ModifiedUnitedHealthcarePolicy 2026T0322LL

Minimally Invasive Procedures for the Treatment of Upper Gastrointestinal Diseases

Defines UnitedHealthcare Commercial and Individual Exchange coverage stance for minimally invasive procedures used to treat upper gastrointestinal conditions (GERD, Achalasia, Diffuse Esophageal Spasm, Gastroparesis) and specifies which procedures are considered medically necessary or not.

Policy Summary

PayerUnitedHealthcare

PolicyMinimally Invasive Procedures for the Treatment of Upper Gastrointestinal Diseases

Policy CodePolicy 2026T0322LL

Change TypeMaterial coverage updates (GES and pyloroplasty addedcodes addedremoval of prior exclusion language)

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of medically refractory status and prior failed standard therapies when requesting GES, pyloroplasty, or POEM.

SourceLink

POLICY UPDATE CHANGES

Gastric electrical stimulation (GES) therapy is proven and medically necessary for treating refractory gastroparesis or chronic intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Surgical pyloroplasty (open or laparoscopic) is proven and medically necessary for treating refractory gastroparesis or chronic intractable nausea and vomiting secondary to diabetic or idiopathic gastroparesis.

Language indicating functional lumen imaging probe technology is unproven and not medically necessary for diagnosing achalasia was removed.

CPT codes 43647, 43648, 43659, 43881, 43882, 64590, and 64595 were added to the applicable codes list.

Medical records documentation section was updated to state that benefit coverage is determined by member-specific benefit plan documents and applicable laws and that documentation may be required to assess clinical criteria but does not guarantee coverage.

GESTherapy designated proven

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Evidence Summaries

inv-01: GES — Medically Necessary

Covered when ALL of the following are met:

GES for Gastroparesis: Gastric electrical stimulation (GES) therapy is proven and medically necessary for treating refractory Gastroparesis that has failed other therapies, or chronic intractable (drug-refractory) nausea and vomiting secondary to Gastroparesis of diabetic or idiopathic etiology.

Refer to the U.S. Food and Drug Administration (FDA) section for information regarding FDA labeling and Humanitarian Device Exemption (HDE) for GES.

inv-02: Pyloroplasty — Medically Necessary

Covered when ALL of the following are met:

Surgical pyloroplasty for refractory gastroparesis: Surgical pyloroplasty (open or laparoscopic) is proven and medically necessary for treating refractory Gastroparesis that has failed other therapies, or chronic intractable (drug-refractory) nausea and vomiting secondary to Gastroparesis of diabetic or idiopathic etiology.

Pyloroplasty has been reported to normalize gastric emptying and improve symptoms in many patients; consider evidence favoring pyloric interventions as a first-line surgical option in selected patients.

inv-03: POEM — Medically Necessary (Achalasia, Diffuse Esophageal Spasm)

POEM for Esophageal Motility Disorders: Per oral endoscopic myotomy (POEM) is proven and medically necessary for treating individuals with Achalasia or Diffuse Esophageal Spasm.

POEM requires advanced endoscopic skill and is indicated for achalasia and diffuse esophageal spasm; randomized trials and systematic reviews support effectiveness, including noninferiority to laparoscopic Heller myotomy.

inv-04: POEM — Not Medically Necessary for other indications

POEM other indications: Per oral endoscopic myotomy (POEM) is unproven and not medically necessary for all other indications (for example, Zenker's diverticula) due to insufficient evidence of efficacy and limited long-term comparative data.

Z-POEM and other non-standard POEM indications lack high-quality prospective comparative evidence and long-term outcomes.

inv-05: G-POEM — Not Medically Necessary

G-POEM: Gastric per oral endoscopic myotomy (G-POEM) is unproven and not medically necessary for the treatment of Gastroparesis due to limited and very low-quality evidence, heterogeneous patient populations, and inadequate long-term safety and durability data.

Available systematic reviews and assessments (including ECRI) conclude evidence is insufficient; RCTs and larger multicenter studies are needed.

inv-06: Endoscopic and implant therapies for GERD — Not Medically Necessary/Investigational

Endoscopic therapies for GERD: Endoscopic therapies, injection or implantation techniques, and the LINX Reflux Management System are unproven and not medically necessary for treating GERD when evidence of efficacy and durability is insufficient; specific devices without FDA approval (e.g., GERDx™) are investigational and not medically necessary.

