ModifiedColorado Rocky Mountain Health PlansPolicy CS046.S

Gastrointestinal Disorders Diagnostic Procedures

Defines coverage and medical necessity stance for selected diagnostic procedures used in gastrointestinal disorders (e.g., MRI defecography, electrogastrography, FLIP, esophageal mucosal integrity testing) for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGastrointestinal Disorders Diagnostic Procedures

Policy CodePolicy CS046.S

Change TypeMaterial content and coding updates

Effective DateApr 1, 2026

Next Review Date

Key ActionDocument that prior diagnostic testing (ARM and balloon expulsion test) was performed and inconclusive before requesting defecography; obtain prior authorization when submitting tests designated as unproven (e.g., FLIP, BSGM, mucosal impedance).

SourceLink

POLICY UPDATE CHANGES

Title changed from 'Gastrointestinal Motility Disorders, Diagnosis and Treatment' and content was reorganized with removal/relocation of gastric electrical stimulation language.

Added 'Functional Lumen Imaging Probe (FLIP) technology for diagnosing Achalasia' to the list of unproven and not medically necessary procedures.

Removed examples listing specific devices (e.g., Gastric Alimetry System, G-Tech Gut Tracker, MiVu Mucosal Integrity Testing System) from the unproven/not medically necessary procedures list.

Removed several CPT codes (43647, 43648, 43881, 43882, 64590, 64595) from the applicable codes list.

Title changed from 'Gastrointestinal Motility Disorders, Diagnosis and Treatment' and template updated; content/language pertaining to the state of Louisiana removed.

Coverage rationale removed and language pertaining to gastric electrical stimulation (GES) therapy relocated to a separate Medical Policy titled 'Minimally Invasive Procedures for the Treatment of Upper Gastrointestinal Diseases'.

List of unproven and not medically necessary procedures updated: added 'Functional Lumen Imaging Probe (FLIP) technology for diagnosing Achalasia' and removed specific examples of cutaneous/mucosal/serosal electrogastrography and esophageal mucosal integrity testing by electrical impedance.

Applicable CPT codes updated with removal of codes 43647, 43648, 43881, 43882, 64590, and 64595.

Supporting sections (Description of Services, Clinical Evidence, FDA, References) updated and Medical Records Documentation Used for Reviews section removed.

Definition of Achalasia was added to the Definitions section.

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4procedures listed as unproven / not medically necessary

6CPT codes removed

95studies in EndoFLIP review

~2,681patients in FLIP meta-analysis

33.3% vs 22.7%BSGM vs GET detection rate

Coverage Criteria and Clinical Use

inv-01: Not Medically Necessary / Unproven

Not medically necessary (unproven) procedures:

Unproven procedures: Magnetic Resonance Imaging (MRI) Defecography for evaluating constipation and anorectal or pelvic floor disorders; cutaneous, mucous, or serosal electrogastrography, electroenterography, or body surface gastric mapping for diagnosing intestinal or gastric disorders including gastroparesis; Esophageal Mucosal Integrity Testing by electrical impedance for diagnosis of GERD, eosinophilic esophagitis (EoE), nonacid reflux disease, or for monitoring treatment response in GERD and EoE; Functional Lumen Imaging Probe (FLIP) technology for diagnosing achalasia.

Listed as unproven and not medically necessary due to insufficient evidence of efficacy (Coverage Rationale).

inv-02: Coverage considerations and clinical-use criteria

Coverage/medical necessity considerations summarized from guideline and evidence statements in the document:

Defecography (indication): Defecography (barium/fluoroscopic or MRD) is appropriate only when: (1) there is clinical suspicion of outlet obstruction or posterior pelvic floor disorder AND (2) anorectal manometry (ARM) and balloon expulsion test (BET) are inconclusive or additional anatomic detail is required for preoperative planning.

Supported by AGA, ACG, and ASCRS guidance; ARM and BET generally suffice otherwise (chunks 26,27,28).

Modality choice considerations: Choose fluoroscopic/video defecography when seated evacuation assessment and higher technical/diagnostic success for evacuation-phase findings are required; consider MRD when soft-tissue resolution or multi-compartment pelvic assessment is needed, recognizing MRD may have lower technical diagnostic success and may not replace evacuation-phase fluoroscopic defecography unless evacuation-phase MRI is performed and documented.

Evidence indicates VD has higher technical success than MRD; MRD sensitivity improves when evacuation phase is included (chunks 21,22).

