Coverage Policy Manual
Policy #: 2001009
Category: Medicine
Initiated: May 2001
Last Review: August 2018
  Glucose Monitoring, Continuous

Description:
Tight glucose control in patients with diabetes has been associated with improved outcomes. Several devices are available to measure glucose levels automatically and frequently (e.g., every 5 to 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 an intermittent or continuous basis.
 
The advent of blood glucose monitors for use by patients in the home over 20 years ago revolutionized the management of diabetes. Using fingersticks, patients could monitor their blood glucose level both to determine the adequacy of hyperglycemia control and to evaluate hypoglycemic episodes. Tight diabetic control, defined as a strategy involving frequent glucose checks and a target hemoglobin A1c (HgA1c) in the range of 7%, is now considered standard of care for diabetic patients. Randomized controlled trials (RCTs) of tight control have demonstrated benefits for type I diabetics in decreasing microvascular complications. The impact of tight control on type II diabetics and on macrovascular complications such as stroke or myocardial infarction (MI) is less certain.
 
However, tight glucose control requires multiple measurements of blood glucose each day (i.e., before meals and at bedtime), a commitment that some patients may be unwilling or unable to meet. In addition, the goal of tight glucose control has to be balanced with an associated risk of hypoglycemia. An additional limitation of periodic self-measurements of blood glucose is that glucose values 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 HgA1c values.
 
Recently, measurements of glucose in interstitial fluid have been developed as a technique of automatically measuring glucose values throughout the day, producing data that show the trends in glucose measurements, in contrast to the isolated glucose measurements of the traditional blood glucose measurements. Although devices measure glucose in interstitial fluid on a periodic rather than a continuous basis, this type of monitoring is referred to as continuous glucose monitoring (CGM).
 
Several devices have received U.S. Food and Drug Administration (FDA) approval. The first two approved devices were the Continuous Glucose Monitoring System (CGMS®) (MiniMed), which uses an implanted temporary sensor in the subcutaneous tissues, and the GlucoWatch G2® Biographer, an external device worn like a wristwatch that measures glucose in interstitial fluid extracted through the skin with an electric current (referred to as reverse iontophoresis).
 
Additional devices that have subsequently been approved include those for pediatric use and those with more advanced software, more frequent measurements of glucose levels, more sophisticated alarm systems, etc. Devices initially measured interstitial glucose every 5 to 10 minutes and, with currently available devices the time intervals at which interstitial glucose is measured ranges from every 1-2 minutes to 5 minutes. While continuous glucose monitors potentially eliminate or decrease the number of required daily fingersticks, it should be noted that, according to the FDA labeling, monitors are not intended to be an alternative to traditional self-monitoring of blood glucose levels but rather provide adjunct, supplying additional information on glucose trends that are not available from self-monitoring. In addition, it is important to note that devices may be used intermittently, e.g., time periods of 72 hours, or on a long-term basis.
 
In addition to stand-alone continuous glucose monitors, several insulin pump systems have included a built-in CGM. This policy addresses continuous glucose monitoring devices, not the insulin pump portion of these systems.
  
Regulatory Status
Several continuous glucose monitoring systems have been approved by the FDA through the premarket approval process:
 
    • The Continuous Glucose Monitoring System (CGMS®) (MiniMed) in 1999 (approved for 3-day use in a physician's office).
    • The GlucoWatch G2® Biographer in 2001. Of note, neither the GlucoWatch nor the autosensors have been available after July 31, 2008.
    • The Guardian®-RT (Real-Time) CGMS (Medtronic, MiniMed) in July 2005. (MiniMed was purchased by Medtronic).
    • The DexCom® STS CGMS system (DexCom) was approved by the FDA in March 2006.
    • The Paradigm® REAL-Time System (Medtronic, MiniMed) was approved by the FDA in 2006. This system integrates a continuous glucose monitor with a Paradigm insulin pump. The second generation integrated system is called the MiniMed Paradigm Revel System.  
    • The FreeStyle Navigator® CGM System (Abbott) was approved in March 2008.
    • The OmniPod® Insulin Management System (Insulet Corporation), integrating the Freestyle Navigator CGM system with the Pod insulin pump, was approved in December 2011.
    • The DexCom G4 Platinum (DexCom) CGM was approved for use in adults 18 years and older in October 2012. The device can be worn for up to 7 days. In February 2014, FDA expanded use of the Dexcom Platinum CGM to include patients with diabetes, age 2 to 17 years-old.
    • The Minimed 530G System (Medtronic) integrating an insulin pump and glucose meter, and including a low glucose suspend feature, was cleared for marketing in September 2013. The threshold suspend tool temporarily suspends insulin delivery when the sensor glucose level is equal to or lower than a preset threshold within the 60 mg/dL 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 to the alarm, the pump automatically suspends action for 2 hours, and then insulin therapy resumes. The device is approved only for use in patients 16 years and older.
    • The Abbott Freestyle Libre Flash Glucose Monitoring System was approved by the U.S. Food and Drug Administration in September 2017 as the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip. The Freestyle Libre System is considered a “Therapeutic” CGM. The receiver and supplies are expected to be billed using K0553 and K0554.
  
Coding
In 2009, CPT code language that specifically described monitoring of glucose levels in the interstitial fluid using implanted devices was revised to state that the devices are used for a minimum of 72 hours:
 
95250 Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording
95251 Interpretation and report.
95249 Same as 95250 but with patient owned equipment (effective 01/01/18).
 
CPT code 99091 might also be used for this monitoring:
99091 Collection and interpretation of physiologic data (eg, ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified healthcare professional, requiring a minimum of 30 minutes of time.
 
HCPCS codes are available specifically for continuous glucose monitoring systems:
 
A9276 Sensor; invasive (eg, 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.
 
In 2017, the Centers for Medicare & Medicaid created 2 new HCPCS codes specific to the use of devices
to make treatment decisions (currently the Dexcom G5 CGM device):
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.
 
Continuous glucose monitoring systems are considered therapeutic CGMs (and therefore DME), if the equipment:
 
    • Is approved by the Food and Drug Administration for use in place of a blood glucose monitor for making diabetes treatment decisions (for example, changes in diet and insulin dosage)
    • Is generally not useful to the individual in the absence of an illness or injury
    • Is appropriate for use in the home
Includes a durable component (a component that CMS determines can withstand repeated use and has an expected lifetime of at least 3 years) that is capable of displaying the trending of the continuous glucose measurements

Policy/
Coverage:
Effective December 2018
 
Meets Primary Coverage Criteria or Is Covered For Contracts Without Primary Coverage Criteria
 
Brief (3 to 7 days) continuous intermittent monitoring of glucose in interstitial fluid meets primary coverage criteria for effectiveness for:
 
        1. Patients with type I diabetes whose diabetes is poorly controlled (poorly controlled diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, uncontrolled hyperglycemia) despite current use of best practices (patients compliant with a regimen including 4 or more finger sticks each day); OR  
        2. Patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels; OR  
        3. Patients with type I diabetes who are pregnant and in whom appropriate diet, exercise, fingerstick monitoring 4 times a day and 3 or more insulin injections or insulin pump use does not control episodes of hypoglycemia or hyperglycemia. Coverage of pregnant women with type 1 diabetes is restricted to no more than 4 episodes (episode = 3 to 7 days) from the 8th to the 32nd weeks of gestation, and must be accompanied by intense review of the data and recommendations of care from the physician/dietician/diabetes specialist nurse.  
 
Continuous monitoring of glucose in interstitial fluid, as a continuous monitoring technique to allow patients to self-manage their type I diabetes, meets primary coverage criteria for:
 
        1. Patients with type I diabetes who have recurrent, unexplained, severe (generally blood glucose levels less than 50 mg/dL) hypoglycemia for whom hypoglycemia puts the patient or others at risk; OR  
        2. Patients with type I diabetes who are pregnant whose type I diabetes is poorly controlled ( poor control includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis);  
 
Provided the following criteria are met:
 
        • Patients who use an FDA approved CGM device specified as appropriate for age; AND
        • Patients who utilize an insulin pump, AND
        • There is verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with type I diabetes mellitus.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Continuous glucose monitoring of interstitial fluid glucose (as contrasted with intermittent glucose monitoring of interstitial fluid glucose up to 7 days) does not meet primary coverage criteria of effectiveness:
        1. For pregnant members with type 2 diabetes mellitus, as only intermittent glucose monitoring of interstitial fluid glucose has been shown to be effective in improving fetal outcome.  
        2. Other uses of continuous monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring are considered investigational.  
 
