DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy (SADI-S) and Related Bariatric Procedure Coverage

Governs medical necessity, coverage, and prior authorization for single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) and lists bariatric procedures considered not covered or not medically necessary for Medicare Advantage and Commercial products. Affects adults and adolescents where specified.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySADI-S and related bariatric procedures coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateMar 18, 2026

Key ActionObtain prior authorization for SADI-S for Medicare Advantage and consider prior authorization for Commercial products; document BMI and failed conservative therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=40BMI threshold (Class 3)

381SADI-S RCT size

2 yrsSADI-S follow-up

12IGB deaths since 2016

22.2% vs 3.4%StomaphyX RCT result

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Coverage and Medical Necessity Criteria

inv-01: SADI-S Medical Necessity Criteria

SADI-S may be considered medically necessary when ALL of the following criteria I–IX are met:

SADI-S eligibility

BMI requirement: Must have one of: Class 3 obesity (BMI ≥40 kg/m2) OR Class 1 obesity (BMI 30.0–34.9 kg/m2) OR Class 2 obesity (BMI 35.0–39.9 kg/m2) AND Type 2 diabetessee BMI thresholds
Conservative treatment: Failed weight loss by conservative measures, including active participation in a formal weight reduction program with frequent documentation of weight, dietary regimen, and exercise
Tobacco use: No tobacco use by history or tobacco-free ≥ 6 weeks prior to surgery6 weeks
Substance use: No substance or alcohol use disorder by history or substance- and alcohol-free period ≥ 1 year1 year
Psychosocial evaluation and clearance by a behavioral health provider
Dietary consultation prior to surgery
Informed consent and adherence: Patient understands the surgical procedure and required post-procedure adherence
Pregnancy planning: No pregnancy or plans for pregnancy within 18 months after surgery18 months
Provider and site requirements: Procedure performed by surgeons adequately trained and experienced in the specific techniques in institutions that support a comprehensive bariatric surgery program including long-term monitoring and follow-up; adolescents require greater consideration for psychosocial and informed consent issues

Revision for complications (note listed in policy text): Revision surgery to address perioperative or late complications (e.g., staple line failure, obstruction, stricture, nonabsorption resulting in hypoglycemia or malnutrition, weight loss of 20% or more below ideal body weight, band slippage not correctable by adjustment) is considered medically necessary.

inv-02: SADI-S Revision Criteria

Revision of primary SADI-S is considered medically necessary in the following scenarios:

Revision for pouch dilation: Revision of a primary SADI-S procedure that has failed due to dilation of the gastric pouch documented by upper gastrointestinal examination or endoscopy is medically necessary if the initial procedure induced weight loss and the individual has been compliant with a prescribed nutrition and exercise program.

Revision for severe reflux: Revision to address severe gastroesophageal reflux disease refractory to medical treatment is considered medically necessary.

Revision for perioperative or late complications: Revision surgery to address perioperative or late complications (including but not limited to staple line failure, obstruction, stricture, nonabsorption resulting in hypoglycemia or malnutrition, excessive weight loss, and band slippage not correctable with manipulation/adjustment) is considered medically necessary.

inv-03: Coverage summaries and evidence-based conclusions

Coverage stance varies by procedure type and evidence strength; listed evidence summaries indicate insufficient evidence for many novel endoscopic and device-based bariatric interventions.

Endoscopic revision procedures: Published data are limited to small case series and a small RCT (eg, StomaphyX) with insufficient durable efficacy; overall evidence is insufficient to determine net health outcome for many endoluminal revision devices.

Supports investigational/noncoverage stance for many endoluminal revision devices.

Intragastric balloons (IGB): RCTs show short-term benefit versus control but long-term follow-up demonstrates weight regain and safety signals (spontaneous inflation, pancreatitis, and reported deaths); evidence is insufficient for clear net health benefit and raises safety concerns.

FDA communications documented deaths and safety warnings.

Aspiration therapy (AT): An RCT demonstrated greater weight loss at 1 year and some maintenance at 4 years among completers, but high dropout rates, device malfunction, and need for replacement limit conclusions; evidence is insufficient to determine long-term net health benefit.