FLIP use: FLIP (EndoFLIP) should be used as a complementary assessment of esophagogastric junction opening dynamics and esophageal wall stiffness and should not be the sole basis for diagnosis or treatment decisions; avoid routine use for GERD diagnosis and do not use FLIP to diagnose EoE (AGA practice update recommendations).

AGA practice update recommends FLIP as adjunctive and not for routine GERD/EoE diagnosis (chunk 18).

EGG/BSGM use: Low-resolution electrogastrography (EGG) lacks convincing evidence for routine clinical diagnosis of gastric stasis/gastroparesis; body surface gastric mapping (BSGM) may improve phenotyping and symptom correlation compared with gastric emptying testing (GET) in some studies, but currently lacks demonstrated improvement in patient-relevant outcomes and remains investigational or adjunctive depending on payer policy.

Based on systematic reviews, cohort studies, and device assessments noting heterogeneous methods and limited clinical utility data (chunks 29,32,36).

inv-03: EGG / Body Surface Gastric Mapping (BSGM)

Coverage stance and conditional recommendations based on evidence summaries and guideline positions

Electrogastrography/BSGM (coverage stance): Electrogastrography (EGG) and Body Surface Gastric Mapping (BSGM): available studies are heterogeneous and often small; while BSGM can provide patient-specific phenotyping and may correlate better with symptoms than gastric emptying testing in some cohorts, there is insufficient evidence that use of BSGM improves patient-relevant outcomes or should replace standard testing. Routine clinical use is investigational; coverage is limited and considered investigational/unproven for routine diagnosis.

Supported by cohort studies, a systematic review/meta-analysis, and AGA position statements indicating EGG is not recommended for routine clinical use (chunks 36,37,32,29,39).

inv-04: Esophageal Mucosal Integrity Testing

Esophageal mucosal integrity testing (MI) using balloon or probe impedance during EGD

Mucosal Impedance (MI) testing (coverage stance): Small prospective and retrospective studies report distinct MI measurement patterns that differentiate GERD, EoE, and non-GERD, and some devices have undergone evidence assessments; however, limitations include small sample sizes, lack of independent validation, and absence of demonstrated clinical utility on outcomes. Therefore MI testing during EGD remains investigational/unproven as a replacement for standard diagnostic methods and is not supported for routine diagnostic use.

ECRI and Hayes reviews and individual studies note limited quality and recommend further validation (chunks 40-44,45).

inv-05: EndoFLIP / Impedance Planimetry

Endolumenal functional lumen imaging probe (EndoFLIP)

EndoFLIP (coverage stance): EndoFLIP is FDA-cleared to measure pressures and dimensions in the esophagus, pylorus, and anal sphincters and is intended as an adjunctive diagnostic tool; professional society guidance recommends using FLIP as a complementary assessment within standardized protocols and not as the sole basis for diagnosis or treatment decisions. Coverage is generally adjunctive and contingent on documentation that standard diagnostic evaluations have been considered or performed.

FDA clearance and AGA practice update support adjunctive use and caution against sole reliance on FLIP; see EndoFLIP/FLIP guidance (chunks 47,18,51).

This Medical Policy does not apply to certain states that maintain their own, state-specific policy or guideline for gastrointestinal diagnostic procedures. Refer to the applicable state-specific policy where noted; examples include Idaho, Kansas, Kentucky, Nebraska, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, and Tennessee. Providers should follow the state policy cited rather than this standard policy for members covered under those state programs.

Per AGA guidance and the Coverage Rationale, FLIP (EndoFLIP) should not be used for routine diagnostic assessment of gastroesophageal reflux disease (GERD) and should not be used to diagnose eosinophilic esophagitis (EoE). FLIP is described as a complementary assessment tool for esophagogastric junction dynamics and esophageal wall stiffness and should not be the sole basis for diagnosis or treatment decisions.

Language and coverage rationale related to gastric electrical stimulation (GES) have been removed from this policy and relocated to a separate, dedicated medical policy for minimally invasive procedures of the upper gastrointestinal tract. References to GES are no longer part of this document's coverage rationale.

For coverage and clinical questions about gastric electrical stimulation (GES) therapy, see the separate Medical Policy titled Minimally Invasive Procedures for the Treatment of Upper Gastrointestinal Diseases, which now contains the relocated GES content and rationale.

