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Artificial Pancreas Device Systems

Policy Number: MP-636

Latest Review Date:   April 2021

Category: Durable Medical Equipment                  

Policy Grade:  A

POLICY:

Effective for dates of service on or after May 07, 2019:

Use of an FDA approved automated insulin delivery system (artificial pancreas device) with a low-glucose suspend feature/hybrid closed-loop insulin delivery system, may be considered medically necessary when ALL of the following prerequisites are met and are clearly documented in the patient’s medical record:

  • At least minimum FDA approved age for device (See Governing Bodies)
  • Type 1 diabetes
  • Glycated hemoglobin value between 5.8% and 10.0%
  • Must meet medical criteria for coverage for a CGM, as listed in medical policy #038, Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid.
  • Must meet medical criteria for coverage for an external insulin pump as listed in medical policy #046, External Ambulatory Insulin Infusion Pump.

Use of an automated insulin delivery system (artificial pancreas device system) is considered investigational in all other situations.

Use of an automated insulin delivery system (artificial pancreas device system) not approved by the Food and Drug Administration is considered investigational.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered not medically necessary.

Effective for dates of service June 21, 2018-May 06, 2019:

Use of an FDA approved artificial pancreas device with a low-glucose suspend feature may be considered medically necessary when ALL of the following prerequisites are met and are clearly documented in the patient’s medical record:

  • At least minimum FDA approved age for device (age 16 and older for MiniMed 530G / 630G and age 7 and older for MiniMed 670G)
  • Type 1 diabetes
  • Glycated hemoglobin value between 5.8% and 10.0%
  • Must meet medical criteria for coverage for a CGM, as listed in medical policy #038, Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid.
  • Must meet medical criteria for coverage for an external insulin pump as listed in medical policy #046, External Ambulatory Insulin Infusion Pump.

Medtronic’s MiniMed 670G, a sensor augmented insulin pump with a low glucose threshold suspend feature, is considered investigational in children younger than 7 years.

Medtronic’s MiniMed 530G/630G, sensor augmented insulin pumps with a low glucose threshold suspend feature, is considered investigational in children younger than 16 years.

Use of an artificial pancreas device system is considered investigational in all other situations.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered not medically necessary.

Effective for dates of service April 15, 2017 - June 20, 2018:

Use of an FDA approved artificial pancreas device with a low-glucose suspend feature may be considered medically necessary when ALL of the following prerequisites are met and are clearly documented in the patient’s medical record:

  • At least minimum FDA approved age for device (age 16 and older for MiniMed 530G / 630G and age 14 and older for MiniMed 670G)
  • Type 1 diabetes
  • Glycated hemoglobin value between 5.8% and 10.0%
  • Must meet medical criteria for coverage for a CGM, as listed in medical policy #038, Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid.
  • Must meet medical criteria for coverage for an external insulin pump as listed in medical policy #046, External Ambulatory Insulin Infusion Pump.

Medtronic’s MiniMed 670G, a sensor augmented insulin pump with a low glucose threshold suspend feature, is considered investigational in children younger than 14 years.

Medtronic’s MiniMed 530G/630G, sensor augmented insulin pumps with a low glucose threshold suspend feature, is considered investigational in children younger than 16 years.

Use of an artificial pancreas device system is considered investigational in all other situations.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered not medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

Automated insulin delivery systems, also known as artificial pancreas device systems, link a glucose monitor to an insulin infusion pump that automatically takes action (e.g., 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.

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 Type 1 diabetes 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 Programa

2017

  Level 1

 

 

 

Level 2

  

 

Level 3

Glucose <70mg/dl but ≥ 54 mg/dl

 

Glucose <54 mg/dl

 

Event characterized by altered mental/physical status requiring assistance

 

 

 

Hypoglycemia

Same as Type 1 Diabetes Outcome Programa

Professional Practice Committee with systematic literature review

 

ADA

2019

Hypoglycemia

 

  Clinical alert for evaluation and/or treatment

  Clinically important or serious

  Severe hypoglycemia

 

 