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
  
Remote monitoring of glucose levels using the mySentry device does not meet member benefit certificate primary coverage criteria because there is a lack of scientific evidence that the use of this device improves health outcomes. For members with contracts without primary coverage criteria, remote monitoring of glucose levels using the mySentry device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Non-invasive continuous glucose monitoring does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, non-invasive continuous glucose monitoring is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to December 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Brief (3 to 7 days) continuous intermittent monitoring of glucose in interstitial fluid meets primary coverage criteria for effectiveness for:
 
    1. Patients with type I diabetes whose diabetes is poorly controlled (poorly controlled diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, uncontrolled hyperglycemia) despite current use of best practices (patients compliant with a regimen including 4 or more fingersticks each day); OR
    2. Patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels; OR
    3. Patients with type I diabetes who are pregnant and in whom appropriate diet, exercise, fingerstick monitoring 4 times a day and 3 or more insulin injections or insulin pump use does not control episodes of hypoglycemia or hyperglycemia. Coverage of pregnant women with type 1 diabetes is restricted to no more than 4 episodes (episode = 3 to 7 days) from the 8th to the 32nd weeks of gestation, and must be accompanied by intense review of the data and recommendations of care from the physician/dietician/diabetes specialist nurse.
 
Continuous monitoring of glucose in interstitial fluid, as a continuous monitoring technique to allow patients to self-manage their diabetes, meets primary coverage criteria for:
 
    1. Patients with type I diabetes who have recurrent, unexplained, severe (generally blood glucose levels less than 50 mg/dL) hypoglycemia for whom hypoglycemia puts the patient or others at risk; OR
    2. Patients with type I diabetes who are pregnant whose diabetes is poorly controlled ( poor control includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis);
 
Provided the following criteria are met:
        • Patients who use an FDA approved CGM device specified as appropriate for age; AND
        • Patients who utilize an insulin pump, AND
        • There is verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Continuous glucose monitoring of interstitial fluid glucose (as contrasted with intermittent glucose monitoring of interstitial fluid glucose up to 7 days) does not meet primary coverage criteria of effectiveness:
    1. For pregnant members with type 2 diabetes mellitus, as only intermittent glucose monitoring of interstitial fluid glucose has been shown to be effective in improving fetal outcome.
    2. Other uses of continuous monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring are considered investigational.
 
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
  
Remote monitoring of glucose levels using the mySentry device does not meet member benefit certificate primary coverage criteria because there is a lack of scientific evidence that the use of this device improves health outcomes. For members with contracts without primary coverage criteria, remote monitoring of glucose levels using the mySentry device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Non-invasive continuous glucose monitoring does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, non-invasive continuous glucose monitoring is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective March 2015 – April 2016
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Brief (3 to 7 days) continuous intermittent monitoring of glucose in interstitial fluid meets primary coverage criteria for effectiveness for:
    1. Patients with type I diabetes whose diabetes is poorly controlled (poorly controlled diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, uncontrolled hyperglycemia) despite current use of best practices (patients compliant with a regimen including 4 or more fingersticks each day); OR
    2. Patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels; OR
    3. Patients with type I diabetes who are pregnant and in whom appropriate diet, exercise, fingerstick monitoring 4 times a day and 3 or more insulin injections or insulin pump use does not control episodes of hypoglycemia or hyperglycemia. Coverage of pregnant women with type 1 diabetes is restricted to no more than 4 episodes (episode = 3 to 7 days) from the 8th to the 32nd weeks of gestation, and must be accompanied by intense review of the data and recommendations of care from the physician/dietician/diabetes specialist nurse.
 
Continuous monitoring of glucose in interstitial fluid, as a continuous monitoring technique to allow patients to self-manage their diabetes, meets primary coverage criteria for:
    • Patients with type I diabetes who have recurrent, unexplained, severe (generally blood glucose levels less than 50 mg/dL) hypoglycemia for whom hypoglycemia puts the patient or others at risk; OR
    • Patients with type I diabetes who are pregnant whose diabetes is poorly controlled ( poor control includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis);
 
Provided the following criteria are met:
1. Patients who use an FDA approved CGM device specified as appropriate for age; AND
2. Patients who utilize an insulin pump, AND
3. There is verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Continuous glucose monitoring of interstitial fluid glucose (as contrasted with intermittent glucose monitoring of interstitial fluid glucose up to 7 days) does not meet primary coverage criteria of effectiveness:
  • For pregnant members with type 2 diabetes mellitus, as only intermittent glucose monitoring of interstitial fluid glucose has been shown to be effective in improving fetal outcome.
  • Other uses of continuous monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring are considered investigational.
 
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
  
 
Remote monitoring of glucose levels using the mySentry device does not meet member benefit certificate primary coverage criteria because there is a lack of scientific evidence that the use of this device improves health outcomes. For members with contracts without primary coverage criteria, remote monitoring of glucose levels using the mySentry device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective December 2014 – January 2015
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Brief (3 to 7 days) continuous intermittent monitoring of glucose in interstitial fluid meets primary coverage criteria for effectiveness for:
    1. Patients with type I diabetes whose diabetes is poorly controlled (poorly controlled diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, uncontrolled hyperglycemia) despite current use of best practices (patients compliant with a regimen including 4 or more fingersticks each day); OR
    2. Patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels; OR
    3. Patients with type I diabetes who are pregnant and in whom appropriate diet, exercise, fingerstick monitoring 4 times a day and 3 or more insulin injections or insulin pump use does not control episodes of hypoglycemia or hyperglycemia. Coverage of pregnant women with type 1 diabetes is restricted to no more than 4 episodes (episode = 3 to 7 days) from the 8th to the 32nd weeks of gestation, and must be accompanied by intense review of the data and recommendations of care from the physician/dietician/diabetes specialist nurse.
 
Continuous monitoring of glucose in interstitial fluid, as a continuous monitoring technique to allow patients to self-manage their diabetes, meets primary coverage criteria for:
 
    • Patients with type I diabetes who have recurrent, unexplained, severe (generally blood glucose levels less than 50 mg/dL) hypoglycemia for whom hypoglycemia puts the patient or others at risk; OR
    • Patients with type I diabetes who are pregnant whose diabetes is poorly controlled ( poor control includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis);
 
Provided the following criteria are met:
 
1. Patients who use an FDA approved CGM device specified as appropriate for age;  AND
 
2. Patients who utilize an insulin pump, AND
 
3. There is verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Continuous glucose monitoring of interstitial fluid glucose (as contrasted with intermittent glucose monitoring of interstitial fluid glucose up to 7 days) does not meet primary coverage criteria of effectiveness for pregnant members with type 2 diabetes mellitus, as only intermittent glucose monitoring of interstitial fluid glucose has been shown to be effective in improving fetal outcome. For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
The use of an artificial pancreas system, including but not limited to closed-loop monitoring devices with low-glucose suspend (LGS) features do not meet member benefit certificate primary coverage criteria as there is a lack of scientific evidence of effectiveness for the use of this device. For members with contracts without primary coverage criteria, the use of an artificial pancreas system is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Remote monitoring of glucose levels using the mySentry device does not meet member benefit certificate primary coverage criteria because there is a lack of scientific evidence that the use of this device improves health outcomes. For members with contracts without primary coverage criteria, remote monitoring of glucose levels using the mySentry device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective May 2013 – November 2014
 
Meets Primary Coverage Criteria
 
Brief (3 to 7 days) continuous intermittent monitoring of glucose in interstitial fluid meets primary coverage criteria for effectiveness for:
      1. Patients with type I diabetes whose diabetes is poorly controlled (poorly controlled diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, uncontrolled hyperglycemia) despite current use of best practices (patients compliant with a regimen including 4 or more fingersticks each day).
      2. Patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels; and
      3. Patients with type I diabetes who are pregnant and in whom appropriate diet, exercise, fingerstick monitoring 4 times a day and 3 or more insulin injections or insulin pump use does not control episodes of hypoglycemia or hyperglycemia.  Coverage of pregnant women with type 1 diabetes is restricted to no more than 4 episodes (episode = 3 to 7 days) from the 8th to the 32nd weeks of gestation, and must be accompanied by intense review of the data and recommendations of care from the physician/dietician/diabetes specialist nurse.   
 