Functional Lumen Imaging Probe (FLIP) technology has been added to the list of procedures considered unproven and not medically necessary for diagnosing Achalasia. The Coverage Rationale lists FLIP for achalasia among technologies with insufficient evidence of efficacy to support routine diagnostic use.

Summary of procedures considered unproven / not medically necessary: MRI defecography for constipation/anorectal or pelvic floor disorders; Electrogastrography/Electroenterography/Body Surface Gastric Mapping (EGG/BSGM) for gastric or intestinal disorders (including gastroparesis); Esophageal Mucosal Integrity Testing by electrical impedance for GERD, EoE, nonacid reflux, or treatment monitoring; and Functional Lumen Imaging Probe (FLIP) technology for diagnosing Achalasia.

Comparative evidence summarized in the policy indicates that MRI defecography (MRD) is not consistently superior to conventional video/fluoroscopic defecography (VD). One retrospective study reported substantially higher technical full diagnostic success for VD (96.9%) versus MRD (45.3%) and noted more frequent detection of enteroceles, intussusception, and rectoceles with VD; systematic reviews conclude MRD does not yet replace evacuation-phase fluoroscopic defecography as the reference standard.

Restating the Coverage Rationale: FLIP and the other procedures listed above are classified as unproven and not medically necessary because current evidence is insufficient to demonstrate their effectiveness in improving patient outcomes or to support routine replacement of established diagnostic tests.

Specifically, the policy lists FLIP technology for diagnosing Achalasia among procedures judged unproven and not medically necessary. This designation reflects the policy's assessment that available evidence does not support the use of FLIP as a standalone diagnostic method for Achalasia.

Applicable Codes and Coding Notes

Applicable Codes (reference list)mixed

0779T	Gastrointestinal myoelectrical activity study, stomach through colon, with interpretation and report.
0868T	High-resolution gastric electrophysiology mapping with simultaneous patient-symptom profiling, with interpretation and report.
43499	Unlisted procedure, esophagus.
72195	Magnetic resonance (e.g., proton) imaging, pelvis; without contrast material(s).
72196	Magnetic resonance (e.g., proton) imaging, pelvis; with contrast material(s).
72197	Magnetic resonance (e.g., proton) imaging, pelvis; without contrast material(s), followed by contrast material(s) and further sequences.
76498	Unlisted magnetic resonance procedure (e.g., diagnostic, interventional).
91132	Electrogastrography, diagnostic, transcutaneous.
91133	Electrogastrography, diagnostic, transcutaneous; with provocative testing.

Procedure and diagnostic codes referencedmixed

No specific CPT/HCPCS/ICD codes listed in this document segment

FDA product codes (informational)mixed

MYE	FDA product code for cutaneous electrogastrography/electroenterography/BSGM devices (informational)
FFX	FDA product code referenced for radiopaque markers/colonic transit testing and other devices

Device product codes with FDA clearancemixed

QIS	MiVu Mucosal Integrity Testing System product code / 510(k) reference

Removed CPT CodesCPT

43647	CPT code removed from Applicable Codes
43648	CPT code removed from Applicable Codes
43881	CPT code removed from Applicable Codes
43882	CPT code removed from Applicable Codes
64590	CPT code removed from Applicable Codes
64595	CPT code removed from Applicable Codes

inv-20: BSGM recording duration — technical parameter: fasting baseline, meal ingestion, ~4-hour postprandial recording

Recording componentsFasting baseline, meal ingestion, and approximately 4‑hour postprandial recording

Typical baseline duration30‑minute preprandial baseline recording reported in studies

Meal stimulusStandardized caloric meal used (example: 482 kcal or 99mTc‑labelled egg meal in cited studies)

Postprandial monitoring intervalFour‑hour postprandial monitoring to capture gastric myoelectrical responses

PurposeCapture fasting and fed-state gastric myoelectrical activity for spectral and spatial biomarker analysis

Prior Authorization, Documentation, and Utilization Guidance

Prior Authorization

Reference Codes and PA Implication

Reference codes and prior authorization implications. Codes listed in this policy are for reference only and do not guarantee coverage. Services designated as unproven may be subject to denial or require prior authorization per the member's benefit plan. Verify federal, state, and contractual benefit terms before proceeding.

Listing of a code does not imply coverage or payment; check benefit plan terms
Unproven services may be denied or require prior authorization

Step Therapy

Defecography Justification and Stepwise Evaluation

Defecography justification and stepwise evaluation prior to advanced imaging. Advanced imaging such as MRI defecography should be requested only after initial, guideline-based evaluation (including anorectal manometry [ARM] and balloon expulsion test [BET]) are inconclusive or when additional anatomic detail is required for preoperative planning. Document prior testing results and clinical indications that justify MRD over standard fluoroscopic/VD.

