CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Ingestible pH and Pressure Capsule

Defines coverage and medical necessity for use of ingestible pH and pressure-sensing capsule (SmartPill GI Monitoring System) to measure gastric emptying and colonic transit times for suspected gastroparesis, constipation, or other gastrointestinal motility disorders for BlueCHiP for Medicare and commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Ingestible pH and Pressure Capsule

Policy CodePolicy N/A

Change TypeClarified (no material change)

Effective DateAug 1, 2006

Next Review Date

Key ActionSubmitters should expect that CPT 91112 is not covered under BlueCHiP for Medicare and is considered not medically necessary for Commercial products for evaluation of suspected gastroparesis, constipation, or other GI motility disorders.

SourceLink

POLICY UPDATE CHANGES

Policy last updated 04/02/2020; coverage position states technology is not covered / not medically necessary due to insufficient evidence.

1CPT codes listed as not covered

2Payer product categories referenced

Coverage Summary

Defines coverage and medical necessity for the use of an ingestible pH and pressure-sensing capsule (SmartPill GI Monitoring System) to measure gastric emptying and colonic transit times for suspected gastroparesis, constipation, or other gastrointestinal motility disorders. Coverage stance: not covered / not medically necessary for the stated indications.

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Coverage / Medical Necessity Determination

Coverage Determination

Measurement of gastrointestinal transit times using an ingestible pH and pressure capsule is covered only as stated below; otherwise not covered/not medically necessary:

ALL of the following

For BlueCHiP for Medicare: Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is not covered for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders because evidence is insufficient to determine effects on health outcomes.
For Commercial Products: Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is considered not medically necessary for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders because evidence is insufficient to determine effects on health outcomes.

Not Covered / Not Medically Necessary

Measurement of gastrointestinal transit times using an ingestible pH and pressure capsule (SmartPill) is not covered for BlueCHiP for Medicare and is considered not medically necessary for Commercial products when used to evaluate suspected gastroparesis, constipation, or other gastrointestinal motility disorders.

Rationale: the evidence is insufficient to determine the effects of the technology on health outcomes; available studies primarily assess concordance with standard tests, provide moderate correlation but limited data on clinical utility or impact on patient outcomes, so net improvement in health outcomes cannot be determined.

Provider Actions / Billing Impact

Denial Risk

Claims for CPT 91112 will be denied / not covered

Submitters should expect that CPT 91112 is not covered under BlueCHiP for Medicare and is considered not medically necessary for Commercial products for evaluation of suspected gastroparesis, constipation, or other GI motility disorders.

91112

Documentation Required

Refer to member Evidence of Coverage / Subscriber Agreement

Benefits may vary by contract; providers must refer to the appropriate Evidence of Coverage or Subscriber Agreement for applicable diagnostic test benefits and coverage determination before billing.

Benefits vary by contract

Background and Evidence

The SmartPill is an ingestible wireless motility capsule that measures pH, pressure, and temperature to infer passage through gastrointestinal segments and estimate gastric emptying and total GI transit times.

The device was FDA 510(k) cleared in 2006 for evaluation of delayed gastric emptying and in 2009 for determination of colonic transit time; it is not for use in pediatric patients.

Gastric emptying scintigraphy is considered the reference standard for gastroparesis (abnormal if > 10% of meal remains at 4 hours), and standard tests for constipation include radioopaque markers and colonic transit scintigraphy; studies show the SmartPill can be correlated with scintigraphic measurements but has limited data on clinical accuracy and utility.

Evidence

Unsupported block type: paragraph

Definitions

Unsupported block type: definition

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Revision History

04/02/2020policy_updateLatest

Policy last updated 04/02/2020; coverage position states measurement of gastrointestinal transit times using an ingestible pH and pressure capsule (SmartPill) is not covered / considered not medically necessary due to insufficient evidence to determine effects on health outcomes.

publication

Provider Updates published variously (Jan 2017, Apr 2015, Jan 2018, Nov/Dec 2018, July 2019, June 2020) with no specific clinical policy change noted in headers.