CurrentAetnaPolicy 0737

Double Balloon Enteroscopy

Clinical policy governing when double balloon enteroscopy is considered medically necessary or investigational for Aetna members; applies to evaluation and treatment of small bowel conditions and certain related indications.

Policy Summary

PayerAetna

PolicyDouble Balloon Enteroscopy

Policy CodePolicy 0737

Change TypeNo material change

Effective DateOct 5, 2007

Next Review DateAug 8, 2024

Key ActionObtain prior authorization documenting that DBE is being performed for a listed medically necessary indication and include prior diagnostic work-up such as capsule endoscopy or imaging when applicable.

SourceLink

≈75%diagnostic yield

67%therapeutic yield

90%enteroscopic success (DBE-ERCP)

6.27%DBE-ERCP complications

80%surgery avoided after dilation

90 minsprocedure time

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Coverage criteria for double-balloon enteroscopy (DBE)

inv-01: Medically necessary indications

Covered when ANY of the following indications are met:

Medically necessary indications for DBE: 1) Dilation of small bowel strictures in Crohn's disease; 2) Evaluation of suspected small-bowel malignancies (e.g., adenocarcinoma, lymphoma, GIST, metastatic tumors); 3) Evaluation of the colon after incomplete colonoscopy; 4) Suspected Meckel's diverticulum with indefinite diagnostic imaging work-up (e.g., CT, Meckel's scan); 5) Investigation of suspected small intestinal bleeding in individuals with objective evidence of recurrent obscure GI bleeding after negative EGD and colonoscopy; 6) Initial diagnosis in suspected Crohn's disease when conventional diagnostic tests (small-bowel follow-through, EGD, colonoscopy) are negative; 7) Removal of entrapped foreign bodies in the small bowel (e.g., retained video capsule); 8) Removal of large polyps (>10 mm) of the small bowel in Peutz-Jeghers syndrome; 9) Treatment of GI bleeding when the small intestine has been identified as the source of bleeding; 10) Use with ERCP in individuals with surgically altered upper GI anatomy.

inv-02: Experimental/Investigational

Considered experimental/investigational (Not covered) when used for:

Experimental or investigational indications: Detection of neuroendocrine tumors of the small bowel; diagnosis of pelvic mass penetrating intestine, including gossypiboma; diagnosis of pyogenic granuloma; treatment of intussusception; treatment of post-operative bile leakage after hepatico-jejunostomy; and other indications not listed as medically necessary.

inv-03: Covered clinical indications

Clinical scenarios in which DBE is indicated based on cited evidence

Indications: DBE may be indicated when ANY of the following are present: (1) Positive capsule endoscopy finding requiring biopsy or therapeutic intervention; (2) High clinical suspicion for small-bowel lesion despite negative capsule endoscopy; (3) Active small-bowel bleeding (obscure GI bleeding, OGIB); (4) Failed or incomplete conventional colonoscopy where DBE can achieve cecal intubation and allow interventions; (5) Management of sizable small-bowel polyps (e.g., Peutz-Jeghers syndrome) amenable to endoscopic resection; (6) Diagnosis of suspected Meckel's diverticulum when other modalities are inconclusive; (7) Facilitation of ERCP in patients with surgically altered GI anatomy where conventional endoscope cannot reach the papilla or biliary anastomosis.

Derived from comparative studies, meta-analyses, and series showing higher diagnostic yield for DBE after positive CE and its therapeutic role.

inv-04: General medical necessity criteria for DBE

Covered when ALL of the following are met

DBE indication: Patient has a clinical indication amenable to DBE (examples: suspected small-bowel bleeding/OGIB, retained video capsule, suspected small-bowel malignancy, Peutz-Jeghers polyps ≥10 mm, foreign body retrieval, or need for ERCP in surgically altered anatomy)

Supported by policy-listed indications and evidence.

Prior work-up: Appropriate prior noninvasive or less invasive evaluation has been performed and is documented as indicated (e.g., EGD and colonoscopy; capsule endoscopy when appropriate; CT/MR enterography; Meckel's scan when relevant)

Evidence and guidelines recommend CE as initial test for OGIB and DBE commonly performed after positive CE or when CE is contraindicated or nondiagnostic.

