CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Artificial Pancreas Device System

Defines medical necessity criteria, prior authorization requirements, covered and non-covered coding for FDA-approved automated insulin delivery (artificial pancreas) systems including low-glucose suspend and hybrid closed-loop systems for BlueCHiP for Medicare and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Artificial Pancreas Device System

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2019

Next Review Date

Key ActionObtain prior authorization (required for BlueCHiP for Medicare; recommended for Commercial) via the online tool for participating providers.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

2Required documented nocturnal hypoglycemic events (in 2 weeks)

5.8-10.0%Allowed HbA1c range

7Min age for hybrid closed-loop

14Min age for low-glucose suspend

Coverage Summary

Overview: This policy covers FDA‑approved automated insulin delivery systems (artificial pancreas device systems) that link a continuous glucose monitor to an insulin pump and an algorithm to suspend or adjust insulin delivery. Coverage stance: covered with criteria — use is medically necessary only when all specified criteria are met. Effective date: 10/01/2019. Last review date: 06/04/2019.

Key thresholds: patients must have HbA1c between 5.8% and 10.0%, have used insulin pump therapy for more than 6 months, and have at least 2 documented nocturnal hypoglycemic events in a 2‑week period. Age thresholds differ by device type: ≥14 years for low‑glucose suspend systems and ≥7 years for hybrid closed‑loop systems.

Key criteria summary

Required documented nocturnal hypoglycemic events (in 2 weeks)2

Allowed HbA1c range5.8-10.0%

Minimum age for hybrid closed-loop7

Minimum age for low-glucose suspend14

Medical-Necessity Criteria

Medically Necessary: Automated insulin delivery system with low-glucose suspend feature (BlueCHiP for Medicare and Commercial)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of type 1 diabetes
Age 14 and older14+
HbA1c: Glycated hemoglobin (HbA1c) value between 5.8% and 10.0%5.8%-10.0%
Pump duration: Used insulin pump therapy for more than 6 months>6 months
Nocturnal hypoglycemia: At least 2 documented nocturnal hypoglycemic events in a 2-week period≥2 in 2 weeks

Medically Necessary: Hybrid closed-loop (hybrid closed-loop insulin delivery system)

Covered when ALL of the following are met (same medical criteria as above, with different age threshold):

ALL of the following

Diagnosis of type 1 diabetes
Age 7 and older7+
HbA1c: Glycated hemoglobin (HbA1c) level between 5.8% and 10.0%5.8%-10.0%
Pump duration: Used insulin pump therapy for more than 6 months

Not Covered / Not Medically Necessary

Not covered when any of the following apply:

Exclusions

Does not meet criteria: Individuals who do not meet the above medical criteria (for BlueCHiP for Medicare: not covered; for Commercial: not medically necessary)
Not FDA approved: Automated insulin delivery systems not approved by the U.S. Food and Drug Administration (for BlueCHiP for Medicare: not covered; for Commercial: not medically necessary)

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Coding

Covered codes when medical criteria are metmixedCovered

E0787	External ambulatory infusion pump, insulin, dosage rate adjustment using therapeutic continuous glucose sensing (new code effective 1/1/20)
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 (covered when the device is approved)

Codes considered inappropriate to bill when device functions as an artificial pancreas (not appropriate / discouraged)mixedNot Covered

E0784	External ambulatory infusion pump, insulin
A4226	Supplies for maintenance of insulin infusion pump with dosage rate adjustment using therapeutic continuous glucose sensing, per week (new code effective 1/1/20)
A9276	Sensor; invasive (e.g. subcutaneous) disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply
A9277	Transmitter; external, for use with interstitial continuous glucose monitoring system
A9278	Receiver (monitor); external, for use with interstitial continuous glucose monitoring system
K0553	Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service
K0554	Receiver (monitor), dedicated, for use with therapeutic continuous glucose monitor system
S1030	Continuous non-invasive glucose monitoring device, purchase (for physician interpretation of data, use CPT code)
S1031	Continuous non-invasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use CPT code)

Provider Actions

Prior Authorization

Prior authorization required (BlueCHiP for Medicare) / recommended (Commercial)

Prior authorization is required for BlueCHiP for Medicare and recommended for Commercial products and must be obtained via the online tool for participating providers.

Documentation Required

Documentation of nocturnal hypoglycemia

Provider must document at least 2 nocturnal hypoglycemic events in a 2-week period to meet medical necessity criteria.

At least 2 nocturnal hypoglycemic events in a 2-week period required

Documentation Required

Documentation of prior insulin pump use

Provider must document that the patient used insulin pump therapy for more than 6 months prior to eligibility.

Patient must have >6 months prior insulin pump therapy documented

Billing guidance: Codes listed as covered apply only when medical criteria are met. The policy identifies specific codes for artificial pancreas device systems (for example, E0787, S1034, S1036, S1037, and S1035 when approved) as covered when criteria are satisfied. Certain legacy pump and CGM codes (for example, E0784, A9276‑A9278, K0553/K0554, S1030/S1031, A4226) are considered inappropriate or discouraged to bill when the device functions as an artificial pancreas with no manual intervention. See the Coding section for the full code lists and application.

Background, Evidence & Definitions

Background: Automated insulin delivery systems (artificial pancreas device systems) link a glucose monitor to an insulin infusion pump and an algorithm that can suspend or adjust insulin delivery to reduce hypoglycemia. Randomized trials and observational studies demonstrated significant reductions in hypoglycemia in people with type 1 diabetes, though limitations in the evidence prevent definitive conclusions about effects on HbA1c and overall glycemic control.

Safety: Trials and analyses reported safety events including episodes of hyperglycemia and potential diabetic ketoacidosis related to threshold‑suspend features, and device‑related adverse events have been infrequently reported; these findings underscore the need for appropriate patient selection and monitoring.

Evidence / Item	Details
ASPIRE trial primary eligibility
ages 16-70, HbA1c 5.8-10.0%, ≥2 nocturnal hypoglycemic events ≤65 mg/dL lasting >20 minutes, ≥6 months pump use
Overall evidence conclusion
Evidence sufficient that technology results in a meaningful improvement in net health outcome for reduction of hypoglycemia in T1D

Term	Definition
Automated insulin delivery system / APDS
Device system linking continuous glucose monitor to insulin pump with algorithm that can suspend or adjust insulin delivery (includes low-glucose suspend and hybrid closed-loop systems).
Low-glucose suspend (LGS)
Feature that suspends insulin infusion when glucose falls below a threshold.
Hybrid closed-loop
System with low glucose suspend and suspend-before-low features that automatically adjusts insulin delivery with some user input.