Continuous monitoring of glucose in interstitial fluid, as a continuous monitoring technique to allow patients to self-manage their diabetes, meets primary coverage criteria for patients 25 years of age or greater with type I diabetes who have been unable to achieve good control (i.e., glycated hemoglobin less than 7.0 %, correction of asymptomatic nocturnal hypoglycemia or uncontrolled postprandial hyperglycemia) despite appropriate diet, exercise, fingerstick monitoring 4 times a day, and 3 or more insulin injections or use of an insulin pump.
 
Note: Continuous glucose monitoring of interstitial fluid glucose whether delivered by intermittent continuous glucose monitoring or by continuous monitoring to allow physician and patient self-regulation is covered only when there is verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Continuous glucose monitoring using any continuous monitoring device does not meet primary coverage criteria for infants or children up to the age of 8 years, as there is lack of evidence of effectiveness in this age group. For members in this age group without primary coverage criteria, continuous glucose monitoring using any continuous monitoring device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Continuous glucose monitoring as a method of patient or physician regulation of their diabetes using any continuous monitoring device does not meet member benefit certificate primary coverage criteria for members ages 8 through 24, as the only evidence-based study to date concludes, “Further work is needed to identify and address the lack of effectiveness of continuous glucose monitoring in children and adolescents.”  Member certificate of benefit Primary Coverage Criteria excludes coverage of services for which randomized controlled trials have shown a lack of effectiveness. For members in this age group with contracts without primary coverage criteria, use of continuous glucose monitoring as a method of patient self-regulation of their diabetes is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Continuous glucose monitoring of interstitial fluid glucose (as contrasted with intermittent glucose monitoring of interstitial fluid glucose up to 7 days) does not meet primary coverage criteria of effectiveness for pregnant members with type 2 diabetes mellitus, as only intermittent glucose monitoring of interstitial fluid glucose has been shown to be effective in improving fetal outcome. For members with contracts without primary coverage criteria, this use is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
The use of an artificial pancreas system, including but not limited to closed-loop monitoring devices with low-glucose suspend (LGS) features do not meet member benefit certificate primary coverage criteria as there is a lack of scientific evidence of effectiveness for the use of this device. For members with contracts without primary coverage criteria, the use of an artificial pancreas system is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Remote monitoring of glucose levels using the mySentry device does not meet member benefit certificate primary coverage criteria because there is a lack of scientific evidence that the use of this device improves health outcomes. For members with contracts without primary coverage criteria, remote monitoring of glucose levels using the mySentry device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective April 2013 to May 2013
Brief (3 to 7 days) continuous intermittent monitoring of glucose in interstitial fluid meets primary coverage criteria for effectiveness for:
    1. Patients with type I diabetes whose diabetes is poorly controlled (poorly controlled diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, uncontrolled hyperglycemia) despite current use of best practices (patients compliant with a regimen including 4 or more fingersticks each day).
    2. Patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels; and
    3. Patients with type I diabetes who are pregnant and in whom appropriate diet, exercise, fingerstick monitoring 4 times a day and 3 or more insulin injections or insulin pump use does not control episodes of hypoglycemia or hyperglycemia.  Coverage of pregnant women with type 1 diabetes is restricted to no more than 4 episodes (episode = 3 to 7 days) from the 8th to the 32nd weeks of gestation, and must be accompanied by intense review of the data and recommendations of care from the physician/dietician/diabetes specialist nurse.  
 
Continuous monitoring of glucose in interstitial fluid, as a continuous monitoring technique to allow patients to self-manage their diabetes, meets primary coverage criteria for patients 25 years of age or greater with type I diabetes who have been unable to achieve good control (i.e., glycated hemoglobin less than 7.0 %, correction of asymptomatic nocturnal hypoglycemia or uncontrolled postprandial hyperglycemia) despite appropriate diet, exercise, fingerstick monitoring 4 times a day, and 3 or more insulin injections or use of an insulin pump.
 
Continuous glucose monitoring using any continuous monitoring device does not meet primary coverage criteria for infants or children up to the age of 8 years, as there is lack of evidence of effectiveness in this age group. For members in this age group without primary coverage criteria, continuous glucose monitoring using any continuous monitoring device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Continuous glucose monitoring as a method of patient or physician regulation of their diabetes using any continuous monitoring device is not covered for members ages 8 through 24, as the only evidence-based study to date concludes, “Further work is needed to identify and address the lack of effectiveness of continuous glucose monitoring in children and adolescents.”  Member certificate of benefit Primary Coverage Criteria excludes coverage of services for which randomized controlled trials have shown a lack of effectiveness. For members in this age group with contracts without primary coverage criteria, use of continuous glucose monitoring as a method of patient self-regulation of their diabetes is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Continuous glucose monitoring of interstitial fluid glucose (as contrasted with intermittent glucose monitoring of interstitial fluid glucose up to 7 days) does not meet primary coverage criteria of effectiveness for pregnant members with type 2 diabetes mellitus, as only intermittent glucose monitoring of interstitial fluid glucose has been shown to be effective in improving fetal outcome. For members with contracts without primary coverage criteria, this use is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Continuous glucose monitoring of interstitial fluid glucose whether delivered by intermittent continuous glucose monitoring or by continuous monitoring to allow physician and patient self-regulation is covered only when there is verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus.
 
The use of an artificial pancreas system, including but not limited to closed-loop monitoring devices with low-glucose suspend (LGS) features do not meet member benefit certificate primary coverage criteria as there is a lack of scientific evidence of effectiveness for the use of this device. For members with contracts without primary coverage criteria, the use of an artificial pancreas system is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to April 2013
Prior to 1 November 2008, short-term continuous glucose monitoring as a diagnostic technique and long-term glucose monitoring as a technique of patient self-management were not covered because of lack of scientific evidence of effectiveness.
 
Beginning November 2008, brief (3 to 7 days) continuous intermittent monitoring of glucose in interstitial fluid meets primary coverage criteria for effectiveness and is covered for
    1. Patients with type I diabetes whose diabetes is poorly controlled (poorly controlled diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, uncontrolled hyperglycemia) despite current use of best practices (patients compliant with a regimen including 4 or more fingersticks each day).
    2. Patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels; and
    3. Patients with type I diabetes who are pregnant and in whom appropriate diet, exercise, fingerstick monitoring 4 times a day and 3 or more insulin injections or insulin pump use does not control episodes of hypoglycemia or hyperglycemia.  Coverage of pregnant women with type 1 diabetes is restricted to no more than 4 episodes (episode = 3 to 7 days) from the 8th to the 32nd weeks of gestation, and must be accompanied by intense review of the data and recommendations of care from the physician/dietician/diabetes specialist nurse.  
 
Beginning November 2008, continuous monitoring of glucose in interstitial fluid, as a continuous monitoring technique to allow patients to self-manage their diabetes, is covered for patients 25 years of age or greater with type I diabetes who have been unable to achieve good control (i.e., glycated hemoglobin less than 7.0 %, correction of asymptomatic nocturnal hypoglycemia or uncontrolled postprandial hyperglycemia) despite appropriate diet, exercise, fingerstick monitoring 4 times a day, and 3 or more insulin injections or use of an insulin pump.
 
Continuous glucose monitoring using any continuous monitoring device is not covered for infants or children up to the age of 8 years, as there is lack of evidence of effectiveness in this age group, and therefore this use does not meet member benefit certificate Primary Coverage Criteria.
 
Continuous glucose monitoring as a method of patient or physician regulation of their diabetes using any continuous monitoring device is not covered for children, adolescents, or adults ages 8 through 24, as the only evidence-based study to date concludes, “Further work is needed to identify and address the lack of effectiveness of continuous glucose monitoring in children and adolescents.”  Member certificate of benefit Primary Coverage Criteria excludes coverage of services for which randomized controlled trials have shown a lack of effectiveness. (For members in the 8 to 24 age range whose contracts do not include Primary Coverage Criteria, use of continuous glucose monitoring as a method of patient self-regulation of their diabetes is considered investigational, as one of the contract definitions of investigational is that further study is needed to determine effectiveness or safety.
 