SADI-S is considered medically necessary only when the documented medical criteria are met. The procedure is specifically not covered for Medicare Advantage Plans and considered not medically necessary for Commercial Products when those criteria are not satisfied. Additionally, SADI-S is not covered for preadolescent individuals (<13 years) for Medicare Advantage Plans and is considered not medically necessary for Commercial Products due to insufficient evidence for this age group.

For Medicare Advantage Plans, and consistent with applicable CMS national or local coverage determinations, the following procedures are listed as not covered because evidence is insufficient to determine net health benefit: open adjustable gastric banding, open sleeve gastrectomy, open and laparoscopic vertical banding gastroplasty, gastric balloon for treatment of obesity, and intestinal bypass.

This medical policy is provided for informational purposes and is not a guarantee of payment. Coverage, benefits, and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement, which supersede this policy. For member-specific benefits or prior authorization requirements, contact the provider call center.

The policy lists additional bariatric procedures considered not medically necessary for Commercial Products or not covered for Medicare Advantage Plans due to insufficient evidence. These include: vertical-banded gastroplasty; gastric bypass using a Billroth II type anastomosis (mini-gastric bypass); biliopancreatic bypass without duodenal switch; long-limb gastric bypass (>150 cm). For Commercial Products, several endoscopic procedures are also not medically necessary as primary or revision bariatric procedures: StomaphyX device insertion, endoscopic gastroplasty, endoscopically placed duodenojejunal sleeve, intragastric balloons, aspiration therapy devices, and EGD with volume adjustment of an intragastric balloon.

Specific procedure codes are identified as not covered or not medically necessary for specified product lines. CPT codes listed as not covered/not medically necessary include 43290 (EGD with deployment of intragastric bariatric balloon), 43842 (vertical-banded gastroplasty), 43843 (gastric restrictive procedure other than vertical-banded gastroplasty), and 0813T (EGD with volume adjustment of intragastric bariatric balloon). For Commercial Products, when used for a long-limb gastric bypass (>150 cm), CPT 43847 is considered not medically necessary. Additionally, HCPCS code S2083 (adjustment of gastric band via port) is listed as not separately reimbursed.

A determination that a service is not medically necessary (or that a medically necessary service is a non-covered benefit) does not constitute an authorization or guarantee of payment. Providers should confirm member-specific benefits and obtain any required prior authorization before proceeding. If services are rendered that are later determined to be not medically necessary, providers may not bill the member unless the member was informed and provided written agreement in advance.

Procedure Codes, Billing and Coding Guidance

Procedure CPT codes mentionedCPT

43847	Gastric restrictive procedure with gastric bypass, for morbid obesity; with small intestine reconstruction to limit absorption (as used in some long-limb Roux-en-Y procedures)
43846	Roux-en-Y gastroenterostomy (short limb) — noted as not applicable to mini-gastric bypass or long-limb bypass descriptions
43843	Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty (used commonly for laparoscopic gastric plication)

CPT codes for SADI-S (use one)CPT

43659	Unlisted laparoscopy procedure, stomach
43999	Unlisted procedure, stomach
44799	Unlisted procedure, small intestine
44238	Unlisted laparoscopy procedure, intestine (except rectum)
43848	Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)

CPT codes not covered / not medically necessary (Medicare Advantage or Commercial as noted)CPTNot Covered

43290	Esophagogastroduodenoscopy, flexible, transoral; with deployment of intragastric bariatric balloon
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
0813T	Esophagogastroduodenoscopy, flexible, transoral, with volume adjustment of intragastric bariatric balloon (New code 1/01/2024)

HCPCS not separately reimbursedHCPCSNot Covered

S2083

Adjustment of gastric band diameter via subcutaneous port by injection or aspiration of saline

CPT code not medically necessary when used for long-limb (>150 cm) gastric bypass (Commercial Products)CPTNot Covered

43847

Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption

BMI categories relevant to SADI-S eligibility

Class 3 obesityBMI ≥ 40 kg/m2

Class 2 obesityBMI 35–39.9 kg/m2

Class 1 obesityBMI 30–34.9 kg/m2

Long-limb gastric bypass length threshold

Long-limb gastric bypass length threshold>150 cm

Associated CPT guidanceCPT 43847 is not medically necessary for Commercial Products when used for long-limb (>150 cm) gastric bypass

Provider Requirements, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage plans and is recommended for Commercial Products for Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy (SADI-S). Prior authorization is also required for Medicare Advantage Plans and is recommended for Commercial Products for CPT code 43847. Refer to Coding and Related Policies sections for details. Prior authorization and benefit determinations are separate from coverage; authorization does not guarantee payment — final payment is contingent on member eligibility and benefit design.

