DraftUnitedHealthcarePolicy CSO79OH.C

Minimally Invasive Procedures for Gastric and Esophageal Diseases (for Ohio Only)

Defines medical necessity and coverage stance for minimally invasive procedures to treat GERD, achalasia, diffuse esophageal spasm, gastroparesis, and Zenker's diverticulum for adults in Ohio; applies to UnitedHealthcare Ohio members and providers.

Policy Summary

PayerUnitedHealthcare

PolicyMinimally Invasive Procedures for Gastric and Esophageal Diseases (for Ohio Only)

Policy CodePolicy CSO79OH.C

Change TypeMaterial coverage update (POEM coverage clarified)

Effective Date03/01/2025

Next Review Date

Key ActionObtain prior authorization documenting objective reflux or motility testing and prior medical therapy when requesting coverage for antireflux or myotomy procedures.

SourceLink

POLICY UPDATE CHANGES

POEM is proven and medically necessary for treating individuals with Achalasia or Diffuse Esophageal Spasm; POEM is unproven and not medically necessary for all other indications (e.g., Zenker's diverticula).

Supporting Information updated (Clinical Evidence and References) to reflect the most current information.

Archived previous policy version CSOZ9OH.B.

OhioGeographic applicability

18+Applies to age

POEM = coveredPOEM coverage

G-POEM = NMN

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03/01/2025Policy effective

Coverage Criteria and Policy Positions

Covered and Not Medically Necessary Positions

Coverage rationale and specific coverage positions stated in the policy:

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

Applies to adults; refer to InterQual for surgical antireflux clinical coverage criteria.

POEM not covered for other indications: Per-oral endoscopic myotomy (POEM) is unproven and not medically necessary for all other indications (e.g., Zenker's diverticula) due to insufficient evidence of efficacy.

Specific Z-POEM evidence is insufficient; see evidence summaries.

G-POEM for Gastroparesis: Gastric per-oral endoscopic myotomy (G-POEM) is unproven and not medically necessary for the treatment of gastroparesis.

Insufficient quality evidence and variable definitions of clinical success across studies.

Endoscopic GERD therapies and LINX: Injection/implantation techniques, endoscopic therapies other than transoral incisionless fundoplication (TIF), and the LINX Reflux Management System are unproven and not medically necessary for treating GERD due to insufficient evidence of efficacy.

Endoluminal therapy with GERDx is investigational and not FDA approved.

FLIP diagnostic utility: Functional lumen imaging probe (FLIP) technology is unproven and not medically necessary for diagnosing achalasia.

Evidence is insufficient to define diagnostic thresholds or demonstrate improved health outcomes.

Study-derived eligibility and response definitions

Study-derived eligibility/response criteria referenced in the evidence:

G-POEM RCT eligibility: Adults >18 years with severe or refractory gastroparesis >6 months with GCSI >2.3 despite medical therapyGCSI > 2.3

From Martinek et al. randomized controlled trial.

G-POEM clinical success definitions: Clinical success defined as decrease ≥50% in total GCSI (Martinek RCT) OR ≥1 point reduction in GCSI or ≥25% reduction in ≥2 subscales (observational studies)>=50% or >=1 point or >=25% in subscales

Definitions reported across RCT and observational series.

Z-POEM clinical success: Clinical success defined by reduction in Dakkak and Bennett dysphagia score (eg, decrease to ~0.25 from ~1.96 in multicenter series) documented pre- and post-procedure

Study-derived coverage considerations

Procedures demonstrated efficacy in selected populations when ALL/majority of these study-based criteria are met:

Study-based candidate profile: Adult patients with chronic GERD symptoms despite optimized PPI therapy, objective evidence of pathologic acid exposure or endoscopic findings, and suitable anatomy (eg, small or absent hiatal hernia for some devices)based on individual trial inclusion criteria

Derived from TIF/TEMPO, EFTP (Kalapala), MUSE and systematic reviews.

Procedural outcome expectations: Documented trial outcomes include ≥50% improvement in GERD‑HRQL, reduction or cessation of daily PPI use, and improvements in objective pH metrics in some studies; outcomes and durability vary by device.device-specific

Examples: EFTP 65.7% ≥50% GERD‑HRQL at 12 months (Kalapala); MUSE 73% >50% improvement off PPI at 6 months; TIF TEMPO shows sustained symptom reduction up to 5 years.