Technical plan and expertise: Procedure will be performed by an experienced endoscopist capable of the planned diagnostic or therapeutic interventions, or at a high-volume/referral center when complex surgically altered anatomy or advanced therapy is required

Referral to high-volume centers suggested for altered anatomy ERCP and complex interventions.

inv-05: Diagnosis of suspected Meckel's diverticulum

Covered when supported by appropriate clinical indication and prior evaluation:

DBE for suspected bleeding Meckel's diverticulum in adults: BAE/DBE is indicated for pre-operative diagnosis of bleeding Meckel's diverticulum in adults when noninvasive imaging (e.g., Meckel's scan, CT, MRI enterography) is negative or nondiagnostic and clinical suspicion persistsdiagnostic necessity after prior non-diagnostic imaging

Multi-center study showed higher diagnostic accuracy for BAE/DBE (85.0%) versus Meckel's scan (21.4%) in adults.

inv-06: DBE-ERCP in altered GI anatomy

Covered when ALL of the following are met:

DBE-ERCP for pancreatico-biliary disease in altered GI anatomy: DBE-ERCP is considered when pancreatico-biliary disease requires diagnostic or therapeutic ERCP but conventional endoscopic access is not feasible due to surgically altered upper GI anatomy (e.g., Roux-en-Y gastric bypass, hepaticojejunostomy, Whipple reconstruction)failure or infeasibility of standard approaches

Meta-analyses report pooled enteroscopy success ≈89–90% and diagnostic/therapeutic success with complication rates cited; studies are heterogeneous and largely retrospective.

inv-07: Dilation of small-bowel strictures in Crohn's disease

Covered when ALL of the following are met:

Endoscopic balloon dilation (EBD) via DBE for Crohn's small-bowel strictures: DBE-assisted balloon dilation is indicated for symptomatic, non-complex small-bowel strictures in Crohn's disease to avoid or defer surgery when stricture characteristics are suitableStricture length ≤ 5 cm; absence of fistula, abscess, deep ulceration, or severe adhesion; symptomatic or evidence of proximal dilation on imaging

Systematic reviews and guidelines report surgery avoided in ~80% and complication rates generally low; Japanese guideline specifies ≤5 cm and absence of associated complications.

inv-08: Limited evidence / case-series indications

Covered selectively or considered experimental/limited evidence:

Limited evidence / case-series indications: DBE-facilitated interventions reported in case series/reports include: endoscopic treatment of post-operative bile leakage after hepatico-jejunostomy; diagnosis of pelvic mass penetrating intestine including gossypiboma; cyanoacrylate injection for small-bowel varices or jejunal varix therapy; and other rare, case-specific therapies. These uses may be considered only when conventional radiologic, endoscopic, or surgical options are infeasible and case-specific justification is provided.absence of feasible alternatives and individual justification

Evidence limited to small series/case reports; further validation needed.

The policy lists specific ICD-10 diagnoses that are not covered for the indications in this Clinical Policy Bulletin. These include codes for small intestine malignancies and related neoplasms (e.g., C7A.010–C7A.019, C17.0–C17.9), pelvic mass/pelvic neoplasm (C76.3), secondary malignant neoplasm of the small intestine (C78.4), lymphomas (C81.00–C88.9), benign and malignant carcinoid tumors of the small intestine (D3A.010–D3A.019), intussusception (K56.1), post‑procedural bile leakage (K91.89), pyogenic granuloma (L98.0), intra‑abdominal/pelvic mass codes (R19.00, R19.07, R19.09), and gossypiboma/complications of retained foreign body codes (T81.509A–T81.509S, T81.599A–T81.599S).

Clinical guidance recommends that capsule endoscopy (CE) is generally used as the initial diagnostic test for small‑bowel evaluation because it is noninvasive and visualizes the entire small bowel; DBE is frequently performed subsequently when CE yields a positive finding that requires biopsy or therapeutic intervention or when CE is contraindicated or nondiagnostic. Documentation of prior CE results or clinical justification for proceeding directly to DBE is expected when CE is feasible.

For routine primary search of suspected small‑bowel neuroendocrine tumors (NETs), the evidence supports a selective approach: DBE may enrich diagnostic possibilities but reported detection rates are modest and studies recommend performing DBE only in selected cases, typically after a positive or inconclusive prior work‑up rather than as an unconditional first‑line search.

Studies of DBE‑facilitated ERCP in surgically altered anatomy show variable procedural success and nontrivial complication rates; because most available studies are retrospective and heterogeneous with limited long‑term follow‑up, the policy notes that the definitive effectiveness of therapeutic DBE‑ERCP is unclear and additional larger, longer‑term studies are needed.