Prior authorization required for Medicare Advantage; recommended for Commercial Products
Prior authorization required for CPT 43847 for Medicare Advantage; recommended for Commercial Products

Billing Rule

Coding for SADI-S

Use the listed unlisted CPT codes when reporting the SADI-S procedure; there is no unique SADI-S code. For revision procedures of a prior gastric restrictive procedure, consider CPT 43848 when applicable. Claims for procedures or indications described as not covered should be filed using the appropriate unlisted CPT code(s) below.

Clinical Background and Scope

Bariatric surgery is an established treatment for morbid obesity after failure of conservative measures; procedures differ in mechanism (restriction, malabsorption, metabolic effects) and in expected outcomes and complication profiles. SADI-S combines sleeve gastrectomy with a single-anastomosis duodeno-ileal bypass and has been evaluated in randomized trials showing greater weight loss versus Roux-en-Y at two years, while other procedures and novel endoscopic or device-based approaches show variable evidence and safety signals that affect coverage decisions.

Definitions and Terminology

Definition of SADI-S

Procedure nameSingle anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S)

DescriptionA bariatric procedure combining sleeve gastrectomy with a single anastomosis bypass of the duodenum to the ileum

Patient population noted in policyProposed alternative to Roux-en-Y gastric bypass; considered medically necessary for adults ≥18 and certain adolescents when criteria met

Endoscopic revision procedures

Technique typesEndoluminal suturing, sclerosing injections, and device-based approaches (eg, StomaphyX)

Clinical intentProcedures intended to revise prior bariatric anatomy to treat weight regain

Policy Version and Revision History

2026-03-18policy_reviewLatest

Policy reviewed; no changes to clinical policy statements were recorded and next review scheduled for 2026-03-18; effective date set to 2026-06-01.

2026-06-01policy_effective

Policy became effective on this date (effective date 2026-06-01).

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySADI-S and related bariatric procedures coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateMar 18, 2026

Key ActionObtain prior authorization for SADI-S for Medicare Advantage and consider prior authorization for Commercial products; document BMI and failed conservative therapy.

SourceLink

On This Page

Device replacement/maintenance expected around 3.5 years in ~50% of cases.

Preoperative EGD: Systematic reviews of observational studies indicate EGD findings altered operative management in about one-fifth of patients; comparative evidence is lacking to support routine use in all patients.

Utility may be selective based on clinical indications.

Bariatric surgery for BMI <35 kg/m2: Limited evidence reports diabetes remission after bariatric surgery in BMI <35, but this is not standard of care and is considered investigational for obesity in patients with BMI <35 kg/m2.BMI <35 kg/m2

Not supported by current specialty society guidelines.

Preadolescent bariatric surgery: No studies focused solely on preadolescents; limited cohort data exist but evidence is insufficient to conclude net health benefit and remains investigational.

Specialized-center data suggest possible safety/effectiveness but comparative studies are needed.

Other bariatric procedures (eg, biliopancreatic bypass): Evidence is insufficient to draw conclusions on many other procedures; some (eg, biliopancreatic bypass) may offer greater weight loss but have higher nutritional complication rates.

Coverage depends on procedure-specific evidence and risk profile.

ImplicationUse of long-limb bypass definitions may affect code applicability and coverage determination

Use one of: 43659, 43999, 44799, 44238, or 43848 (revision only) when reporting SADI-S
No unique CPT for SADI-S; file unlisted code when no specific code exists

Note

Coverage Contingent on Meeting Criteria

The SADI-S procedure is considered medically necessary only when the medical criteria in this policy are fully met. If the criteria are not met, the procedure is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. Coverage is contingent on meeting all listed criteria, including age requirements and clinical thresholds.

