ModifiedCapital BluecrossPolicy MP 6.007

External Infusion Pumps for Insulin Delivery and Automated Insulin Delivery Systems

Governs medical necessity and coverage criteria for external insulin infusion pumps and FDA-cleared automated insulin delivery (AID) systems for individuals with diabetes, including indications, replacement rules, device classifications, and documentation required for prior authorization.

Policy Summary

PayerCapital Bluecross

PolicyExternal Infusion Pumps for Insulin Delivery and Automated Insulin Delivery Systems

Policy CodePolicy MP 6.007

Change TypeCriteria revisedAID coverage expanded to T2D when criteria met

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and provide documentation of medical necessity (age, diagnosis, prior pump use, glycemic control, hypoglycemia history) when requesting external pumps or FDA-cleared AID systems.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for external infusion pumps; Automated insulin delivery systems now medically necessary for type 2 diabetes when medical necessity criteria is met.

Automated insulin delivery system section criteria updated; allowance for T2D removed previously then reinstated as medically necessary when criteria met.

Policy renamed from Artificial Pancreas System to Automated Insulin Delivery System.

>=6 yrsMinimum age for many AID indications

A1c 5.8–10.0%Glycated hemoglobin range for certain AID coverage

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Clinical trials supporting AID systems

MP 6.007Policy identifier

11/20/2025Most recent minor review

Coverage Criteria for External Infusion Pumps and AID Systems

External insulin infusion pumps (general)

Covered when ALL of the following are met

External infusion pump necessity: External insulin infusion pumps for treatment of insulin dependent diabetes mellitus may be considered medically necessary in individuals who cannot be controlled by intermittent dosing.

Acceptable routes are subcutaneous and intravenous.

AID with low glucose suspend (type 1 diabetes)

Covered when ALL of the following are met

Age and diagnosis: Age 6 years and older and diagnosis of type 1 diabetes.>=6 years

Glycated hemoglobin level between 5.8% and 10.0%.5.8% to 10.0%

Prior pump use: Used insulin pump therapy for more than 6 months.>6 months

Hypoglycemia history: At least 2 documented nocturnal hypoglycemic events in a 2-week period.>=2 events in 2 weeks

Hybrid closed-loop (type 1 diabetes) — age-specific criteria

Covered when ALL of the following are met (two alternative age-based branches)

Branch A: Age >=6: Age over 6 years AND glycated hemoglobin level between 5.8% and 10.0% AND used insulin pump therapy for more than 6 months AND at least 2 documented nocturnal hypoglycemic events in a 2-week period.

Branch B: Age 2–6: Age 2 to 6 years AND clinical diagnosis of type 1 diabetes for 3 months or more AND used insulin pump therapy for more than 3 months AND glycated hemoglobin level <10.0% AND minimum daily insulin requirement (total daily dose) >= 8 units.TDD >= 8 units

Closed-loop AID (type 1 diabetes)

Covered when ALL of the following are met

Age 6 years and older.>=6 years

Duration of diagnosis: Clinical diagnosis of type 1 diabetes for 12 months or more.>=12 months

Insulin use duration: Using insulin for at least 12 months.>=12 months

Stable regimen: Diabetes managed using the same regimen (either pump or multiple daily injections, with or without continuous glucose monitoring) for 3 months or longer.

Hybrid closed-loop AID (type 2 diabetes)

Covered when ALL of the following are met

Age 18 years and older.>=18 years

Duration: Diagnosed with type 2 diabetes for at least 12 months.>=12 months

Insulin regimen: On multiple daily injections (insulin administration >3 times per day) or using an insulin infusion pump for at least 3 months.>=3 months or >3 injections/day

Multiple daily injections defined in policy as 3 or more per day.

Glycemic control or hypoglycemia:

Evidence-based coverage rationale for AID device classes

Summary conclusions from evidence sections

AID systems with low glucose suspend: Evidence from randomized controlled trials and observational studies demonstrates reduced hypoglycemia and clinically significant benefits in individuals with type 1 diabetes; the evidence is sufficient to determine improvement in net health outcome.

Supports coverage with medical necessity determination

Hybrid closed-loop systems: Pivotal trials and device studies show reductions in hypoglycemia, improved time-in-range, and low rates of device-related adverse events; evidence is sufficient to determine improvement in net health outcome.

Supports coverage with medical necessity determination

Closed-loop systems: A multicenter randomized controlled trial (iLet Bionic Pancreas) demonstrated significant HbA1c reduction versus usual care with acceptable safety; evidence is sufficient to determine improvement in net health outcome.

Supports coverage with medical necessity determination

Revised coverage stance (history notes)

Policy history indicates distinct coverage criteria groups have been revised over time for external infusion pumps and AID systems; current coverage reflected elsewhere

policy_changes: Automated insulin delivery systems are now medically necessary for type 2 diabetes when medical necessity criteria are met; external infusion pump criteria have been updated in recent minor reviews.

Treat external infusion pumps and AID systems as separate coverage groups in the main policy document.