Stretta randomized sham-controlled trial showed no significant benefit versus sham in a 2020 RCT; overall evidence for many endoscopic approaches is limited by small, nonrandomized studies and short follow-up.

inv-07: GES — Covered with criteria (conditional)

Coverage considerations for GES (evidence summary)

GES evidence and recommendation logic: Consider GES only for medically refractory gastroparesis after failure of standard therapy; evidence is low quality and randomized trials show inconsistent benefit compared with unblinded studies, and the device is associated with complications and device/lead movement with device removal rates reported between 7% and 12%.

Professional guidance provides conditional recommendations; additional randomized placebo-controlled data are needed.

inv-08: Pyloroplasty / Pyloric interventions — Covered with criteria

Coverage considerations for pyloric surgical interventions

Pyloric interventions evidence: Surgical pyloroplasty and other pyloric interventions have been reported to normalize gastric emptying and improve symptoms in many patients with refractory gastroparesis; some systematic reviews suggest pyloric interventions may provide superior symptom relief compared to GES and can be considered as a first-line surgical therapy in selected patients.

Success rates and combinations with fundoplication or GES vary across studies; consider pyloric interventions as part of stepwise management.

inv-09: POEM — Covered with criteria

Coverage considerations for POEM (evidence summary)

POEM indication and evidence: POEM is effective for achalasia (types I–III) with high clinical success rates and has demonstrated noninferiority to laparoscopic Heller myotomy (LHM) with similar or fewer adverse events in randomized trials; consider POEM for appropriate achalasia patients but note increased risk of post-procedure reflux.

Guideline bodies (AGA, SAGES) support POEM, particularly for type III achalasia; operator experience and center volume are important considerations.

inv-10: POEM for achalasia and spastic esophageal disorders

Evidence summary and guideline position

Evidence and guideline summary: Systematic reviews and meta-analyses report high pooled clinical success for POEM in type III achalasia and other spastic esophageal disorders (weighted pooled rate ~87%) with adverse event rates reported around 11-16%; AGA and SAGES guidance recognize POEM as effective and recommend it be performed by experienced operators, with preference for POEM in type III achalasia.

Randomized trials (eg, Werner et al.) demonstrated noninferiority to LHM but noted higher post-procedure reflux.

inv-11: Z-POEM for Zenker's diverticulum

Comparative observational evidence and uncertainty

Evidence summary: Existing comparative observational studies and meta-analyses suggest Z-POEM may have comparable or higher clinical success versus flexible endoscopic septotomy with similar adverse event and recurrence rates, but data are retrospective, limited beyond one year, and at risk of bias.

High-quality prospective comparative data with long-term follow-up are lacking.

inv-12: G-POEM for refractory gastroparesis

Evidence mixed; limited quality and generalizability

Effectiveness evidence: Systematic reviews and meta-analyses report variable clinical success for G-POEM (approximately 70% at 1 year in some analyses; other reviews report higher rates using uniform criteria), and a small RCT showed benefit over sham at 6 months (Martinek 2022).

Heterogeneous definitions of success, patient etiologies, and tertiary center bias limit generalizability.

Safety and durability concerns: Adverse events reported include bleeding, mucosal tears, peripyloric abscess, and dumping syndrome; long-term safety and durability remain inadequately characterized and evidence quality is very low per ECRI.

Large multicenter RCTs and longer follow-up are needed.

inv-13: Endoscopic radiofrequency (Stretta) for GERD

Evidence assessed as insufficient or low-quality

Trial evidence: Randomized sham-controlled data (Zerbib 2020) showed no significant benefit of Stretta versus sham for GERD outcomes at 24 and 48 weeks; other observational series report symptomatic improvement but are limited by lack of controls and potential biases.

Overall evidence for Stretta is low quality with uncertainty compared to laparoscopic fundoplication.

inv-14: Selected coverage criteria for endoscopic GERD procedures

Coverage depends on procedure and evidence; where evidence demonstrates benefit in selected patients, coverage may be considered when ALL of the following are met:

Baseline requirement: Documented chronic GERD symptoms with prior medical management (including PPI use) and objective evidence of pathologic reflux where reported in device studies (for example, pH monitoring or abnormal DeMeester score).

Most device trials enrolled PPI-dependent or refractory patients.

Appropriate candidacy: Patient selection matches device-specific study criteria (for example, hiatal hernia size limits reported in trials, typically ≤ 2–3 cm for many endoscopic fundoplication/MUSE/TIF studies).hiatal hernia ≤ 2–3 cm

Several device studies excluded large hernias and severe esophagitis.

