CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Ingestible pH and Pressure Capsule

This policy governs coverage and medical necessity determinations for use of an ingestible pH and pressure-sensing capsule (e.g., SmartPill) to measure gastric emptying, colonic transit time, and total gastrointestinal transit time for suspected gastroparesis, constipation, and 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 change

Effective DateAug 1, 2006

Next Review DateFeb 5, 2025

Key ActionDo not submit claims for measurement of GI transit times using an ingestible pH and pressure capsule for suspected gastroparesis or constipation because it is not covered / considered not medically necessary.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredPolicy stance

91112Not covered code

2006FDA clearance

2009FDA expanded use

Feb 05, 2025Last review

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Coverage Criteria

Coverage stance for ingestible pH and pressure capsule testing

Policy position

Policy position: Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is not covered/not medically necessary for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders as the evidence is insufficient to determine the effects of the technology on health outcomes.

Applies to Commercial Products and Medicare Advantage per document

The SmartPill (ingestible pH and pressure capsule) is not for use in pediatric patients per FDA labeling.

For Commercial Products, measurement of gastrointestinal transit times using an ingestible pH and pressure capsule 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 motility capsule study with interpretation and report) is listed as not medically necessary / not covered for Commercial Products and Medicare Advantage.

Coding

Not covered / not medically necessaryCPTNot Covered

91112

Wireless motility capsule study with interpretation and report

Scintigraphic threshold for abnormal gastric emptying

Abnormal gastric emptying threshold (scintigraphy reference)>10% of meal remaining at 4 hours

Scintigraphy timingImages at 0, 1, 2, and 4 hours postprandially

Reference standardGastric emptying scintigraphy is the reference standard for diagnosing gastroparesis

Provider Actions and Administrative Requirements

Prior Authorization

Prior authorization is not required.

Note

Medical Criteria

Medical criteria: Not applicable.

Documentation Required

Benefit Verification and Member-Specific Documentation

Benefits may vary between groups/contracts. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable diagnostic test benefits/coverage. For member-specific coverage determinations, verify eligibility and benefits before providing services.

Verify member eligibility and benefits prior to scheduling diagnostic testing.

Background

Gastroparesis is a chronic disorder characterized by delayed gastric emptying in the absence of mechanical obstruction; symptoms are nonspecific and may be idiopathic, diabetic, or postsurgical. Standard diagnostic testing for gastroparesis typically relies on gastric emptying scintigraphy, while constipation evaluation may use radioopaque markers or colonic transit studies.

An ingestible pH and pressure-sensing capsule (SmartPill) measures pH, pressure, and temperature changes during gastrointestinal transit to infer segmental transit: a rise in pH of approximately 2 units typically signals gastric emptying and a subsequent decrease of about 1 unit indicates passage to the ileocecal junction. The capsule allows calculation of total gastrointestinal transit time and was FDA-cleared in 2006 for evaluation of delayed gastric emptying and expanded in 2009 to determine colonic transit time.

This policy position reflects that measurement of gastric emptying, colonic transit time, and total gastrointestinal transit time using an ingestible pH and pressure capsule is not covered / not medically necessary for the evaluation of suspected gastroparesis, constipation, or other GI motility disorders due to insufficient evidence of impact on health outcomes.

Definitions

SmartPill / ingestible pH and pressure capsule (definition and regulatory status)

Device descriptionOrally administered pH and pressure-sensing capsule (SmartPill) that measures pH, pressure, and temperature during GI transit

Gastric emptying signalGastric emptying is signaled by an increase of ~2 or more pH units as the capsule moves from stomach to small intestine

Ileocecal passage signalPassage to the ileocecal junction is usually indicated by a decrease of ~1 or more pH units

Regulatory statusFDA-cleared in 2006 for evaluation of delayed gastric emptying; FDA expanded use in 2009 to determine colonic transit time; not for use in pediatric patients