Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease

Policy ID: S-145-025

Section: Surgery

Effective Date: July 01, 2019

Revised Date: May 23, 2023

Revision Effective Date: July 03, 2023

Last Reviewed: May 23, 2023

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.

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.

Criteria

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 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 (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

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 ICD-10 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.

Links

References

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-145-024

Section: Surgery

Effective Date: July 01, 2019

Revised Date: September 15, 2021

Revision Effective Date: October 01, 2021

Last Reviewed: September 28, 2022

Archived Date: July 02, 2023

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.

Criteria

The following transendoscopic therapies for the treatment of GERD are considered experimental/investigational and therefore non-covered. The long-term efficacy of these procedures has not yet been established.

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

Procedure Codes

43192

43201

43212

43236

43253

43266

43499

43659

43999

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication (TIF) (e.g., 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
Have adequate esophageal peristalsis; and
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 experimental/investigational because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

43210

43257

43659

Savary-Miller classification of reflux esophagitis:

Grade 1: Single erosion above gastro-esophageal mucosal junction

Grade 2: Multiple, non-circumferential erosions above gastro-esophageal mucosal junction

Grade 3: Circumferential erosion above mucosal junction

Grade 4: Chronic change with esophageal ulceration and associated stricture

Grade 5: Barrett’s esophagus with histologically confirmed intestinal differentiation within columnar epithelium.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes 43210 and 43257

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 ICD-10 Update; removed K21.0 and added K21.00 and K21.01.

Internal Medical Policy Committee 9-21-2021 Coding update; adding procedure codes: 43192; 43201; 43212; 43236; 43253; 43266; 43499; 43999; 43659 and diagnosis code: K22.8.

Internal Medical Policy Committee 9-21-2021 Coding update; Added procedure codes: 43192; 43201; 43212; 43236; 43253; 43266; 43499; 43999; 43659 and Added diagnosis code: K22.89 effective October 01, 2021.

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

Links

References (PDF)

Disclaimer

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