CurrentPremera BluecrossPolicy 1.01.30

Automated Insulin Delivery Systems

Defines medical necessity criteria, documentation requirements, and coding for FDA-cleared automated insulin delivery systems (including low glucose suspend, predictive suspend, hybrid closed-loop, and closed-loop systems) for persons with type 1 and type 2 diabetes. Includes device regulatory status, evidence summary, and guideline context.

Policy Summary

PayerPremera Bluecross

PolicyAutomated Insulin Delivery Systems

Policy CodePolicy 1.01.30

Change TypeAnnual review; criteria unchanged (June 1, 2026)

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis/age, history and physical, hemoglobin A1c, insulin pump usage, nighttime hypoglycemia events, and total daily insulin dose as applicable.

SourceLink

POLICY UPDATE CHANGES

Policy title changed to 'Automated Insulin Delivery Systems' effective 12/01/25 and new indication added for FDA-approved hybrid closed-loop systems in individuals ≥18 years with type 2 diabetes.

June 1, 2026 annual review updated literature through Feb 12, 2026; policy statements unchanged.

Multiple prior revisions adjusted age cutoffs and added pediatric indications (e.g., lowered to 6 years in 2020 reinstatement; added 2–6 years in 2021).

Type1 & Type2Covered Indications

MultipleRegulatory devices summarized

ExpandedType 2 adult indications noted

≥2 yrsPediatric age inclusion

Outside criteriaInvestigational use

Coverage Summary

This policy defines medical necessity criteria for FDA-cleared or -approved Automated Insulin Delivery (AID) systems (including low glucose suspend, predictive suspend/suspend-before-low, hybrid closed-loop, and closed-loop systems) for individuals with type 1 diabetes and for specified adults with type 2 diabetes. Coverage is limited to devices cleared or approved by the US Food and Drug Administration and requires documentation that the individual meets the device- and criteria-based limits (for example, age, hemoglobin A1c thresholds, duration of diabetes or insulin use, history of pump use, nocturnal hypoglycemia frequency, and minimum daily insulin for young children). The policy title and scope were updated effective 06/01/2026 with last review on 05/11/2026 (annual reviews and prior date changes noted in the history).

Key thresholds and quick facts

HbA1c (T1 LGS & HCL adults)>= 5.8% and <= 10.0%

HbA1c (T1 children 2-6 yrs)< 10.0%

HbA1c (T2 hybrid HCL)>= 7% (or significant hypoglycemia)

Minimum daily insulin (young children)>= 8 units/day

Nocturnal hypoglycemia requirement>= 2 events in 2-week period

Threshold suspend preset range60-90 mg/dL; automatic suspend up to 2 hours

Pediatric scope noteSome systems indicated down to >=2 years (device-specific) — check FDA indication

Investigational use noteUse is investigational when criteria not met or device not FDA-cleared/approved

Medical Necessity Criteria

Low Glucose Suspend (LGS) feature - Type 1 diabetes

Use of a US Food and Drug Administration (FDA) cleared or approved automated insulin delivery system with a low glucose suspend (LGS) feature may be considered medically necessary when ALL of the following are met:

ALL of the following

An individual aged 6 years and older
Clinical diagnosis of type 1 diabetes
Glycated hemoglobin (hemoglobin A1c) level between 5.8% and 10.0%5.8% - 10.0%
Used insulin pump therapy for more than 6 months
Operational documentation should include duration of pump use

Indications, Regulatory Approvals, and Evidence

Regulatory excerpts list multiple FDA-cleared or -approved AID systems and expanded indications: Control‑IQ+ (t:slim X2 with Control‑IQ+ technology) and the t:slim X2 Control‑IQ family (De Novo and subsequent approvals), the t:slim X2 Basal‑IQ (Basal‑IQ was FDA approved June 2018 but discontinued Dec 2023 with service/support maintained), Medtronic MiniMed 530G, 630G, 670G, 770G, and 780G systems (threshold suspend/LGS and hybrid closed‑loop iterations with pediatric indications for some models), the tubeless Omnipod 5 system (approved Jan 2022 for ≥6 years, age expanded to ≥2 years Aug 2022, and approval extended to adults ≥18 years with type 2 diabetes Aug 2024), the iLet Bionic Pancreas (first closed‑loop system cleared May 2023), the twiist AID System (Alternate Controller Enabled Infusion Pump, indicated for T1D), and others (e.g., Control‑IQ+ and MiniMed 780G PMA supplements). The regulatory record notes expanded indications for adults with type 2 diabetes for select hybrid closed‑loop systems (Control‑IQ+ Feb 2025; Omnipod 5 Aug 2024; MiniMed 780G Aug 2025) and pediatric age expansions for several devices (for example, MiniMed 770G approved for ages ≥2 years and Omnipod 5 expanded to ≥2 years). Device discontinuation (t:slim Basal‑IQ) and manufacturer support statements are also noted.

Evidence highlights (trials & real-world)

ASPIRE trial (threshold suspend) - eligibility/outcomeAges 16–70, T1D, HbA1c 5.8%–10.0%, >=2 nocturnal events in 2-week run-in; reduced hypoglycemia but suggested increased hyperglycemia/DKA signals in some analyses

Multicenter RCTs (HCL systems) - T1DPivotal multicenter RCTs showed increased time-in-range, HbA1c reductions, and reduced hypoglycemia with acceptable safety

Coding

HCPCS - AID systems and componentsHCPCSCovered

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.
S1035	Sensor; invasive (e.g., subcutaneous), disposable, for use with artificial pancreas device system, 1 unit = 1 day supply.
S1036	Transmitter; external, for use with artificial pancreas device system.
S1037	Receiver (monitor); external, for use with artificial pancreas device system.

No procedure/CPT/HCPCS codes listed in this partmixed

No codes listed

Provider Actions & Documentation Requirements

Documentation Required

Submit medical records documenting criteria

Medical records submitted for review should document that medical necessity criteria are met. Include documentation of diagnosis and age, a history and physical examination, hemoglobin A1c results, history of insulin pump usage, documentation of nighttime hypoglycemia events, and total daily insulin dose if applicable.

Diagnosis and age
History and physical examination
Hemoglobin A1c results
History of insulin pump usage
Documentation of nighttime hypoglycemia events
Total daily insulin dose (if applicable)

Prior Authorization

Definitions

Automated Insulin Delivery (AID) system: A system linking a continuous glucose monitor to an insulin pump with a control algorithm that automatically adjusts, suspends, or resumes insulin infusion based on sensor glucose readings.

Low Glucose Suspend (LGS): Sensor‑initiated suspension of basal insulin delivery when sensor glucose falls below a preset threshold, with suspension for up to two hours.

Predictive Low Glucose Management (PLGM) / Suspend before low: Suspends basal insulin when glucose is near the low limit and predicted to fall below it within a set timeframe; insulin resumes after a maximum suspend period of two hours.

Hybrid closed‑loop (HCL): A system that automatically adjusts basal insulin delivery but requires user input for premeal boluses (automatic basal adjustments with manual meal boluses).

Closed‑loop: A fully automated insulin delivery system that continually adjusts insulin dosing without individual intervention (except calibration).

Threshold Suspend / LGS (alternate definition): Feature that temporarily suspends insulin delivery when sensor glucose is at or below a preset threshold (commonly in the 60–90 mg/dL range); may trigger an alarm and auto‑suspend for up to 2 hours.

Hybrid Closed‑Loop System (alternate phrasing): An AID system that automatically adjusts basal insulin levels while the user administers premeal insulin boluses.

Medicare Determinations

Type	Effective Text
National Coverage Determination (NCD)	There is no national coverage determination.

Revision History

12/01/25annual_review_materialLatest

Annual review approved Nov 11, 2025; literature review through Feb 17, 2025; references added. Policy title changed to 'Automated Insulin Delivery Systems' effective 12/01/25 and new indication added for FDA‑approved hybrid closed‑loop systems in individuals ≥18 years with type 2 diabetes.

05/11/26annual_review_non_material

Annual review approved May 11, 2026; literature review through Feb 12, 2026; references added. Policy statements unchanged (non‑material update).

2015–2024history_summary_material

Policy Summary

PayerPremera Bluecross

PolicyAutomated Insulin Delivery Systems

Policy CodePolicy 1.01.30

Change TypeAnnual review; criteria unchanged (June 1, 2026)

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis/age, history and physical, hemoglobin A1c, insulin pump usage, nighttime hypoglycemia events, and total daily insulin dose as applicable.

SourceLink

On This Page

At least two documented nocturnal hypoglycemic events in a two-week period

See Hypoglycemia definitions; nocturnal event documentation should include date/time and glucose values

Hybrid closed-loop with LGS and suspend-before-low features - Type 1 diabetes (primary criteria)

Use of an FDA cleared or approved hybrid closed‑loop automated insulin delivery system (with low glucose suspend and suspend‑before‑low features) may be considered medically necessary for type 1 diabetes as described below.

ANY of the following

Individuals over age 6 years
- An individual over age 6 years
- Clinical diagnosis of type 1 diabetes
- Glycated hemoglobin (hemoglobin A1c) level between 5.8% and 10.0%5.8% - 10.0%
- Used insulin pump therapy for more than 6 months
  Operational documentation should include duration of pump use
- At least one of
  - At least two documented nocturnal hypoglycemic events in a two-week period
    Document date/time and glucose values
  - Evidence of recurrent daytime clinically significant hypoglycemia despite optimized therapy
    Include clinical notes describing events and treatments
Individuals aged 2 to 6 years
- Age between 2 and <6 years
- Clinical diagnosis of type 1 diabetes for 3 months or more>= 3 months
- Used insulin pump therapy for more than 3 months> 3 months
- Glycated hemoglobin (hemoglobin A1c) level < 10.0%< 10.0%
- Minimum daily insulin requirement (total daily dose) of greater than or equal to 8 units.>= 8 units/day

Hybrid closed-loop with LGS and suspend-before-low features - Type 2 diabetes

ALL of the following

An individual aged 18 years and older
Diagnosed with type 2 diabetes for at least 12 months>= 12 months
On multiple daily injections (insulin administration >= 3 times/day) for at least 3 months or use of an insulin infusion pump for at least 3 months
Document insulin regimen and duration; mixed insulin regimens permitted if stable
Glycemic threshold
- Glycated hemoglobin (hemoglobin A1c) level greater than or equal to 7%>= 7%
- Experience of clinically significant hypoglycemia (including recurrent or severe hypoglycemia)
  Document events, dates, treatments, and glucose values; threshold per Hypoglycemia definitions

Closed-loop insulin delivery system - Type 1 diabetes

Use of an FDA cleared or approved closed‑loop insulin delivery system may be considered medically necessary in individuals with type 1 diabetes when ALL of the following are met:

ALL of the following

An individual aged 6 years and older
Clinical diagnosis of type 1 diabetes for 12 months or more>= 12 months
Using insulin for at least 12 months>= 12 months
Includes insulin by pump or multiple daily injections
Diabetes managed using the same regimen (either insulin pump or multiple daily injections, with or without continuous glucose monitoring) for 3 months or longer>= 3 months
Document regimen and stability for the specified duration

Investigational / Not medically necessary

Use of an automated insulin delivery system is considered investigational and not medically necessary when the device or its intended use does not meet the criteria above or the device is not cleared or approved by the US Food and Drug Administration (FDA).

ANY of the following

Use of an automated insulin delivery system outside the indications or age ranges specified in this policy
Use of an automated insulin delivery system that is not cleared or approved by the US Food and Drug Administration (FDA)
Devices and intended clinical uses lacking FDA clearance/approval are investigational and not covered

Indications and Regulatory Approvals (excerpt)

Indications and Regulatory Approvals (excerpt):

ALL of the following

Devices must be US FDA cleared or approved for the specific indication and age group described in the relevant criteria
Examples of FDA‑approved hybrid closed‑loop systems for type 2 diabetes include Omnipod 5 AID and t:slim X2 with Control‑IQ+ per manufacturer approvals noted in Related Information
Device labeling and approved age ranges drive the age thresholds used in this policy
Consider FDA device indications when applying policy age criteria

Pivotal trials (T2 HCL)Omnipod 5 and Control-IQ+ pivotal trials in adults with T2D showed significant HbA1c and time-in-range improvements

iLet Bionic Pancreas pivotal RCT13-week RCT (ages 6–79) showed HbA1c reduction (mean adj diff -0.5%) and improved net health outcome

Real-world evidenceLarge observational datasets and single-arm studies (eg, Omnipod 5 real-world N=69,902) report sustained glycemic benefits

Safety signals and considerationsRCTs and observational studies report rare DKA instances; ASPIRE noted hyperglycemia/DKA signals related to suspend features

FDA-cleared/approved device requirement

Coverage applies only for FDA-cleared or FDA-approved automated insulin delivery systems. Use of an automated insulin delivery system that is not cleared or approved by the U.S. Food and Drug Administration is considered investigational and is not covered.

Documentation Required

Use CGM and fingerstick confirmation

For certain systems (for example, the MiniMed 630G and MiniMed 670G), continuous glucose monitor (CGM) values are not intended to be used directly for making manual insulin therapy adjustments. Therapy adjustments should be based on measurements obtained using a home glucose monitor (fingerstick).

Documentation Required

Device discontinuation/service note

Note that the t:slim X2 Insulin Pump with Basal‑IQ Technology was discontinued as of December 2023; the manufacturer will continue to maintain service for supply refills and/or technical support.

History entries from 2015–2024 document multiple prior revisions adjusting age criteria and adding pediatric indications: policy created 03/10/15; age criteria and hybrid closed‑loop statements added and age cutoffs lowered over time (notably lowered to ≥6 years in 2020 reinstatement and addition of 2–6 years pediatric indication in 07/01/21); other updates between 2016–2024 added hybrid/closed‑loop indications and device‑specific approvals.