Continuous glucose monitoring of interstitial fluid glucose (as contrasted with intermittent glucose monitoring of interstitial fluid glucose up to 7 days) is not covered for pregnant members with type 2 diabetes mellitus, as only intermittent glucose monitoring of interstitial fluid glucose has been shown to be effective in improving fetal outcome.
 
Continuous glucose monitoring of interstitial fluid glucose whether delivered by intermittent continuous glucose monitoring or by continuous monitoring to allow physician and patient self-regulation is covered only when there is verification of the suitability of the patient for use of this device by a board eligible/certified endocrinologist or by a physician with verified supplemental training beyond standard residence training in the treatment of patients with diabetes mellitus.

Rationale:
This policy was initiated in May 2001 following FDA approval of a continuous glucose monitoring device.  Data presented to the FDA advisory committee meeting consisted of studies validating the correlation between the measurements of glucose in interstitial fluid with the blood glucose measurements made with home monitoring devices. (CGMS: FDA Summary of Safety and Effectiveness: GlucoWatch G2 Biographer; FDA Summary of Safety and Effectiveness: Tamada 1999)   The panel found that the overall trends in glucose levels detected by frequent measurements produced potentially clinically important information.  However, there were no clinical data presented regarding improvements in hemoglobin A1c  measurements or a decreasing incidence of hypoglycemic episodes in those whose antidiabetic medications were managed based on more frequent readings of interstitial fluid glucose. However, members of the advisory panel felt that more frequent measurements should extrapolate to improved diabetic management. For example, prior studies have shown that hemoglobin A1c levels are lowest among patients who have the highest frequency of daily blood glucose measurements (Evans, 1999).  Nevertheless, the use of trends of daily glucose levels implies a different type of diabetic management compared to traditional methods of serial fingerstick glucose methods. The following clinical applications were suggested by the FDA advisory panels:
    • Hypoglycemic episodes can be identified more readily by the use of an alarm in the GlucoWatch device. This may be particularly helpful in patients with hypoglycemic unawareness or overnight hypoglycemia. In addition, patients with adequate glucose control, as measured by hemoglobin A1c (HbA1c), may undergo monitoring to ensure that this control does not come at the expense of unrecognized hypoglycemia.
    • Unsuspected postprandial hyperglycemia may be detected, which contributes to elevated HbA1c concentrations in patients whose HbA1c levels are considered adequate.  Postprandial hyperglycemia has been related to increased cardiovascular risks.  Both fast-acting insulin (insulin lispro) and fast-acting oral hypoglycemics (i.e., repaglinide) may be particularly effective in treating postprandial hyperglycemia.
    • The devices may be used periodically to confirm the status of current antidiabetic therapy. Currently, some patients may perform 7–9 fingersticks a day on a periodic basis to confirm the success of the diabetic management.
    • Patients may use the devices in specific circumstances when the normal routine is upset, i.e., changes in work shifts or while traveling.
    • The devices may be used to monitor changes in insulin therapy, i.e., the initiation of an insulin pump.
    • The device may be used as an educational tool to more easily illustrate how glucose levels vary with activities and meal choices.
    • Quality of life may be improved by decreasing the number of fingersticks.
 
Results of 4 randomized trials have been reported. The largest of them, enrolling 128 adult patients with type 1 diabetes randomized to insulin therapy adjustments using data from either the CGMS or self-monitoring of blood glucose (SMBG) using a home blood glucose monitor over a 12-week period (Tanenberg, 2004).  At 12 weeks, HbA1c levels and hyperglycemic event frequency and duration did not differ with any statistical significance in the treatment groups. However, at 12 weeks, events of hypoglycemia (glucose < or = 60 mg/dL) were found to be significantly shorter in the CGMS group than in the SMBG group (49.4 +/- 40.8 vs. 81.0 +/- 61.1 minutes per event, p = .009). The authors concluded that durations of hypoglycemia could be further reduced by adjusting insulin therapy with data from the CGMS rather than using SMBG data alone.   Among the 109 patients completing the 3-month trial (there was a 15% dropout rate), there was no statistically significant difference in HbA1c levels.  Mean HbA1c levels in both the control and study group declined from 9% at baseline to 8.3% at 3 months. In another randomized study of 75 patients, there was no statistical difference in HbA1c levels after the 3-month intervention (Chico, 2003).  The clinical significance of these test results has not been established, i.e., there is insufficient evidence showing the link between increased duration of asymptomatic hypoglycemia and subsequent clinical outcomes.
 
2006-2007 Update
Additional studies continue to evaluate continuous glucose monitoring systems.  Lagarde and colleagues (2006) found a slight improvement in HbA1c levels using CGMS compared to controls in children with type 1 diabetes.  However, the difference did not reach statistical significance (p = 0.13).  In a European study using a cross-over design, Deiss and colleagues reported that CGMS did not decisively influence glycemic control of the total study cohort of children and adolescents with type 1 diabetes.  They suggested that more frequent use of CGMS at shorter intervals may be of greater value (Deiss[a], 2006). A 2007 recent review raised questions about the accuracy of these systems (Med Letter, 2007).  
 
Garg (2006) reported that in 91 patients with diabetes (75 were type 1) real-time continuous glucose monitoring was able to reduce glycemic excursions by reducing hyperglycemia without increasing the risk of hypoglycemia.  They also indicated that this type of monitoring may reduce long-term complications of diabetes.  Recently, Deiss reported on a 3-month study of 81 children and 81 adults with stable type 1 diabetes who had HbA1c levels of 8.1% or greater (Deiss[b], 2006).  Patients were randomized to continuous real-time monitoring, continuous monitoring for 3 days every 2 weeks, or self-monitoring of blood glucose. At 3 months, 50% of patients with continuous real-time monitoring had a decrease in HbA1c of at least 1% compared to 37% of those with intermittent continuous monitoring, and 15 % of controls. These results suggest that continuous glucose monitoring may have potential for improving control in patients with diabetes:  however, as the authors note, additional work is needed to determine long-term efficacy, clinical feasibility in patients with varying levels of glycemic control, and effect on rates of hypoglycemia.
 
April 2008 Update
The policy was updated with a literature review using MEDLINE from January 2007 through February 2008.  No publications were identified that present results from randomized trials that show an impact of long-term continuous glucose monitoring on relevant patient outcomes.  Recent publications continue to report results on case series and often do not clearly link to patient outcomes.
 
Guillod reported on a retrospective study that described findings from a group of 88 patients with type I diabetes that underwent a CGMS exam (Guillod, 2007).  The prevalence of nocturnal hypoglycemia (NH) was 67% (32% of them unsuspected).  A measured hypoglycemia at bedtime (22–24 hr) had a sensitivity of 37% to detect NH, while a single measure 4 mmol/l or less at 03-hour had a sensitivity of 43%.  In this study, nocturnal hypoglycemic measurements were not associated with morning hyperglycemia but with morning hypoglycemia.  After 6–9 months, suspicions of nocturnal hypoglycemia decreased from 60% to 14% (p<0.001). The authors concluded that NH was highly prevalent and often undetected. Self-monitoring blood glucose at bedtime, which detected hypoglycemia, had sensitivity almost equal to that of 03-hour and should be preferred because it is easier to perform. Tubiana-Rufi reported on an uncontrolled study of 182 patients (children and adults) with poorly controlled type I diabetes (Tubiana-Rufi, 2007).  Using the Guardian RT system, which the authors indicated required 3 calibrations a day, resulted in improvement in HbA1c levels over 3 months.  The DirecNet Study Group reported results of another non-comparative study of 30 patients with type I diabetes that used an insulin pump with the FreeStyle Navigator CGM system for 13 weeks (Buckingham, 2007).  During this time, the mean HbA1c levels improved from 7.1% to 6.8% and the percentage of glucose values between 71 and 180 mg/dL increased from 52% to 60%.  Two patients had severe skin reactions related to the sensor mount adhesive. Wilson and colleagues, as part of the Diabetes Research in Children Network (DirecNet), evaluated the accuracy and precision of the FreeStyle Navigator CGMS in 30 children with type 1 diabetes (mean age 11.2 years) (Wilson, 2007).  The Navigator glucose values were compared with reference serum glucose values of blood samples obtained in an inpatient clinical research center and measured in a central laboratory and in an outpatient setting with a FreeStyle meter.  Median absolute difference (AD) and median relative absolute difference (RAD) were computed for sensor-reference and sensor-sensor pairs.  The median AD and RAD were 17 mg/dL and 12%, respectively, for 1,811 inpatient sensor-reference pairs, and 20 mg/dL and 14%, respectively, for 8,639 outpatient pairs. The median RAD between two simultaneous Navigator measurements (n = 1,971) was 13%. Ninety-one percent of sensors in the inpatient setting and 81% of sensors in the outpatient setting had a median RAD of 20% or less.  The authors concluded that the Navigator's accuracy does not yet approach the accuracy of current-generation home glucose meters, but it is sufficient to believe that the device has the potential to be an important adjunct to treatment of youth with type 1 diabetes.
 