Coverage with criteria: patient selection for TIF or MSA

Covered when ALL of the following are met (based on clinical trial inclusion/selection across studies):

TIF/MSA candidate selection: Patient has chronic GERD with troublesome regurgitation or persistent symptoms despite optimized PPI therapyPPI-refractory or persistent regurgitation

Supported by randomized and prospective trials comparing TIF/TF and MSA to continued PPI therapy.

Objective diagnostic confirmation: Objective evidence of pathologic reflux on ambulatory pH testing or equivalent testingabnormal esophageal acid exposure / DeMeester > normal

Many trials (eg, TEMPO, Hunter TF) required abnormal pH monitoring for inclusion.

Anatomic suitability: Hiatal hernia absent or small (commonly <2 cm for TIF; <2–3 cm used in trials) and absence of advanced esophagitis or Barrett's esophagus grade C/D in trial populations

MSA (LINX) — coverage with clinical criteria

Covered when ALL of the following are met (evidence and guideline–based selection considerations):

MSA patient selection: Objective evidence of pathologic GERD (eg, abnormal esophageal pH monitoring) and persistent symptoms despite medical therapy

Supported by randomized and observational studies showing symptom control and PPI reduction with MSA.

Anatomy and contraindications: Absence of large hiatal hernia or Barrett's esophagus and hiatal hernia size within trial limits; device less appropriate for large herniashiatal hernia typically <3 cm in trials

Pre-approval and post-approval series selected patients with limited hernia size and without advanced Barrett's or severe esophagitis.

Informed consent and counseling: Patient informed of short- and mid-term outcomes and risks including dysphagia, need for dilation, device removal, and rare erosion

Safety profiles and device removal/erosion rates summarized across studies and society guidance.

EndoFLIP (FLIP) — investigational/insufficient

Not routinely covered/considered investigational when used for diagnostic or procedural guidance outside defined research or specialized protocols because evidence is insufficient:

EndoFLIP uses with insufficient evidence: Use of EndoFLIP to assess esophageal and gastric disorders, guide procedures, or predict outcomes lacks sufficient high-quality evidence and standardized thresholds and therefore is investigational for routine use.

Systematic reviews and technology assessments report low-quality, heterogeneous evidence with no validated DI threshold associated with prolonged clinical success.

POEM — Medical necessity

Covered when the following is met for POEM:

POEM coverage for achalasia/diffuse esophageal spasm: Per-oral endoscopic myotomy (POEM) is proven and medically necessary for treating individuals with Achalasia or Diffuse Esophageal Spasm.

Policy History: Summary of Changes clarified coverage stance.

POEM — Unproven / Not Medically Necessary

Not covered when the following is present:

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

Policy History: Summary of Changes clarified that POEM is not covered for indications outside achalasia and diffuse esophageal spasm.

Per the policy revision effective 03/01/2025, POEM (per‑oral endoscopic myotomy) is considered proven and medically necessary when used to treat achalasia or diffuse esophageal spasm. The policy also specifies that POEM is unproven and not medically necessary for all other indications (for example, Zenker's diverticulum) because available evidence is insufficient to establish safety and efficacy.

Procedures regarded as investigational or lacking sufficient evidence for routine coverage include techniques for which long‑term safety and effectiveness have not been established. Examples called out in the policy are G‑POEM (gastric POEM) for gastroparesis, and Stretta radiofrequency therapy; the policy notes study limitations such as small sample size, single‑center experience, heterogeneity of patient populations, and limited long‑term follow‑up.

Endoscopic procedures intended to treat GERD are not supported when performed in patients who lack objective diagnostic evidence of pathologic reflux or when alternative explanations for symptoms exist. The policy emphasizes the need for objective testing (eg, ambulatory pH monitoring, endoscopy) and documents that several endoscopic plication/suturing and TIF studies showed symptom improvement without consistent long‑term normalization of esophageal acid exposure.

Certain anatomic or disease factors exclude patients from trial‑based indications and therefore affect coverage eligibility. The policy identifies exclusions such as a large hiatal hernia, severe esophagitis (LA grade C/D), or Barrett's esophagus in some study cohorts. Trial populations for devices like TIF and MSA commonly required small or absent hernia (commonly <2–3 cm) and absence of advanced esophagitis.

