CurrentMass General Brigham Health PlanPolicy 030

Insulin Pumps

Mass General Brigham Health Plan's medical policy governing coverage and medical necessity determinations for external insulin pumps and related supplies for plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyInsulin Pumps

Policy CodePolicy 030

Change TypeAnnual updateadded MassHealth and Medicare variations

Effective DateDec 1, 2024

Next Review Date

Key ActionTreating endocrinologist must sign a prescription for any requested insulin pump or supply at least yearly.

SourceLink

POLICY UPDATE CHANGES

Added MassHealth Variation.

Added policy article to Medicare Variation.

Prior authorization is currently not required for insulin pumps.

Not requiredPrior auth

1Annual prescriber signature

4+Document types

A4230-A4232Informational codes

Coverage Criteria

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Coverage criteria — general

Covered when recommended by the member's providers and medical necessity is supported by clinical documentation:

Medical necessity documentation: Medical history; diabetes education received; treatment to date; glucose reading logs; treatment plan; pertinent laboratory testing

Documentation must support provider recommendation

Prescriber authorization: Treating endocrinologist must sign a prescription for any requested insulin pump/supply at least yearly

Annual prescription signature required

Coding / Clinical Thresholds

Informational codesHCPCS

A4230	Infusion set for external insulin pump, non-needle cannula type.
A4231	Infusion set for external insulin pump, needle type.
A4232	Syringe with needle for external insulin pump, sterile, 3 cc.
A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories.
E0784	External ambulatory infusion pump, insulin.

Hypoglycemia thresholds

Treatment thresholdBlood glucose ≤70 mg/dL — treat with fast-acting carbohydrates

Clinically significant hypoglycemiaBlood glucose <54 mg/dL — considered serious/clinically significant

Severe hypoglycemiaSevere cognitive impairment requiring assistance from another person for recovery

Provider Actions and Billing Rules

Note

Prior Authorization Not Required

Prior authorization is not required for insulin pumps under Mass General Brigham Health Plan. Providers should still follow standard documentation and billing practices when submitting claims.

Applies to Commercial, MassHealth, and Medicare Advantage: No Prior Authorization required

Step Therapy

There are no step therapy requirements specified for insulin pumps. Providers may order pumps as clinically indicated without completing prior step-therapy trials.

Denial Risk

Replacement and Repair — Denial Triggers

Replacement or repair requests for insulin pumps may be denied when specific conditions are met. Providers should confirm and document device status and clinical need before submitting requests.

Replacement/repair denied if member has a functioning model and an upgraded/newer model is not medically necessary
Denied for loss/theft or damage due to improper care, misuse, or neglect — Mass General Brigham Health Plan may require proof (police report, pictures, or corroborating statement)
Denied when devices or features are primarily for convenience and not medically necessary
Denied when devices or features are experimental or investigational

Documentation Required

Required Clinical Documentation

Clinical documentation used to determine medical necessity should be included with requests and maintained in the medical record.

Medical history
Diabetes education received
Treatment to date
Glucose reading logs
Treatment plan
Pertinent laboratory testing
Prescription signed annually by treating endocrinologist

Background

External insulin pumps are computerized, wearable devices that deliver insulin subcutaneously to manage blood glucose. Coverage decisions distinguish between pump systems covered under the medical benefit and self-administered transdermal delivery systems (such as V-Go) excluded from the medical benefit and potentially payable under the pharmacy benefit. Replacement and repair coverage is limited when a functioning model exists, when upgrades lack medical necessity, or when devices are lost, stolen, or damaged through misuse—documentary proof may be required.

Definitions

External insulin pump definition

Primary definitionExternal insulin pump: a computerized, battery-powered device with programming capabilities that delivers insulin subcutaneously

Delivery methodDelivers insulin in a programmed and controlled manner to eliminate need for self-injection

Clinical goalAims to achieve near-normal blood glucose to prevent acute and chronic complications of diabetes

Continuous Glucose Monitors (CGM) definition

DefinitionContinuous Glucose Monitors (CGM): minimally invasive or noninvasive devices that measure interstitial fluid glucose continuously over days to provide information not captured by intermittent testing

Measurement methodMeasure interstitial fluid (ISF) glucose with a subcutaneously implanted sensor; may require calibration with fingerstick testing

IntegrationSome insulin pump systems include a built-in CGM; CGM with intensive insulin regimens can lower HbA1c in selected patients

Hypoglycemia definition and thresholds

DefinitionHypoglycemia: low blood glucose requiring treatment — see thresholds

Threshold for treatment≤70 mg/dL — sufficiently low for treatment with fast-acting carbohydrates

Clinically significant threshold<54 mg/dL — considered serious, clinically significant hypoglycemia

Glycated hemoglobin (HbA1c) definition

DefinitionGlycated hemoglobin (HbA1c): hemoglobin with glucose attached, reflecting average glucose exposure over the ~120-day red blood cell lifespan

Diagnostic threshold (ADA)HbA1c ≥6.5% is one criterion for diagnosing diabetes (2018/2019 ADA Standards)

Clinical useMeasuring glycated hemoglobin assesses effectiveness of diabetes therapy by reflecting average glycemic exposure

Revision History

2024-12annual_updateLatest

Annual update: Added MassHealth Variation and added policy article to Medicare Variation; effective December 2024.

2023-01annual_update

Annual update: Added insulin pumps to the Overview and added MassHealth statement to Coverage Guidelines.

2023-12annual_update

Annual update: Medicare Advantage added to table 1 and Medicare Variation language updated; references updated.

2021-12annual_update

Annual update: References updated.

2019-12policy_change

Annual update: Prior authorization requirement removed from table 1; pulsatile intravenous insulin therapy exclusion removed; Definitions and References updated.

2018-12annual_update

Annual update.

2018-04coding_update

Added billing codes to the policy.

2017-11annual_update

Annual update.

2017-02criteria_change

InterQual criteria replaced McKesson's criteria as indicated in the policy.

2016-07annual_update

Annual update.

2015-07effective_date

Policy effective date established.

Policy Summary

PayerMass General Brigham Health Plan

PolicyInsulin Pumps

Policy CodePolicy 030

Change TypeAnnual updateadded MassHealth and Medicare variations

Effective DateDec 1, 2024

Next Review Date

Key ActionTreating endocrinologist must sign a prescription for any requested insulin pump or supply at least yearly.

SourceLink

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