Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease

Policy ID: S-145-026

Section: Surgery

Effective Date: July 01, 2019

Revised Date: April 24, 2025

Revision Effective Date: July 07, 2025

Last Reviewed: May 13, 2025

Applies To: Commercial and Medicaid Expansion

Description

A variety of transesophageal endoscopic therapies have been developed for the treatment of gastroesophageal reflux disease (GERD). These include transesophageal (or transoral) incisionless fundoplication (TIF) suture plication of the proximal gastric folds, injection of bulking agents or implantation of a bioprosthesis into the lower esophageal sphincter.

The Stretta procedure uses radiofrequency energy to treat GERD and involves insertion of a flexible balloon-tipped catheter with needle electrodes for energy delivery via the esophagus. Precisely controlled radiofrequency energy is delivered to create lesions in the smooth muscle of the gastroesophageal junction.

Magnetic Esophageal Sphincter Augmentation involves a laparoscopically implanted ring composed of interlinked titanium beads with magnetic cores. The device (LINX® Reflux Management System) is placed around the esophagus at the level of the gastroesophageal junction in individuals who have GERD symptoms despite maximum medical therapy.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of processing, regardless of service date. and/or

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The following transendoscopic therapies for the treatment of GERD are considered not medically necessary.

Endoscopic/endoluminal gastroplasty, gastroplication with suturing of the esophagogastric junction (i.e., EndoCinch and Muse); and
Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (i.e., polymethylmethacrylate beads, zirconium oxide spheres, Enteryx, Durasphere, Gatekeeper Reflux Repair System).

Procedure Codes

43192

43201

43212

43236

43253

43266

43289

43499

43659

43999

Surgical Fundoplication

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of processing, regardless of service date.

Surgical fundoplication for the treatment of GERD may be considered medically necessary when ALL of the following criteria are met:

Daily heartburn or regurgitation for greater than six (6) months; and
Unsuccessful or partial response to anti-secretory pharmacologic therapy, have poor proton pump inhibitor (PPI) tolerance, or high concern for long term PPI use; and
No specific motility disorder; and
Evidence of reflux disease or the individual develops comorbidities (i.e., Barrett's).

Surgical fundoplication not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

43280

43325

43327

43328

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication (TIF) (i.e., StomaphyX, EsophyX, GERDX) may be considered medically necessary for a select population of individuals, who are greater than or equal to 18 years of age with refractory GERD, who meet ALL of the following criteria:

Daily heartburn or regurgitation for greater than six (6) months; and
Unsuccessful or partial response to anti-secretory pharmacologic therapy, have poor proton pump inhibitor (PPI) tolerance, or high concern for long term PPI use; and
No specific motility disorder; and
Evidence of reflux disease; and
- Either have a 24-hour pH study demonstrating pathologic acid reflux (total acid exposure time greater than four (4%) percent), or a DeMeester composite score greater than 14.7; or
- Have non-erosive reflux disease; or
- Have grade I and II esophagitis by Savary-Miller criteria or have grades of esophagitis healed by drug therapy.

Contraindications:

Greater than two (2) cm hiatal hernia (unless simultaneous or prior repair of hiatal hernia is performed; or
Significant dysphagia; or
Incomplete lower esophageal sphincter relaxation.

Transesophageal endoscopic radiofrequency therapy or transoral incisionless fundoplication not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

43210

43257

43659

A laparoscopically implantable magnetic esophageal ring (LINX® Reflux Management System) may be considered medically necessary when ALL of the following conditions are met:

When used as an alternative treatment to surgical fundoplication; and
When the individual presents with gastroesophageal reflux disease (GERD) and is symptomatic two (2) or more times per week; and
When the individual presents with GERD symptoms despite medical therapy or is intolerant to medical therapy.

