CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Transesophageal Endoscopic Treatments for Gastroesophageal Reflux Disease

Defines BCBSRI coverage stance for transesophageal/transoral endoscopic therapies for GERD for Commercial products, including TIF, radiofrequency (Stretta), and endoscopic implantation/injection procedures. Applies to providers submitting claims to Blue Cross Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyTransesophageal Endoscopic Treatments for Gastroesophageal Reflux Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 10, 2015

Next Review DateN/A

Key ActionDo not submit claims for TIF, Stretta, or endoscopic implantation/injection procedures for GERD as these are considered not medically necessary for Commercial products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3procedure types discussed

MultipleCPT codes not medically necessary

Commercialpolicy applicability

Enteryxdevice withdrawal noted

Coverage Criteria for Transesophageal Endoscopic GERD Procedures

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Procedures considered not medically necessary

Not medically necessary statements

Not medically necessary procedures: Transoral incisionless fundoplication (TIF) (e.g., Esophyx), transesophageal radiofrequency procedures to create submucosal thermal lesions of the gastroesophageal junction (e.g., Stretta), and endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (e.g., polymethylmethacrylate beads, zirconium oxide spheres) are considered not medically necessary for treatment of gastroesophageal reflux disease (GERD) due to insufficient peer‑reviewed evidence of effectiveness and unresolved safety and durability concerns.

Applies to Commercial Products. Implantation of inert polymers (Enteryx) is a contract exclusion as it was withdrawn from the market following serious complications.

Implantation of inert polymers (Enteryx™) is a contract exclusion. Enteryx was voluntarily removed from the market after reports of serious adverse events related to polymerization and unrecognized transmural injections causing injury; therefore coverage for Enteryx is excluded under applicable contracts.

For Commercial Products, the following are considered not medically necessary for treatment of gastroesophageal reflux disease (GERD): transoral incisionless fundoplication (TIF, e.g., Esophyx®), transesophageal radiofrequency procedures (Stretta®), and endoscopic submucosal implantation or injection of prostheses/bulking agents. Additionally, CPT code 43257 and CPT codes 43201, 43210, 43212, 43236, and 43266 when filed with ICD-10 diagnosis K21.0 or K21.9 are considered not medically necessary and may be denied.

Coding — CPT and Diagnosis Codes

Not medically necessary CPT codeCPTNot Covered

43257

Upper gastrointestinal endoscopy, with delivery of thermal energy to the muscle of the lower esophageal sphincter and/or gastric cardia

Not medically necessary CPT codes when filed with GERD diagnosesCPTNot Covered

43201	Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance
43210	Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed
43212	Esophagoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and postdilation and guide wire passage, when performed)
43236	Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance
43266	Esophagogastroduodenoscopy, flexible, transoral; with placement of endoscopic stent (includes preand dilation and guide wire passage, when performed)

ICD-10 diagnoses referencedICD-10

K21.0	Gastro-esophageal reflux disease with esophagitis
K21.9	Gastro-esophageal reflux disease without esophagitis

Provider Actions and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is not required for these services.

Note

Contract-level Requirements

Benefits and coverage vary by contract. Providers must follow the member's Subscriber Agreement or member certificate for benefit-specific requirements and contract exclusions; those documents supersede this medical policy.

Documentation Required

Benefit Verification and Documentation

Providers should verify member benefits and eligibility prior to providing services and retain documentation of benefit verification and any pre-service communications. For member-specific benefit questions, contact the provider call center.

Denial Risk

Denial Triggers — Non‑covered Transesophageal/Endoscopic GERD Procedures

The following procedures and CPT codes are considered not medically necessary or are contract exclusions for commercial products and may be denied: Transoral incisionless fundoplication (TIF, e.g., Esophyx); transesophageal radiofrequency procedures to create submucosal thermal lesions of the gastroesophageal junction (Stretta); endoscopic submucosal implantation of a prosthesis or injection of bulking agents; implantation of inert polymers (Enteryx) is a contract exclusion. Not medically necessary CPT: 43257. Not medically necessary when billed with ICD-10 K21.0 or K21.9: 43201, 43210, 43212, 43236, 43266. Claims for these services may be denied as not medically necessary or non-covered per the subscriber agreement.

Affected CPT codes: 43257, 43201, 43210, 43212, 43236, 43266
Affected ICD-10 diagnoses triggering noncoverage: K21.0, K21.9
Contract exclusion: Enteryx (implantation of inert polymers)

Background

Minimally invasive transesophageal endoscopic procedures—such as transoral incisionless fundoplication (TIF/gastroplication), transesophageal radiofrequency (Stretta) to create submucosal thermal lesions, and endoscopic submucosal implantation or injection of bulking agents—have been developed as alternatives to medical therapy and surgical fundoplication. Several devices and techniques have been studied, but the policy concludes there is insufficient peer‑reviewed evidence demonstrating consistent long‑term safety and objective efficacy (for example, reduced esophageal acid exposure), and some devices have been withdrawn or are no longer marketed due to safety concerns.

Definitions of Procedures

Transoral incisionless fundoplication (TIF) — definition and mechanism

TermTransoral incisionless fundoplication (TIF)

DefinitionEndoscopic fundoplication in which sutures or fasteners are placed at the lower esophageal sphincter to strengthen and lengthen the sphincter and decrease reflux.

MechanismSutures/fasteners create a partial or full-thickness plication of the gastroesophageal junction to reinforce the lower esophageal sphincter and reduce reflux.

Examples / DevicesEndoCinch, NDO Plicator, Esophyx (Esophyx received 510(k) clearance for full-thickness plication).

Radiofrequency (Stretta) procedure — definition and mechanism

TermRadiofrequency (Stretta) procedure

DefinitionApplication of radiofrequency (RF) energy through electrodes inserted into the esophageal wall at multiple sites near the gastroesophageal junction to produce submucosal thermal lesions.

MechanismThermal lesions may ablate nerve pathways responsible for sphincter relaxation or induce tissue tightening via heat-induced collagen contraction, leading to reduced reflux symptoms.

Example / DeviceCSM Stretta System (510[k] clearance); currently manufactured by Mederi Therapeutics (Stretta).

Endoscopic submucosal implantation/injection — definition and examples

TermEndoscopic submucosal implantation/injection

DefinitionInjection or implantation of prosthetic devices or bulking agents into the lower esophageal sphincter or submucosa to increase bulk and reduce reflux.

ExamplesEnteryx (biocompatible liquid polymer that polymerized into a spongy mass), Durasphere (pyrolytic carbon-coated zirconium oxide spheres), Gatekeeper Reflux Repair System (polyacrylonitrile-based hydrogel prosthesis), polymethylmethacrylate beads.

Safety noteEnteryx was voluntarily removed from the market after reports of serious adverse events from transmural injections; use of some bulking agents for GERD would be off-label.

Revision History

2019-11-05policy_review/updateLatest

Policy last updated — review confirmed; coverage position maintained that TIF, Stretta, and endoscopic submucosal implantation/injection procedures are not medically necessary for Commercial products due to insufficient evidence.

2015-10-01effective_date

Policy effective date established for Transesophageal Endoscopic Treatments for Gastroesophageal Reflux Disease; procedures including TIF, Stretta, and submucosal implantation/injection were identified as not medically necessary for Commercial products.

2005-09-23device_withdrawal

Enteryx (polymer implant) voluntarily removed from the market following reports of serious adverse events and device recall, noted as a contract exclusion in the policy.