DBE is considered experimental and investigational (not covered) for indications other than those explicitly listed as medically necessary in this policy. Examples include detection of small‑bowel neuroendocrine tumors, diagnosis of pelvic masses penetrating the intestine (including gossypiboma), diagnosis of pyogenic granuloma, treatment of intussusception, and treatment of post‑operative bile leakage after hepatico‑jejunostomy.

When capsule endoscopy is an appropriate, less invasive option for initial small‑bowel evaluation, the policy cautions against using DBE as the first diagnostic test; CE should be considered first to determine the need for and optimal route of subsequent DBE when indicated.

The policy states that DBE is not supported as an unconditional first‑line diagnostic test for primary tumor search in all patients with suspected small‑bowel NETs. Available series report modest diagnostic yields and recommend selective use of DBE guided by prior positive or inconclusive investigations.

In adults with suspected bleeding Meckel's diverticulum, the policy highlights limitations of Meckel's scan: reported diagnostic accuracy of Meckel's scan in adults is low (~21.4% in a multicenter series), and balloon‑assisted enteroscopy (including DBE) demonstrated substantially higher diagnostic accuracy (reported ~85.0%) and is recommended as the preferred preoperative diagnostic modality when noninvasive imaging is negative or inconclusive.

Coding and billing references

Polyp size threshold (Peutz-Jeghers) — > 10 mm

Polyp size threshold (Peutz-Jeghers)> 10 mm

Stricture length for balloon dilation — <= 5 cm (per Japanese guideline and other reviews)

Stricture length for balloon dilation<= 5 cm (per Japanese guideline and other reviews)

Provider actions, prior authorization, and documentation

Prior Authorization

Prior authorization — indicate covered indications

Prior authorization may be required for double balloon enteroscopy (DBE). When prior authorization is requested, clearly indicate that the procedure is being performed for one of the medically necessary indications listed in the policy (e.g., dilation of Crohn’s small-bowel strictures; suspected small-bowel malignancy; incomplete colonoscopy evaluation; suspected Meckel’s diverticulum with indeterminate imaging; investigation of obscure GI bleeding after negative EGD/colonoscopy; initial diagnosis of suspected Crohn’s when conventional tests are negative; removal of retained capsule/foreign body; polypectomy in Peutz‑Jeghers; or DBE to treat a documented small‑intestinal source of bleeding).

List the specific indication in the authorization request and attach relevant records (see documentation callouts).
If the indication is not one of the listed medically necessary uses, state that DBE is considered experimental/investigational and may be denied.

Prior Authorization

Prior testing and justification

Document prior diagnostic testing and rationale in the request. Capsule endoscopy (CE/VCE) is commonly the recommended initial diagnostic test for obscure GI bleeding and often guides the route and yield of subsequent DBE; when CE is positive, DBE diagnostic yield is substantially higher. If DBE is being requested without prior CE, provide justification (e.g., active/hemodynamically significant bleeding requiring immediate intervention, contraindication to CE, or clinical urgency).

Background and context

Double‑balloon enteroscopy is an endoscopic technique that uses an enteroscope and overtube with two balloons to pleat and advance the scope through the small intestine via oral (anterograde) or anal (retrograde) routes. It permits deep small‑bowel visualization and enables diagnostic sampling and therapeutic interventions (for example, polypectomy, argon plasma coagulation, dilation, stent placement, or foreign‑body removal) over longer lengths of small bowel than push enteroscopy, though it typically requires longer procedure time, additional sedation, and sometimes fluoroscopic assistance.

Definitions and key terms

Double balloon enteroscopy (DBE) — device and scope description

Device descriptionDBE employs a 200-cm enteroscope and a 140-cm overtube, each with balloons used to pleat and advance the scope through the small intestine via oral (anterograde) or anal (retrograde) approaches.

Balloon designTwo balloons: one at the tip of the enteroscope and one at the distal end of the overtube; overtube balloon grips intestinal wall to prevent loop formation.

Scope typesThin observation endoscope (for stepwise examination) and therapeutic double-balloon endoscope (larger accessory channel for interventions).

Obscure gastrointestinal bleeding (OGIB) — definition

OGIB definitionRecurrent small intestinal bleeding (e.g., iron-deficiency anemia, positive fecal occult blood, or visible bleeding) after negative upper and lower endoscopies.