Indications: inconclusive ARM/BET, need for additional anatomic information, preoperative planning

Background and Rationale

Constipation, fecal incontinence, and gastroparesis are common gastrointestinal conditions that may require specialized functional or imaging testing to establish diagnosis and guide treatment. The policy emphasizes adherence to validated, standardized protocols (for example, radionuclide gastric emptying scintigraphy is the reference standard for diagnosing gastroparesis) and documentation of objective evidence when required by the diagnostic gold standard. Where evidence is limited or technologies are adjunctive, the policy classifies those procedures as investigational or unproven and not medically necessary.

Terms and Definitions

inv-38: Achalasia definition — primary esophageal motor disorder (added in this revision)

DefinitionA primary esophageal motor disorder characterized by degeneration of the myenteric plexus resulting in impaired relaxation of the esophagogastric junction and loss of organized peristalsis in the esophageal body.

Clinical featuresImpaired EGJ relaxation and absent or disordered peristalsis leading to dysphagia and other obstructive symptoms.

Policy noteDefinition added to the Definitions section in the current revision of the policy.

inv-39: Electrogastrography (EGG) — definition of non-invasive gastric myoelectrical measurement

DefinitionA non‑invasive method for measurement of gastric myoelectrical activity using cutaneous electrodes placed on the abdominal skin over the stomach.

Clinical role

Policy Updates and Revision History

2026-06-01administrative update

Updated state-specific policy reference link for Idaho; administrative application update noted.

2026-05-01administrative update

Updated state-specific policy reference link for North Carolina; administrative application update noted.

2026-04-01material revision

Title changed from 'Gastrointestinal Motility Disorders, Diagnosis and Treatment' and template updated; content language pertaining to gastric electrical stimulation (GES) was removed and relocated to a separate Medical Policy ('Minimally Invasive Procedures for the Treatment of Upper Gastrointestinal Diseases').

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGastrointestinal Disorders Diagnostic Procedures

Policy CodePolicy CS046.S

Change TypeMaterial content and coding updates

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Document prior ARM and BET results and why they were insufficient

Consider fluoroscopic/video defecography first; MRD has lower technical success in some studies

Documentation Required

Prior Testing Documentation for Defecography

Prior testing documentation for MRI/defecography requests. When requesting MR defecography after inconclusive testing, include objective documentation of ARM and BET results, clinical symptoms, and rationale for why fluoroscopic/VD is not sufficient or feasible.

Attach ARM report and BET results (dates, abnormal findings)
Summarize clinical exam and symptom chronology supporting advanced imaging
If MRD requested for preoperative planning, state specific surgical questions to be addressed

Denial Risk

Technical/Diagnostic Inferiority Risk for MR Defecography

Technical/diagnostic inferiority risk of MRI defecography vs video/fluoroscopic defecography. Evidence shows MRD may have lower technical success and detect fewer abnormalities (e.g., enteroceles, intussusception, rectocele) compared with seated video defecography; consider this when selecting modality and document reasons for MRD use.

VD reported higher fully diagnostic rates than MRD in comparative studies
MRD advantage: soft-tissue resolution and lack of radiation; disadvantage: often supine position and lower detection rates for some dynamic findings

Prior Authorization

Prior Authorization for Device-Based Adjunct Diagnostics

Prior authorization for device-based adjunct diagnostics (e.g., FLIP, MI testing, body-surface mapping). Even if devices have FDA clearance, their use as adjunct diagnostic tools may require prior authorization and documentation of medical necessity per the member's plan. FDA clearance alone is not a basis for coverage.

EndoFLIP (FLIP) is FDA-cleared as an adjunct; FLIP should not replace standard manometry without justification
MiVu mucosal integrity testing has FDA de novo/510(k) clearance but limited evidence — may require PA
Device CPT/HCPCS codes remain reference-only; PA may still be required

Note

Use of FLIP Relative to Standard Tests

Use of FLIP relative to standard tests. FLIP is a complementary, adjunct tool and should not be used as a standalone replacement for high-resolution manometry or barium esophagram for primary diagnosis of achalasia; document intolerance or inability to complete standard tests if FLIP is used instead.

