MEDICAL POLICY – 1.01.30

Artificial Pancreas Device Systems

BCBSA Ref. Policy: 1.01.30

Effective Date: April 1, 2020

Last Revised: March 10, 2020

Replaces: N/A

RELATED MEDICAL POLICIES:

None

Select a hyperlink below to be directed to that section.

POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING

RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

An artificial pancreas device system combines a glucose monitor and an insulin infusion pump.

The goal is to try to match how a normal pancreas would work. The pancreas releases insulin

based on changing levels of glucose in the blood. In this system, insulin is either withheld or

released based on the blood glucose level shown on the monitor. For those with type 1

diabetes, these systems may help improve overall glycemic control. They can be especially

helpful in controlling episodes of very low blood sugar at night. This policy discusses when an

artificial pancreas device system may be considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

Policy Coverage Criteria

Device Medical Necessity Artificial pancreas device

system

Use of a U.S. Food and Drug Administration (FDA) approved

automated insulin delivery system (artificial pancreas device

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Device Medical Necessity system) with a low-glucose suspend feature may be considered

medically necessary in patients with type 1 diabetes who meet

all of the following criteria:

• Age 14 years of age or older

AND

• Glycated hemoglobin (hemoglobin A1c) value between 5.8%

and 10.0%

AND

• Used insulin pump therapy for more than 6 months

AND

• At least two documented nocturnal hypoglycemic events in a

two-week period (see definition below)

Hybrid closed loop insulin

delivery system

Use of a U.S. Food and Drug Administration (FDA) approved

automated insulin delivery system (artificial pancreas device

system) designated as hybrid closed-loop insulin delivery

system (with low glucose suspend and suspend before low

features) may be considered medically necessary in patients

with type 1 diabetes who meet all of the following criteria:

• Age 7 and older

AND

• Glycated hemoglobin level between 5.8% and 10.0%

AND

• Used insulin pump therapy for more than 6 months

AND

• At least 2 documented nocturnal hypoglycemic events in a 2-

week period

Device Investigational Automated insulin delivery

system

Use of an automated insulin delivery system (artificial

pancreas device system) is considered investigational for

individuals who do not meet the above criteria

Use of an automated insulin delivery system (artificial

pancreas device system) not approved by the Food and Drug

Administration is considered investigational.

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Documentation Requirements The patient’s medical records submitted for review should document that medical necessity

criteria are met. The record should include clinical documentation of:

• Diagnosis/condition

• History and physical examination documenting the severity of the condition

• Hemoglobin A1c (glycated hemoglobin) results

• History of insulin pump usage

• Documentation of nighttime hypoglycemia events

Coding

Code Description

HCPCS 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

S1035 Sensor; invasive (eg, 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

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

Consideration of Age

The ages stated in this policy for which the artificial pancreas system may be considered

medically necessary is based on the FDA approved indications for the device.

Evidence Review

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Description

Automated insulin delivery systems, also known as artificial pancreas device systems, link a

glucose monitor to an insulin infusion pump that automatically takes action (eg, suspends or

adjusts insulin infusion) based on the glucose monitor reading. These devices are proposed to

improve glycemic control in patients with insulin-dependent diabetes, in particular, reduction of

nocturnal hypoglycemia.

Background

Diabetes and Glycemic Control

Tight glucose control in patients with diabetes has been associated with improved health

outcomes. The American Diabetes Association has recommended a glycated hemoglobin level

below 7% for most patients. However, hypoglycemia, may place a limit on the ability to achieve

tighter glycemic control. Hypoglycemic events in adults range from mild to severe based on a

number of factors including the glucose nadir, the presence of symptoms, and whether the

episode can be self-treated or requires help for recovery. Children and adolescents represent a

population of type 1 diabetics who have challenges in controlling hyperglycemia and avoiding

hypoglycemia. Hypoglycemia is the most common acute complication of type 1 diabetes (T1D).

Table 1 is a summary of selected clinical outcomes in T1D clinical management and research.