Documentation and follow-up: Pre-procedure objective testing and a plan for post-procedure follow-up and outcome measurement (symptom scores, PPI use) are documented in the medical record.

inv-15: Device-specific typical inclusion criteria reported in trials

Evidence-based indications and typical trial inclusion features for device-based GERD interventions (as reported in cited studies):

TIF typical patient criteria: Adult with chronic GERD refractory to PPI therapy; absent or hiatal hernia ≤ 2–3 cm in many trials; abnormal esophageal acid exposure on pH testing; symptom assessment via GERD-HRQL/RSI; documented failure or incomplete response to medical therapy.hiatal hernia ≤ 2–3 cm; abnormal pH

Most TIF trials excluded large hernias and severe esophagitis.

LINX (MSA) typical patient criteria: Adults with medically refractory regurgitative GERD, objective abnormal pH/DeMeester score, hiatal hernia < 3 cm, BMI < 35 kg/m2, absence of advanced esophagitis or Barrett's esophagus in many trials; diagnostic testing including endoscopy and pH monitoring documented.hiatal hernia < 3 cm; BMI < 35 kg/m2; abnormal DeMeester

RCT inclusion criteria and guideline statements describe these candidate features.

inv-16: Evidence limitations

Evidence limitations and follow-up considerations:

Evidence limitations: Many studies are small, single-arm, or nonrandomized; long-term comparative data versus laparoscopic Nissen fundoplication are limited; heterogeneity across studies and variable objective outcome reporting limit generalizability.

Payors may consider these limitations when assessing medical necessity.

inv-17: Magnetic Sphincter Augmentation (LINX) — candidate selection

Evidence-based summaries supporting consideration of MSA for GERD when criteria are met:

MSA candidate criteria (as supported by RCT inclusion and guideline statements): Patient has medically refractory regurgitation or objective evidence of GERD despite optimized PPI therapy; selected patients have BMI < 35 kg/m2, hiatal hernia < 3 cm, absence of advanced esophagitis or Barrett's esophagus; diagnostic testing includes pH monitoring and endoscopy.BMI < 35 kg/m2; hiatal hernia < 3 cm

Based on RCT inclusion criteria and ACG guideline recommendations; MSA has RCT evidence demonstrating superior regurgitation control versus PPI.

inv-18: Guideline recommendations (ACG)

Guideline-based coverage considerations for antireflux procedures:

Guideline-supported options for patients with persistent GERD: Antireflux surgery is a recommended option for long-term treatment for patients with objective GERD; MSA may be considered as an alternative to laparoscopic fundoplication for patients with regurgitation failing medical management; TIF may be considered for selected patients who decline surgery and lack severe esophagitis or large hiatal hernia; radiofrequency (Stretta) is not recommended by ACG due to inconsistent efficacy data.

ACG and AGA guideline statements summarized; procedures should be individualized and performed in appropriate candidates.

inv-19: G-POEM / POEM guidance

Recommendations related to G-POEM and POEM

Gastroparesis and Achalasia procedural guidance: ACG suggests pyloromyotomy over no treatment for refractory gastroparesis (conditional recommendation, low-quality evidence). AGA and SAGES advise G-POEM and POEM be performed by experienced operators at high-volume centers; POEM is appropriate as primary therapy for type III achalasia.

Guidance emphasizes operator experience and center volume for complex endoscopic myotomy procedures.

inv-20: Gastric electrical stimulation — Medical necessity

Covered when ALL of the following are met (policy-level statements):

GES for refractory gastroparesis: Gastric electrical stimulation (GES) therapy is proven and medically necessary for treating refractory gastroparesis that has failed other therapies, or chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Refer to the U.S. Food and Drug Administration (FDA) section for labeling and Humanitarian Device Exemption (HDE) information; evidence is limited and randomized trials show inconsistent benefit.

inv-21: Surgical pyloroplasty — Medical necessity

Covered when ALL of the following are met (policy-level statements):

Surgical pyloroplasty for refractory gastroparesis: Surgical pyloroplasty (open or laparoscopic) is proven and medically necessary for treating refractory gastroparesis that has failed other therapies, or chronic intractable (drug-refractory) nausea and vomiting secondary to diabetic or idiopathic gastroparesis.

Pyloroplasty has evidence showing improvement in symptoms and gastric emptying; consider as a surgical option in patients who have failed medical therapy.