If FLIP used because manometry cannot be completed, document reason (e.g., intolerance, technical failure)
Include FLIP findings and correlate with clinical, endoscopic, and manometry data when available

Denial Risk

Esophageal Mucosal Integrity Testing — Evidence Limits and Documentation

Esophageal mucosal integrity (MI) testing evidence limits and documentation expectations. Current evidence is limited for MI testing (electrical impedance) as a sole diagnostic tool for GERD, EoE, or nonacid reflux; clinical utility data are insufficient. If MI testing is performed, include endoscopic findings and histology/pH monitoring results to support interpretation.

MI testing should not be billed as a standalone definitive diagnostic study; provide supporting endoscopy/pathology or pH monitoring
Document how MI results will change management or why standard diagnostics are inadequate

Prior Authorization

Prior Authorization and Utilization Review

Prior authorization and utilization review tools. The plan may require prior authorization or apply utilization management tools (including third-party criteria such as InterQual) to administer benefits for the services described. Ensure PA is obtained when required by the member's benefit plan.

Check member-specific benefit terms for PA requirements before scheduling
When PA is required, submit complete documentation (see documentation callouts)

Denial Risk

Denial Risk for Unproven Procedures

Denial risk for unproven procedures. Procedures designated as unproven or not medically necessary in this policy (e.g., MRI defecography for certain indications, cutaneous electrogastrography, MI testing for primary diagnosis, FLIP for diagnosing achalasia) may be denied. Submit thorough clinical justification and supporting documentation if pursuing coverage.

Unproven services may be coded but ultimately denied if documentation does not demonstrate medical necessity
If seeking exception, include detailed clinical rationale and prior conservative/diagnostic steps

Documentation Required

Required Clinical Documentation

Required clinical documentation. Provide objective evidence and complete documentation to support medical necessity: relevant history, prior diagnostic test reports (ARM, BET, manometry, pH studies, endoscopy/biopsy), imaging reports, and notes describing how results will affect management.

Attach prior test reports with dates and abnormal findings
Include symptom timeline, prior conservative treatments tried, and rationale for advanced testing
State explicitly how test results will alter patient management or surgical planning

Documentation Required

Documentation When MI Testing Is Used

Documentation when mucosal impedance (MI) testing is used during EGD. If MI testing is performed during EGD, include endoscopic appearance, biopsy/histology results when obtained, and correlate MI measurements with these findings in the documentation submitted for coverage consideration.

Provide endoscopy report, images if available, and histopathology reports
Explain how MI measurements influenced diagnosis or management decisions

Note

Reference Applicable Benefit Plan Terms and Benefit Plan Conflict Risk

Reference applicable benefit plan terms and conflict resolution. Always reference the federal, state, or contractual benefit terms that govern the member's coverage. In case of conflict between this policy and the member's benefit plan, the benefit plan terms govern.

Check member-specific plan documents for coverage differences or mandated services
When in doubt, obtain prior authorization and cite applicable benefit language

Note

Not Specified — Provider Action

Not otherwise specified / provider action. If an indication or circumstance is not explicitly addressed by this policy, submit a detailed summary of clinical findings, prior evaluations, and rationale for the requested service to support case-by-case review.

Provide comprehensive documentation for exceptions or novel clinical scenarios
Consider pre-service review to reduce risk of denial

Studied as an adjunctive diagnostic tool for gastric disorders but evidence is insufficient to support routine clinical use for diagnosing gastric stasis/gastroparesis.

Evidence limitationsStudies vary in technique and quality; standardized recording, analysis, and interpretation protocols are needed.

inv-40: Magnetic Resonance Defecography — definition of MRD

DefinitionA noninvasive MRI test that obtains images at various stages of defecation to evaluate pelvic floor anatomy, dynamic motion, and rectal evacuation.

Typical findingsUsed to detect rectocele, enterocele, intussusception and dyssynergic defecation and to assess multi‑compartment pelvic floor anatomy.

Comparative noteMRD may provide soft‑tissue resolution but in some studies (eg, Pääkkö et al.) had lower technical diagnostic success compared with video/fluoroscopic defecography.

inv-41: Functional Lumen Imaging Probe (FLIP) — definition of catheter-based distensibility measurement

DefinitionA catheter‑based endoscopic system designed to measure esophageal distensibility and lumen dimensions to assess motility and EGJ opening dynamics.

Intended useProvides simultaneous measurement of diameter and pressure to inform assessment of esophagogastric junction compliance as an adjunct to other diagnostics.