Table 1. Outcome Measures for Type 1 Diabetes

Measure Definition Guideline type Organization Date

Hypoglycemia

Stakeholder survey,

expert opinion with

evidence review

Type 1 Diabetes

Outcome Programa1

2017

Level 1

Level 2

Level 3

Glucose

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Measure Definition Guideline type Organization Date

Hypoglycemia Same as Type 1 Diabetes

Outcome Programa

Professional Practice

Committee with

systematic literature

review

ADA2 2019

Hypoglycemia

Clinical alert for

evaluation and/or

treatment

Clinically important or

serious

Severe hypoglycemia

Glucose 250 mg/dL

Type 1 Diabetes

Outcome Programa1

2017

Time in Rangeb Percentage of glucose

readings in the range of 70–

180 mg/dL per unit of time

Type 1 Diabetes

Outcome Programa

2017

Diabetic ketoacidosis

(DKA)

Elevated serum or urine

ketones > ULN

Serum bicarbonate

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Hypoglycemia

Hypoglycemia affects many aspects of cognitive function, including attention, memory, and

psychomotor and spatial ability. Severe hypoglycemia can cause serious morbidity affecting the

central nervous system (eg, coma, seizure, transient ischemic attack, stroke), heart (eg, cardiac

arrhythmia, myocardial ischemia, infarction), eye (eg, vitreous hemorrhage, worsening of

retinopathy), as well as cause hypothermia and accidents that may lead to injury. Fear of having

hypoglycemia symptoms can also cause decreased motivation to adhere strictly to intensive

insulin treatment regimens.

The definition of a hypoglycemic episode is not standardized. In the pivotal Automation to

Simulate Pancreatic Insulin Response randomized controlled trial, a nocturnal hypoglycemic

episode was defined as a sensor glucose value of 65 mg/dL or less between 10 PM and 8 AM for

more than 20 consecutive minutes in the absence of a pump interaction within 20 minutes. In

2017, the American Diabetes Association defined serious, clinically significant hypoglycemia as

glucose levels

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minimize the incidence and severity of hypoglycemic and hyperglycemic events. An APDS

control algorithm is embedded in software in an external processor or controller that receives

information from the CGM and performs a series of mathematical calculations. Based on these

calculations, the controller sends dosing instructions to the infusion pump.

Threshold Suspend Device System

Different APDS types are currently available for clinical use. Sensor augmented pump therapy

(SAPT) with low glucose suspend (LGS) (suspend on low) may reduce the likelihood or severity of

a hypoglycemic event by suspending insulin delivery temporarily when the sensor value reaches

(reactive) a predetermined lower threshold of measured interstitial glucose. Low glucose

suspension (LGS) automatically suspends basal insulin delivery for up to two hours in response

to sensor-detected hypoglycemia.

A sensor augmented pump therapy with predictive low glucose management (PLGM) (suspend

before low) suspends basal insulin infusion with the prediction of hypoglycemia. Basal insulin

infusion is suspended when sensor glucose is at or within 70 mg/dL above the patient-set low

limit and is predicted to be 20 mg/dL above this low limit in 30 minutes. In the absence of a

patient response, the insulin infusion resumes after a maximum suspend period of two hours. In

certain circumstances, auto-resumption parameters may be used.

When a sensor value is above or predicted to remain above the threshold, the infusion pump

will not take any action based on CGM readings. Patients using this system still need to monitor

their blood glucose concentration, set appropriate basal rates for their insulin pump, and give

premeal bolus insulin to control their glucose levels.

Control-to-Range System

A control-to-range system reduces the likelihood or severity of a hypoglycemic or

hyperglycemic event by adjusting insulin dosing only if a person's glucose levels reach or

approach predetermined higher and lower thresholds. When a patient's glucose concentration is

within the specified range, the infusion pump will not take any action based upon CGM

readings. Patients using this system still need to monitor their blood glucose concentration, set

appropriate basal rates for their insulin pump, and give premeal bolus insulin to control their

glucose levels.

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Control-to-Target System

A control-to-target system sets target glucose levels and tries to maintain these levels at all

times. This system is fully automated and requires no interaction from the user (except for

calibration of the CGM). There are two subtypes of control-to-target systems: insulin-only and

bihormonal (eg, glucagon). There are no systems administering glucagon marketed in the

United States.

An APDS may also be referred to as a “closed-loop” system. A closed-loop system has

automated insulin delivery and continuous glucose sensing and insulin delivery without patient

intervention. The systems utilize a control algorithm that autonomously and continually

increases and decreases the subcutaneous insulin delivery based on real-time sensor glucose

levels. There are no completely closed-loop insulin delivery systems marketed in the United

States.

A hybrid closed-loop system also uses automated insulin delivery with continuous basal insulin

delivery adjustments. However, at mealtime, the patient enters the number of carbohydrates

they are eating in order for the insulin pump to determine the bolus meal dose of insulin. A

hybrid system option with the patient administration of a premeal or partial premeal insulin

bolus can be used in either control-to-range or control-to-target systems.