Endoluminal therapy using the GERDx™ system is considered investigational and not medically necessary for treatment of gastroesophageal reflux disease (GERD). The policy states GERDx™ has not received U.S. Food and Drug Administration (FDA) approval and, therefore, lacks sufficient evidence to support routine coverage.

Procedures performed in patients who do not have documented, medically refractory symptoms or who lack documentation of failure of standard therapy (for example, an adequate trial of proton pump inhibitor therapy and appropriate objective testing where indicated) are not supported by the evidence and guidance summarized in this policy. Prior treatment failure and objective candidacy criteria should be documented when seeking coverage.

Endoscopic therapies for GERD, including radiofrequency energy treatment (Stretta), are considered unproven for routine treatment of GERD because available studies are limited by small sample sizes, heterogeneous populations, short follow-up, and methodological weaknesses. A randomized, double‑blind, sham‑controlled trial (Zerbib et al. 2020) found no significant benefit of Stretta versus sham, and ACG guidance does not recommend radiofrequency energy (Stretta) as an antireflux procedure due to inconsistent efficacy data.

Procedures for which there is insufficient evidence of long‑term durability or for which objective improvement in acid exposure or other physiologic measures has not been demonstrated should be considered unproven. The literature contains multiple small, single‑arm or short‑term studies and systematic reviews that note progressive loss of symptomatic benefit over longer follow‑up, limiting conclusions about durability and routine coverage.

Several older or alternative endoscopic procedures and injectable/implantable techniques (for example, Plexiglas, Durasphere injectable bulking agents, EndoCinch and other early suturing/plication systems) are considered investigational or not medically necessary because available evidence is sparse, inconsistent, or lacks adequate long‑term follow‑up to establish safety and effectiveness.

The Enterra™ gastric electrical stimulation (GES) system has specific contraindications and patient selection considerations per FDA labeling. The device should not be used in patients with gastric obstruction or pseudo‑obstruction, prior gastric resection, prior fundoplication, eating disorders, history of seizures, primary swallowing disorders, chemical dependency, or psychogenic vomiting. Clinicians should confirm patient eligibility and document rationale and prior conservative therapy when considering Enterra implantation.

Language that previously listed functional lumen imaging probe technology as explicitly unproven and not medically necessary for diagnosing achalasia has been removed from this policy. The policy history documents this change to prior exclusion language.

Per‑oral endoscopic myotomy (POEM) is not medically necessary for indications other than achalasia and diffuse esophageal spasm. The policy supports POEM for achalasia and spastic esophageal disorders based on available evidence, but indicates POEM is unproven for other uses (for example, Zenker's diverticulum and other non‑achalasia indications) where evidence of efficacy is insufficient.

Evidence for gastric electrical stimulation (GES) is inconsistent across randomized and uncontrolled studies. Systematic reviews and HTAs note low overall quality of evidence and variable randomized trial results; therefore, benefit documentation is necessary and the policy emphasizes selective use for medically refractory gastroparesis with appropriate prior therapy documented.

The Stretta radiofrequency system lacks convincing randomized, sham‑controlled evidence of clinically meaningful benefit. A 2020 randomized, double‑blind, sham‑controlled trial showed no significant difference between Stretta and sham at 24 and 48 weeks, and systematic assessments conclude that uncertainty remains regarding comparative effectiveness and long‑term benefit.

When randomized sham‑controlled trials fail to demonstrate benefit or when long‑term improvements are not sustained, the policy reflects a stance that such procedures are considered not proven and thus not medically necessary for routine coverage. The Zerbib 2020 Stretta RCT and long‑term follow‑up data for several endoscopic techniques inform this position.

Endoscopic bulking agents and several older endoscopic procedures (for example, injectable bulking agents, early suturing/plication devices) have insufficient evidence regarding durable efficacy and safety. Systematic reviews and randomized trials with long‑term follow‑up frequently demonstrate loss of benefit over time or conflicting results versus surgical approaches, supporting their classification as unproven.

The American College of Gastroenterology (ACG) guideline notes inconsistent efficacy data for radiofrequency energy (Stretta) and does not recommend Stretta as an antireflux procedure. This guideline position supports the policy's stance that Stretta and similar endoscopic antireflux procedures are not supported for routine coverage.

Archival policy language previously listed functional lumen imaging probe technology as unproven and not medically necessary for diagnosing achalasia; that explicit exclusion has been removed in the current policy version as noted in the policy revision history.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding

Prior authorization may be required for listed procedures, device implantations, and newly added CPT codes. Benefit coverage is determined by the member-specific benefit plan document and applicable laws; inclusion of a code in this policy does not guarantee coverage or reimbursement.

