CurrentModa HealthPolicy N/A

Endoscopic Procedures for the Treatment of Gastroesophageal Reflux Disease (GERD) (Transoral Incisionless Fundoplication)

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Defines medical necessity and coverage stance for transoral incisionless fundoplication (TIF) and other endoscopic GERD procedures for Moda Health members; specifies criteria, covered and not-covered CPT/HCPCS codes, and documentation required for prior authorization.

Policy Summary

PayerModa Health

PolicyEndoscopic Procedures for the Treatment of GERD (TIF)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Last ReviewJul 23, 2025

Next Review DateJul 23, 2025

Key ActionObtain prior authorization with submission of clinical records including exam, symptom history, prior treatments and PPI use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered primary procedure (TIF) criteria set

>10Endoscopic procedures listed as experimental/investigational

2CPT/HCPCS groups listed

K21

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CurrentModa HealthPolicy N/A

Endoscopic Procedures for the Treatment of Gastroesophageal Reflux Disease (GERD) (Transoral Incisionless Fundoplication)

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Sign up for all Moda Health policy alerts

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Policy Summary

PayerModa Health

PolicyEndoscopic Procedures for the Treatment of GERD (TIF)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Last ReviewJul 23, 2025

Next Review DateJul 23, 2025

Key ActionObtain prior authorization with submission of clinical records including exam, symptom history, prior treatments and PPI use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered primary procedure (TIF) criteria set

>10Endoscopic procedures listed as experimental/investigational

2CPT/HCPCS groups listed

K21

Applicable ICD-10 codes

Coverage Criteria for Endoscopic GERD Procedures

COVERAGE CRITERIA — Transoral incisionless fundoplication (TIF)

Transoral incisionless fundoplication (TIF) is considered medically necessary when ALL of the following are met:

TIF medical necessity criteria

Age: Patient is 18 years of age or older.
Diagnostic confirmation: Confirmed diagnosis of esophageal reflux by endoscopy, ambulatory pH testing, or barium swallow.
Symptom duration and frequency: History of GERD symptoms for one year occurring 2 to 3 times per week.
BMI: Body mass index (BMI) ≤ 35.≤ 35
PPI therapy: History of daily proton pump inhibitor (PPI) use for greater than 6 months.> 6 months of daily PPI use
Absence of exclusionary conditions
- Hiatal hernia greater than 2 cm (hiatal hernia is allowed only if 2 cm or less).
  If hiatal hernia >2 cm, criterion not met
- Esophagitis severity: Esophagitis Los Angeles (LA) grade C or D.
  LA classification defined in document
- Barrett's esophagus.
- Achalasia.
- Esophageal ulcer.
- Esophageal motility disorder.

Experimental procedures exclusion: All other endoscopic procedures for the treatment and management of GERD or other esophageal disorders are considered experimental and investigational and are not covered.

Examples listed (not exhaustive): Angelchik prosthesis; EndoCinch/BESS; Apollo OverStitch; Enteryx; LINX (except Medicare); StomaphyX; Full-Thickness Plicator; Durasphere; Gatekeeper; PMMA implantation; Endoscopic Plicator System; Stretta; Syntheon ARD Plicator; EndoStim.

Moda Health considers all other endoscopic procedures for the treatment and management of GERD or other disorders of the esophagus to be experimental and investigational and/or unproven because there is insufficient published scientific evidence demonstrating long-term safety and effectiveness compared with other GERD treatment options.

When Medicare beneficiaries are involved, applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) must be followed. Compliance with these CMS policies is required where applicable, and additional indications may be covered at the discretion of the health plan.

Coding: CPT/HCPCS, ICD-10, and Billing Notes

Covered CPT or HCPC codes if criteria metCPTCovered

43210	Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed.
43659	Unlisted laparoscopy procedure, stomach

CPT or HCPC codes NOT covered for above listed proceduresCPTNot Covered

43201	Esophagoscopy, rigid or flexible; with directed submucosal injection(s), any substance.
43236	Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with directed submucosal injection(s), any substance.
43257	Injection(s), any substance Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease.
43499	Unlisted procedure, esophagus

Applicable ICD-10 diagnosis codesICD-10

K21	Gastro-esophageal reflux disease
K21.9	Gastro-esophageal reflux disease without esophagitis

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD)ICD-10

No codes listed

MAC / Jurisdiction referencesmixed

Jurisdiction 5	Medicare Part B Administrative Contractor jurisdiction
Jurisdiction 8	Medicare Part B Administrative Contractor jurisdiction
Noridian	Medicare Part B Administrative Contractor (example): Noridian Healthcare Solutions, LLC

BMI — criterion/value (≤ 35)

BMI thresholdPatient BMI must be ≤ 35 to meet TIF medical necessity criteria.

ContextBMI requirement is one of six required criteria for TIF medical necessity (age, diagnostic confirmation, symptom duration, BMI, PPI history, absence of exclusions).

Source detailListed under Moda Health TIF criteria: 'GERD patients with body mass index (BMI) ≤ 35.'

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; covered CPT/HCPCS codes

Prior authorization is required for TIF; submit clinical records with the request. If the criteria are met, covered procedure codes include CPT 43210 and CPT 43659.

Submit complete clinical records with the prior authorization request.
Covered CPT codes when criteria are met: 43210 and 43659.

Note

Verify Medicare Part B / MAC jurisdiction and LCDs

Check the applicable Medicare Administrative Contractor (MAC) jurisdiction and any Local Coverage Determinations (LCDs) that may affect prior authorization or coverage decisions (example jurisdictions listed: 5 and 8; example contractor: Noridian).

