Latest Review Date: July 2024

Category:Durable Medical Equipment (DME)  

POLICY:

Dates of service October 1, 2021, and after:

Continuous monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique of diabetic monitoring, may be considered medically necessary for Type 1 or Type 2 diabetes mellitus, when one of the following is criteria is met :

• The patient’s medication history includes use of a rapid acting insulin (e.g., Admelog, Afrezza, Apidra, Fiasp, Humalog, Novolog)

OR

• Regular insulin within the past 90 days.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered investigational.

Other uses of continuous monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring are considered investigational.

The use of implantable CGM devices (i.e., Eversense Continuous Glucose Monitoring System) are considered investigational.

Coverage for non-medical items, even when the items may be used to serve a medical purpose, such as smart devices (smart phones, tablets, personal computers, etc.) are non-covered. This includes smart devices used in conjunction with Continuous Glucose Monitors.

Devices or software programs used to calculate insulin doses and/or send data to providers are considered investigational.

Continuous Glucose Monitoring devices (CGMs) under the Medical benefit are only covered for members who do not have coverage for CGMs under their Pharmacy benefit. Exceptions noted below in the following circumstances only.

• Members who use a CGM device prior to 10/1/2021 may continue to obtain an identical device and supplies through a DME supplier under their Medical benefit.
• Members receiving their first CGM device must obtain that device under their Pharmacy benefit unless they do not have coverage for CGMs under that benefit.

For Medtronic’s MiniMed 630G/670G/770G ,Tandem T:slim X2® with CONTROL-IQ or BASAL-IQ technology, or Omnipod 5®, refer to Medical Policy #636 Artificial Pancreas Device Systems.

Dates of service prior to October 1, 2021:

Intermittent Monitoring

Intermittent monitoring, i.e., 72 hours of glucose levels in interstitial fluid may be considered medically necessary in patients with Type 1 diabetes mellitus whose diabetes is documented in the medical records as *poorly controlled despite current use of **best practices.

*Poorly controlled Type 1 diabetes mellitus includes the following clinical situations:

• Unexplained hypoglycemic episodes;
• Hypoglycemic unawareness;
• Suspected postprandial hyperglycemia;
• Recurrent diabetic ketoacidosis.

Intermittent monitoring of glucose levels in interstitial may be considered medically necessary in patients with Type 1 diabetes prior to insulin pump initiation to determine basal insulin levels.

Intermittent monitoring is generally conducted in 72-hour periods. It may be repeated at a subsequent time depending on the patient’s level of diabetes control.

Continuous Monitoring

Continuous, i.e., long-term, monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique of diabetic monitoring, may be considered medically necessary when the following situations are documented in the medical records and occur despite use of **best practices:

• Patients with Type I diabetes who have recurrent, unexplained, severe (generally blood glucose levels less than 50 mg/dL) hypoglycemia or impaired awareness for whom hypoglycemia puts the patient or others at risk; or
• Patients with Type I diabetes who are pregnant.

** Best practices in diabetes control for patients with diabetes mellitus include:

• Compliance with a regimen of four (4) or more fingersticks each day; or
• Use of insulin pump; or
• Prior use of intermittent (72-hour) glucose.

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

The glucose sensor and transmitter components of a continuous glucose monitor used with a combined continuous subcutaneous insulin infusion and blood glucose monitoring devices may be considered medically necessary when all the above criteria met.

Other uses of continuous monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring are considered investigational.

The use of implantable CGM devices (i.e., Eversense Continuous Glucose Monitoring System) are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Tight glucose control in individuals with diabetes has been associated with improved outcomes. Several devices are available to measure glucose levels automatically and frequently (e.g., every 5-10 minutes). The devices measure glucose in the interstitial fluid and are approved as adjuncts to traditional self-monitoring of blood glucose levels. Devices can be used on a long-term (continuous) or short-term (often referred to as intermittent) basis.

Blood Glucose Control

The advent of blood glucose monitors for use by individuals in the home revolutionized the management of diabetes. Using fingersticks, patients can monitor their blood glucose levels both to determine the adequacy of hyperglycemia control and to evaluate hypoglycemic episodes. Tight glucose control, defined as a strategy involving frequent glucose checks and a target hemoglobin A1C (HbA1c) level in the range of 7%, is now considered the standard of care for diabetic patients. Randomized controlled trials assessing tight control have demonstrated benefits for patients with type 1 diabetes in decreasing microvascular complications. The impact of tight control on type 1 diabetes and macrovascular complications such as stroke or myocardial infarction is less certain. The Diabetes Control and Complications Trial (2002) demonstrated that a relative HbA1c level reduction of 10% is clinically meaningful and corresponds to approximately a 40% decrease in risk for progression of diabetic retinopathy and a 25% decrease in risk for progression of renal disease.

Due to an increase in turnover of red blood cells during pregnancy, HbA1c levels are slightly lower in women with a normal pregnancy compared with nonpregnant women. The target A1C in women with diabetes is also lower in pregnancy. The American Diabetes Association recommends that, if achievable without significant hypoglycemia, the A1C levels should range between 6.0% to 6.5%; an A1C level less than 6% may be optimal as the pregnancy progresses.

Tight glucose control requires multiple daily measurements of blood glucose (i.e., before meals and at bedtime), a commitment that some patients may find difficult to meet. The goal of tight glucose control has to be balanced with an associated risk of hypoglycemia. Hypoglycemia is known to be a risk in patients with type 1 diabetes. While patients with insulin-treated type 2 diabetes may also experience severe hypoglycemic episodes, there is a lower relative likelihood of severe hypoglycemia compared with patients who had type 1 diabetes. An additional limitation of periodic self-measurements of blood glucose is that glucose levels are seen in isolation, and trends in glucose levels are undetected. For example, while a diabetic patient’s fasting blood glucose level might be within normal values, hyperglycemia might be undetected postprandially, leading to elevated HbA1c levels.

Management

Measurements of glucose in the interstitial fluid have been developed as a technique to measure glucose values automatically throughout the day, producing data that show the trends in glucose levels. Although devices measure glucose in the interstitial fluid on a periodic rather than a continuous basis, this type of monitoring is referred to as continuous glucose monitoring (CGM).

Currently, CGM devices are of two designs; real-time CGM (rtCGM) provide real-time data on glucose level, glucose trends, direction, and rate of change and, intermittently viewed (iCGM) devices that show continuous glucose measurements retrospectively. These devices are also known as flash-glucose monitors (FGM).