Use of an automated insulin delivery system that is not cleared or approved by the FDA is considered investigational. The policy states there is insufficient evidence to support a general conclusion concerning health outcomes or benefits for devices that lack FDA clearance or approval.

Requests for replacement of an insulin pump that is out of warranty must include documentation that the pump is non‑operational (from treating physician notes or device supplier customer service notes) or documentation that the member reverted to multiple daily injections or used a loaner pump because the pump was non‑operational. Replacement for other reasons is considered investigational.

Certain device features (for example threshold suspend/low glucose suspend) are not intended to be used directly for making manual insulin therapy adjustments. These features provide an indication that a finger‑stick glucose check may be required; therapy adjustments should be based on measurements from a home glucose monitor rather than on the device’s sensor values.

The policy's Benefit Variations Section was removed (6/23/2025). Providers should review the active policy text for current exclusions and any benefit‑specific variations that may affect coverage determinations.

Use of an automated insulin delivery system (AID) is considered investigational for individuals who do not meet the specific coverage criteria outlined in this policy, due to insufficient evidence to support benefit for other indications.

Some components of AID systems — for example the continuous glucose monitoring or threshold suspend features — are not intended to be used directly for making manual therapy adjustments, but rather to signal when confirmatory finger‑stick testing or clinician‑directed adjustments are needed.

Previous limitations and allowances (for example earlier statements that AID systems were allowed only for type 1 diabetes) have been revised in policy history. Consult the current policy language for explicit statements of when AID systems are medically necessary versus not medically necessary.

Coding and Device Listings

FDA-approved device tablemixed

No codes listed

Covered when medically necessaryHCPCS

E0784	External ambulatory insulin pump (as listed)
A4225	Procedure code listed in coding section
E0787	Procedure code listed in coding section
A4226	Procedure code listed in coding section
S1034	Procedure code listed in coding section
A4230	Procedure code listed in coding section
S1035	Procedure code listed in coding section
A4231	Procedure code listed in coding section
S1036	Procedure code listed in coding section
A4232	Procedure code listed in coding section

1–10 of 12

1/2

Policy coding changes noted in historyHCPCS

A4226	code added to policy in 2020
E0787	code added to policy in 2020
A4239	code added to policy in 11/29/2022 administrative update
E2103	code added to policy in 11/29/2022 administrative update

Predictive low glucose management trigger

Predictive low glucose management triggerSuspend when sensor glucose is at or within 70 mg/dL above patient-set low limit and predicted to be 20 mg/dL above low limit in 30 minutes.

Maximum automatic suspend durationInfusion resumes after a maximum suspend period of two hours unless patient responds or auto-resumption parameters apply.

Action when sensor above thresholdWhen a sensor value is above or predicted to remain above the threshold, the infusion pump will not take any action based on CGM readings.

Note(Inventory placeholder — no explicit label or content provided in source brief.)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required to establish medical necessity for external insulin infusion pumps and FDA‑cleared automated insulin delivery (AID) systems. Providers must confirm member eligibility and benefits prior to submission; listing of a code does not guarantee coverage.

Prior authorization required to document medical necessity for pumps and AID systems.
Coverage and payment are subject to member's benefit program and eligibility on date of service.

Billing Rule

Coding and Coverage Depend on Benefit and Medical Necessity

Coding and coverage depend on the member’s benefit plan and documented medical necessity. The presence of HCPCS or procedure codes in the policy’s coding section does not imply automatic coverage; verify benefits and obtain prior authorization as needed.

Background and Clinical Context

External infusion pumps are portable, battery‑operated devices that provide continuous ambulatory drug infusion (including subcutaneous insulin) and are used when intermittent dosing cannot adequately control diabetes. These pumps deliver basal and bolus insulin over extended periods to manage insulin‑dependent diabetes.

Definitions

External Infusion Pump (EIP)

TermExternal Infusion Pump (EIP)

DefinitionA portable battery-operated device intended to provide continuous ambulatory drug infusion therapy over an extended time period; includes pumps delivering drugs via subcutaneous, intravenous and other routes; reservoir refilling is noninvasive.

Alternate namesAlso known as external pump, ambulatory pump, or mini-infuser.

RoutesProposed delivery routes include intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, intrathecal, and intraventricular.

Automated Insulin Delivery System (AID)

TermAutomated Insulin Delivery System (AID)

Policy Revision History

2025-11-20Minor review - materialLatest

Updated criteria for external infusion pumps; automated insulin delivery systems (AID) made medically necessary for type 2 diabetes when medical necessity criteria are met.

2024-12-27Minor review - material

Automated insulin delivery system section criteria updated; allowance limited to individuals with type 1 diabetes (T1D).

2023-12-14

Policy Summary

PayerCapital Bluecross

PolicyExternal Infusion Pumps for Insulin Delivery and Automated Insulin Delivery Systems

Policy CodePolicy MP 6.007

Change TypeCriteria revisedAID coverage expanded to T2D when criteria met

Effective DateMay 1, 2026

Next Review Date

SourceLink

On This Page

Glycated hemoglobin level >7% or experiencing significant hypoglycemia.