Several authors note that these results provide a compelling rationale for conducting a randomized controlled trial (RCT) of use of continuous glucose monitoring in type 1 diabetes. Recent advances in technology now allow linkage between the CGM device and an insulin pump.  Wolpert (2008) discussed the skills needed for diabetes management using real-time monitoring and commented specifically on the role of calibration as well as understanding the lag between capillary and interstitial glucose levels.
 
October 2008 Update
A recent systematic review of randomized studies identified 7 studies with 335 patients that fulfilled their inclusion criteria (Chetty, 2008).  Study duration varied from 12 to 24 weeks.  This review concluded that compared with self-monitoring, CGMS was associated with a non-significant reduction in HbA1c levels and that evidence is insufficient to support the notion that CGMS provides a superior benefit over self-monitoring for HbA1c reduction. There was some indication from this review of improved detection of asymptomatic nocturnal hypoglycemia in the CGMS group.
 
The 2007 Standards of Medical Care by the American Diabetes Association (ADA) did not mention this technology in the section on assessment of glycemic control (American Diabetes Association, 2007).  Recommendations in this section are for self-monitoring of blood glucose 3 or more times daily for patient using multiple insulin injections.  The 2008 Standards of Care from the ADA include a recommendation that “CGMS may be a supplemental tool to SMBG for selected patients with type 1 diabetes, especially those with hypoglycemia unawareness” (American Diabetes Association, 2008). This recommendation is level E, based on expert consensus or clinical experience.
 
The results of the Juvenile Diabetes Research Foundation (JDRF) study that randomly assigned 322 adults and children with type I diabetes to continuous glucose monitoring or self (home) monitoring, were released in 2008 (Juvenile Diabetes Research Foundation CGM Study Group, 2008).  With HbA1c as the primary outcome measure, there was a significant difference among patients 25 years of age or older that favored continuous monitoring (mean HbA1c difference 0.53%), while the difference between groups was not statistically significant for those age 15 to 24 years or 8 to 14 years. Unlike many prior studies, this study was sufficiently large to detect a meaningful change in HbA1c levels between groups. The authors concluded, “With respect to the generalizability of the result, it is important to recognize that before the study, patients were receiving intensive insulin therapy with either an insulin pump or multiple daily injections and frequent home blood glucose monitoring, and most had better-than-average glycated hemoglobin levels.  In addition to be eligible for the study, patients needed to show the ability to wear a sensor and insert a new sensor at home.  Therefore, the results do not shed light on the use of such devices in a less well controlled, less motivated population of patients with type 1 diabetes.  Although the results in patients using multiple daily injections were similar to the results in those using an insulin pump, the number of patients using multiple daily injections was too small for a definitive assessment.  
 
“The results of our study indicate that continuous glucose monitoring improves glycated hemoglobin levels and may enhance the management of type 1 diabetes in adults who have the motivation to use this technology and the capability to incorporate it into their own daily diabetes management.  Further work is needed to identify and address the lack of effectiveness of continuous glucose monitoring in children and adolescents.”
 
Almost simultaneous with the publication of the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, a small randomized controlled trial of intermittent glucose monitoring of interstitial fluid glucose compared to standard monitoring during pregnancy was published in the British Medical Journal (Murphy, 2008).  This study evaluated intermittent continuous glucose monitoring as compared to intermittent fingerstick monitoring in both type 1 and type 2 diabetics with the primary outcome being number of singleton infants born with macrosomia, and showed a decrease in the number of infants with macrosomia when compared to the control group.  Seventy-one of 93 women had type 1 diabetes, and 25 had type 2 diabetes. The details of the study do not give specific information regarding results in type 2 diabetics, only to say that 8 of those with macrosomia were born to women with type 2 disease.  In this study, the women only used the continuous monitoring for 7 days, and this was accompanied by intense interaction with health care professionals.  Neither participants nor professionals had access to the glucose measurements during sensor use.  The women removed the sensors after 5-7 days, or earlier if they had adverse events.  Thirty-six of the women used the monitor an average of 4.2 weeks intermittently during pregnancy.  After each week, the data was then downloaded and given to the participant and the physician for review.  No reduction in hemoglobin A-1-c was seen compared to the control group until the last 6 weeks of pregnancy.  The authors stated that evidence of effectiveness on long term glycemic control or diabetes related morbidity has not to date been established, with previous studies limited to the use of blood glucose or HbA1c levels as surrogate markers of morbidity from diabetes (they had included review of the JDRF trial).  Thirty-eight women were randomized to the continuous glucose monitoring intervention and 33 to standard antenatal care. The authors stated, “a learning curve also exists for women and health professionals when using continuous glucose monitoring to optimize lifestyle and therapeutic management, which in our experience takes several consultations.  Indeed, we consistently observed that improvements in glycemic profiles were achieve gradually over pregnancy, rather than after one consultation.  This emphasizes the importance of using the data from continuous glucose monitoring as a tool to facilitate patient education and shared problem solving, and the necessity to reinforce the benefits over several visits.”   
 
In summary, the available studies demonstrate that intermittent glucose monitoring provides a different type of data than results from fingerstick glucose levels. In addition to providing more data points, it also provides information about trends (direction) in glucose levels. This additional information is most likely to benefit those patients with type I diabetes that do not have adequate control, including episodes of hypoglycemia, despite use of current best practices including multiple (4 or more) daily checks of blood glucose and use of an insulin pump. Thus, based on the available data, intermittent, i.e., 3 to 7 day, continuous glucose monitoring of interstitial fluid is covered for members with type 1 diabetes mellitus age 25 and above those whose diabetes is poorly controlled despite use of best practices.
 
The data supporting use of continuous (long-term) glucose monitoring are still limited, but the recent information from the JDRF randomized trial provides more evidence-based support for the use of continuous monitoring of interstitial fluid glucose to improve physician and self-management of diabetics who have recurrent, unexplained, severe symptomatic hypoglycemia, despite use of current best practices, that puts the patient or others at risk.
 
The data on continuous monitoring for women who are diabetic comes from a single trial which looked at both type 1 and type 2 diabetes to determine if continuous intermittent monitoring for up to 7 days for an average of 4 periods between 8 and 32 week’s gestation.  The number of type 2 patients was too small, and there was no description of the outcomes in the type 2 patients as a single group.  The risk of macrosomia was significantly reduced in the trial group for type 1 diabetics.
 
Data to support use (that show improved outcomes) of devices that allow wireless connectivity between a continuous monitoring device and insulin pump are still lacking.
 
2011 Update
The investigators from the Juvenile Diabetes Research Foundation (JDRF) Study group conducted a non-blinded single-arm 6-month extension to the randomized trial discussed in the 2008 Update of this policy (JDRF Study Group, 2008) in which patients in the control group were offered a CGM device (JDRF Study Group, 2010).  A total of 214 of 219 (98%) in the control group participated in the extension. This included 80 (37%) who were at least 25 years old, 73 (34%) who were 15-24 years old and 61 (29%) who were 8-14 years old. The mean HbAIC level at the time of initiation of CGM use was 7.4 +/- 0.7%. Patients were instructed to use the device on a daily basis. Among the 154 patients with baseline A1C at least 7%, there was a significant decrease in A1C 6 months after initiating device use in the older age group (mean change in A1C= -0.4% +/- 0.5%, p<0.001). A1C did not decrease significantly in the 15-24 year olds (0.01 +/- 0.7%, p=0.95) or the 8-14 year olds (0.02 +/- 0.7%, p=0.85). Greater decrease in HbA1C was associated with more frequent use of the CGM device (p=0.001, adjusted for age group). Frequency of device used tended to decrease over time, with less of a decrease in the older age group. At month 6, median use of CGM devices was 6.5 days per week among the older age group, 3.3 days among the 15-24 year olds and 3.7 days per week among the children. During the 6-month extension, the rate of severe hypoglycemic events was 15 per 100 person-years of follow-up.
 