Approved devices now include devices indicated for pediatric use and those with more advanced software, more frequent measurements of glucose levels, or more sophisticated alarm systems. Devices initially measured interstitial glucose every 5 to10 minutes and stored data for download and retrospective evaluation by a clinician. With currently available devices, the intervals at which interstitial glucose is measured range from every 1-2 minutes to 5 minutes, and most provide measurements in real-time directly to patients. While CGM potentially eliminates or decreases the number of required daily finger sticks, according to the Food and Drug Administration labeling, some marketed monitors are not intended as an alternative to traditional self-monitoring of blood glucose levels but rather as adjuncts to monitoring, supplying additional information on glucose trends not available from self-monitoring while other devices are factory calibrated and do not require finger stick blood glucose calibration.

KEY POINTS:

This evidence review was created and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through May 16, 2024.

Summary of Evidence:

Type 1 Diabetes

For individuals with type 1 diabetes who are willing and able to use the device, and have adequate medical supervision, who receive long-term CGM, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. RCTs have evaluated both real-time and intermittently scanned CGMs. Long-term CGM resulted in significantly improved glycemic control for adults and children with type 1 diabetes, particularly highly compliant patients. Two RCTs in patients who used multiple daily insulin injections and were highly compliant with CGM devices during run-in phases found that CGM was associated with a larger reduction in HbA1c levels than previous studies. One of the 2 RCTs prespecified hypoglycemia-related outcomes and reported that time spent in hypoglycemia was significantly less in the CGM group. One RCT in pregnant women with type 1 diabetes, which compared real-time CGM with self-monitoring of blood glucose, has also reported a difference in change in HbA1c levels, an increased percentage of time in the recommended glucose control target range, a smaller proportion of infants who were large for gestational age, a smaller proportion of infants who had neonatal intensive care admissions lasting more than 24 hours, a smaller proportion of infants who had neonatal hypoglycemia requiring treatment, and reduced total hospital length of stay all favoring CGM. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with type 1 diabetes who receive short-term glucose monitoring, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity as well as intermediate outcomes related to measures of glucose control such as frequency and time in hypoglycemia and hyperglycemia. The evidence for short-term monitoring of glycemic control is mixed, and there was no consistency in HbA1c levels. Some trials have reported improvements in glucose control for the intermittent monitoring group but limitations in this body of evidence preclude conclusions. The definitions of control with short-term CGM use, duration of use and the specific monitoring protocols varied. In some studies, short-term monitoring was part of a larger strategy aimed at optimizing glucose control, and the impact of monitoring cannot be separated from the impact of other interventions. Studies have not shown an advantage for intermittent glucose monitoring in reducing severe hypoglycemia events but the number of events reported is generally small and effect estimates imprecise. The limited duration of use may preclude an assessment of any therapeutic effect. Two RCTs of short-term CGM use for monitoring in pregnancy included women with both type 1 and 2 diabetes, with most having type 1 diabetes. One trial reported a difference in HbA1c levels at 36 weeks; the proportion of infants that were large for gestational age (>90th percentile) favored CGM while the second trial did not. The differences in the proportions of infants born via cesarean section, gestational age at delivery, and infants with severe hypoglycemia were not statistically significant in either study. Limitations of the published evidence preclude determining the effects of the technology on net health outcome.

Type 2 Diabetes

For individuals with type 2 diabetes who are treated with insulin therapy who receive long-term CGM, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. RCTs have included individuals on intensive insulin therapy and individuals on basal insulin. Three RCTs have evaluated CGM compared to SMBG in individuals with type 2 diabetes on intensive insulin therapy; 1 using real-time CGM and 2 using an intermittently scanned device. One RCT evaluated CGM in patients treated with basal insulin. All found either improved glycemic outcomes or no difference between groups with no increase in hypoglycemic events. In the DIAMOND trial, the adjusted difference in mean change in HbA1c level from baseline to 24 weeks was -0.3% (95% CI, -0.5% to 0.0%; p=.022) favoring CGM. The adjusted difference in the proportion of patients with a relative reduction in HbA1c level of 10% or more was 22% (95% CI, 0% to 42%; p=.028) favoring CGM. There were no events of severe hypoglycemia or diabetic ketoacidosis in either group. Yaron et al (2019) reported higher treatment satisfaction with CGM compared to control (the primary outcome). At 12-month follow-up in one of the trials of the Freestyle Libre device, hypoglycemic events were reduced by 40.8% to 61.7% with a greater relative reduction in the most severe thresholds of hypoglycemia. In the Martens trial of individuals treated with basal insulin without prandial insulin, there was a statistically significantly greater decrease in mean HbA1c in the CGM group (adjusted difference, -0.4%; 95% CI -0.8% to -0.1%; p=.02), with 1 hypoglycemic event in each group. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with type 2 diabetes who are not treated with insulin therapy who receive long-term CGM, the evidence includes 4 RCTs. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. Results were mixed regarding benefits of CGM with respect to glycemic control. Participant populations were heterogeneous with regard to their diabetic treatment regimens, and participants might not have been receiving optimal therapy. In individuals on oral antidiabetic agents only, routine glucose monitoring may be of limited additional clinical benefit. Additional evidence would be needed to show what levels of improvement in blood glucose excursions and HbA1c levels over the short-term in this population would be linked to meaningful improvement in long-term health outcomes such as diabetes-related morbidity and complications. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with type 2 diabetes who receive short-term continuous glucose monitoring, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity as well as intermediate outcomes related to measures of glucose control such as frequency and time in hypoglycemia and hyperglycemia. The evidence for short-term monitoring of glycemic control is mixed, and there was no consistency in HbA1c levels. Some trials have reported improvements in glucose control for the short-term monitoring group but limitations in this body of evidence preclude conclusions. The definitions of control with short-term CGM use, duration of use and the specific monitoring protocols varied. In some studies, short-term monitoring was part of a larger strategy aimed at optimizing glucose control, and the impact of monitoring cannot be separated from the impact of other interventions. Studies have not shown an advantage for intermittent glucose monitoring in reducing severe hypoglycemia events but the number of events reported is generally small and effect estimates imprecise. The limited duration of use may preclude an assessment of any therapeutic effect. Three RCTs of short-term CGM use for monitoring in pregnancy included women with both type 1 and 2 diabetes, with most having type 1 diabetes. One trial reported a difference in HbA1c levels at 36 weeks; the proportion of infants that were large for gestational age (>90th percentile) favored CGM while the other trials did not. The differences in the proportions of infants born via cesarean section, gestational age at delivery, and infants with severe hypoglycemia were not statistically significant in studies in which these outcomes were reported. Limitations of the published evidence preclude determining the effects of the technology on net health outcome. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Gestational Diabetes

