Automated Insulin Delivery Systems (Clinical UM Guideline)
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Clinical guideline for coverage and medical necessity of automated insulin delivery systems (open-loop, hybrid closed-loop, and fully closed-loop) combining insulin pumps and continuous interstitial glucose monitors for management of diabetes mellitus; intended for use by Blue Cross Blue Shield - North Carolina in utilization review and coverage determinations.
Revised medical necessity criteria for hybrid open- and hybrid closed-loop devices to include type 2 diabetes.
Updated Coding section with 10/01/2025 ICD-10-CM changes; added E11.A to end of range.
Removed criteria related to HbA1c range and revised criteria related to blood glucose concentrations and self-monitoring.
Coverage and Medical Necessity Criteria
Open-loop or Hybrid Closed-loop Initial Use
Covered when ALL of the following are met:
Fully Closed-loop Initial Use
Covered when ALL of the following are met:
Continued Use
Covered when ALL of the following are met:
Replacement of Previously Approved Device
Covered when ALL of the following are met:
Evidence summaries
Clinical outcomes reported in the guideline (evidence summary):
refs include Agrawal 2015; Bergenstal 2013; Forlenza 2019; Gómez 2017; Ly 2013
refs include Bergenstal 2016; Breton 2020/2021; Brown 2019/2021; Kudva 2024/2025
refs include Russell 2022; Beck 2022; Lynch 2022; Messer 2022; others
refs include Pasquel 2025; Kudva 2025b
Evidence summaries
Evidence and device authorization summaries included in this section
See Beck 2022, Forlenza 2016, Thabit 2017, Brown 2017, Bally 2018
FDA-authorized/cleared devices
Devices that have FDA authorization/clearance noted in the document
FDA links provided in original document.
Medical Necessity (revised)
Policy includes medical necessity criteria for hybrid open- and hybrid closed-loop AID devices; criteria were revised to include type 2 diabetes and to remove HbA1c range requirements.
MPTAC review and coding updates documented in History.
Use of a non–FDA-approved open-loop, hybrid closed-loop, or fully closed-loop automated insulin delivery system is considered not medically necessary under all circumstances.
Coverage determinations must follow Federal and State law, the member's contract language (benefits in effect on the date of service), and the plan's Medical Policy; these take precedence over Clinical UM Guidelines. Adoption of a Clinical UM Guideline may vary by plan, and utilization review or prior authorization requirements should be confirmed with the customer service number on the member's card.
Devices that have not received FDA approval or clearance and are not commercially available in the U.S. (examples include DiAs, Dana Diabecare-based investigational systems, and dual‑hormone or bionic‑pancreas devices) are considered investigational and are not addressed for coverage in this guideline.
Federal and State law, contract provisions (including definitions and explicit coverage provisions or exclusions), and Medical Policy may include specific terms that take precedence over these Clinical UM Guidelines and must be applied first when determining eligibility for coverage.
Requests for insulin pumps alone are addressed elsewhere; the list of device product names in this document is illustrative only and is not exhaustive or a recommendation of any specific product.
When the policy medical necessity criteria are not met, requests for use, continued use, or replacement of an automated insulin delivery system are not medically necessary. This includes replacement of devices that are currently functional and still under warranty, and procedure codes describing such services are not medically necessary when criteria are not satisfied or for diagnoses not listed.
The policy removed prior criteria related to specific HbA1c range requirements; therefore, specific HbA1c ranges are no longer required elements for determining not‑medically‑necessary status in this guideline.
Billing and Diagnosis Codes
| E0784 | External ambulatory infusion pump, insulin [ when specified as a component of an automated insulin delivery system in conjunction with a continuous glucose monitoring device] |
| E0787 | External ambulatory infusion pump, insulin, dosage rate adjustment using therapeutic continuous glucose sensing |
| S1034 | Artificial pancreas device system (e.g., low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices |
| E08.00-E08.9 | Diabetes mellitus due to underlying conditions |
| E09.00-E09.9 | Drug or chemical induced diabetes mellitus |
| E10.10-E10.A2 | Type 1 diabetes mellitus |
| E11.00-E11.A | Type 2 diabetes mellitus |
| E13.00-E13.9 | Other specified diabetes mellitus |
| O24.011-O24.93 | Diabetes mellitus in pregnancy, childbirth and the puerperium |
| P70.2 | Neonatal diabetes mellitus |
| © CPT Only -American Medical Association | CPT copyright notice shown in document |
| E11.A | ICD-10-CM code added to end of range (document notes coding update) |
Prior Authorization, Documentation, and Utilization Review
Verify plan adoption of Clinical UM Guidelines before utilization review
Clinical UM Guidelines are used when a plan performs utilization review; verify whether the member’s plan has adopted this Clinical UM Guideline and contact the customer service number on the back of the member’s card to determine if prior authorization or utilization review is required.
