Artificial Pancreas Device Systems
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This policy governs medical necessity coverage for automated insulin delivery systems (artificial pancreas/closed-loop/hybrid closed-loop systems and sensor-augmented pumps with low glucose suspend features) for BCBSNC members with insulin-dependent diabetes.
Positive coverage criteria were added for use of automated insulin delivery systems with low glucose suspend or hybrid closed‑loop features for individuals with type 2 diabetes.
When covered criteria updated to remove requirement for at least 2 documented nocturnal hypoglycemic events and to shorten required prior pump therapy from 6 months to 3 months; HgbA1c limit of 10% removed.
Added coding for new CPT codes (0740T, 0741T) and previously A4226/E0787; added investigational statement for d‑Nav technology.
Coverage Criteria and Policy Scope
Medical necessity criteria
BCBSNC will provide coverage when ALL specified criteria are met for each indication group.
Applies to automated insulin delivery systems with low glucose suspend features or hybrid closed-loop designation
Applies to automated insulin delivery systems with low glucose suspend features or hybrid closed-loop designation
Applies to systems designated as closed-loop insulin delivery systems
Coverage policy highlights
Policy coverage has been updated over time; recent material additions include coverage for hybrid closed‑loop systems and extension to some individuals with type 2 diabetes.
Added/clarified across 2012–2024 updates
Added 7/15/26
Implemented 7/17/24
Use of an artificial pancreas device system in situations other than those explicitly specified in this policy is considered investigational. Requests that do not meet the defined coverage criteria (for example, lacking required diagnosis, therapy duration, age or HbA1c thresholds where applicable) may be denied as investigational.
Automated insulin delivery systems that are not approved by the U.S. Food and Drug Administration (FDA) are considered investigational and are not covered under this policy. Providers should confirm FDA approval status before submission; non‑FDA approved systems are subject to denial.
The policy specifically identifies the use of d‑Nav technology for automated, intermittent glucose monitoring and insulin titration as investigational. Such uses are not covered.
Consistent with the policy updates, any automated insulin delivery system that lacks FDA approval is considered investigational and non‑covered. This includes technologies described in policy examples (e.g., d‑Nav) and other non‑approved AID systems; requests for these systems may be denied.
Any use of an artificial pancreas device system that does not meet the specific coverage criteria set forth in this policy is considered investigational/not covered. Providers should document how the member meets all required criteria when seeking coverage.
Examples of investigational or non‑covered scenarios include use of AID systems that are not FDA‑approved and use of technologies specifically named in policy updates (for example, d‑Nav). Note: the policy was updated on 10/1/24 to add the investigational statement for d‑Nav and to update coding; providers should reference the most recent policy version when submitting claims.
Billing, Codes, and Clinical Thresholds
| 95250 | Continuous glucose monitoring, professional (i.e., professional CGM) — listed as applicable code |
| 95251 | Continuous glucose monitoring, analysis of recorded CGM data |
| A4226 | Infusion pump supply, insulin infusion pump syringe/needle/other supply — listed as applicable code |
| E0787 | External ambulatory infusion pump, insulin |
| S1034 | Continuous glucose monitor, professional (specific description per policy list) |
| S1035 | Continuous glucose monitor, nonprofessional |
| S1036 | Continuous glucose monitor, transmitter |
| S1037 | Continuous glucose monitor, receiver |
| 0740T | Closed-loop glucose control device system (investigational/applicable code listed) |
| 0741T | Closed-loop glucose control device system, subsequent month (investigational/applicable code listed) |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required; codes listed do not guarantee reimbursement
Prior authorization is required for devices and supplies associated with artificial pancreas device systems. Inclusion of a code in the Billing/Coding section does not guarantee reimbursement; for reimbursement details see BCBSNC administrative policies.
Upgrades/new device types may require prior authorization and updated coding
Certain device upgrades, new device types, or services tied to artificial pancreas systems may require prior authorization and updated billing/coding; new CPT codes (0740T, 0741T) have been added to the Billing/Coding section.
Step‑therapy: document prior insulin/pump use
No formal step therapy protocol is specified in the policy; however, documentation of prior use (for example, prior insulin pump therapy) is required within the coverage criteria for hybrid closed‑loop and LGS systems.
- Coverage criteria require use of insulin or insulin pump therapy for more than 3 months for hybrid/LGS systems
- Providers should document prior therapy in authorization requests
Prior pump therapy requirement shortened to 3 months (operational)
The policy previously required 6 months of prior insulin pump therapy; as of 7/17/24 this requirement was shortened to 3 months—providers should document at least 3 months of prior insulin pump therapy when applicable.
- Prior insulin pump therapy requirement reduced from 6 months to 3 months (effective 7/17/24)
Medical records may be requested; letters alone often insufficient
BCBSNC may request medical records to determine medical necessity; letters of support or explanation are useful but are not sufficient unless they include all specific information needed for the determination.
- Provide full medical records when requested to support prior authorization
- Letters alone are insufficient unless they contain all required clinical details
Provide physician justification when requesting upgraded device
Requests for an upgraded device (such as a hybrid closed‑loop system) must include physician documentation indicating the rationale for the necessity of the upgrade if the member's existing device is still under warranty.
- Include physician rationale when requesting an upgrade while existing device is under warranty
- Document clinical reasons the upgrade is medically necessary
Document rationale when existing device remains in use
If a member's existing device remains in place (including if under warranty), physician documentation must indicate the clinical rationale for upgrading to a hybrid closed‑loop device.
- Document why the current device is inadequate and why upgrade is needed
- Attach supporting clinical information to the prior authorization request
Risk of denial for investigational use outside policy criteria
Use of an artificial pancreas device system in situations other than those specified in the policy is considered investigational and may be denied; providers should ensure all coverage criteria are met before requesting coverage.
- Confirm patient meets all listed criteria for the applicable indication group
- Anticipate denial if device use falls outside specified policy criteria
Non‑FDA approved automated insulin delivery systems may be denied
Automated insulin delivery systems that are not FDA‑approved are considered investigational and may be denied; prior authorization requests for non‑FDA approved systems should not be expected to be approved.
- Do not submit requests for non‑FDA approved AID systems expecting coverage
- Example: non‑FDA technologies are classified as investigational
Hybrid closed‑loop upgrade requests require physician documentation
Requests to upgrade to a hybrid closed‑loop system must include physician documentation indicating the rationale for the necessity of the upgrade; this requirement is explicitly stated in the Billing/Coding/Physician Documentation Information.
- Attach physician rationale when submitting upgrade prior authorization
- Document clinical benefit expected from hybrid closed‑loop upgrade
Non‑FDA approved systems (example: d‑Nav) are investigational/non‑covered
Automated insulin delivery systems not approved by the FDA are considered investigational and non‑covered; the policy explicitly lists d‑Nav technology as investigational and not covered.
- Do not expect coverage for d‑Nav technology; it is considered investigational
- Ensure requested device is FDA‑approved and meets policy criteria
Clinical Background and Rationale
Automated insulin delivery systems integrate a continuous glucose monitor and an insulin infusion device with control algorithms to adjust or suspend insulin delivery. These systems range from sensor‑augmented pumps with low glucose suspend (LGS) and predictive low glucose management (suspend‑before‑low) features to hybrid closed‑loop systems (automated basal adjustments with user‑entered meal information) and fully closed‑loop/control‑to‑target systems that automate glucose targeting with minimal user interaction. The technology is intended to reduce hypoglycemia and improve glycemic control by automatically suspending or modulating basal insulin delivery and, in hybrid systems, adjusting basal rates based on CGM input while still requiring some user interaction for meal boluses.
Key Definitions
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