For individuals who are pregnant with gestational diabetes who receive long-term (continuous) or short-term (intermittent) glucose monitoring, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, quality of life, and treatment-related morbidity. In the RCTs, trial reporting was incomplete; however, there was no difference between the groups for the majority of the reported outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Continuous Glucose Monitoring with an Implantable Device (Eversense)

For individuals with type 1 or type 2 diabetes who receive continuous glucose monitoring with an implantable device, the evidence includes an RCT and nonrandomized studies. The RCT compared implantable CGM with control (self-monitoring of blood glucose or intermittently scanned CGM). The RCT was conducted in France and enrolled participants in 2 cohorts; cohort 1 (n=149)included participants with type 1 or type 2 diabetes with HbA1c >8.0% while cohort 2 (n=90) included participants with type 1diabetes with time spent with glucose values below 70 mg/dL for more than 1.5 hours per day in the previous 28 days. In cohort1, there was no difference in mean HbA1c, time in range, or patient-reported outcomes at day 180. In cohort 2, the mean difference in time spent below 54 mg/dL between days 90 and 120 was statistically significant favoring implantable CGM(difference=-1.6% [23 minutes]; 95% CI, -3.1 to -0.1; p=.04). There were no differences in patient reported outcomes. Nonrandomized prospective studies and post-marketing registry studies assessed the accuracy and safety of an implanted glucose monitoring system. Accuracy measures included the mean absolute relative difference between paired samples from the implanted device and a reference standard blood glucose measurement. The accuracy tended to be lower in hypoglycemic ranges. The initial approval of the device has been expanded to allow the device to be used for glucose management decision-making. The same clinical study information was used to support what the FDA considered a reasonable assurance of safety and effectiveness of the device for the replacement of finger stick blood glucose monitoring for diabetes treatment decisions. In February 2022, approval of the device for use up to 180 days. Approval was based on the FDA expanded PROMISE pivotal clinical trial, which assessed accuracy and safety but not glycemic outcomes. Limitations of the evidence base include limited comparisons to SMBG, lack of differentiation in outcomes for type 1 diabetes versus type 2 diabetes, and variability in reporting of trends in secondary glycemic measures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American Association of Clinical Endocrinologists 

In 2023, the American Association of Clinical Endocrinology (AACE) published an updated consensus statement on an algorithm for type 2 diabetes management. A subset of the statements regarding CGM are below.

• "CGM is highly recommended to assist persons with diabetes in reaching goals safely. CGM has provided a major advance in the treatment of persons with all forms of DM."
• "The use of CGM is recommended for persons treated with insulin to optimize glycemic control while minimizing hypoglycemia."

In 2022, the American Association of Clinical Endocrinology (AACE) published clinical practice guideline for developing diabetes care plans and made the following recommendations (level of evidence) on CGM:

• "All persons who use insulin should use continuous glucose monitoring (CGM) or perform blood glucose monitoring(BGM) a minimum of twice daily and ideally before any insulin injection." (Grade A; Best Evidence Level 1)
• "Real-time continuous glucose monitoring (rtCGM) or intermittently scanned continuous glucose monitoring (isCGM) is recommended for all persons with T1D, regardless of insulin delivery system, to improve A1C levels and to reduce the risk for hypoglycemia and DKA." (Grade A; Best Evidence Level 1)
• "rtCGM or isCGM is recommended for persons with T2D who are treated with insulin therapy, or who have high risk for hypoglycemia and/or with hypoglycemia unawareness." (Grade A; Best Evidence Level 1)

In 2021, The American Association of Clinical Endocrinology (AACE) published recommendations on the use of advanced technology in the management of diabetes and made the following recommendations (level of evidence) on CGM:

• CGM is strongly recommended for all persons with diabetes treated with intensive insulin therapy, defined as 3 or more injections of insulin per day or the use of an insulin pump. (Grade A; High Strength of Evidence)
• CGM is recommended for all individuals with problematic hypoglycemia (frequent/severe hypoglycemia, nocturnal hypoglycemia, hypoglycemia unawareness).(Grade A; Intermediate-High Strength of Evidence)
• CGM is recommended for children/adolescents with T1D. (Grade A; Intermediate-High Strength of Evidence)
• CGM is recommended for pregnant women with T1D and T2D treated with intensive insulin therapy. (Grade A; Intermediate-High Strength of Evidence)
• CGM is recommended for women with gestational diabetes mellitus (GDM) on insulin therapy. (Grade A; Intermediate Strength of Evidence)
• CGM may be recommended for women with GDM who are not on insulin therapy. (Grade B; Intermediate Strength of Evidence)
• CGM may be recommended for individuals with T2D who are treated with less intensive insulin therapy. (Grade Intermediate Strength of Evidence)

American Diabetes Association

The American Diabetes Association (2023) “Standards of Medical Care in Diabetes" made the following recommendations (level of evidence) on CGM devices:

• "Real-time CGM (A) or intermittently scanned continuous glucose monitoring (B) should be offered for diabetes management in adults with diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are capable of using devices safely (either by themselves or with a caregiver). The choice of device should be made based on patient circumstances, desires, and needs."
• Real-time CGM (A) or intermittently scanned continuous glucose monitoring (C) should be offered for diabetes management in adults with diabetes on basal insulin who are capable of using devices safely (either by themselves or with a caregiver). The choice of device should be made based on patient circumstances, desires, and needs."
• "Real-time continuous glucose monitoring or intermittently scanned continuous glucose monitoring should be offered for diabetes management in youth with type 2 diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are capable of using the devices safely (either by themselves or with a caregiver). The choice of device should be made based on the individual’s circumstances, preferences, and needs." (E)
• When used as an adjunct to pre- and postprandial blood glucose monitoring, CGM can help to achieve A1c targets in diabetes and pregnancy (B)
• Periodic use of real-time or intermittently scanned cCGM or use of professional CGM can be helpful for diabetes management in circumstances where continuous use of CGM is not appropriate, desired, or available (C).

National Institute for Health and Care Excellence

In 2022, the National Institute for Health and Care Excellence (NICE) updated its guidance on management of type 1 and type 2 diabetes. The guidance included the following updated recommendations on continuous glucose monitoring (refer to source documents for complete guidance):

Type 1 Diabetes

"Offer adults with type 1 diabetes a choice of real-time continuous glucose monitoring (rtCGM) or intermittently scanned continuous glucose monitoring (isCGM, commonly referred to as 'flash'), based on their individual preferences, needs, characteristics, and the functionality of the devices available. "

"When choosing a (CGM) device:

• use shared decision making to identify the person's needs and preferences, and offer them an appropriate device
• if multiple devices meet their needs and preferences, offer the device with the lowest cost"

Type 2 Diabetes

"Offer intermittently scanned continuous glucose monitoring (isCGM, commonly referred to as 'flash') to adults with type 2 diabetes on multiple daily insulin injections if any of the following apply:

• they have recurrent hypoglycaemia or severe hypoglycaemia
• they have impaired hypoglycaemia awareness
• they have a condition or disability (including a learning disability or cognitive impairment) that means they cannot self-monitor their blood glucose by capillary blood glucose monitoring but could use an isCGM device (or have it scanned for them)
• they would otherwise be advised to self-measure at least 8 times a day."

"Offer is CGM to adults with insulin-treated type 2 diabetes who would otherwise need help from a care worker or healthcare professional to monitor their blood glucose."

"Consider real-time continuous glucose monitoring (rtCGM) as an alternative to is CGM for adults with insulin-treated type 2 diabetes if it is available for the same or lower cost."

The guidance and accompanying evidence review do not specifically mention implantable CGM devices.

Endocrine Society

The Endocrine Society (2022) published clinical practice guidelines of management of individuals at high risk of hypoglycemia and included the following recommendations on CGM:

• We recommend CGM rather than self-monitoring of blood glucose (SMBG) by finger stick for patients with type 1 diabetes(T1D) receiving multiple daily injections (MDIs).
• We suggest real-time continuous glucose monitoring CGM be used rather than no CGM for outpatients with type 2diabetes (T2D) who take insulin and/or sulfonylureas (SUs) and are at risk for hypoglycemia.

The Endocrine Society (2016) published clinical practice guidelines that included the following recommendations on CGM:

• 6. "Real-time continuous glucose monitors in adult outpatients
• 6.1 We recommend real-time continuous glucose monitoring (RT-CGM) devices for adult patients with T1DM [type 1 diabetes mellitus] who have A1C levels above target and who are willing and able to use these devices on a nearly daily basis.
• 6.2 We recommend RT-CGM devices for adult patients with well-controlled T1DM who are willing and able to use these devices on an early daily basis.
• Use of continuous glucose monitoring in adults with type 2 diabetes mellitus [T2DM]
• 6.3 We suggest short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C levels ≥7%and are willing and able to use the device."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

GlucoWatch®, wrist glucose monitor, Glucose Biographer, AutoSensor, and GlucoWatch® G2™ Biographer, continuous monitoring of glucose in the interstitial fluid, intermittent monitoring of glucose in the interstitial fluid, Continuous Glucose Monitoring System, CGMS, CGMS® System Gold™, Minimed, MiniMed Paradigm 522 or 722 insulin pumps, MiniMed Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System, combined continuous subcutaneous insulin infusion and blood glucose monitoring device, DexCom STS Continuous Glucose Monitoring System, CGMS iPro Recorder, Freestyle Navigator® Continuous Glucose Monitoring System, Guardian® REAL-Time Continuous Glucose Monitoring System, CGM, Dexcom G5, Abbott® Freestyle Libre Flash, Dexcom G6, Eversense, implantable , Freestyle® Libre 2, Eversense E3 

APPROVED BY GOVERNING BODIES:

Multiple continuous glucose monitoring systems have been approved by the FDA through the premarket approval process:

CGM devices labeled as “Pro” for specific professional use with customized software and transmission to health care professionals are not enumerated in this list. The

Flash glucose monitors (e.g., FreeStyle Libre, Abbott) use intermittent scanning.

Table 1. CGM Systems Approved or Cleared by the U.S. Food and Drug Administration

Device	Manufacturer	Approval	Indications
Continuous Glucose Monitoring System (CGMS®)	MiniMed	1999	3-d use in physician's office
GlucoWatch G2® Biographer		2001	Not available since 2008
Guardian®-RT (Real-Time) CGMS	MiniMed (now Medtronic)	2005
Dexcom® STS CGMS system	Dexcom	2006
Paradigm® REAL-Time System (second-generation called Paradigm Revel System)	MiniMed (now Medtronic)	2006	Integrates CGM with a Paradigm insulin pump
FreeStyle Navigator® CGM System	Abbott	2008
Dexcom® G4 Platinum	Dexcom	2012	Adults ≥18 y; can be worn for up to 7 d
		2014	Expanded to include patients with diabetes 2-17 y
Dexcom® G5 Mobile CGM	Dexcom	2016a	Replacement for fingerstick blood glucose testing in patients ≥2 y. System requires at least 2 daily fingerstick tests for calibration purposes, but additional fingersticks are not necessary because treatment decisions can be made based on device readings5,
Dexcom® G6 Continuous Glucose Monitoring System	Dexcom	2018	Indicated for the management of diabetes in person’s age ≥2 years. Intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. with 10-day wear
Freestyle Libre®Flash Glucose Monitoring System	Abbott	2017	Adults ≥18 y. Indicated for the management of diabetes and can be worn up to 10 days It is designed to replace blood glucose testing for diabetes treatment decisions.
Freestyle Libre® Flash Glucose Monitoring System	Abbott	2018	Adult’s ≥18 y. Extended duration of use to 14 days
Freestyle® Libre 2 Flash Glucose Monitoring System	Abbott	June 2020	Children ≥ 4 years of age, adolescents and adults
Guardian Connect	Medtronic MiniMed	2018	Adolescents and adults (14-75 years) Continuous or periodic monitoring of interstitial glucose levels. Provides real-time glucose values, trends, and alerts through a Guardian Connect app installed on a compatible consumer electronic mobile device
Eversense Continuous Glucose Monitoring System	Senseonics	2018 2019	Adult’s ≥18 y. Continually measuring glucose levels up to 90 days. Use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices. Adult’s ≥18 y. Continually measuring glucose levels up to 90 days. Indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. Historical data from the system can be interpreted to aid in providing therapy adjustments.
Eversense E3 Continuous Glucose Monitoring System	Senseonics	2022	Adults ≥18 y. Continually measuring glucose levels up to 180 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to provide real-time glucose readings, provide glucose trend information, and provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.

CGM: continuous glucose monitoring.

a As a supplement to the G4 premarketing approval.

