CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Artificial Pancreas Device System (Automated Insulin Delivery)

Covers medical necessity, prior authorization, coding, and clinical background for FDA-cleared automated insulin delivery (artificial pancreas) systems for individuals with type 1 diabetes under Blue Cross Blue Shield of Rhode Island Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyArtificial Pancreas Device System (Automated Insulin Delivery)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (required for Medicare Advantage; recommended for Commercial) and confirm member meets the medical criteria before coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 6+Minimum age for many covered systems

5.8%–10.0%HbA1c coverage range

≥2 nocturnal eventsEvent requirement for eligibility

RequiredPrior authorization

MultipleCovered codes listed

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Coverage Criteria for Automated Insulin Delivery Systems

Covered with Criteria

Use of an FDA-cleared or approved automated insulin delivery (artificial pancreas device system) may be considered medically necessary when ALL of the following apply (criteria differ by system type and age):

Low-glucose suspend feature (Medicare Advantage & Commercial): Patient has type 1 diabetes and all of: age 6 years and older; glycated hemoglobin (HbA1c) between 5.8% and 10.0%; at least 2 documented nocturnal hypoglycemic events in a 2-week period; used insulin pump therapy for more than 6 months.age >=6; HbA1c 5.8-10.0%; >=2 nocturnal events/2 weeks; pump use >6 months

Hybrid closed-loop system (general) (Medicare Advantage & Commercial): Patient age over 6 years AND used insulin pump therapy for more than 6 months; glycated hemoglobin (HbA1c) between 5.8% and 10.0%; at least 2 documented nocturnal hypoglycemic events in a 2-week period.age >6; pump use >6 months; HbA1c 5.8-10.0%; >=2 nocturnal events/2 weeks

Hybrid closed-loop system (age 2–6 years) (Medicare Advantage & Commercial): Age 2 to 6 years AND used insulin pump therapy for more than 3 months AND clinical diagnosis of type 1 diabetes for 3 months or more AND glycated hemoglobin (HbA1c) <10.0% AND minimum daily insulin requirement (total daily dose) >= 8 units.age 2-6; pump use >3 months; T1D dx >=3 months; HbA1c <10%; TDD >=8 units

Closed-loop insulin delivery system: Clinical diagnosis of type 1 diabetes for 12 months or more; age 6 years and older; using insulin for at least 12 months; diabetes managed using the same regimen (either pump or multiple daily injections, with or without continuous glucose monitoring) for 3 months or longer.T1D >=12 months; age >=6; insulin >=12 months; consistent regimen >=3 months

Use of an automated insulin delivery (artificial pancreas device) system that is not approved by the U.S. Food and Drug Administration (FDA) is not covered for Medicare Advantage Plans and is not medically necessary for Commercial Products. Additionally, automated insulin delivery systems that do not meet the medical criteria specified in this policy are not covered for Medicare Advantage Plans and are considered not medically necessary for Commercial Products.

If services are determined to be not medically necessary or otherwise non-covered benefits, the provider may not charge the member for those services unless the provider has obtained the member’s prior written agreement to accept financial responsibility. Benefit and eligibility determinations are governed by the member’s subscriber agreement, member certificate, and/or employer agreement, which supersede this policy; contact the provider call center for member-specific information.

For Commercial Products, use of an automated insulin delivery system that is not FDA‑cleared is explicitly stated as not medically necessary. For Medicare Advantage Plans, such devices are not covered. Providers should verify member benefits and obtain any required authorizations prior to ordering, since subscriber/employer agreements and benefit documents dictate coverage and may differ between Commercial and Medicare Advantage plans.

This policy is provided for informational purposes and is not a guarantee of payment. Benefits and eligibility are determined by the member’s subscriber or employer agreement and may supersede this policy. If a service is determined to be not medically necessary or a non-covered benefit, the provider may not bill the member unless there is a prior written agreement; refer to participation agreements and contact the provider call center for member-specific benefit verification.