Use of the EndoFLIP (FLIP) system for routine diagnostic assessment or to guide therapeutic procedures is considered unproven. The policy cites multiple assessments and systematic reviews concluding evidence is insufficient to demonstrate improved health outcomes or standardized, validated thresholds (eg, distensibility index) that predict clinical success.

The policy reiterates that POEM for indications other than achalasia or diffuse esophageal spasm (for example, Zenker's diverticulum or other off‑label uses) is unproven and not medically necessary because high‑quality evidence of efficacy and long‑term safety is lacking.

The policy lists multiple procedures considered unproven or not medically necessary for treating GERD or related disorders, including G‑POEM (for gastroparesis), injectable or implantation bulking agents (eg, Plexiglas, Durasphere), most endoscopic GERD therapies other than TIF, and the LINX Reflux Management System. The document also notes that FLIP for routine diagnostic use is not supported.

The policy states that Z‑POEM, G‑POEM, and Stretta should be considered investigational when proposed for patients who have not undergone appropriate prior medical therapy or objective diagnostic testing consistent with those used in clinical studies. Insufficient high‑quality, long‑term evidence for these procedures increases the risk that coverage will be denied.

Endoscopic plication/suturing techniques and polymer injection approaches have not demonstrated consistent, durable benefit in available studies. The policy highlights progressive loss of symptomatic benefit over time in some series and notes limitations such as small sample sizes, lack of randomization, and short follow‑up, supporting an investigational or not medically necessary stance.

Polymer injection and implantation techniques (for example, Plexiglas or Durasphere) are described as having insufficient evidence to support routine use. Systematic reviews and small case series show inconsistent results and limited long‑term data, leading the policy to consider these approaches investigational.

The policy concludes that use of EndoFLIP to guide procedures or to improve clinical outcomes has not been demonstrated. Reviews and technology assessments found the evidence inconclusive, with low‑quality studies, inconsistent protocols, and no validated DI thresholds to guide treatment decisions; therefore EndoFLIP is not supported for routine clinical use.

Restating the coverage stance: POEM is considered unproven and not medically necessary when used for any indication other than achalasia or diffuse esophageal spasm. This restatement reflects the Policy History change effective 03/01/2025.

Coding, Codes, and Related Clinical Thresholds

Referenced CPT codes (reference only)CPT

43210	Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, complete, includes duodenoscopy when performed partial.
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.
43999	Unlisted procedure, stomach.

Covered CPT Codesmixed

No codes listed

Coding noted: none specifiedmixed

No explicit CPT/ICD/HCPCS codes listed in these document excerpts.

FDA-cleared endoluminal devices mentionedmixed

FDA clearances noted

Stretta System, Bard EndoCinch, NDO Surgical Endoscopic Plication System, EsophyX2 — FDA approval/clearance history referenced; no CPT/HCPCS codes listed in this section.

Devices with FDA clearance/approval referencedmixed

FDA PMA (LINX)	LINX Reflux Management System — PMA-approved device (Torax Medical)
510(k) (MUSE)	Medigus Ultrasound Surgical Endostapler (MUSE) — 510(k) clearance for endoscopic anterior partial fundoplication
Cleared device (EsophyX2)	EsophyX2 cleared as substantially equivalent for transoral tissue approximation and treatment of chronic GERD
Cleared device (EndoFLIP)	EndoFLIPe System indicated to measure pressure and dimensions in the esophagus for motility disorder evaluation
Cleared device (Stretta, EndoCinch)	Stretta System and Bard EndoCinch — FDA-approved/cleared for endoluminal treatments as described

GCSI threshold used to define severe gastroparesis for trial eligibility

GCSI threshold for trial eligibility> 2.3 on the Gastroparesis Cardinal Symptom Index (GCSI)

ContextUsed in RCT eligibility for severe or refractory gastroparesis (Martinek et al. 2022)

Duration requirementSymptoms > 6 months despite medical therapy in trial populations

Hiatal hernia size — trial inclusion commonly required < 2–3 cm

Typical hiatal hernia size allowed in trial inclusion< 2–3 cm (trial inclusion commonly required hiatal hernia <2–3 cm)

Relevance

Prior Authorization, Documentation, and Provider Guidance

Billing Rule

Coding Reference Note

The following procedure and diagnosis codes are provided for reference only and may be used for prior authorization and claims processing. Inclusion of a code does not guarantee coverage or reimbursement; verify benefit, state/contractual requirements, and billing policies.

