CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Ingestible pH and Pressure Capsule

This policy governs coverage and medical necessity determinations for using an ingestible pH and pressure-sensing capsule (SmartPill®) to measure gastrointestinal transit times (gastric emptying and colonic transit) for suspected gastroparesis, constipation, or other GI motility disorders for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyIngestible pH and Pressure Capsule

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2006

Next Review DateN/A

Key ActionVerify member-specific benefits and diagnostic test coverage in the member's benefit documents prior to testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1CPT codes not covered

2006FDA initial clearance

2009FDA expanded indication

08/17/2022Policy last updated

Coverage Determination

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Coverage determination (Not covered / Not medically necessary)

Covered when ALL of the following are met:

Coverage determination

Medicare Advantage: Not covered for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders because the evidence is insufficient to determine the effects of the technology on health outcomes.
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Commercial Products: Considered not medically necessary for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders because the evidence is insufficient to determine the effects of the technology on health outcomes.
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Evidence summary: Available studies assess test concordance with imperfect reference standards and provide limited data on true accuracy and clinical utility; evidence is insufficient to determine effects on health outcomes.
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For Commercial products, measurement of gastrointestinal transit times (including gastric emptying and colonic transit) using an ingestible pH and pressure capsule (SmartPill®) is considered not medically necessary for evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders because the evidence is insufficient to determine effects on health outcomes. CPT code 91112 (wireless capsule gastrointestinal transit and pressure measurement) is listed as not medically necessary / not covered for Commercial products.

Billing and Codes

Not covered / Not medically necessary CPT codeCPTNot Covered

91112

Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report

inv-05: Abnormal gastric retention at 4 hours — numeric threshold criterion

Numeric threshold> 10% of meal remaining at 4 hours

Test timingImaging typically performed at 0, 1, 2, and 4 hours postprandially

Interpretation context>10% retention at 4 hours commonly indicates abnormal gastric emptying (gastroparesis)

Provider Requirements and Billing Guidance

Prior Authorization

No prior authorization applicable. However, services are subject to benefit verification and may be denied as not medically necessary.

Documentation Required

Benefit Verification

Verify member-specific benefits and diagnostic test coverage in the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement prior to scheduling or billing.

Step Therapy

No step therapy requirements specified for this service.

Denial Risk

Denial Risk for CPT 91112

Claims for CPT 91112 (Wireless capsule gastrointestinal transit and pressure measurement, stomach through colon, with interpretation and report) are not covered for Medicare Advantage plans and are considered not medically necessary for Commercial products; such claims may be denied.

CPT 91112: Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report

Clinical Background

Gastroparesis is a disorder of delayed gastric emptying in the absence of mechanical obstruction; symptoms (nausea, vomiting, early satiety, bloating, abdominal pain) are often nonspecific and can overlap with other gastrointestinal conditions. Objective assessment of gastric emptying can help confirm the diagnosis and guide management.

Gastric emptying scintigraphy is the reference-standard diagnostic test and measures meal retention at intervals (commonly 0, 1, 2, and 4 hours); retention of > 10% of the meal at 4 hours is commonly used to define abnormal gastric retention. Alternative tests include radioopaque markers or colonic transit scintigraphy for colonic transit assessment.

An ingestible pH and pressure-sensing capsule (SmartPill®) was FDA 510(k)-cleared in 2006 for evaluation of delayed gastric emptying and later in 2009 for determining colonic transit time. The capsule records pH, pressure, and temperature as it transits the GI tract to infer segmental passage (for example, a rise of about 2 pH units typically indicates gastric emptying) and to calculate total gastrointestinal transit time, but it does not directly measure scintigraphic 50% emptying time.

Device and Test Definitions

inv-11: Ingestible pH and pressure capsule (SmartPill) — device description and measured parameters

Device nameIngestible pH and pressure-sensing capsule (SmartPill® GI Monitoring System)

Measured parameterspH, intraluminal pressure, and temperature during transit through the GI tract

Primary physiologic markerspH changes mark segment passage (e.g., ~2-unit pH rise indicates gastric emptying; ~1-unit fall indicates ileocecal passage)

Calculated metricsTotal gastrointestinal transit time and segmental transit times (can be correlated with scintigraphic 50% emptying time)

Regulatory status noteFDA 510(k) cleared in 2006 for evaluation of delayed gastric emptying; indication expanded in 2009 for colonic transit assessment

inv-12: Gastric emptying scintigraphy — reference standard test description

Test nameGastric emptying scintigraphy (reference standard)

ProcedurePatient ingests a radionuclide-labeled standard meal with images acquired at 0, 1, 2, and 4 hours postprandially

Primary measurementPercent of meal retained in the stomach at each imaging interval

Abnormal criterion> 10% of the meal remaining at 4 hours indicates abnormal gastric emptying