Glucose <70mg/dl

Glucose <54 mg/dl

Severe cognitive impairment requiring external assistance by another person to take corrective action

Clinical Practice Consensus

ISPAD

2018

Hyperglycemia

 

 

 

  Level 1

 

 

 

  Level 2

 

 

 

 

Glucose >180 mg/dL and ≤250 mg/dL

 

Glucose >250 mg/dL

 

 

Type 1 Diabetes Outcome Programa

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 <15 mEq/L

 Blood pH <7.3

 

Type 1 Diabetes Outcome Programa

2017

 

 

 

 

 

ADA: American Diabetes Association, ISPAD: International Society for Pediatric and Adolescent Diabetes; ULN: upper limit of normal.

aSteering Committee: representatives from American Association of Clinical Endocrinologists (AACE), American Association Diabetes Educators, the American Diabetes Association (ADA), the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, T1D Exchange.

b Time in range: has also been adopted by researchers evaluating the precision and effectiveness of emerging glucose monitoring and automated insulin delivery technologies

Treatment

Type 1 diabetes is caused by the destruction of the pancreatic beta cells which produce insulin, and the necessary mainstay of treatment is insulin injections. Multiple studies have shown that intensive insulin treatment, aimed at tightly controlling blood glucose, reduces the risk of long-term complications of diabetes, such as retinopathy and renal disease. Optimal glycemic control, as assessed by glycated hemoglobin, and avoidance of hyper- and hypoglycemic excursions have been shown to prevent diabetes-related complications. Currently, insulin treatment strategies include either multiple daily insulin injections or continuous subcutaneous insulin infusion with an insulin pump.

The use of the continuous glucose monitoring (CGM) component of diabetes self-management is specifically addressed in Medical Policy #038 Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid.

KEY POINTS:

This evidence review was performed through March 04, 2021.

Summary of Evidence:

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. 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. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

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 (i.e., 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 evidence is sufficient to determine that the technology results in an  improvement in the net health outcome.

Practice Guidelines and Position Statements

American Diabetes Association

The American Diabetes Association has released multiple publications on controlling type 1 diabetes (see Table 2).

Table 2. Recommendations on Diabetes

Date

Title

Publication Type

Recommendation (Level of Evidence)

2021

Standards of Medical Care in Diabetes

Guideline standard[American Diabetes Association. 7. Diabetes Technol.... ppl 1): S85-S99. PMID 33298418]

Sensor-augmented pump therapy with automatic low glucose suspend may be considered for adults and youth with diabetes to prevent/mitigate episodes of hypoglycemia.(B)

Automated insulin delivery systems may be considered in youth and adults with type 1 diabetes to improve glycemic control. (A)

Individual patients may be using systems not approved by the U.S. Food and Drug Administration, such as do-it-yourself closed-loop systems and others; providers cannot prescribe these systems but should provide safety information/troubleshooting/backup advice for the individual devices to enhance patient safety. (E)

2017

Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes

Consensus report,a

Developed definitions for hypoglycemia, hyperglycemia, time in range, and diabetic ketoacidosis in type 1 diabetes

HbA1c: hemoglobin A1c

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.LOE: Level of Evidence. HbA1c: hemoglobin A1c

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not applicable.

KEY WORDS:

Medtronic Minimed® 670G, Medtronic Minimed® 530G, Medtronic Minimed® 630G, artificial pancreas, insulin pump, SmartGuard HCL, LGS, low glucose suspend, Medtronic Paradigm Veo system, t:slim X2 Insulin Pump, Basal-IQ Technology, automated insulin delivery system, T  slim x2 Control-IQ technology, Control-IQ,automated insulin dosing (AID) system, Minimed 770G

APPROVED BY GOVERNING BODIES:

The Food and Drug Administration (FDA) describes the basic design of an artificial pancreas device system (APDS) as a CGM linked to an insulin pump with the capability to automatically stop, reduce, or increase insulin infusion based on specified thresholds of measured interstitial glucose.

The APDS components are designed to communicate with each other to automate the process of maintaining blood glucose concentrations at or near a specified range or target and to 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.

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.

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.

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 (e.g., 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.