A laparoscopically implantable magnetic esophageal ring (LINX® Reflux Management System) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

43284

43285

43289

The Los Angeles classification of esophagitis

Grade A: One (1) (or more) mucosal break no longer than 5 mm, that does not extend between the tops of two (2) mucosal folds

Grade B: One (1) (or more) mucosal break more than 5 mm long that does not extend between the tops of two (2) mucosal folds

Grade C: One (1) (or more) mucosal break that is continuous between the tops of two (2) or more mucosal folds but which involves less than 75% of the circumference

Grade D: One (1) (or more) mucosal break which involves at least 75% of the oesophageal circumference

Diagnosis Codes

Non-Covered Diagnosis Codes for Procedure Codes 43192; 43201; 43212; 43236; 43253; and 43266

K21.00

K21.01

K21.9

Covered Diagnosis Codes for Procedure Codes 43280; 43325; 43327; and 43328

K21.00

K21.01

K21.9

K22.70

K22.710

K22.711

K22.719

Covered Diagnosis Codes for Procedure Codes 43257; and 43210

K21.00

K21.01

K21.9

K22.89

Covered Diagnosis Codes for Procedure Code 43284

K21.00

K21.01

K21.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-15-2019

Updated to allow Transoral Incisionless Fundoplication (TIF) when criteria is met

Internal Medical Policy Committee 5-19-2020 Annual Review

Internal Medical Policy Committee 9-21-2020 Coding Update

Removed K21.0; and
Added K21.00 and K21.01.

Internal Medical Policy Committee 9-21-2021 Coding update - Effective October 01, 2021

Added procedure codes: 43192; 43201; 43212; 43236; 43253; 43266; 43499; 43999; 43659; and
Added diagnosis code: K22.89.

Internal Medical Policy Committee 9-28-2022 Annual Review-no changes in criteria.

Internal Medical Policy Committee 5-23-2023 Revision - Effective July 03, 2023

Added criteria for Surgical fundoplication for the treatment of GERD; and
Added procedure codes 43280, 43289, 43325, 43327 and 43328; and
Added diagnosis codes K22.70, K22.710, K22.711, and K22.719.

Internal Medical Policy Committee 5-14-2024 Annual Review-no changes in criteria.

Added Policy Application

Internal Medical Policy Committee 5-13-2025 Revision with coding - Effective July 07, 2025

Revised Description; and
Added GERDX; and
Added LINX section (from S-233 which was archived); and
Added procedure codes 43284; 43285; and 43289 (LINX) section as medically necessary; and
Added diagnosis codes for procedure code 43284: K21.00; K21.01; and K21.9.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-145-025

Section: Surgery

Effective Date: July 01, 2019

Revised Date: May 23, 2023

Revision Effective Date: July 01, 2024

Last Reviewed: May 14, 2024

Archived Date: July 06, 2025

Applies To: Commercial and Medicaid Expansion

Description

A variety of transesophageal endoscopic therapies have been developed for the treatment of gastroesophageal reflux disease (GERD). These include suture plication of the proximal gastric folds, injection of bulking agents or implantation of a bioprosthesis into the lower esophageal sphincter implantation of titanium beads with magnetic cores and radiofrequency energy.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

The following transendoscopic therapies for the treatment of GERD are considered not medically necessary.

Endoscopic/endoluminal gastroplasty, gastroplication with suturing of the esophagogastric junction (i.e., EndoCinch and Muse); and
Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent (i.e., polymethylmethacrylate beads, zirconium oxide spheres, Enteryx, Durasphere, Gatekeeper Reflux Repair System).

Procedure Codes

43192

43201

43212

43236

43253

43266

43289

43499

43659

43999

Surgical Fundoplication

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of processing, regardless of service date.

Surgical fundoplication for the treatment of GERD may be considered medically necessary when ALL of the following criteria are met:

Daily heartburn or regurgitation for greater than six (6) months; and
Unsuccessful or partial response to anti-secretory pharmacologic therapy, have poor proton pump inhibitor (PPI) tolerance, or high concern for long term PPI use; and
No specific motility disorder; and
Evidence of reflux disease or the individual develops comorbidities (i.e., Barrett's).

