CurrentGeisinger Health PlanPolicy MP256

Transoral Incisionless Fundoplication

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Defines coverage, prior authorization requirements, and clinical criteria for Transoral Incisionless Fundoplication (including EsophyX/SerosaFuse) for Geisinger Health Plan members across Commercial, Medicare, and Medicaid business segments.

Policy Summary

PayerGeisinger Health Plan

PolicyTransoral Incisionless Fundoplication

Policy CodePolicy MP256

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization from a Plan Medical Director or designee with documentation confirming GERD diagnosis, duration and response to PPI therapy, Hill grade, BMI, and absence of exclusion conditions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum member age for commercial coverage

6 monthsPPI trial duration

<=2 cmmax hiatal hernia

<=35BMI threshold

Not covered

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CurrentGeisinger Health PlanPolicy MP256

Transoral Incisionless Fundoplication

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Policy Summary

PayerGeisinger Health Plan

PolicyTransoral Incisionless Fundoplication

Policy CodePolicy MP256

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum member age for commercial coverage

6 monthsPPI trial duration

<=2 cmmax hiatal hernia

<=35BMI threshold

Not covered

Coverage Criteria for Transoral Incisionless Fundoplication (TIF)

Commercial Coverage

Covered when ALL of the following are met:

Commercial coverage criteria: Member is 18 years of age or greater; diagnosis of GERD established by endoscopy, ambulatory pH testing, or barium swallow; history of daily bothersome GERD symptoms inadequately controlled with individually maximized daily PPI use (unless intolerant or contraindicated) for at least 6 months; documentation of gastroesophageal valve (Hill grade I-II) at the gastroesophageal junction (unless TIF is performed with concurrent laparoscopic hiatal repair); BMI ≤ 35; none of the following exclusion conditions are present: hiatal hernia > 2 cm (unless simultaneous or prior repair of hiatal hernia is performed), esophagitis grade C or D, Barrett's esophagus > 2 cm, esophageal ulcer/stricture/narrowing, portal hypertension and/or varices, active gastro-duodenal ulcer, gastric outlet obstruction/stenosis, symptomatically uncontrolled gastroparesis, history of uncontrolled or untreated coagulation disorder, cervical spine fusion, Zenker's diverticulum.

Medicare Coverage

Covered when ALL of the following are met:

Medicare coverage criteria: Symptomatic chronic gastroesophageal reflux (defined as > 6 months of symptoms); symptoms responsive to proton pump inhibitors as judged by GERD-HRQL scores (≤ 12 while on PPIs and ≥ 20 when off PPIs for 14 days, or a difference ≥ 10 between off and on therapy); hiatal hernia ≤ 2 cm, if present.

Requests for Transoral Incisionless Fundoplication that do not meet the policy coverage criteria will not be covered. For the Commercial business segment, coverage is denied when any of the required criteria are not satisfied, including but not limited to: hiatal hernia greater than 2 cm (unless repaired simultaneously or previously), Los Angeles esophagitis grade C or D, Barrett's esophagus greater than 2 cm, esophageal ulcer/stricture/narrowing, portal hypertension or varices, active gastro-duodenal ulcer, gastric outlet obstruction/stenosis, uncontrolled gastroparesis, uncontrolled or untreated coagulation disorder, cervical spine fusion, or Zenker's diverticulum.

The Plan does NOT provide coverage for Transoral Incisionless Fundoplication (TIF), including but not limited to the EndoGastric Solutions SerosaFuse™ implantable fasteners and the associated EsophyX delivery device, when the criteria for coverage set forth in this policy are not met.

Coverage for experimental, investigational, or unproven treatments, services, and procedures is specifically excluded under the member's certificate with Geisinger Health Plan. Unproven services performed outside of an approved clinical trial are also excluded and are not covered by this policy.

Transoral incisionless fundoplication is not a covered Medicaid benefit unless a Program Exception is granted. Any requests for services that do not meet the criteria in the PARP may be evaluated on a case-by-case basis; consideration through the Program Exception process is required for Pennsylvania Medicaid members.

TIF is considered not covered when it is experimental, investigational, or unproven, or when the specific coverage criteria in this policy are not satisfied. In such cases, the Plan will not provide coverage for the procedure or associated devices.

Billing and Coding

Covered CPT Codesmixed

No codes listed

Informational CPT CodesCPT

43210	Esophogastroduodenoscopy with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed
43499	Unlisted procedure, esophagus

inv-10: Symptom duration — > 6 months

Required symptom duration> 6 months of daily bothersome GERD symptoms despite therapy

Commercial criterion wordingHistory of daily bothersome GERD symptoms inadequately controlled with individually maximized daily PPI use for at least 6 months (unless intolerant/contraindicated)

Medicare criterion wordingSymptomatic chronic gastroesophageal reflux defined as > 6 months of symptoms

inv-11: Hiatal hernia size — <= 2 cm (Medicare); < 2 cm for Commercial unless repaired concurrently

Medicare maximum hiatal hernia size<= 2 cm if present

Commercial allowanceHiatal hernia greater than 2 cm is an exclusion unless simultaneous or prior repair of hiatal hernia is performed

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required

Transoral incisionless fundoplication requires prior authorization by a Plan Medical Director or designee.

Prior Authorization

Check member contract and Geisinger resources

Prior authorization and/or pre-certification may be required; consult the member's contract and Geisinger provider resources for specific requirements and precertification lists.