Codes listed as examples only — use InterQual and plan contract for coverage decisions
Check state (Ohio) requirements before approving services

Prior Authorization

Novel Procedures — Prior Authorization Recommended

Novel and emerging procedures (for example, G-POEM, Z-POEM, and other peroral endoscopic myotomy variants) have limited and evolving evidence. Prior authorization is recommended to ensure appropriate patient selection and documentation of medical necessity.

Background and Context

Background: Gastroesophageal reflux disease (GERD) results from a weak or dysfunctional lower esophageal sphincter and can lead to esophagitis, strictures, Barrett's esophagus, or adenocarcinoma. Achalasia is a primary esophageal motor disorder characterized by impaired esophagogastric junction relaxation and loss of organized peristalsis; available treatments include pharmacologic, endoscopic (eg, POEM), and surgical approaches. Gastroparesis is chronic delayed gastric emptying without mechanical obstruction and has diverse etiologies.

Terms and Definitions

Achalasia — definition and pathophysiology

DefinitionAchalasia: a primary esophageal motor disorder characterized by degeneration of the myenteric plexus causing impaired relaxation of the esophagogastric junction (EGJ) and loss of organized peristalsis.

PathophysiologyDegeneration of the myenteric plexus leads to failure of EGJ relaxation and absent coordinated esophageal peristalsis.

Clinical relevanceManometry is the diagnostic gold standard; treatments include pharmacologic, endoscopic (eg, POEM), and surgical approaches.

Diffuse Esophageal Spasm — definition

DefinitionDiffuse esophageal spasm: a rare esophageal motility disorder with simultaneous, uncoordinated, or rapidly propagated contractions accompanied by dysphagia.

Clinical feature

Policy History and Changes

2025-03-01policy_revisionLatest

Added coverage clarification: POEM is proven and medically necessary for treating individuals with Achalasia or Diffuse Esophageal Spasm; POEM is unproven and not medically necessary for other indications (e.g., Zenker's diverticula).

2025-03-01supporting_information_update

Updated Clinical Evidence and References sections to reflect the most current information.

2025-03-01administrative_change

Policy Summary

PayerUnitedHealthcare

PolicyMinimally Invasive Procedures for Gastric and Esophageal Diseases (for Ohio Only)

Policy CodePolicy CSO79OH.C

Change TypeMaterial coverage update (POEM coverage clarified)

Effective Date03/01/2025

Next Review Date

Key ActionObtain prior authorization documenting objective reflux or motility testing and prior medical therapy when requesting coverage for antireflux or myotomy procedures.

SourceLink

On This Page

Dakkak and Bennett score decrease to near resolution

From Yang et al. multicenter case series.

hiatal hernia <2–3 cm; no LA grade C/D esophagitis

Trial inclusion criteria for TIF and MSA often limited to small hernias and absence of severe esophagitis.

Preprocedural evaluation documented: Preoperative assessments documented including GERD-HRQL, upper endoscopy, manometry, and ambulatory pH monitoring as appropriatecomplete diagnostic workup documented

Described in TIF, MSA cohorts and randomized trials.

Small or absent hiatal hernia was required for candidate selection in TIF and MSA studies

Exclusion noteLarge hiatal hernia often excluded and may preclude device suitability

Abnormal pH testing / DeMeester — abnormal esophageal acid exposure required for many trials

Objective abnormal pH requirementPathologic esophageal acid exposure (abnormal pH/DeMeester above normal thresholds) required for many trials

Use in preoperative assessmentAmbulatory esophageal pH monitoring commonly used to confirm reflux prior to MSA/TIF enrollment

Example trial criteriaBell et al. and Louie et al. required abnormal pH testing for inclusion in MSA studies

EndoFLIP distensibility index (DI) — no validated DI threshold established for clinical success

Validated DI thresholdNo validated EndoFLIP distensibility index (DI) threshold established for clinical success

Evidence summarySystematic reviews and observational studies report correlations between DI and outcomes but precise DI cutoff for success remains undetermined

Clinical implicationEndoFLIP utility for diagnosis/procedural guidance is investigational pending standardized thresholds and confirmatory studies

Hiatal hernia size for EsophyX indication — < 2 cm

Hiatal hernia size in EsophyX indicationReduction of hiatal hernia < 2 cm is included in EsophyX2 clearance indications

Device contextEsophyX2 cleared for full-thickness plication and treatment of chronic GERD in patients who require and respond to pharmacologic therapy

Regulatory noteFDA 510(k) clearance documentation references hiatal hernia <2 cm in indication language

Prior authorization recommended before scheduling
Consider referral to tertiary center or clinical trial when appropriate

Prior Authorization

Prior Authorization Requirements

Prior authorization requests must include documentation demonstrating that procedural criteria are met and must be evaluated in the context of federal, state (Ohio), and contractual requirements. UnitedHealthcare will use InterQual clinical criteria and its medical policies when applicable.