An additional randomized trial by the Juvenile Diabetes Research Foundation, published in 2009, studied the potential benefits of continuous glucose monitoring (CGM) in the management of adults and children with well-controlled type 1 diabetes (JDRF Study Group, 2009). In this study, 129 adults and children with intensively treated type 1 diabetes (age range 8-69 years) and HbA1c <7.0% were randomly assigned to either continuous or standard glucose monitoring for 26 weeks. The main study outcomes were time with glucose level at or below 70 mg/dL, HbA1c level, and severe hypoglycemic events. At 26 weeks, biochemical hypoglycemia (at or below 70 mg/dL) was less frequent in the CGM group than in the control group (median 54 vs. 91 min/day), but the difference was not statistically significant (P = 0.16). Time out of range (70 or less or greater than 180 mg/dL) was significantly lower in the CGM group than in the control group (377 vs. 491 min/day, p=0.003). There was a significant treatment group difference favoring the CGM group in mean HbA1c at 26 weeks adjusted for baseline values. One or more severe hypoglycemic events occurred in 10 and 11% of the 2 groups, respectively (p not significant). The authors concluded that the weight of evidence suggests that CGM is beneficial for individuals with type 1 diabetes who have already achieved excellent control with HbA1c <7.0%. This is a relatively small study. In addition, the clinical significance of some of these findings is not certain. Some of the patients in this group would likely meet policy statements for use of CGM.
 
The MITRE trial, published by Newman and colleagues in 2009, was conducted to evaluate whether the additional information provided by use of minimally invasive glucose monitors resulted in improved glucose control in patients with poorly controlled insulin-requiring diabetes (Newman, 2009). This was a 4-arm randomized, controlled trial conducted at secondary care diabetes clinics in 4 hospitals in England. In this study, 404 people aged over 18 years with insulin-treated diabetes mellitus (types 1 or 2) for at least 6 months, who were receiving 2 or more injections of insulin daily, were eligible. The majority of participants, 57%, had type 1 diabetes, 41% had type 2 diabetes and 2% were classified as ‘other’. Participants had 2 HbA1c values of at least 7.5% in the 15 months prior to entry and were randomized to one of four groups. Two groups received minimally invasive glucose monitoring devices (GlucoWatch Biographer or MiniMed Continuous Glucose Monitoring System); the CGMS was performed over several days at various points in the study. These groups were compared with an attention control group (standard treatment with nurse feedback sessions at the same frequency as those in the device groups) and a standard control group (reflecting common practice in the clinical management of diabetes). Change in HbA1c from baseline to 3, 6, 12, and 18 months was the primary indicator of short- to long-term efficacy in this study. At 18 months, all groups demonstrated a decline in HbA1c levels from baseline. Mean percentage changes in HbA1c were -1.4 for the GlucoWatch group, -4.2 for the CGMS group, -5.1 for the attention control group and -4.9 for the standard care control group. In the intent-to-treat analysis, no significant differences were found between any of the groups at any of the assessment times. There was no evidence that the additional information provided by the devices resulted in any change in the number or nature of treatment recommendations offered by the nurses. Use and acceptability indicated a decline in use of both devices, which was most marked in the GlucoWatch group by 18 months (20% still using GlucoWatch versus 57% still using the CGMS). In this study of unselected patients, use of continuous glucose monitors (CGMS on an intermittent basis) did not lead to improved clinical outcomes.
 
A substantial proportion of patients in the MITRE trial, discussed above, had insulin-dependent type 2 diabetes; this trial did not find a significant additional benefit when CGM devices were used. Several randomized trials are underway that are specifically evaluating continuous glucose monitoring for people with type 2 diabetes. A randomized trial sponsored by the Walter Reed Medical Center is comparing continuous glucose monitoring to episodic self-blood glucose monitoring in adult patients with type 2 diabetes who have A1C levels between 7% and 12% (NCT00529815). The intervention period is 12 weeks and patients will be followed for a year As of February 24, 2010, the study is ongoing but not recruiting participants. Another ongoing study, currently recruiting participants, is sponsored by the Park Nicollet Institute (NCT01237301). The study is including adult patients with type 2 diabetes who have an HbA1c of at least 7%. Patients are being randomized to unblinded use of a continuous glucose monitoring device or to self-monitoring of blood glucose with fingersticks 4 to 7 times a day. The intervention period is 16 weeks.
 
Continuous glucose monitoring systems integrated with an insulin pump
Recent advances in technology now allow linkage between the CGM device and an insulin pump. In 2007, Halvorson reported on an uncontrolled pilot trail of 10 children with type 1 diabetes. The small size and lack of control group limit the ability to draw any conclusions from this study (Halvorson, 2007). In a randomized study of 132 adults and children from France reported in 2009, Raccah and colleagues reported improved HbA1c levels (change in A1c of 0.96% vs. 0.55%) in patients who were fully protocol compliant for use of an insulin pump integrated with CGMS compared to those using a pump with standard glucose self monitoring (Raccah, 2009). This study is limited by its small sample size and also by lack of comparison to intermittent use of CGMS.
 
The SWITCH Study (Sensing with Insulin pump Therapy to Control HbA1c) is underway (NCT00598663). This is a multicenter randomized cross-over study sponsored by Medtronic. The study is evaluating insulin pump treatment with and without continuous glucose monitoring in patients with type 1 diabetes who are suboptimally controlled with pump therapy alone. The study description on clinicaltrials.gov was last updated on September 17, 2010. The final data collection date for the primary outcome was stated to be July 2010; study results have not yet been posted.
 
The American Diabetes Association (ADA) makes the following recommendations concerning continuous glucose monitoring (CGM) in its 2011 standards of medical care in diabetes.  
 
• Continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens can be a useful tool to lower A1c in selected adults (age at least 25 years) with type 1 diabetes. (Level of evidence A)
 
• Although the evidence of A1c lowering is less strong in children, teens, and younger adults, CGM may be helpful in those groups. Success correlates with adherence to ongoing use of the device. (Level of evidence C)
 
• CGM may be a supplemental tool to SMBG [self-monitoring of blood glucose] in those with hypoglycemic unawareness and/or frequent hypoglycemic episodes. (Level of evidence E)
 
The findings of the literature search for this update do not prompt a change in the coverage statement.
 
Nov 2011 Update
A medical literature search has failed to identify high-level evidence that intermittent continuous glucose monitoring improves health outcomes for type II diabetics who require insulin.
 
2013 Update
A literature search was conducted using the MEDLINE database through February 2013. Most recently under development is an artificial pancreas or artificial pancreas device system (APDS). Artificial pancreas systems, as currently in development, consist of a series of devices including a CGM, insulin pump and blood glucose device, controlled by a computer algorithm to automatically monitor glucose levels and adjust insulin doses. As of February 2013, there are no FDA-approved artificial pancreas devices.
 
One published study has used a CGM device integrated with Paradigm® VEO™ insulin pump and evaluated a feature to suspend insulin delivery when glucose levels fall below a pre-specified threshold, known as a “low glucose suspend (LGS)” feature. The study, called the “Automation to Simulate Pancreatic Insulin Response” (ASPIRE) was published in 2012 by Garg and colleagues (Garg, 2012). It was a randomized, crossover trial that included 50 patients with type 1 diabetes who had at least 3 months experience with an insulin pump system. After a 2-week run-in period to verify and optimize basal rates, patients underwent 2 in-clinic exercise sessions to induce hypoglycemia. The LGS feature on the insulin pump was turned on in one session and off in the other session, in random order. When on, the LGS feature was set to suspend insulin delivery for 2 hours when levels reached 70 mg/dL or less. The goal of the study was to evaluate whether the severity and duration of hypoglycemia was reduced when the LGS feature was used. The study protocol called for patients to start exercise with a glucose level of 100-140 mg/dL, and to use a treadmill or stationary bicycle until their plasma glucose level was 85 mg/dL or less. The study outcome, duration of hypoglycemia, was defined as the period of time glucose values were lower than 70 mg/dL and above 50 mg/dL and hypoglycema severity was defined as the lowest observed glucose value. A successful session was defined as an observation period of 3-4 hours and with glucose levels above 50 mg/dL. Patients who did not attain success could repeat the experiment up to 3 times.
 