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.

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

Table 3 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 670G System (c)(hybrid closed-loop, LGS or PLGM)

≥14 y

≥7-13 y

Medtronic

Sep 2016

Jul 2018

P160017/OZP

P160017/S031

MiniMed 770G System hybrid closed-loop ≥2 y Medtronic Aug 2020 P160017/S076

t:slim X2 Insulin Pump with Basal-IQ Technology (LGS) 

≥6y

Tandem

June 2018

P180008/OZO, PQF

t:slim X2 Insulin Pump with Control-IQ Technology (HCL)

≥6y

Tandem

Dec 2019

DEN180058/QFG

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. 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. 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 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. 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 MiniMed 770G System is an iteration of the MiniMed 670G System. In July 2020, the device was approved for use in children ages 2 to 6 years. In addition to the clinical studies that established the safety and effectiveness of the MiniMed 670G System in users ages 7 years and older, the sponsor performed clinical studies of the 670G System in pediatric subjects ages 2 to 6 years. FDA concluded that these studies establish a reasonable assurance of the safety and effectiveness of the MiniMed 770G System because the underlying therapy in the 670G system, and the associated Guardian Sensor (3), are identical to that of the 770G System.

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.

In December 2019, FDA approved the t:slim X2 Insulin Pump with Control-IQ Technology through the De Novo process. Control-IQ™ technology automatically adjusts insulin levels based on Dexcom G6 continuous glucose monitoring (CGM) readings. The device uses the same pump hardware as the insulin pump component of the systems approved in t:slim X2 Insulin Pump with Basal-IQ Technology (P180008) and P140015. A custom disposable cartridge is motordriven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

HCPCS:

A4226

 

Supplies for maintenance of insulin infusion pump with dosage rate adjustment using therapeutic continuous glucose sensing, per week (effective 01/01/20)

 

A4255

Supplies for external insulin infusion pump, syringe type cartridge, sterile, each

 

A9276

Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, one 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

E0784

External ambulatory infusion, pump, insulin

E0787

External ambulatory infusion pump, insulin, dosage rate adjustment using therapeutic continuous glucose sensing (effective 01/01/20)

K0553 Supply allowance for therapeutic continuous glucose monitor (CGM) system, includes all supplies and accessories, 1 month supply = 1 unit of service.
K0554 Receiver (monitor), dedicated, for use with therapeutic continuous glucose monitor system.

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

REFERENCES:

  1. Abraham MB, Nicholas JA, Smith GJ, et al. Reduction in Hypoglycemia with the Predictive Low-Glucose Management System: A Long-term Randomized Controlled Trial in Adolescents with Type 1 Diabetes. Diabetes Care. Feb 2018;41(2):303-310.
  2. Agrawal P, Zhong A, Welsh JB, et al. Retrospective analysis of the real-world use of the threshold suspend feature of sensor-augmented insulin pumps. Diabetes Technol Ther. May 2015; 17(5):316-319.
  3. Agiostratidou G, Anhalt H, Ball D, et al. Standardizing clinically meaningful outcome measures beyond HbA1c for type 1 diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Diabetes Care. Dec 2017;40(12):1622-1630.
  4. American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2019. Diabetes Care. Jan 2019;42(Suppl 1):S71-s80.
  5. American Diabetes Association. 7. Approaches to glycemic treatment. Diabetes Care. Jan 2015; 38 Suppl:S41-48.
  6. American Diabetes Association. 6. Glycemic Targets. Diabetes Care. Jan 2017; 40(Suppl 1):S48-S56.
  7. American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2019. Diabetes Care. Jan 2019;42(Suppl 1):S61-s70.
  8. American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2019. Diabetes Care. Jan 2019;42(Suppl 1):S71-s80.
  9. American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2021. Diabetes Care. Jan 2021; 44(Suppl 1): S85-S99.
  10. Beato-Vibora PI, Gallego-Gamero F, Lazaro-Martin L, et al. Prospective Analysis of the Impact of Commercialized Hybrid Closed-Loop System on Glycemic Control, Glycemic Variability, and Patient-Related Outcomes in Children and Adults: A Focus on Superiority Over Predictive Low-Glucose Suspend Technology. Diabetes Technol Ther. Dec 2020; 22(12): 912-919.
  11. Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA. Oct 4 2016; 316(13):1407-1408.
  12. Bergenstal RM, Klonoff DC, Garg SK, et al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. Jul 18 2013; 369(3):224-232.
  13. Blue Cross and Blue Shield Technology Evaluation Center (TEC). Artificial Pancreas Device Systems. TEC Assessments. 2013; Volume 28:Tab 14.
  14. Breton MD, Kanapka LG, Beck RW, et al. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med. Aug 27 2020; 383(9): 836-845.
  15. Brown SA, Kovatchev BP, Raghinaru D et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N. Engl. J. Med. 2019 Oct;381(18).
  16. Chiang JL, Maahs DM, Garvey KC, et al. Type 1 diabetes in children and adolescents: A Position Statement by the American Diabetes Association. Diabetes Care. Sep 2018;41(9):2026-2044.
  17. Cobry EC, Kanapka LG, Cengiz E, et al. Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control. Diabetes Technol Ther. Jan 28 2021.
  18. Faulds ER, Zappe J, Dungan KM. REAL-WORLD IMPLICATIONS OF HYBRID CLOSE LOOP (HCL) INSULIN DELIVERY SYSTEM. Endocr Pract. May 2019; 25(5): 477-484.
  19. Forlenza GP, Deshpande S, Ly TT, et al. Application of zone model predictive control artificial pancreas during extended use of infusion set and sensor: a randomized crossover-controlled home-use trial. Diabetes Care. Aug 2017; 40(8):1096-1102.
  20. Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, et al. Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther. Jan 2019;21(1):11-19.
  21. Food and Drug Administration (FDA). Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems [draft]. 2012; https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259305.pdf. Accessed March 23, 2021.
  22. Food and Drug Administration (FDA). Premarket Approval (PMA): MINIMED 530G SYSTEM. 2013; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120010. Accessed March 23, 2021.
  23. Food and Drug Administration (FDA). Premarket Approval (PMA): MINIMED 630G SYSTEM WITH SMARTGUARD(TM). 2016; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=320606. Accessed March 23, 2021.
  24. Food and Drug Administration (FDA). Premarket Approval (PMA): MiniMed 670G System. 2016; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017. Accessed March 23, 2021.
  25. Food and Drug Administration (FDA). Types of Artificial Pancreas Device Systems. //www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/ucm259555.htm. Accessed October 21, 2016.
  26. Food and Drug Administration (FDA). t:slim X2 Insulin Pump with Basal-IQ Technology Premarket Approval (2018). https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180008A.pdf. Accessed March 23, 2021.
  27. Food and Drug Administration (FDA). t:slim X2 Insulin Pump with Control-IQ Technology. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN190034.pdf
  28. Food & Drug Administration. MiniMed 770G System. Summary of Safety and Effectiveness Data. 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017S076B.pdf. Accessed March 12, 2021.
  29. Garg S, Brazg RL, Bailey TS, et al. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in-clinic ASPIRE study. Diabetes Technol Ther. Mar 2012; 14(3):205-209.
  30. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther. Mar 2017; 19(3):155-163.
  31. Gomez AM, Marin Carrillo LF, Munoz Velandia OM, et al. Long-term efficacy and safety of sensor augmented insulin pump therapy with low-glucose suspend feature in patients with type 1 diabetes. Diabetes Technol Ther. Feb 2017;19(2):109-114.
  32. Grunberger G, Handelsman Y, Bloomgarden ZT, et al. American Association of Clinical Endocrinologists and American College of Endocrinology 2018 Position Statement on integration of insulin pumps and continuous glucose monitoring in patients with diabetes mellitus. Endocr Pract. Mar 2018;24(3):302-308.
  33. Haidar A, Legault L, Messier V, et al. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycemic control in patients with Type I diabetes: an open-label randomized controlled crossover trial. Lancet Diabetes Endocrinol. Nov 26 2014.
  34. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  35. Kanapka LG, Wadwa RP, Breton MD, et al. Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes. Diabetes Care. Feb 2021; 44(2): 473-478.
  36. Ly TT, Nicholas JA, Retterath A, et al. Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial. JAMA. Sep 25 2013; 310(12):1240-1247.
  37. 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.
  38. National Institute for Health and Care Excellence. Integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system). Diagnostics guidance [DG21]. Feb 2016. https://www.nice.org.uk/guidance/dg21/chapter/1-Recommendations. Accessed October 21, 2016.
  39. Nimri R, Atlas E, Ajzensztejn M, et al. Feasibility study of automated overnight closed-loop glucose control under MD-logic artificial pancreas in patients with type 1 diabetes: the DREAM Project. Diabetes Technol Ther. Aug 2012; 14(8):728-735.
  40. Nimri R, Danne T, Kordonouri O, et al. The "Glucositter" overnight automated closed loop system for Type I diabetes: a randomized crossover trial. Pediatr Diabetes. May 2013; 14(3):159-167.
  41. Nimri R, Muller I, Atlas E, et al. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. Nov 2014; 37(11):3025-3032.
  42. Nimri R, Muller I, Atlas E, et al. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis. Pediatr Diabetes. Mar 2014; 15(2):91-99.
  43. Phillip M, Battelino T, Atlas E, et al. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. Feb 28 2013; 368(9):824-833.
  44. Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet. Oct 13 2018;392(10155):1321-1329.
  45. Trevitt S, Simpson S, Wood A. Artificial pancreas device systems for the closed-loop control of type 1 diabetes: what systems are in development? J Diabetes Sci Technol. May 2016; 10(3):714-723.
  46. 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.
  47. https://www.tandemdiabetes.com/products/t-slim-x2-insulin-pump/control-iq
  48. www.tandemdiabetes.com/safetyinfo.