Coding and Clinical Thresholds

Covered HCPCS/S Codes when criteria metHCPCSCovered

E0787	External ambulatory infusion pump, insulin, dosage rate adjustment therapeutic continuous glucose sensing using
S1034	Artificial pancreas device system (eg, low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices
S1036	Transmitter; external, for use with artificial pancreas device system
S1037	Receiver (monitor); external, for use with artificial pancreas device system
S1035	Sensor; invasive (e.g., subcutaneous), disposable, for use with artificial pancreas device system

Codes considered inappropriate to bill separately when system functions as artificial pancreasHCPCSNot Covered

E0784	External ambulatory infusion pump, insulin
A4226	Supplies for maintenance of insulin infusion pump with rate adjustment therapeutic continuous glucose sensing; per week
E2103	Non-adjunctive, non-implanted continuous glucose monitor or receiver (New Code Effective 1/1/2023)
A4239	Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (CGM), includes all supplies and accessories; 1 month supply unit of service (New Code Effective 1/1/2023)
A9277	Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose monitoring system (Text Revision Effective 1/1/2023)
A9276	Sensor; invasive (subcutaneous), disposable, for use non-durable medical equipment interstitial continuous glucose monitoring system, one unit = day supply (Text Revision Effective 1/1/2023)
A9278	Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose monitoring system (Text Revision Effective 1/1/2023)
K0554	Receiver (monitor), dedicated, for use with therapeutic continuous glucose monitor system (Code Deleted Effective 12/31/2022)
K0553	Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories month supply = 1 unit of service (Code Deleted Effective 12/31/2022)
S1030	Continuous non-invasive glucose monitoring device, purchase (for physician interpretation of data, use CPT code)

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inv-08: Glycated hemoglobin (HbA1c)

Covered HbA1c range (general)Glycated hemoglobin level between 5.8% and 10.0%

HbA1c for hybrid closed-loop (age 2–6 yrs)Glycated hemoglobin level <10.0%

Purpose of thresholdUsed as part of medical necessity criteria for FDA‑cleared automated insulin delivery systems

inv-09: Nocturnal hypoglycemic events — frequency requirement

Required nocturnal eventsAt least 2 documented nocturnal hypoglycemic events in a 2‑week period

Timeframe for documentationEvents must be documented within a 2‑week interval

Provider Actions, Prior Authorization, and Billing Risk

Prior Authorization

Prior Authorization Required / Recommended

Prior authorization is required for Medicare Advantage members. For Commercial members, prior authorization is recommended. Participating providers must use the payer's online prior-authorization tool to submit requests. See Related Policies (Preauthorization via Web-Based Tool for Durable Medical Equipment) for tool access and submission instructions.

Medicare Advantage: prior authorization required
Commercial Products: prior authorization recommended
Submit via online prior-authorization tool for participating providers

Documentation Required

Prior authorization guidance — contact provider call center and verify benefits

Before providing services, verify the member's specific benefits and coverage limitations by contacting the provider call center. Benefit determination is based on the member's subscriber agreement, certificate, and/or employer agreement; those documents supersede this policy. Document the benefit verification interaction (date, representative name/ID, summary of information) in the patient's record and include benefit/eligibility information with the prior authorization submission as applicable.

Background and Context

Automated insulin delivery systems (also termed artificial pancreas device systems) link a continuous glucose monitor to an insulin infusion pump and automated control algorithm to suspend or adjust insulin infusion based on glucose readings. These systems include features such as low‑glucose suspend, suspend before low, and hybrid closed‑loop insulin delivery; they are intended to improve glycemic control and reduce hypoglycemia in individuals with type 1 diabetes when used according to the medical criteria in this policy.

Definitions

inv-21: Definition of Artificial pancreas device system / Automated insulin delivery system

DefinitionA system that links a glucose monitor to an insulin infusion pump and automatically suspends or adjusts insulin infusion based on glucose readings

Includes features such asLow‑glucose suspend, suspend before low, hybrid closed‑loop, and closed‑loop insulin delivery

Primary clinical goalImprove glycemic control and reduce nocturnal hypoglycemia in insulin‑dependent (type 1) diabetes

inv-22: Predictive Low-Glucose Suspend / Hybrid Closed-Loop features and device modalities

Predictive Low‑Glucose Suspend (PLGS)Feature that predicts impending hypoglycemia and automatically suspends insulin delivery to reduce hypoglycemia duration

Hybrid closed‑loop