Source: https://www.fda.gov/medical-devices/artificial-pancreas-device-system/what-pancreas-what-

artificial-pancreas-device-system Accessed January 2020

https://www.fda.gov/medical-devices/artificial-pancreas-device-system/what-pancreas-what-artificial-pancreas-device-systemhttps://www.fda.gov/medical-devices/artificial-pancreas-device-system/what-pancreas-what-artificial-pancreas-device-system

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These systems are regulated by the FDA as class III device systems.

Summary of Evidence

The following conclusions are based on a review of the evidence, including but not limited to,

published evidence and clinical expert opinion, solicited via BCBSA’s Clinical Input Process.

Low-Glucose Suspend Device

For individuals who have type 1 diabetes (T1D) who receive an artificial pancreas device system

with a low-glucose suspend feature, the evidence includes two randomized controlled trials

(RCTs) conducted in home settings. The relevant outcomes are symptoms, change in disease

status, morbid events, resource utilization and treatment-related morbidity. Primary eligibility

criteria of the key RCT, the Automation to Simulate Pancreatic Insulin Response (ASPIRE) trial,

were ages 16-to-70 years old, T1D, glycated hemoglobin levels between 5.8% and 10.0%, and at

least 2 nocturnal hypoglycemic events (≤65 mg/dL) lasting more than 20 minutes during a 2-

week run-in phase. Both trials required at least six months of insulin pump use. Both RCTs

reported significantly less hypoglycemia in the treatment group than in the control group. In

both trials, primary outcomes were favorable for the group using an artificial pancreas system;

however, findings from one trial were limited by nonstandard reporting of hypoglycemic

episodes, and findings from the other trial were no longer statistically significant when two

outliers (children) were excluded from analysis. The RCT limited to adults showed an

improvement in the primary outcome (area under the curve for nocturnal hypoglycemic events).

The area under the curve is not used for assessment in clinical practice but the current

technology does allow user and provider review of similar trend data with continuous glucose

monitoring. Results from the ASPIRE study suggested that there were increased risks of

hyperglycemia and potential diabetic ketoacidosis in subjects using the threshold suspend

feature. This finding may be related to whether or not actions are taken by the user to assess

glycemic status, etiology of the low glucose (activity, diet or medication) and to resume insulin

infusion. Both retrospective and prospective observational studies have reported reductions in

rates and severity of hypoglycemic episodes in automated insulin delivery system users. The

evidence is sufficient that the magnitude of reduction for hypoglycemic events in the T1D

population is likely to be clinically significant. Limitations of the published evidence preclude

determining the effects of the technology on overall glycemic control as assessed by HbA1c and

other parameters and thus, net health outcomes. Evidence reported through clinical input

supports that the outcome of hypoglycemia prevention provides a clinically meaningful

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improvement in net health outcome, and this use is consistent with generally accepted medical

practice. The evidence is sufficient to determine that the technology results in a meaningful

improvement in the net health outcome.

Hybrid Closed-Loop Insulin Delivery System

For individuals who have T1D who receive an artificial pancreas device system with a hybrid

closed-loop insulin delivery system, the evidence includes multicenter pivotal trials using devices

cleared by the Food and Drug Administration, supplemental data and analysis for expanded

indications and more recent studies focused on children and adolescents. Three crossover RCTs

using a similar first-generation device approved outside the United States have been reported.

Relevant outcomes are symptoms, change in disease status, morbid events, resource utilization

and treatment-related morbidity. Of the three crossover RCTs assessing a related device

conducted outside the United States, two found significantly better outcomes (ie, time spent in

nocturnal hypoglycemia and time spent in preferred glycemic range) with the device than with

standard care and the other had mixed findings (significant difference in time spent in nocturnal

hypoglycemia and no significant difference in time spent in preferred glycemic range). For the

U.S. regulatory registration pivotal trial, the primary outcomes were safety and not efficacy.