Clinical context

Policy Summary

PayerAetna

PolicyDouble Balloon Enteroscopy

Policy CodePolicy 0737

Change TypeNo material change

Effective DateOct 5, 2007

Next Review DateAug 8, 2024

SourceLink

On This Page

Attach results/images from prior CE when available.
If CE was negative but clinical suspicion remains high, include explanation and supporting data (ongoing bleeding, transfusion requirement, or imaging suggesting a lesion).

Prior Authorization

Prior authorization for DBE in specialized indications

Prior authorization should be requested for specialized indications where DBE is used for definitive therapy or complex diagnostic situations (for example, surveillance and polypectomy of large small-bowel polyps in Peutz‑Jeghers syndrome, or pre-operative localization of suspected small‑bowel malignancy). Provide disease-specific documentation to support medical necessity.

For Peutz‑Jeghers syndrome, include prior imaging (MRE/CT) and polyp size/number and rationale for enteroscopic polypectomy.
For suspected malignancy, include imaging, tumor markers, or other findings suggesting neoplasm.

Prior Authorization

Prior authorization recommended for complex DBE interventions

Recommend prior authorization for DBE procedures that are complex or combined with other high‑risk interventions (for example, DBE‑ERCP or enteroscopy‑assisted ERCP in patients with surgically altered anatomy). These procedures have higher technical complexity and complication rates and may warrant review prior to scheduling.

When requesting DBE‑ERCP, include prior operative reports describing surgical anatomy (e.g., Roux‑en‑Y, hepaticojejunostomy), prior ERCP attempts, and rationale for enteroscopic approach.
State anticipated interventions (sphincterotomy, stone removal, stent placement) and provide relevant imaging/labs.

Billing Rule

Coding and indication mismatch

DBE coding does not have a single, unique CPT code; related CPT/HCPCS codes may be submitted depending on the route and any concurrent procedures (diagnostic enteroscopy, polypectomy, ERCP codes, dilation, foreign‑body removal). Ensure that selected codes match the documented indication and interventions to avoid coding/coverage mismatches.

Include narrative describing route (antegrade vs retrograde), procedures performed (biopsy, polypectomy, dilation, foreign‑body extraction), and corresponding CPT/HCPCS codes.
If using ERCP CPT/HCPCS codes with enteroscopy, document that papilla/anastomosis was reached and ERCP maneuvers performed.

Documentation Required

Technical failure leading to unsuccessful ERCP

If DBE‑assisted ERCP or enteroscopy fails to reach the papilla or anastomosis, document all attempted routes, technical obstacles (afferent limb entered but anastomosis not reached, angulation, jejunojejunostomy not identified), and reasons for procedural failure. This information is important for claims adjudication and to justify alternative or repeat procedures.

Include operative/procedure note detailing routes attempted (oral/anal), length advanced, and specific anatomic/technical barriers.
If cannulation failed after reaching the target, document cannulation attempts and methods used.

Denial Risk

Risks that may prompt payer review

DBE‑ERCP and other enteroscopy‑assisted complex interventions carry higher complication rates (including perforation, pancreatitis, cholangitis, bleeding). Requests for high‑risk procedures may be scrutinized; include risk–benefit discussion and prior less‑invasive options attempted.

List patient comorbidities that increase procedural risk.
Provide rationale why alternative modalities (percutaneous or surgical) are less desirable or not feasible.

Note

None specified in this section

This policy excerpt does not specify additional plan-level step‑therapy requirements or quantity limits for DBE. Providers should still follow standard prior authorization processes and supply complete documentation to support medical necessity.

If plan documents elsewhere impose step therapy, that requirement is separate and must be followed.

Documentation Required

Indication documentation

Indication documentation: when submitting a request, include the clinical indication and demonstrate it matches one of the policy's medically necessary indications. Provide presenting symptoms (e.g., overt/obscure GI bleeding, iron‑deficiency anemia, abdominal pain), prior endoscopic findings, and any supporting lab or imaging results.

Cite prior EGD/colonoscopy reports showing failure to identify bleeding source for OGIB indications.
For Crohn’s dilation, document stricture length, symptoms, and imaging/endoscopic correlation.

Documentation Required

Required procedural documentation

Required procedural documentation: include the indication, pre‑procedure diagnostic findings (e.g., positive CE), detailed procedure note describing route(s) attempted, depth/length advanced, interventions performed (biopsy, polypectomy, dilation, APC, tattooing, foreign‑body extraction), complications, and post‑procedure plan.

Attach CE images/reports if available and pathology results for biopsies.
If multiple procedures were performed in one session, itemize each and supply corresponding documentation to support coding.

Documentation Required