Applicable CPT/HCPCS codes in this policy may be subject to prior authorization per the member's plan.
Newly added CPT codes (see Applicable Codes) may require prior authorization per member benefit documents.

Denial Risk

Documentation Requirement and Denial Risk

Lack of required clinical documentation demonstrating that the member meets policy criteria may result in denial of the request. Medical records used for reviews must support the indication and prior therapies; documentation alone does not guarantee coverage.

Applicable Procedure Codes, Devices, and Coding Notes

Applicable CPT Codes (part 1)CPT

43210	Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed.
43257	Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease.
43284	Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (i.e., magnetic band), including cruroplasty when performed.
43289	Unlisted laparoscopy procedure, esophagus.
43497	Lower esophageal myotomy, transoral (i.e., peroral endoscopic myotomy [POEM]).
43499	Unlisted procedure, esophagus.
43647	Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum.
43648	Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum.
43659	Unlisted laparoscopy procedure, stomach.
43881	Implantation or replacement of gastric neurostimulator electrodes, antrum, open

Applicable CPT Codes (part 2)CPT

43882	Revision or removal of gastric neurostimulator electrodes, antrum, open.
43999	Unlisted procedure, stomach.
64590	Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver.
64595	Revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array.

Devices discussedmixed

Enterra (device)

Gastric electrical stimulator (implantable) — referenced device

Esophageal myotomy proceduresmixed

POEM	Per-oral endoscopic myotomy (procedure)
LHM	Laparoscopic Heller myotomy ± fundoplication (procedure)

Pyloric proceduresmixed

Pyloroplasty / Pyloric interventions

Surgical pyloroplasty, pyloric interventions (procedures)

Coding notes from evidence sectionmixed

not listed

Document does not list exact CPT/HCPCS/ICD codes for TIF, EsophyX, or LINX procedures in this section

FDA device clearances / PMA numbers mentionedmixed

P100049	FDA PMA number for LINX Reflux Management System
K071651	FDA 510(k) for Bard EndoCinch Endoscopic Suturing System
K071553	FDA 510(k) for NDO Surgical Endoscopic Plication System
K143634	FDA 510(k) for MUSE System
K233240	FDA 510(k) for GERDx-System (Product Code ODE)

Applicable CPT Codes (added)CPT

43647	CPT code added (document lists as applicable)
43648	CPT code added (document lists as applicable)
43659	CPT code added (document lists as applicable)
43881	CPT code added (document lists as applicable)
43882	CPT code added (document lists as applicable)
64590	CPT code added (document lists as applicable)
64595	CPT code added (document lists as applicable)

Gastric emptying scintigraphy (reference standard)

Reference standardGastric emptying scintigraphy is the reference standard for measurement of gastric emptying and is required to demonstrate objective evidence of clearly delayed gastric emptying in symptomatic patients.

Indication contextUsed to confirm delayed gastric emptying when evaluating candidates for therapies for gastroparesis (e.g., GES, pyloroplasty).

Diagnostic requirementDiagnosis of gastroparesis requires objective evidence of clearly delayed gastric emptying on scintigraphy in symptomatic patients.

Hiatal hernia size

Clinical Background and Definitions

Gastroesophageal reflux disease (GERD) results from a weak or dysfunctional lower esophageal sphincter allowing gastric contents to reflux into the esophagus. Untreated or poorly controlled GERD can lead to esophagitis, strictures, Barrett's esophagus, and, rarely, adenocarcinoma. Understanding the potential complications underscores the importance of confirming objective evidence of pathologic reflux and documenting failure of optimized medical therapy when considering procedural interventions.

Achalasia — definition

DefinitionAchalasia: A primary esophageal motor disorder characterized by degeneration of the myenteric plexus, impaired relaxation of the esophagogastric junction, and loss of organized peristalsis in the esophageal body.

Diffuse Esophageal Spasm — definition

DefinitionDiffuse esophageal spasm: A rare esophageal motility disorder characterized by simultaneous, uncoordinated, or rapidly propagated contractions of normal amplitude accompanied by dysphagia.

Gastroesophageal Reflux Disease — definition

Policy Changes and Version History

2026-02-01material_additionLatest

Added language relocating GES (gastric electrical stimulation) coverage statements into this policy and designated GES as proven and medically necessary for refractory gastroparesis and chronic intractable nausea/vomiting of diabetic or idiopathic etiology.