Food and Drug Administration product codes: MDS, PQF, QCD

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 contracts:  Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT codes:

95249	Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; patient-provided equipment, sensor placement, hook-up, calibration of monitor, patient training, and printout of recording
95250	Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of  72 hours; physician or other qualified health care professional (office) provided equipment, sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording
95251	Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; analysis, interpretation and report
99091	Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time
0446T	Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training
0447T	Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision
0448T	Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation
0740T	Remote autonomous algorithm-based recommendation system for insulin dose calculation and titration; initial set-up and patient education (Effective 01/01/2023)
0741T	Remote autonomous algorithm-based recommendation system for insulin dose calculation and titration; initial set-up and patient education; provision of software, data collection, transmission, and storage, each 30 days (Effective 01/01/2023)

 

HCPCS:

A4238	Supply allowance for adjunctive, non-implanted continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service
A4239	Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service (Effective 01/01/23)
A9276	Sensor; invasive (e.g., subcutaneous), disposable, for use with non-durable medical equipment interstitial continuous glucose monitoring system, one unit = 1 day supply
A9277	Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose monitoring system
A9278	Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose monitoring system
A9999	Miscellaneous DME supply, accessory, and/or service component of another HCPCS code
E1399	Durable medical equipment, miscellaneous
E2102	Adjunctive, non-implanted continuous glucose monitor or receiver
E2103	Non-adjunctive, non-implanted continuous glucose monitor or receiver (Effective 01/01/23)
G0564	Creation of subcutaneous pocket with insertion of 365 day implantable interstitial glucose sensor, including system activation and patient training(Effective 01/01/2025)
G0565	Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new 365 day implantable sensor, including system activation(Effective 01/01/2025)
S1030	Continuous noninvasive glucose monitoring device purchase (for physician interpretation of data, use CPT code)
S1031	Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use CPT code)

REFERENCES:

1. Aleppo G, Beck RW, Bailey R, et al. The Effect of Discontinuing Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin. Diabetes Care. Dec 2021; 44(12): 2729-2737.
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. Ajjan, RR, Abougila, KK, Bellary, SS, Collier, AA, Franke, BB, Jude, EE, Rayman, GG, Robinson, AA, Singh, BB. Sensor and software use for the glycaemic management of insulin-treated type 1 and type 2 diabetes patients. Diab Vasc Dis Res, 2016 Mar 24;13(3).
4. Ajjan RA, Abougila K, Bellary S, et al. Sensor and software use for the glycaemic management of insulin-treated type 1 and type 2 diabetes patients. Diab Vasc Dis Res. May 2016; 13(3): 211-9.
5. American Association of Clinical Endocrinology and American College of Endocrinology. Comprehensive Type 2 Diabetes Management Algorithm. 2020. https://pro.aace.com/disease-state-resources/diabetes/clinical-practice-guidelines-treatment-algorithms/comprehensive. Accessed November 2, 2020.
6. American Diabetes Association. Standards of Medical Care in Diabetes. 2022. https://professional.diabetes.org/content-page/practice-guidelines-resources.
7. American Diabetes A. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2018. Diabetes Care. Jan 2018;41(Suppl 1):S55-S64.
8. American Diabetes Association. 7. Approaches to glycemic treatment. Diabetes Care. Jan 2015; 38 (suppl: S41-48).
9. American Diabetes Association.  Standards of medical care in diabetes—2010.  Diabetes Care 2010; 33(suppl 1):S11-61.
10. American Diabetes A. Standards of medical care in diabetes--2013. Diabetes Care 2013; 36 Suppl 1:S11-66.
11. American Diabetes Association. Standards in Medical Care in Diabetes, 2014. 2014; www.care.diabetesjournals.org/content/37/Supplement_1/S14.full.pdf+html American Diabetes Association (ADA). Glycemic Targets. Diabetes Care. Jan 2017; 40(Suppl 1):S48-S56.
12. American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2019. Diabetes Care, 2018 Dec 19;42(Suppl 1). 
13. American DA.  Executive summary: standards of medical care in diabetes—2011.  Diabetes Care 2011; 34(Suppl 1):S4-S10.
14. American Diabetes Association. Standards of Medical Care in Diabetes. 2020. https://professional.diabetes.org/content-page/practice-guidelines-resources.
15. American Diabetes Association. Standards of Medical Care in Diabetes. 2021. https://professional.diabetes.org/content-page/practice-guidelines-resources.
16. Aronson R, Brown RE, Chu L, et al. IMpact of flash glucose Monitoring in pEople with type 2 Diabetes Inadequately controlled with non-insulin Antihyperglycaemic ThErapy (IMMEDIATE): A randomized controlled trial. Diabetes Obes Metab. Apr 2023; 25(4): 1024-1031.
17. Bailey KJ, Little JP, Jung ME. Self-monitoring using continuous glucose monitors with real-time feedback improves exercise adherence in individuals with impaired blood glucose: a pilot study. Diabetes Technol Ther. Mar 2016; 18(3):185-193.
18. Battelino T, Conget I, Olsen B et al.  The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial Diabetologia 2012; 55(12):3155-3162.
19. Battelino T, Danne T, Bergenstal RM, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation:Recommendations From the International Consensus on Time in Range. Diabetes Care. Aug 2019; 42(8): 1593-1603.
20. Beck RW, Riddlesworth TD, Ruedy K, et al. Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial. Ann Intern Med. Sep 19 2017; 167(6):365-374.
21. Beck RW, Riddlesworth T, Ruedy K, et al. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomized clinical trial. Jama. Jan 24 2017; 317(4):371-378.
22. Benkhadra K, Alahdab F, Tamhane S, et al. Real-time continuous glucose monitoring in type 1 diabetes: a systematic review and individual patient data meta-analysis. Clin Endocrinol (Oxf). Mar 2017; 86(3):354-360.
23. Bergenstal RM, Klonoff DC, Garg SK et al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med 2013; 369(3):224-32.  
24. Blue Cross Blue Shield Association Technology Evaluation Criteria (TEC) Assessment. Use of intermittent or continuous interstitial fluid glucose monitoring in patients with diabetes mellitus. TEC Assessments 2003; Volume 18, Tab 16.
25. Christiansen, MM, Klaff, LL, Brazg, RR, Chang, AA, Levy, CC, Lam, DD, Denham, DD, Atiee, GG, Bode, BB, Walters, SS, Kelley, LL, Bailey, TT. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol. Ther., 2018 Jan 31;20(3).
26. Christiansen, MM, Klaff, LL, Bailey, TT, Brazg, RR, Carlson, GG, Tweden, KK. A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study. Diabetes Technol. Ther., 2019 Mar 30;21(5). 
27. Deiss D, Irace C, Carlson G, et al. Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles ofUse: A Post-Market Registry Study. Diabetes Technol Ther. Jan 2020; 22(1): 48-52.
28. Eeg-Olofsson K, Svensson AM, Franzén S, et al. Real-world study of flash glucose monitoring among adults with type 2 diabetes within the Swedish National Diabetes Register. Diab Vasc Dis Res. 2023; 20(1): 14791641211067418.
29. Erhardt NM, Chellapa M, Walker MS et al. The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus. J Diabetes Sci Technol 2011; 5(3):668-75.
30. Feig DS, Donovan LE, Corcoy R, et al. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. Nov 25 2017; 390(10110):2347-2359.
31. Floyd B, Chandra P, Hall S et al.  Comparative analysis of the efficacy of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes mellitus.  J Diabetes Sci Technol 2012; 6(5):1094-1102.
32. Food and Drug Administration (FDA). Summary of Safety and Effectiveness (SSED): Dexcom G5 Mobile Continuous Glucose Monitoring System. 2016; www.accessdata.fda.gov/cdrh_docs/pdf12/P120005S041b.pdf. 
33. Food and Drug Administration (FDA). News Release:  Freestyle Libre Flash Glucose Monitoring System. 2017; www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm. 
34. Food and Drug Administration. Summary of Safety and Effectiveness Data: Eversense Continuous Glucose Monitoring System(2019). https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160048B.pdf. 
35. Furler J, O'Neal D, Speight J, et al. Use of professional-mode flash glucose monitoring, at 3-month intervals, in adults with type2 diabetes in general practice (GP-OSMOTIC): a pragmatic, open-label, 12-month, randomised controlled trial. Lancet DiabetesEndocrinol. Jan 2020; 8(1): 17-26.
36. Gandhi GY, Kovalaske M, Kudva Y et al. Efficacy of continuous glucose monitoring in improved glycemic control and reducing hypoglycemia: a systematic review and meta-analysis of randomized trials. J Diabetes Sci Technol 2011; 5(4):952-65.
37. Garber, AA, Abrahamson, MM, Barzilay, JJ, Blonde, LL, Bloomgarden, ZZ, Bush, MM, Dagogo-Jack, SS, DeFronzo, RR, Einhorn, DD, Fonseca, VV, Garber, JJ, Garvey, WW, Grunberger, GG, Handelsman, YY, Hirsch, II, Jellinger, PP, McGill, JJ, Mechanick, JJ, Rosenblit, PP, Umpierrez, GG. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract, 2019 Feb 12;25(1).
38. Garg S, Brazg RL, Bailey TS et al. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery:  the in-clinic ASPORE study. Diab Technol Ther 2012; 14(3):205-9.
39. Garg SK, Liljenquist D, Bode B, et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study. Diabetes Technol Ther. Feb 2022; 24(2): 84-92.
40. Gehlaut RR, Dogbey GY, Schwartz FL, et al. Hypoglycemia in type 2 diabetes--more common than you think: a continuous glucose monitoring study. J Diabetes Sci Technol. Sep 2015; 9(5):999-1005.
41. Grunberger G, Sherr J, Allende M, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons with Diabetes Mellitus. Endocr Pract. Jun 2021; 27(6): 505-537.
42. Guerci B, Roussel R, Levrat-Guillen F, et al. Important Decrease in Hospitalizations for Acute Diabetes Events Following FreeStyle Libre System Initiation in People with Type 2 Diabetes on Basal Insulin Therapy in France. Diabetes Technol Ther. Jan 2023; 25(1): 20-30.
43. Gupta A, Mukherjee S, Kumar Bhadada S, et al. Impact of short-term application of continuous glucose monitoring system(CGMS) onlong-term glycemic profile in adolescents and adults with type 1 diabetes mellitus: An open-label randomized control cross over study. Diabetes Res Clin Pract. Apr 2024; 210: 111610.
44. Haak, TT, Hanaire, HH, Ajjan, RR, Hermanns, NN, Riveline, JJ, Rayman, GG. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther, 2016 Dec 22;8(1).
45. Haak, TT, Hanaire, HH, Ajjan, RR, Hermanns, NN, Riveline, JJ, Rayman, GG. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther, 2017 Apr 13;8(3).
46. Ida, SS, Kaneko, RR, Murata, KK. Utility of Real-Time and Retrospective Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. J Diabetes Res, 2019 Feb 19;2019:4684815.
47. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
48. Klonoff DC, Buckingham B, Christiansen JS et al. Continuous glucose monitoring:  an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011; 96(10):2968-79.
49. Kropff, JJ, Choudhary, PP, Neupane, SS, Barnard, KK, Bain, SS, Kapitza, CC, Forst, TT, Link, MM, Dehennis, AA, DeVries, JJ. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care, 2016 Nov 7;40(1). 
50. Laffel LM, Kanapka LG, Beck RW, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents andYoung Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. Jun 16 2020; 323(23): 2388-2396.
51. Lai M, Weng J, Yang J, et al. Effect of continuous glucose monitoring compared with self-monitoring of blood glucose in gestational diabetes patients with HbA1c 6%: a randomized controlled trial. Front Endocrinol (Lausanne). 2023; 14: 1174239.
52. Langendam M, Luijf YM, Hooft L et al. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochran Database Syst Rev 2012; 1:CD0081010.
53. Leelarathna L, Evans ML, Neupane S, et al. Intermittently Scanned Continuous Glucose Monitoring for Type 1 Diabetes. N Engl J Med.Oct 20 2022; 387(16): 1477-1487.
54. Lind M, Polonsky W, Hirsch IB, et al. Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: The GOLD randomized clinical trial. Jama. Jan 24 2017; 317(4):379-387.
55. Lind N, Christensen MB, Hansen DL, et al. Comparing Continuous Glucose Monitoring and Blood Glucose Monitoring in Adults With Inadequately Controlled, Insulin-Treated Type 2 Diabetes (Steno2tech Study): A 12-Month, Single-Center, Randomized Controlled Trial. Diabetes Care. May 01 2024; 47(5): 881-889.
56. Little SA, Leelarathna L, Walkinshaw E, et al. Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 x 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care. Aug 2014; 37(8):2114-2122.
57. 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.
58. Martens T, Beck RW, Bailey R, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. Jun 08 2021; 325(22): 2262-2272.
59. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2018. Diabetes Care. Jan 2018; 41(Suppl 1):S137-s143.
60. Mauras N, Beck R, Xing D et al. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years.  Diabetes Care 2012; 35(2):204-210.
61. National Center for Health and Care Excellence (NICE). Type 1 diabetes in adults: diagnosis and management. www.nice.org.uk/guidance/ng17?unlid=382286372016220232952. 
62. National Institute for Health and Care Excellence. (2022) Type 1 Diabetes in Adults: Diagnosis and Management.https://www.nice.org.uk/guidance/ng17/chapter/Recommendations#blood-glucose-management. 
63. National Institute for Health and Care Excellence. 2022. Type 2 Diabetes in Adults: Management.https://www.nice.org.uk/guidance/ng28. 
64. 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. 
65. Pazos-Couselo M, Garcia-Lopez JM, Gonzalez-Rodriguez M, et al. High incidence of hypoglycemia in stable insulin-treated type 2 diabetes mellitus: continuous glucose monitoring vs. self-monitored blood glucose. Observational prospective study. Can J Diabetes. Oct 2015; 39(5):428-433.
66. Perkins BA, Bebu I, de Boer IH, et al. Risk Factors for Kidney Disease in Type 1 Diabetes. Diabetes Care. 2019 42(5):883-890.
67. Peters AL, Ahmann AJ, Battelino T, et al. Diabetes technology-continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. Nov 2016; 101(11):3922-3937.
68. Polonsky WH, Hessler D, Ruedy KJ, et al. The impact of continuous glucose monitoring on markers of quality of life in adults with type 1 diabetes: further findings from the DIAMOND randomized clinical trial. Diabetes Care. Jun 2017; 40(6):736-741.
69. Poolsup N, Suksomboon N, Kyaw AM. Systematic review and meta-analysis of the effectiveness of continuous glucose monitoring (CGM) on glucose control in diabetes. Diabetol Metab Syndr 2013; 5(1):39.
70. Pratley RE, Kanapka LG, Rickels MR, et al. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. Jun 16 2020; 323(23): 2397-2406.
71. Price DA, Deng Q, Kipnes M, et al. Episodic Real-Time CGM Use in Adults with Type 2 Diabetes: Results of a Pilot Randomized Controlled Trial. Diabetes Ther. Jul 2021; 12(7): 2089-2099.
72. Phillip M, Battelino T, Atlas E et al. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med 2013; 368(9):824-33.
73. Rama Chandran S, Rahman N, Gandhi M, et al. Intermittently scanned continuous glucose monitoring provides no benefit over structured self-monitoring of blood glucose in type 2 diabetes not on prandial insulin, in the context of diabetes self-management education: GLucose monitoring programme SingaporE (GLiMPSE). Diabetes Res Clin Pract. May 2024; 211: 111678.
74. Renard E, Riveline JP, Hanaire H, et al. Reduction of clinically important low glucose excursions with a long-term implantable continuous glucose monitoring system in adults with type 1 diabetes prone to hypoglycaemia: the France Adoption Randomized Clinical Trial. Diabetes Obes Metab. May 2022; 24(5): 859-867.
75. Riddlesworth T, Price D, Cohen N, et al. Hypoglycemic event frequency and the effect of continuous glucose monitoring in adults with type 1 diabetes using multiple daily insulin injections. Diabetes Ther. Aug 2017;8(4):947-951. 
76. Riveline JP, Roussel R, Vicaut E, et al. Reduced Rate of Acute Diabetes Events with Flash Glucose Monitoring Is Sustained for 2 Years After Initiation: Extended Outcomes from the RELIEF Study. Diabetes Technol Ther. Sep 2022; 24(9): 611-618.
77. Roussel R, Riveline JP, Vicaut E, et al. Important Drop in Rate of Acute Diabetes Complications in People With Type 1 or Type 2Diabetes After Initiation of Flash Glucose Monitoring in France: The RELIEF Study. Diabetes Care. Jun 2021; 44(6): 1368-1376.
78. Sanchez P, Ghosh-Dastidar S, Tweden KS, et al. Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor. Diabetes Technol Ther. Dec 2019; 21(12): 677-681.
79. Samson SL, Vellanki P, Blonde L, et al. American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm - 2023 Update. Endocr Pract. May 2023; 29(5): 305-340.
80. Sato J, Kanazawa A, Ikeda F, et al. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. Feb 2016; 44(1):109-121.
81. Secher AL, Ringholm L, Andersen HU et al. The Effect of Real-Time Continuous Glucose Monitoring in Pregnant Women with Diabetes: a randomized controlled trial. Diabetes care 2013 Jul 2013; 36(7):1877-1883.
82. Secher AL, Pedersen-Bjergaard U, Svendsen OL, et al. Flash glucose monitoring and automated bolus calculation in type 1 diabetestreated with multiple daily insulin injections: a 26 week randomised, controlled, multicentre trial. Diabetologia. Dec 2021; 64(12): 2713-2724.
83. Sequeira PA, Montoya L, Ruelas V, et al. Continuous glucose monitoring pilot in low-income type 1 diabetes patients. Diabetes Technol Ther. Oct 2013; 15(10):855-858.
84. Tweden KS, Deiss D, Rastogi R, et al. Longitudinal Analysis of Real-World Performance of an Implantable Continuous GlucoseSensor over Multiple Sensor Insertion and Removal Cycles. Diabetes Technol Ther. May 2020; 22(5): 422-427.
85. Tweden KS, Deiss D, Rastogi R et al. Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor Over Multiple Sensor Insertion and Removal Cycles.. Diabetes Technol. Ther., 2019 Nov 8.
86. van Beers CA, DeVries JH, Kleijer SJ, et al. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycemia (IN CONTROL): a randomized, open-label, crossover trial. Lancet Diabetes Endocrinol. Nov 2016; 4(11):893-902.
87. Vigersky RA, Fonda SJ, Chellappa M et al. Short-and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care 2012; 35(1):32-38.
88. Voormolen DN, Devries JH, Frax A et al. Effectiveness of continuous glucose monitoring during diabetic pregnancy (GlucoMOMS trial); a randomised controlled trial. BMCPrgnancy Childbirth 2012; 12(1):164.
89. Voormolen DN, Devries JH, Evers IM et al. The efficacy and effectiveness of continuous glucose monitoring during pregnancy: a systematic review. Obstet Gynecol Surv 2013; 68(11):753-63.
90. Wada E, Onoue T, Kobayashi T, et al. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. Jun 2020; 8(1).
91. Wei Q, Sun Z, Yang Y, et al. Effect of a CGMS and SMBG on maternal and neonatal outcomes in gestational diabetes mellitus: a randomized controlled trial. Sci Rep. 2016; 6:19920.
92. Wilkie G, Melnik V, Brainard L, et al. Continuous Glucose Monitor Use in Type 2 Diabetes Mellitus in Pregnancy and Perinatal Outcomes: A Systematic Review and Meta-Analysis. Am J Obstet Gynecol MFM. Apr 13 2023: 100969.
93. Wojcichowski P, Rys P, Lipowska A et al. Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes. Pool Arch Med Wewn 2011; 121(10):333-343.
94. Yan J, Zhou Y, Zheng X, et al. Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. Diabetes Metab Res Rev. May 2023; 39(4): e3614.
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POLICY HISTORY:

Medical Policy Administration Committee, March 2002

Available for Comment April 15-May 29, 2002

Medical Policy Group, March 2003 (1)

Medical Policy Administration Committee, March 2003

Available for comment April 1-May 16, 2003

Medical Policy Group, March 2004

Medical Policy Administration Committee, April 2004

Available for comment April 6-May 20, 2004

Medical Policy Group, March 2005 (1)

Medical Policy Group, March 2006 (1)

Medical Policy Group, June 2006 (2)

Medical Policy Administration Committee, June 2006

Available for comment July 7-August 21, 2006

Medical Policy Group, January 2007 (3)

Medical Policy Administration Committee, February 2007

Available for comment February 10-March 26, 2007

Medical Policy Group, July 2007 (1)

Medical Policy Group, October 2007 (2)

Medical Policy Administration Committee, October 2007

Available for comment October 20-December 3, 2007

Medical Policy Group, June 2008 (2)

Medical Review Committee, June 2008

Medical Policy Administration Committee, July 2008

Available for comment August 7-September 22, 2008

Medical Policy Group, November 2008 (2)

Medical Policy Administration Committee, December 2008

Medical Policy Group, January 2009 (2)

Medical Policy Group, February 2009 (2)

Medical Policy Panel, March 2010

Medical Policy Group, May 2010(2)

Medical Policy Group, December 2012 (3): 2013 Coding Updates: Verbiage changes to Code 99091.

Medical Policy Panel, March 2013

Medical Policy Group, May 2013 (2): Policy statement added that artificial pancreases are considered investigational.  Definition of poorly controlled Type 1 diabetes added.  Definition of best practices added.  Description, Key Points, Key Words, and References updated to support Policy Statements.  Policy Statements prior to June 28, 2008 removed.

Medical Policy Administration Committee, June 2013

Available for Comment May 30 through July 13, 2013

Medical Policy Group, April 2014 (5): Policy statement added for coverage of sensor-augmented insulin pump therapy with the low glucose threshold suspend feature; Sensor-augmented insulin pump therapy with the low glucose threshold suspend feature is considered investigational in children younger than 16 years; Replacement or upgrade of properly functioning equipment, even if warranty has expired, is considered not medically necessary. Removed closed-loop monitoring device with LGS feature from being considered investigational. Description, Key Points, Key Words, Practice Guidelines & Position Statements, Approved Governing Bodies, and References updated to support Policy Statements.

Medical Policy Administration Committee, April 2014

Available for comment April 4 through May 19, 2014

Medical Policy Group, May 2014 (5): Added new codes S1034, S1035, S1036, and S1037 effective 7/1/2014.

Medical Policy Group, January 2015 (6): Updates – Key Points and References; no change to policy statement.

Medical Policy Panel, June 2016

Medical Policy Group, July 2016 (6):Updated: Description, Key Points, Summary, U.S. Preventive Services Task Force Recommendations, Key Words, Practice Guidelines and Position Statements and References; No change to policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, December 2016 (6): Updated Description, Key Points, Key Words, Governing Bodies, Summary, Practice Guidelines and References.

Medical Policy Group, February 2017 (6): Removed Artificial Pancreas information from Description, Policy statement, Key Points, Key Words, Practice Guidelines, Governing Bodies, References and Coding. Moved to policy #636, Artificial Pancreas Device Systems.

Medical Policy Group, June 2017: Quarterly Coding update.  Added HCPCs K0553 and K0554 to Current Coding.

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies, Key Words, Coding and References.

Medical Policy Group, September 2017 (6): Updated policy statement bullet to include “or impaired awareness”.

Medical Policy Group, November 2017 (6): Updated coding section to address system limitations of providers for billing the Dexcom G5 CGM.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Added new CPT code 95249 effective 1/1/18 to Current Coding; updated description for revised codes 95250 and 95251.

Medical Policy Group, December 2017 (6): Removed coding instructions from Coding Section.

Medical Policy Group, January 2018 (6): Updated Governing Bodies, Key Words and References to include the Abbott Freestyle Libre CGM. No change to policy statement.

Medical Policy Group, January 2018 (6): Added verbiage to policy section: Coverage for non-medical items, even when the items may be used to serve a medical purpose, such as smart devices (smart phones, tablets, personal computers, etc.) are non-covered. This includes smart devices used in conjunction with Continuous Glucose Monitors.

Medical Policy Panel, March 2018

Medical Policy Group, May 2018 (6): Updates to Description, Key Points, Governing Bodies, Key Words and References.

Medical Policy Panel, November 2018

Medical Policy Group, November 2018 (6): Updates to Key Points, Practice Guidelines, Governing Bodies and References.

Medical Policy Panel, July 2019

Medical Policy Group, August 2019 (6): Updates to Description,Policy statement to include Eversense CGM,  Key Points, Practice Guidelines, Key Words (Eversense CGM), Governing Bodies and References.

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

Medical Policy Panel, December 2019

Medical Policy Group, December 2019 (6): Updates to Description, Policy statement verbiage to include “implantable”, Key Points, Key Words ( Eversense, implantable ), Practice Guidelines, Coding ( added 0446T, 0447T, 0448T) and References.

Medical Policy Group, June 2020 (6): Updates to Governing Bodies and Key Words to include Freestyle® Libre 2.

Medical Policy Group, July 2020 (6): Removed code A4226.

Medical Policy Panel, December 2020

Medical Policy Group, December 2020 (6): Updates to Description, Key Points, Practice Guidelines and References. No change to policy intent.

Medical Policy Group (6): August 2021: Policy update to include expanded coverage for insulin dependent T2D October 1, 2021. Updates to Policy section and Key Points. Removed References prior to 2010. Policy on DRAFT through 10/1/21.

Medical Policy Panel December 2021

Medical Policy Group, December 2021 (6): Updates to Key Points, Practice Guidelines and References. Policy title changed to: Continuous Glucose Monitoring.

Medical Policy Group, March 2022 Quarterly Coding Update. Added HCPCS A4238/E2102 to Current Coding section.

Medical Policy Group, June 2022: Quarterly Coding Update. Added HCPCS codes G0308-G0309 to Current Coding Section.

Medical Policy Group, June 2022 (6): Update to Policy section to include non-covered statement for devices or software programs used to calculate insulin doses and/or send data to providers.

Medical Policy Panel, July 2022

Medical Policy Group, August 2022 (6): Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words and References.

Medical Policy Group, November 2022: 2023 Annual Coding Update. Added CPT codes 0740T-0741T to Current Coding Section.

Medical Policy Group, December 2022: 2023 Annual Coding Update. Added HCPCS codes A4239, E2103. K0553-K0554, G0308-G0309 moved to Previous Coding section. A4238, E2102, A9276-A9278 were revised.

Medical Policy Panel, July 2023

Medical Policy Group, July 2023 (6): Updates to Description, Key Points, Practice Guidelines, Benefit Application and References.

Medical Policy Panel, July 2024

Medical Policy Group, July 2024 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, November 2024 (6): 2025 Annual Coding Update. Added HCPCS G0564/G0565.

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.