codeHCPCS

C9785

Endoscopic outlet reduction, gastric pouch application, with endoscopy and intraluminal tube insertion, if performed, including all system and tissue anchoring components.

Place/Type of Servicemixed

Type of Service: Surgery
Place of Service: Inpatient/Outpatient

Codingmixed

No codes listed

Provider Actions & Billing Guidance

Documentation Required

Verify member benefits and contract exclusions

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered; verify individual member benefits and contract exclusions before proceeding.

Prior Authorization

Prior approval reference for gastric restrictive procedures

Prior approval is not applicable for this investigational policy. For gastric restrictive procedures that do require prior approval, follow the Wellmark Authorization Table and the InterQual® medical necessity clinical coverage criteria.

Denial Risk

Background and Evidence Summary

Background: The policy reviews regulatory approvals and safety communications for implantable bariatric devices. It lists FDA premarket approvals and clearances for specific intragastric balloon systems and other implantable devices, including the Obalon intragastric balloon system (PMA Sept 2016; labeled for adults with BMI 30 to 40 kg/m2, maximum placement time 6 months), the AspireAssist System (PMA Jun 2016; labeled for adults age >22 years with BMI 35.0 to 55.0 kg/m2), and the ORBERA intragastric balloon system (PMA Aug 2015; labeled for adults with BMI 30 to 40 kg/m2, maximum placement time 6 months). The policy also documents FDA approvals/clearances for other devices (eg, ReShape Integrated Dual Balloon System, TransPyloric Shuttle) and endoscopic suturing systems.

Safety communications: The policy cites FDA safety communications concerning intragastric balloons, including FDA letters reporting spontaneous balloon inflation, cases of pancreatitis, and multiple unanticipated deaths (5 deaths reported in 2016–2017 and a total of 12 deaths worldwide reported through June 2018), and continued FDA recommendations for close patient monitoring and counseling about potentially life-threatening complications (eg, balloon deflation, gastrointestinal obstruction, perforation, acute pancreatitis, spontaneous hyperinflation).

Policy determination: Despite device-specific regulatory approvals, the policy concludes that the listed surgical and minimally invasive procedures (including intragastric balloons, gastrointestinal liners, endoscopic sleeve gastroplasty, duodenal-jejunal sleeves, and others) are considered investigational for treatment of obesity because overall evidence quality is low and long-term efficacy and safety data from large well-designed trials are insufficient to demonstrate a net health benefit.

Evidence	Summary
Quality of evidence
Low; limited by lack of large well-designed trials and long-term data
MERIT ESG RCT outcome
ESG showed significant weight loss vs lifestyle at 52 weeks (mean %EWL 49.2% vs 3.2%); 2% serious adverse events
BAE single-arm study
Weiss 2019 single-arm study: mean total weight loss 7.6 kg at 12 months; mean excess weight loss 11%
DJBL systematic review
Chen 2024 systematic review at 12 months: BMI reduction 4.8 kg/m2; EWL 41.3%; early removal rate 19%; severe adverse events 17%
Evidence gap statements
Several procedures (silastic ring vertical bypass, transoral endoscopic surgery, two-stage bariatric surgery) lack robust RCT evidence and long-term outcomes; additional confirmatory RCTs needed.

Definitions and guideline BMI thresholds

Medicare Coverage Determinations

Year	Title	Number	Type
2006
Bariatric Surgery for the Treatment of Morbid Obesity
CAG-00250R
NCD

Revision History

2024-05Revision

Policy revised May 2024; document notes regular updates and literature search through June 2025 (most recent literature search through June 2025).

2025-06RevisionLatest

Annual Review; Policy Renewed June 2025; history lists iterative annual reviews and revisions from 2015 through June 2025.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyMiscellaneous Bariatric Procedures

Policy CodePolicy 02.01.56

Change TypeRevised (May 2024)Annual Review (June 2025)

Effective DateDecember 2015

Next Review Date

Key ActionBenefit determinations are based on the applicable contract language in effect at time services rendered; verify individual member benefits and contract exclusions before proceeding.

SourceLink

On This Page

Investigational procedures not covered

Procedures listed as investigational are considered not proven to improve net health outcome and are therefore not covered under this policy unless contract language provides otherwise.

Documentation Required

Use appropriate procedure and diagnosis coding

Report provider services using the appropriate CPT, HCPCS, Revenue, and/or ICD diagnosis codes listed in the policy when billing for bariatric and endoscopic bariatric procedures. Affected codes include: 43290, 43291, 43659, 43842, 43843, 43889, 43999, 44799, and C9785.

Affected codes: 43290, 43291, 43659, 43842, 43843, 43889, 43999, 44799, C9785
Report services using appropriate CPT, HCPCS, Revenue, and/or ICD diagnosis codes as listed

Documentation Required

Special arrangements for certain procedures per NICE

Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy should only be used with special arrangements for clinical governance, consent, audit, or research per NICE; document governance, consent, and audit arrangements when applicable.

Billing Rule

Report appropriate CPT/HCPCS for intragastric balloon removal or gastric restrictive procedures

Use CPT 43291 for endoscopic removal of intragastric bariatric balloon(s). Use the listed CPT/HCPCS codes (including unlisted codes) that correspond to the performed gastric restrictive or related procedures and report appropriate place of service and type.

Use CPT 43291 for removal of intragastric bariatric balloon(s)
Report other procedures using listed CPT/HCPCS codes (including unlisted codes) and appropriate place/type of service

EWL (Excess weight loss)Defined in brief as excess weight loss (term EWL) with MERIT trial primary endpoint reported as %EWL

TWL / TBWL (Total body weight loss)Total body weight loss; recommended primary outcome measure is %TBWL with 5% clinically important difference

ESG (Endoscopic sleeve gastroplasty)Endoscopic suturing procedure to reduce stomach volume (ESG); MERIT RCT showed %EWL 49.2% vs 3.2% at 52 weeks

BMI thresholds per guidelineBMI >=40 kg/m2 without comorbidities or BMI >=35 kg/m2 with >=1 severe obesity-related complication; BMI 30-34.9 kg/m2 may be considered with T2D uncontrolled on therapy; adjust BMI criteria for ethnicity