Surgical fundoplication not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

43280

43325

43327

43328

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication (TIF) (i.e., StomaphyX, EsophyX) may be considered medically necessary for a select population of individuals, who are greater than or equal to 18 years of age with refractory GERD, who meet ALL of the following criteria:

Daily heartburn or regurgitation for greater than six (6) months; and
Unsuccessful or partial response to anti-secretory pharmacologic therapy, have poor proton pump inhibitor (PPI) tolerance, or high concern for long term PPI use; and
No specific motility disorder; and
Evidence of reflux disease; and
- Either have a 24-hour pH study demonstrating pathologic acid reflux (total acid exposure time greater than four (4%) percent), or a DeMeester composite score greater than 14.7; or
- Have non-erosive reflux disease; or
- Have grade I and II esophagitis by Savary-Miller criteria or have grades of esophagitis healed by drug therapy.

Contraindications:

Greater than two (2) cm hiatal hernia (unless simultaneous or prior repair of hiatal hernia is performed; or
Significant dysphagia; or
Incomplete lower esophageal sphincter relaxation.

Transesophageal endoscopic radiofrequency therapy or transoral incisionless fundoplication not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

43210

43257

43659

Surgical fundoplication for the treatment of GERD may be considered medically necessary when ALL of the following criteria are met:

Daily heartburn or regurgitation for greater than six (6) months; and
Unsuccessful or partial response to anti-secretory pharmacologic therapy, have poor proton pump inhibitor (PPI) tolerance, or high concern for long term PPI use; and
No specific motility disorder; and
Evidence of reflux disease or the individual develops comorbidities (i.e., Barrett's).

Surgical fundoplication not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

43280

43325

43327

43328

The Los Angeles classification of esophagitis

Grade A: One (1) (or more) mucosal break no longer than 5 mm, that does not extend between the tops of two (2) mucosal folds

Grade B: One (1) (or more) mucosal break more than 5 mm long that does not extend between the tops of two (2) mucosal folds

Grade C: One (1) (or more) mucosal break that is continuous between the tops of two (2) or more mucosal folds but which involves less than 75% of the circumference

Grade D: One (1) (or more) mucosal break which involves at least 75% of the oesophageal circumference

Diagnosis Codes

Non-Covered Diagnosis Codes for Procedure Codes 43192, 43201, 43212, 43236, 43253 and 43266

K21.00

K21.01

K21.9

Covered Diagnosis Codes for Procedure Codes 43280, 43325, 43327, and 43328

K21.00

K21.01

K21.9

K22.70

K22.710

K22.711

K22.719

Covered Diagnosis Codes for Procedure Codes 43257 and 43210

K21.00

K21.01

K21.9

K22.89

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-15-2019

Updated to allow Transoral Incisionless Fundoplication (TIF) when criteria is met

Internal Medical Policy Committee 5-19-2020 Annual Review

Internal Medical Policy Committee 9-21-2020 Coding Update

RemovedK21.0;and
Added K21.00; and K21.01.

Internal Medical Policy Committee 9-21-2021 Coding update - Effective October 01, 2021

Added procedure codes: 43192; 43201; 43212; 43236; 43253; 43266; 43499; 43999; 43659; and
Added diagnosis code: K22.89.

Internal Medical Policy Committee 9-28-2022 Annual Review-no changes in criteria.

Internal Medical Policy Committee 5-23-2023 Revision - Effective July 03, 2023

Added criteria for Surgical fundoplication for the treatment of GERD; and
Added procedure codes 43280; 43289; 43325; 43327; and 43328; and
Added diagnosis codes K22.70; K22.710; K22.711; and K22.719.

Internal Medical Policy Committee 5-14-2024 Annual Review-no changes in criteria.

Added Policy Application

Medical Policies Quick Search

Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease

Description

Policy Application

Criteria

Procedure Codes

Surgical Fundoplication

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Procedure Codes

Surgical Fundoplication

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer