CurrentPremera BluecrossPolicy 1.01.30

Automated Insulin Delivery Systems

Defines medical necessity criteria, documentation and coding for FDA-cleared/approved automated insulin delivery systems (including low glucose suspend, predictive suspend, hybrid closed-loop, and closed-loop systems) for individuals with type 1 and type 2 diabetes; lists devices with FDA indications and related evidence/guidance.

Policy Summary

PayerPremera Bluecross

PolicyAutomated Insulin Delivery Systems

Policy CodePolicy 1.01.30

Change TypeRevised / Added (2025–2026 regulatory updates)

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, age, H&P, HbA1c, insulin pump use history, nighttime hypoglycemia events, and total daily insulin dose for medical necessity review.

SourceLink

POLICY UPDATE CHANGES

Policy last revised May 11, 2026; effective date Jun 1, 2026.

Policy title changed to Automated Insulin Delivery Systems on 12/01/25 and new medically necessary statement added for FDA‑approved hybrid closed‑loop systems in individuals ages 18+ with type 2 diabetes.

June 2025 FDA approval extensions noted: Control‑IQ+ technology, Omnipod 5, and MiniMed 780G approvals expanded to include certain adults with type 2 diabetes.

06/01/26 annual review approved May 11, 2026; policy updated with literature review through Feb 12, 2026 with references added; policy statements unchanged.

4AID system categories with criteria (LGS, hybrid closed-loop T1, hybrid closed-loop T2, closed-loop)

S1034-S1037HCPCS codes for device and components

≥2Required nocturnal hypoglycemic events in 2-week period

MultipleFDA-cleared/approved AID systems discussed

3FDA expansions for type 2 diabetes noted (Control‑IQ+, Omnipod 5, MiniMed 780G)

Coverage Summary

This policy (Policy No. 1.01.30) covers Automated Insulin Delivery Systems (AID) and defines medical necessity criteria, documentation, and coding for FDA‑cleared or approved devices including low glucose suspend (LGS), predictive low glucose management (PLGM), hybrid closed‑loop, and closed‑loop systems for individuals with type 1 and type 2 diabetes. Coverage stance: covered_with_criteria. Effective date: 2026-06-01. Last review: 2026-05-11.

Quick facts / thresholds

Number of AID system categories with criteria4

HCPCS code rangeS1034-S1037

Required nocturnal hypoglycemic events≥2 events in a 2-week period

FDA expansions count (notable devices to T2D)3 (Control‑IQ+, Omnipod 5, MiniMed 780G)

HbA1c thresholdsRanges depend on device/type: 5.8%–10.0% (many T1 indications); <10.0% for 2–6 y hybrid closed‑loop; ≥7% for certain T2 hybrid closed‑loop eligibility

MiniMed preset threshold range60–90 mg/dL

MiniMed automatic suspend durationUp to 2 hours

Medical-Necessity Criteria

Automated insulin delivery system with low glucose suspend feature (Type 1 diabetes)

Use of an FDA cleared or approved automated insulin delivery system with a low glucose suspend feature may be considered medically necessary in individuals with type 1 diabetes who meet ALL of the following criteria:

ALL of the following

Age ≥ 6 years
Glycated hemoglobin (hemoglobin A1c) level between 5.8% and 10.0%5.8%-10.0%
Used insulin pump therapy for more than 6 months
At least two documented nocturnal hypoglycemic events in a two-week period

Coding

HCPCS codes for automated insulin delivery 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.

Provider Actions

Documentation Required

Medical record documentation for medical necessity review

Medical records submitted for review must document that medical necessity criteria are met and include: diagnosis and age; history and physical documenting severity; hemoglobin A1c results; history of insulin pump usage; documentation of nighttime/nocturnal hypoglycemia events; and total daily dose of insulin when applicable.

Diagnosis/condition and age
History and physical examination documenting severity
Hemoglobin A1c (glycated hemoglobin) results
History of insulin pump usage
Documentation of nighttime hypoglycemia events
Total daily dose of insulin, if applicable

Billing Rule

Background & Evidence

Automated insulin delivery systems link a continuous glucose monitor with an insulin pump and a control algorithm to suspend, reduce, or increase insulin delivery. System types described include: Low Glucose Suspend (LGS) (threshold suspend that temporarily suspends basal insulin when sensor glucose reaches a preset low threshold, often 60–90 mg/dL, and may suspend up to 2 hours); Predictive Low Glucose Management (PLGM) / Suspend‑Before‑Low (suspends infusion when glucose is near the low limit and predicted to reach it); Hybrid closed‑loop systems (automatically adjust basal insulin but require user premeal boluses); and Closed‑loop (fully automated control‑to‑target systems). The FDA has cleared/approved multiple devices across these categories (examples: MiniMed 530G/630G/670G/770G/780G, t:slim X2 with Control‑IQ/Control‑IQ+, Omnipod 5, iLet Bionic Pancreas, and others) with varying age and indication expansions noted in the regulatory summary.

Study	Key Finding
ASPIRE trial	Randomized trial showed reduced nocturnal hypoglycemia with threshold suspend but suggested increased hyperglycemia and potential DKA risk in some subjects; primary adult RCT showed improvement in nocturnal hypoglycemia (AUC) with noted safety signals
Pivotal trials for hybrid closed-loop systems	Multicenter RCTs demonstrated increased time in range and HbA1c reductions in T1D and T2D; pivotal 13-week and 6-month trials showed improved TIR, HbA1c and favorable safety with few device‑related adverse events
Randomized trials/real-world studies	Multiple randomized crossover and parallel RCTs and large real‑world cohorts report reduced hypoglycemia, increased time in range, sustained glycemic improvements and supportive safety data across age groups and device types

Key definitions

Automated insulin delivery (AID) systemA system linking a continuous glucose monitor to an insulin pump with a control algorithm that can automatically stop, reduce, or increase insulin infusion based on sensor glucose readings.

Low glucose suspend (LGS)A threshold‑suspend feature that suspends basal insulin delivery temporarily when sensor glucose reaches a preset low threshold, typically up to two hours.

Predictive low glucose management (PLGM) / suspend before low

Medicare Determinations

Determination	Notes
No national coverage determination (NCD)	There is no Medicare national coverage determination for automated insulin delivery systems

Revision History

2026-06-01annual_review_effectiveLatest

06/01/26 annual review (approved May 11, 2026); policy updated with literature review through Feb 12, 2026 with references added; policy statements unchanged. (Policy effective date Jun. 1, 2026; Last revised May 11, 2026.)

2025-12-01annual_review_approved

12/01/25 annual review approved November 11, 2025 with literature review through Feb 17, 2025; references added; policy title changed to 'Automated Insulin Delivery Systems' and new medically necessary statement added for FDA‑approved hybrid closed‑loop systems in individuals ages 18+ with type 2 diabetes. (History entry 12/01/25 approved Nov 11, 2025.)

2025-06-01

Policy Summary

PayerPremera Bluecross

PolicyAutomated Insulin Delivery Systems

Policy CodePolicy 1.01.30

Change TypeRevised / Added (2025–2026 regulatory updates)

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, age, H&P, HbA1c, insulin pump use history, nighttime hypoglycemia events, and total daily insulin dose for medical necessity review.

SourceLink

On This Page

≥2 events in 2 weeks

See hypoglycemia definition section for examples (e.g., sensor glucose ≤65 mg/dL between 10 PM and 8 AM for >20 consecutive minutes in ASPIRE trial)

Hybrid closed-loop insulin delivery system with LGS and suspend-before-low features (Type 1 diabetes)

Use of an FDA cleared or approved AID system designated as a hybrid closed-loop insulin delivery system (with LGS and suspend-before-low features) may be considered medically necessary in individuals with type 1 diabetes who meet ALL of the following criteria:

Either adult/older child criteria OR younger child criteria

Individuals over age 6 years
- Age > 6 years
- Glycated hemoglobin (hemoglobin A1c) level between 5.8% and 10.0%5.8%-10.0%
- Used insulin pump therapy for more than 6 months
- At least two documented nocturnal hypoglycemic events in a two-week period≥2 events in 2 weeks
Individuals aged 2 to 6 years
- Age 2 to 6 years
- Clinical diagnosis of type 1 diabetes for ≥ 3 months
- Used insulin pump therapy for more than 3 months
- Glycated hemoglobin (hemoglobin A1c) level < 10.0%<10.0%
- Minimum daily insulin requirement (total daily dose) ≥ 8 units≥8 units/day

Hybrid closed-loop insulin delivery system with LGS and suspend-before-low features (Type 2 diabetes)

ALL of the following

Age ≥ 18 years
Diagnosed with type 2 diabetes for at least 12 months
On multiple daily injections (insulin administration ≥ 3x/day) or use of insulin infusion pump for at least 3 months≥3 injections/day or pump ≥3 months
Policy text indicates requirement: On multiple daily injections (≥3x/day) or pump for at least 3 months
Glycated hemoglobin level ≥ 7% OR experience significant hypoglycemiaHbA1c ≥7% or significant hypoglycemia

Closed-loop insulin delivery system (Type 1 diabetes)

Use of an FDA cleared or approved automated insulin delivery system designated as a closed-loop insulin delivery system may be considered medically necessary in individuals with type 1 diabetes who meet ALL of the following criteria:

ALL of the following

Age ≥ 6 years
Clinical diagnosis of type 1 diabetes for ≥ 12 months
Using insulin for at least 12 months
Diabetes managed using the same regimen (either insulin pump or multiple daily injections, with or without continuous glucose monitoring) for ≥ 3 months≥3 months

Investigational / Not medically necessary

Use of an automated insulin delivery system is considered investigational when:

ANY of the following

Individual does not meet the above criteria for the applicable device/type
Use of an automated insulin delivery system not cleared or approved by the FDA

Use specified HCPCS S-codes

Report the listed HCPCS S-codes for automated insulin delivery systems and components. Note that S1035 is billed with 1 unit = 1 day supply.

S1034
S1035 (1 unit = 1 day supply)
S1036
S1037

Documentation Required

Use therapy adjustments based on home glucose monitor

Therapy adjustments should be based on measurements obtained using a home blood glucose monitor and not on CGM values provided by specified systems; CGM values are to indicate when a finger stick may be required.

Documentation Required

Responding to threshold suspend alarms

When threshold-suspend (low glucose suspend) alarms occur, individuals can respond to continue or cancel the insulin suspend; if they fail to respond, the pump may automatically suspend insulin delivery for up to two hours, after which insulin delivery resumes.

A predictive suspend feature that suspends basal insulin infusion when sensor glucose is near the low limit and predicted to reach a lower threshold within a set timeframe (suspend before low).

Threshold suspend / Low‑Glucose Suspend (LGS)A device feature that temporarily suspends insulin delivery when sensor glucose is at or below a preset threshold (commonly within 60–90 mg/dL) and may automatically suspend for up to two hours if the user does not respond to an alarm.

Hybrid closed‑loop systemAn AID system that automatically adjusts basal insulin delivery but requires the individual to administer premeal insulin boluses.

fda_approval_extensions

June 2025: FDA approval extensions noted — Control‑IQ+ technology approval extended February 24, 2025 for adults with type 2 diabetes; additional FDA approvals in 2025 include devices (e.g., twiist AID System April 2025, t:slim X2 Control‑IQ+ Feb 2025) and MiniMed 780G expanded indication in Aug 2025; policy documents these FDA expansions through Aug 2025 and Feb 2025 in Regulatory Status.

2025-12-01title_change_and_coverage_added

12/01/25 policy title changed to 'Automated Insulin Delivery Systems' and a new medically necessary statement was added for FDA‑approved hybrid closed‑loop systems in individuals ages 18 years and older with type 2 diabetes. (Approved Nov 11, 2025; literature through Feb 17, 2025; references added.)