External Infusion Pumps for Insulin Delivery and Automated Insulin Delivery Systems
Customize your policy alerts
Sign up for Capital Bluecross Policy MP 6.007 alerts
Get alerted when Policy MP 6.007 changes without checking for updates manually.
Monitor payer policy activity
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.
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.
Coverage Criteria for External Infusion Pumps and AID Systems
External insulin infusion pumps (general)
Covered when ALL of the following are met
Acceptable routes are subcutaneous and intravenous.
AID with low glucose suspend (type 1 diabetes)
Covered when ALL of the following are met
Hybrid closed-loop (type 1 diabetes) — age-specific criteria
Covered when ALL of the following are met (two alternative age-based branches)
Closed-loop AID (type 1 diabetes)
Covered when ALL of the following are met
Hybrid closed-loop AID (type 2 diabetes)
Covered when ALL of the following are met
Multiple daily injections defined in policy as 3 or more per day.
See policy guidelines for trial evidence supporting approvals (e.g., Omnipod 5 and t:slim X2 approvals).
Evidence-based coverage rationale for AID device classes
Summary conclusions from evidence sections
Supports coverage with medical necessity determination
Supports coverage with medical necessity determination
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
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
| No codes listed |
| 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 |
Provider Actions, Prior Authorization, and Documentation
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.
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.
- 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.
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.
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).
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.
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
Policy Revision History
Updated criteria for external infusion pumps; automated insulin delivery systems (AID) made medically necessary for type 2 diabetes when medical necessity criteria are met.
Automated insulin delivery system section criteria updated; allowance limited to individuals with type 1 diabetes (T1D).
Policy title changed from Artificial Pancreas System to Automated Insulin Delivery System; modified AID criteria and allowances for type 2 diabetes.
Administrative update added new billing codes A4239 and E2103 to the policy coding table.
New 2020 codes A4226 and E0787 were added to the policy.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.