2026-02-01material_addition

Added language designating surgical pyloroplasty (open or laparoscopic) as proven and medically necessary for refractory gastroparesis and chronic intractable nausea/vomiting of diabetic or idiopathic etiology.

Policy Summary

PayerUnitedHealthcare

PolicyMinimally Invasive Procedures for the Treatment of Upper Gastrointestinal Diseases

Policy CodePolicy 2026T0322LL

Change TypeMaterial coverage updates (GES and pyloroplasty addedcodes addedremoval of prior exclusion language)

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of medically refractory status and prior failed standard therapies when requesting GES, pyloroplasty, or POEM.

SourceLink

On This Page

Documentation Required

Required Clinical Documentation for G-POEM Consideration

For consideration of G-POEM, provide documentation of severity, refractory status, and prior therapies. Required records should demonstrate medically refractory gastroparesis and objective testing results.

Validated symptom score (e.g., GCSI) showing severe gastroparesis (study definitions often used GCSI > 2.3).
Documentation of symptoms persisting > 6 months despite optimized medical therapy and less invasive interventions.
Results of gastric emptying testing (4‑hour gastric emptying scintigraphy) and any correlation with symptom change.

Documentation Required

Required Documentation for Candidacy and Follow-up

Documentation should include pre-procedure candidacy data and planned post-procedure follow-up. Objective testing and device-specific follow-up are expected when applicable.

Pre-procedure: validated symptom questionnaires (GCSI), prior therapy details, gastric emptying study results, and prior pyloric intervention attempts if applicable.
Post-procedure: follow-up symptom scores, objective testing (repeat gastric emptying studies when indicated), and reporting of adverse events or device complications.
Device-specific follow-up protocols per manufacturer/FDA guidelines when an implantable device is used (e.g., Enterra).

Documentation Required

Required Clinical Documentation for GERD/Antireflux Procedures

Before considering device-based or procedural GERD interventions, document a trial of conservative therapy and objective evidence of reflux. A documented trial of PPI therapy and abnormal objective testing are expected.

Trial of optimized PPI therapy with documentation of symptom persistence or PPI dependence.
Objective testing: ambulatory pH monitoring/DeMeester score, endoscopy findings, hiatal hernia size, and GERD‑HRQL or RDQ scores as appropriate.
For MSA or antireflux procedures, include preoperative assessments (endoscopy, barium swallow, manometry, pH testing).

Step Therapy

Consideration of Pyloric Interventions First

Consider less invasive pyloric-directed interventions (e.g., pyloric dilatation, botulinum toxin, endoscopic or surgical pyloroplasty) prior to more invasive or novel procedures when clinically appropriate. Document attempts and responses to these interventions.

Evidence of trial and failure or contraindication to less invasive pyloric interventions prior to G-POEM or surgical gastrectomy.
When pyloric interventions were performed, provide procedural notes and outcome assessments.

Step Therapy

Conservative Therapy Expected Prior to Procedure

Conservative and/or optimized medical therapy is expected before endoscopic or surgical procedures for gastroparesis or GERD. Ensure records show trials of dietary modification, prokinetics, antiemetics, and PPI therapy where indicated.

Document duration, dosing, and response (or intolerance) to medical therapy, including prokinetics and antiemetics for gastroparesis.
For GERD, document optimized PPI therapy (dose, duration, and persistence of symptoms) prior to procedural consideration.

Step Therapy

Step Therapy: Trial of PPI Prior to Device-Based Interventions

Step therapy requires a documented trial of PPI therapy prior to device-based antireflux interventions. Records should show PPI dependence, inadequate symptom control on PPIs, or intolerance to medical therapy.

Documented trial of appropriate PPI therapy (dose and duration) with continued symptom burden or PPI dependence.
Objective evidence of reflux (abnormal pH/DeMeester, endoscopic findings) supporting procedural candidacy.

GES — definition and HDE context

DefinitionGastric electrical stimulation (GES): Implantable gastric pacemaker therapy (e.g., Enterra Therapy System) that delivers electrical pulses to the stomach to enhance gastric motility and reduce refractory gastroparesis symptoms; the Enterra system has an FDA Humanitarian Device Exemption (HDE) for chronic, drug-refractory nausea and vomiting secondary to diabetic or idiopathic gastroparesis.

ClassificationGES is described in guidance as a humanitarian use device (HUD/HDE) and may be considered for medically refractory diabetic or idiopathic gastroparesis per professional society documents.