- Confirm plan adoption of Clinical UM Guidelines
- Call customer service on the member’s card to verify review/authorization requirements
Contact plan for prior authorization requirements
Plans may require utilization review or prior authorization based on contract language; contact the customer service number on the back of the member’s card to determine plan‑specific requirements.
- Use the member’s contract benefits in effect on the date of service when determining review requirements
Contact customer service to confirm utilization review need
To determine whether utilization review or prior authorization is required for this Clinical UM Guideline, contact the customer service number on the back of the member’s card.
- Member’s contract benefits in effect on date of service must be used
Determine if prior authorization is required for member
Utilization review may be required for services under this guideline; contact the customer service number on the back of the member’s card to determine if prior authorization is needed for the member’s plan.
- Apply the member’s contract benefits in effect on the date services are rendered
Document prior use and continued use of self‑monitoring and insulin regimens
Before requesting an automated insulin delivery system, document that the individual has tried and continues to use self‑monitoring and insulin administration regimens (multiple daily injections or an insulin pump) to optimize care.
- Insulin injections required multiple times daily or use of an insulin pump must be documented
- Evidence of ongoing self‑monitoring and optimization of usual care should be included
Step therapy not specified
No step therapy requirements are specified in these document sections.
Required documentation for initial and continued coverage
Documentation submitted for eligibility and continued use must show the diabetes type, the member’s age consistent with FDA approval or authorization for the device, and that insulin injections multiple times daily or use of an insulin pump are required; for continued use, include documentation that the device has resulted in clinical benefit.
- State diabetes diagnosis (type 1 or type 2)
- Age consistent with device FDA approval/authorization
- Evidence of requirement for multiple daily insulin injections or insulin pump use
- For continued use: documentation of clinical benefit (e.g., improved/stable HbA1c or fewer symptomatic hypo/hyperglycemia episodes)
Use Clinical UM Guidelines and member contract during utilization review
When performing utilization review, use the Clinical UM Guidelines and the member’s contract benefits in effect on the date services are rendered; contact the customer service number on the back of the member’s card to determine if review is required.
- Consider Clinical UM Guidelines before applying medical opinion
- Verify member contract benefits on date of service
Consult Clinical UM Guidelines and contact plan to confirm review need
Consider Clinical UM Guidelines when making medical determinations and contact the customer service number on the back of the member’s card to confirm whether the plan requires utilization review or prior authorization for this guideline.
- Clinical UM Guidelines address medical efficacy and should be reviewed before relying on medical opinion
- Call customer service to determine plan review requirements
Denial triggers when criteria or device approval not met
Requests for automated insulin delivery systems will be denied when the policy’s medical necessity criteria are not met, when continued‑use or replacement criteria are not met, for replacement of functional or warrantied devices, or for non‑FDA‑approved systems.
- Denial triggers include failure to meet medical necessity, continued use, or replacement criteria
- Non‑FDA‑approved automated insulin delivery systems are not medically necessary under any circumstances
Apply federal/state law, contract, and Medical Policy first
Federal and State law, contract language (including definitions and specific coverage provisions/exclusions), and Medical Policy take precedence over Clinical UM Guidelines and must be considered first when determining eligibility for coverage.
- Use the member’s contract benefits in effect on the date services are rendered
- Clinical UM Guidelines are supplemental and may not be adopted by all plans
Contract language and law take precedence in coverage decisions
Coverage determinations must follow federal and state law, the member’s contract language, and Medical Policy; failure to apply the member’s contract benefits in effect on the date of service may result in denial.
- Verify contract terms and coverage provisions before authorizing services
Confirm precedence of law and contract over Clinical UM Guidelines
Federal and State law and the member’s contract benefits take precedence over Clinical UM Guidelines and must be used first when determining eligibility for coverage; confirm plan‑specific adoption and benefit terms before proceeding.
- Contact customer service on the member’s card to confirm plan adoption of guidelines and review requirements
Background and Scope
Automated insulin delivery systems combine an external insulin pump and a continuous interstitial glucose monitor (CGM) to automate many insulin administration tasks. Systems are classified by automation level as open‑loop, hybrid closed‑loop (automatic basal adjustments with manual meal boluses), or fully closed‑loop (minimal routine user intervention). The guideline is intended to support utilization review and coverage determinations for these systems by documenting clinical indications, evidence summaries, and device availability.
Key Definitions and Concepts
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