HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-145-021
Topic:
Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease (GERD)
Section:
Surgery
Effective Date:
February 18, 2019
Issued Date:
February 18, 2019
Last Revision Date:
January 2019
Annual Review:
January 2019
 
 

A variety of transesophageal endoscopic therapies have been developed for the treatment of 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.

Policy Position

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).

43210

 

 

 

 

 

 




Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication (TIF) (e.g., StomaphyX, EsophyX) may be considered medically necessary for a select population of patients, 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
  • 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; and
    • 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 2cm hiatal hernia; or
  • Significant dysphagia; or
  • Incomplete lower esophageal sphincter relaxation.

The use of transesophageal endoscopic radiofrequency is considered experimental/investigational, and therefore, non-covered for all other indications. Peer reviewed literature does not support the use of transesophageal endoscopic radiofrequency for any indications other than those listed in this medical policy.

43257

43210

 

 

 

 

 




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.


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).

Transesophageal endoscopic radiofrequency therapy (Stretta), or transoral incisionless fundoplication (TIF) (e.g., StomaphyX, EsophyX) may be considered medically necessary for a select population of patients, 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
  • 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; and
    • 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 2cm hiatal hernia; or
  • Significant dysphagia; or
  • Incomplete lower esophageal sphincter relaxation.

The use of transesophageal endoscopic radiofrequency is considered experimental/investigational, and therefore, non-covered for all other indications. Peer reviewed literature does not support the use of transesophageal endoscopic radiofrequency for any indications other than those listed in this medical policy.


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.


Related Policies

Refer to Table Attachment for Savary-Miller classification of reflux esophagitis.

Refer to medical policy G-24 bariatric surgery for morbid obesity for additional information.

Refer to medical policy HMK M-77 Upper Gastrointestinal Endoscopy/Esophagoscopy for additional information.

Refer to medical policy HMK S-4 Endoscopic Procedures and Related Services for additional information.

Refer to medical policy S-233 Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease for additional information.


Covered Diagnosis Codes for Procedure Code 43257, 43210

K21.0

K21.9

 

 

 

 

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Transesophageal endoscopic therapies for GERD is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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