The 50 patients attempted 134 exercise sessions; 98 of these were successful. Duration of hypoglycemia was significantly less during the LGS-on sessions (mean: 138.5 minutes, SD: 68 minutes) than the LGS- off sessions (mean: 170.7 minutes, SD:91): p=0.006. Hypoglycemia severity was significantly lower in the LGS-on group. The mean lowest glucose level was 59.5 mg/dL (SD: 72) in the LGS-on group and 57.6 mg/dL (SD: 5.7) in the LGS-off group, p=0.015. The Garg study evaluated the LGS feature in a research setting and over a short time period. Another arm of the ASPIRE study evaluating the LGS feature in the outpatient setting over 5 months is underway (see section below on ongoing clinical trials).
 
A second RCT evaluating a low-glucose suspend device was performed by the Diabetes Wireless Artificial Pancreas Consortium, using the MD-Logic Artificial Pancreas System (Philip, 2013). The study included 56 type I diabetics who were attending a diabetes camp, were 10-18 years old, and had used an insulin pump for at least 3 months. The study was done over two consecutive nights, during which each patient received an artificial pancreas one night and a continuous glucose monitor the other night, in random order. The primary endpoints were the number of hypoglycemic episodes (defined as glucose <63mg/dl for at least 10 minutes), the total time that glucose levels were <60mg/dl, and the mean overnight glucose levels.
 
There were fewer episodes of hypoglycemia recorded in the artificial pancreas group compared to the CGM group (7 versus 22, p=0.003). The median time that patients had a Hgb <60 was 0 minutes in both groups, but the time was significantly less in the artificial pancreas group (p=0.02). There was no significant difference in the mean glucose level in the artificial pancreas group compared to the CGM group (126.4mg/dl versus 140.4mg/dl).
 
mySentry Remote Monitoring Device
A remote monitoring device designed to be used with the Paradigm REAL-Time Revel insulin pump was approved in December 2011.  This device is designed to allow monitoring of someone’s glucose levels by a second party in another room up to 50 feet away or greater. Information is transmitted wirelessly from the insulin pump to a remote monitor by radiofrequency transmission. The manufacturer’s website cautions that electrical interference or interception is possible. Additionally, the website instructs that the remote monitoring system is not to be used for making therapy adjustments. Specifically stating, “All therapy adjustments should be based on measurements obtained using a blood glucose meter and not based on the value displayed by the monitor or Paradigm REAL-Time Revel insulin pump” (Medtronic, 2013).
 
There were no prospective studies identified assessing the clinical outcomes of the mySentry remote monitoring system.  Therefore, there is a lack of scientific evidence that the use of remote monitoring of glucose values with the mySentry device improves health outcomes in patients with diabetes mellitus.
  
Ongoing Clinical Trials
Outpatient Study to  Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature (ASPIRE) (NCT01497938):  This study is the in-home arm of the ASPIRE study evaluating the Paradigm Low Glucose Suspend (LGS) System; the in-clinic arm is described above (18). The study is including 260 patients age 16 to 70 with type 1 diabetes. Patients will be randomized to a treatment arm that uses the Paradigm® VEO™ Pump and the LGS feature on or a control arm that uses a Paradigm® VEO™ Pump without the LGS feature. Patients will use the devices continuously for 5 months. The main objective of the study is to evaluate whether home use of the LGS feature is safe i.e., not associated with glycemic deterioration. The primary study outcome is a comparison between groups in change in HbA1C from baseline to the end of the 5-month period. The estimated date of study completion is June 2013.
 
Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (REACT3) (NCT01237301): This study is including adult patients with type 2 diabetes who have an HbA1c of at least 7%. Patients are being randomized to unblinded use of a CGM device or to self-monitoring of blood glucose with fingersticks 4 to 7 times a day. The expected date of study completion is November 2013. The study is ongoing but is no longer recruiting participants; total sample size is estimated at 136.
 
Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control (CGM-Teens) (NCT00945659):  This RCT is comparing continuous glucose monitoring, CGM plus behavioral therapy, and standard care in adolescents between the ages of 11 and 16 who have had type 1 diabetes for at least 2 years and who are not achieving targeted HbA1c levels (>7.5%). The primary outcome is change in HbA1c levels. The expected date of study completion is November 2013. The study is currently recruiting participants; estimated total enrollment is 150 patients.
 
2014 Update
 
This policy is being updated with a search of the MEDLINE database and clinicaltrials.gov through April 2014. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Continuous glucose monitoring systems
 
Type 1 diabetes
Most recently, a 2013 systematic review by Poolsup et al included RCTs that compared CGM with SMBG, had interventions lasting at last 8 weeks, and reported HbA1c as an outcome (Poolsup, 2013). For type 1 diabetes, only studies in children were included. Ten RCTs including pediatric patients with type 1 diabetes met inclusion criteria and were included in a meta-analysis. Overall, the investigators did not find that CGM had a significantly greater impact on HbA1c than SMBG. The pooled estimate of the difference in HbA1c between groups was -0.13% (95% CI, -0.38% to 0.11%). In a subgroup analysis by approach to CGM, devices that provided data retrospectively (retrospective CGM) did not result in better glucose control than SMBG (5 studies; pooled mean difference, -0.05%; 95% CI, 0.46% to 0.35%). However, real-time CGM was superior to SMBG in terms of improving glycemic control (5 studies; pooled mean difference, 0.18%; 95% CI, 0.35% to 0.02%).
 
Type 2 diabetes
There was no new literature identified assessing the use of continuous glucose monitoring systems in patients with type 2 diabetes.
 
Pregnant women with diabetes
In 2013, Voormolen et al published a systematic review of the literature on CGM during pregnancy (Voormolen, 2013). The authors identified 11 relevant studies (ie, published in peer-review journals and evaluating the utility of CGM in pregnancy). Two of the studies were RCTs. The 11 studies included a total of 534 women; the largest study was an RCT that had 154 participants. Seven of the studies used retrospective CGM, and the remaining 4 studies used real-time CGM. The authors did not pool study findings; they concluded that evidence is limited on the efficacy of CGM during pregnancy. The 2 published RCTs are described next:
 
In 2008, Murphy et al in the U.K. randomized 71 pregnant women with type 1 (n=46) or type 2 (n=25) diabetes to CGM or usual care (Murphy, 2008). The intervention consisted of up to 7 days of CGM at intervals of 4 to 6 weeks between 8 and 32 weeks’ gestation. In addition to CGM, the women were advised to measure blood glucose levels at least 7 times a day. Baseline HbA1c was 7.2% (SD=0.9) in the CGM group and 7.4% (SD=1.5) in the usual care group. The primary study outcome was maternal glycemic control during the second and third trimesters. Mean HbA1c levels were consistently lower in the intervention arm, but differences between groups were not statistically significant at any time point. For example, between 28 and 32 weeks’ gestation, mean HbA1c levels were 6.1% (SD=0.60) in the CGM group and 6.4% (SD=0.8) in the usual care group (p=0.10). The prevalence of large-for-gestational age infants (at least 90th percentile) was a secondary outcome. Thirteen of 37 (35%) infants in the CGM group were large-for-gestational age compared with 18 of 30 (60%) in the usual care group. The odds ratio for reduced risk of a large-for-gestational age infant with CGM was 0.36 (95% CI, 0.13 to 0.98; p=0.05).
 
Artificial pancreas device systems, including low glucose suspend technology
In 2013, an industry-sponsored trial using the Medtronic Paradigm Veo pump was published (Bergenstal, 2013). A total of 247 patients were randomly assigned to an experimental group, in which the low glucose suspend feature was used (n=121), or a control group that did not use the LGS feature (n=126). Key eligibility criteria were 16 to 70 years old, type 1 diabetes, and an HbA1c level between 5.8% and 10.0%. In addition, patients needed to have at least 2 nocturnal hypoglycemic events (≤65 mg/dL) lasting more than 20 minutes during a 2-week run-in phase. The randomized intervention phase lasted 3 months. Patients in the low glucose suspend group were required to use the feature at least between 10 pm and 8 am. The threshold value was initially set at 70 mg/dL and could be adusted to a value between 70 to 90 mg/dl. The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemia events during the intervention phase and the primary safety outcome was change in HbA1c. Seven patients withdrew early from the study; all 247 were included in the ITT analysis.
 