Additional evidence from device performance studies and clinical studies all demonstrate

reductions in time spent in various levels of hypoglycemia, improved time in range (70-

180mg/dl), rare diabetic ketoacidosis and few device-related adverse events. The evidence is

sufficient that the magnitude of reduction for hypoglycemic events in the T1D population is

likely to be clinically significant. The variations in the definition of primary and secondary

outcomes in the study design and conduct of the published evidence are limitations that

preclude determining the effects of the technology on net health outcomes. Evidence reported

through clinical input supports that the use of hybrid closed loop APDS systems provides a

clinically meaningful improvement in net health outcome and is consistent with generally

accepted medical practice. Reduction in the experience of hypoglycemia and inappropriate

awareness of hypoglycemia and glycemic excursions were identified as important acute clinical

outcomes in children, adolescents, and adults and are related to the future risk for end-organ

complications. The evidence is sufficient to determine that the technology results in meaningful

improvement in the net health outcome.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 2.

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Table 2. Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Ongoing

NCT02748018 Multi-center, Randomized, Parallel, Adaptive, Controlled

Trial in Adult and Pediatric Patients With Type 1 Diabetes

Using Hybrid Closed Loop System and Control (CSII, MDI,

and SAP) at Home

1500 Dec 2021

NCT03859401 Hypoglycemia Prevention During and After Moderate

Exercise in Adults With Type 1 Diabetes Using anArtificial

Pancreas With Exercise Behavior Recognition

33 Dec 2019

NCT02733211 An Open-label, Two-center, Randomized, Cross-over

Study to Evaluate the Safety and Efficacy of Night Closed-

loop Control Using the MD-LogicAutomated Insulin

Delivery SystemCompared to Sensor Augmented Pump

Therapy in Poorly Controlled Patients With Type 1

Diabetes at Home

28 Dec 2019

NCT03739099 Assessment of the Efficacy of Closed-loop Insulin Therapy

(Artificial Pancreas) on the Control of Type 1 Diabetes in

Prepubertal Child in Free-life: Comparison Between

Nocturnal and 24-hour Use on 18 Weeks, Followed by an

Extension on 18 Weeks

120 Sep 2020

NCT03844789a The International Diabetes Closed Loop (iDCL) Trial:

Clinical Acceptance of theArtificial Pancreas in Pediatrics:

A Study of t:Slim X2 With Control-IQ Technology

101 Mar 2020

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Clinical Input from Physician Specialty Societies and Academic Medical

Centers

While the various physician specialty societies and academic medical centers may collaborate

with and make recommendations during this process, through the provision of appropriate

reviewers, input received does not represent an endorsement or position statement by the

physician specialty societies or academic medical centers, unless otherwise noted.

https://clinicaltrials.gov/ct2/show/NCT02748018https://clinicaltrials.gov/ct2/show/NCT03859401?cond=NCT03859401&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT02733211?cond=NCT02733211&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT03739099?cond=NCT03739099&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT03844789?cond=NCT03844789&draw=1&rank=1

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2019

In response to requests, while this topic was under review in 2019, clinical input on the use of an

artificial pancreas device system with a hybrid closed-loop insulin delivery system for individuals

with type 1 diabetes was received from 4 respondents, including 4 physician-level responses

identified through 2 specialty societies including physicians with academic medical center

affiliations. Evidence from clinical input is integrated within the Summary of Evidence.

2015

In response to requests, input on artificial pancreas device systems was received from 2

physician specialty societies and 4 academic medical centers when the policy was under review

in 2015. Input was mixed on whether artificial pancreas systems, including closed-loop

monitoring devices with a low-glucose suspend threshold feature, are considered medically

necessary. Most reviewers thought there was sufficient supportive data on devices with a low-

glucose suspend feature in patients at high risk of hypoglycemia, but some thought the data

insufficient.

Practice Guidelines and Position Statements

American Diabetes Association

The American Diabetes Association has released multiple publications on controlling type 1

diabetes (see Table 3).

Table 3. Recommendations on Diabetes

Date Title Publication

Type

Recommendation LOE

2019 Standards of Medical

Care in Diabetes

Guideline

standard

Automated insulin delivery systems improve

glycemic control and reduce hypoglycemia in

adolescents and should be considered in

adolescents with type 1 diabetes

B

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Date Title Publication

Type

Recommendation LOE

2017 Standardizing

Clinically Meaningful

Outcome Measures

Beyond HbA1c for

Type 1 Diabetes

Consensus

report21,a

Developed definitions for hypoglycemia,

hyperglycemia, time in range, and diabetic

ketoacidosis in type 1 diabetes

N/A

HbA1c: hemoglobin A1c; LOE: Level of Evidence.

a Jointly published with American Association of Clinical Endocrinologists, the American Association of Diabetes

Educators, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the

Pediatric Endocrine Society, and the T1D Exchange.