A1c >7% or significant hypoglycemia

See policy guidelines for trial evidence supporting approvals (e.g., Omnipod 5 and t:slim X2 approvals).

ActionNo threshold or value specified in the policy brief for this inventory item.

Multiple daily injections

DefinitionMultiple daily injections defined as 3 or more insulin injections per day.

ContextUsed in policy criteria for patients with type 2 diabetes considered for hybrid closed‑loop AID: on multiple daily injections (insulin administration >3x/day) or using an insulin infusion pump for at least 3 months.

Policy history noteMultiple daily injections clarified as 3 or more per day in 12/14/2023 minor review.

Confirm coverage with member's benefit information before billing.
Use codes listed in the policy's coding section only when medical necessity criteria are met and benefits allow coverage.

Documentation Required

Replacement Supporting Documentation

Requests for replacement of an insulin pump that is out of warranty must include clear and conclusive documentation that the pump is non‑operational (from treating physician notes or device supplier customer service notes) or documentation that the member reverted to multiple daily injections or used a loaner pump because the pump was non‑operational. Replacement requests lacking this documentation are investigational/not covered.

Acceptable documentation: physician office notes or device supplier service notes confirming non‑operation.
Alternatively, documentation that the member reverted to multiple daily injections or used a loaner pump due to non‑operation.

Step Therapy

Prior Treatment/Therapy Requirements

Coverage of external infusion pumps and AID systems requires documented prior treatment attempts where applicable. External infusion pumps are considered when diabetes cannot be controlled by intermittent dosing; AID coverage requires documented prior therapy attempts per the policy's medical necessity criteria (for example, prior use of insulin pump therapy for specified durations in the criteria for AID systems).

External infusion pumps: considered when intermittent dosing fails to control diabetes.
AID systems: meet the specific prior therapy and duration requirements listed in the policy (e.g., >3–6 months of prior pump use where applicable).

Note

Policy History and Updates

Policy history documents changes to criteria and coding over time; providers should reference the current MP 6.007 for exact documentation, coding, and prior authorization requirements. Updates to criteria may change coverage determinations.

Refer to MP 6.007 policy history for past revisions to clinical criteria and coding updates.
Consult the current policy text for the most recent documentation requirements and coverage rules.

A system combining continuous glucose monitoring (CGM) and an insulin pump with a control algorithm that automatically stops, reduces, or increases insulin infusion based on measured interstitial glucose to maintain glucose near a target range.

ComponentsIncludes CGM, insulin pump, and an external processor/controller with embedded control algorithm that communicates dosing instructions to the pump.

HCL (hybrid closed-loop)

TermHybrid closed-loop (HCL)

DefinitionSystems that autonomously adjust basal insulin delivery in response to sensor glucose values but still require the user to administer premeal (prandial) insulin boluses manually.

CapabilitiesMay automatically increase or decrease basal insulin; next-generation systems can also deliver automatic correction boluses but still require prandial dosing by the person with diabetes.

Closed-loop (CL)

TermClosed-loop (CL)

DefinitionAutomated insulin delivery with continuous glucose sensing and insulin delivery that operates without patient intervention, using a control algorithm that autonomously and continually adjusts subcutaneous insulin delivery based on real-time sensor glucose.

DistinctionClosed-loop systems differ from hybrid systems by providing insulin delivery without requiring patient-initiated prandial boluses.

LGS / PLGM

TermLGS / PLGM

DefinitionLow glucose suspend (LGS) / Predictive low glucose management (PLGM) — features that suspend insulin delivery at or before low glucose thresholds to reduce hypoglycemia risk.

PLGM trigger examplePLGM suspends basal infusion when sensor glucose is at or within 70 mg/dL above patient-set low limit and predicted to be 20 mg/dL above that low limit in 30 minutes.

Automated Insulin Delivery System (policy term)

Term updateAutomated Insulin Delivery System (policy term)

Former termPreviously titled 'Artificial Pancreas System' — renamed in policy updates.

MeaningDenotes integrated systems (pump + algorithm + CGM) that automate insulin dosing.

Continuous Subcutaneous Insulin Infusion (insulin pump)

TermContinuous Subcutaneous Insulin Infusion (insulin pump)

DefinitionAn external infusion pump delivering continuous basal and bolus insulin subcutaneously; used for ambulatory insulin delivery and referenced in clinical literature and guidelines.

ContextIncluded in the policy's definitions and background as a form of external infusion pump for insulin delivery.

Minor review - administrative/clarifying

Policy title changed from Artificial Pancreas System to Automated Insulin Delivery System; modified AID criteria and allowances for type 2 diabetes.

2022-11-29Administrative update - coding

Administrative update added new billing codes A4239 and E2103 to the policy coding table.

2020-01-01Administrative update - coding

New 2020 codes A4226 and E0787 were added to the policy.