Mean HbA1c changed from 7.26 to 7.24 in the low glucose suspend group and from 7.21 to 7.14 in the control group. Change was minimal and there was not a statistically significant difference between groups. The AUC for nocturnal events was 980 (SD=1200) in the low glucose suspend group and 1568 (SD=1995) in the control group. The difference between groups was statistically significant, p<0.001, favoring the intervention group. As cited in the TEC Assessment, among secondary outcomes, the LGS group also experienced fewer hypoglycemic episodes, 1 per week than the control group (3.3±2.0 vs 4.7±2.7; p<0.001), and the percentage of 2 sensor glucose values at or below 50 mg/dL was 57.1% lower in the LGS group 3 (0.9% vs 1.9%, respectively; p<0.01). For patients in the LGS group, the mean number of times the feature was triggered per patient was 2.08 per day, for a median of 1.42 minutes (mean, 25.5 minutes), and 0.77 times per night. Insulin infusion was suspended for the whole 2 hours in only 19.6% of episodes.
 
Also in 2013, Nimri et al published a randomized crossover trial that included 12 patients at least 10 years-old who had type 1diabetes and had used an insulin pump for at least 3 months (Nimri, 2013). The study was conducted in the inpatient setting over 2 consecutive nights. The artificial pancreas was used 1night and an insulin pump was used the other night, in random order. The primary end point, number of hypoglycemic episodes defined as glucose less than 63 mg/dL for at least 10 minutes, did not differ significantly between groups (p=0.18). There were no events in the artificial pancreas group and 3 in the insulin pump group. A secondary outcome was the percentage of time spent in the target range, ie, a glucose level between 80 and 120 mg/dL. Time in the target range was significantly higher when the artificial pancreas device was used than when the insulin pump alone was used (p=0.002). The percentage of time in the target range was 94% (95% CI, 86 to 100) when the artificial pancreas device was used and 74% when it was not used (95% CI, 42 to 96).
 
Ongoing Clinical Trials
A search of online site ClinicalTrials.gov on February 10, 2014, identified a number of open-label randomized crossover trials evaluating artificial pancreas device systems. This includes the following trials:
 
The Performance of an Artificial Pancreas at Home in People With Type 1 Diabetes (NCT02040571) (Melbourne, 2014): This randomized crossover study includes patients age 14 and older with type 1 diabetes. There will be a 1-night in-hospital phase and a 5-night in-home phase. A closed-loop artificial pancreas device will be compared with an open-loop insulin pump system. A Medtronic artificial pancreas device will be used. The study is currently recruiting patients; estimated enrollment is 24 patients. The expected date of study completion is January 2015.
 
Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home (NCT01726829) (www.clinicaltrials.gov, 2014): This randomized crossover trial that is evaluating blood glucose control overnight with MD-Logic Artificial Pancreas system in patients with type 1 diabetes. The intervention consists of 4 consecutive nights using the artificial pancreas device and 4 nights using regular pump therapy, with a 10-day washout period between arms. The study is currently recruiting patients; estimated enrollment is 75 patients. An interim analysis of this ongoing study was published in 2013.(26)
 
Practice Guidelines and Position Statements
In 2013, the American Diabetes Association made the following recommendations concerning continuous glucose monitoring (American Diabetes Association, 2013):
 
  • CGM in conjunction with intensive insulin regimens can be a useful tool to lower A1c in selected adults (age at least 25 years) with type 1 diabetes. (Level of evidence A)
  • Although the evidence of A1c lowering is less strong in children, teens, and younger adults, CGM may be helpful in those groups. Success correlates with adherence to ongoing use of the device. (Level of evidence C)
  • CGM may be a supplemental tool to SMBG [self-monitoring of blood glucose] in those with hypoglycemic unawareness and/or frequent hypoglycemic episodes. (Level of evidence E)
 
Addendum 2014 Update
An additional review of the policy and literature search was conducted through November 2014. One prospective study and two systematic reviews were assessed (Rachmiel, 2014; Health Quality Ontario; 2011; Langendam, 2012). The policy statement has been changed to remove age restrictions and add additional criteria.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
One trial of real-time CGM in pregnant women with type 1 diabetes has been reported. Feig et al reported results of 2 multicenter RCTs in women ages 18 to 40 with type 1 diabetes who were receiving intensive insulin therapy and who were either pregnant (≤13 weeks and 6 days of gestation) or planning a pregnancy (Feig, 2017). The trial enrolling pregnant women is reviewed here. Women were eligible if they had a singleton pregnancy and HbA1c levels between 6.5% and 10.0%. The trial was conducted at 31 hospitals in North America and Europe. Women were randomized to CGM (Guardian REAL-Time or MiniMed Minilink system) plus capillary glucose monitoring or capillary glucose monitoring alone. Women in the CGM group were instructed to use the devices daily. Women in the control group continued their usual method of capillary glucose monitoring. The target glucose range was 3.5 to 7.8 mmol/L and target HbA1c levels were 6.5% or less in both groups. The primary outcome was the difference in change in HbA1c levels from randomization to 34 weeks of gestation. The proportion of completed scheduled study visits was high in both groups; however, participants using CGM had more unscheduled contacts, which were attributed both to sensor issues and to sensor-related diabetes management issues. The median frequency of CGM use was 6.1 days per week (interquartile range, 4.0-6.8) and 70% of pregnant participants used CGM for more than 75% of the time. The between-group difference in the change in HbA1c levels from baseline to 34 weeks of gestation was statistically significant favoring CGM (MD = -0.19%; 95% CI, -0.34 to -0.03; p=0.02). Women in the CGM group spent an increased percentage of time in the recommended glucose control target range at 34 weeks of gestation (68% vs 61%, p=0.003). There were no between-group differences in maternal hypoglycemia, gestational weight gain, or total daily insulin dose. A smaller proportion of infants of mothers in the CGM group were large-for-gestational age (odds ratio [OR], 0.51; 95% CI, 0.28 to 0.90; p=0.02). In addition, for infants of mothers in the CGM group, there were fewer neonatal intensive care admissions lasting more than 24 hours (OR=0.48; 95% CI, 0.26 to 0.86; p=0.02), fewer incidences of neonatal hypoglycemia requiring treatment with intravenous dextrose (OR=0.45, 0.22 to 0.89; p=0.025), and reduced total length of hospital stay (3.1 days vs 4.0 days; p=0.0091). Skin reactions occurred in 49 (48%) of 103 CGM participants and 8 (8%) of 104 control participants.
 
 
The largest RCT, Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIAMOND), was reported by Beck et al (Beck, 2017). DIAMOND was performed at 25 endocrinology practices in North America (22 in the United States, 3 in Canada) and enrolled adults with type 2 diabetes receiving multiple daily injections of insulin. One-hundred fifty-eight patients were randomized into 2 groups, CGM and usual care (n=79 in each group). Patients compliant during a run-in period were eligible for randomization.
 
Patients in both groups were given a blood glucose meter. Participants in the CGM group were given a Dexcom G4 Platinum CGM System (Dexcom) and instructions on use. Change in HbA1c level from baseline to 24 weeks was the primary outcome. Analyses were adjusted for baseline HbA1c levels and clinic were performed using intention-to-treat analysis with missing data handling by multiple imputation. At baseline, the mean total daily insulin dose was 1.1 U/kg/d. Week 24 follow-up was completed by 97% of the CGM group and 95% of the control group. Mean CGM use was greater than 6 d/wk at 1 month, 3 months, and 6 months. 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=0.022) 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=0.028) favoring CGM. There were no events of severe hypoglycemia or diabetic ketoacidosis in either group. The treatment groups did not differ in any of the quality of life measures.   

CPT/HCPCS:
0446TCreation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training
0447TRemoval of implantable interstitial glucose sensor from subcutaneous pocket via incision
0448TRemoval of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation
95249Ambulatory 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
95250Ambulatory 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
95251Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; analysis, interpretation and report
99091Collection and interpretation of physiologic data (eg, 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
A9276Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply
A9277Transmitter; external, for use with interstitial continuous glucose monitoring system
A9278Receiver (monitor); external, for use with interstitial continuous glucose monitoring system
K0553Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 Unit Of Service
K0554Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system
S1030Continuous noninvasive glucose monitoring device, purchase (for physician interpretation of data, use CPT code)
S1031Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use CPT code)

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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