American Association of Clinical Endocrinologists et al

The American Association of Clinical Endocrinologists and American College of Endocrinology

(2018) published a joint position statement on the integration of insulin pumps and continuous

glucose monitoring in patients with diabetes.22 The statement emphasized the use of continuous

glucose monitoring and insulin pump therapy for type 1 diabetes patients who are not in

glycemic target ranges despite intensive attempts at self-blood glucose monitoring and multiple

insulin injection therapy.

Medicare National Coverage

There is no national coverage determination.

Regulatory Status

Table 4 summarizes the FDA-approved automated insulin delivery systems.

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Table 4. FDA-Approved Automated Insulin Delivery Systems (Artificial

Pancreas Device Systems)

Device Age

Indication

Manufacturer Date

Approved

PMA No./

Device Code

MiniMed 530G Systema (open-

loop, LGS)

≥16 y Medtronic Jul 2013 P120010/OZO

MiniMed 630G System with

SmartGuard™b (open-loop, LGS)

≥16 y

≥14 y

Medtronic Aug 2016

Jun 2017

P150001/OZO

P150001/S008

MiniMed 670GSystemc (hybrid

closed-loop, LGS or PLGM)

≥14 y

≥7-13 y

Medtronic Sep 2016

Jul 2018

P160017/OZP

P160017/S031

FDA: Food and Drug Administration; LGS: low glucose suspend; OZO: Artificial Pancreas Device System, threshold

suspend; OZP: Automated Insulin Dosing Device System, Single Hormonal Control; PMA: premarket approval; PLGM:

predictive low glucose management.

a MiniMed 530G System consists of the following devices that can be used in combination or individually: MiniMed

530G Insulin Pump, Enlite™ Sensor, Enlite™ Serter, the MiniLink Real-Time System, the Bayer Contour NextLink

glucose meter, CareLink® Professional Therapy Management Software for Diabetes, and CareLink® Personal Therapy

Management Software for Diabetes (at time of approval).

b MiniMed 630G System with SmartGuard™ consists of the following devices: MiniMed 630G Insulin Pump, Enlite®

Sensor, One-Press Serter, Guardian® Link Transmitter System, CareLink® USB, Bayer’s CONTOUR ® NEXT LINK 2.4

Wireless Meter, and Bayer’s CONTOUR® NEXT Test Strips (at time of approval).

c MiniMed 670G System consists of the following devices: MiniMed 670G Pump, the Guardian Link (3) Transmitter, the

Guardian Sensor (3), One-Press Serter, and the Contour NEXT Link 2.4 Glucose Meter (at time of approval).

The MiniMed® 530G System includes a threshold suspend or LGS feature.5 The threshold

suspend tool temporarily suspends insulin delivery when the sensor glucose level is at or below

a preset threshold within the 60- to 90-mg/dL range. When the glucose value reaches this

threshold, an alarm sounds. If patients respond to the alarm, they can choose to continue or

cancel the insulin suspend feature. If patients fail to respond, the pump automatically suspends

action for two hours, and then insulin therapy resumes.

The MiniMed® 630G System with SmartGuard™, which is similar to the 530G, includes updates

to the system components including waterproofing.6 The threshold suspend feature can be

programmed to temporarily suspend delivery of insulin for up to two hours when the sensor

glucose value falls below a predefined threshold value. The MiniMed 630G System with

SmartGuard™ is not intended to be used directly for making therapy adjustments, but rather to

provide an indication of when a finger stick may be required. All therapy adjustments should be

based on measurements obtained using a home glucose monitor and not on the values

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provided by the MiniMed 630G system. The device is not intended to be used directly for

preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to

respond to the SmartGuard™ Suspend on Low alarm to take measures to prevent or treat

hypoglycemia themselves.

The MiniMed® 670G System is a hybrid closed-loop insulin delivery system consisting of an

insulin pump, a glucose meter, and a transmitter, linked by a proprietary algorithm and the

SmartGuard Hybrid Closed Loop.7, The system includes an LGS feature that suspends insulin

delivery; this feature either suspends delivery on low-glucose levels or suspends delivery before

low-glucose levels, and has an optional alarm (manual mode). Additionally, the system allows

semiautomatic basal insulin-level adjustment (decrease or increase) to preset targets (automatic

mode). As a hybrid system; basal insulin levels are automatically adjusted, but the patient needs

to administer premeal insulin boluses. The CGM component of the MiniMed 670G System is not

intended to be used directly for making manual insulin therapy adjustments; rather it is to

provide an indication of when a glucose measurement should be taken.