GuidanceAGA advises FLIP is complementary and should not be used alone for diagnosis or treatment decisions; not recommended for routine GERD diagnosis or to diagnose EoE.

inv-42: Esophageal Mucosal Integrity Testing — definition as adjunct endoscopic procedure

DefinitionAn adjunct endoscopic procedure performed during EGD that uses impedance measurements to assess esophageal mucosal integrity and help differentiate GERD, EoE, and non‑GERD conditions.

Intended roleProposed as an alternative to prolonged (24‑48 hour) pH monitoring and biopsies to speed diagnostic differentiation during endoscopy.

Evidence considerationsSmall prospective and retrospective studies show distinct MI patterns for GERD vs EoE, but clinical utility on outcomes remains unproven.

inv-43: Functional lumen imaging probe (FLIP) — another FLIP definition/clarification

DefinitionAn FDA‑cleared measurement tool that quantifies simultaneous pressure and diameter to assess esophagogastric junction opening dynamics and esophageal wall stiffness.

Clinical roleIntended as a complementary assessment to standard diagnostics (eg, manometry) and not as the sole basis for diagnosis or treatment decisions.

AvailabilityAvailable commercially as EndoFLIP (Endolumenal FLIP) and has been in clinical use since approximately 2009.

inv-44: Body Surface Gastric Mapping (BSGM) — definition and commercial example

DefinitionA noninvasive, high‑resolution method of recording gastric myoelectrical activity from the body surface to phenotype gastric dysfunction; commercial example cited in the policy is Gastric Alimetry.

Comparative findingsBSGM has shown improved symptom correlation and expanded phenotyping compared with gastric emptying testing in some exploratory studies, but direct evidence of improved patient outcomes is lacking.

Recording protocolStudies report a fasting baseline, standardized meal ingestion, and approximately four‑hour postprandial recording for analysis.

inv-45: MRI defecography (MRD) — definition and typical findings detected

DefinitionDynamic MRI‑based imaging of pelvic floor and defecatory function obtained at stages of evacuation to evaluate anatomy and function.

Typical findings detectedRectocele, enterocele, intussusception, and dyssynergic defecation; can provide multi‑compartment soft‑tissue assessment.

LimitationsTechnique variability and inclusion of an evacuation phase affect sensitivity; MRD may have lower technical diagnostic success than fluoroscopic/video defecography in some studies.

inv-46: BSGM/High-resolution electrogastrography — alternative naming for BSGM

SynonymsAlso referred to as Body Surface Gastric Mapping (BSGM) or high‑resolution electrogastrography (high‑resolution EGG).

ContextHigh‑resolution methods aim to overcome limitations of low‑resolution EGG by providing enhanced spectral and spatial biomarker analyses.

Evidence statusEvolving technology with exploratory studies and systematic reviews highlighting heterogeneity and need for standardized protocols and outcome studies.

inv-47: Balloon catheter or probe-based esophageal mucosal integrity measurement during EGD — mucosal impedance (MI) testing definition

DefinitionA balloon catheter or probe‑based impedance measurement performed during EGD to assess esophageal mucosal integrity (mucosal impedance, MI).

Potential advantageProvides immediate intra‑endoscopic assessment of mucosal integrity that may distinguish GERD, EoE, and non‑GERD patterns.

Regulatory noteMiVu MI system has received FDA de novo clearance (Class II) and subsequent 510(k) references are noted; however, FDA clearance alone is informational and not a coverage determinant.

inv-48: Achalasia — added definition entry in Definitions section (text not present in excerpt)

StatusAchalasia definition was added to the Definitions section in the current policy revision.

Policy implicationFLIP technology for diagnosing achalasia was added to the list of procedures considered unproven and not medically necessary.

Definition sourcePolicy definitions cite standard specialty society descriptions (see Achalasia definition in Definitions).

2026-04-01material change

Functional Lumen Imaging Probe (FLIP) technology for diagnosing achalasia was added to the list of unproven and not medically necessary procedures; examples of specific devices for electrogastrography and mucosal impedance testing were removed from the unproven list.

2026-04-01coding update

Applicable CPT codes 43647, 43648, 43881, 43882, 64590, and 64595 were removed from the Applicable Codes list.

2026-04-01supporting sections updatedLatest

Supporting sections (Description of Services, Clinical Evidence, FDA, and References) were updated and the 'Medical Records Documentation Used for Reviews' section was removed.