Authorization decisions reference InterQual and UnitedHealthcare Medical Policies
Confirm any additional state or contract-specific requirements prior to approval

Documentation Required

Prior Authorization: Confirm Refractory GERD and Diagnostic Workup

For GERD-related procedures, prior authorization must confirm that symptoms are refractory to optimized medical therapy and that a comprehensive diagnostic workup has been completed demonstrating objective evidence of pathologic reflux when required by the specific procedure.

Document history of PPI therapy (dose, duration, response)
Include validated symptom scores (e.g., GERD-HRQL, GCSI as applicable)
Provide results of objective testing: esophageal pH or pH-impedance, DeMeester score, EGD, and manometry when indicated

Prior Authorization

Prior Authorization Recommended for MSA/LINX

Magnetic sphincter augmentation (MSA / LINX) and similar device-based antireflux procedures generally require prior authorization. Verify appropriate patient selection and objective evidence of GERD before approval.

Require objective evidence of pathologic acid reflux (eg, abnormal pH testing or DeMeester score) for MSA candidacy
Confirm hiatal hernia size and absence of contraindications (e.g., advanced esophagitis or Barrett's with advanced dysplasia) per device labeling and InterQual

Prior Authorization

Authorization Requirement

Authorization is required for services identified in this policy and determinations will use InterQual criteria and UnitedHealthcare policies. Always check federal, state (Ohio), and contractual requirements which may override standard policy language.

Use InterQual for primary medico-surgical criteria
If InterQual lacks applicable criteria, apply UnitedHealthcare Medical Policies and Utilization Review Guidelines

Denial Risk

Denial Risk for Unproven Services

Services described in this policy as unproven, investigational, or lacking sufficient evidence (for example, certain injection/implantation techniques, some endoscopic plication/suturing approaches, and non‑POEM uses such as POEM for Zenker's) are at risk for denial.

Denials may be issued when procedures are outside proven indications or lack sufficient supporting evidence
Consult the Coverage Rationale section and InterQual guidance when uncertain

Denial Risk

Evidence Insufficiency May Prompt Denial

Lack of high-quality evidence, small sample sizes, single-center series, short follow-up, or absent long-term outcome data for a procedure may prompt denial of coverage. Provide robust clinical data when requesting authorization for procedures with limited evidence.

Include published evidence and rationale for deviation from standard indications
Highlight ongoing clinical trials or registries if relevant

Denial Risk

Insufficient Long-term Objective Control / Evidence

For several endoscopic and device procedures (e.g., TIF, MSA), long-term objective reflux control and comparative effectiveness versus standard antireflux surgery remain incompletely characterized. Absence of long-term objective control or comparative data may be a basis for denial or request for additional information.

Provide long-term follow-up data when available (pH normalization, DeMeester scores, reoperation rates)
Document sustained symptom relief and PPI discontinuation with objective testing where possible

Denial Risk

Comparative Effectiveness and Long-term Data Gaps

Comparative effectiveness gaps between novel/endoscopic procedures and established surgical options (eg, Nissen fundoplication) should be addressed in authorization requests. When comparative evidence is limited, include justification for chosen therapy and why surgery is not appropriate or acceptable.

Explain prior surgical candidacy assessment and reasons for alternative minimally invasive approach
Attach relevant comparative studies if available

Denial Risk

Denial Risk for NMN Indications

Procedures performed for indications deemed not medically necessary (NMN) in this policy — for example POEM for non-achalasia indications such as Zenker's — are at high risk for denial. Confirm that the indication matches those accepted by the policy and InterQual.

Do not submit authorization for procedures with NMN indications without strong, peer-reviewed justification
Requests for NMN indications will be evaluated against Ohio OAC and contract terms

Documentation Required