Verify relevant Jurisdiction(s): 5, 8.
Confirm MAC contractor guidance (example: Noridian Healthcare Solutions, LLC).
Review any applicable NCDs/LCDs on the CMS coverage database.

Background and Clinical Context

Gastroesophageal reflux disease (GERD) occurs when failure of the lower esophageal sphincter (LES) permits reflux of gastric contents into the esophagus, producing symptoms such as heartburn and risking mucosal injury. First‑line management includes lifestyle modifications and pharmacologic therapy (notably proton pump inhibitors); surgical laparoscopic fundoplication is an established definitive treatment, while endoscopic approaches (for example transoral incisionless fundoplication or various plication, suturing, bulking, radiofrequency, and stimulation techniques) have variable evidence and regulatory status and are addressed specifically in this policy.

Definitions and Procedure Summaries

Transoral Incisionless Fundoplication (TIF) — definition and summary

DefinitionTransoral Incisionless Fundoplication (TIF) is an endoscopic procedure, commonly performed with the EsophyX® device, intended to repair a defective gastroesophageal valve and reduce small hiatal hernias to control GERD symptoms and mucosal damage.

Clinical objectiveAims to mechanically repair the gastroesophageal valve and reduce small hiatal hernias to control symptoms and mucosal injury.

Patient selection noteModa Health considers TIF medically necessary only when ALL specified criteria are met (see policy criteria set).

Radiofrequency (Stretta) and related endoscopic techniques — definitions and summary

Radiofrequency (Stretta)Delivery of thermal energy to the lower esophageal sphincter via endoscopically placed needles (example: Stretta™ System). FDA-cleared device example noted; mechanism may involve ablation of nerve pathways affecting sphincter relaxation.

Policy Summary

PayerModa Health

PolicyEndoscopic Procedures for the Treatment of GERD (TIF)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Last ReviewJul 23, 2025

Next Review DateJul 23, 2025

Key ActionObtain prior authorization with submission of clinical records including exam, symptom history, prior treatments and PPI use.

SourceLink

On This Page

Altered anatomy: Altered esophageal anatomy preventing insertion of the device.

Prior anti-reflux surgery: Previous failed anti-reflux surgery or procedure (must be absent).

Step Therapy

Conservative therapy required prior to endoscopic intervention

Ensure patients have attempted conservative therapy before consideration of endoscopic procedures: lifestyle modifications and proton pump inhibitor (PPI) therapy. TIF criteria require a history of daily PPI use for greater than 6 months.

Document lifestyle modification attempts and response.
Document daily PPI use for >6 months as required for TIF eligibility.

Note

No additional provider action specified

No specific provider action text provided in source for this placeholder inventory item.

Documentation Required

Information required with prior authorization

Include the patient's physical exam findings and symptom description, prior treatments attempted for GERD, and prior medical history and surgeries/procedures related to GERD with the prior authorization request.

Provider records of physical exam and symptoms.
Documentation of prior treatments attempted.
Prior medical history and surgeries/procedures related to GERD.

Documentation Required

Follow Medicare Benefit Policy Manual and applicable NCDs/LCDs

When documenting Medicare Part B outpatient coverage matters, follow the Medicare Benefit Policy Manual, Chapter 15 §50, and comply with any applicable NCDs/LCDs referenced by the MAC jurisdiction.

Reference: Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50.
Comply with applicable National or Local Coverage Determinations (NCDs/LCDs).

Denial Risk

Denial risk: non‑TIF endoscopic procedures and criteria nonconcordance

Requests for endoscopic GERD procedures other than transoral incisionless fundoplication (TIF) will be denied as experimental/investigational; TIF requests may be denied if the patient does not meet ALL listed criteria.

All listed non-TIF endoscopic procedures are considered experimental/investigational and will be denied.
TIF will be denied if the patient fails to meet all medical necessity criteria (e.g., age, diagnostic confirmation, symptom duration, BMI, PPI history, absence of exclusions).

Denial Risk

Denial risk for noncompliance with NCDs/LCDs

Noncompliance with applicable NCDs and LCDs may result in denial of Medicare Part B coverage for the requested service.

Ensure documentation and requests conform to any applicable NCDs/LCDs for the member's MAC jurisdiction.

Gastric plication/suturing techniquesEndoscopic placement of sutures or plication (e.g., EndoCinch™, Bard BESS, Full Thickness Plicator™) to strengthen and lengthen the LES and reduce reflux.

Polymer injection/implantation (bulking)Endoscopic submucosal implantation of materials (e.g., PMMA beads, expandable hydrogel prostheses such as Gatekeeper™) intended to provide bulking support to the sphincter; several devices have limited evidence or recall history.

Medicare Part B outpatient drugs coverage guidance

Manual referenceMedicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 covers Medicare outpatient (Part B) drugs and biologicals and applies where relevant to outpatient drug coverage.

Compliance noteProviders must follow Chapter 15 §50 and applicable NCDs/LCDs when documenting outpatient Part B drug use related to endoscopic GERD procedures.

CMS resourcesNCDs and LCDs can be located via the CMS Medicare Coverage Database: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx.

National or Local Coverage Determination (NCD/LCD) — definition and relation to MAC jurisdictions

DefinitionNational Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) are Medicare coverage policies that govern Part B services and are issued at the national or contractor (MAC) level.

Relation to MACsLCDs are developed by Medicare Administrative Contractors (MACs) for their jurisdictions; providers should check applicable MAC jurisdictions (e.g., Jurisdictions 5, 8) and contractors like Noridian for relevant LCDs.

Plan requirementCompliance with applicable NCDs/LCDs is required where they exist; additional indications may be covered at the discretion of the health plan.