The most recent supplemental approval for the MiniMed® 670G System in July 2018 followed

the granting a designation of breakthrough device status.

On June 21, 2018, the FDA approved the t:slim X2 Insulin Pump with Basal-IQ Technology (PMA

P180008) for individuals who are 6 years of age and older. The System consists of the t:slim X2

Insulin Pump paired with the Dexcom G5 Mobile CGM (Continuous Glucose Monitor), as well as

the Basal-IQ Technology. The t:slim X2 Insulin Pump is intended for the subcutaneous delivery of

insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring

insulin. The t:slim X2 Insulin Pump can be used solely for continuous insulin delivery and as part

of the System as the receiver for a therapeutic CGM. The t:slim X2 Insulin Pump running the

Basal-IQ Technology can be used to suspend insulin delivery based on CGM sensor readings.

Introduction into clinical care is planned for summer 2019.

References

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29162582.

2. American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2019. Diabetes Care. Jan

2019;42(Suppl 1):S61-s70. PMID 30559232.

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https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259305.pdf

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20. Wood MA, Shulman DI, Forlenza GP, et al. In-Clinic Evaluation of the MiniMed 670G System "Suspend Before Low" Feature in

Children with Type 1 Diabetes. Diabetes Technol Ther. Nov 2018;20(11):731-737. PMID 30299976

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259305.pdfhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120010https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=320606https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017

Page | 17 of 18 ∞

21. Messer LH, Forlenza GP, Sherr JL, et al. Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the

MiniMed 670G System. Diabetes Care. Apr 2018;41(4):789-796. PMID 29444895.

22. American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2019. Diabetes Care. Jan

2019;42(Suppl 1):S71-s80. PMID 30559233.

History

Date Comments 03/10/15 New Policy. Policy created with information on this topic previously addressed in Policy

No. 1.01.522 and a literature review through December 20, 2014. FDA-approved

artificial pancreas device system with low glucose suspend feature may be considered

medically necessary for patients with type 1 diabetes who meet criteria; otherwise

artificial pancreas device systems are considered investigational.

01/12/16 Annual Review. Added Related Policy 1.01.522 Continuous or Intermittent Monitoring

of Glucose in Interstitial Fluid. Policy updated with literature review through October 1,

2015; references added. Policy statements unchanged.

04/12/16 Minor update. Removal of related policy 1.01.522, policy was archived on April 30,

2016.

11/08/16 Minor update. Language added to support that this policy applies only to those age 16

and older as indicated by FDA approval for the use of the device.

02/01/17 Annual Review, approved January 10, 2017. Policy updated with literature review

through October 4, 2016; references added. Policy statements unchanged.

04/11/17 Policy moved into new format; no change to policy statements. Evidence Review

section reformatted.

02/01/18 Annual Review, approved January 16, 2018. Policy updated with literature review

through October 2017; references updated. Policy statement added that use of hybrid

closed loop insulin delivery system as an artificial pancreas device system (age 14 and

older) is considered investigational.

9/01/18 Minor update. Re-added language supporting that this policy applies to those age 16

and older; it was inadvertently removed in a previous update.

03/01/19 Minor update, added Documentation Requirements section.

07/01/19 Annual Review, approved June 11, 2019. Policy updated with literature review through

March 2019, references 1, 3-7, 13, 17, 18, and 20-24 added. Policy statements changed:

the age criterion changed in the first medically necessary statement; medically

necessary statement added on FDA-approved automated insulin delivery system

(artificial pancreas device system) designated as hybrid closed loop insulin delivery

system in patients with type 1 diabetes who meet specified criteria; and investigational

Page | 18 of 18 ∞

Date Comments statement added on use of an automated insulin delivery system (artificial pancreas

device system) for individuals who have not met specified criteria.

02/01/20 Annual Review, approved January 9, 2020. Policy updated with literature review

through September 2019; references added. Policy statements unchanged.

04/01/20 Delete policy, approved March 10, 2020. This policy will be deleted effective July 2,

2020, and replaced with InterQual criteria for dates of service on or after July 2, 2020.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

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037338 (07-2016)

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Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter e sta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357).

Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357).

Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357).

Español ( ): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este

tiene derecho a recibir esta información y ayuda en su idioma sin costo

aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted

alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

Spanish

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).

ไทย (Thai): ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกน สขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย โทร 800-722-1471 (TTY: 800-842-5357)

้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่ ่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่

Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).