POLICY HISTORY:

Medical Policy Panel, November 2016

Medical Policy Group, January 2017 (6): Artificial Pancreas information transferred from medical policy #038, Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid and medical policy #046, External Ambulatory Insulin Infusion Pump.

Medical Policy Administration Committee, March 2017

Medical Policy Group, April 2017 (6): Policy statement changed to include “Must meet medical criteria for coverage for a CGM, as listed in medical policy #038, Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid and Must meet medical criteria for coverage for an external insulin pump as listed in medical policy #046, External Ambulatory Insulin Infusion Pump, Removed “Used insulin pump therapy for more than 6 months And At least 2 documented nocturnal hypoglycemic events in a 2-week period”, Coding updated.

Medical Policy Administration Committee, April 2017

Available for comment April 19 through June 2, 2017

Medical Policy Panel, November 2017

Medical Policy Panel, December 2017

Medical Policy Group, December 2017 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines and References. No change to policy statement.

Medical Policy Group, March 2018 (6): Updates to Key Points. No change in policy statement.

Medical Policy Group, August 2018 (6): Updated policy statement to include new FDA approval of Medtronic 670G for ages 7 and older. Governing Bodies updated to include new age allowance for 670G.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (6): Updates to Description, Key Points, Governing Bodies, Key Words (t:slim X2 Insulin Pump, Basal-IQ Technology, automated insulin delivery system) and References. Policy section revised to reference the Governing Bodies section for FDA approval age limits. No change to policy intent.

Medical Policy Group, December 2019 (6): 2020 Annual Coding Update, Added A4226,E0787.

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (6): Updates to Description, Key Points, Key Words (T:slim x2 Control-IQ technology, Control-IQ,automated insulin dosing (AID) system), Governing Bodies and References. No change to policy intent.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Panel, June 2020

Medical Policy Group, July 2020 (6): Updates to Key Points, Governing Bodies and References. No change to policy intent.

Medical Policy Group, September 2020 (6): Updated Governing Bodies to include Medtronic MiniMed 770G System.

Medical Policy Group, January 2021 (6): Updated Governing Bodies, added coding (K0553/K0554).

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (6): Updates to Key Points, Governing Bodies, Practice Guidelines and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.