Prior authorization requirements available at: https://www.geisinger.org/health-plan/providers/ghp-clinical-policies
Precertification lists in the member's contract specific benefit document

Step Therapy

Background on Transoral Incisionless Fundoplication

Transoral Incisionless Fundoplication (TIF) using the EsophyX system with SerosaFuse fasteners is an endoluminal, transoral procedure that creates full-thickness fundoplication plications at the gastroesophageal junction to treat symptomatic chronic gastroesophageal reflux disease (GERD). It is indicated for patients who respond to pharmacologic therapy and may reduce small hiatal hernias (<2 cm).

Definitions and Grading Systems

inv-24: Hill Classification — grading system describing gastroesophageal flap valve anatomy and hiatal hernia types

DefinitionGrading system describing the gastroesophageal flap valve anatomy and types of hiatal hernia (Types I-IV)

PurposeUsed to document valve status prior to TIF (reports Hill grade I–IV)

Examples of typesType I: sliding hiatal hernia; Type II: pure paraesophageal hernia; Type III: combined; Type IV: other structure in hernia sac

inv-25: Los Angeles (LA) Grading of Esophagitis — scale A-D; grade C or D esophagitis is an exclusion for commercial coverage

LA grading scaleScale A–D describing extent of esophageal mucosal breaks

Grade C definitionMucosal break(s) continuous between ≥2 mucosal folds, involving <75% of the esophageal circumference

Policy Summary

PayerGeisinger Health Plan

PolicyTransoral Incisionless Fundoplication

Policy CodePolicy MP256

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Commercial default requirementDocumentation of gastroesophageal valve (Hill grade I-II) unless TIF is done with concurrent laparoscopic hiatal repair

inv-12: BMI — <= 35

BMI threshold for coverageBMI of 35 or less

Commercial criterion contextMember has a BMI of 35 or less as part of commercial coverage criteria

Exclusion implicationBMI > 35 would not meet the listed commercial criteria

inv-13: GERD-HRQL scores (Medicare) — <=12 on PPIs and >=20 off PPIs for 14 days, or difference >=10 between off and on therapy

Medicare GERD-HRQL on-PPI threshold<= 12 while on PPIs

Medicare GERD-HRQL off-PPI threshold>= 20 after being off PPIs for 14 days

Alternate acceptable metricA difference of >= 10 between off-therapy and on-therapy GERD-HRQL scores is also acceptable

PPI trial requirement (≥6 months)

Members must have a history of daily bothersome GERD symptoms inadequately controlled with individually maximized daily PPI use for at least 6 months unless PPI therapy is intolerant or contraindicated.

Commercial: at least 6 months of inadequate response to maximized daily PPI therapy
Medicare: chronic GERD defined as >6 months and symptoms must be PPI-responsive per GERD‑HRQL scoring

Note

Line-of-business applicability

Eligibility, benefits, limitations, and exclusions vary by line of business; line-of-business benefit documents (and for Medicare, applicable LCDs/NCDs) supersede this policy.

For Medicare, applicable LCDs and NCDs will supersede this policy
PA Medicaid business segment: this policy applies as written

Documentation Required

Required documentation for prior authorization

Documentation submitted for prior authorization must demonstrate diagnostic confirmation of GERD, duration and response to PPI therapy, gastroesophageal valve (Hill) grade, BMI, and absence of listed exclusion conditions.

Diagnostic confirmation: endoscopy, ambulatory pH testing, or barium swallow
Duration/response to PPI therapy (including GERD‑HRQL scores for Medicare when applicable)
Gastroesophageal valve documentation (Hill grade I–II unless concurrent hiatal repair)
BMI (≤35 for commercial) and absence of exclusions (e.g., hiatal hernia >2 cm, LA grade C/D esophagitis, Barrett's >2 cm, esophageal ulcer/stricture, varices, active ulcer, gastric outlet obstruction, uncontrolled gastroparesis, coagulation disorder, cervical spine fusion, Zenker's diverticulum)

Documentation Required

Prior auth / documentation note

Prior authorization and/or pre-certification requirements may apply; check Geisinger provider resources for current prior authorization processes and note that listed codes are informational and do not guarantee coverage.

Inclusion of procedure or device codes does not imply coverage or guarantee reimbursement
Consult CMS or local MAC for Medicare coding and coverage rules

Denial Risk

Coverage denial risk if criteria unmet

Requests that do not meet the policy's coverage criteria will not be covered.

Denial Risk

No coverage when coverage criteria are not met

The Plan does NOT provide coverage for Transoral Incisionless Fundoplication when the criteria for coverage in this policy are not met.

Denial Risk

Experimental / unproven exclusion

Coverage for experimental, investigational, or unproven treatments and services is specifically excluded under the member's certificate; unproven services outside approved clinical trials are also excluded.

See MP015 for the process and details regarding experimental/investigational determinations

Coverage impactEsophagitis grade C or D is an exclusion for commercial coverage

inv-26: TIF / EsophyX — Endoluminal fundoplication procedure using devices such as the EsophyX delivery device and SerosaFuse fasteners

Procedure descriptionEndoluminal fundoplication procedure using devices such as the EsophyX delivery device and SerosaFuse implantable fasteners for transoral creation of a fundoplication

PurposeCreates full-thickness plications at the gastroesophageal junction to treat symptomatic chronic GERD

Coding noteAssociated CPT codes are listed for informational purposes; inclusion does not imply coverage