Coverage contingent on meeting all policy criteria (I–IX)
Not covered / not medically necessary if criteria not met

Denial Risk

Noncovered Codes May Be Denied

Certain CPT and HCPCS codes are explicitly listed as not covered or not medically necessary for the products noted; claims using these codes may be denied. When services represent not-covered indications described in this policy, file with unlisted CPT codes as instructed.

Not covered / not medically necessary codes for Medicare Advantage and Commercial Products: 43290, 43842, 43843, 0813T
When used for long-limb gastric bypass (>150 cm) for Commercial Products, 43847 is not medically necessary

Denial Risk

Member Billing and Denial Risk

Providers may be billed by the member if services rendered are determined to be not medically necessary or are non-covered benefits under the member's plan unless the member was informed in advance and agreed in writing to be responsible for charges. Verify member eligibility and benefits prior to service and obtain necessary authorization and advance written agreements if proceeding with a non-covered service.

Member may be billed if service is determined not medically necessary or non-covered and no prior written member agreement exists
Verify eligibility and benefits with the provider call center before performing services

Documentation Required

Required Clinical Documentation

Required clinical documentation must be provided with authorization and claims to support medical necessity. Documentation should include BMI and age, evidence of failed conservative therapy with participation in a formal weight-reduction program, tobacco/substance/alcohol use history and required abstinence periods, psychosocial evaluation and clearance, dietary consultation, informed consent demonstrating patient understanding and planned post-procedure adherence, pregnancy status/plans, and surgeon/institution credentials and program availability.

BMI and age documentation (meet threshold criteria)
Documentation of failed conservative therapy and participation in a formal weight-reduction program
Tobacco-free ≥6 weeks and substance/alcohol-free ≥1 year documentation where applicable
Psychosocial evaluation and behavioral health clearance
Dietary consultation notes and informed consent/planned adherence documentation
Pregnancy status and plans (no pregnancy or planned pregnancy within 18 months)
Surgeon experience and facility program that supports comprehensive bariatric surgery

Note

Evidence-Limited Devices

Novel endoscopic and intragastric devices (for example, intragastric balloons and aspiration therapy devices) have limited long-term evidence and have been associated with safety signals including device malfunction, serious adverse events, and rare deaths. The evidence is insufficient to determine long‑term health outcomes for many of these devices; monitor applicable device-specific safety communications and FDA guidance.

Intragastric balloon devices: limited long-term data; reported adverse events and deaths; monitor FDA communications
Aspiration therapy devices: limited data with device‑related adverse events and device replacement considerations

Evidence notePublished data are limited (small case series and limited RCT data); comparative trials are lacking

Intragastric balloon (IGB)

Device descriptionTemporary, endoscopically placed space-occupying device in the stomach to induce weight loss

Safety signalsAssociated with rare but serious adverse events including spontaneous inflation, pancreatitis, and reported deaths

DurabilityRCTs show short-term benefit but long-term follow-up suggests weight regain; additional long-term data needed

Aspiration therapy (AT)

Therapy descriptionDevice-based therapy using a gastrostomy A-tube to aspirate gastric contents after meals to produce weight loss

Evidence summaryRCT (PATHWAY) showed greater weight loss at 1 year; 69% achieved ≥10% TWL at 4 years or withdrawal in subset, but high dropout and device malfunction concerns

Device maintenanceA-tube expected to require replacement in ~50% of cases by ~3.5 years post-gastrostomy

Esophagogastroduodenoscopy (EGD)

Procedure roleUpper endoscopy (EGD) used preoperatively to detect contraindicating GI pathology and conditions that may alter procedure selection or timing

Impact on managementSystematic reviews found EGD altered operative management or postponed surgery in about one-fifth of patients

Evidence gapRoutine preoperative EGD is not definitively supported by comparative evidence; use may be selective based on clinical indications

Professional guideline sources

American Society for Metabolic and Bariatric Surgery (ASMBS) / IFSOASMBS and IFSO indications and guidance cited as foundational references

American Association of Clinical Endocrinology (AACE)AACE clinical practice guidance cited among referenced guidelines

VA/DoD and CMSVA/DoD clinical practice guidance and CMS decision memos are listed among professional sources informing the policy